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Sterility testing is required to ensure viable contaminating microorganisms are not evident in a product. This testing is conducted by direct inoculation or membrane filtration methods and can be performed in an isolator or cleanroom environment. 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 µm pore size filter, and all inhibiting compounds are rinsed using a suitable rinse solution. Appropriate 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. With our new device, we are raising the industry‘s standards, and driving innovation to provide you the most secure and reliable test ever.
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