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The article published in the September-October 1993 issue of the Journal of Parenteral
Science and Technology, entitled “The Incubation Period in Sterility Testing” is a subject that …

Manufacture by aseptic processing accompanied by end product compendial sterility testing
has been the predominant means of production and disposition of therapeutics requiring the …

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

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 …

AbstractValidating sterile product manufacturing processes requires the use of biological
indicators to demonstrate the lethality of sterilization techniques. The indicator organisms …

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 …

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 …

In this issue, the report of the second national survey of quality assurance activities for
pharmacy-prepared ster ile products (page 2591) and the editorial by Klein (page 2581) …

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 …