Revision to ISO bio-contamination cleanroom standard stopped or just delayed?
International Standards Organisation (ISO) has two series of clean room standards, ISO14644 and ISO14698. Both standards have been under review for many years and whilst sections 1 and 2 of ISO14644 have been issued as draft international standards (DIS), further work on ISO14698 for bio-contamination has stopped.
It is reported that after seven years of trying, a consensus could not be reached on developing a revised standard. The main sticking point was agreement about creation of microbial cleanliness tables for classes of cleanroom that would allow users to classify by bio-contamination, not just particulate levels. It would seem therefore that cleanrooms will continue to be defined biologically by guidelines such as EU GMP Annex 1.
However, Annex 1, which advises pharmaceutical manufacturers regarding production and filling of sterile products, is currently under formal review with the aim to issue a revision during 2016. It has been suggested that Annex 1 should reference ISO14698. ISO/TC209 is the technical committee that oversees revisions to the ISO standard, it is understood that advice is also being sought from the European Medicines Agency with regards to referencing ISO14698 within the revised Annex 1. This extended interest may prompt a renewed effort with regards to revision of 14698.
Other guidance documents are making reference to 14698, such as the PHSS Technical Monograph Nº 20 Bio-contamination. Therefore, the referencing of ISO14698 within Annex 1 would seem a logical step, as the current Annex 1 fully embraces the cleanroom certification standard, ISO14644. Cross referencing and ultimately unification of the clean room standards will undoubtedly make compliance easier for all concerned. However, the biggest challenge would appear to be avoiding any contradiction between a revised ISO14698 and EU GMP, or indeed FDA guidance or USP chapter <1116> and is probably why consensus couldn’t be reached on the revised standard.
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