Pre-use/Post sterilization integrity testing (PUPSIT) has been stated in Annex 1 documents for decades. However, the sporadic enforcement of the use of PUPSIT started to happen, when in 2007 a Good Manufacturing Practice Q&A document was added to European regulators website. Within the Q&A it was suggested that particulate load of the feed stream can block pathways through the filter, which was then interpreted as a flawed filter could be masked and passes the post-use integrity test. No evidence that such masking could occur was available and the PDA/BioPhorum collaboration decided to perform such masking trials to determine whether pre-use integrity tested flawed filters could be masked and pass the post-use integrity test. The masking studies test protocol and results of the trials will be presented in this webinar.
This will be a 90-minute webinar to ensure ample time for questions.
This webinar will be the second in a series presenting the background of, reasons for, challenges to, and approach for mitigating the risk of sterilizing filtration, that has prompted the use of PUPSIT. Learn more about the three-part webinar series, The Science, Implementation, and Implications of PUPSIT in Terminal Sterilizing Filtration.