Sterilization Subcontractor - Quality Control

#1
Hi,

I'm not a expert in sterilization process and for that, I have a doubt about the quality control of a sterilization subcontractor.

We are starting a OBL process and our OEM sterilizes the medical devices through a sterilization subcontractor. This company has the EN ISO 11137 certification (gamma sterilization).

I asked (directly to the sterilization company) for the instalation qualification (IQ) and operational qualification (OQ) and they told me these documents are classified as confidential and for that they will not send them.

I'm in the right to ask for these documents or ISO certification is enough?


Another thing, to control the OEM I established the procedure for dose mapping, the quartely control and the reports from the sterilization company? Is this enough?

Thanks in advance.
 
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planB

Trusted Information Resource
#2
Hi,

I'm not a expert in sterilization process and for that, I have a doubt about the quality control of a sterilization subcontractor.

We are starting a OBL process and our OEM sterilizes the medical devices through a sterilization subcontractor. This company has the EN ISO 11137 certification (gamma sterilization).

I asked (directly to the sterilization company) for the instalation qualification (IQ) and operational qualification (OQ) and they told me these documents are classified as confidential and for that they will not send them.

I'm in the right to ask for these documents or ISO certification is enough?


Another thing, to control the OEM I established the procedure for dose mapping, the quartely control and the reports from the sterilization company? Is this enough?

Thanks in advance.
pfcustodio,

I guess your OEM has the contract containing the necessary controls of the sterilization process and you do not have a direct relationship with the sterilization subcontractor? If yes, you would technically have to go through your OEM to get access to the information you are longing for. rahter than approaching the sterilization contractor directly.

It is common practice that IQ and to some part also OQ documents are reviewed during supplier audits on site, and sterilization sub-contractors are used to be audited also in these areas.

For their certification, this should be readiliy available, at least through your OEM.

It is a good thing, that you defined a sterilization (validation) procedure for your OEM. Also make sure that your OEM has proper supplier controls in place, i.e. a well-defined contract with the sterilization sub-contractor, an audit plan which contains the audit requirements with which you are comfortable with (e.g. annual on-site visits), a documented process specification and all rationales that explain why certain thing are done in a certain way (e.g. definition of product families/processing groups, frequency of dose audits, ...)

HTH,

Gerhard
 
#3
Hi planB (Gerhard),

thanks for your answer.

It's like you said, i do not have a direct contact with the sterilization subcontractor.

I hope i'm wrong but my OEM doesn't seem to have too much control in this process because i already asked for the internal quality control of the sterilization and just received the ISO certificate of the sterilization subcontractor. :frust:

With your guidance, i will push the OEM to provide more information.
 

planB

Trusted Information Resource
#4
pfcustodio,

make sure you have your required controls defined in the contract with your OEM. Otherwise, it will become very tedious or impossible to relay your requirements.

Your contract with the OEM should also include provisions that allow you to audit your OEM. A supplier audit would be another possibility to verify that your OEM has proper sterilization controls in place.

Maybe you could even think of changing the supply chain in way that you turn the (currently indirect) sterilization contractor into your direct supplier, though I am not sure whether this would jeopardize your OEM supplier setup.

HTH,

Gerhard
 
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