Sterile Filtration in the Annex 1 Era: Interpreting PDA TR 26 (Revised 2025)
Webinar
Key updates in PDA TR 26 (Revised 2025) and their practical implications:
- How the industry is shifting from compliance-based validation to risk-based sterility assurance
- The role of PUPSIT and integrity testing in closing critical sterility gaps
- Understanding risk window and flaw masking in filtration systems
- Practical approaches to meeting Annex 1 expectations with confidence
Speakers
Partha Banerjee
Merck
Technical Application Expert, Downstream India
Partha Banerjee is a Technical Application Expert at Merck with over 17 years of experience in downstream bioprocessing and biopharmaceutical process development. He specializes in sterile filtration, filter optimization, troubleshooting, and regulatory-aligned validation strategies. Known for translating scientific concepts into practical solutions, he supports biopharma manufacturers in achieving robust and compliant processes. Partha holds a Master’s degree in Pharmaceutical Chemistry and has expertise in IPR and patent management.
Aria Kang
Merck
Regional Strategy Execution Manager - Downstream Process
Aria has diverse background in the broader pharmaceutical, clinical research, and life sciences industries that commenced with a degree in Biotechnology over a decade ago, her passion is to understand the needs and drivers of the market and deliver applicable Downstream solutions to customers.
Pharma and biopharma manufacturing
- Downstream Processing
Duration:1h
Language:English
Session 1:presented August 4, 2026