Monday, 30 March 2020

Guide to sterility test isolators


An isolator is an arrangement of physical barriers that are integrated so that the workspace (an enclosed environment) within the isolator is sealed from the outside environment. Isolators provide a testing environment free from contamination, through routine sanitization using a validated cycle and confirmed by environmental monitoring.

In addition, these devices enable the isolation between the operator and the process. There are many complications with isolators, from design to qualification, and with general operation.

It certainly remains that isolators cannot prevent contamination caused by GMP deficiencies such as poor aseptic procedures and inadequate training of operators.

To address these concerns and to outline best practices, Tim Sandle has written a new Pharmig guide:

Sandle, T. (2019) Guide to sterility test isolators, Pharmig, Stanstead Abbotts: UK (ISBN 978-0-9560804-9-3)

Foe details see: https://www.pharmig.org.uk/en/products/publications/

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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