Rapid Sterility Testing: A New Solution For Short Shelf Life Products
All drug products must undergo sterility testing to comply with Good Manufacturing Practices (GMP). Parenteral drug products,...
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EO Residue Levels in Medical Devices: Best Practices for Demonstrating Compliance with ISO 10993-7
Sterilizing medical devices via ethylene oxide (EO) gas is an effective and widely used practice within the...
Designing an End-to-End Sterility Assurance Program
Sterility assurance for pharmaceutical products is of paramount importance, encompassing numerous aspects beyond the actual sterilization cycle...
New Guidance on Product Family Adoption for Radiation Sterilization: TIR 35:2016
Product family grouping, as discussed in Clause 4 of ANSI/AAMI/ISO 11137-2:2013, titled ‘Sterilization of Health Care Products...