Sterilization Adoption - Design House - Adoption Letter from Contract Manufacturer

[rwend07]

We are a simple design firm and do not do any of our own manufacturing. Our current contract manufacturer (ISO 13485 certified) has adopted our first sterilized product (Class I sterile) into their current EO sterilization process. They have provided us an adoption letter that seems to address all aspects of family adoption.

With all of that said, I'm not sure what control a notified body would expect to see over our contract manufacturer for our sterilization audit. We're having a bit of trouble parsing out our requirements vs our contract manufacturer's requirements when it comes to sterilization validation. Could anyone point us in the right direction for what a NB would expect to see?

 

[paulag]

Re: Sterilization Adoption - Design House - Adoption Letter from Contract Manufacture

We are a simple design firm and do not do any of our own manufacturing. Our current contract manufacturer (ISO 13485 certified) has adopted our first sterilized product (Class I sterile) into their current EO sterilization process. They have provided us an adoption letter that seems to address all aspects of family adoption.

With all of that said, I'm not sure what control a notified body would expect to see over our contract manufacturer for our sterilization audit. We're having a bit of trouble parsing out our requirements vs our contract manufacturer's requirements when it comes to sterilization validation. Could anyone point us in the right direction for what a NB would expect to see?

Hello Rwend,

our Notified Body wants to see the whole sterilization validation file, at each audit... simple as that They particularly check if any new or changed requirements of the sterilization standards have been implemented in a timely manner, and if the process has been revalidated after the change. They also checked wether our staff knows what the data on the sterilization certificates mean and if they would recognize out of spec values, etc. As a critical supplier, your Notified Body might also want to perform an audit at the sterilizator's facility...

 

[pkost]

Re: Sterilization Adoption - Design House - Adoption Letter from Contract Manufacture

There is more to sterilisation than validation, the controls that ensure that production occurs within the parameters that have been validated are important.

How do you know that your subcontractor is able to maintain these parameters? include the environmental conditions, have they been clearly specified and are they tested/verified? to what level are they tested/verified?

What checks has your subcontractor carried out on the sterilisation plant? What is their supplier approval process like? is it a tick box exercise? is the sterilisation plant well known? Do they have ISO certification? Has your sub contractor audited them?

What controls does the sterilisation plant have in place to maintain controlled sterilisation?

For validation, what labs are used? are they the same as the sterilisation company or an independent lab?....

What controls are in place to ensure sterilisation has occurred before product release?

What shelf life have you detailed on the product? have you validated this? have you validated that the packaging is able to maintain sterile conditions throughout the supply chain?


In summary:
Look at the whole process, top to bottom, risk assess it and document it how it's validated and sub processes are adequate.

 

[rwend07]

Re: Sterilization Adoption - Design House - Adoption Letter from Contract Manufacture

Thank you both for your replies/help. It's been settled that I will be making a trip to China to audit their sterilization procedures/validation.