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Creating Robust Sterility Testing Processes

From Thermo Fisher Scientific 4 min Reading Time

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Sterility testing is a crucial part of pharmaceutical manufacturing, and the consequences of non-compliance can be fatal. It is, however, a time- and resource- hungry process, needing to be carried out under aseptic conditions by specialized staff according to detailed protocols.

Sterility testing failure is not an option for organizations that are committed to protecting both human and business health.(Source: ©  Andrey - stock.adobe.com)
Sterility testing failure is not an option for organizations that are committed to protecting both human and business health.
(Source: © Andrey - stock.adobe.com)

Finished product samples must undergo a 14-day incubation period before being cleared for release onto the market. Anything less than a 100 % pass rate can relegate an entire batch unable to reach the people who depend on it.

So, what can pharmaceutical laboratories do to mitigate the risk of costly contamination during the manufacturing process? Building robust, validated protocols is the key to reducing the risk of avoidable test failures and smoothing the road from component intake to product release.