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1. Products for Microbiological Control

6. Microbiological Enumeration 6 Intro Microbial Enumeration is the quantitative determination of microorganisms present in a sample. To assure the quality of a manufacturing process, raw materials, in-process samples, as well as final products, are subject to microbiological testing. These samples are examined for microbial colony and | or particle counts to ensure product safety and compliance. Whether it is about testing the sterility of a final product or evaluating the microbial contamination of water, it is essential to be able to rely on the quality of results test after test. At the same time, it is important to be able to comply with the ever increasing and demanding requirements of international and national regulations. The potential health impact of pathogens or other contaminations in water, beverages or pharmaceutical products makes the absolute reliability of the test results indispensable. With public safety in mind, Membrane Filtration is still the established method of choice for the detection and quantification of microorganisms in liquid samples. The principle of this method is based on the concentration of microorganisms from relatively large samples on the surface of the membrane filter, and on subsequently culturing these captured microbes on a nutrient medium. Benefit from Sartorius’ long-standing expertise in Microbiological Quality Control and choose from a wide range of dedicated products for Microbial Limit testing and more. The comprehensive range of Membrane Filters, Filtration Units, Filtration Systems and Culture Media will help you reach the highest levels of safety with reproducible, reliable results for in-process and final release testing – while streamlining your workflow and simplifying your testing procedures. Find out more about our filtration equipment, membrane filters and smart consumables which offer: – Full compliance with regulations – Total Ease of Use – Systematic risk mitigation – Highest Level of Safety and Efficiency

28. Microbiological Enumeration 28 Filtration Units

18. Microbiological Enumeration 18 Culture Media

40. Microbiological Enumeration 40 Filtration Equipment

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85. Mycoplasma Contamination Control 85 Intro 87 Microsart ® AMP Mycoplasma 90 Microsart ® ATMP Mycoplasma 92 Microsart ® RESEARCH Mycoplasma 94 Microsart ® AMP Extraction 95 Microsart ® Coating Buffer 96 Microsart ® Validation Standard 97 Microsart ® Calibration Reagent Mycoplasma Contamination Control Table of Contents

67. Sterility Testing 67 Intro Intro 69 Sterisart NF – Sterility Test Consumables 74 Sterisart Universal Pumps 76 Sterisart BD Media and Fluids 78 EXPAND Training 79 EXTEND Instrument Services 83 CONFIDENCE ® Validation Services Sterility Testing Table of Contents

68. Sterility Testing 68 Intro Sterility Testing is the analysis for sterility of defined pharmaceutical products which must be sterile accord- ing to international pharmacopeia. This test directly ex- amines the final product in the given container, whether it might be filled in a syringe, bottle, vial or bag. There is also no exception on the physical form the pharmaceuti- cal products may have. Liquids or powders, ointments or oils, creams and solid forms, suspensions and emulsions, they all have to be tested for microbial contamination. The potential impact that pathogens could have on human or animal health, underlines the importance of the “Sterility Test”. Almost any kind of microorganism, assume given the chance, can become pathogenous and do severe physical harm to living organisms. Injection of micro organisms directly into the bloodstream enables the infection and colonization of tissues which are usually considered as being sterile. The principle of the test for sterility is based upon the “membrane filtration method”, which initially enables the concentration of microorganism from a variety of sample volumes, by simultaneously washing out growth inhibiting substances. After 14 days of cultivation in defined media the sample has to be analyzed visually for turbidity: No turbidity means no contamination! Parenterals, opthalmics and surgical devices have to follow the same stringent microbiological controls. They benefit from Sartorius’ long-standing expertise in manufacturing a wide range of dedicated products, especially designed for use in cleanrooms. The compre- hensive range of consumables with dedicated adapters, ensure reliable results and “make your lab life easier”. Find more about our Sterility Test solution, which fully complies to international pharmacopeia and our extensive service package: – More than 20 different sterility test consumables available – Dedicated cleanroom pumps for use in Isolator or Clean bench – EXPAND ® Training – EXTEND Instrument Services – CONFIDENCE ® Validation Services

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86. Mycoplasma Contamination Control 86 Intro Mycoplasma are among the world’s smallest bacteria capable of independent reproduction. They belong to the class of Mollicutes and have a very slow and parasitic growth. They cause many infections in animals and plants. Mycoplasma are very difficult to control as they lack the bacterial cell wall, which is the main point of attack for many antibiotics. For this reason, a complete retention with conventional cell structure sterile filters (0.2 μm pore size) is not possible. The risk is that the Mycoplasma with a cell size between 0.5 and 0.8 μm could pass through the pores due to their great flexibili- ty and capacity for deformation. Without causing any visible changes in the culture a Mycoplasma contamina- tion can reach high numbers, with no effect on viability and thus may go undetected. This means, the earlier you detect Mycoplasma contamination, the higher your long-term savings. Early detection means more time to react, saving you valuable time and considerable expense. The detection of Mycoplasma with conventional methods is labour-intensive and requires a cultivation time of at least 28 days before a contamination with these slow-growing bacteria can be ruled out with certainty. Real-time PCR based kits offer a fast and easy-to-use solution for early detection at all stages of your process, whether you are screening in the lab or testing in your production line. Sartorius offers the Microsart ® AMP Mycoplasma, Microsart ® ATMP Mycoplasma and Microsart ® RESEARCH Mycoplasma detection kits for your different needs and levels of security.

99. Air Monitoring Intro 99 101 Gelatine Membrane Filters (GMF) 102 BACTair™ 103 MD8 airscan ® 105 AirPort MD8 106 Accessories 110 EXTEND Instrument Services Air Monitoring Table of Contents

52. Microbiological Enumeration 52 Filtration Equipment Accessories and Replacement Parts Description Qty. Order No. Rubber vacuum hose (1 m) 1 16623 Vacuum tubing with Quick Connection, silicone, 20 cm 1 1ZA---0006 Vacuum tubing with Quick Connection, silicone, 1 m 1 1ZAS--0016 Silicone tubing, pressure-sided, 1 m 1 1ZAS--0007 Silicone tubing, pressure-sided, 10 m 1 1ZAS--0020 Silicone tubing, pressure-sided, 2 m 1 1ZAS--0019

54. Microbiological Enumeration 54 Filtration Equipment Replacement Parts for Traditional Individual Filter Holders Replacement Parts for Traditional Manifolds

5. Microbiological Enumeration Intro 5 Membrane Filters 7 Gridded Cellulose Nitrate Membrane Filters (Cellulose Mixed Ester) 12 Microsart ® e.motion Membrane Filters 13 Microsart ® e.motion Dispenser 14 Ungridded Cellulose Nitrate and Cellulose Acetate Membrane Filters 16 Hydrophobic Edged Membrane Filters Culture Media 19 Microsart ® @media 21 Nutrient Pad Sets 26 Culture Media in Bottles and Tubes Filtration Units 29 Biosart ® 100 Monitors 32 Biosart ® 100 Nutrient Media 33 Microsart ® Funnel 100 | Microsart ® Funnel 250 35 Microsart ® @filter 100 | Microsart ® @filter 250 38 Biosart ® 250 Funnels Filtration Equipment 41 Combisart ® – The Sterile-Vented Filter Station 47 Microsart ® Combi.jet 49 How to Setup a Vacuum Filtration System 49 Traditional Multi-Branch Manifolds and Individual Filter Holders 52 Accessories for Vacuum Filter Holders and Manifold Systems 58 Electric Vacuum Pumps Microbiological Enumeration Table of Contents

80. Sterility Testing 80 EXTEND Instrument Services Preventive Maintenance Sterisart Pump The objective of preventive maintenance is a continuous, precise operation of your equipment, to secure your investments for the long term and to guarantee correct and proper function. Preventive maintenance will be performed in accordance with Sartorius’ fixed stand- ards and in between the contractually stipulated time intervals between the customer and Sartorius. Specifications − Inspection visit at fixed intervals or as needed − Visual inspection − Maintenance check according to maintenance checklist − Check of flow rate capacity and uniform performance − Start-up test Prerequisites Required by the Customer − System is standing at the maintenance location − Unobstructed access to the system − When ordering, a responsible person has to be appointed − Access by automobile is possible | parking lot is available Repairs, spare parts as well as shipping costs, travel costs and expenses are not covered in scope of services and will be invoiced separately.

100. Air Monitoring 100 Intro Active Air Monitoring is the quantitative determination of microbes present in a given environment. To assure the quality of a manufacturing process, a valid method that eliminates adverse effects on the test area is mandatory. Microbes are a potential threat of contamination for (final) products and raw materials, therefore potentially endangering the health of humans and animals. Sampling of air with active devices is a commonly used method for evaluation of particles, microorganisms and even viruses and bacteriophages. Whether its about testing the environment in most critical areas such as Isolators, filling lines and class B rooms, or evaluation of microbiological contamination in laboratories and warehouses, it’s essential to be able to rely on the quality of the results. Active sampling of a defined volume of air in a defined time can be performed with two physically different methods: Filtration with Gelatine Membrane Filters (GMF) or Impaction on agarplates with BACTair™. Sartorius offers both solutions, depending on your application. Quantitative and qualitative results can be obtained by use of defined growth media. Find out more about our Air Sampling solution and our extensive service package: – Unique Gelatine Membrane Filter (GMF) for sampling of microorganisms, viruses and bacteriophages – Portable, battery powered AirPort MD8 – BACTAir™ Media plates for direct sampling and incubation – EXTEND Instrument Services

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45. Microbiological Enumeration 45 Filtration Equipment Accessories and Replacement Parts for the Combisart ® System Description Qty. Order No. Minisart ® SRP25, sterile filter for venting, 0.2 μm, individually sterile-packaged, could be autoclaved 5 times 50 17575--------ACK Plug luer lock, to close the Minisart ® inlet, if sterile venting is not required 12 17012----------E Plug, conical, to close the venting hole beside the 3-way-valve, if sterile venting is not required 10 6980225 Silicone O-ring for single base 16840 male thread (also 1ZU---0002) 3 6980274 Silicone O-ring for manifold female threads 3 6980235 Silicone flat gasket underneath the frit (16840) 1 6980124 PTFE flat gasket underneath the frit (16840) 1 6980104 Stainless-steel frit, 50 mm diameter (16840) 1 6980102 Stainless-steel frit, 47 mm diameter (16840) 1 6980103 Quick Connection Nipple, stainless-steel 1 1EAS--0026 Hose nipple, stainless-steel, DN 10 1 6980272 Stainless-steel frit for Microsart ® Base 47 mm (1ZU---0002) 1 1ZU---0001 Rubber vacuum hose (1 m) 1 16623 Tubing with Coupling Quick Con., PSU 1 1ZA---0006 Vacuum hose with Quick Con., silicone, 1 m 1 1ZAS--0016 Silicone tubing, pressure-sided, 1 m 1 1ZAS--0007 Silicone tubing, pressure-sided, 10 m 1 1ZAS--0020 Silicone tubing, pressure-sided, 2 m 1 1ZAS--0019

113. Chemical Compatibility Intro 113 114 Filter Materials 116 Filter Holder | O-ring Materials Chemical Compatibility Table of Contents

118. 118 Index Index Absorbent Pads 26 Accessories for vacuum filter holders and manifold systems 56 Airborne bacteria and viruses 106 Air Monitoring 99 AirPort MD8 79 , 105 , 106 , 111 Air Sampler 102 , 103 , 104 , 105 Aluminum stack 107 BACTair™ 102 Biosart ® 100 Monitor 29 , 30 , 31 , 46 Biosart ® 100 Nutrient media 32 Biosart ® 250 Funnel 38 , 39 Calibration Unit 56 , 57 Case for MD8 airscan ® 107 Cellulose acetate 7 , 14 , 16 Cellulose Nitrate (Cellulose Ester) 5 , 7 , 8 , 10 , 14 , 65 Chemical Compatibility 113 Colony Counter 64 Combisart ® multi-branch systems 41 CONFIDENCE ® Validation Services 81 , 83 Container for anaerobic incubation 65 Culture media 21 , 26 , 32 , 102 Dispenser 13 , 27 Dosing syringe 63 EXPAND ® Training 78 EXTEND Instrument Services 79 , 80 , 110 , 111 Filter dispenser 13 Filter holders and manifolds 41 Filter holders, individual 53 Gelatine membrane filters 101 Gridded membrane filters, type 111 15 Gridded membrane filters, type 113 15 Gridded membrane filters, type 114 9 , 11 Gridded membrane filters, type 130 9 , 11 Gridded membrane filters, type 131 17 Gridded membrane filters, type 135 17 Gridded membrane filters, type 138 9 , 11 Gridded membrane filters, type 139 9 , 11 Hand-operated vacuum pump with gauge 63 High-flow membranes 7 , 29 Hydrophobic edged membrane filters 16 Laboratory pump 62 Manifolds, multi-branch 53 MD8 airscan ® 101 , 103 , 104 , 105 , 106 , 107 , 108 MD8 Calibration Unit 56 , 57 MD8 devices 106 , 107 , 108 , 109 Media 21 Microsart ® @filter 100 and 250 35 Microsart ® @vance ® 35 Microbiological Enumeration 5 Microsart ® AMP Extraction 94 Microsart ® AMP Mycoplasma 87 , 88 , 89 Microsart ® ATMP Mycoplasma 90 Microsart ® Calibration Reagent 2 , 85 , 97 Microsart ® Coating Buffer 2 , 85 , 95 Microsart ® Combi.jet 47 Microsart ® e.jet 51 , 60 , 61 Microsart ® e.motion Dispenser 13 Microsart ® e.motion Membrane Filters 12 , 24 Microsart ® Funnel 100 and 250 33 Microsart ® maxi.vac 58 , 59 Microsart ® @media 5 , 19 Microsart ® mini.vac 50 , 58 , 59 Microsart ® RESEARCH Mycoplasma 92 , 93 Microsart ® Validation Standard 2 , 85 , 96 Minisart ® SRP 45 , 48 Multi-branch manifolds, traditional 53 NPS 21 , 63 Nutrient media broth 32 Nutrient pad sets in petri dishes 21 Preassembled Monitors 29 Quick Connection for Tubings 48 , 61 Ready-to-use units including media 29 Rubber vacuum hose 57 Sartochem ® 70 Single-use funnels 38 Stainless-steel filter holder, 50 mm, with vacuum control 53 Stainless-steel funnels 41 , 43 Sterisart NF 69 Sterisart Universal Pump 74 , 75 Suction Flask, 2 Liter Capacity 56 Vacusart ® 50 , 56 , 57 Vacuum filtration system 49 Vacuum pump 58 Water jet pump 63 Water trap, Vacusart ® 57 Woulff’s bottle 57 Index

51. Microbiological Enumeration 51 Filtration Equipment Combisart ® 1- Branch Stainless-Steel Manifold plus Microsart ® e.jet Ordering Information Pos. Description Qty. Order No. Detailed Information on Page Combisart ® stainless-steel equipment: 41 1 Combisart ® single base, 50 mm 1 16840 2 Combisart ® 1-branch manifold 1 16844 Sterile venting of the filter station: 45 3 Minisart ® SRP25, 0.2 μm 1 17575--------ACK 4 Silicone tubing with Quick Connection Coupling, 20 cm, vacuum-sided Silicone tubing with Quick Connection Coupling, 1 m, vacuum-sided 1 1ZA---0006 1ZAS--0016 61 Vacuum Pump: 60 5 Microsart ® e.jet Transfer Pump 1 166MP-4 6 Silicone tubing, pressure-sided, 1 m Silicone tubing, pressure-sided, 2 m Silicone tubing, pressure-sided, 10 m 2* 1ZAS--0007 1ZAS--0019 1ZAS--0020 61 Additional accessories: Microsart ® e.motion Dispenser 1 16712 13 Stainless-steel tweezers 1 16625 65 Colony Counter 1 17649 64 Incubator 1 18119 64 Stainless-steel prefilter attachment 1 16807 65 Container for anaerobic incubation 1 16671 65 * required length depends on distance between vacuum source and drain

58. Microbiological Enumeration 58 Filtration Equipment Electric Vacuum Pumps Sartorius neoprene membrane pumps, operate with low noise level, are oil and maintenance free and has providing reliable sources of vacuum. The new vacuum pump series provides up to date technology for daily use in the Microbiology laboratory environment. The vacuum produced by the new pumps is controlled and can be easily adjusted to your specifications. Thus damageable cells (e.g. bacteria) are concentrated on the surface or a membrane filter under better conditions, which results in decreased sub lethals, higher recovery rates and shorter incubation times. Specifications Microsart ® maxi.vac 16694-2-50-22 16694-1-60-22 Microsart ® mini.vac 16694-2-50-06 16694-1-60-06 Delivery 22 l/min 6 l/min Ultimate Vacuum 100 mbar 100 mbar Noise level [100 mbar] 57.5–59.0 dBA 53.5 dBA Operating Pressure 1 bar 2.5 bar Materials (contact with filtrate possible) Aluminum, CR (Neoprene), NBR (Perbunan) PPS, EPDM, FPM (Fluoroelastomer) Connectors for Tube (mm) ID 9 ID 4 Ambient Temperature 5 ... 40°C 5 ... 40°C Mains 16694-2-50-22: 230 V | 50 Hz 16694-1-60-22: 115 V | 60 Hz 16694-2-50-06: 230 V | 50 Hz 16694-1-60-06: 115 V | 60 Hz Motor Protection IP 44 IP 20 Power P1 130 W 65 W Operating Current 0.9 A 0.63 A Weight 7.1 kg 1.9 kg Dimensions W|H|D (mm) 261 | 204 | 110 164 |141| 90 Recommended application All multi-branch manifolds Single filtration run up to 3-branch manifolds Microsart ® mini.vac | Microsart ® maxi.vac

76. Sterility Testing 76 Sterisart BD Media and Fluids Sterisart BD Media and Fluids Sterisart BD Media and Fluids are sterilized by autoclaving in their final primary bottles. They are used on clean benches or in clean rooms. Special packaging types are ideal for transferring media from non-sterile areas into sterile areas such as isolators. – Transparent labels allow a clear view of media and cultures – Labels resist alcohol and chlorine treatment – Color-coded caps and labeling for the nutrient media allow easy product identification – Specially developed clear FTM for much easier growth detection – Growth performance test conforms to EP and USP requirements – Extensive Certificates of Analysis showing microbial recovery of all microorganisms listed in EP and USP Multi-packaged, ETO-sterile The autoclaved filled bottles are packaged into a polypropylene box which is then sealed into a Stericlin ® bag and sterilized by ethylene oxide (ETO). This treatment pro- vides a sterile outer surface of the bottles and the packaging. The multiple-packaging allows the transfer of the bottles into clean rooms from a non-sterile area into a sterile area. – Sterile outer surface of the bottles eliminates the need for spraying down bottles before transferring them into clean rooms or isolators – Polypropylene boxes reduce shedding of particles to a minimum – Compact packaging saves working space. – Optimal for small clean room areas such as isolators due to clever waste management Individually Double-packaged, Sterile The filled bottles are packaged into two Stericlin ® bags prior to autoclaving. This unique manufacturing process results in a bottle exterior that is free from microbial contaminants. – Double-packaging ensures that the area under the cap remains sterile, therefore reducing the risk of false positive results – Sterisart BD Media and Fluids are validated at a sterility assurance level (SAL) of 10 -6 – Sterisart BD Media and Fluids comply with the requirements set forth in the International Pharmacopoeia such as EP and USP – Optimal for all clean room areas including isolators due to easy and reliable transfer into the sterile area

73. Sterility Testing 73 Sterisart NF – Sterility Test Consumables Accessories Description Application Order No. Sterisart NF gamma tubing system with two dual-needle metal spikes of different length, needles made of flamable stainless-steel Dissolving and diluting of hardly soluble powders in closed containers 16470--------GBD Needle with venting filter, 4 cm, stainless-steel, individually sterile packaged, gamma-irradiated, pack size 50 Sterile venting of containers with rinsing solution and nutrient media, additional sterile venting needles, equal to the included needles of the Sterisart NF units, i.e. type 16467, 16468 and 16477 16596--------HNK Further units on request.

81. Sterility Testing 81 CONFIDENCE ® Validation Services Validation of Sterility Testing with the Sterisart System Introduction Sterility testing is a critical step in pharmaceutical product release. It is a very exacting procedure where aseptic conditions, well-trained personnel and validated methods must be adhered to for the consistent interpretation of results. Validation of the sterility test is essential for a quality program and to meet regulatory requirements. Every precau- tion must be taken to ensure that the environment, procedures, test materials and personnel do not inadvertently contaminate routine testing while still making the detection of product contamination possible. Customized Study – An experienced technical team will select representative products for testing based on a scientifically sound bracketing approach with supporting rationale – Products are classified in groups according to their chemical and anti- microbial properties; the worst-case products are selected for testing – Validation is conducted according to routine procedures using the same testing parameters, volume of filtered product, fluid rinse cycles and testing environment – Tests are conducted by the laboratory according to USP and | or EP require- ments

23. Microbiological Enumeration 23 Culture Media NPS Type (Filter Type) 1 Determination of Order No. 2 Nutrient Pad Sets for Yeasts and Molds, individually, sterile packaged in petri dishes, 100 per box, with 100 individually, sterile packaged 47 mm membrane filters (order no. -RDN = Microsart ® e.motion Membranes) Lysine (3) Wild yeasts 14061--47------N Malt Extract (8) Yeasts and molds 14086--47----CCN Malt Extract (6) Yeasts and molds 14086--47------N Sabouraud (10) Yeasts and molds 14069--47------N Schaufus Pottinger | m green yeast and mold (4) Yeasts and molds 14070--47------N Schaufus Pottinger | m green yeast and mold (5) Yeasts and molds 14072--47------N Schaufus Pottinger | m green yeast and mold (6) Yeasts and molds 14080--47----RDN Schaufus Pottinger | m green yeast and mold (6) Yeasts and molds 14080--47------N Schaufus Pottinger | m green yeast and mold (3) Yeasts and molds 14083--47------N Schaufus Pottinger | m green yeast and mold (8) Yeasts and molds 14091--47----RDN Schaufus Pottinger | m green yeast and mold (8) Yeasts and molds 14091--47------N Wallerstein Nutrient | WL Nutrient (2) Yeasts and molds and bacteria 14089--47------N Wort (3) Yeasts and molds 14058--47----RDN Wort (3) Yeasts and molds 14058--47------N Wort (8) Yeasts and molds 14092--47----RDN

31. Microbiological Enumeration 31 Filtration Units Biosart ® 100 Monitors, 100 ml, 47 mm, Sterile, 48 Units Pore Size Membrane Filter* Color | Grid Color Order No. 0.45 μm High-Flow CN white | black 16401-47-H6-V--K 0.45 μm CN white | black 16401-47-06-V--K 0.45 μm CN gr e y | white** 16403-47-06-V--K 0.8 μm CN gr e y | white** 16403-47-04-V--K * CN = Cellulose Nitrate (Cellulose ester) RC = Regenerated Cellulose ** Grey membranes after wetting black Biosart ® 100 Monitor Adapters and Membrane Lifter Description Adaptation Order No. Biosart ® 100 Adapter, polypropylene with a silicone O-ring Biosart ® 100 Monitor onto Sartorius stainless-steel base 1ZU---0002 Microsart ® Base 47 mm (stainless-steel base for Combisart ® and Microsart ® Combi.jet) 16424 Biosart ® 100 Adapter, silicone Biosart ® 100 Monitor onto Sartorius stainless-steel frits e.g. 16840 (Combisart ® single base, 50 mm) or onto 16841 (individual base) 16414 Biosart ® 100 Membrane Lifter, ABS For easy transfer of the membrane onto agar 16417

50. Microbiological Enumeration 50 Filtration Equipment Combisart ® 1-Branch Stainless-Steel Manifold Plus Microsart ® mini.vac Ordering Information Pos. Description Qty. Order No. Detailed Information on Page Combisart ® stainless-steel equipment: 41 1 Combisart ® single base, 50 mm 1 16840 2 Combisart ® 1-branch manifold 1 16844 Sterile venting of the filter station: 45 3 Minisart ® SRP25, 0.2 μm 1 17575--------ACK 4 Rubber vacuum hose, 1 m 3* 16623 57 Suction flask and stopper: 56 5 Tube connector 1 17204 6 Silicone stopper 1 17173 7 Suction flask, 2 liters 1 16672 Water trap for pump protection: 57 8 Vacusart ® , 0.45 μm 1 17804----------M Vacuum Pump: 58 9 Microsart ® mini.vac, 230 V, 50 Hz Microsart ® mini.vac, 115 V, 60 Hz 1 16694-2-50-06 16694-1-60-06 Additional accessories: Microsart ® e.motion Dispenser 1 16712 13 Stainless-steel tweezers 1 16625 65 Colony Counter 1 17649 64 Incubator 1 18119 64 Stainless-steel prefilter attachment 1 16807 65 Container for anaerobic incubation 1 16671 65 * required length depends on distance between the filter station and the vacuum source The filter station is connected to a suction flask, which is connected to a filtrate-protected vacuum pump.

74. Sterility Testing 74 Sterisart Universal Pumps Sterisart Universal Pumps International pharmacopeias require the complete sterility of pharmaceutical prod- ucts that are injected into the blood stream or that otherwise enter the body below the skin surface. The manufacture of such products are required to supply proof of sterility of the final product batch. The Sterisart Universal Pump is available in two versions: the basic version 16419 and the upgraded version 16420 with display and user software. The pump can be used in clean rooms, integrated into clean benches, or installed countersunk in the working sur- face of isolators. Its low, compact design has a space-saving footprint – a great benefit for most clean room benchtops and isolators. Additional Features and Benefits – Enhanced safety due to the closed system without ventilation – Robust stainless-steel housing – Compact and ergonomic construction – Modular design – Pump available with special software (menu-driven prompts for operator guidance; all process sequences can be logged; barcode recognition) Special brochures available on request. Order no. SLD1003-e, SLD2010 Services IQ | OQ and maintenance service on request, see also page 83 Photo: SKAN AG, Switzerland

20. Microbiological Enumeration 20 Culture Media Ordering Information Media Type Target Microorganisms Typical Incubation Time and Temperature Order No. TSA (Tryptic Soy Agar) Total Count 48 to 72 hrs (USP) or 1 to 5 days (EP) at 30 to 35°C 14313--47----ACN SDA (Sabouraud Dextrose) Yeasts and molds 5 to 7 days at 20 to 25°C 14314--47----ACN R2A Total Count 5 to 7 days at 20 to 28°C 14322--47----ACN Accessories Description Order No. Microsart ® e.jet Transfer Pump 166MP-4 Combi.jet manifold 16848-CJ Microsart ® Base 47 mm 1ZU---0002 Silicone Pressure Tubing, pressure sided, 1 meter lengths 1ZAS--0007 Silicone tubing pressure-sided, 2 m 1ZAS--0019 Silicone tubing pressure-sided, 10 m 1ZAS--0020 Minisart ® SRP25 vent filters 17575--------ACK

39. Microbiological Enumeration 39 Filtration Units Specifications Material Polypropylene Capacity 250 ml, 50 ml graduations Filter diameter 47 mm (or 50 mm), prefilter 40 mm Filtration area 12.5 cm 2 Max. operating pressure Vacuum only Sterilization 16407--25----ALK: Ethylene oxide 16407--25----ACK: Gamma Irradiation Lot certificates Sterility and performance tests Ordering Information Biosart ® 250 Funnels, Ready to Use Filter Funnels, 250 ml, 50 Units Description Order No. Biosart ® 250 Funnel, 50 units, individually, sterile-packaged 16407--25----ACK Biosart ® 250 Funnel, 50 units, sterile-packaged 16407--25----ALK Further information available on request f.o.c. Order no. SL-3017-e

59. Microbiological Enumeration 59 Filtration Equipment Ordering Information Description Order No. Microsart ® maxi.vac for multiple filtration runs, 230 V, 50 Hz 16694-2-50-22 Microsart ® maxi.vac for multiple filtration runs, 115 V, 60 Hz 16694-1-60-22 Microsart ® mini.vac up to 3 filter stations in parallel, 230 V, 50 Hz 16694-2-50-06 Microsart ® mini.vac up to 3 filter stations in parallel, 115 V, 60 Hz 16694-1-60-06 Replacement Parts Description Order No. Replacement kit for 16694-2-50-22 and -1-60-22, set of one membrane, two valve springs and two head seals 1ED---0055 Replacement kit for 16694-2-50-06 and -1-60-06, set of one membrane, two valve springs and two head seals 1ED---0054 Sound absorber for 16694-2-50-22 and -1-60-22 1EH---0002 Sound absorber for 16694-2-50-06 and -1-60-06 1EH---0001 Fine adjustment head for 16694-2-50-22 and -1-60-22 1EV---0002 Fine adjustment head for 16694-2-50-06 and -1-60-06 1EV---0001 Fine adjustment head for 16694-2-50-06 and -1-60-06, for pressure filtration 1EV---0003

69. Sterisart NF Septum version Sterility Testing 69 Sterisart NF – Sterility Test Consumables Sterisart NF – Sterility Test Consumables Sterisart NF is a completely closed system for the sterility testing of pharmaceutical products. It is based on the membrane filter method, however it eliminates the procedure of manipulating the filters. By doing this it means the main risk of a secondary contamination and false positive results is eliminated. A peristaltic pump transfers the sample into the filtration units. After rinsing, the filtration units are filled with media and used for incubation of the filters without any contact to the environment. As different pharmaceutical products and their containers need different systems for a convenient and secure sample transfer, different versions adapted to the needs are available. Detailed information can be found in the corresponding data sheets Order no. SLD1002-e, SL-2019-e, SLD2006-e, SLD2005-e, SLD2007-e, S--2019-e, SLD2009-e, SLD2011-e and the overview brochure Order no. SLD1004-e. Sterisart NF Offers the Following Features and Benefits Unique Septum version for aseptic sampling and supplement. The sterile, medical grade septum enables and facilitates the aseptic sampling out of the canister during | after 14 days of incubation, which is required for: – dilution – rapid detection or for supplement of – additives which inactivate growth inhibiting substances – microorganism during validation (Bacteriostasis | Fungistasis test, Stasis Test) Ergonomical and safe handling – Easy to open packaging – Large color-coded clamps for optimized use with gloves – Protective shields to avoid injuries Reliable results – Sartochem ® membrane for highest retention of microbes, low adsorption and high mechanical stability – Gas-impermeable packaging for use in isolators – Product and lot information on units and additionally as barcode on packaging Flexible use – Different variants with several user friendly adapters for the most common sample containers – Septum variants for sampling during incubation At Sartorius, together with our customers, we steadily improve the features and ease of use of every product we manufacture to make your life in the lab easier. The Sterisart NF Septum version features a septum with a membrane made of latex for aseptically taking samples out of the Sterisart NF canister without risking secondary contamination. This may be applicable for different purposes, for exam- ple for the validation of pharmaceutical products (stasis test), for the supplement of additives (ß-Lactamase), or for the dilution and transfer of materials being tested that render the medium turbid USP <71>. Services Validation on request, refer also to page 83. Sterisart BD Media and Fluid refer to page 76.

110. Air Monitoring 110 EXTEND Instrument Services Preventive Maintenance AirPort MD8 | MD8 airscan ® The objective of preventive maintenance is a continuous, precise operation of your equipment, to secure your investments for the long term and to guarantee correct and proper function. Preventive maintenance will be performed in accordance with Sartorius’ fixed stand- ards and in between the contractually stipulated time intervals between the customer and Sartorius. Specifications − Inspection visit at fixed intervals or as needed − Visual inspection − Maintenance check according to maintenance checklist − Calibration of flow rate sensor − Start-up test Prerequisites Required by the Customer − Device is standing at the maintenance- location − Unobstructed access to the equipment − When ordering, a responsible person has to be appointed − Access by automobile is possible | parking lot is available Repairs, spare parts as well as shipping costs, travel costs and expenses are not covered in scope of services and will be invoiced separately. The MD8 airscan ® (16746; 16747) is not in compliance with the “Restriction of Hazardous Substances Directive (RoHS, 2011/65/EU)” and therefore its (spare part) availability is restricted for exchange and maintenance only.

24. Microbiological Enumeration 24 Culture Media NPS Type (Filter Type) 1 Determination of Order No. 2 Nutrient Pad Sets for Product-Spoiling Microorganisms, individually, sterile packaged in petri dishes, 100 per box, with 100 individually, sterile packaged 47 mm membrane filters (order no. -RDN = Microsart ® e.motion Membranes) Glucose Tryptone (2) Thermophilic spore formers and mesophilic bacteria 14066--47------N Jus de Tomate | Tomato Juice (1) Leuconostoc oenos and other wine-spoiling organ. 14079--47------N MRS (1) Lactobacilli and other soft drink-spoiling microorganisms 14077--47------N Orange Serum | pH 5.5 (1) Acid-tolerant microorganisms 14062--47----RDN Orange Serum | pH 5.5 (1) Acid-tolerant microorganisms 14062--47------N Orange Serum | pH 3.2 (6) Acid-tolerant microorganisms 14096--47----RDN Orange Serum | pH 3.2 (6) Acid-tolerant microorganisms 14096--47------N VLB-S7-S (2) Lactobacilli and Pediococci and other beer-spoiling microorganisms 14059--47------N Weman (1) Mesophilic slime-forming bacteria esp. Leu. mesenteroides 14065--47------N Nutrient Pad Sets Starter Kit, individually, sterile packaged in petri dishes, 100 per box, with 100 individually, sterile packaged 47 mm membrane filters Mixed types: Endo, Standard, Wort (1, 2, 3) E. coli and coliforms, total count, yeasts and molds 14095--47------N Special brochure available on request f.o.c. Order no. SM-4017-e. 1) The membrane filters are selected for optimum growth, together with the corresponding nutrient media. The supplied membrane filter type is listed within brackets: (1) = Green with dark-green grid, 0.45 μm pore size (2) = White with green grid, 0.45 μm pore size (3) = Grey (after wetting black) with white grid, 0.65 μm pore size (4) = White with green grid, 0.65 μm pore size (5) = White with green grid, 1.2 μm pore size (6) = Grey (after wetting black) with white grid, 0.8 μm pore size (7) = White with black grid, 0.45 μm pore size (8) = Grey (after wetting black) with white grid, 0.45 μm pore size (9) = White with green grid, 0.45 μm pore size, High-Flow (ideal for E. coli) (10) = Grey (after wetting black) with white grid, 0.45 μm pore size, High-Flow 2) Diameter of the membrane filter, 47 mm. Order number for Nutrient Pad Set with 50 mm membrane filter as above, but --47------N replaced by --50------N. Most of the NPS types are also available with Microsart ® e.motion Membrane Filters: Order number as above, but ---N replaced by -RDN. Other NPS types and NPS with Microsart ® e.motion Membrane Filters on request.

62. Microbiological Enumeration 62 Filtration Equipment Traditional Pumps Description Order No. Multiple filtration runs: 13 mbar final vacuum, 26 l/min max., 220 V, 50 Hz 16612 Multiple filtration runs: 13 mbar final vacuum, 26 l/min max., 110 V, 60 Hz 16615 Individual filtration run: 100 mbar final vacuum, 20 l/min max., 220 V, 50 Hz 16692 Individual filtration run: 100 mbar final vacuum, 20 l/min max., 110 V, 60 Hz 16695 Replacement Parts Description Order No. Set of two neoprene membranes, four valve springs and two neoprene head seals for 16612/16615 6986017 Set of one neoprene membrane, two valve springs and one neoprene head seal for 16692/16695 6986105 Rubber tubing 16623

46. Microbiological Enumeration 46 Filtration Equipment Funnels, Lids, Seals and Filter Holders to Connect on the Combisart ® System Description Capacity Membrane Filter Diameter Order No. Stainless-steel funnel with closure clamp 100 ml 47 | 50 mm 6981065 Lid, stainless-steel for 100 ml funnel 6981063 Lid seal, silicone for 100 ml funnel 6981064 Stainless-steel funnel with closure clamp 500 ml 47 | 50 mm 6981002 Lid, stainless-steel for 500 ml funnel 6981001 Lid seal, silicone for 500 ml funnel 6981003 Stainless-steel funnel with closure clamp 40 ml 47 | 50 mm 6981004 Polycarbonate filter holder, complete with filter support and funnel 250 ml 47 mm 16511 Glass filter holder, complete with filter support, funnel and metal clamp 30 ml 25 mm 16306 Glass filter holder, complete with filter support, funnel and metal clamp 250 ml 47 | 50 mm 16307 Combisart ® Adapter, to Accommodate Various Funnel Types Description Adaptation Order No. Biosart ® 100 Adapter, silicone Biosart ® 100 Monitors onto 16840 (Combisart ® single base) or onto 16841 (individual base) 16424 Biosart ® 100 Adapter, stainless-steel with silicone stopper Biosart ® 100 Monitors onto Combisart ® manifolds 16844, 16842 and 16843 16835 Glass funnel Adapter, stainless-steel with silicone stopper 16306 | 15 (glass funnel, 30 ml) onto Combisart ® manifolds 16844, 16842 and 16843 16836 Glass funnel Adapter, stainless-steel with silicone stopper 16307 (glass funnel, 250 ml) onto Combisart ® manifolds 16844, 16842 and 16843 16837

79. Sterility Testing 79 EXTEND Instrument Services Installation and Commissioning Sterisart Pump The reliability and the service life of your equipment significantly depend on its installation and configuration according to the specifications. Installation and commissioning by our service professionals will ensure that your Sterisart pump successfully operates right from the start. Sartorius Service installs and configures according to regulatory requirements and quality standards. Specifications − Check of scope of delivery − Check of device for transport damage − Manufacturer’s ID label check − Installation of system components and utilities connection − Positioning of the system at the installa- tion location (not installation in isolator*) − Initial start-up − Brief instructions to operating personnel (not application training) − General maintenance discussion * The installation in an isolator is charged on time basis. Prerequisites Required by the Customer − System is standing at the installation location − Unobstructed access to the system − Power is available at the installation location − When ordering, a responsible person has to be appointed Ordering Information Description Order No. Installation and Commissioning Sterisart Pump S8740INST

14. Microbiological Enumeration 14 Membrane Filters Sterile, individually packed filters have long become standard for routine micro biological quality control. They are pre-sterilized and ready-to-use and save preparatory time. As they are individually packed, they avoid the possibility of contaminating the remaining filters in opened packs and conform with GLP, having the filter identification and lot number printed on each individual envelope. Materials The membranes are made of even cellulose nitrate (cellulose ester – a material which assures effective retention with high-flow rates and optimal colony growth) or cellu- lose acetate (a material which combines high-flow rates and thermal stability with very low adsorption characteristics.) Applications Membrane filters for colony counting, sterility testing, particle testing and microscopy. Additional Applications 11301, a white CN membrane filter with a pore size of 8 μm is used as a prefilter in a special prefilter attachment (16807) for bacteriological analysis. It retains the coarse suspended particles, whereas it allows microorganisms to pass through. These microbes are trapped on the surface of the underlying bacteria-retentive membrane filter (e.g. 0.45 μm). 11107, a white CA membrane filter with a pore size of 0.2 μm is the filter of choice for sterile filtration, such as nutrient media, buffer and sera. This membrane is validated by the Bacteria Challenge Test. Benefits Some of the advantages you will benefit from when using this type of membrane filter: – Outstanding recovery rates for microorganisms – Defined particle retention – 0.45 μm are acc. to ISO 7704 – 0.2 μm are validated by BCT – Certified quality – Gamma-irradiated, 25 kGrey Ungridded Membrane Filters Cellulose Nitrate and Cellulose Acetate, White, Individually, Sterile Packaged

15. Microbiological Enumeration 15 Membrane Filters Specifications Design 25, 47 or 50 mm in diameter, white Growth Promotion Test acc. to ISO 7704 – No enhancement or inhibition by the sterilization process – No enhancement or inhibition due to chemical extractables Sterility test Sterile Thermal resistance CN: 130°C max. | CA: 180°C max. Thickness acc. to DIN 53105 CN: 115 –145 μm | CA: 120 μm (average value) Chemical compatibility Aqueous solutions (pH 4–8), hydrocarbons and several other organic solvents. Detailed information in section “Chemical Compatibility” under Cellulose Nitrate type 113 and Cellulose Acetate type 111 (page 113). Ordering Information Cellulose Nitrate Membrane Filters, White, for Colony Counting, Sterility Testing, Particle Count and Microscopy, Type 113, Individually, Sterile Packaged Pore Size Diameter Pack Size Order No. 0.45 μm 25 mm 100 11306--25----ACN 47 mm 100 11306--47----ACN 50 mm 100 11306--50----ACN 0.65 μm 47 mm 100 11305--47----ACN 50 mm 100 11305--50----ACN 0.8 μm 47 mm 100 11304--47----ACN 50 mm 100 11304--50----ACN 1.2 μm 47 mm 100 11303--47----ACN 50 mm 100 11303--50----ACN 3 μm 47 mm 100 11302--47----ACN 50 mm 100 11302--50----ACN 8 μm 47 mm 100 11301--47----ACN 50 mm 100 11301--50----ACN Cellulose Acetate* Membrane Filters, White, for Colony Counting, Sterility Testing, Particle Count and Microscopy, Type 111, Individually, Sterile Packaged 0.2 μm 47 mm 100 11107--47----ACN 50 mm 100 11107--50----ACN 0.45 μm 47 mm 100 11106--47----ACN 50 mm 100 11106--50----ACN * If cellulose nitrate is not compatible

71. Sterility Testing 71 Sterisart NF – Sterility Test Consumables Ordering Information Description Type of Sample Type of Sample Container Order No. Sterisart NF gamma with long dual-needle metal spike, sterile-vented LVPs Closed glass bottles with septum 16466--------GBD Sterisart NF gamma with long needle and protective plate, inclusive sterile venting needle LVPs SVPs Open containers (i.e. glass ampoules, glass bottles), collapsible bags 16467--------GBD Sterisart NF gamma with Luer or Luer Lock connection, inclusive, long needle and sterile venting needle Medical devices Tubing systems and bags with Luer or Luer Lock connectors 16468--------GBD Sterisart NF gamma with syringe-adapter and long dual-needle metal spike, sterile-vented Pre-filled syringes Syringes with and without needles 16469--------GBD Sterisart NF gamma with two dual-needle metal spikes of different length, one is sterile-vented Lyophilisates, soluble powders, liquid antibiotics Closed glass vials with septum 16475--------GBD Sterisart NF gamma with short dual-needle metal spike, sterile-vented SVPs Closed glass vials with septum 16476--------GBD Sterisart NF gamma with long needle (side opening, with solid pointed tip, non-coring), protective plate, inclusive sterile venting needle LVPs, SVPs, eye drops Closed plastic containers | vials | ampoules, plastic containers of Blow- Fill-Seal fillings 16477--------GBD Sterisart NF gamma with female Luer Lock connector NEW Medical devices Containers | bags with Luer Lock male connectors 16478--------GBD Disposable units for sterility testing in isolators, individually sterile, double-packaged, gamma irradiated, needles made of flame-sterilizable stainless - steel, 10 units. Sterisart NF gamma

72. Sterility Testing 72 Sterisart NF – Sterility Test Consumables Ordering Information Description Type of Sample Type of Sample Container Order No. Sterisart NF gamma Septum with long dual-needle metal spike, sterile-vented LVPs Closed glass bottles with septum 16466--------GSD Sterisart NF gamma Septum with long needle and protective plate, inclusive sterile venting needle LVPs SVPs Open containers (i.e. glass ampoules, glass bottles), collapsible bags 16467--------GSD Sterisart NF gamma Septum with syringe-adapter and long dual-needle metal spike, sterile-vented Pre-filled syringes Syringes with and without needles 16469--------GSD Sterisart NF gamma Septum with two dual-needle spikes of different length, one is sterile-vented Lyophilisates, Soluble powders, Liquid antibiotics Closed glass vials with septum 16475--------GSD Sterisart NF gamma Septum with short dual-needle, sterile vented SVPs Closed glass vials with septum 16476--------GSD Disposable units for sterility testing in isolators, Sterisart NF containers with integrated septum for reliable sterile sampling during incubation. Individually sterilized, double- packaged, gamma irradiated, needles made of flame-sterilizable stainless-steel, 10 units. Sterisart NF gamma Septum NEW

70. Sterility Testing 70 Sterisart NF – Sterility Test Consumables Ordering Information Description Type of Sample Type of Sample Container Order No. Sterisart NF alpha with long dual-needle metal spike, sterile-vented LVPs Closed glass bottles with septum 16466--------ACD Sterisart NF alpha with long needle and protective plate, inclusive sterile venting needle LVPs SVPs Open containers (i.e. glass ampoules, glass bottles), collapsible bags 16467--------ACD Sterisart NF alpha with Luer or Luer Lock connector, inclusive long needle and sterile venting needle Medical devices Tubing systems and bags with Luer or Luer Lock connectors 16468--------ACD Disposable units for sterility testing in clean rooms, individually, sterile packaged, ETO-sterilized, needles made of flame-sterilizable stainless-steel, 10 units Sterisart NF alpha Specifications Pore size of the Sartochem ® membrane filter 0.45 μm, retention of 10 Million Serratia marcescens per cm 2 of active filtration area Filter area 15.7 cm 2 in each Sterisart container Flow rate (for water) 500 ml/min at 1 bar (approx. 15 psi) Pore size of the air filters 0.2 μm PTFE, validated acc. to HIMA for the retention of B. diminuta Sample container capacity 120 ml (graduation marks at 50, 75 and 100 ml) Max. operating pressure 3 bar (approx. 44 psi) at 20°C Max. operating temperature 50°C Sterilization ETO (ethylene oxid gas) or gamma irradiation

12. Microbiological Enumeration 12 Membrane Filters The Microsart ® e.motion membrane filters specifically designed for use with the Microsart ® e.motion dispenser allows simple insertion and faster exchange of filter types - even without having to completely use up a complete package quantity. Each box contains 100 membrane filters individually sealed on a special pleated band and is designed for easy opening and sealing for storage. Microsart ® e.motion – reliable help in your lab. Benefits Some of the advantages you will benefit from when using the Microsart ® e.motion membrane filters: – Outstanding recovery rates for microorganisms – 0.45 μm are acc. to ISO 7704 – Multi-fit: Fits into various dispensers – Protective paper-free – Packaged on a special pleated band – Product data are printed on – High-Flow membranes available – Gamma irradiated, 25 kGrey Specifications Please refer to the membrane type: Cellulose nitrate (cellulose ester), gridded, individually, sterile packaged. See page 8 Ordering Information Order Numbers for Microsart ® e.motion Membrane Filters Diameter 47 mm or 50 mm, in Pack of 3 + 100 Membranes, Individually, Sterile Packaged, Without Protective Paper Membrane Filter Color | Grid Color Pore Size Order No. White | black 0.2 μm 11407Z-47----SCM White | black 0.2 μm 11407Z-50----SCM White | black 0.45 μm High-Flow 114H6Z-47----SCM White | black 0.45 μm High-Flow 114H6Z-50----SCM White | black 0.45 μm 11406Z-47----SCM White | black 0.45 μm 11406Z-50----SCM White | black 0.8 μm 11404Z-47----SCM White | black 1.2 μm 11403Z-47----SCM White | black 1.2 μm 11403Z-50----SCM White | black 3 μm 11402Z-47----SCM White | green 0.45 μm High-Flow 139H6Z-47----SCM White | green 0.45 μm 13906Z-47----SCM White | green 0.45 μm 13906Z-50----SCM Green | dark green 0.45 μm 13806Z-47----SCM Green | dark green 0.45 μm 13806Z-50----SCM Grey* | white 0.45 μm High-Flow 130H6Z-47----SCM Grey* | white 0.45 μm High-Flow 130H6Z-50----SCM Grey* | white 0.45 μm 13006Z-47----SCM Grey* | white 0.45 μm 13006Z-50----SCM Grey* | white 0.65 μm 13005Z-47----SCM Grey* | white 0.65 μm 13005Z-50----SCM Grey* | white 0.8 μm 13004Z-47----SCM Grey* | white 0.8 μm 13004Z-50----SCM * Grey membranes after wetting black Microsart ® e.motion Membrane Filters are also available together with Nutrient Pads (page 21). Microsart ® e.motion Membrane Filters

41. Microbiological Enumeration 41 Filtration Equipment The Sartorius Combisart ® system enables you to select the optimal hardware and consumables for your needs in microbio- logical analysis or particle count in quality assurance. Combisart ® features a modular design and field-proven standard accesso- ries to make your choice easier. Description At the heart of the Combisart ® system is a high-grade stainless-steel manifold or individual system designed to accommo- date all types of filter holders and funnels such as: – Ready-to-use units like Microsart ® Funnels 100 and 250, Microsart ® @filter 100 and 250, Biosart ® 100 Monitors and Biosart ® 250 Funnels – Flammable units such as stainless-steel funnels for colony counting – Autoclavable reusable funnels made of glass or polycarbonate The outlet of the 1- and 3-branch mani- folds are newly Quick Connection Nipples, which could be used together with Quick Connection Couplings (more information under Microsart ® Combi.jet) or as hose nipples for vacuum tubings. The low height of the manifold ports is particularly advan- tageous for working on a clean bench. For low number of samples, we recommend the use of the 1-branch manifold 16844 or the individual base 16841 on the top of a suc- tion flask. For large number of samples, we recommend the 3- or 6-branch manifolds. Sterile Venting A special feature of the Combisart ® system is the stainless-steel three-way valve (tap). This allows the vacuum for each filter holder to be individually controlled and each filter station to be sterilely vented. This rules out secondary contamination of the underside of the filter. Sterilization The system is compliant with ISO 8199 with regards to the sterilization methods of the equipment described in the “General Guide to enumeration of micro-organisms by culture”. Since the most reliable sterilization method is autoclaving, the Combisart ® design offers a unique advan- tage for this method. After inserting the membrane filters in the filter holders, you can simply unscrew them as an entire unit from each workstation and autoclave them. This method increases reliability and saves sterilization capacity. The Right Equipment for Your Application In connection with the single base 16840 (for 50 mm membranes) the manifolds are flexible to adapt disposable Biosart ® 250 or stainless-steel funnels. The stainless-steel filter support of the single base 16840 allows a homog enous distribution of the residues on the membrane filter surface. Alternatively to 16840, the Microsart ® Base 1ZU---0002 is highly recommended for all 47 mm membrane filters, Microsart ® Funnels and for Microsart ® @filter. The adapter 16424 ensures that the Biosart ® 100 Monitors are positioned perfectly, minimizing the risk of contami- nation during filtration. 3 or 6 polycarbonate holders of the type 16511 can be screwed onto the manifold directly. Glass units (16306 or 16307) can be fitted by using corresponding adapter- | stopper- combinations. Combisart ® – The Sterile-Vented Filter Station Individual and Multi-Branch Systems

83. Sterility Testing 83 CONFIDENCE ® Validation Services Conducted by Customer Following the routine procedure, one complete sterility test validation run should be performed by the customer’s operators in their routine environment. Regulatory Compliance USP <71> Sterility Tests EP 2.6.1 Biological Tests – Sterility ISO17025 certified and FDA registered Laboratory – Complies with general requirements for the competence of testing and calibration laboratories, cGMP recommendations are applied for test procedures Documentation Provided Detailed protocols and reports including rationale, test results and method transfer assessment are provided based on the health authorities’ requirements. Full traceability is given according to cGMP recommendations and internal quality systems. Assay Duration Typically five weeks after samples receipt and protocol approval, the study report for non-inhibitory products can be provided.

9. Microbiological Enumeration 9 Membrane Filters Ordering Information White Membrane with Black Grid, for Detection of Bacteria with Dyed Media, Particle Count and Microscopy, Type 114, Individually, Sterile Packaged Pore Size Diameter Pack Size Order No. 0.2 μm 47 mm 100 11407--47----ACN 47 mm 1,000 11407--47----ACR 50 mm 100 11407--50----ACN 50 mm 1,000 11407--50----ACR 0.45 μm 47 mm 100 11406--47----ACN 47 mm 1,000 11406--47----ACR 50 mm 100 11406--50----ACN 50 mm 1,000 11406--50----ACR 0.45 μm High-Flow* 47 mm 100 114H6--47----ACN 47 mm 1,000 114H6--47----ACR 50 mm 100 114H6--50----ACN 50 mm 1,000 114H6--50----ACR 0.65 μm 47 mm 100 11405--47----ACN 50 mm 100 11405--50----ACN 0.8 μm 47 mm 100 11404--47----ACN 47 mm 1,000 11404--47----ACR 50 mm 100 11404--50----ACN 1.2 μm 47 mm 100 11403--47----ACN 47 mm 1,000 11403--47----ACR 50 mm 100 11403--50----ACN 50 mm 1,000 11403--50----ACR White Membrane with Green Grid, for Detection of Bacteria with Dyed Media, Particle Count and Microscopy, Type 139, Individually, Sterile Packaged 0.45 μm 47 mm 100 13906--47----ACN 47 mm 1,000 13906--47----ACR 50 mm 100 13906--50----ACN 50 mm 1,000 13906--50----ACR 0.45 μm High-Flow* 47 mm 100 139H6--47----ACN 47 mm 1,000 139H6--47----ACR 50 mm 100 139H6--50----ACN 0.65 μm 47 mm 100 13905--47----ACN 1.2 μm 47 mm 100 13903--47----ACN Green Membrane with Dark-Green Grid, Providing Optimal Contrast to Light- Colored or Transparent Bacteria Colonies, Type 138, Individually, Sterile Packaged 0.45 μm 47 mm 100 13806--47----ACN 47 mm 1,000 13806--47----ACR 50 mm 100 13806--50----ACN 50 mm 1,000 13806--50----ACR Grey Membrane (After Wetting Black) with White Grid, for Detection of Yeasts and Molds, Particle Count and Microscopy, Type 130, Individually, Sterile Packaged 0.45 μm 47 mm 100 13006--47----ACN 47 mm 1,000 13006--47----ACR 50 mm 100 13006--50----ACN 50 mm 1,000 13006--50----ACR 0.45 μm High-Flow 47 mm 100 130H6--47----ACN 47 mm 1,000 130H6--47----ACR 50 mm 100 130H6--50----ACN 50 mm 1,000 130H6--50----ACR 0.65 μm 47 mm 100 13005--47----ACN 50 mm 100 13005--50----ACN 50 mm 1,000 13005--50----ACR 0.8 μm 47 mm 100 13004--47----ACN 47 mm 1,000 13004--47----ACR 50 mm 100 13004--50----ACN

36. Microbiological Enumeration 36 Filtration Units Specifications Materials Funnel: Polypropylene, Base: ABS (Acrylnitril-Butadien-Styrol), Membrane filter: Cellulose Nitrate (C. mixed Ester), Regenerated Cellulose; choice of various colours and pore sizes Capacity 100 ml, graduations at 20, 50 and 100 ml 250 ml, 50, 100, 200 and 250 ml graduations Filter diameter 47 mm, prefilter 40 mm (particle testing only) Filtration area 13.2 cm 2 Max. operating pressure Vacuum only Sterilization Gamma irradiation Lot certificate Recovery rate, sterility and performance test Ordering Information Microsart ® @filter 100, Sterile Disposable Filter Units with Lid, 47 mm, 100 ml, Packaged on Trays, Ideal for the Use in Clean Benches, 24 Units Pore Size Membrane Filter* Color | Grid Color Order No. 0.2 CN white | black 16D01--10-07--TG 0.45, High-Flow CN white | black 16D01--10-H6--TG 0.45, High-Flow CN grey | white** 16D03--10-H6--TG 0.45 CN green | dark green 16D02--10-06--TG 0.45 RC white (w/o grid) 16D05--10-06--TG*** 0.45 CN white | black 16D01--10--06--TG Microsart ® @filter 250, Sterile Disposable Filter Units with Lid, 47 mm, 250 ml, Packaged on Trays, Ideal for the Use in Clean Benches, 16 Units Pore Size Membrane Filter* Color | Grid Color Order No. 0.2 CN white | black 16D01--25-07--TF 0.45, High-Flow CN white | black 16D01--25-H6--TF 0.45, High-Flow CN grey | white** 16D03--25-H6--TF 0.45 CN green | dark green 16D02--25-06--TF 0.65 CN gr e y | white** 16D03--25-05--TF 0.45 CN white | black 16D01--25--06--TF

89. Mycoplasma Contamination Control 89 Microsart ® AMP Mycoplasma Ordering Information Mycoplasma Kits Description Quantity Order No. Microsart ® AMP Mycoplasma 25 tests SMB95-1001 Microsart ® AMP Mycoplasma 100 tests SMB95-1002 Accessories Microsart ® AMP Extraction 50 extractions SMB95-2003 Vivaspin 6, 100,000 MWCO 25 units VS0641 Vivaspin 20, 100,000 MWCO 12 units VS2041 Microsart ® AMP Coating Buffer 20 + 2 ml SMB95-2002

96. Mycoplasma Contamination Control 96 Microsart ® Validation Standard Microsart ® Validation Standard Microsart ® Validation Standard is used for validating robustness and sensitivity of NAT-based mycoplasma detection methods in combination with cell cultures, cell culture media components and cell culture derived biologicals according to European Pharmacopoeia (EP) 2.6.7 Mycoplasmas . The European Pharmacopoeia 2.6.7 Myco- plasmas requires validation of sensitivity and robustness with respect to sample matrix and lab precision. In addition, the method shall show a performance equal or better to the classical cultivation procedure. As most test and cell culture labs are reticent to cultivate mycoplasma , such comparison is not easy to accomplish. Microsart ® Validation Standards are not infectious, and therefore safe in use. They are titrated to 10 CFU/ml, the sensitivity limit for NAT-based methods like PCR to replace the traditional culture method. The mycoplasma used for the manufacture of Microsart ® Validation Standard are low passage reference strains cultivated in culture broth described in EP 2.6.7. The cultures are harvested in the early logarithmic phase of the growth to avoid an atypical high ratio of dead Mycoplasma particles, titrated immediately in culture broth and plated on Hayflick and Frey medium for quantification based on colony forming units (CFU). Specifications Kit Component Quantity Cap Colour Mycoplasma Acholeplasma Spiroplasma 3 × lyophilized green Negative Control 2 × lyophilized white Ordering Information Description Order No. Mycoplasma arginini SMB95-2011 Mycoplasma orale SMB95-2012 Mycoplasma gallisepticum SMB95-2013 Mycoplasma pneumonia SMB95-2014 Mycoplasma synoviae SMB95-2015 Mycoplasma fermentans SMB95-2016 Mycoplasma hyorhinis SMB95-2017 Acholeplasma laidlawii SMB95-2018 Spiroplasma citri SMB95-2019

97. Mycoplasma Contamination Control 97 Microsart ® Calibration Reagent Microsart ® Calibration Reagent Titrated genomic DNA can be used as amplification and sensitivity control of end point PCR (gel-based evaluation). For quantitative PCR-titrated genomic DNA can serve for creating standard curves by using dilutions of the material as sample in the PCR. The software of various devices will be able to calculate from qPCR data corresponding concentrations and will generate a standard curve, which can be used to determine unknown DNA concentrations. This product provides isolated genomic DNA of a specific Mycoplasma species. To obtain the microorganisms, a special liquid culture medium was inoculated with an early passage strain and harvested at the end of the logarithmic growth phase by repeated washing and centrifugation. The DNA was extracted with a classic phenol-chloroform protocol and further purified with adsorption chromatography. The concentration of the DNA was quanti- fied photometrically (OD260/280) and with an ultrasensitive fluorescent nucleic acid stain for quantitating double-stranded DNA (dsDNA) calibrated to weight refer- ence standards and controlled by qPCR (compared against exactly quantified cali- brator plasmids). The DNA concentration was adjusted with regular TE80 buffer. Specifications Kit Component Quantity Cap Colour Mycoplasma Acholeplasma Spiroplasma 1 × lyophilized green Buffer 3 white Ordering Information Description Order nr. Mycoplasma arginini SMB95-2021 Mycoplasma orale SMB95-2022 Mycoplasma gallisepticum SMB95-2023 Mycoplasma pneumonia SMB95-2024 Mycoplasma synoviae SMB95-2025 Mycoplasma fermentans SMB95-2026 Mycoplasma hyorhinis SMB95-2027 Acholeplasma laidlawii SMB95-2028 Spiroplasma citri SMB95-2029

7. Microbiological Enumeration 7 Membrane Filters Sterile and Individually Packaged for Colony Counting Sterile, individually packed filters have long become standard for routine microbi- ological quality control because of the user benefits they offer. They are pre-sterilized and ready-to-use and save preparatory time. As they are individually packed, they avoid the possibil- ity of contamination of remaining filters in opened packs and conform with GLP – with filter identification and lot number printed on each individual envelope. These membrane filters are in accordance with the following norms: ISO 7704, ISO 7899-2, ISO 8199, ISO 9308-1 and ISO 16266. In combination with Sartorius Nutrient Pads, they offer excellent growth results and are in accordance with e.g. the AFNOR (French Standards), the APHA Standard Methods, the European Brewery Commu nity, the European Drinking Water Guideline 98/83, the European Pharmaco- poeia or the United States Pharmacopoeia. The Membrane Filters Cellulose Nitrate membranes are mixed cellulose ester membranes containing cellulose nitrate and cellulose acetate, a material which assures effective retention with high-flow rates and optimal colony growth. The printed grid with a size of 3.1 + 3.1 mm makes the counting easier, especially for higher bacteria counts and for microcolonies, but does neither inhibit nor enhance the growth. The various filter colours allow the best contrast to the colonies and particles for easy and reliable quantification and identification. High-Flow Membranes The standard membrane filter for micro- biological analysis is a 0.45 μm filter. One special variant is the High-Flow mem- brane. It provides 30% higher flow rates in comparison to traditional 0.45 μm mem- branes due to the special pore structure which thus allows shorter filtration times. Especially for the detection of E. coli, High- Flow Membranes are highly recommended as they achieve the best growth promotion results. As every Sartorius 0.45 μm mem- brane filter lot, these membranes are also tested and released according to ISO 7704. Additional Membrane Filters Cellulose nitrate (cellulose ester) membrane filters, gridded, non-sterile packaged (page 10). Cellulose nitrate (cellulose ester) and cellulose acetate membrane filters, white, individually, sterile packaged (page 14). Hydrophobic edge membranes are used mainly in the sterility testing of solutions containing antibiotics (page 16). Gridded Membrane Filters Cellulose Nitrate (Cellulose Mixed Ester)

11. Microbiological Enumeration 11 Membrane Filters Ordering Information White Membrane with Black Grid, for Detection of Bacteria with Dyed Media, Particle Count and Microscopy, Type 114, Non-Sterile Pore Size Diameter Pack Size Order No. 0.2 μm 25 mm 100 11407--25------N 47 mm 100 11407--47------N 47 mm 1,000 11407--47------R 50 mm 100 11407--50------N 0.45 μm 25 mm 100 11406--25------N 47 mm 100 11406--47------N 47 mm 1,000 11406--47------R 50 mm 100 11406--50------N 50 mm 1,000 11406--50------R 0.65 μm 47 mm 100 11405--47------N 0.8 μm 25 mm 100 11404--25------N 47 mm 100 11404--47------N 50 mm 100 11404--50------N 1.2 μm 25 mm 100 11403--25------N 47 mm 100 11403--47------N 50 mm 100 11403--50------N White Membrane with Green Grid, for Detection of Bacteria with Dyed Media, Particle Count and Microscopy, Type 139, Non-Sterile 0.45 μm 47 mm 100 13906--47------N 47 mm 1,000 13906--47------R 50 mm 100 13906--50------N 50 mm 1,000 13906--50------R Green Membrane with Dark-Green Grid, Providing Optimal Contrast to Light-Colored or Transparent Bacteria Colonies, Type 138, Non-Sterile 0.45 μm 47 mm 100 13806--47------N 47 mm 1,000 13806--47------R 50 mm 100 13806--50------N 50 mm 1,000 13806--50------R Grey Membrane (After Wetting Black) with White Grid, for Detection of Yeasts and Molds, Particle Count and Microscopy, Type 130, Non-Sterile 0.45 μm 25 mm 100 13006--25------N 47 mm 100 13006--47------N 47 mm 1,000 13006--47------R 50 mm 100 13006--50------N 0.65 μm 47 mm 100 13005--47------N 50 mm 100 13005--50------N 0.8 μm 47 mm 100 13004--47------N 50 mm 100 13004--50------N

30. Microbiological Enumeration 30 Filtration Units Specifications Housing Polystyrene Membrane filter Cellulose nitrate (cellulose ester): choice of white, green or grey, with grid; Regenerated cellulose: white; membranes removable for filing Plug and adapter Polyethylene Pad Cellulose Capacity 100 ml, 10 ml graduations Pore size 0.2 μm, 0.45 μm or 0.8 μm Filter diameter 47 mm Filtration area 14.5 cm 2 Max. operating pressure Vacuum only Outlet 6.5 + 1.5 mm Lot certificates Recovery rate, sterility and specifications Ordering Information Biosart ® 100 Monitors, 100 ml, 47 mm, Individually Packaged, Sterile, 48 Units Pore Size Membrane Filter* Color | Grid Color Order No. 0.2 μm CN white | black 16401-47-07--ACK 0.45 μm CN white | black 16401-47-06--ACK 0.45 μm CN green | dark green 16402-47-06--ACK 0.45 μm CN grey | white** 16403-47-06--ACK Biosart ® 100 Monitors, 100 ml, 47 mm, Packaged on Trays, Sterile, 48 Units 0.2 μm CN white | black 16401-47-07----K 0.45 μm High-Flow CN white | black 16401-47-H6----K 0.45 μm CN white | black 16401-47-06----K 0.45 μm CN green | dark green 16402-47-06----K 0.45 μm CN gr e y | white** 16403-47-06----K 0.8 μm CN gr e y | white** 16403-47-04----K 0.45 μm RC white 16404-47-06----K

32. Microbiological Enumeration 32 Filtration Units Biosart ® 100 Nutrient Media Each box of Biosart ® 100 Nutrient Media contains 50 ampoules with sterile media, each with 2.5 ml and a lot certificate. If stored under proper conditions (+4°C), the culture media have a shelf life of 12 months (except for Endo, KF Strep, Lauryl Sulfate and Tergitol which have a 9 month shelf life). Biosart ® 100 Nutrient Media comply with international regula- tions and recommendations: International pharmacopoeias, DIN and ISO standards, the American Standards for Water and Foods, mineral water regulations, guide- lines of the food and beverage industries. Within the scope of the quality assurance procedure and the stringent quality control standards every batch has passed Sartorius in-house tests of growth promotion, sterility, physical and technical parameters have been passed successfully. Biosart ® 100 Nutrient Media are convenient in use and eliminating the handling of glass ampoules. Application Microbial enumeration. Benefits Safe and Reliable – Pre-sterilized media – Certificate of Quality for every batch – In compliance with international standards – Consistent recovery Economical – Ready-to-use – Long shelf life Ordering Information Biosart ® 100 Nutrient Media, 2.5 ml, Individually, Sterile-Packaged in Ampoules, 50 Units Media Type Determination of Order No. Caso (acc. USP) Total count 16400-02----CA-K R2A (acc. EP) Total count 16400-02----RA-K TGE | Total Count Total count 16400-02----TC-K Total Count TTC Total count 16400-02----TZ-K m Endo E. coli and coliforms 16400-02----EN-K m FC E. coli and coliforms 16400-02----MF-K Lauryl Sulfate | Teepol E. coli and coliforms 16400-02----LS-K Tergitol TTC E. coli and coliforms 16400-02----TT-K KF Strep|Azide Enterococci 16400-02----KF-K Cetrimide Pseudomonas aeruginosa 16400-02----CE-K Sabouraud (acc. USP) Yeasts and molds 16400-02----SB-K m Green yeast and mold | Schaufus Pottinger Yeasts and molds 16400-02----MG-K m Green yeast and mold selective Yeasts and molds 16400-02----GS-K Wort Yeasts and molds 16400-02----WZ-K WL Nutrient | Wallerstein Nutrient Yeasts and molds and bacteria 16400-02----WN-K WL Differential | Wallerstein Differential Bacteria in fermentation processes 16400-02----WL-K Orange Serum Acid-tolerant microorganisms 16400-02----OS-K

82. Sterility Testing 82 CONFIDENCE ® Validation Services Conducted by Confidence ® 1. Chemical compatibility between the product sample and the Sterisart system is demonstrated on all plastic parts (needles, connections, tubing and containers). In addition, the filter integrity of the Sartochem ® membrane is tested. 2. Microbial growth should not be inhibited by the sample under routine testing conditions in a controlled environment. – One series of positive control tests is performed. Six strains (Staphylococcus aureus, Bacillus atrophaeus, Pseudomonas aeruginosa, Clostridium sporogenes, Candida albicans and Aspergillus brasiliensis) in neutral solution are individually inoculated directly into the filtration unit (100 CFU per filtration unit) – One series with strains is inoculated (100 CFU per filtration unit) in the solution to be tested and filtered through the filtration unit in routine conditions – The sterility and fertility of the Thioglycollate and Soybean Casein Digest media are checked – Equivalent microbial growth must be observed in both testing series 3. Sterility test Sterility testing is performed according to routine SOP in a controlled environment. Study Design All Sterisart disposable systems are designed with a unique and reliable membrane that has high retention of microorganisms, low adsorption and high chemical | mechanical stability. Conducted by Confidence ® Validation Services Conducted by Customer Chemical compatibility between Sterisart system and Product Microbial: Growth promo- tion test (six strains), culture condition (media, duration and temperature) Final Validation test: complete sterility testing

95. Mycoplasma Contamination Control 95 Microsart ® Coating Buffer Microsart ® Coating Buffer The Microsart ® AMP Coating Buffer is an essential requirement to perform a test for mycoplasma according to European Pharmacopoeia 2.6.7 with volumes from 0.2 to 18 ml. Mycoplasma particles which might be present in the sample are concen- trated with Vivaspin 6 and 20 and Vivacell 70 prior DNA extraction as part of the sample preparation procedure. The Micro- sart ® AMP Coating Buffer is required to condition the sample matrix for use with the filtration membrane. Principle The Microsart AMP Coating Buffer contains high molecular weight components in a physiological matrix to save the particle integrity. The high molecular weight components stick to the filtration mem- brane to allow easy retention of the Mycoplasma particles after centrifugation and to avoid disruption of the mycoplasma due to surface tensions. Reagent Each kit contains 20 × 2 ml sufficient for 40 filtration (1 ml each) using Vivaspin 6 units with sample volumes from 0.2 to 5 ml or sufficient for 20 filtrations (2 ml each) using Vivaspin 20 units with sample volumes from 5 to 18 ml. Ordering Information Description Quantity Order No. Microsart ® Coating Buffer 20 × 2 ml SMB95-2002

16. Microbiological Enumeration 16 Membrane Filters Hydrophobic edge membranes are used mainly for colony counting and sterility testing of solutions containing substances with antibiotic characteristics. The hydro- phobic edge avoids the penetration of any growth-inhibitory substance into the membrane clamp zone where it could not be rinsed out and the substance could inhibit microbial growth during incubation. Materials The membranes are available in three different materials: – Cellulose nitrate (cellulose ester) – a material which assures effective reten- tion with high-flow rates and optimum colony growth – Cellulose acetate – a material which combines high-flow rates and thermal stability with very low adsorption characteristics – Regenerated cellulose – a material which combines excellent chemical resistance and thermal stability with very low adsorption characteristics Applications Membrane filters for colony counting and sterility testing Benefits Some of the advantages you will benefit from when using this type of membrane filter: – Outstanding retention rates for microorganisms – 0.45 μm are acc. to ISO 7704 – 0.2 μm are validated by BCT – Certified quality Specifications Design 25, 47 or 50 mm in diameter, white or white with black grid Growth Promotion Test acc. to ISO 7704 – No enhancement or inhibition by the grid lines – No enhancement or inhibition due to chemical extractables – No enhancement or inhibition by the sterilization process Sterility te s t Sterile Thermal resistance CN: 130°C max. | CA and RC: 180°C max. Thickness acc. to DIN 53105 CN: 115–145 μm | CA: 120 μm (average value) | RC: 160–200 μm Chemical compatibility Aqueous solutions (pH 4–8), hydrocarbons and several other organic solvents, RC is resistant to almost all solvents and is compatible in a pH-range of 3-12. Detailed information in section “Chemical Compatibility” under Cellulose Nitrate type 113, page 113, Cellulose Acetate type 111 and Regenerated Cellulose type 184. Hydrophobic Edged Membrane Filters Cellulose Nitrate (Cellulose Mixed Ester), Cellulose Acetate and Regenerated Cellulose Individually, Sterile and Non-Sterile

38. Microbiological Enumeration 38 Filtration Units Biosart ® 250 Funnels In microbiological quality control, sterility of the equipment used for processing samples is a necessary basic requirement. The reuseable funnels made of stainless- steel or other materials which are used for membrane filtration are usually sanitized between samples by flaming or with hot water. Both of these methods can be insufficiently reliable when not properly performed. Alternatively, the funnels could be sterilized by autoclaving, but this is too laborious for routine use. A disposable sterile funnel in a certified quality is the ideal solution. Description The Biosart ® 250 Funnel has been specifi- cally designed for microbiological and analytical quality assurance. Biosart ® 250 are sterile funnels which allows for fast filtration required in the routine testing of pharma ceutical and cosmetic products, water, food and beverages and other liquids. A Sartorius gridded membrane is placed on a stainless-steel filter support. A Biosart ® 250 Funnel is simply fitted on and the sample is filtered. The funnel is made of polypropylene and is sufficiently elastic for optimal sealing with a bayonet- type closure. Graduations are marked at 50, 100, 150, 200 and 250 ml for exact sample volumes. The large inner diameter ensures a high-flow rate. The conical form allows a thorough rinsing of the system subsequent to filtration. No liquid is retained in the filter funnel. Applications Microbial enumeration, particle testing and microscopy Benefits Superior Performance – High-flow rate – High total throughput Safe and Reliable – Sterile or individually, sterile packaged – No risk of cross contaminations – No leakages due to proven closure technique – No holding of hot funnels – Visibility of the complete filtration Economical – Ready to connect and easy to use – Minimal amount of equipment needed – Autoclavable (to a limited extend)

77. Sterility Testing 77 Sterisart BD Media and Fluids Nutrient Media Types FTM – Fluid Thioglycollate Medium according to USP | EP: Liquid nutrient medium for the sterility testing of biologics and for the enrichment and cultivation of anaerobes, aerobes, and microaerophiles acc. to USP and EP. In order to avoid secondary contamination, the Sterisart BD Media Type FMT is not under vacuum, but the headspace of the FTM is gassed with a stream of nitrogen to maintain anaerobiosis. Sterisart BD Media Type FTM contains a special quality of agar, resulting in a high clarity of the prepared medium. Color code: red TSB – Tryptic Soy Broth according to USP | EP: A general purpose liquid nutrient medium used in sterility testing for the detection, isolation, and cultivation of fastidious and non fastidious microorganisms acc. to USP and EP. Sterisart BD Media Type TSB is a nutritious medium that will support the growth of a wide variety of microorganisms, including common aerobic and facultatively anaero- bic bacteria and fungi. Color code: blue Rinsing and Diluting Fluids Fluid A and Fluid D according to USP Three different steps are required by the compendia depending on the condition of the sample: – Rinsing: Sterile devices or materials are rinsed in order to release adhered micro- organisms. After filtration of the sample, the Pharmacopoeia also require rinsing steps to be performed on the entire Sterisart NF unit – Diluting: Small volumes or viscous liquids are diluted for better filterability – Dissolving: Solid samples or ointments are dissolved for better filterability Fluid A (Peptone Water) Fluid A is used for diluting, dissolving and rinsing of all types of samples. Fluid D (Fluid A with 0.1% Polysorbate 80) Fluid D is peptone water with 0.1% poly- sorbate 80 (TWEEN ® 80). It is used for those samples types which contain lecithin or oil. Another application is to rinse articles and devices with bacteriostatic or fungistatic activity. Polysorbate 80 may act as an inactivator of microbicides present in or on a testing sample. The use of Sterisart BD Fluid A and Fluid D does not affect the viability of microorganisms. Both Sterisart BD Fluid Types, Fluid A and Fluid D, are according to the specifications of the United States Pharmacopoeia (USP). Sterisart BD Media and Fluids on request

94. Mycoplasma Contamination Control 94 Microsart ® AMP Extraction Microsart ® AMP Extraction The Microsart ® AMP Extraction kit can be used for the isolation of genomic DNA from different types of sample material, most preferably cell culture supernatants. The kit was especially designed to fit the Microsart ® AMP Mycoplasma , Microsart ® ATMP Mycoplasma and Microsart ® RESEARCH Mycoplasma qPCR kits and to provide best performance in means of sensitivity and robustness for the detection of Mycoplasma within the test sample. Principle Cells are lysed by a combination of detergents and chaotropic salt. The lysate is directly applied onto the spin columns. The DNA is selectively bound to the highly specified silica membrane. Two subsequent washes remove residual contaminants, like proteins, metabolites, dyes, detergents etc. The purified DNA is eluted in Tris buffer. The procedure is completed in 30 min. The DNA is ready-to-use for PCR. Specifications Kit Component Quantity Required Supplements Spin columns 50 Collection Tubes 100 Sample Storage Tubes 50 Buffer A 20 ml Buffer B 11.5 ml 15 ml Ethanol Buffer C 8 ml 18.6 ml Ethanol Buffer D 6 ml Ordering Information Description Quantity Order No. Microsart ® AMP Extraction 50 SMB95-2003

111. Air Monitoring 111 EXTEND Instrument Services Installation and Commissioning AirPort MD8 | MD8 airscan ® The reliability and the service life of your equipment significantly depend on its installation and configuration according to the specifications. Installation and commissioning by our service professionals will ensure that your MD8 successfully operates right from the start. Sartorius Service installs and configures according to regulatory requirements and quality standards. Specifications − Check of scope of delivery − Check of device for transport damage − Manufacturer’s ID label check − Initial start-up − Brief instructions to operating personnel (not application training) − General maintenance discussion Prerequisites Required by the Customer − System is standing at the installation location − Unobstructed access to the system − Power is available at the installation location − When ordering, a responsible person has to be appointed Ordering Information Description Order No. Installation and Commissioning AirPort MD8 | MD8 airscan ® S8739INST The MD8 airscan ® (16746; 16747) is not in compliance with the “Restriction of Hazardous Substances Directive (RoHS, 2011/65/EU)” and therefore its (spare part) availability is restricted for exchange and maintenance only.

87. Mycoplasma Contamination Control 87 Microsart ® AMP Mycoplasma Microsart ® AMP Mycoplasma Rapid Real-time PCR Mycoplasma Detection Kit Rapid methods for the detection of Mycoplasma contamination are essential for improving monitoring of the produc- tion process of biologicals. The first member of the product line qPCR kits for Mycoplasma detection is the Microsart ® AMP Mycoplasma. The Microsart ® AMP can be easily implemented into your process because no specific hardware is needed. The test procedure takes only 3 hours and is successfully validated for sensitivity, specificity and robustness according to EP 2.6.7. Carefully selected primer | probe combinations are highly specific for a region within the 16S rRNA gene for more than 70 Mycoplasma species. Due to the prior enrichment step using the Sartorius Vivaspin 6 and | or Vivaspin 20, you have the ability to be flexible in the testing volume for the DNA extraction. With thus concentration step you have the option to analyze a testing volume from 200 μl up to 18 ml ensuring you the highest sensitivity. The kit contains all essential components in a function-tested ready-to-use master mix including the polymerase. The use of TaqMan ® probes adds specificity to the PCR detection system. The analysis is performed during the cycling process – no melting curve analysis is needed. A detection limit of less than 10 CFU/ml for all Mycoplasma species mentioned in the European Pharmacopoeia fulfills the requirements for the needed sensitivity. Features and Benefits Flexible sample volume from 200 μl to 18 ml The level of security can be adapted to specific needs. Microsart ® AMP Mycoplasma is based on Real-time PCR technology Easy-to-use and Fast: Results within hours, not days! Microsart ® AMP Mycoplasma is validated according to EP guidelines Easy implementation for regulated in-process and lot release testing. Applications The Microsart ® AMP Mycoplasma kit is specifically designed for microbiological QC labs in the bio-pharmaceutical industry or contract labs performing Mycoplasma contamination in-process controls and | or lot release testing according to EP 2.6.7. It is used for direct detection of Mollicutes (Mycoplasma, Acholeplasma, Spiroplasma) in cell cultures, cell culture media compo- nents and derived biologicals. Sample types: – Master cell banks – Working cell banks – Virus seed lots – Virus harvests – Final lots of biologicals produced by cells Notice to purchaser: Limited License Purchase of this product includes an immunity from suit under patents specified in the product insert to use only the amount purchased solely in industrial microbiology QA/QC field and also for the purchaser’s own internal research. No other patent rights are conveyed expressly, by implication, or by estoppel. Further information on purchasing licenses may be obtained by contacting the Director of Licensing, Applied Biosystems, 850 Lincoln Centre Drive, Foster City, California 94404, USA. Real-time PCR kit for the specific and sensitive detec- tion of Mycoplasma DNA

90. Mycoplasma Contamination Control 90 Microsart ® ATMP Mycoplasma Microsart ® ATMP Mycoplasma Rapid Real-time PCR Mycoplasma Detection Kit for testing ATMPs The Microsart ® ATMP Mycoplasma detec- tion kit is the second member of the new rapid qPCR product line for an easy and fast detection of Mycoplasma . With the use of the Microsart ® ATMP Mycoplasma you will reduce your testing time from weeks to 3 hours. The Microsart ® ATMP Mycoplasma has been effectively validated according to EP 2.6.7 in combination with EP 2.6.21 with respect to detection limit for all listed Mycoplasma species, specificity and robust- ness for autologous cell transplants (e.g chondrocytes). The use of TaqMan ® probes adds specificity to the PCR detection system. The analysis is performed during the cycling process – no melting curve analysis is needed. Feature and Benefits Microsart ® ATMP Mycoplasma is based on Real-time PCR technology Easy-to-use and Fast: Results within a day! Microsart ® ATMP Mycoplasma is validated according to EP guidelines for autologous cell transplants Easy implementation for regulated in-process and lot release testing. No specific hardware requirements Easy implementation and no additional costs for the hardware package. Applications The Microsart ® ATMP Mycoplasma real- time PCR kit is especially designed for all hospitals, institution and companies which are involved in testing Mycoplasma contamination according to EP 2.6.7 in cell-based therapeutics like autologous chondrocyte transplants (ATMPs – advandced therapy medicinal products). Notice to purchaser: Limited License Purchase of this product includes an immunity from suit under patents specified in the product insert to use only the amount purchased solely in industrial microbiology QA/QC field and also for the purchaser’s own internal research. No other patent rights are conveyed expressly, by implication, or by estoppel. Further information on purchasing licenses may be obtained by contacting the Director of Licensing, Applied Biosystems, 850 Lincoln Centre Drive, Foster City, California 94404, USA.

108. Air Monitoring 108 Accessories For the monitoring of isolators with MD8 airscan ® , we recommend using stainless- steel accessories such as adapters 17016 (DN25) or 17030 (DN30), clamps 17033 for sanitary flanges, connector 17659---001 or 17659---003 (for tri clamp) and the filter holder for gelatine filter disposables 17801---001 as well as a Sartofluor ® capsule with PTFE membrane and sanitary flange inlet and outlet, for sterile air filtra- tion inserted between the MD8 airscan ® and isolator. This construction makes it possible that the MD8 air sampler remains outside the critical work area (the barrier function between different clean-room classes is maintained). Ordering Information Description Order No. Adapter (DN 25 hose barb to 1”– 1 1/2” sanitary flange) to connect MD8 airscan ® to an isolator via silicone tubing and a filter capsule, stainless-steel 17016 Adapter (DN 30 hose barb to 1”– 1 1/2” sanitary flange) to connect MD8 airscan ® to an isolator via flexible PVC hose and filter capsule, stainless-steel 17030 Clamp for 1”–1 1/2” sanitary flanges, stainless-steel Clamp for 1”–1 1/2” sanitary flanges, stainless-steel 17033 Connector (flexible hose to filter holder | adapter), hose nipple, stainless-steel 17659---001 Connector (flexible hose to filter holder | adapter), tri clamp, stainless-steel 17659---003 Adapter for gelatine filter disposables, stainless-steel 17801---001 Sartofluor ® MidiCap Capsule with PTFE membrane and sanitary flange inlet and outlet, for sterile air filtration inserted between the MD8 airscan ® and isolator 5185307TS-----SS Users of the MD8 airscan ® now have the possibility of operating this air sampler from a distance, using either of two remote control configurations: 1. Via a PC (with Microsoft 95/98 or higher) with MD8 airscan ® dialog system and cable connection to the MD8 airscan ® (1ZE---0004). 2. Via a PLC interface unit (1ZE---0003). Ordering Information Description Order No. Remote control (Interface) for MD8 airscan ® designed for PLC units 1ZE---0003 Remote control for MD8 airscan ® for use with PC (dialog system software) 1ZE---0004 The MD8 airscan ® (16746; 16747) is not in compliance with the “Restriction of Hazardous Substances Directive (RoHS, 2011/65/EU)” and therefore its (spare part) availability is restricted for exchange and maintenance only. Accessories for Isolator Application Accessories for Remote Control Function

34. Microbiological Enumeration 34 Filtration Units Specifications Material Polypropylene Capacity 100 ml, graduations at 20, 50 and 100 ml 250 ml, graduations at 50, 100, 200 and 250 ml Filter diameter 47 mm, prefilter 40 mm (particle testing only) Filtration area 13.2 cm 2 Max. operating pressure Vacuum only Sterilization Ethylene oxide Lot certificate Sterility and performance test Ordering Information Microsart ® Funnel 100, Sterile Disposable Funnel, 100 ml, 100 Units Description Order No. Microsart ® Funnel 100, sterile in 5 sealed bags 16A07--10------N Microsart ® Funnel 250, Sterile Disposable Funnels, 250 ml, 96 Units Description Order No. Microsart ® Funnel 250, sterile in 6 sealed bags 16A07--25------N Accessories and Replacement Parts Description Order No. Microsart ® Funnel Dispenser Funnel dispenser for secure removal of single, sterile Microsart ® Funnels 16A08 Microsart ® Base 47 mm, with frit, stainless-steel base for Combisart ® and Microsart ® Combi.jet Optimized for the use with 47 mm membranes, Click-Fit closure for Microsart ® Funnel, Microsart ® @filter and other funnel types sealed by bayonet closure 1ZU---0002 Silicone O-ring for Microsart ® Base 47 mm male thread (pack size 3) 6980274 Replacement frit for Microsart ® Base, stainless-steel 1ZU---0001 Further information about Microsart ® Combi.jet and Combisart ® stainless-steel manifolds are on the following pages.

49. 1 4 5 2 3 Microbiological Enumeration 49 Filtration Equipment How to Set-up a Vacuum Filtration System Microsart ® Combi.jet 2-Branch Stainless-Steel Manifold plus Microsart ® e.jet Ordering Information Pos. Description Qty. Order No. Detailed Information on Page Microsart ® Combi.jet stainless-steel equipment: 48 1 Microsart ® Base 47 mm 2 1ZU---0002 2 Microsart ® Combi.jet 2-branch manifold 1 16848-CJ Sterile venting of the filter station: 45 3 Minisart ® SRP25, 0.2 μm 1 17575--------ACK 4 Silicone tubing, pressure-sided, 1 m Silicone tubing, pressure-sided, 2 m Silicone tubing, pressure-sided, 10 m 2* 1ZAS--0007 1ZAS--0019 1ZAS--0020 61 Vacuum Pump: 60 5 Microsart ® e.jet Transfer Pump, 230 V, 50 Hz 1 166MP-4 Additional accessories: Microsart ® @filter 100, sterile filter units, packaged on trays 1 16D01--10-H6--TG 35 Stainless-steel tweezers 1 16625 65 Colony Counter 1 17649 64 Incubator 1 18119 64 Container for anaerobic incubation 1 16671 65 * required length depends on distance between Transfer Pump and drain The filter stations are directly connected to the Transfer Pump for simultaneous transfer of the filtrate to waste. Easy assembling thanks to Quick Connection technology.

92. Mycoplasma Contamination Control 92 Microsart ® RESEARCH Mycoplasma Microsart ® RESEARCH Mycoplasma Rapid Real-time PCR Mycoplasma Detection Kit Microsart ® RESEARCH Mycoplasma enables a fast and reliable detection of Mycoplasma DNA in cell culture supernatants most applicable in research and development. Carefully selected primer | probe combi- nations are highly specific for a region within the 16 S rRNA gene of at least 110 Mycoplasma species. The detection procedure can be performed within 3 hours. The use of TaqMan ® probes adds specificity to the PCR detection system. 2 μl of sample material, e.g. cell culture supernatant, can be added directly to the PCR reaction tube. For the detection of Mycoplasma DNA a TaqMan ® real-time qPCR is used. Depending on the sample matrix a standard spin-column based DNA preparation can be done prior to PCR analysis to increase sensitivity or prevent inhibition. 200 μl sample volume can be used as starting material for DNA prepara- tion if using the Microsart ® AMP Extraction kit. 2 μl of isolated DNA extract is ampli- fied in a qPCR cycler and the evaluation can be performed with the standard cycler software. Feature and Benefits Microsart ® RESEARCH Mycoplasma is based on Real-time PCR technology Easy-to-use and Fast: Results in hours, not days! Primers and probes detect a highly conserved region of the 16S rRNA gene of numerous Mycoplasma species High specificity to detect all 9 Mycoplasma species according to EP and easy result interpretation. No specific hardware requirements Easy implementation and no additional costs for hardware package. Applications The Microsart ® RESEARCH Mycoplasma real-time PCR protocol is especially designed for fast and reliable screening of cell culture super nantants most applicable in research and development, e.g. biotech and biopharmaceutical research and development, university and governmental research groups. It is used for direct detection of Mollicutes ( Mycoplasma, Acholeplasma, Spiroplasma ) in cell culture, cell culture media compo- nents and derived biologicals. Notice to purchaser: Limited License Purchase of this product includes an immunity from suit under patents specified in the product insert to use only the amount purchased solely in industrial microbiology QA/QC field and also for the purchaser’s own internal research. No other patent rights are conveyed expressly, by implication, or by estoppel. Further information on purchasing licenses may be obtained by contacting the Director of Licensing, Applied Biosystems, 850 Lincoln Centre Drive, Foster City, California 94404, USA.

19. Microbiological Enumeration 19 Culture Media Microsart ® @media Advanced System for Agar and Membrane Transfer Microsart ® @media are media dishes pre-filled with different agar media types, sterile packaged and ready-to-use. Togeth- er with the Microsart ® @filter units, they introduce a brand new agar and membrane transfer concept for the Microbial Limit Test. The innovative active lid of Microsart ® @media allows a touch-free membrane transfer from the Microsart ® @filter base and thus reduces the risk of secondary contamination to an absolute minimum. Applications Microsart ® @media and the Microsart ® @vance ® product line enhance the safety of microbiological quality control in biopharmaceutical laboratories. Features Innovative Membrane Transfer Concept The active lid enables touch-free mem- brane transfer and, therefore, reduces the risk of secondary contamination. Thanks to its special design, no air bubbles are entrapped. Benefits Easy Handling Fits perfectly onto the Microsart ® @filter base and thus allows an easy and reliable transfer of the membrane filter onto the agar. No powerful cracking of plastic is needed! Safe and Reliable Touch-free membrane transfer rules out manipulation and handling, minimizing major sources of secondary contamination. Results in best growth conditions and reliable results. Time-saving Innovative click-fit closure permits fast and easy removal of the funnel after filtration. Easy and Fast Levelling Two simple-to-adjust feet and an out- standingly simple-to-read level indicator on the front.

60. Microbiological Enumeration 60 Filtration Equipment The Microsart ® e.jet is a new vacuum laboratory pump able to create sufficient vacuum for vacuum filtration and con- comitantly transferring the filtered liquid directly to waste. The second generation of Microsart ® e.jet is ideal for sample prep- aration in Microbiology achieving a trans membrane pressure of 600 mbar and a higher flow rate of > 4.0 Nl/min (4.0 Norm- liters water displacement by air in one minute). Constant flow rates and a defined maximum vacuum guarantee smooth and reliable filtration. Reducing Operating Complexity Until now vacuum equipment for the Membrane Filtration Method consists of numerous parts including connectors, tubes, vacuum containers, protection filter, Woulff’s bottle and a vacuum pump. After several samples the vacuum must be broken to empty the filtrate collection con- tainer. The complete traditional equipment requires far more laboratory space and is time consuming to operate and maintain. Microsart ® e.jet will eliminate the need for side-arm flasks or Woulff’s bottles from the laboratory filtration bench. The Microsart ® e.jet pump is an ideal accessory for manifolds up to 3 filter stations. Compared to traditional equip- ment Microsart ® e.jet and a stainless-steel manifold require only 30% of the average space meaning in particular less congestion working in Laminar Flow Cabinets. Traditional vacuum pumps often lose their efficiency and capability to generate sufficient vacuum, when liquid is drawn into the pump head. The Microsart ® e.jet is designed to pump both gas and liquids, meaning no loss of efficiency or malfunc- tions from water drawn into the pump head. Quick Connection Building up the vacuum filtration system is easy and fast thanks to the innovative Quick Connections. The Microsart ® e.jet Transfer Pump is equipped with Quick Connection Nipples assembled to Quick Connection Couplings on hose nipples for DN 10 tubings. Simply push-to-connect for assembling and pull-to-disassemble the whole system within seconds. The Quick Connections are non-shut-off. Some of the advantages you will benefit from when using the Microsart ® e.jet – Ideal for microbiology applications – No need of suction flasks and water traps – Saving 70% of work space while saving money – that’s economic efficiency Specifications Flow rate > 4.0 Nl/min Max. vacuum 0.4 bar Max. pressure 1.0 bar Mains 100–240 V | 47–63 Hz Materials (in contact with filtrate) PTFE, ETFE, Polypropylene, EPDM, POM, PSU Weight Pump: 1425.3 g Power supply: 242.6 g Dimensions ( W|L|H) 120 + 170 + 190 mm Max. ambient temp. +5 ... +40°C Max. temp of liquid +5 ... +80°C Max. viscosity <150 cSt Protection type IP 64 Protection class III Inlet | Outlet Quick Connection on hose nipples for DN 10 tubings Microsart ® e.jet Transfer Pump with Quick Connection

106. Air Monitoring 106 Accessories Accessories For the MD8 Air Samplers Calibration Unit The user can calibrate the MD8 airscan ® and AirPort MD8 directly on the job by means of the calibration unit*. This is absolutely necessary above all within the scope of validation steps, for which it is important that the shown air flow rate (desired value at the MD8) corresponds to the actual air amount (actual value at the calibration device). The calibration unit is supplied complete with battery charger | power supply unit (specific for the country in which it is used), filter holder, connec- tors set and connection tube (PVC, 2 m). * Alternatively, a maintenance agreement can be signed. Within the scope of the contractual services, Sartorius technicians will carry out a calibration of the MD8 at regular intervals. Specifications Calibration Unit Dimensions Length, 300 mm (without filter holder), Width, 390 mm with handles Height, 182 mm min., 200 mm max. (adjustable feet) Connectors Quick locks (bayonet principle) Operational life with full battery Approx. 4 hours Charge time for empty battery Approx. 10 hours Measuring range 1–16 m 3 /h Max. error 1–16 m 3 /h, ±2% Type of protection IP 40 Allowable ambient temperature Min. 0°C, max. 40°C Weight Approx. 11 kg Special brochure available on request. Order no. SL-2028-e Ordering Information Description Order No. Calibration unit for the MD8 air samplers 16756 The MD8 airscan ® (16746; 16747) is not in compliance with the “Restriction of Hazardous Substances Directive (RoHS, 2011/65/EU),” and therefore its (spare part) availability is restricted for exchange and maintenance only.

63. Microbiological Enumeration 63 Filtration Equipment Simple vacuum source. For connection to a water tap with G3/4 male thread. Ordering Information Description Order No. Water jet pump, with G 3/4 female thread 16611 Water Jet Pump Practical vacuum source e.g. for the use outside of a laboratory. Up to 80% vacuum can be obtained. The body is made of PVC. Supplied completely with gauge, vacuum release lever and a 60 cm clear plastic tubing. Hand-Operated Vacuum Pump Ordering Information Description Order No. Hand-operated vacuum pump with gauge 16673 The most convenient way to moisten the NPS with water is to use a dosing syringe with an adapted Minisart ® syringe filter. Simultaneous sterilization and dispensing of demineralized water in e.g. 3.5 ml steps Dosing Syringe is easily done by simply dropping the sinker at the end of the suction tubing into the water, then filling the dosing syringe and dispensing sterile water by operating the trigger automatically. Ordering Information Description Order No. Dosing syringe, 0.5–5 ml 16685-----2 Minisart ® , 0.2 μm, individually, sterile-packaged 17597----------K Replacement part: tubing with sinker for 16685-2 and 16685 6986125 Service Kit for Dosing Syringe 16685-----2 1EP---0002

65. Microbiological Enumeration 65 Filtration Equipment Membrane filters should only be handled with suitable tweezers to avoid contami- nation since the stainless-steel tweezers Stainless-Steel Tweezers can be flamed and are auto clavable. They have blunt-edged tips for a careful, firm hold of the membrane filter. Ordering Information Description Order No. Stainless-steel tweezers 16625 The stainless-steel prefilter holder allows the removal of coarse, solid particles from samples for microbiological analysis before and during the actual bacteria retentive fil tration. The device is clipped between funnel and base of the stainless-steel vacuum filter holders. It can be autoclaved and flamed. 11301, a white cellulose nitrate (cellulose mixed ester) membrane filter with a pore size of 8 μm is used as a Stainless-Steel Prefilter Attachment prefilter which retains the coarse suspend- ed particles from the sample, whereas it allows microorganisms to pass through. The microbes are trapped on the surface of the underlying bacteria-retentive membrane filter (e. g. 0.45 μm). After the filtration is completed, the test filter is incubated, and the colonies can grow on the filter surface without disturbance from, or being hidden by, an excess of particles. Ordering Information Description Order No. Stainless-steel prefilter attachment 16807 Cellulose nitrate membranes with 50 mm diameter and 8 μm pore size for the prefilter holder, pack of 100, individually, sterile packaged 11301--50----ACN Replacement part: support plate, autoclavable, flame treatment resistent 6981139 Stainless-steel container with 11.8 cm inner diameter, 10.7 cm depth and with a metal insert for convenient insertion and removal of petri dishes. The plastic lid holds two taps for the vacuum exhaust and for Container for Anaerobic Incubation cleaning with inert gas, with 6 mm hose nipples (for 16623), vacuum gauge and sealing ring. For up to fourteen 60 mm, or up to six 90 mm petri dishes. Ordering Information Description Order No. Anaerobic container 16671

104. Air Monitoring 104 Air Sampler Ordering Information MD8 airscan ® Air Sampler Description Order No. MD8 airscan ® air sampler, 230 V, 50 Hz 16746 MD8 airscan ® air sampler, 115 V, 60 Hz 16747 Each version can be switched from 50 to 60 Hz and back. Accessories Order No. Holder for disposable gelatine filter units 17801 Consumables Disposable gelatine units, sterile, pack of 10 Order No. Individually packed in 1 polyethylene bag each 17528--80----ACD Individually packed in 3 polyethylene bags each 17528--80----BZD Individually packed in 3 polyethylene bags each, but label on innermost bag 17528--80----VPD Special brochures available on request. Order no. SMI2001-e | SM-3011-e The MD8 airscan ® (16746; 16747) is not in compliance with the “Restriction of Hazardous Substances Directive (RoHS, 2011/65/EU)” and therefore its (spare part) availability is restricted for exchange and maintenance only.

17. Microbiological Enumeration 17 Membrane Filters Ordering Information Cellulose Nitrate Membrane Filters, White with Black Grid, for Colony Counting and Sterility Testing, Type 131, Pack Size 100 Pore Size Diameter Hydrophobic Edge Packaged Order No. 0.2 μm 47 mm 3 mm Individually, sterile packaged 13107--47----ACN 50 mm 3 mm 13107--50----ACN 0.2 μm 25 mm 3 mm Non-sterile 13107--25------N 47 mm 3 mm 13107--47------N 47 mm 6 mm 13107--47----HCN 50 mm 3 mm 13107--50------N 0.45 μm 47 mm 3 mm Individually, sterile packaged 13106--47----ACN 47 mm 6 mm 13106--47----HEN 50 mm 3 mm 13106--50----ACN 0.45 μm 25 mm 3 mm Non-sterile 13106--25------N 47 mm 3 mm 13106--47------N 47 mm 6 mm 13106--47----HCN 50 mm 3 mm 13106--50------N 8 μm 47 mm 3 mm Non-sterile 13101--47------N 50 mm 3 mm 13101--50------N Cellulose Nitrate Membrane Filters, White, for Colony Counting and Sterility Testing, Type 131, Pack Size 100 8 μm 50 mm 3 mm Non-sterile 13101--50----AHN Cellulose Acetate* Membrane Filters, White with Black Grid, for Colony Counting and Sterility Testing, Type 135, Pack Size 100 0.2 μm 47 mm 3 mm Individually, sterile packaged 13507--47----ACN 0.2 μm 47 mm 3 mm Non-sterile 13507--47------N 0.45 μm 47 mm 3 mm Individually, sterile packaged 13506--47----ACN 50 mm 3 mm 13506--50----ACN 0.45 μm 47 mm 3 mm Non-sterile 13506--47------N 47 mm 6 mm 13506--47----HCN Cellulose Acetate* Membrane Filters, White with Black Grid, for Colony Counting and Sterility Testing, Type 135, Pack Size 100 Packaged of 10 Discs per Sleeve 0.45 μm 47 mm 3 mm Sterile 13506--47----ALS Regenerated Cellulose* Membrane Filters, White, for Colony Counting and Sterility Testing, Type 184, Pack Size 100 0.45 μm 47 mm 3 mm Individually, sterile packaged 18406--47----ACN 47 mm 4 mm 18406--47----HDN * If cellulose nitrate is not compatible

47. Microbiological Enumeration 47 Filtration Equipment Microsart ® Combi.jet 2-Branch Stainless-Steel Manifold for Microbiological Analysis The Microsart ® Combi.jet is a 2-branch manifold, made of high-grade stainless- steel. The manifold has been specifically designed for the use together with the Microsart ® e.jet Transfer Pump. The system is able to create sufficient vacuum for vacuum filtration concomitantly transfer- ring the filtered liquid directly to waste. Microsart ® Combi.jet and Microsart ® e.jet can be easily connected and disassembled by the innovative Quick Connection technology. Compact Design The complete traditional equipment, such as connectors, tubes, suction flask, protection filter, Woulff’s bottle and a vacuum pump, requires a lot of laboratory space and is time consuming to operate and maintain. Microsart ® Combi.jet reduces operating complexity due to its small and compact design. The Transfer Pump Microsart ® e.jet fits visually and ergonomi- cally into this design. Quick Connection Building up the vacuum filtration system is easy and fast thanks to the innovative Quick Connection Coupling and Nipples at the Microsart ® Combi.jet manifold and Microsart ® e.jet Transfer Pump. Simply push-to-connect for assembling and pull-to-disassemble the whole system within seconds. Sterile Venting A special feature of the Microsart ® Combi.jet manifold are the stainless-steel three-way valves (taps). They allow the vacuum for each filter holder to be individually controlled and each filter station to be sterilely vented. This rules out secondary contamination of the underside of the filter. Maximum Flexibility The Microsart ® Combi.jet enables you to select the optimal hardware and consum- ables for your needs in microbiological analysis in quality assurance. The heart of the whole system is the Microsart ® Combi.jet, the stainless-steel 2-branch manifold, designed to accommodate all types of filter holders and funnels such as: – Ready-to-use units Microsart ® @filter 100 and 250 – Ready-to-use units Microsart ® Funnel 100 and 250 – Ready-to-use units Biosart ® 100 Monitors – Ready-to-use units Biosart ® 250 Funnels – Flammable units such as stainless-steel funnels – Autoclavable glass filter holders – Autoclavable polycarbonate filter holder Reliability: Ideal for Microbiology Applications – Sterile venting after filtration – Easy to clean and sanitize – Smooth and reliable filtration Economically Efficient – Saving time due to Quick Connection technology – Saving work space (saves 70%) – No need for suction flasks and water traps

57. Microbiological Enumeration 57 Filtration Equipment Used between suction flask and vacuum source, in order to prevent overflow of filtrate into an electric vacuum pump. Vacusart ® Vacusart ® is a ready-to-connect filtration unit, consisting of a polypropylene housing and a hydrophobic, but air-permeable PTFE membrane with a pore size of 0.45 μm. Vacusart ® is perfectly suitable for the protection of vacuum pumps. It could be put directly into the hole of the bored stopper and connected with the rubber hose to the vacuum pump. Ordering Information Description Order No. Vacusart ® water trap, pack of 3 17804----------M Woulff’s Bottle, 500 ml Used between suction flask and vacuum source. Allows simple control of the vacu- um with glass units without a separate tap and prevents the filtrate from overflowing from the suction flask. Ordering Information Description Order No. Woulff’s bottle, 500 ml 16610 Rubber Vacuum Hose (1 Meter) Thick walled rubber hose for connecting the system components, e. g. suction flasks, vacuum pumps, etc. When ordering, please state length required in meters. Ordering Information Description Order No. Rubber vacuum hose (1 meter) 16623 Water Traps

109. Air Monitoring 109 Accessories Gelatine membrane filters are still available as 80 mm filter discs, suitable for the filter hold er supplied with the MD8 airscan ® . The filters are sterile-supplied, but the filter holders have to be sterilized by dry heat (180°C, 2h) and then equipped with the filters under sterile conditions. For per- forming routine check-ups a stack is recommended. Ordering Information Gelatine Disc Filters, 3 μm Pore Size, 80 mm, 50 Pieces/Pack Description Order No. Gelatine disc filter, sterile, sealed in units of five each in a polyethylene bag 12602-080 ALK If gelatine filters cannot be used (high humidity, high temperature), it is recom- mended to use cellulose nitrate filters. Ordering Information Cellulose Nitrate Membrane Filters, 80 mm Diameter, 100 Pieces/Pack Description Order No. Cellulose nitrate membrane filters, 0.8 μm, white with black grid, pre-sterilized in bags of 5 11404--80----ALN Cellulose nitrate membrane filters, 0.8 μm, grey with white grid, pre-sterilized in bags of 5 13004--80----ALN Cellulose nitrate membrane filters, 8 μm, white no grid, pre-sterilized in bags of 5 11301--80----ALN The MD8 airscan ® (16746; 16747) is not in compliance with the “Restriction of Hazardous Substances Directive (RoHS, 2011/65/EU)” and therefore its (spare part) availability is restricted for exchange and maintenance only. Gelatine Membrane Filter, 80 mm, Sterile, Pack of 50 for Use with Stack Further Consumables for Air Monitoring

29. Microbiological Enumeration 29 Filtration Units The membrane filtration method is the suitable technique for microbiological analysis of pharmaceuticals, water, cosmet- ics, foods and beverages. The use of ready- to-use disposable units are optimal for these applications. Biosart ® 100 Monitors Biosart ® 100 Monitors have been specifical- ly designed for the detection and enumera- tion of microorganisms in pharmaceuticals, cosmetics, food, beverages, water and other liquids. These sterile disposables with an incorporated membrane filter and cellulose pad are ready to use. After filtration, just remove the 100 ml funnel to convert the Monitor into a petri dish eliminating the need for membrane manipulation. Culture media for wetting the pad are available in individually sterilized, convenient plastic ampoules. Biosart ® 100 Monitors are ready- to-use filter units designed to be placed onto the bases of a vacuum manifold, eliminating the cleaning and sterilization required of reusable funnels. Compliance with International Standards The membrane filter method is accepted worldwide and the preferred method of choice for the analysis of microbial con- tamination in liquid samples. Biosart ® 100 Monitors and Media are in compliance with the membrane filtration procedures referenced in the: – European drinking water directive (Council Directive 98/83/EC on the quality of water) – Standard Methods for the Examination of Water and Waste Water, 20th edition – U.S. Environmental Protection Agency, 600/8-78-017 – International Standard’s microbiological methods, such as ISO 7704, ISO 9308-1, DIN EN ISO 16266, ISO 8199 – WHO Guidelines for Drinking Water Quality, 1997 – International Pharmacopoeia, such as the current editions of the USP and EP High-Flow Membranes Biosart ® 100 Monitors are also available with the new 0.45 μm High-Flow mem- branes. The special pore structure allows shorter filtration times due to 30% higher flow rates. Especially E. coli shows best growth promotion on High-Flow Mem- branes. Applications Microbial enumeration, particle testing and microscopy Benefits Superior Performance – High-flow rate – High total throughput Safe and Reliable – Sterile or individually, sterile packaged – Consistent recovery – Membranes meet ISO 7704 – Membranes available in various colours – Without any hydrophobic adhesive areas Economical – Ready to connect and easy to use – Minimal amount of equipment needed Biosart ® 100 Monitors

22. Microbiological Enumeration 22 Culture Media Ordering Information NPS Type (Filter Type) 1 Determination of Order No. 2 Nutrient Pad Sets for Total Colony Counting, individually, sterile packaged in petri dishes, 100 per box, with 100 individually, sterile packaged 47 mm membrane filters (order no. -RDN = Microsart ® e.motion Membranes) Caso (1) Total count 14063--47------N R2A (1) Total count 14084--47----RDN R2A (1) Total count 14084--47------N Standard TTC (1) Total count 14055--47----RDN Standard TTC (1) Total count 14055--47------N Standard TTC I mod. (1) Total count 14085--47------N Standard (1) Total count 14064--47------N TGE | Tryptone Glucose Extract (1) Total count 14076--47----RDN TGE | Tryptone Glucose Extract (1) Total count 14076--47------N Yeast Extract (1) Total count 14090--47------N Nutrient Pad Sets for E. coli, Coliforms and Enterobacteria, individually, sterile packaged in petri dishes, 100 per box, with 100 individually, sterile packaged 47 mm membrane filters (order no. -RDN = Microsart ® e.motion Membranes) CHROMOCULT ® * (7) E. coli and coliforms 14087--47----RDN CHROMOCULT ® * (7) E. coli and coliforms 14087--47------N ECD (2) E. coli 14082--47------N Endo (9) E. coli and coliforms 14053--47----RDN Endo (9) E. coli and coliforms 14053--47------N MacConkey (2) Enterobacteria, E. coli 14097--47------N m FC (2) E. coli and coliforms 14068--47------N Teepol | Lauryl Sulphate (2) E. coli and coliforms 14067--47----RDN Teepol | Lauryl Sulphate (2) E. coli and coliforms 14067--47------N Tergitol TTC (2) E. coli and coliforms 14056--47----RDN Tergitol TTC (2) E. coli and coliforms 14056--47------N Nutrient Pad Sets for Other Faecal Bacteria, individually, sterile packaged in petri dishes, 100 per box, with 100 individually, sterile packaged 47 mm membrane filters (order no. -RDN = Microsart ® e.motion Membranes) Azide | KF Strep (1) Enterococci 14051--47----RDN Azide | KF Strep (1) Enterococci 14051--47------N Bismuth Sulfite (1) Salmonellae 14057--47------N Nutrient Pad Sets for Non-Faecal, Pathogenic Bacteria, individually, sterile packaged in petri dishes, 100 per box, with 100 individually, sterile packaged 47 mm membrane filters (order no. -RDN = Microsart ® e.motion Membranes) Cetrimide (2) Pseudomonas aeruginosa 14075--47----RDN Cetrimide (2) Pseudomonas aeruginosa 14075--47------N Chapman (2) Staphylococci, Staph. aureus 14074--47------N * Trademark owner and manufacturer is Merck KGaA

103. Air Monitoring 103 Air Sampler MD8 airscan ® Air Sampler for Critical Applications The system consists of the MD8 airscan ® air sampler and disposable gelatine filter units. The system is routinely used for the quantitative detection of air-borne organ- isms, mainly at filling lines in sterile areas of class A (classification according to “EU Guide for GMP”), isolators, or blow-fill-seal machines. The exceptionally high air flow rate of 8 m 3 /h enables isokinetic sampling at flow rates that are usual in laminar flow as well as filtration of 1 m 3 air very quickly (less than 8 minutes). The filter unit can be placed separately from the air sampler for remote sampling. The MD8 airscan ® air sampler allows the user to make selective adjustments and easily sample air flow rate and removal speed? By means of a specially developed calibration unit (see accessories), the user can calibrate the MD8 airscan ® locally, e.g. within the scope of validation steps. After removing the sample, the gelatine filter can be placed directly on the agar culture medium for incubation and colony growth. Specifications MD8 airscan ® Air Sampler Air flow rate 2.0 m 3 /h – 8 m 3 /h adjustable in 100-liter steps Timer 1–99 minutes, adjustable in 1-minute steps Max. deviation ±5% in a temperature range of 15°–35°C Noise level For gelatine membrane filters, max. 62 dB (A) Weight Approx. 6.5 kg Dimensions (L + W + H) 375 + 242 + 228 mm Correction of the air flow When the entered air flow rate cannot be attained, rate setting the display shows the max. attainable flow rate for a corresponding new setting below this value. Included filter holder 17655 (Gelatine disc filters) The MD8 airscan ® (16746; 16747) is not in compliance with the “Restriction of Hazardous Substances Directive (RoHS, 2011/65/EU)” and therefore its (spare part) availability is restricted for exchange and maintenance only.

78. Sterility Testing 78 EXPAND ® Training EXPAND ® Training Courses and Seminars Sterility Testing Who should attend Staff working in the field of microbiologi- cal quality control who perform or are responsible for the performance of sterility testing. “Because sterility testing is a very exacting procedure, where asepsis of the procedure must be ensured for a correct interpreta- tion of results, it is important that per- sonnel be properly trained and qualified” USP <71>. This workshop is designed to give partici- pants theoretical knowledge and practical experience in the handling of sterility testing in clean rooms and isolators. Theoretical Aspects Include – Regulation and guidance – Sterility test methods | test limitations – Validation – Interpretation of sterility test results – Microbiological monitoring Practical Exercises – Sterility testing of different sterile products (LVPs | SVPs | ampoules | syringes | medical devices) – Performing sterility test in isolators Course date | venue on demand Course Duration 1.5 days Start first day: 1:00 pm End last day: 4:00 pm Trainer Dr. Dagmar Simons Course Fee on demand

101. Air Monitoring 101 Gelatine Membrane Filters (GMF) Gelatine Membrane Filters (GMF) Gelatine filters in conjunction with the MD8 air samplers (gelatine filter method) are used for the collection of airborne microbes and viruses. Gelatine filter disposables are individually packed, pre-sterilized and ready-to-connect units, each consisting of a gelatine membrane filter and a holder. Gelatine membrane filters are still available as filter discs, suitable for the filter holder 17655 (80 mm diameter) supplied with the MD8 airscan ® air samplers, as well as in smaller diameters. Gelatine filters in conjunction with the MD8 air samplers offer the following features and benefits: – “Absolute” retention rate (99.9995% for Bac. sub. niger spores, 99.94% for T3 phages) – The filter maintains the viability of collected microorganisms for a relevant and meaningful sampling time – Gelatine filters are completely water- soluble. Therefore, microbes in one sam- ple can be cultivated in | on different nutrient media or low and high bacteria counts can be measured. The sample is not affected by inhibitors – The solubility of the gelatine filter is a prerequisite for virus sampling Specifications Gelatine filters Water soluble, pore size 3 μm, 80 mm diameter, thickness approx. 250 μm Thermal resistance Max. 60°C Air flow rate Approx. 2.7 l/min./cm 2 at ' P = 0.05 bar Retention rates 1. Bac. subtilis niger spores 99.9995% at 0.25 m/s inlet velocity. 2. Coli phages: phage T1, 99.9% at 0.3 m/s inlet velocity and 50% rel. air humidity. Phage T3, 99.94% at 0.3 m/s inlet velocity and 80% rel. humidity. Filtration area 38.5 cm 2 Conditions for use Room temperature, max. 30°C, max. air humidity 85% Sterilization Supplied pre-sterilized by gamma irradiation Ordering Information Disposable Gelatine Units, Sterile, Pack of 10 Description Order No. Individually packed in 1 polyethylene bag each 17528--80----ACD Individually packed in 3 polyethylene bags each 17528--80----BZD Individually packed in 3 polyethylene bags each, but label on innermost bag 17528--80----VPD Gelatine Disc Filter, Sterile, Sealed in Units of Five Each in a Polyethylene Bag Diameter Package Size Order No. 80 mm 50 12602--80----ALK 50 mm 100 12602--50----ALN 50 mm 50 12602--50----ALK 47 mm 100 12602--47----ALN 47 mm 50 12602--47----ALK 37 mm 50 12602--37----ALK Special brochure available on request. Order no. SM-3011-e The MD8 airscan ® (16746; 16747) is not in compliance with the “Restriction of Hazardous Substances Directive (RoHS, 2011/65/EU)” and therefore its (spare part) availability is restricted for exchange and maintenance only.

21. Microbiological Enumeration 21 Culture Media Nutrient Pad Sets Dehydrated Media Pads in Petri Dishes, with Suitable Membrane Filters for Economical, Time-Saving Microbiological Quality Control Sartorius Nutrient Pad Sets have been used successfully in the membrane filter method for 30 years. Practical and easy to handle, they reduce labor and simplify many microbiological testing procedures. Nutrient pads are sterile, dehydrated culture media. Once they are moistened with 3.0–3.5 ml of sterile and demineral- ized (or distilled) water, they are ready to use immediately. Ready-to-Use up to 24 Months The standard NPS box contains 100 sterile nutrient pads, each of which is individually inserted in a petri dish and sterilized. Ten each of these petri dishes are sealed in an aluminum bag. This special packaging in bags protects the sensitive formula constit- uents of the nutrient pads during transport and storage from fluctuations in humidity and temperature. As a result, it guarantees the high quality of our NPS throughout their entire shelf life up to 24 months. This makes the Sartorius Nutrient Pads Sets unique: No other ready-to-use culture media around the globe assures such consistently high quality and reproducible results up to 24 months. Compliance with International Standards Currently, Sartorius offers more than 30 different Nutrient Pad Set types to meet the diverse objectives of microbiological analysis. Aside from the European drinking water directive, they comply with other interna tional regulations and recommen- dations: international pharmacopoeias, DIN and ISO standards, the American Standards for Water and Foods, mineral water regulations, brewery guidelines, such as MEBAC or EBC, and recommendations of the food industry, such as LMBG, NCA and ICUMSA, etc. Inclusive Membranes All Nutrient Pad Set types are supplied with the suitable membrane filters, which are also pre-sterilized and individually packaged. Nutrient Pad Sets are also avail- able with Microsart ® e.motion Membrane Filters which are specially designed for the Microsart ® e.motion Dispenser and can be conveniently inserted. The membrane filters then are automatically removed from their sterile package. All membrane filters tailored to meet the special require- ments of microbial detection are available with 47 mm or 50 mm diameters. Benefits Economy No time-consuming and labor-intensive preparation of the nutrient media (sterili- zation, cleaning, etc.). Easy Handling Nutrient Pad Sets can also be used in laboratories without comprehensive microbiological equipment. Consistently Quality During the production, each nutrient pad set batch is compared with the correspond- ing agar medium, in order to guarantee consistently quality and reproducible results. Trouble-Free Storage Nutrient Pad Sets can be stored at room temperature in a warehouse, up to 24 months.

42. Microbiological Enumeration 42 Filtration Equipment Maximum Flexibility The turnable single base for 50 mm membranes 16840 or the Microsart ® Base 47 mm features additional advantages you will benefit from: – You can pour out a non-filterable sample from each unit – Filtration equally easy for left- or right handed users in your laboratory, because funnels can be positioned to suit the individual user Some of the advantages you will benefit from when using the Combisart ® System: Safe and Reliable – Sterile venting of each membrane after filtration – Sterilization acc. to ISO 8199 – Special polished stainless-steel surfaces allow easy cleaning and rinsing – Low height is advantageous for working on a clean bench Saves Time – Filtration of 3 or 6 samples in parallel – Easy pouring out of non-filterable samples – Equally easy for right- and left-handed users Economical – Maximum flexibility due to different set-ups – Space-saving in the autoclave – Stainless-steel 304 – long lifecycle Combisart ® Hardware Setups Filtration systems fast and easy completed at www.sartorius.com/microbio Specifications Stainless-steel quality High-grade stainless-steel: B.S. 304S31 | AISI 304 Dimensions in mm (L | H | D) 3-branch manifold: 435 | 103 | 120 6-branch manifold: 910 | 103 | 120 Max. operating pressure Vacuum only Sterilization By autoclaving (max. 134°C), By dry heat (max. 180°C), By flaming, By other methods acc. to ISO 8199 Parts and materials Lid, funnel, base part, filter support, clamp and tap made of stainless-steel. Silicone flat gasket. Silicone lid seal Flow rate per filter station for water at 90% vacuum 200 ml/min with 0.2 μm membrane filter 600 ml/min with 0.45 μm membrane filter Filtration area 12.5 cm 2 (if using stainless-steel funnels) Suitable membrane filter diameter 50 mm (47 mm, if using a 47 mm frit 6980103) Outlet spout (individual system) 10 mm outer diameter Inlet (branches only) Female thread, TR 20 + 2 Outlet (1- and 3-branches only) Quick Connection Nipple DN 7 (tubings with DN 10 are connectable) Outlet (6-branch) Hose nipple DN 10

37. Microbiological Enumeration 37 Filtration Units Microsart ® @filter 100, Sterile Disposable Filter Units, 47 mm, 100 ml, Stacked and Packaged in Bags, Ideal for the Use with Microsart ® Funnel Dispenser, 60 Units Pore Size Membrane Filter* Color | Grid Color Order No. 0.2 CN white | black 16D01--10-07--BL 0.45, High-Flow CN white | black 16D01--10-H6--BL 0.45, High-Flow CN grey | white** 16D03--10-H6--BL 0.45 CN green | dark green 16D02--10-06--BL 0.45 RC white (w/o grid) 16D05--10-06--BL*** 0.45 CN white | black 16D01--10--06--BL Microsart ® @filter 250, Sterile Disposable Filter Units, 47 mm, 250 ml, Stacked and Packaged in Bags, Ideal for the Use with Microsart ® Funnel Dispenser, 48 Units Pore Size Membrane Filter* Color | Grid Color Order No. 0.2 CN white | black 16D01--25-07--BK 0.45, High-Flow CN white | black 16D01--25-H6--BK 0.45, High-Flow CN grey | white** 16D03--25-H6--BK 0.45 CN green | dark green 16D02--25-06--BK 0.65 CN gr e y | white** 16D03--25-05--BK 0.45 CN white | black 16D01--25--06--BK Microsart ® @filter 100, Individually Sterile Packed, 100 ml Capacity, with Covers, 27 Units Pore Size Membrane Filter* Color | Grid Color Order No. 0.45, High-Flow CN white | black, 100 ml 16D01--10-H6-ACG 0.45, High-Flow CN black | white, 100 ml 16D03--10-H6-ACG 0.2 CN black | white, 100 ml 16D01--10-07-ACG Microsart ® @filter 250, Individually Sterile Packed, 250 ml Capacity, with Cover, 18 Units Pore Size Membrane Filter* Color | Grid Color Order No. 0.45, High-Flow CN white | black, 250 ml 16D01--25-H6-ACF 0.45, High-Flow CN black | white, 250 ml 16D03--25-H6-ACF 0.2 CN white | black, 100 ml 16D01--25-07-ACF Accessories Description Order No. Lids for Microsart ® @filter 100 and 250, Pack size: 100 (4 bags with 25 pieces each), gamma sterilized 1ZSF-K0007 Microsart ® Funnel Dispenser 16A08 Funnel dispenser for secure removal of single, sterile Microsart ® @filter packaged in bags. * CN = Cellulose Nitrate (Cellulose ester), RC = Regenerated Cellulose ** Grey membranes after wetting black *** not to be used in combination with Microsart ® @media

48. Microbiological Enumeration 48 Filtration Equipment Specifications Microsart ® Combi.jet Stainless-steel quality High-grade stainless-steel: B.S. 304S31 | AISI 304 Dimensions in mm (L | H | D) 246 | 98 | 130 Max. operating pressure Vacuum only Sterilization By autoclaving (max. 134°C) Parts and materials Manifold: stainless-steel, silicone O-ring Quick Connection Coupling PVDF, closure: stainless-steel, sealing: FKM | FPM Inlet (manifold) Female thread, TR 20 + 2 Outlet Quick Connection Coupling (female), inner diameter NW 7, non-shut-off Microsart ® Base 47 mm Materials stainless-steel, silicone O-ring Suitable membrane filter diameter 47 mm Filtration area (e. g. for the use with Microsart ® Funnels) 12.5 cm² Ordering Information Microsart ® Combi.jet 2-Branch Manifold, Made of High-Grade Stainless-Steel, Without Frits and Funnels, to Accommodate Various Funnel Types Description Order No. Microsart ® Combi.jet 2-branch manifold, without base support and frits 16848-CJ Microsart ® Base 47 mm, with frit, stainless-steel base for Combisart ® and Microsart ® Combi.jet Optimized for the use with 47 mm membranes, Click-Fit closure for Microsart ® Funnel, Microsart ® @filter and other funnel types sealed by bayonet closure 1ZU---0002 Accessories and Replacement Parts Description Qty. Order No. Minisart ® SRP25, sterile filter for venting, 0.2 μm, individually sterile-packaged, could be autoclaved 5 times 50 17575--------ACK Plug luer lock, to close the Minisart ® inlet, if sterile venting is not required 12 17012----------E Plug, conical, to close the venting hole beside the 3-way-valve, if sterile venting is not required 10 6980225 Silicone O-ring for Microsart ® Base 47 mm male thread 3 6980274 Silicone O-ring for manifold female threads 3 6980235 Combisart ® single base, stainless-steel, optimal for the use with 50 mm membrane filters, funnel closure by bayonet or adapter 1 16840 Microsart ® Combi.jet Coupling, Quick Connection, PVDF 1 1EAS--0022 Funnels and filter holders to connect onto the Microsart ® Combi.jet manifold are equivalent to those for the use with the Combisart ® system (page 41).

8. Microbiological Enumeration 8 Membrane Filters Applications Membrane filters for colony counting, particle testing and microscopy. Benefits Some of the advantages you will benefit from when using this type of membrane filter: – Outstanding recovery rates for micro organisms – 0.45 μm are acc. to ISO 7704 – High-Flow membranes available – Three different colours available – Certified quality – Gamma irradiated, 25 kGrey – Easy counting of colonies due to perfect visibility of grid lines Specifications Design 47 or 50 mm in diameter, white, grey or green and gridded Growth Promotion Test acc. to ISO 7704 – No enhancement or inhibition by the grid lines – No enhancement or inhibition due to chemical extractables – No enhancement or inhibition by the sterilization process Sterility test Sterile Thermal resistance 130°C max. Thickness acc. to DIN 53105 115–145 μm Chemical compatibility Aqueous solutions (pH 4-8), hydrocarbons and several other organic solvents. Detailed information in section “Chemical Compatibility” under Cellulose Nitrate type 113 (page 113). Typical Performance Rates for Various Pore Sizes Pore size 0.2 μm* 0.45 μm** 0.45 μm High-Flow** 0.65 μm Flow rate for water per cm 2 at 1 bar acc. to DIN 58355 in ml/min 20 70 100 130 Coliform retention in % 100 100 100 n. a. Recovery rate lot-released acc. to ISO 7704 in % > 90 > 90 > 90 > 90 *) Pore size determined by quantitative retention of Brevundimonas diminuta in accordance with the ASTM Document F 838-83 (1993) Standard test method for determining bacterial retention of membrane filters utilized for liquid filtration. **) Pore size determined by quantitative retention of Serratia marcescens in accordance with the Standard Methods of Water and Waste Water Gridded Membrane Filters Cellulose Nitrate (Cellulose Mixed Ester), Individually, Sterile Packaged

10. Microbiological Enumeration 10 Membrane Filters Applications Membrane filters for colony counting, particle testing and microscopy. Benefits Some of the advantages you will benefit from when using this type of membrane filter: – Outstanding recovery rates for microorganisms – 0.45 μm are acc. to ISO 7704 – Three different colours available Specifications Design 25, 47 or 50 mm in diameter, white, grey or green and gridded Growth Promotion Test acc. to ISO 7704 – No enhancement or inhibition by the grid lines – No enhancement or inhibition due to chemical extractables Thermal resistance 130°C max. Thickness acc. to DIN 53105 115–145 μm Chemical compatibility Aqueous solutions (pH 4-8), hydrocarbons and several other organic solvents. Detailed information in section “Chemical Compatibility” under Cellulose Nitrate type 113 (page 113). Typical Performance Rates for Various Pore Sizes Pore size 0.2 μm* 0.45 μm** 0.65 μm Flow rate for water per cm 2 at 1 bar acc. to DIN 58355 in ml/min 20 70 130 Coliform retention in % 100 100 n. a. Recovery rate lot-released acc. to ISO 7704 in % > 90 > 90 > 90 *) Pore size determined by quantitative retention of Brevundimonas diminuta in accordance with the ASTM Document F 838-83 (1993) Standard test method for determining bacterial retention of membrane filters utilized for liquid filtration. **) Pore size determined by quantitative retention of Serratia marcescens in accordance with the Standard Methods of Water and Waste Water Gridded Membrane Filters Cellulose Nitrate (Cellulose Mixed Ester), Non-Sterile Packaged

26. Microbiological Enumeration 26 Culture Media Agar Media The traditional culture media for microor- ganisms is agar media. This can be used for the membrane filtration method or for direct incubation. There are two different forms available: Agar media in tubes are for pouring agar plates. The content of one tube is sufficient for two 90 mm or three 60 mm petri dishes. Agar media in bottles are the cost-effective alternative for cast- ing plates. Liquid Broth Media Liquid culture media broth for direct incubation or for wetting an absorbent pad before a membrane filter is placed on it. They are available in tubes and bottles. Absorbent Pads Sartorius 1.4 mm thick absorbent pads are wetted with the appropriate liquid culture medium before a membrane filter is placed on them. They come pre-sterilized in plastic magazines, which fit onto the Sartorius manual dispensing device. The absorbent pads are available in two diameters: – 47 mm with approx. 3 ml absorption capacity and – 50 mm with approx. 3.5 ml absorption capacity Culture Media in Bottles and Tubes Absorbent Pads and Petri Dishes Ordering Information Agar Media in 250 ml Bottles, 4 Bottles per Box Determination of Agar Type Order No. Total count Nutrient 14144----------A Yeasts and molds Wort 14157----------A Wild yeasts Lysine 14143----------A Lactobacilli and Pediococci and other beer-spoiling organisms VLB-S7-S 14148----------A Agar Media in 20 ml Tubes, 50 Tubes per Box Determination of Agar Type Order No. Total count Nutrient 14137----------K Total count Standard 14131----------K Yeasts and molds Wort 14138----------K Acid-tolerant microorganisms Orange serum 14130----------K Leuconostoc oenos and other wine-spoiling organ. Jus de tomate (tomato juice) 14140----------K Liquid Broth Media, for Drinking Water Analysis in 100 ml Bottles, 4 Bottles per Box Determination of Media Type Order No. Lactose fermenting Enterobacteria (E. coli and coliform bacteria) Lactose Broth 14155----------A

33. Microbiological Enumeration 33 Filtration Units Microsart ® Funnel 100 | Microsart ® Funnel 250 Sterile Disposable Funnels with Click-Fit In microbiological quality control, sterility of the equipment used for processing samples is a necessary basic requirement. The re-useable funnels made of stainless- steel or other materials which are used for membrane filtration are usually sanitized between samples by flaming or with hot water. Both of these methods can be insuf- ficiently reliable if not properly performed. Alternatively, the funnels can be sterilized by autoclaving which often is too laborious for routine use. A disposable filter funnel is the ideal choice for more reliability and saving time. Description Microsart ® Funnels are sterile plastic fun- nels, which are available for the filtration of various sample volumes. They allow quick performance of the filtration steps required in the routine testing of water, food and beverages, pharmaceutical and cosmetic products. The funnel is made of polypropylene and thus is elastic enough for optimal sealing with a Click-Fit closure. Graduations are marked to allow accurate sample volumes. The large inner diameter ensures a high- flow rate and the optimized shape allows thorough rinsing of the system sub sequent to filtration: no liquid is retained in the filter funnel. Microsart ® Base 47 mm The Microsart ® Base 47 mm is the perfect addition to existing Combisart ® and Microsart ® Combi.jet stainless-steel mani- folds. The slightly recessed frit ensures the plane positioning of the membrane filter. Recessed parts for the tweezers at the rim of the base make sure that the membrane can be removed easily after filtration. Microsart ® Funnel Dispenser The Funnel Dispenser for secure removal of single, sterile Microsart ® Funnels. Even after opening the bag, the remaining funnels are protected from secondary contamination. Applications Colony counting, particle testing and microscopy. Benefits Some of the advantages you will benefit from when using Microsart ® Funnel 100 | 250: – Reliable Results Use a new, sterile funnel for each test for secure prevention of cross contami- nation! – Time-Saving Just change the funnel, rather than spending time and money sanitizing it! – Simpler Handling No more flaming, thus no holding of hot funnels! The clear material allows easy visualisation of the status of filtration, particularly useful in routine testing.

56. Microbiological Enumeration 56 Filtration Equipment Accessories for Vacuum Filter Holders and Manifold Systems Suction Flask, 2 Liter Capacity Vacuum-resistant flask made of duran 50 glass with plastic safety hose nipple according to the German Industrial Standard No. 12476. Outer diameter of the hose nipple, 9 mm. Inner diameter of the opening, 60 mm. Stoppers are not enclosed. A 1-liter capacity flask is available for countries which do not have safety restrictions on glass hose nipples. Ordering Information Suction Flasks Description Order No. Suction flask, 5 liters acc. to DIN 12476, incl. stopper 75 D and glass tube 16672-----1 Suction flask, 2 liters acc. to DIN 12476, without stopper 16672 Tube connector for connecting a Combisart ® stainless-steel manifold to a suction flask 1 or 2 liters (not necessary when a Vacusart ® is connected directly to the bored stopper) 17204 Suction flask, 1 liter (not available in countries which have safety restrictions on glass hose nipples) 16606 Replacement Parts Description Order No. Glass tube for silicon stopper 75 D for suction flask 5 liters 16672-----1 1EAQ--0017 Bored stopper 75 D for suction flask 5 liters 16672-----1 1EAS--0019 Assembling kit for hose barb for suction flask 5 liters 16672-----1 1EA---0018 Hose barb, complete, Polypropylene, for suction flask 2 liters 16672 6983003 Bored Stoppers for Suction Flask 2 Liters 16672 Description Adaptation Order No. Silicone stopper Combisart ® individual base 16841 or other individual stainless-steel filter holders (16201, 16219, 16220) onto the suction flask 16672 17173 Silicone stopper 16306 |15 (glass funnels, 30 ml) onto the suction flask 16672 17174 Silicone stopper 16307 (glass funnel, 250 ml) onto the suction flask 16672 17175 Bored Stoppers for Suction Flask 1 Liter 16606 Description Adaptation Order No. Silicone stopper Combisart ® individual base 16841 or other individual stainless-steel filter holders (16201, 16219, 16220) onto the suction flask 16606 17004 Silicone stopper 16306 |15 (glass funnels, 30 ml) onto the suction flask 16606 17005 Silicone stopper 16307 |16 (glass funnel, 250 ml) onto the suction flask 16606 17006 Suction Flasks and Stoppers

13. Microbiological Enumeration 13 Membrane Filters Fully automated membrane filter dispenser for high throughput of membrane filters. The membrane filters are automatically individually removed from their sterile packaging – either in a touch-free mode via an optical sensor or at the touch of a button. A foot switch can be optionally connected to the dispenser. Thanks to their motorized traction roller, each filter is quickly and reliably dispensed. A dispensing operation is triggered when the optical sensor detects approaching tweezers. It’s simple and fast. Applications Membrane filters for colony counting, particle testing and microscopy. Benefits The clear, compact design of the dispenser allows quick and easy cleaning. The dispenser’s low weight makes it easy to be transported. Both its functions and design are ideal, giving you the versatility and flexibility you need in your lab. Some of the advantages you will benefit from when using the Microsart ® e.motion dispenser: – Fully automated membrane filter dispenser – Works hands-free by an optical sensor – Works by the touch of a button – Rapid and reliable transport – Easy insertion of the filter band – Easy-to-clean – Robust – Small footprint Specifications Dimensions (L + H + W) in mm 204 + 213 + 165 Weight 2.9 kg Operating voltage 110 V/230 V optional Frequency 50–60 Hz Max. power Consumption 10 W Dispensing speed 0.5 sec Dispenser delay 5 sec Certificates CE Mark and EMC Directive, European Standards EN 50081-1 and –2, EN 50082-1 and -2, EN 61010 Ordering Information Description Order No. Microsart ® e.motion dispenser, fully automated membrane filter dispenser 16712 Foot switch for Microsart ® e.motion dispenser 1ZE---0028 Microsart ® e.motion Dispenser

61. 1 4 3 5 2 Microbiological Enumeration 61 Filtration Equipment Microsart ® e.jet with Quick Connection Ordering Information Description Order No. No. in Picture Microsart ® e.jet Transfer Pump with Quick Connection, without tubings, inlet and outlet hose nipples for DN 10 tubings 166MP-4 1 Accessories Description Order No. No. in Picture Tubing with Quick Connection Coupling (PSU), silicone, 20 cm, for vacuum-sided connection, inner diameter DN 10, outer diameter DN 20, wall thickness 5 mm (when ordering, please state length required in meters) 1ZA---0006 2 Silicone tubing with Quick Connection Coupling, 1 m, vacuum sided 1ZAS--0016 Silicone tubing, 1 m, for pressure-sided connection, inner diameter DN 10, outer diameter DN 14, wall thickness 2 mm 1ZAS--0007 3 Silicone tubing pressure-sided, 2 m 1ZAS--0019 Silicone tubing pressure-sided, 10 m 1ZAS--0020 Foot switch for Microsart ® e.jet Transfer Pump 1ZE---0053 Replacement Parts Description Order No. No. in Picture Pump head complete for 166MP-3 and 166MP-4 1EP---0003 Power supply complete for 166MP-3 and 166MP-4 1EE---0012 Threaded Fittings Quick Connection set, 2 Nipples (POM) on R3/8” male thread and 2 Couplings (PSU) on DN 10 hose nipple 1EAS--0027 4 Quick Connection Nipple, stainless-steel 1EAS--0026 5 DN 10 hose nipple on R3/8” male thread 1EAF--0020

64. Microbiological Enumeration 64 Filtration Equipment Colony Counter Compact, handy battery-operated colony counter, as simple to use as a ball point pen, and has a 4-digit LCD-display. The counter is supplied with an additional marker refill. Ordering Information Description Order No. Colony counter 17649 Replacement part: Black marker refill 6981540 Specifications Voltage 100–240 V Frequency 50 | 60 Hz Rated power 0.045 kW Weight 7.2 kg (15 lbs) Max. shelf load 2 kg (4.4 lbs) Dimensions W|H|D (mm) Inner 290 | 180 | 310 Outer 470 | 260 | 415 Temperature range 17°C to 40°C Temperature stability at 37°C Less than ±0.2°C Temperature uniformity at 37°C ±1.2°C Capacity approx. 18 liters Ordering Information Description Order No. Incubator 18119 Compact, space-saving incubator for the incubation of membrane filters on nutrient pads or other nutrient media. The incubator has a capacity of 18 liters and is designed to hold the following numbers and sizes of petri dishes: 200 + 47 mm or 160 + 56 mm | 60 mm or 72 + 90 mm. Incubator The swing-up cover and removable insertion plate simplify loading and unloading. The cover is opaque, avoiding light penetration into the chamber.

53. Microbiological Enumeration 53 Filtration Equipment Individual Filter Holders The three stainless-steel holder types differ only in the funnel capacity (either 40 ml, 100 ml or 500 ml). They have been designed specifically for applications in which the particles or microorganisms retained on the membrane filter surface are of interest. The stainless-steel frit filter support ensures a uniform distribution of the residues. Simple handling is very important regard- ing routine examinations. Stainless-steel taps in the base allow the vacuum to be turned on and off. The special closure clamps simplify the addition or removal of the funnels adding to the ease of use. Multi-Branch Manifolds The manifold systems are available with 100 ml or 500 ml capacity funnels. The three or six separate filter holders save time when mass examinations have to be carried out. Due to the stainless-steel taps on the manifold ports, the vacuum for each holder can be turned on and off individually. The stainless-steel frit allows homogenous dis- tribution of the residues on the membrane filter surface. Funnel and filter support can be disinfected by flaming. Glass Filter Holders These filter holders are available for the filtration of small volumes with a 30 ml top part and for larger volumes with a 250 ml top part. They can be sterilized by auto- claving (max. 134°C) or by dry heat (max. 180°C). The glass frit ensures uniform distribution of retained residue. Polycarbonate Filter Holders Type 16510 is complete with receiver flask, and can be operated with vacuum as well as with slight overpressure (0.5 bar is recommended for highest standing times). Type 16511 is like 16510, but without receiver flask. It is used on a suction flask or a vacuum manifold e. g. Combisart ® systems. Both devices can be sterilized by autoclaving (max. 121°C). Traditional Multi-Branch Manifolds and Individual Filter Holders Made of Stainless-Steel, Glass and Polycarbonate Specifications Stainless-steel quality High-grade stainless-steel: B.S. 304S31 | AISI 304 Dimensions in mm (W|H|D) 3-branch manifold: 3 + 100 ml: 432 | 184 | 120 3 + 500 ml: 442 | 262 | 132 6-branch manifold: 6 + 100 ml: 906 | 268 | 120 6 + 500 ml: 916 | 329 | 132 Max. operating pressure Vacuum or max. 2 bar pressure (29 psi) Sterilization By autoclaving (max. 134°C), By dry heat (max. 180°C), By flaming, By other methods acc. to ISO 8199 Parts and materials Lid, funnel, base part, – filter support, clamp and tap made of stainless-steel. Silicone flat gasket. Silicone lid seal Flow rate per filter station for water at 90% vacuum 200 ml/min with 0.2 μm membrane filter 600 ml/min with 0.45 μm membrane filter Filtration area 12.5 cm 2 Suitable membrane filter diameter 50 mm (47 mm, if using a 47 mm frit filter support 6980103) Outlet spouts (individual system) 10 mm outside diameter Outlet (branches only) Hose nipple, DN 10

44. 6981001 stainless steel lid 6981003 silicone lid seal 6981002 funnel 500 ml with clamp 6980264 clamp 6980102 stainless steel frit 50 mm 6980103 stainless steel frit 47 mm 16840* (incl. 50 mm frit and silcone gasket) stainless steel single base 16840* single base 16840* single base 6980124 silicone flat gasket 6980104 PTFE flat gasket 6980235 silicone O-ring (pack of 3) 6980271 silicone O-ring 16 2 mm + 1EAS--0026 quick connection nipple 6980271 silicone O-ring 16 2 mm + 6980270 stainless steel cap 16844 1-branch 16842 3-branch 16843 6-branch Manifolds without base supports and funnels: 6981063 stainless steel lid 6981064 silicone lid seal 6981065 funnel 100 ml with clamp 6980264 clamp 6981004 funnel 40 ml with clamp 6980267 stainless steel 3-way tap 6980268 knurled nut 6980225 Plug conical (pack of 10) 17575-ACK Minisart SRP (pack of 50) 17012-E Plug Luer Lock (pack of 12) 6980274 8 20 + silicone O-ring *) Alternatively to 16840 the Microsart Base 47 mm is highly recommended for all 47 mm membrane filters, Microsart Funnels and Microsart @filter units. ® ®® 6980272 hose nipple Microbiological Enumeration 44 Filtration Equipment Replacement Parts for Combisart ® Individual Filter Holders Replacement Parts for Combisart ® Manifolds

107. Air Monitoring 107 Accessories If the disposable gelatine filter unit is not placed directly at the MD8 airscan ® , but at a distance from it, a flexible plastic hose (2 m or 5 m), a connectors set and, if not available, a holder (tripod 16970, double socket 16976, clamp 17037), are necessary for the connection between filter and MD8 airscan ® . The autoclavable silicone hose is used instead of the flexible plastic hose, if the MD8 airscan ® has to be used in sterile rooms, operating rooms, isolators, blow-fill- seal machines, etc. With this hose attached to the air outlet connector (exhaust), the waste air can be led off into another room. Ordering Information Description Order No. Flexible PVC hose with reinforced ends (2 m) 17085 Flexible PVC hose with reinforced ends (5 m) 17088 Silicone tubing, sterilizable (1 m, state length required) 17662 Set of connectors (consisting of 17658 and 17659), aluminum 17657 Connector (air sampler inlet to flexible hose), aluminum 17658 Connector (flexible hose to filter holder | adapter), aluminum 17659 A stable case for the transport and storage of a MD8 airscan ® , incl. accessories. Ordering Information Description Order No. Case for MD8 airscan ® 17208 It consists of a middle part, 10 numbered filter holders and 2 end caps. The stack is first sterilized (by 180°C dry heat, 2 h), and then equipped with the filters under sterile conditions (LF cleanbench). The prepared filter holders are put on one side of the middle part. After removing the sample, the inserted filter holders are put on the other side of the middle part, so that used and unused filter holders are separated from each other. Ordering Information Aluminium Stack Description Order No. Aluminum stack for MD8 air samplers 17656 Replacement Parts Description Order No. Individual filter holders for gelatine filter type 12602--80----ALK 17655 Middle part 17660 End cap 17661 The MD8 airscan ® (16746; 16747) is not in compliance with the “Restriction of Hazardous Substances Directive (RoHS, 2011/65/EU)” and therefore its (spare part) availability is restricted for exchange and maintenance only. Tubing and Connectors Set Case Aluminum Stack

114. Chemical Compatibility 114 Filter Materials 1. Filter Materials Cellulose Acetate Cellulose Nitrate Reg. Cellulose PTFE Polyamide Glass Fiber Polycar- bonate Poly ether- sulfone Solvents 111 113 184 118 250 134 230 154 Acetone – – • • – • – Acetonitrile ? ? • • – ? ? • Gasoline •••••••• Benzene ••••••? • Benzyl alcohol ••••? – n-Butyl acetate –•••••• n-Butanol •••••••• Cellosolve • – • • ? • – • Chloroform – •••••–– Cyclohexane ••? ••– Cyclohexanone – – ••••? ? Diethylacetamide – – ••••? ? Diethyl ether • – •••••? Dimethyl formamide – – • •–? Dimethylsulfoxide – – ••••–– Dioxane – – ••••–• Ethanol, 98% • •••••• Ethyl acetate – – ••••? – Ethylene glycol • ••? ••• Formamide ? ? ? • ? • – ? Glycerine •••••••• n-Heptane ••••? •? ? n-Hexane •••••••? Isobutanol •••••? Isopropanol • •••••• Isopropyl acetate – • • ? • ? • Methanol, 98% • – • • ? • • • Methyl acetate – – ••••? – Methylene chloride – ••••–– Methyl ethyl ketone – – ••••? – Methyl isobutyl ketone • – ••••? ? Monochlorobenzene ••••••–? Nitrobenzene • ••••–? n-Pentane •••••••? Perchloroethylene •••••••? Pyridine – – ••••–– Carbon tetrachloride •••••? • Tetrahydrofuran – – ••••–– Toluene • • ••••? • Key to symbols see next page.

102. Air Monitoring 102 BACTair™ BACTair™ – Big Impact Microbiological Air Monitoring by the Impaction Method A new developed system for sampling airborne organisms that allows impaction onto culture media plates, where the plates function directly as collection heads. This means that the collection properties are integrated right into the culture media plates. Metal sieve plates or metal collection heads with slots, which have to be sterilized for routine samplings on a regular basis, are elimi- nated. Now, non-sterile sieves or slots have become a thing of the past. The geometry of the culture medium plate and the 400 holes in the sieve plate yield exceptional sampling efficiency, which is generally higher than that of other impaction samplers. This new method uses the AirPort MD8 air sampler to draw the air stream over the BACTair™ Culture Media Plates. BACTair™ is ready-to-connect to the AirPort MD8. BACTair™ offers the following benefits: – Individually, sterile packaged – Integrated disposable sieve – Pre-filled with agar media – Samples 1 m 3 in just 8 min – Optimized geometry Specifications Material Polystyrene Dimensions 116 + 24 mm Number of impaction holes 400 holes, d 0.47 mm each High retention of particles > 0.65 μm Sterilization Gamma irradiation Ordering Information BACTair™ Culture Media Plates with Agar, 110 mm, Individually, Sterile Packaged, 10 Units Determination of Medium Type Order No. Total Count Tryptic Soy Agar (TSA) 14320-110----ACD Yeasts and molds Sabouraud Agar (acc. USP) 14321-110----ACD Air Sampler Description Order No. AirPort MD8 Air Sampler for BACTair™ incl. charger 16757 Accessories Order No. Adapter for BACTair™ on the AirPort MD8 air sampler 17803 Covers for BACTair™ Culture Media Plates, 10 + 2 units individually, sterile packaged 1ZPX-D0002 BACTair ™ Plates, sterile, without media, 50 units 14301-110------K Special brochures are available on request. Order no. SM-4023-e and SL-2047-e

43. Microbiological Enumeration 43 Filtration Equipment Ordering Information Combisart ® Individual System and Multi-Branch Manifolds, Made of High-Grade Stainless-Steel, Pre-Assembled with Stainless-Steel Funnels and Lids Description Capacity Order No. Combisart ® individual filter holder, stainless-steel, 100 ml 1 + 100 ml 16219-CS Combisart ® individual filter holder, stainless-steel, 500 ml 1 + 500 ml 16201-CS Combisart ® 1-branch stainless-steel manifold, 100 ml 1 + 100 ml 16844-CS Combisart ® 1-branch stainless-steel manifold, 500 ml 1 + 500 ml 16845-CS Combisart ® 3-branch stainless-steel manifold, 100 ml 3 + 100 ml 16824-CS Combisart ® 3-branch stainless-steel manifold, 500 ml 3 + 500 ml 16828-CS Combisart ® 6-branch stainless-steel manifold, 100 ml 6 + 100 ml 16832-CS Combisart ® 6-branch stainless-steel manifold, 500 ml 6 + 500 ml 16831-CS Combisart ® Individual and Multi-Branch Bases, Made of High-Grade Stainless-Steel, Without Funnels and Lids, to Accommodate Various Funnel Types Description Order No. Combisart ® individual base, stainless-steel, with frit (50 mm), to accommodate stainless-steel funnels and Biosart ® 100 | 250 16841 Combisart ® 1-branch stainless-steel manifold, without frit 16844 Combisart ® 3-branch stainless-steel manifold, without frits 16842 Combisart ® 6-branch stainless-steel manifold, without frits 16843 Combisart ® Single base with frit (for 50 mm membranes), stainless-steel, accommodate stainless-steel funnels and Biosart ® 100 | 250 16840 Microsart ® Base 47 mm, with frit, stainless-steel base for Combisart ® and Microsart ® Combi.jet Optimized for the use with 47 mm membranes, Click-Fit closure for Microsart ® Funnel, Microsart ® @filter and other funnel types sealed by bayonet closure 1ZU---0002 Combisart ® Hardware Set-Ups Choose complete filtration systems easy and fast under: www.sartorius.com/microbio

35. Microbiological Enumeration 35 Filtration Units The pharmaceutical and biotech industries are driven by the need to optimize their work flows and increase efficiency without compromising their level of safety. Prod- ucts and raw materials used in the pharma- ceutical or biotech industry require control of microbial levels during processing and handling. All components of the filtration system must comply with international guidelines, such as USP, EP or ISO stand- ards. Description Microsart ® @filter 100 and 250 filter units are a ready-to-use combination of funnel, filter base and gridded membrane in one unit. The range of Microsart ® @filter types has been tailored to meet individual needs: It is possible to choose between two vol- ume sizes, 100 ml and 250 ml, different pore sizes and different filter colours for contrasting backgrounds during evaluation. The filter units exist as tray versions with lids or are stacked in bags for safe removal using the Microsart ® Funnel Dispenser. Despite the diversity of Microsart ® @filters one thing is common: The optimal design. – Click-Fit fastening allows for easy remov- al of funnels – Leaking-free procedure due to innovative Click-Fit and bayonet closures – Bayonet closure allows for easy mounting and removal of units – Sterile Filter Base with recesses allows for simple membrane removal – Innovative geometry of the funnel allows for effective rinsing after filtration (no sample residue is left in the funnel) They have been specifically developed for the detection and enumeration of microor- ganisms in pharmaceuticals, biopharma- ceuticals and cosmetics. Microsart ® @vance ® The Microsart ® product family consists of all the most recent products from Sartorius for microbiological analysis, which are especially characterized by innovation and clever design. Microsart ® @filter not only saves time and labor costs but minimizes the risk of second- ary contamination – that’s advanced colony counting by Sartorius. Microsart ® Funnel Dispenser The Funnel Dispenser for secure removal of single, sterile Microsart ® @filter. Even after opening the bag, the remaining funnels are protected from secondary contamination. Applications Filtration and enumeration of micro- organisms in liquids like pharmaceuticals, biopharmaceuticals and cosmetics. Benefits Some of the advantages you will benefit from when using Microsart ® @filter units: Safe and Reliable – Sterile Packaged Sterilization at the point of use is not required – Fully Disposable Base and Funnel Preparation-and sterilization-free procedure reduces the risk of secondary contamination – Optimized Design and Materials No liquid remains after filtration, eliminates the need of rinsing Easy Handling – Click-Fit Closure Fast in routine analysis, eliminates the risk of leakage Economy – Adaptable on Combisart ® Given flexibility, no additional invest- ment required – Transparent Funnel Material Visibility of the complete filtration Microsart ® @filter 100 | Microsart ® @filter 250 Sterile Disposable Filter Units for Advanced Colony Counting

105. Air Monitoring 105 Air Sampler AirPort MD8 AirPort MD8 is an air sampler for the pharmaceutical, biotechnology, and food and beverage industries, and for hospitals’ environmental care and for work safety. AirPort MD8 Offers the Following Benefits – Battery powered and portable for universal use – Battery power level clearly indicated so constant performance during sampling is guaranteed – Ergonomic design and easy to clean – Flexible adjustment possibilities of the volume flow and the sample volume – User-friendly prompting with the option of four languages; English, French, German and Spanish – Parameters last used stored even after automatic shut-off – The device can be calibrated locally For guaranteeing reliable and exact measurement results, AirPort MD8 uses the gelatine membrane filter method or the impaction method with BACTair™. Specifications AirPort MD8 Volume flow regulation By an integrated impeller wheel. Volume flow adjustable 30 l/min., 40 l/min., 50 l/min. and 125 l/min. Fixed given sample volumes 25, 50, 100, 250, 500, 750 and 1000 liters. In addition, the sample volume can be chosen manually in 5-liter steps. Operational life with one battery Approx. 4.5 hours for 50 l/min battery charge Noise level For gelatine membrane filters 48 dB (A) Weight Approx. 2.5 kg Dimensions (L + W + H) 300 + 135 + 165 mm Inclusive adapter 17801 (for disposable gelatine filter units) Power Supply Battery NiMH 16.8 Volt/3800 mAh Battery charger input 100–240 V/47–63 Hz/600 mA Battery charger output 24 V/1000 mA Charging time Approx. 4.5 hours for empty battery Ordering Information AirPort MD8 Description Order No. AirPort MD8, complete with two adapters (17801 and 17803) and battery charger (69898525). 16757 Accessories and Replacement Parts Order No. Adapter for BACTair™ on the AirPort MD8 air sampler 17803 Holder for disposable gelatine filter units 17801 Battery charger 69898525 Ordering Information for Consumables Please refer to the following pages. Special brochures available on request. Order no. SM-1502-e and SM-4023-e

55. Microbiological Enumeration 55 Filtration Equipment Ordering Information Individual Stainless-Steel Filter Holders, Pre-Assembled with Stainless-Steel Funnels and Lids Description Capacity Order No. Individual stainless-steel filter holder, 100 ml 1 + 100 ml 16219 Individual stainless-steel filter holder, 500 ml 1 + 500 ml 16201 Individual stainless-steel filter holder without lid, 40 ml 1 + 40 ml 16220 Multi-Branch Manifolds, Stainless-Steel, with Stainless-Steel Funnels and Lids Description Capacity Order No. 3-branch stainless-steel manifold, 100 ml 3 + 100 ml 16824 3-branch stainless-steel manifold, 500 ml 3 + 500 ml 16828 6-branch stainless-steel manifold, 100 ml 6 + 100 ml 16832 6-branch stainless-steel manifold, 500 ml 6 + 500 ml 16831 Glass Filter Holders Description Membrane Filter Diameter Capacity Order No. Glass filter holder, complete with filter support, funnel and metal clamp 25 mm 30 ml 16306 Glass filter holder, complete with filter support, funnel and metal clamp 47 | 50 mm 250 ml 16307 Polycarbonate Filter Holder Description Membrane Filter Diameter Capacity Order No. Polycarbonate filter holder, with 250 ml top part and receiver flask, for vacuum or pressure filtration 47 mm 250 ml 16510 Polycarbonate filter holder, with 250 ml top part, for vacuum filtration only 47 mm 250 ml 16511

75. Sterility Testing 75 Sterisart Universal Pumps Specifications Pump flow rate 70–650 ml/min Power requirements 100–240 VAC Frequency 50–60 Hz Power consumption 100 W Dimensions Pump Pump with holding ring for bottles, container approx. 336 + 260 + 210 mm (with lever) (W + D + H) approx. 440 + 365 + 485 mm (W + D + H) Weight Basic version 16419 Upgraded version 16420 with display and user software approx. 13.5 kg approx. 14.6 kg Ordering Information Description Order No. Sterisart Universal pump, basic version 16419 Sterisart Universal pump, upgraded version with display and user software 16420 Accessories Description Order No. Footswitch 1ZE---0033 Adapter for Sterisart NF units, fitting into container for draining of Millipore Equinox pump 1ZG---0014 Transport trolley 1ZE---0039 Communication kit 1ZE---0040 Installation kit for isolators 1ZE---0050 Container for draining 1ZG---0028 Drain Tubing 1ZA---0002 Further accessories are available on request.

116. Chemical Compatibility 116 Filter Holder | O-ring Materials 2. Filter Holder | O-ring Materials Glass Poly- carbonate Poly- propylene PTFE Stainless- Steel EPDM O-ring PTFE O-ring Silicone O-ring Fluoro- elastomer O-ring Solvents Acetone • • ••••–– Acetonitrile • ? • • • •–• Gasoline • • ••–•–• Benzene • – – • • – • – • Benzyl alcohol • – • • • ••• n-Butyl acetate • – ••••–– n-Butanol • • • •••••• Cellosolve • – – • • •–– Chloroform • – – • • – • – • Cyclohexane • • ••–•–• Cyclohexanone • – • • • – • – – Diethylacetamide • – ? • • ? • • – Diethyl ether • – ••–•–– Dimethyl formamide • – • •••• – Dimethylsulfoxide • ? ? • • ? • – Dioxane • – ••••–– Ethanol, 98% • • • •••••• Ethyl acetate • – • ••••–– Ethylene glycol • • • •••••• Formamide • – • ••••– Glycerine • • •••••• n-Heptane • • • • • – • • • n-Hexane • • • • • – • – • Isobutanol • • • •••••• Isopropanol • • •••••• Isopropyl acetate • • • ••••–– Methanol, 98% • – • •••••• Methyl acetate • ? • ••••–– Methylene chloride • – – • • – • – Methyl ethyl ketone • – • ••••–– Methyl isobutyl ketone • – ? • • – • – – Monochlorobenzene • – • • • – • – • Nitrobenzene • – ••–•–– n-Pentane • • • • • – • – • Perchloroethylene • – ••–•–• Pyridine • – ••–•–– Carbon tetrachloride • – ••–•–• Tetrahydrofuran • – ••–•–– Toluene • – • • • – • – Key to symbols see next page.

27. Microbiological Enumeration 27 Culture Media Broth Media in 20 ml Tubes, 50 Tubes per Box Determination of Broth Type Order No. Lactobacilli and Pediococci and other beer-spoiling organisms VLB-S7-S 14127----------K Absorbent Pads, 47 mm, Sterile Packaged in 10 Magazines, Each with 100 Pads Description Packaging Order No. Absorbent Pads, 10 + 100 pads 1,000 per box, incl. one dispenser 15410--47----ALR Absorbent Pad Set, 10 + 100 pads plus 1,000 membrane filters (0.45 μm, white | green) 1,000 per box, incl. two dispensers 13906--47----APR Absorbent Pads, 47 mm, Sterile Packaged of 10 Discs per Sleeve Description Packaging Order No. Absorbent Pad Set, 10 + 10 pads in sleeves plus 100 membrane filters (0.2 μm, white | black) 100 per box 13707--47----ALN Absorbent Pad Set, 10 + 10 pads in sleeves plus 100 membrane filters (0.45 μm, white | black) 100 per box 13706--47----ALN Absorbent Pads, 50 mm, Sterile-Packaged in 10 Magazines, Each with 100 Pads Description Packaging Order No. Absorbent Pads, 10 + 100 pads 1,000 per box, incl. one dispenser 15410--50----ALR Absorbent Pads, 50 mm, Sterile-Packaged in Petri Dishes Description Packaging Order No. Absorbent Pad Set, 100 pads in petri dishes, sterile packaged 100 per box 15400--50------N Absorbent Pad Set, 100 pads in petri dishes plus 100 membrane filters (0.45 μm, green | dark green) 100 per box 15400--50----FRN Disposable Petri Dishes, Auto-Sterile, 100 per Box Diameter Order No. 60 mm 14311--60------N 90 mm 14311--90------N

88. Media Preparation Working Cell Bank Seed Culture Harvest Fermentation Sampling Mycoplasma Contamination Control 88 Microsart ® AMP Mycoplasma Typical Sampling Steps for Mycoplasma Testing Specifications Each kit contains reagents for 25 or 100 reactions. The expiration date of the unopened package is specified on the package label. The kit components are to be stored until use at +2 to +8°C and must be stored after opening and rehydration below –18°C. The lot-specific Certificate of Analysis can be downloaded from the manufacturer’s website (www.minerva-biolabs.com). Kit Component 25 Reactions 100 Reactions Order No. SMB95-1001 SMB95-1002 Mycoplasma Mix 1 + lyophilized 4 + lyophilized Rehydration Buffer 1 + 1.3 ml 4 + 1.3 ml Positive Control 1 + lyophilized 4 + lyophilized Internal Control 1 + lyophilized 4 + lyophilized PCR grade Water 1 + 1.4 ml 4 + 1.4 ml

93. Mycoplasma Contamination Control 93 Microsart ® RESEARCH Mycoplasma Specifications Each kit contains reagents for 25 or 100 reactions. The expiration date of the unopened package is specified on the package label. The kit components are to be stored until use at +2 to +8°C, and must be stored after opening and rehydration below –18°C. The lot-specific Certificate of Analysis can be downloaded from the manufacturer’s website (www.minerva-biolabs.com). Kit Component 25 Reactions 100 Reactions Order No. SMB95-1005 SMB95-1006 Mycoplasma Mix 1 + lyophilized 4 + lyophilized Rehydration Buffer 1 + 1.0 ml 3 + 1.0 ml Positive Control 1 + lyophilized 1 + lyophilized PCR grade Water 1 + 1.0 ml 1 + 1.0 ml Ordering Information Mycoplasma Kits Description Quantity Order No. Microsart ® RESEARCH Mycoplasma 25 SMB95-1005 Microsart ® RESEARCH Mycoplasma 100 SMB95-1006 Accessories Microsart ® AMP Extraktion 50 extractions SMB95-2003 Related Products Microsart ® AMP Mycoplasma 25 SMB95-1001 Microsart ® AMP Mycoplasma 100 SMB95-1002 Microsart ® ATMP Mycoplasma 25 SMB95-1003 Microsart ® ATMP Mycoplasma 100 SMB95-1004

91. Mycoplasma Contamination Control 91 Microsart ® ATMP Mycoplasma Specifications Each Kit contains all required reagents for 25 or 100 reactions including polymerase as part of the Mycoplasma Mix. The expiration date of the unopened package is specified on the package label. The kit components are to be stored until use at +2 to +8°C and must be stored after opening and rehydration below -18°C. The lot-specific Certificate of Analysis can be downloaded from the manufacturer’s website (www.minerva-biolabs.com). Kit Component 25 Reactions 100 Reactions Order No. SMB95-1003 SMB95-1004 Mycoplasma Mix 1 + lyophilized 4 + lyophilized Rehydration Buffer 1 + 1.0 ml 2 + 1.0 ml Positive Control 1 + lyophilized 1 + lyophilized Internal Control 1 + lyophilized 4 + lyophilized PCR grade Water 1 + 1.5 ml 4 + 1.5 ml Ordering Information Mycoplasma Kits Description Quantity Order No. Microsart ® ATMP Mycoplasma 25 SMB95-1003 Microsart ® ATMP Mycoplasma 100 SMB95-1004 Accessories Microsart ® AMP Extraktion 50 extractions SMB95-2003 Related Products Microsart ® AMP Mycoplasma 25 SMB95-1001 Microsart ® AMP Mycoplasma 100 SMB95-1002 Microsart ® RESEARCH Mycoplasma 25 SMB95-1005 Microsart ® RESEARCH Mycoplasma 100 SMB95-1006

117. Chemical Compatibility 117 Filter Holder | O-ring Materials Glass Poly- carbonate Poly- propylene PTFE Stainless- Steel EPDM O-ring PTFE O-ring Silicone O-ring Fluoro- elastomer O-ring Solvents Trichloroethane • – ? • • – • – • Trichloroethylene • – – • • – • – • Xylene • – ••–•– Acids Acetic acid, 25% • • • •••••– Acetic acid, 96% • – • ••••? – Hydrofluoric acid, 25% – – • • – •– Hydrofluoric acid, 50% – – • • – •– Perchloric acid, 25% • • •–••–• Phosphoric acid, 25% • •• ••–• Phosphoric acid, 85% • •• ••–• Nitric acid, 25% • – • • – •–• Nitric acid, 65% • – – • – – • – • Hydrochloric acid, 25% • ••– •–• Hydrochloric acid, 37% • – • • – • • – • Sulfuric acid, 25% • • • • ••–• Sulfuric acid, 98% • – – • – – • – • Trichloroacetic acid, 25% • • •–••–– Bases Ammonium, 1N • – • ••••–– Ammonium hydroxide, 25% • – • •••••– Potassium hydroxide, 32% • – • •••• Sodium hydroxide, 32% • – • •••• • Sodium, 1N • – • •••••• Aqueous Solutions Formaline, 30% • • • •••• • Sodium hypochlorite, 5% • • • •••••• Hydrogen peroxide, 35% • • • •••••• Key to Symbols • = compatible = limited compatibility – = not compatible ? = not tested Contact time: 24 hours at 20°C Chemical compatibilities can be influenced by various factors. Therefore, we recommend that you confirm compatibility with the liquid you wish to filter by performing a trial filtration run before you begin with actual filtration.

115. Chemical Compatibility 115 Filter Materials Cellulose Acetate Cellulose Nitrate Reg. Cellulose PTFE Poly- amide Glass Fiber Polycar- bonate Poly ether- sulfone Solvents 111 113 184 118 250 134 230 154 Trichloroethane •••? •? ? Trichloroethylene ••••••–• Xylene •••••••• Acids Acetic acid, 25% •••• ? • Acetic acid, 96% – – • • – ? ? • Hydrofluoric acid, 25% • •–? •? Hydrofluoric acid, 50% • – • – ? • ? Perchloric acid, 25% – •– ??? Phosphoric acid, 25% • •– ??? Phosphoric acid, 85% •– ? –? Nitric acid, 25% – – • – ? • • Nitric acid, 65% –––•– ? •• Hydrochloric acid, 25% – – • – ? • • Hydrochloric acid, 37% –––•– ? •• Sulfuric acid, 25% – •–•? • Sulfuric acid, 98% –––•– ? –? Trichloroacetic acid, 25% – ••–? ? ? Bases Ammonium, 1N • • •••–• Ammonium hydroxide, 25% – – • – • Potassium hydroxide, 32% – – • –• Sodium hydroxide, 32% – – • – • Sodium, 1N – •••– • Aqueous Solutions Formaline, 30% • • •• • Sodium hypochlorite, 5% • •• •? ? Hydrogen peroxide, 35% • • • ??? Key to Symbols • = compatible = limited compatibility – = not compatible ? = not tested E = compatible after replacing silicone O-ring with an EPDM O-ring V = compatible after replacing the silicone O-ring with a Fluoroelastomer O-ring Contact time: 24 hours at 20°C Chemical compatibilities can be influenced by various factors. Therefore, we recommend that you confirm compatibility with the liquid you wish to filter by performing a trial filtration run before you begin with actual filtration.

119. Get an overview of our high-quality laboratory instruments, high-grade consumables and excellent services. Our product portfolio focuses on laboratory instruments, such as lab balances, pipettes and laboratory water purification systems. Moreover, we offer the widest range of consumables like laboratory filters and pipette tips. Did You k n ow ... ... that you can order more lab catalo g s ? P u rifi cat i o n Pr oducts Laboratory Water Purification Products Publication No.: SL-0002-e Order No.: 85037-548-54 Laboratory Filtration Products Laboratory Filtration Products Publication No.: SLU0006-e Order No.: 85032-543-83 Laboratory Weighing Products Publication No.: WL-0007-e Order No.: 98649-018-13 Pr oducts fo r Microbiolo g ical Contro l Products for Microbiological Control Publication No.: SL-1530-e Order No.: 85034-538-81 Lb t Wihi Sartorius Liquid Handling Products Publication No.: SUL0002-e Order No.: 85032-542-25 Download our lab catalo g s from our website: w ww.sartorius.com/lab-catalo gs Sartorius Liquid Handling Sartorius Li q uid Handlin g Product s

120. Specifications subject to change without notice. Printed in the EU on paper bleached without chlorine. | W Publication No.: SL-1530am150602 · Order No.: 85037-548-35 · Ver. 06 | 2015 Europe Germany Sartorius Lab Instruments GmbH & Co. KG Weender Landstrasse 94–108 37075 Goettingen Phone +49.551.308.0 Fax +49.551.308.3289 France & Suisse Romande Sartorius France 2, rue Antoine Laurent de Lavoisier ZA de la Gaudrée 91410 Dourdan Phone +33.1.70.62.50.00 Fax +33.1.64.59.76.39 Austria Sartorius Austria GmbH Modecenterstrasse 22 1030 Vienna Phone +43.1.7965760.0 Fax +43.1.7965760.24 Belgium Sartorius Belgium N.V. Leuvensesteenweg, 248/B 1800 Vilvoorde Phone +32.2.756.06.71 Fax +32.2.253.45.95 Finland & Baltics Sartorius Biohit Liquid Handling Oy Laippatie 1 00880 Helsinki Phone +358.9.755.951 Fax +358.9.755.95.200 Hungary Sartorius Hungária Kft. Kagyló u. 5. 2092 Budakeszi Phone +3623.457.227 Fax +3623.457.147 Ireland Sartorius Ireland Ltd. Unit 41, The Business Centre Stadium Business Park Ballycoolin Road Dublin 11 Phone +353.1.8089050 Fax +353.1.8089388 Italy Sartorius Italy S.r.l. Viale A. Casati, 4 20835 Muggiò (MB) Phone +39.039.4659.1 Fax +39.039.4659.88 Netherlands Sartorius Netherlands B.V. Phone +31.30.60.53.001 Fax +31.30.60.52.917 info.netherlands@sartorius.com Poland Sartorius Poland sp.z o.o. ul. Wrzesinska 70 62-025 Kostrzyn Phone +48.61.6473830 Fax +48.61.6473839 Russian Federation LLC “Sartorius ICR”and LLC “Biohit” Uralskaya str. 4, Lit. B 199155, Saint-Petersburg Phone +7.812.327.5.327 Fax +7.812.327.5.323 Spain & Portugal Sartorius Spain, S.A. Avda. de la Industria, 32 Edificio PAYMA 28108 Alcobendas (Madrid) Phone Spain +34.902.123.367 Phone Portugal +351.800.855.800 Fax Spain +34.91.358.96.23 Fax Portugal +351.800.855.799 Switzerland Sartorius Mechatronics Switzerland AG Ringstrasse 24a 8317 Tagelswangen (ZH) Phone +41.44.746.50.00 Fax +41.44.746.50.50 U.K. Sartorius UK Ltd. Longmead Business Centre Blenheim Road, Epsom Surrey KT19 9QQ Phone +44.1372.737159 Fax +44.1372.726171 Ukraine LLC “Biohit” Post Box 440 “B” 01001 Kiev, Ukraine Phone +380.44.411.4918 Fax +380.50.623.3162 Americas USA Sartorius Corporation 5 Orville Drive, Suite 200 Bohemia, NY 11716 Phone +1.631.254.4249 Toll-free +1.800.635.2906 Fax +1.631.254.4253 Argentina Sartorius Argentina S.A. Int. A. Ávalos 4251 B1605ECS Munro Buenos Aires Phone +54.11.4721.0505 Fax +54.11.4762.2333 Brazil Sartorius do Brasil Ltda Avenida Senador Vergueiro 2962 São Bernardo do Campo CEP 09600-000 - SP- Brasil Phone +55.11.4362.8900 Fax + 55.11.4362.8901 Canada Sartorius Canada Inc. 2179 Dunwin Drive #4 Mississauga, ON L5L 1X2 Phone +1.905.569.7977 Toll-Free +1.800.668.4234 Fax +1.905.569.7021 Mexico Sartorius de México S.A. de C.V. Circuito Circunvalación Poniente No. 149 Ciudad Satélite 53100, Estado de México México Phone +52.5555.62.1102 Fax +52.5555.62.2942 Asia | Pacific Australia Sartorius Australia Pty. Ltd. Unit 5, 7-11 Rodeo Drive Dandenong South Vic 3175 Phone +61.3.8762.1800 Fax +61.3.8762.1828 China Sartorius Scientific Instruments (Beijing) Co., Ltd. 33 Yu An Road, Airport Industrial Park Zone B, Shunyi District, Beijing 101300, P.R.China Phone +86.10.8042.6300 Fax +86.10.8042.6486 Hong Kong Sartorius Hong Kong Ltd. Unit 1012, Lu Plaza 2 Wing Yip Street Kwun Tong Kowloon, Hong Kong Phone +852.2774.2678 Fax +852.2766.3526 India Sartorius Weighing India Pvt. Ltd. #69/2-69/3, NH 48, Jakkasandra, Nelamangala Tq 562 123 Bangalore, India Phone +91.80.4350.5250 Fax +91.80.4350.5253 Japan Sartorius Japan K.K. 4th Fl., Daiwa Shinagawa North Bldg. 8-11, Kita-Shinagawa 1-chome Shinagawa-ku, Tokyo, 140-0001 Japan Phone +81.3.3740.5408 Fax +81.3.3740.5406 Malaysia Sartorius Malaysia Sdn. Bhd Lot L3-E-3B, Enterprise 4 Technology Park Malaysia Bukit Jalil 57000 Kuala Lumpur, Malaysia Phone +60.3.8996.0622 Fax +60.3.8996.0755 Singapore Sartorius Singapore Pte. Ltd 1 Science Park Road, The Capricorn, #05-08A, Singapore Science Park II Singapore 117528 Phone +65.6872.3966 Fax +65.6778.2494 South Korea Sartorius Korea Ltd. 8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-Gu SeongNam-Si, GyeongGi-Do, 463-400 Phone +82.31.622.5700 Fax +82.31.622.5799 Thailand Sartorius (Thailand) Co. Ltd. 129 Rama 9 Road, Huaykwang Bangkok 10310 Phone +66.2643.8361-6 Fax +66.2643.8367 Sales and Service Contacts For further contacts, visit www.sartorius.com www.sartorius.com

25. SM-0001-e140606 | 85030-503-74 · Ver.: 06| 2014 Nutrient Pad Sets Typical Application Examples Product Detection and enumeration of... Nutrient Pad type Beer Lactobacilli and Pediococci and VLB-S7-S other beer spoiling organisms Total colony count Standard, Standard TTC, Wild yeasts Lysine Yeasts and molds Malt Extract*, Wallerstein Nutrient, Wort Foods Acid-tolerant microorganisms Orange Serum Enterobacteria, E. coli and coliforms CHROMOCULT ® ** , ECD, Endo, (MacConkey), m FC, Teepol | Lauryl Sulphate, Tergitol TTC Enterococci, Enterococcus faecalis Azide | KF Strep Pseudomonas aeruginosa Cetrimide Salmonellae Bismuth Sulfite Staphylococci, Staphylococcus aureus Chapman Thermophilic spore formers and Glucose Tryptone mesophilic bacteria Total colony count Caso, Standard, Standard TTC, TGE | Tryptone Glucose Extract Yeasts and molds Malt Extract, Wort Fruit juice Enterobacteria, E. coli and coliforms Endo, (MacConkey) Tergitol TTC* Oenococcus and other product Jus de Tomate | Tomato Juice, spoiling organisms Orange Serum Yeasts and molds Malt Extract, m Green yeast and mold | Schaufus Pottinger, Wallerstein Nutrient, Wort Milk E. coli and coliforms Endo Enterococci, Enterococcus faecalis Azide | KF Strep Salmonellae Bismuth Sulfite Pharmaceuticals, Enterobacteria, E. coli MacConkey WFI, raw materials, Enterococci, Enterococcus faecalis Azide | KF Strep and cosmetics Pseudomonas aeruginosa Cetrimide (cosmetics only) Salmonellae Bismuth Sulfite Staphylococci, Staphylococcus aureus Chapman Total colony count Caso, R2A Yeasts and molds, Candida albicans Sabouraud Soft drinks, Acid-tolerant microorganisms, Orange Serum, VLB-S-7-S concentrates Lactic-acid bacteria Enterobacteria, E. coli and coliforms Endo, MacConkey Mesophilic slime-forming bacteria, Weman Leuconostoc Total colony count Standard*, Standard TTC*, TGE | Tryptone Glucose Extract Yeasts and molds Malt Extract, m Green yeast and mold | Schaufus Pottinger, Wallerstein Nutrient, Wort Sugar, E. coli and coliforms Endo sugar products Mesophilic slime-forming bacteria, Weman Leuconostoc Thermophilic spore formers and Glucose Tryptone mesophilic bacteria Yeasts and molds Malt Extract*, Schaufus Pottinger | m Green yeast and mold, Wort* Water Acid-tolerant microorganisms, Orange Serum Lactic-acid bacteria Enterobacteria, E. coli and coliforms CHROMOCULT ® ** , ECD, Endo, (MacConkey), m FC, Teepol | Lauryl Sulphate, Tergitol TTC Enterococci, Enterococcus faecalis Azide | KF Strep Pseudomonas aeruginosa Cetrimide Salmonellae Bismuth Sulfite Staphylococci, Staphylococcus aureus Chapman Total colony count Caso, R2A, Standard, Standard TTC, TGE | Tryptone Glucose Extract, Yeast Extract Yeasts and molds, Candida albicans Sabouraud Wine Acetobacter Orange Serum, Wort (both wetted with 5-8% ethanol) Acid-tolerant microorganisms, Orange Serum Lactic-acid bacteria Oenococcus and other wine Jus de Tomate | Tomato Juice spoiling microorgan. Yeasts and molds Malt Extract, m Green yeast and mold | Schaufus Pottinger, Wallerstein Nutrient, Wort * These NPS types are suitable for the determination of the mentioned microorganisms, although the media are not explicit declare d in references. The description of the typical results or any pictures show typical appearance of the mentioned microorganisms. In particular cases, color and shape of the colonies could vary from the expected habitus. Further tests may be necessary to validate the result. Sartorius Stedim Biotech shall not be liable for consequential and | or incidental damage sustained by any customer from the use of its products. Nutrient Pad Sets (NPS) are subject to continuous product improvement as part of our product development program to align our products with changing application requirements. For current specifications and lot release criteria please visit our homepage under: www.sartorius-stedim.com/NPSSearch. ** Trade mark owner and manufacturer is Merck KGaA (general quality), mineral water, natural water, waste water Caso Staphylococcus aureus Mixed culture from process water R2A Escherichia coli Mixed culture from water Standard TTC Bacillus subtilis Mixed culture from well water Standard Escherichia coli Mixed culture from drinking water TGE Escherichia coli Mixed culture from water Yeast Extract Escherichia coli Mixed culture from river water Total colony count E. coli and coliforms, Enterobacteria CHROMOCULT ® ** Escherichia coli Mixed culture from water Other faecal bacteria Non-faecal, pathogenic bacteria Yeasts and molds Azide Enterococcus faecalis Enterococci from waste water Bismuth Sulfite Salmonella typhosa, streak Salmonellae from waste water Cetrimide Pseudomonas aeruginosa Mixed culture with Pseudomonas aeruginosa Chapman Staphylococcus aureus Mixed culture of staphylococci Lysine Torulopsis spec. “Wild yeasts” from lager beer Malt Extract Saccaromyces cerevisiae Mixed culture from Saccaromyces and Rhodutorula Sabouraud Alternaria humicola Yeasts and molds from cough syrup Torula lipolytica Mixed culture from a soft drink Yeasts and molds Wallerstein (WL Nutrient) Saccharomyces cerevisiae Lactobacillus plantarum Saccharomyces cerevisiae Yeasts and molds from spoiled beer Glucose Tryptone Bacillus coagulans, the “flat sour” colony Mixed culture from canned vegetables Jus de Tomate Lactic-acid bacteria, streak Oenococcus oeni from wine Orange Serum Rhodotorula spec. Mixed culture from a soft drink VLB-S7-S Lactobacillus brevis Lactobacilli and pediococci from sediment, streak Weman Leuconostoc mesenteroides Mixed culture from sugar syrup ECD Escherichia coli E. coli colonies fluoresence in UV light Endo Escherichia coli E. coli and coliforms from river water MacConkey Escherichia coli E. coli and coliforms from river water m FC Escherichia coli E. coli and coliforms from waste water Teepol Escherichia coli E. coli and coliforms from waste water Tergitol TTC Escherichia coli E. coli and coliforms from waste water Microbiological Enumeration 25 Culture Media Nutrient Pad Set Poster The photo shows a poster, original size 70 cm + 50 cm, with growth patterns and typical applications for the Nutrient Pad Sets, described on the previous page. On request, you can obtain this poster free of charge. Order no. SM-0001-e.

2. 2 Microbiological Analysis Content Microbiological Enumeration 7 Membrane Filters 18 Culture Media 28 Filtration Units 40 Filtration Equipment Sterility Testing of Final Pharmaceutical Products 69 Sterisart NF – Sterility Test Consumables 74 Sterisart Universal Pumps 76 Sterisart BD Media and Fluids 78 EXPAND ® Training 79 EXTEND Instrument Services 83 CONFIDENCE ® Validation Services Mycoplasma Contamination Control 87 Microsart ® AMP Mycoplasma 90 Microsart ® ATMP Mycoplasma 92 Microsart ® RESEARCH Mycoplasma 94 Microsart ® AMP Extraction 95 Microsart ® Coating Buffer 96 Microsart ® Validation Standard 97 Microsart ® Calibration Reagent Air Monitoring 101 Gelatine Membrane Filters (GMF) 102 BACTair™ 103 MD8 airscan ® 105 AirPort MD8 106 Accessories 110 EXTEND Instrument Services Chemical Compatibility 114 Filter Materia ls 116 Filter Holde r | O-ring Materi als 118 Index Table of Contents Benefit from Sartorius’ long-standing expertise in microbiological quality control while increasing performance and enhancing your workflows. To help improve the safety of quality-critical processes, we offer premium products for microbial limit testing, sterility testing, air monitoring and mycoplasma detection. Obtain reproducible, reliable results for in-process and final release testing to meet the industry’s requirements of today and anticipate the demands of tomorrow.

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