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
Validation Project Manager
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.
Learn how Pall's Accelerator Validation Services Can Support You on Your Validation Journey
Download the brochure to read about Pall's depth of validation expertise, consultancy services, testing capabilities and analytical methods
This talk will focus on an overall application of USP <665> starting from risk assessment to qualification of disposable manufacturing systems based on USP<665> data set. All the key principles with examples where these principles need to be satisfied before one can apply the USP<665> data for disposable manufacturing system qualification will be discussed and illustrated. Lastly, different qualification approaches will also be presented to provide broader understanding.