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

 

 

Charlotte Masy

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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September 2020

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.

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