Single-Use Systems for Closed Processing
WEBINAR
Although single-use systems (SUS) are well established in the biopharmaceutical industry, there is limited guidance on regulatory expectations. The challenge when moving from stainless steel equipment to SUS is the shift of responsibilities for quality control of the manufacturing equipment from the end-user to their supplier. In final filtration and filling operations, sterility assurance, particles risk, as well as the interaction of the plastic components and the process fluid, are closely reviewed during submissions and inspections. We will focus on key considerations of SUS implementation in the light of expectations addressed in the upcoming European GMP Annex 1 on Manufacture of Sterile Products.
In this webinar, you will learn about:
- Regulatory expectations when implementing and using single-use systems
- Quality control of single-use systems – a shift of responsibility from end-user to supplier
- How single-use systems enable closed processing
Speaker
Simone Biel, Ph.D.
Merck
Senior Regulatory Expert
Simone specializes in Single-Use Technology and filtration within biopharmaceutical manufacturing. She provides regulatory guidance to diverse stakeholders and has helped many drug manufacturers successfully implement Single-Use Technology. Her main focus is to ensure product performance meets quality and regulatory standards. Simone is an active member of the Parenteral Drug Association (PDA) and BioPhorum. She holds a Ph.D. in Microbiology from the University of Frankfurt.
Pharma and biopharma manufacturing
- Downstream Processing
Duration:1h 5min
Language:English
Session 1:presented July 12, 2022