ISO Revised 14644-1 & 2, Have you revise your clean-room qualification procedures?

ISO revised the clean room standards 14644 -1 and 2 with effect from Dec 15 2015.The title of the guideline ISO 14644-1 is revised from "classification of air cleanliness" to "classification of air cleanliness by particle concentration. "

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 were being sampled previously. The no of sampling locations which were calculated from the formula square root of surface area will now no longer be followed.

The minimum number of samples is now determined from a lookup table (instead of an equation), and that number is set to be statistically significant.

The limit of 5 micron particles for ISO 5 class has now been removed.

According to ISO, the new method for selecting the sites and number of sampling collections uses a more consistent statistical approach based “where samples are drawn randomly without replacement from a finite population. The new approach allows each location to be treated independently with at least a 95% level of confidence that at least 90% of the clean room or clean zone areas will comply with the maximum particle concentration limit for the target class of air cleanliness.

With this change in guidance document organizations may require to revise their clean room qualification procedures and protocols. Its a good time to go ahead and review existing HVAC clean room validation protocols and standards to incorporate latest changes from ISO 14644-1&2. Like every GMP auditor says find it and fix it before some one else finds and let you fix it.

Thank you

20th Sept 2017