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 µm pore size filter, and all inhibiting compounds are rinsed using a suitable rinse solution. Large volumes and oily products dissolved in emulsifying agents can also be tested by membrane filtration method, increasing sensitivity and reducing volume of culture media. Appropriate culture media, 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 by checking turbidity.
Our sterility test consumables ensure that pharmaceutical products are never exposed to the environment during the testing process. Filtering, rinsing, media transferring, and incubating are all conducted within the Steritest™ NEO closed system.
There is no need to open the containers or manipulate the membrane at any time-greatly reducing the risk of adventitious contamination resulting in false positive.
When used with the Steritest™ Symbio pump and accessories, and Steritest™ culture media and rinsing fluids, the Steritest™ NEO devices offer the highest levels of quality and reliability and a fully regulatory compliant testing process.
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Sterility testing using the direct inoculation method for non-filterable samples
It is not possible to test all samples using the membrane filtration method, so we offer a range of sterility testing media including soybean casein digest medium (TSB), and Fluid Thioglycollate medium (FTM standard and clear). We also offer a wide range of customized media in various volume sizes and bottle closures in order to fit your applications.
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