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.
Speakers
Ramesh Raju
Merck
Head of Operations BioReliance® Validation Services Lab
Ramesh is currently the head of operations, BioReliance® Validation Services lab of Merck at Bangalore which provides aseptic filter validation services to Asia & Oceana, Middle East, Africa, LATAM, and Mexico along with the Indian subcontinent. Previously, he was managing the technology management team in India at Merck. Ramesh has more than 20 years of experience in aseptic processing and validation of injectables. He is currently pursuing his doctorate program in extractable and leachable from Kuvempu University.
Sumit Gupta
Merck
Validation Service Technical Expert, BioReliance® Validation Services
Sumit Gupta is a technical expert for Bioreliance® filter validation services based in Bangalore, India. He supports creating and developing the global standard operating procedures, specifications, and other best practices to support microbial services. He provides regulatory responses and technical consultation to improve practices throughout the global labs.
He has worked at Merck for 15 years, heading lab operations for aseptic filter validation studies including physical testing, bacterial retention testing as well as extractable and leachable studies and validation studies.
Pharma and biopharma manufacturing
- Sterile Filtration Strategies
Duration:1h
Language:English
Session 1:presented October 7, 2021
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