Pharmaceutical regulatory frameworks are constantly evolving as the demand for sterile drug production capacity grows. The draft of Annex 1 of the European GMP version 12 becomes the international reference text for the latest sterile drug manufacturing standards. It encourages the use of innovative technologies, including barrier technologies which are becoming essential.
While Annex 1 makes multiple references to « Barrier Technologies » with the main objective of reducing direct interactions between sources of contamination and aseptic processes, Chapter 4 provides many details on their design and management.
During these A3P Barrier Technologies 2021 days, we will address the future challenges of our industry through technical and regulatory topics and provide answers through practical applications:
– Update on regulations – Management of points of fragility : ergonomics, transfers, integrity, management of gloves and glove supply. – Design of an isolator line to the highest standards and upgrading of a RABS filling line to RABS standards. – Use of new technologies in the design phases.
Official conference language: French Simultaneous translation of conferences: French <-> English
Tuesday 14th September
Welcome of the participants
Introduction GIC Barrier Technology - link Annex1 V12
Julien TRIQUET - GSK
Operational responses to regulatory requirements (including revised Annex1) on Barrier Technologies
Marc BESSON - MB GMP COMPLIANCE
Gloves of Isolator & RABS: what quality and operational criteria are used to select a supplier? What qualification program for gloves?
A dedicated exhibition space where you can install your products and communication tools: roll-up, product, … A basic equipment which includes a 180×80 cm table, 2 chairs and 1 electrical connection (2kw) without a protective circuit breaker, the loan of a Nespresso coffee machine with pods
Breaks and meals listed in the programme
A badge that allows you free access to the entire technical and scientific programme
The list of the event participants
Possibility to register an additional person at the accompanying rate (590 € excluding taxes)
If you wish to book a stand, please fill in the exhibition form.