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
From October 20th to November 19th
There is no single vaccine manufacturing approach. There are, however, flexible technologies that can meet each of the challenges during process development and at GMP scale.
Accelerating vaccine development and manufacturing by coupling research advances in vaccine technology with systems that support agility through a Quality by Design approach is critical to deliver life-saving immunizations to those in need globally.
Diversity in the type of vaccine antigen, along with the inherent variation in the targets, have created challenges for vaccine manufacturers when compared to a relatively small number of platform processes that exist.
There are flexible technologies that can meet each of the challenges during PD and at GMP scale.
Join this webinar series and learn more about securing process quality with flexible manufacturing solutions.
Webinars available
- Vaccines development, regulations and manufacturing Parts 1 & 2
- Developing scalable upstream workflows for recombinant and viral vaccine processes
- Downstream process development for vaccine manufacturing
- Implementing single-use technologies in formulation and filling of vaccines