GXP

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

Biocontamination control is generally concerned with microorganisms, viruses, microbial toxins, and particulates (2). However, in relation to this definition, the scope of the new standard limits the definition of contamination 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.  The standard seeks to replace the current international two-part contamination control standard ISO 14698 Parts 1 and...

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