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Validation of Isolators
7-8 October 2008
Basle, Switzerland
Please click here to view the program of this conference or course
To book for this program, just click on the option:
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At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
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Learning Goals
Why should you attend this event?
You get an update on the validation of 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
Each participant takes part in all 3 workshops. The workshops are held at the plant of Skan AG, partly including operational isolators. This brings the participants as close to daily practice as possible.
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.
Quite recently, 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 014-2 „Isolators used for Aseptic Processing and Sterility Testing“. |
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