PDA reviews an industry survey of concerns and best practices regarding the EU GMP’s required PUPSIT test for filters used in sterile filtration. Performance of a pre-use, post-sterilization integrity ...
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Correction: This article was edited on 15 September 2022 to correct Jorg Zimmermann's title. Sterile drug manufacturers should start preparing a gap analysis to identify what needs to be done to ...
Recent revisions to EU manufacturing guidelines are changing how drug makers test processing technologies, according to the author of a new study, who cites growing use of an approach known as PUPSIT ...
The draft revisions of Annex 1 are driven by a quality risk management approach and will provide more clarity and detail for manufacturers. Pre-use, post-sterilization integrity testing (PUPSIT) is ...
RADNOR, PA — Avantor, Inc. (NYSE: AVTR) has introduced a new line of pre-engineered PUPSIT (pre-use, post-sterilization integrity testing) assemblies and a comprehensive sterile sampling suite, ...
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