Cleaning process center change

S

srinu

Registered
#1
#1
Our Knee System products are approved FDA and CE,
I would like to know one thing regarding the Cleaning process, we would like to change the cleaning process center then what are the Re validations needed to our approved system?
As per our knowledge ,change in the cleaning process will affect the biocompatibility so we are thinking to do the biocompatibility tests and cleaning re validation .

My question is Do we need to do revalidation on sterilization (Gamma and Eto)?
 
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planB

planB

Super Moderator
#2
#2
srniu,

the response is: it depends.

If you come to the conclusion in your risk assessment, that the change in cleaning process

(1) might adversely affect the safety and efficacy of your cleaning process, then yes, you have to re-validate and also potentially re-evaluate the biological safety of your final product.

(2) has a potentially adverse impact on your subsequent validated sterilization process, then you would have to cover these aspects in re-validation activities. An example might be, that your intended change alters the bioburden / bacterial endotoxin levels of your product.

The extent of re-validation activities depends on the exact nature of your intended change (e.g. is it "just" a site change where you move your existing process to, or do you intend to use a different cleaning process?) and the associated risk assessment for this change.

You might also have a look into this thread and the change management sections in ISO 10993-1, ISO 11137-1 and ISO 11135, respectively.

Hope this helps,
 
S

srinu

Registered
#3
#3
Thanks @planB for your clarification..
We are changing the site with same conditions of cleaning process, only thing is in our risk management ,we are planning to verify like
1. we are thinking to do the Endotoxin test and check with our old report ,if the result are equivalent then the process is not effect
2.Another way to do the cleaning process validation and check the result with previous result, if the results are equivalent then the process in not effect
My question is which way is the best to prove the changed process is safe and avoid biological and sterilization revalidations?

If you put some light on this, it's more useful for me to conclude this risk assessment.

Thank you.
 
planB

planB

Super Moderator
#4
#4
Srinu,

you might want to gather objective evidence from your supplier that supports the conclusion that you are just transferring an unchanged process to a new site.

This could include (but not limited to):
- IQ, OQ, PQ data of the equipment at the new site, demonstrating equivalent functionality
- process at the new site: any OQ, PQ data available that the process conforms to the very same parameter specification? Any In-process monitoring data (such as conductivity, TOC, turbidity, ...) that would substantiate equivalency?

ad (1) In case (bacterial) endotoxins are one validation endpoint of your cleaning process, then yes, re-testing endotoxin levels at nominal (or at worst-case conditions) might help you building your case. What other validation acceptance criteria are in place?

ad (2) yes, this would be an option.

Hope this helps,
 
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