Sterilization Validation Accreditation - A mandated standard requirement?

shruti_hiregange

Involved In Discussions
#1
We have a major non-conformance to handle which is against a product's validation procedure issued in a continuous assessment in audit for ISO 13485. The procedure of sterilization is supposed to happen only at the customer end. And the non-conformance lies in the fact that we have not got the sterilization process validated. So we were asked to get that done from a laboratory that is accredited. After doing some good amount of searching we managed to find one lab which had the required facility to do the same. And has accreditation from NABL (National Accreditation Board for testing and Calibration Laboratories) in accordance with ISO/IEC 17025 for 'biological' and 'chemical' testing.
The same was conveyed to the auditor, he now asks if the scope for 'biological' and 'chemical' testing includes sterilization validation or not.:frust:
My question is this a standard requirement or is this a requirement particular to the body who's granted us ISO 13485? Because satisfying both the criteria's is something that's proving to be an uphill task here.
Please shed some light! Thanks!
 
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MIREGMGR

#2
he now asks if the scope for 'biological' and 'chemical' testing includes sterilization validation or not.
That seems like a good question for an auditor to ask. The lab might have expertise in agricultural processes, or any of a zillion other things that would have nothing to do with medical sterilization processes. So...what does their certification actually say about their scope of recognized expertise?

is this a standard requirement or is this a requirement particular to the body who's granted us ISO 13485?
It may not be spelled out in the standard, but it's an appropriate element of an audit process, because it goes directly to supplier qualification and process effectiveness.
 

shruti_hiregange

Involved In Discussions
#3
Well the same question about the scope of registration when forwarded to the lab, they very curtly say they are capable of performing the sterilization validation, but its not mentioned in their biological scope as this is not the very commonly asked requirement. And the lab didn't seem to be some small-time business place, it was a big one which gave out accreditations itself.
Well I agree with them to some extent because sterilization is a very broad category, and finding a lab specifically accredited only for moist heat sterilization validation sounds a little out of feasibility for me. Okay to quote an instance we found one lab, which was accredited to perform sterilization validation, but that was with regards to only radiation sterilization which is not something we recommend.
Agreed the point is a valid one, that the process effectiveness needs to be verified but there has to be some scope for feasibility in performing it...
If they are providing me the protocol for the test and also telling me the standard against which it will be done (17665-1 in my case) wouldn't that suffice?
Being new in the field..I may be wrong..but this is what I feel strongly..
 
G

Gert Sorensen

#4
Not a very comforting situation when your supplier does not provide the information you need, especially considering that you are in a pickle, and they are supposed to be experts at this.

Looks like there might be some uncertainty as to what is expected from the laboratory given their reply and the auditors question. It is all good and fine to have a certified or competent lab do various testing in connection with sterilization validation, but that does not ensure that they are competent when it comes to the actual validation of the sterilization process. There is a significant difference between e.g. ETO and Gamma sterilization or as is the case here Moist-Heat-Sterilization, and the competencies needed for validating each kind of process. The lab may not have those competencies.

So, the question is valid. If I were you I would engage in a more open dialogue with your NB to verify what they want you to do to close this observation, and then revert to the lab to ensure that they can fulfill the needs that you will then have.
 

shruti_hiregange

Involved In Discussions
#5
Yes, I completely agree that the auditor is correct in asking for if the lab is capable of carrying out the tests for the required validation.
We did ask our NB that we are experiencing a lot of trouble in finding a lab that has accreditation that specific. And especially after its stated above that all the various sterilization process validations differ for each type..finding the type that suits our product that still is a problem.
So the reply we received from the NB is that we must just ensure that the labs are capable of performing the tests..and they should be in accordance with ISO 11737-1 (for determination of population on microorganisms of products) and ISO 11737-2 (Tests of sterility performed in the definition, validation and maintenance of a sterilization process) Now I dont know how far this suggestion will work when it be taken up for review later....
 

Ronen E

Problem Solver
Staff member
Moderator
#6
I might be missing something here, but for what it's worth -

the basic NC was for lack of validation of the suggested sterilization process. As far as I understand, there's nothing wrong with you performing / orchestrating such validation process in house, especially when a specific applicable standard (or standards) is prescribed by your auditor / certifying body. The only part that would typically require outsourcing is the microbiological tests, and I believe you could fairly easily locate a qualified and certified pathology / microbiological lab in one of the larger hospitals in your area. These are not very special or rare tests. You may also need to outsource the actual sterilization if you don't have the equipment in-house, but I guess this shouldn't be a serious problem (perhaps you could do it in the same hospital, or ask your customer to assist with that). As a last resort maybe hire or purchase the moist heat equipment, assuming it's nothing huge or ultra-expensive.

My :2cents:.

Cheers,
Ronen.
 
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