Aseptic Filtration Processes: A Holistic Approach to Filter Validation
About the webinar
The workshop gives an outline of the activities needed in order to choose the most fit-for-purpose sterilizing liquid filtration apparatus and how to properly validate it, following both PDA TR 26 and Annex I 2022 requirements.
Real case studies will be presented focusing on different lab-scale setups for different applications.
Topics
The following topics are some of the ones that will be touched upon in this webinar:
- Product Wetted Integrity Test (PWIT)
- Chemical Compatibility Test
- Filter Adsorption Test
- Bacterial Viability Test
- Bacterial Challenge or Retention Test
- E&L
Who should attend?
Managers, directors, engineers, and scientists responsible for research and development, product development, quality assurance, and regulatory compliance. Further, procurement, business leaders, and project management personnel responsible for requesting testing quotations.
When?
June 27th 2023
15:00 - 16:00 (CET)
Where?
Speaker
Michele is Test Facility Manager (GLP and ISO 17025) for Eurofins BioPharma Product Testing Italy, for over 14 years. He is also Senior Scientific Director for virus clearance validation studies according to ISO 22442-3 & UFDA requirements as well as the virucidal efficacy of chemical & chemo-thermal processes on surfaces & equipment & virus retention procedures. Also member of the European Committee CEN TC 216.