Why should you attend this event?
- You get an update on isolators for aseptic manufacture and for sterility testing
- You get to know the results of recent studies on the validation of isolators
- You have the opportunity to discuss your individual questions personally with experts
- You can translate the theory directly into practice during 3 workshops at the manufacturing site of Skan in Allschwil
The use of isolators is increasing both in sterility testing and in the production of sterile medicinal products, particularly in aseptic manufacture. It ensures a greater microbiological safety of the products, but at the same time requires increased inputs as regards the qualification of these systems and the validation of the production processes.
In 2004, Annex 1 to the FDA Guidance for Industry “Sterile Drug Products Produced by Aseptic Processing” defined new regulatory requirements on using this technology, as did the PIC/S document PI 014-3 “Isolators used for Aseptic Processing and Sterility Testing“.