Tuesday 11 August 2015

ISO 14644 ballot delay

As regular readers of this website – PharmaceuticalMicrobiology – will be aware, the main international cleanroom standard is at final draft stage for parts 1 and 2. With this comes the proposal to change the way that the particle count classification of cleanrooms is undertaken. This includes the introduction of a ‘look-up table’ for particle count locations; and new approach to sample volumes; and key guidance for in-process monitoring.

The provisional implementation date was mooted to be September 2015.  ISO have now indicated that final ballots on FDIS 14644-1 and FDIS 14644-2 will open on 27th August 2015.

Based on this information interested parties should not expect the revised standards to be published until later this year or early into 2016.

Posted by Tim Sandle

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