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

 

 

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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Our webinars keep you informed on the latest products and technologies, current industry topics, the latest trends and a range of innovations and solutions to help continuously improve your processes.
March 2021
Case Study: Swissfillon’s Approach to Single-Use Formulation & Filling

Biotech | Pall Corporation 웨비나 시리즈

In 2019 Swissfillon were inspected and approved by the FDA to supply drug products into the USA, following on from EU approval in 2018. This young fill finish CMO was started in Switzerland in 2013 and built a state-of-the-art cGMP production facility from the ground up.

Swissfillon recognized early on that single-use systems met their requirements for multi-product manufacturing and would help their clients get their drugs to market faster.

During this case-study webinar, participants will learn:

  1. How working in partnership with a supplier can be part of a QbD approach to minimize risk
  2. Strategies & design improvements for single-use systems to reduce risk in the process
  3. How a shadowboard can be used to make single-use system leak tests, PUPSIT and the filtration process fast, safe and simple
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