As drug manufacturing regulation such as EU GMP Annex 1 continues to evolve, so does the manufacturing equipment to help ensure the highest levels of the safety and sterility of medicinal products for human use. Single-use systems can enable you to meet these regulatory needs, such as PUPSIT, while tailoring them to fit your fill finish process requirements.
In this webinar, you will learn how you can implement PUPSIT with manual operation or fully automated to minimize risks in sterile filtration processes and how next generation, gloveless isolators with single-use filling assemblies are simplifying your contamination control strategy (CCS).
In this webinar, you will learn:
- How to interpret the EU GMP Annex 1 regulation
- What this regulation means for your fill finish process and equipment
- Industry trends such as fully automated PUPSIT systems and gloveless isolators using single-use systems
Speaker
Chuck Raye
Merck
Senior Strategic Product Manager, Single-use Fill Finish Products
Chuck Raye has 14 years of experience in the bioprocessing industry, designing, validating, and managing single-use (SU) components and systems. He has also supported operational teams in the manufacturing of SU systems. In his current role, he works directly with customers, R&D, and operations to develop solutions that advance SU technology in the fill finish processes of sterile filtration and filling. Chuck holds a B.S. in mechanical engineering from Syracuse University.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
기간:1h
언어:English
세션 1:발표 완료 September 26, 2024
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