Thursday 29 October 2015

ISO 14644 Parts 1 and 2 approved

Via a tweet, IEST announces that the revised ISO 14644-1 and -2 cornerstone cleanroom standards have been approved as International Standards.

ISO 14644-1, the first document in the 14644 series, was published in 1999, and ISO 14644-2 was published the following year. The documents have been subject to revision for several years. ISO 14644-1 specifies classes of air cleanliness for the world’s cleanrooms and controlled environments in terms of the number of particles expressed as a concentration in air volume. To determine the class, a specified testing method is required, which includes selection of sampling locations.

ISO 14644-2 emphasizes the need to consider a monitoring strategy in addition to the execution or evaluation of the classification provisions of ISO 14644-1.

Revisions of ISO 14644-1 and -2 were released In December 2010 as Draft International Standards. Four years later, a second round of revisions to ISO 14644-1 and -2 was released as Draft International Standards. These revisions provided a clearer classification of air cleanliness in cleanrooms and associated controlled environments exclusively in terms of concentration of airborne particles of a designed size range. Final Draft International Standards of both documents were released in August 2015.

The improved sampling method in the revised ISO 14644-1 document along with the enhanced guidance for particle counter calibration and performance will provide improved confidence to cleanroom users that their cleanroom is delivering the preferred level of quality-controlled environment for critical life science applications.

Posted by Tim Sandle

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