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Sterility testing for pharmaceutical and biopharmaceutical manufacturing
An essential component of pharmaceutical and biopharmaceutical quality control programs, sterility tests are used to evaluate sterile products for the presence of viable microorganisms. Effective sterility tests help support compliance with pharmacopeial requirements (including those described in USP <71>, EP 2.6.1, and JP 4.06) and regulatory expectations while contributing to ultimate goals of product quality and patient safety.
Because sterility testing is performed on a limited sample size and often at the end of the manufacturing process, effective contamination control throughout production remains essential. Sterility testing is one component of a comprehensive contamination control strategy that includes environmental monitoring, aseptic process simulation, and validated manufacturing processes.
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Applications
Sterility testing is performed across a range of pharmaceutical and biopharmaceutical manufacturing environments, including:
- Injectable drug products
- Biologics and biosimilars
- Cell and gene therapies
- Vaccines
- Ophthalmic products
- Sterile medical devices
- Advanced therapy medicinal products (ATMPs)
- Raw materials and process intermediates intended for sterile manufacturing
Supporting sterility testing workflows
Successful sterility testing requires appropriate media, testing accessories, sample handling procedures, and contamination control practices. Laboratories must also consider regulatory requirements, workflow efficiency, and method suitability when establishing sterility testing programs.
Our products support sterility testing workflows and batch release testing through a range of prepared culture media and microbiological testing materials designed for pharmaceutical and biopharmaceutical applications.
For Research Use Only. Not for use in diagnostic procedures.