Complete solutions for complete confidence Sterility Testing
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Complete solutions Sterility Testing Merck Millipore is a division of 'MERCK

Sterility Testing Quality – Reliability – Variety Sterility testing is required for monitoring all products that are manufactured according to GMP and purporting to be sterile. But not all sterility testing solutions are created equal. Quality, convenience and suitability can vary greatly – affecting the credibility of your ndings. Indeed, false negative results may lead to the release of contaminated products, with potentially severe consequences for both patients and manufacturers. On the other hand, cross-contamination and false positive results would imply lengthy and costly...

With a broad range of high-quality products, readyto-use validation protocols and comprehensive services, Merck Millipore provides optimal solutions for all your sterility testing applications. We offer over 35 years of expertise in compliance of regulatory requirements for sterility testing. Manufacturing and validation are performed according to stringent quality standards in ISO® 9001:2000-certied facilities. Merck Millipore has been and continues to be a leading manufacturer of sterility testing systems. The Steritest™ closed ltration devices were invented in the early 1970s to minimize...

Merck Millipore provides a broad range of culture media and uids suitable for virtually any sterility testing application. These applications include: • TSB for media ll • FTM/TSB media for lterable samples • Media intended for direct inoculation Serving as your one-stop supplier, we have based our range on extensive experience in sample preparation devices, hardware equipment, culture media, rinsing uids and services for equipment and methods. But we don’t stop there. We are continuously developing new products and services to help you optimize your sterility tests with maximum safety and...

Sterility Testing Page Quality - Reliability - Variety _2 Membrane Filtration Sterility Test Page Sterility testing of filterable samples 4 Culture Media and Fluids Page Developed for Steritest™ devices _ _ 8 Sterility Testing Pump Page Sterility testing transfer system _ 12 Direct Inoculation Method Page Sterility testing of non-filterable samples _ 14 Services Page Your personal team of experts 16 Ordering information Page Membrane Filtration Sterility Test _ _ 22 Culture Media and Fluids _24 Sterility Testing Pump _25

Membrane Filtration Sterility Test Sterility testing of lterable samples The Membrane Filtration Sterility Test is the regulatory method of choice for lterable pharmaceutical products. The test is particularly suitable for samples containing preservative, bacteriostatic or fungistatic compounds, which inhibit microbial growth of potential contaminants. With membrane ltration, microorganisms are retained by a 0.45-micron pore size lter and all inhibiting compounds are rinsed using a suitable rinse solution. Appropriate media, which are selected based upon their ability to support the growth...

Membrane Filtration Sterility Test Steritest™ system – meet the industry benchmark No single sterility testing platform can efciently and reliably accommodate today’s enormous variety of drugs, delivery systems and packages. That’s why the Steritest™ product line includes hardware, a diverse selection of membranes, canisters, adapters and accessories, as well as sterile media and rinse uids. Each Steritest™ EZ device is subjected to rigorous in-process and release quality checks including 100% membrane and canister integrity tests as well as intense physical and microbiological testing. The...

Countless congurations How do you choose? Selecting the right system conguration for your needs is relatively simple. It starts with three basic questions: What drug product are you testing? The characteristics of your sample – especially its ltration properties, chemical compatibility and microbial inhibition potential – will help determine the optimum membrane type and canister design. Steritest™ EZ canisters are color-coded to indicate the membrane and housing polymer combination (see Steritest™ system Wall Chart). How is the drug packaged? Steritest™ EZ adapters accommodate virtually...

Membrane Filtration Sterility Test For more information on how to choose the right device and download the Steritest™ system Wall Chart click: www.merckmillipore.com/choose-your-steritest-device

Culture Media and Fluids Developed for Steritest™ devices Merck Millipore sterility media and rinse uids are a critical component of our Steritest™ solution. They provide the highest level of purity and testing condence and have been formulated and tested to meet the requirements of the United States, European and Japanese pharmacopoeias. All media and rinse solutions are validated and packaged in convenient test volumes with aseptically designed screw caps, ip caps and septum closures for ease of operation, thus fullling all of your sterility and bioburden testing needs. Made for your...

Fluid K Suitable for testing specimens that contain petrolatum, oils, or oily solutions. Excellent for rinsing pathways of medical devices and for samples that are “difcult” to lter or dissolve. Fluid D Suitable for testing specimens that contain lecithin or oil and compatible with most antibiotics. Excellent for rinsing sterile pathways of devices and typically needed for rinse method testing of medical devices. Culture Media and Fluids Fluid A Suitable as a general rinse buffer and compatible with most samples. Excellent for dissolving or diluting samples, reconstituting commercial...

Sterility Testing Pump Steritest™ Equinox The innovative hardware design and control software offer an easy-to-use, intelligent system for optimizing productivity and performance. Ergonomic design Ergonomically designed for easy operation and cleaning, the Steritest™ Equinox pump ts in Class A/ISO 5 laminar ow hoods and isolators. Its unique prole prevents undesirable air turbulence in the area where handling is performed, eliminating the risk of false positives. The drain tray and the stainless steel surfaces of the pump, pump head and bottle holder are easily cleaned using standard...