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.

At this two day training course experts in the field of Isolator usage will share their knowledge.

You will get an update on isolators for aseptic manufacture and for sterility testing.
You will get to know the results of recent studies on the validation of isolators.
You will 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 course will cover:

Isolators and associated technologies
From the conceptual design to the validated equipment
Mock-up study
Process development of isolator decontamination
Bioindicators
Troubleshooting in isolator technology
Glove integrity testing
Sterility testing in isolators
Aseptic / toxic isolators
Microbiology in filling and sterility isolators
Regulatory requirements and trends

Each participant will take part in 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.

The workshops will cover:

Workshop 1:
Validation Planning for an Aseptic Isolator
Performance of Selected Qualification Tests
Glove integrity testing

Workshop 2:
Development and Quantification of H2O2
Decontamination Cycles

Workshop 3:
Isolators in Routine

For more information click here: