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.

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

2020-04-01T15:26:00.000Z
더 Biotech Webinars
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.
May 2021
Overcome Exosome Production Challenges

Biotech | Pall Corporation 웨비나 시리즈

Hailed as the “next frontier” in cell therapy and regenerative medicine, exosomes are a type of extracellular vesicle and play a key role in the regulation of the intercellular communication processes.

David Haylock of VivaZome will present on upstream production of angiogenic exosomes using the iCELLis® nano fixed bed bioreactor. This will be followed by a presentation by Roberto Ciboldi of Pall Corporation on a platform solution including cell culture, purification and sterile filtration of exosomes.

Participants will be able to:

 

  • Compare the performance of the iCELLis Nano bioreactor to traditional flasks for exosome production from adherent cell culture
  • Understand how an integrated end to end platform delivers highly   purified and consistently-sized exosomes
  • Discover an innovative cGMP scalable manufacturing platform for   exosomes
시청