Eto Sterilisation Re-Validation Requirements

[AliceW]

If a new cleanroom is built to meet the specs of the old cleanroom and the product has not changed, the process has not changed and the operators have not changed - do you need to re-validate the sterilisation process?

[iamtroll]

You can probably justify with a paper review by restating all of those factors in detail if you can provide proof that your bioburden is in the same range.

[Ronen E]

In Reply to Parent Post by iamtroll

...if you can provide proof that your bioburden is in the same range.

Pay attention to both numbers and types of organisms.

If a new cleanroom is built... the process has not changed...

I'm 99% sure that if the operations have moved to a new cleanroom facility, the process must have changed in some ways, not necessarily negligible, regardless of specs, SOPs, personnel etc. If you look close enough you will spot the differences...

[Ajit Basrur]

In Reply to Parent Post by AliceW

If a new cleanroom is built to meet the specs of the old cleanroom and the product has not changed, the process has not changed and the operators have not changed - do you need to re-validate the sterilisation process?

Yes, the relocation involves dismantling and reinstalling ... that calls for a requalification and revalidation.

There was an earlier FDA warning Letter issued to Lydall Inc. for ETO relocation -

2. Failure to review and evaluate a process and perform revalidations where appropriate when changes or process deviations occur, as required by 21 CFR 820.75 (c). (FDA 483 item #2) Specifically,

a When your manufacturing process was relocated to North Carolina, the Et0 sterilization process was not revalidated. (FDA 483 item # 1.c).

[AliceW]

Many thanks for sending the link - this helps enormously