Monday, 25 March 2013

Validation and Operation of a Sterility Testing Isolator


A new peer-reviewed article of interest has been published 'Validation and Operation of a Sterility Testing Isolator: a Study Proposal'.

The article has been written by Tim Sandle and Nancy Tours for the re-vamped Institute of Validation Technology website's on-line Journal of Validation Technology.

The opening section of the article reads:

"One of the concerns with the sterility test, especially when high-value products are handled, is the risk of false positives that can lead to expensive and lengthy failure investigations (and where proving a false positive is extremely difficult, therefore, the outcome can often be batch rejection). A false positive can be described as a contaminating microorganism that has been transferred into the test media through cross-contamination by personnel or from the test environment; in contrast, to microbial contamination being present in the product under test.  Where the sterility test is..."

The reference is:

Sandle, T. and Tours, N. (2013).  Validation and Operation of a Sterility Testing Isolator: a Study Proposal, Journal of Validation Technology, Vol. 19, No.1, on-line.

To find out more about the article and how to view it, go IVT

Posted by Tim Sandle

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