Isolation Technology: Challenge and Compliance to the New Annex 1
: 3 Oct 2023
Sector : Pharmaceutical
Type : Webinar
The ROAD TO PHARMA MICROBIOLOGY CONGRESS 2023 presents: Isolation Technology: Challenge and Compliance to the New Annex 1 – FREE WEBINAR
Sponsored by IMA
The approval in August 2022 of the new EU GMP Annex 1 has formalized several innovative concepts and requirements for sterility assurance and defined a new standard for the design of RABS, isolators, and related machines used in aseptic fill-finish processes. The presentation analyses the requirements inside the new Annex that impact on the isolation technology area. The goal is to explain how isolators and RABSs can maximize compliance and, at the same time, guarantee process flexibility and plant productivity. The most critical design and process aspects will be analysed, such as requests relating to “first air” protection, management of direct and indirect contact part, and RTU material introduction. The discussion covers case studies with traditional liquid or freeze-dried productions or toxic/biohazard scenarios where sterility assurance must necessarily be cross-referenced with the problems relating to high containment.
Speaker: Giacomo Guidi, R&D Isolation Technologies, IMA
Duration: 60 minutes
The ROAD TO PHARMA MICROBIOLOGY CONGRESS 2023 is a series of FREE WEBINARS that will accompany us till the Pharma Microbiology Congress 2023 in November.
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