Monday, 28 January 2013

ISO 14698 revision process underway

The following article of interest has been posted by Cleanroom Technology.

Following a recent meeting, a decision has been taken by the international cleanroom community to move forward with the work to revise ISO 14698 – Cleanroom Biocontamination Control.

The standard will seek to establish control requirements such as the important environmental quality attributes. It will also refer to test methods and validation, including assessment of environmental monitoring equipment like air samplers. There will also be a section on data handling.

The main changes to ISO 14698 under discussion are:
  • ·         A new classification system for viable counts, split into surface and air cleanliness,
  • ·         Guidance for assessing cleanrooms at start-up or after modifications for bioburden, in a similar way that cleanrooms are currently assessed for particle counts,
  • ·         Guidance on viable monitoring methods,
  • ·         Recommendations for data analysis.

The vote was accepted with 13 countries giving ‘Yes’ votes and only the USA ANSI team voting ‘No’.

The countries that voted a ‘Yes’ in support of this work were Brazil (ABNT), Germany (DIN), China (SAC), France (AFNOR), Japan (JISC), Sweden (SIS), Italy (UNI), Korea, Republic of (KATS), Ireland (NSAI), Switzerland (SNV), Netherlands (NEN), Denmark (DS), UK (BSI). Twelve of the countries are putting forward experts to take part (Korea is not sending an expert).

The US team has stated it will no longer be putting forward an expert for the ongoing work on this document.

The standard is seen by some in the US as adding unnecessary cost to industry. In addition the US Pharmacopoeia Chapter <1116> "Microbiological Evaluation of Clean Rooms and Other Controlled Environments”, which has only recently been updated, would possibly be at variance with some of the resulting ISO revisions.

Speaking about the potential revisions, Tim Sandle, Head of Microbiology, BPL, considers that one aim of the revised standard – to have a viable classification approach for cleanrooms – requires further discussion. “Cleanrooms are clean if verified by their physical parameters and remain so provided people do not enter them. The current thinking of orientating monitoring locations and frequencies towards risk seems a more sensible approach. Another aspect, to have an average count for a clean area on classification, stands in contrast to the current USP approach that looks at incident rates.”

Source: CleanroomTechnology 

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