Microbiology: Sterility Testing - Overview

A Complete Solution for Reliable Results


	Choosing the right methodology and material is the key to securing your sterility testing results. With more than 35 years of expertise shared with our users all over the world, EMD Millipore is your partner.

Sterility testing results deliver crucial information required to meet high regulatory requirements. Sterility testing is a specific control application to monitor the sterility of samples from pharmaceutical products that are purported to be sterile. With time, money, and the integrity of the end product at stake, confidence in the methodology and material used for testing is of utmost importance.

EMD Millipore brings more than 35 years of expertise to the field of sterility testing, providing a complete solution including products and services for a wide variety of drugs in all types of product packages.

The Right Configuration for Your Application

EMD Millipore offers a wide selection of hardware, filtration units, culture media, and rinse buffers to meet the needs of your specific application. The correct configuration will depend on product packaging as well as relevant characteristics of the sample, such as its filtration properties, chemical compatibility, and microbial inhibition potential.

EMD Millipore provides method development services to help you set up easy and efficient test procedures for your specific samples. Comprehensive validation protocols and on-site validation engineers can streamline your validation process. To keep your system’s performance compliant with validated specifications and regulatory requirements, EMD Millipore offers a full range of maintenance agreements.

Steritest EZ Filtration Units Reduce Risks

EMD Millipore’s Steritest EZ filtration units provide a choice of two membranes – mixed esters of cellulose or PVDF. The standard pharmacopeias (European, United States and Japanese) recommend sterility testing using membrane filtration whenever the nature of the product permits, choosing the correct membrane according to the product tested (EP 2.6.1; USP Chapter <71>; JP 4.06; CPMP/ICH/294/95). The Steritest system complies with the pharmacopeias.

Minimize the Risk of False Positives: Steritest EZ filtration units reduce the risk of false positive results to avoid costly investigation and risk of batch loss. Steritest EZ filtration units protect the test product from external contamination. The entire process from sampling to reading is never exposed to the environment.

Minimize the Risk of False Negatives: Steritest EZ filtration units reduce the risk that false negative results pose to patients. Through specific membranes, patented sealing technology and optimized device design, the process allows complete elimination of bacteriostatic, fungistatic, or bacteriocidal agents present in the pharmaceutical product formulation that could impede culture growth and generate risky false negative results.

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