Tuesday 11 January 2022

How ‘sterile’ are your cleanroom consumables? The importance of validating sterility


The expectations for the sterility assurance of cleanroom consumables and single-use products has increasingly become an area of regulatory concern. Purchasers of items intended to be sterile must have confidence that the manufacturer has undertaken the sterilisation process correctly, using an established method and that the sterilisation process has been validated, as this article explains. 

Purchasers should also ensure that the actual product they are obtaining has also been subject to validation (that is, the method selected is capable of eliminating any bioburden present). The most common method of sterilisation for cleanroom consumables is gamma radiation.

To review the key factors to consider, see STAXS.


Sandle, T. (2021) How ‘sterile’ are your cleanroom consumables? The importance of validating sterility, Staxs Article #1 at: http://staxs-5651425.hs-sites.com/the-importance-of-validating-sterility-0?submissionGuid=49c2927f-8cb0-41fb-b86c-2246b41321fa

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


  1. Thanks a bunch for sharing this. Keep posting such issues

  2. Shouldn’t we verify the sterility of cleanroom consumables ( Initial 3 lots and subjected to periodic verification. Only for core area sterile consumables) ?

  3. Shouldn’t we verify the sterility of initial 3 lots of core area cleanroom consumables (and subject to periodic verification) ?


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