In Part 2 of this webinar series, our experts use case studies to demonstrate how different design options can be utilized for multiple drug delivery systems, from generic formulations to complex injectables. Specifically, we will discuss incorporating critical process parameters (CPP) such as sterilization parameter simulation, Pre-use Post Sterilization Integrity Testing (PUPSIT), and sequential filtration.
In this webinar, you will learn:
- How bacterial retention testing (BRT) fits into the validation strategy for aseptic filters
- About current regulatory trends and expectations for BRT
- How to best incorporate critical process parameters for various drug delivery systems
The 1st webinar in this series, Impact of Regulation and Critical Process Parameter (CPP) on Bacterial Retention Testing (BRT) Design, is also available.
Pharma and biopharma manufacturing
- Sterile Filtration Strategies
Doba trvání:1h
Jazyk:English
Relace 1:předložené October 7, 2021
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