Whitepaper: Rapid sterility testing: a new solution for short shelf life products
Posted: 21 May 2020 | Nelson Laboratories LLC | No comments yet
All drug products have to undergo sterility testing to comply with Good Manufacturing Practices (GMP). Rapid sterility testing, which offers an incubation period of five days or less, provides a solution.
All drug products have to undergo sterility testing to comply with Good Manufacturing Practices (GMP). Parenteral drug products go through especially rigorous testing to ensure sterility and safety. To do otherwise would risk contamination, which can lead to expensive, reputation-damaging recalls and illness. Until recently though, current testing methods have fallen short for products intended for immediate use. Rapid sterility testing, which offers an incubation period of five days or less, provides a solution. The “rapid” turnaround suits today’s tailored medicines and allows companies to get their product to market faster.
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Analytical techniques, Biologics, Biopharmaceuticals, Excipients, Gene therapy, Good Manufacturing Practice (GMP), Ingredients, Microbiology, QA/QC, Vaccines