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ISO 14644 Cleanroom Validation - "Operational"

W

WisdomseekerSC

#1
During a recent surveillance audit by our certification body we received a nonconformance to ISO 13485 clause 7.5.2.1. Auditor stated "the validation of the clean room "at rest" does not challenge the worst case scenarios of the clean room's intent regarding particle count contamination. The validation for worst case scenario must be done in "Operation". The auditor shared an email from an official at FDA to emphasis his point :mg:.

We have performed particle counts in "operation" but not routinely. We do use a contracted service to annually certify the cleanrooms. Their Certificates of Compliance certifies our cleanrooms in compliance to air cleanliness classification for an ISO Class 7 under "at rest" conditions, as outlined in ISO 14644-1:1999. We also measure particle counts to verify continued compliance monthly ourselves, also "at rest". We are now considering changing to particle counts to "operation" instead of "at rest" although my understanding is that most folks in the industry perform this monitoring "at rest". Anybody have some insight regarding this practice?
 
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somashekar

Staff member
Super Moderator
#3
Your cleanroom class can quickly slip to next lower level by the sheer loading and personnel behavior. The design of cleanroom to a certain class considers operations that are planned to be performed in that room. It so makes sense that you know your operations are indeed happening in your planned environment. This comes form validation in operation condition.
 
M

MIREGMGR

#4
I have regulatory responsibility for a US facility and a China facility...both claiming conformance to an appropriate level of ISO 14644, and both subject to US FDA regulation. (And also microbiological supervision by our NB.)

At both facilities, we do daily testing under operational conditions.

At both facilities, the respective third party certifier does certification testing under operational conditions, and so states in the certification.

I agree with Somashekar that operational testing should be fundamentally required by the OQ element of the validation process.
 
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