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.
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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.
How to learn about PUPSIT in terminal sterilizing filtration – the science, implications and implementation
How to learn about PUPSIT in terminal sterilizing filtration – the science, implications and implementation Pre-use post-sterilization integrity testing (PUPSIT) continues to generate considerable debate in the industry. Committing to a PUPSIT strategy is no mean feat because, while some regulatory bodies are asserting its need, it may compromise downstream sterility and it is expensive to mitigate these risks. To help clarify industry...