Yearly Cleanroom Revalidation Test Requirements - Questions for users clean room ISO7

[Jojo63]

Hi all,

We have a iso7 cleanroom.

Each year, it is qualified with this tests:
- airborne particulate counting
- HEPA filters test
- air velocity
- supply flow rate
- turnover
- differencial pressure


Except airborne particulate counting, is it absolutely necessary to perform all other tests

Thanks you for you feedback.

Jojo

 

[Stijloor]

Re: Yearly Cleanroom Revalidation Test Requirements - Questions for users clean room

A Quick Bump!

Can someone help?

Thank you very much!!

Stijloor.

 

[MIREGMGR]

Re: Yearly Cleanroom Revalidation Test Requirements - Questions for users clean room

It might be reasonable for parameters that are evaluated during an IQ and as a matter of engineering and physics are not plausibly likely to change due to use, wear or age (i.e. facility area and volume, construction materials) to be assumed constant unless self-evidently changed.

As to parameters that originally were evaluated during OQ or PQ and are subject to change over time due to use, wear or age, is there some way other than testing for the qualifier to know that the facility continues to meet the applicable requirements?

 

[Jojo63]

Re: Yearly Cleanroom Revalidation Test Requirements - Questions for users clean room

Each week, we control airborne particulate counting, lighter that during the qualification and each day we record the differencial pressure. The ISO 14644 quotes airborne particle counting, flow rate and pressure differencial but it says nothing about testing HEPA and renewal rates. Jojo

 

[MIREGMGR]

Re: Yearly Cleanroom Revalidation Test Requirements - Questions for users clean room

If you're self certifying, you may be able to write a rationale for doing less annual re-qualification that will satisfy whoever may inspect you, based on continuous review of your daily performance testing. This however will be difficult to do convincingly if it involves a decrease in compliance activities, since you have no evidence that future instances of the annual qualification wouldn't have discovered an incipient problem before you produced out of spec product.

If someone else (i.e. a cleanroom technical specialist) is certifying your facility, you have to play by their rules. If they're not comfortable re-certifying without annual re-qual, so be it.

If you are subject to a third party's audit under international rules, for instance for a CE certificate that covers controlled-bioburden manufacturing of devices that will be sterilized, you have to play by the rules expectations of that organization.

If you are subject only to FDA oversight, the answer will depend to some extent on the criticality of what you do in the facility and on what commitments you made, explicitly or implicitly, in applicable pre market clearance processes.

 

[Jojo63]

Re: Yearly Cleanroom Revalidation Test Requirements - Questions for users clean room

Thank you for your help, Miregmgr.

Jojo.