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PDA PUPSIT Webinar Series

Assessing the Risk of Filter Masking – Test Description and Results

Sep 08, 2020
10:00 AM
-
11:30 AM
| Eastern Standard Time
Online
  • Webinar
  • Virtual
  • Online

Overview

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.

Highlighted Speakers

Maik W. Jornitz
Maik W. Jornitz
G-CON Manufacturing

Registration Fees

Register Now
Registration Type Price
Member $99
Non-member $99
Gov't/Health Auth./Academic $99
PUPSIT Webinar Series Bundle* $250

*Register for one or more of the webinars individually or take advantage of a package discount when you register for all three in the series! Contact PDA Registration for information on bundle registration.

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