Wednesday 5 May 2021

Cleanrooms and Associated Controlled Environments - Biocontamination Control: Dissecting The Standard


 

Biocontamination control is generally concerned with microorganisms, viruses, microbial toxins, and particulates. A new standard has been produced to examine aspects of this – EN 17141. The standard also seeks to be the replacement of ISO14698.

 

This article assesses the content of EN 17141: 2020 and discusses the points of importance, focusing on those which add value to those who are tasked with ensuring effective biocontamination control, as well as describing some areas of ambiguity, contradiction, and potential inaccuracy.

 

The scope of the new standard limits the definition of contamination too narrowly, to bacteria and fungi (or what are described as ‘mould and yeast’ in the standard). While viruses and prions are a relatively specialist area, it is immediately disappointing that endotoxin does not feature in the scope of the document.

 

Tim Sandle reviews the standard and identifies the gaps.

 

Sandle, T.(2021) Cleanrooms and Associated Controlled Environments - Biocontamination Control: Dissecting The Standard, Journal of GxP Compliance, 25 (1): https://www.ivtnetwork.com/article/cleanrooms-and-associated-controlled-environments-biocontamination-control-dissecting-standa

 

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

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