This article presents an update on the efforts of the joint PDA and BioPhorum collaboration workstreams—masking studies, historical data mining, filter manufacturing and use risk assessments and PUPSIT risk assessment and the development of a best practice guide.
Post sterilization pre integrity testing
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SFQRM: Test process and results of potential masking of sterilizing grade filters
Jul 2020 | Fill Finish, Sterile Filtration QRM & PUPSIT
This paper is one in a series of publications that are the result of the collaboration, and these should be considered together and viewed holistically in order to determine the best course of action with regard to PUPSIT. This paper examines the test process and looks at the results of potential masking of sterilizing grade filters.