Membrane Filtration Sterility Test
The membrane filtration sterility test is the regulatory method of choice for filterable pharmaceutical products. The test is particularly suitable for samples containing preservative, bacteriostatic or fungistatic compounds, which inhibit microbial growth of potential contaminants. With membrane filtration, microorganisms are retained by a 0.45-micron pore size filter, and all inhibiting compounds are rinsed using a suitable rinse solution. Appropriate media, which are selected based upon their ability to support the growth of anaerobic and aerobic microorganisms, are then transferred to the membrane filters. A 14-day incubation period is required to obtain final test results.
No single sterility testing platform can efficiently and reliably accommodate today’s enormous variety of drugs, delivery systems and packages. That’s why the Steritest™ System product line includes hardware, a diverse selection of membranes, canisters, adapters and accessories, as well as sterile media and rinse fluids.
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 detailed Certificates of Quality are available to download from our website.
Blue Base – Steritest™ Devices
with standard MCE (Mixed Cellulose Esters) membranes for regular pharmaceutical products.
Red Base – Steritest™ Devices
with special low-binding Durapore membranes for products with inhibitory properties e.g. antibiotics.
Green Base – Steritest™ Devices
with high chemical compatibility for applications requiring the presence of solvents.
Closed Steritest™ EZ filtration units reduce the risk of false positive results to avoid costly investigation and possible batch loss. The entire testing process, from aliquoting to reading, is never exposed to the environment. There are no open containers or membrane manipulations, which could increase the risk of adventitious contamination.
Steritest™ EZ filtration units are the right answer to the danger that false negative results pose to patients. Through specific membranes, unique sealing technology and optimized device design, the unit allows efficient elimination of bacteriostatic, fungistatic, or bactericidal agents present in the pharmaceutical product formulation.
For more detailed information on our EZ devices being available for your product-specific requirements and how to choose the right device click below: