Whitepaper: Combining rapid and EP bioburden testing
Posted: 10 December 2020 | Merck | No comments yet
A combined testing procedure to overcome the manufacturing bottleneck caused by the time needed for compendial bioburden testing according to EP.
The compendial membrane filtration method for bioburden testing can take up to five days because contaminant microorganisms need time to grow into visible colonies. During this time, further processing or product release are put on hold, and storage costs mount. This article describes a combined procedure in which compendial testing is complemented by a simultaneous rapid test that uses the identical sample to generate much earlier results while allowing the compendial test to continue.
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Analytical techniques, Biopharmaceuticals, Formulation, Manufacturing, QA/QC, Regulation & Legislation, Research & Development (R&D)
