Shelf-Life - Accelerated Age Test

medwise · May 27, 2010

Dear All,

Our device is a class II (a) sterile and is used for skin closure.

This device used to be gamma irradiated but from last two years we use EtO.

The shelf life of the device is 5 years.

Packaging material and packaging machine is exactly the same. Manufacturing process is exactly the same. One change is the sterilization process. From gamma to EtO.

We do sterility test of the product which has undergone EtO and found that it is sterile.

My question is do I have to conduct age testing because we change from gamma to EtO?

We are doing EtO from 2008 so the only option is Accelerated age test., which we are happy to do. But I was wondering wouldn't risk assessment be sufficient (including the sterility test) because the packaging material and machine has been the same.

Any guidance will be much appreciated.

Thank you

Kindest regards,
Romit

ontheopenroad · May 27, 2010

You would need to revalidate your shelf life (using accelerated aging as you suggested, followed-up by real time study). You should revalidate because:

a) change in sterilization method may have a negative (or even positive) impact on the package integrity.
b) change in sterilization method may have a negative (or even positive) impact on device integrity.

:2cents:

MIREGMGR · May 27, 2010

I agree with OTOR.

Statistical Steven · May 27, 2010

Romit -

Unfortunately at the time of the sterilization change you did not initiate a real time stability program. Based on the risk assessment, you could claim that a real time stability plan would be appropriate. You have to show that the change in method does not have a long term (stability) impact in the package and/or sterility of the product. Unless you have a good Arrenhius model, accelerated stability might not be effective. My :2cents:

romit singh said:
Dear All,

Our device is a class II (a) sterile and is used for skin closure.

This device used to be gamma irradiated but from last two years we use EtO.

The shelf life of the device is 5 years.

Packaging material and packaging machine is exactly the same. Manufacturing process is exactly the same. One change is the sterilization process. From gamma to EtO.

We do sterility test of the product which has undergone EtO and found that it is sterile.

My question is do I have to conduct age testing because we change from gamma to EtO?

We are doing EtO from 2008 so the only option is Accelerated age test., which we are happy to do. But I was wondering wouldn't risk assessment be sufficient (including the sterility test) because the packaging material and machine has been the same.

Any guidance will be much appreciated.

Thank you

Kindest regards,
Romit

Bev D · May 27, 2010

ask your reviewing body. The change from irraditiaon to eto is significant as this is a 'special process' and they are fundamentally different sterilization models.

accelerated testing is usually not acceptable. As Steven said most accelerated testing is not well correlated and often the model is not correct in real life.

In the context of biologicals, accelerated testing is often good for detecting differences but not in predicting life...

MIREGMGR · May 27, 2010

Bev D said:
accelerated testing is usually not acceptable.

In my experience, environmentally accelerated testing frequently is used to establish both sterile-barrier-packaging shelf life and product functional shelf life, so that the product can be brought to market while the real time testing proceeds.

I don't disagree that this approach is uncertain because of the imperfect validity of the acceleration concept, but it's the best alternative to waiting for the real-time period to introduce new medical developments...which itself would have a social cost in terms of improved medical care foregone.

The FDA explicitly expects accelerated testing with approval submissions, while real-time testing proceeds.

My FDA/EC/HC experience is mostly with regulatorily simple products, though. For what particular device classes is the "not acceptable" statement definitely the EC rule?

Bev D · May 27, 2010

I agree that for some devices accelerated testing is allowed and expected while real time studies proceed. for complex biologicals, this is not always true. it can vary depending on your reviewer...certainly pharmaceuticals and vaccines fall in this category although they are not medical devices. A diagnostic test is a medical device and they are complex biologicals that don't fit well into accelerated testing models... I have been restricted to real time testing studies when implementing a sterility change for irriadiation and eto for diagnostic devices... A well crafted plan for sterility properly presented will generally be accepted. that is where a collaborative relationship with your reviewing body helps...

medwise · May 27, 2010

Dear All,

Thank you for your quick response and help. I really appreciate it. :thanks:

I just forgot to mention that we also want to change the storage temperature of the device from 25 degrees C to 45 degrees C. So can I just do accelerated aging test with 45 degrees C and then do the performance test of the device.

Also, since our device is a wound closure strip and is packaged in such a way that there will be no moisture inside the packaging. For the accelerated test do I still have to consider relative humidity, and if yes then what is the limit of RH%?

:thanx:

Kindest regards
Romit Singh

MIREGMGR · May 28, 2010

That casts an entirely different light on the situation, in my opinion.

A change of that magnitude needs to be re-evaluated from a design perspective as to effect on device functionality, re-evaluated from a risk perspective, re-evaluated from a packaging perspective, and generally re-validated.

The unassured correspondence between real time behavior and accelerated environmental-conditions aging is a key factor in your question. I don't think accelerated aging would be in any way adequate to support such a storage temperature change.

Your moisture question needs to be addressed at the packaging-design-performance level. Accelerated aging by itself is not an appropriate tool for doing what you want to do.

Shelf-Life - Accelerated Age Test

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