Using sterilization data obtained from batch release for CE submission

[shimonv]

hi all,
Can someone tell me if it?s possible to use sterilization data obtained from batch release for CE submission? (instead of full validation data)
Any reference to a standard will be most helpful.

Thanks,
Shimon

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[planB]

Re: sterilization data for CE submission

Shimon,

sterilization is a process that cannot be fully verified and thus, has to be validated. Depending on your chosen sterilization method, there are approaches to validate single batches on their own merits.

To provide you with more information, it would be most helpful, if you could provide more details about the sterilization method you are using.

HTH,

Gerhard

 

[shimonv]

Re: sterilization data for CE submission

Hi Gerhard,
The sterilization method is EtO.
I am very interested to know how can we validate single batch on their own merits.

Tahnks!
Shimon

 

[planB]

Re: sterilization data for CE submission

Here are some links that may be helpful:

http://medicaldevicequality.blogspot.co.at/2011/09/fee-fi-fo-fim-sterilization-matters.html

http://www.mdtmag.com/blogs/2014/01...lized-medical-devices-or-those-need-go-trials

https://www.youtube.com/watch?v=4bZtgDC_JZw


HTH,

Gerhard

 

[shimonv]

Thank you for the info. Now, coming back to my original question:
Can we use batch release sterilization data (instead of full validation) to obtain CE mark? and if so, does it come with post market stipulations of some sort.

AAMI TIR 16 specifically talks about batch release, but it's not an harmonized standard.


Regards,
Shimon

 

[Ronen E]

Thank you for the info. Now, coming back to my original question:
Can we use batch release sterilization data (instead of full validation) to obtain CE mark? and if so, does it come with post market stipulations of some sort.

AAMI TIR 16 specifically talks about batch release, but it's not an harmonized standard.


Regards,
Shimon

How do you intend to justify that ER 8.4 was satisfied?

Devices delivered in a sterile state must have been manufactured and sterilized by an appropriate, validated method.

 

[shimonv]

Hi Ronen,
I have seen that too but it doesn't mean that batch release are not validated. Batch release has its own method and biological indicators are tested after sterilization load.
From what I understand its a shorter process because its aim is to validate a single lot, but there is no compromise on safety & effectiveness.


Shimon

 

[shimonv]

P.S. I think the key question is does the harmonized standars allow in any way to do a lot release?

 

[Ronen E]

There are 2 issues here:

(a) It is the method that is required to be validated, not the specific batch results.

(b) If you only ever intend to place that single batch on the market, looking at validating that batch might be relevant; however, if you intend to place consequent batches you need some overarching validation. Do you intend to "validate" each and every single batch?

 

[shimonv]

It?s not that simple, but let?s say we intended to start with one or two batches and later on move into full validation. The key issue is time-to-market and the question is how will a notified body react to a submission based on batch release. I suspect it?s on the border line between challenge and impossible. What do you think?

Thanks,
Shimon