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Concern over the occurence of false positives within the sterility testing process has been
and will continue to be of grave concern to pharmaceutical manufacturers. To date, very few …

The current compendial sterility test has a 14-day incubation time and is often the time-
limiting step in the Assess and Release Process of pharmaceutical products. There is an …

BACKGROUND The compendial Sterility Test is not a test for product sterility. This is not a
new, nor a particularly insightful observation. It has been frequently presented as a flawed …

The USP chapter titled “Sterility Tests” will be almost completely rewritten in USP XXI. Drafts
for comment will shortly appear in Pharmacopeial Forum and USP Comment Proofs.“Sterility …

The pharmacopeial standard applying to sterile products is that sterile products must be
capable of passing a test for sterility. The sterility test is an important, microbiological test in …

Maria Toutoudak/Getty ImagesSterility assurance is of paramount importance in parenteral
drug manufacturing. These products are administered directly into the bloodstream …

Two sterility test methods, the ScanRDI® rapid sterility test and the United States
Pharmacopeia/European Pharmacopoeia/Japanese Pharmacopoeia (USP/EP/JP) …

The design, validation, and monitored delivery of the sterilization process, and validated
post-process integrity of the product package are the primary means to assure the end-use …

Terminally sterilized products are typically released for market distribution on the basis of a
satisfactory review of the sterilization cycle records and compliance with sterility test results …