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Cleanroom Monitoring Plan - ISO14644-2:2015 - Risk Assessment

Hi, I am looking for a sanity check...….. I was recently reviewing a Class 8 cleanroom and asked about routine monitoring and whether they had a Monitoring Plan, (as per ISO14644-2:2015 chapter 4). In practice, the cleanroom is subject to an annual re-certification and the monitoring frequency is 12-months. Consequently, other than the annual recertification, no other monitoring is performed and no Monitoring Plan or risk assessment justifying the 12-month period has been performed.

Looking back through ISO14644-2015, I can't see anything discussing the monitoring frequency, other than saying it should be specified. Can you simply provide a Risk Assessment saying once every 12 months is sufficient?



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Can annual monitoring even be considered monitoring? Having a risk assessment present is one thing, but would the content of that document really be able to justify annual "monitoring"? How would they possibly catch any excursions?


Starting to get Involved
I know some manufacturers and all perform annual monitoring ( unless there is any condition which require revalidation). I will be so glad if anyone say something: Is 1-year period monitoring really sufficient?


Involved In Discussions
I would say annual monitoring would only be okay if the following were true:
- Particulates pose no or extremely low risk to the product.
- There was a previous period of monitoring at greater frequency showing the level of particulate remained the same over time.
- No changes have occurred which would affect the level of contamination (e.g., number of people have stayed the same, the product is the same, equipment is the same).

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