This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
News|Articles|November 18, 2021
Evolution of Aseptic Processing: INTERPHEX Keynote Part 4
Author(s)Felicity Thomas
Rafael Beaus, Global Consultancy Manager, Azbil Telstar, discusses Annex 1 and trends in aseptic production.
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For aseptically produced products, contamination control is critical. As a result, various associations and regulatory bodies have published guidance documents on the many safeguards required to ensure compliance with requirements. Most recently, industry has been awaiting the revised Annex 1 guidance from the European Union, which is currently still under consideration in draft form. Additionally, there is an increasing proportion of products in development that cannot be terminally sterilized, meaning there is a rising need for efficient aseptic processing solutions. In a keynote session titled “Evolution of Aseptic Processing”, presented at INTERPHEX 2021 on Oct. 20, 2021, several experts discussed the evolution of aseptic processing and provided insights into some of the challenges and opportunities facing the bio/pharma industry today.
The session was moderated by Felicity Thomas, European editor, Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International. In this video, Felicity interviewed Rafael Beaus, Global Consultancy Manager, Azbil Telstar. Rafael spoke about Annex 1 and trends in aseptic production.
This video is part 4 of 5. The other speakers in this session were:
Part 1: Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex. Part 2: Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG. Part 3: Luke Stockhausen, Lead Process Engineer, CRB. Part 5: Jordi Serrat, Product & Technology Director, Azbil Telstar.
Watch other videos in this keynote series:
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