Gamma Ray Sterilization Quarterly Dose Auditing Supplier Requirements

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Ktrna

Guest
#1
Our company produces Class I sterile Medical Devices.
How could I qualify a company performing our Quarterly Dose Audits for Gamma Ray sterilization if they do not have a quality system in place?
On their results it does say "ANSAI/AAMI/1S0 11137:2006 Method 1 Results Summary" at the top of the page.
When asked about their certification this company said they have no certification (ISO or otherwise) and have no plans to obtain certification.
The owner of our company wishes to keep using this company for our Quarterly Dose Audits.
What criteria can I use to qualify this company?

Thanks in advance
 

v9991

Quite Involved in Discussions
#2
Re: Gamma Ray Sterilization Quarterly Dose Auditing Suppier Requirements

I am not sure if there is a requirement for a contract services lab to be certified!!!
What is emphasized is that
1)the agency has systems/capabilities which support the competency -
2)your assessment/audit - (include assessment of their accreditation with local agencies which allow operate in particular category of services/work etc., something like approval from Locl authorities or government etc.,)
3)agreement to comply with your requirements/systems -
4)your plan for continuous monitoring of results.

Hence, you have to first list out all the requirements of competencies, infrastructure, systems which the contract agency has to meet (basically an comprehensive audit checklist) and then a plan to do a periodic monitoring; (in this case you might have to do an additional monitoring, as they are not governed by any additional/external monitoring agencies)

hope that helps.
 
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Esther Broekmaat

Guest
#3
I think the most easiest way is to make a list with requirements as part as your supplier-qualification. I suppose that there are procedures within your supplier in place, you could perform an audit to see how they opperate. Check training-files, corrective and preventive actions, maintenance and calibration of equipment. If everything is in place you might want to accept your supplier.
If you do need an independent microbiological ISO 13485 certified lab, please contact.
 

treesei

Inactive Registered Visitor
#4
Our company produces Class I sterile Medical Devices.
How could I qualify a company performing our Quarterly Dose Audits for Gamma Ray sterilization if they do not have a quality system in place?
On their results it does say "ANSAI/AAMI/1S0 11137:2006 Method 1 Results Summary" at the top of the page.
When asked about their certification this company said they have no certification (ISO or otherwise) and have no plans to obtain certification.
The owner of our company wishes to keep using this company for our Quarterly Dose Audits.
What criteria can I use to qualify this company?

Thanks in advance
The Covers have had good advice regarding how to qualify this lab. I have some other concern: How do your internal procedures define supplier qualification and management to comply with 13485 based on risks and conditions? Any criteria?
 

Ronen E

Just a person
Super Moderator
#5
Our company produces Class I sterile Medical Devices.
How could I qualify a company performing our Quarterly Dose Audits for Gamma Ray sterilization if they do not have a quality system in place?
On their results it does say "ANSAI/AAMI/1S0 11137:2006 Method 1 Results Summary" at the top of the page.
When asked about their certification this company said they have no certification (ISO or otherwise) and have no plans to obtain certification.
The owner of our company wishes to keep using this company for our Quarterly Dose Audits.
What criteria can I use to qualify this company?

Thanks in advance
Hi,

I'm not 100% sure I understand what you mean by "performing our Quarterly Dose Audits". This sort of activity is many times orchestrated by the manufacturer (you in this case) whilst the irradiation is performed at/by the sterilization service provider, and any required microbiological testing is typically carried out by a certified test lab (certified to the relevant tests). The part typically taken by the manufacturer involves planning, sample preparation and tracking, logistic activities (shipment etc.), and sometimes analysis and final report compilation. Following ISO 11137 is a good measure towards ensuring a proper dose audit. having said all that, I'm not sure exactly what activities you outsource to the supplier you mentioned.

Anyway, I'm not aware of a specific certification requirement relevant to this case. As the service in question clearly affects your product quality, formal supplier (service provider in this case) assessment and qualification would be the right thing to do; however, the way to do that is not prescribed in detail by the regulation. I don't know of a clear regulatory requirement of such a supplier to have a certified (or any) QMS, although that may be a big bonus and streamline the qualification process. The important issue is that your company identify the critical requirements of suh a supplier and ensure that they meet them all, before being formally approved.

If that supplier is formally committing to meet the applicable requirements of ISO 11137 (or a parallel standard) then it may (or may not, at your reasoned discretion) suffice; however, to build some confidence I would have considered doubling several audits with at least another independent body, before deciding that this supplier is worthy of your trust. If this is impractical then I would at least monitor/audit them very closely during/shortly after the first few dose audits, to ascertain that the standard was indeed properly followed.

Cheers,
Ronen.
 
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Esther Broekmaat

Guest
#6
The quartely dose audit mentioned in this question is about the microbiological sterility-level. It has to be performed according to ISO 11137 (and making use of ISO 11737-1 and -2). As owner of the product you have to prove that your product is sterile after gamma-irradiation (initial validation), after succeeding for this initial microbiological validation you have to prove periodically that the process is still under control and no changes in bioburden (number and/or flora) are occuring. That's why you have to prove the sterility level periodically (mostly quartely).
 
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