Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.
The International Organization for Standardization (ISO) have published the long-awaited revisions to its standards for classification and monitoring of air cleanliness in cleanrooms. ISO 14644-1:2015 “Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration” (1) replaces ISO 14644-1:1999, and ISO 14644-2:2015 “Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration” (2) replaces ISO 14644-2:2000.
ISO 14644-1:2015: The primary changes to Part 1 involve the number of samples and the selection of sampling locations. The number of samples will increase from what was required previously. The minimum number of samples is now determined from a lookup table (instead of an SQ Root equation).
Also the exclusion of particles > 5 microns from the classification table for ISO Class 5
ISO 14644-2:2015: The primary changes to ISO 14644-2 is to prove continued compliance with ISO 14644-1 by performing tests to demonstrate control. ISO 14644-2:2015 suggests a monitoring program in addition to the annual cleanroom revalidation in order to gain a continuing trending and monitoring of data over time. This will provide a detailed knowledge of the performance of the cleanroom and demonstrate that your cleanroom is in a controlled state. The benefits of these improved controls should be reduced costs and product losses.
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