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Microbiological Control Microbiological Control Table of Contents Microbiological Quality Control 4 Microsart® @filter 100 and 250 33 Air Monitoring Microsart® Funnel 100 and 250 35 ® MD8 airscan 6 Biosart® 250 Funnels 37 AirPort MD8 7 Combisart® Systems 38 Gelatine Membranes 8 Microsart® Combi.jet 42 BACTair™ - Big Impact 9 How to Set Up a Vacuum Accessories for MD8 devices 10 Filtration System 44 Colony Counting Traditional Filter Holders 47 Gridded Membranes 12 Accessories 50 ® Microsart e.motion 14 School Kit 58 Gridded Membranes 16 Sterility Testing Membranes without Grid 20 Sterisart® Universal Pump 59 Hydrophobic Edged Membranes 22 Sterisart® NF 60 Nutrient Pad Sets 24 Reusable System 64 Culture Media and Absorbent Pads 28 Services and Trainings ® Biosart® 100 Monitors 30 CONFIDENCE Validation Services 66 ® Biosart® 100 Nutrient Media 32 EXPAND Trainings and Seminars 67 Chemical Compatibility 68 3 Microbiological Quality Control Colony counting not require any interleaving paper. Moreover, Quantitative and reproducible detection of Sartorius Stedim Biotech also offers individu- trace contamination or infection as well as ally, sterile-packaged membrane filters in the capability of performing efficient, cost- easy-to-open envelopes. Each one is clearly effective testing procedures under routine labeled with the product identification and conditions are the requirements placed on lot number. Membranes with a 0.45 µm pore a practical microbiological testing method. size are used on a standard basis for micro- The membrane filter method optimally meets biological analysis. these requirements, and Sartorius Stedim Biotech offers the ideal range of filters and Sartorius Stedim Biotech additionally supplies equipment to carry out this method. special membrane versions known as high- flow membranes. They deliver 30% higher In the standard membrane filter method, a flow rates compared with conventional membrane filter with the appropriate pore 0.45 µm pore size membranes. The specially size is placed in a filter holder and the sample designed pore structures of 0.45 µm pore is filtered. Any microorganisms present in size membranes enable faster filtration runs the sample are retained by the pore structure thanks to their high flow rate performance on the surface of the membrane filter. The and throughput. Especially E. coli shows best membrane filter is then placed on an appro- growth promotion on High Flow Membranes. priate culture medium and incubated to Just like every lot of Sartorius Stedim Biotech detect these microbes. During incubation, the 0.45 µm membrane filters, the special high exchange of nutrients and metabolites takes flow versions are tested and released in place through the pore system of the mem- compliance with ISO 7704. brane filter. The colonies that develop during incubation on the membrane filter surface Microsart® @vance® – are then counted and related to the filtered Advance your microbiological control sample volume. of Pharma-Biotech products A new product line within the successful Sartorius Stedim Biotech specifically manu- Microsart® product family is aimed directly at factures individually packaged gridded microbiological applications in the pharma- membrane filters for this application. These ceutical and biotech industry: Microsart® are ready to use and strictly quality controlled @vance®. @vance® stands for even more for colony growth. progress and intelligent design, enhanced safety and thus more reliable results. Microsart® – The product family for Following the trend of using single-use innovative colony counting products, these products are delivered sterile, The Microsart® product family consists of all ready-to-use and can be disposed of in an the most recent products from SSB for micro- environmentally friendly manner. The new biological analysis, which are especially charac- Microsart® @vance® product line is being terized by innovation and clever design. Simple launched with the Microsart® @filter 100 and handling on less working area in comparison 250 filter units, a ready-to-use combination to conventional products that's it where funnel and gridded membrane in one unit. ® Microbiological Quality Control Microsart products have always stood out. The process of producing pharmaceuticals – Easy membrane removal and bringing new drugs to the market is – Easy funnel removal becoming an increasingly costly business. – All consumables are ready-to-use The pharmaceutical and biotech industries – The hardware is intelligent and functional are driven by the need to optimize their work in design flows and increase efficiency without com- promising their level of safety. Microsart® The fully automated Microsart® e.motion @filter not only saves time and labor costs membrane filter dispenser releases gridded but minimizes the risk of secondary contami- membranes from their individual, specially nation – that's advanced colony counting developed and sterile packaging that does by Sartorius Stedim Biotech. Nutrient Pad Sets: Individually packaged, Page 24 gridded membrane filters: Page 12 Microsart® e.motion Microsart® @filter: Membrane filter dispenser: Page 33 Page 14 4 Nutrient Pad Sets (NPS) provide added con- microbes in cleanroom and isolator moni- venience. These are dehydrated culture media toring. In addition, their effectiveness in that are already individually inserted in a collecting the smallest airborne viruses and petri dish and sterilized. After they have been bacteriophages has been proven. The reason: moistened with 3.0–3.5 ml of demineralized, Gelatin appears to have a protective effect on sterile water, they are ready to use immedi- the viruses collected and can be dissolved in ately. To find out which colonies typically buffer or a different medium for subsequent grow on which NPS, please refer to page 24. identification of the type of virus (page 8). Our wide array of culture media covers all the types needed in the food and beverage indus- Gelatin membrane filters can also be used for try and in the pharmaceutical industry as well routine monitoring of bacteriophages in the as for water analysis. ambient air of dairies. NPS are continuously enhanced as part of our For faster and more convenient filtration development program to adapt our products of samples to changing application requirements. Besides Sterile single-use funnels and preassembled the new NPS types, we also offer Nutrient Monitors can be used in place of stainless Pads in a new packaging design. The standard steel funnels and vacuum filters holders. NPS box contains 100 sterile Nutrient Pads, each of which is individually inserted in a Biosart® 250 Funnels petri dish and sterilized. Ten each of these The 250-ml Biosart® funnels eliminate time- petri dishes are sealed in an aluminum bag. consuming sterilization of one sample to the This special packaging in bags protects the next. The large inner diameter of the funnel sensitive formula constituents of the Nutrient base ensures exceptionally fast filtration runs Pad from fluctuations in humidity and tem- (page 37). perature during transportation and storage. As a result, it guarantees the high quality of Biosart® 100 Monitors our NPS throughout their entire shelf life These complete Monitors featuring a 100-ml up to 24 months. capacity are available with incorporated fil- ters in a choice of different pore sizes, filter And this is precisely what makes the Sartorius colors and diameters. The completely sterile Stedim Biotech Nutrient Pads Sets so unique: units need to be used in conjunction with No other ready-to-use culture media around various culture media. After pouring in an the globe assure such consistently high quality appropriate liquid culture medium to wet the and reproducible results for up to 24 months. interior cellulose pad, the lid and base of the Monitor can be easily converted into a petri Other bacteriological water tests dish (page 30). A procedure for collecting Legionella organisms specifies polyamide membranes Combisart® Systems (diameter 142 mm), of the pore size 0.2 µm The Combisart® design enables equipment or 0.45 µm. and consumables to be optimally combined to meet specific needs. Each filter station on For isolation of bacteriophages from water, the multi-branch manifold has an air filter for Microbiological Quality Control Sartocon cross-flow filter cassettes with poly- sterile venting. ether sulfone membrane (100,000 MWCO) deliver excellent results. Sterisart® Sterisart® enables sterility testing to be Airborne bacteria and viruses performed in a completely closed system Gelatin membrane filters are routinely according to international pharmacopeias. used for quantitative sampling of airborne Gelatin Biosart® 250 Funnels: Combisart® membrane filters: Page 37 Page 38 Page 8 Biosart® 100 Monitors: Sterisart® Page 30 Page 59 5 Air Sampler for Critical Applications The system consists of the MD8 airscan® air The MD8 airscan® air sampler allows to adjust sampler and disposable gelatine filter units. selectively and easily air flow rate and sample The system is routinely used for the quantita- removal speed. By means of a specially devel- tive detection of air-borne organisms, mainly oped calibration unit (see accessories), the at filling lines in sterile areas of class A user can calibrate the MD8 airscan® locally, (classification according to “EU Guide for e.g. within the scope of validation steps. GMP”), isolators, or blow-fill-seal machines. After removing the sample, the gelatine filter The exceptionally high air flow rate of 8 m3/h can be placed
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