Background

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 two-day training will provide an update on Isolators for aseptic manufacture and sterility testing.

Programme

• Regulatory requirements for Isolators for aseptic use
• Isolator and associated technologies
• Isolator application/projects: from the concept to the validated equipment
• Isolators used for sterility testing
• Bioindicators/process development of Isolator decontamination
• Troubleshooting in Isolator technology 
• Microbiology in filling and sterility Isolators

Workshop Sessions

Workshop 1: Validation Planning for an Aseptic Isolator

Workshop 2: Development and Quantification of H2O Decontamination Cycles

Workshop 3: Isolators according EU Annex 1

Delegates will have the opportunity to translate the theory directly into practice during 3 workshops at the manufacturing site of SKAN in Allschwil