(Michel Thibaudon, RNSA and biocontamination expert instructed by ASPEC for the National Mirror Committee AFNOR X44B | 6 March 2017)
A collated text, albeit still in a relatively draft format, was sent to the CEN for ratification in February 2017.
ISO 14698, which was published at the end of 2003 and transposed into an AFNOR standard in March 2004, had two main parts: Part 1: Cleanrooms and associated controlled environments – Biocontamination control: General principles and methods; and Part 2: Evaluation and interpretation of biocontamination data.
Despite being essential at the time, these initial versions were found to be both incomplete and insufficient as regards the techniques and interpreting the results. Therefore, applying the usual procedure for amending standards, in 2012 the ISO/TC 209 Committee launched a working group to make the necessary changes, culminating in the production of draft standard in 2014. However, this document was deemed unacceptable by a certain number of members in contributing countries, including the USA.
The deal breakers included a microbiological classification of cleanrooms and controlled environments that used questionable techniques. Given the failure to reach an international consensus, this working group was dissolved and Europe has instead begun to develop a biocontamination standard via a CEN/TC 243 (European Committee for Standardisation) working group, WG5.
The group held its preliminary meeting in Dublin in September 2015 in order to discuss its plan of action, and the first full meeting then took place in Delft (Netherlands) in January 2016. Sub-working groups have been set up to focus either on traditional methods for measuring biocontamination that require microbiological cultures and are therefore limited solely to cultivable particles, or on new methods involving techniques that do not require cultures and are therefore especially suitable for measuring all viable particles, irrespective of whether they are cultivable. Other sub-working groups are working on the various fields of application.
In November 2016, the WG5 met in Milan and the heads of each sub-working group submitted their draft documents, which were then amended and ratified by the members of the WG5.
In February 2017, the collated document, still in relatively draft format, was sent to the CEN for ratification by the various member states. A working meeting will be held in September 2017 in Paris to discuss any comments and propose an updated text.
The goal is to have a European standard ready for publication in 2018. Five experts who sit on the AFNOR X44B Mirror Committee are contributing to this work, Michel Thibaudon, Sabine Bessières, Isabelle Tovena, Jean-Sébastien Bonin and Karine Bizet.