Requirements of Sterilizing Filtration Validation
Requirements of Sterilizing Filtration Validation
The landscape for manufacture of sterile medicinal products is evolving. Sterilizing filtration requirements are changing to reflect more complex fomulations. Expectations from regulatory authorities related to the evaluation of potential impurities or leachables for polymeric components with drug contact is also on the rise. We will share our updates on how we are working with end users to support them through these challenges.
Participants will learn about:
- Regulatory and reference guidelines for filter validation and extractables and leachables evaluation
- Typical filter validation tests
- A risk assessment decision tree for E&L evaluation
- A validation services process workflow
Speaker
Elisabeth Rizzo
Validation Project Manager
(Scientist II)
Elisabeth is a project manager within the European Validation team, supporting customers to document their Pall filter and single-use technology validation, to ensure their sterile manufacturing process will perform as intended in alignment with GMP requirements and industry guidelines.
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Biotech | Pall Corporation webinar series
Integrity Assurance for Single-Use Systems An End-User’s Perspective
What should you consider when building an integrity control strategy for your single-use systems (SUS)? How do you overcome application challenges?
Join leading industry experts Charlotte Masy of GSK and Patrick Evrard from Pall Corporation to gain insights and answers in this webinar from BioPharma Asia on integrity Assurance for Single-Use Systems, an End-User’s Perspective. They will present several case studies to show how integrity concerns can be practically addressed for cGMP manufacturing applications and the results observed a few years on.
Attendees will learn about:
- The latest regulatory requirements for integrity assurance of SUS
- The different technologies available to control integrity of SUS
- Key parameters that affect integrity measurements
Register now for this webinar from industry experts on October 6.