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, Appendix 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“.
This course will provide:
Update on isolators for aseptic manufacture and for sterility testing
Results of recent studies on the validation of isolators
The opportunity to discuss your individual questions personally with experts
Translate the theory directly into practice during 3 workshops at the manufacturing site of Skanin Allschwil
Download pdf brochure at www.gmp-compliance.org