Accelerated Stability Studies - Class III Medical Gloves

Re: Accelerated Stability Studies - Class III Medical Gloves

Hi Cove,

I need some ideas to carry out accelerated aging of gloves. What would be the best temperatures & time interval to do the study?

Thanks.

Re: Accelerated Stability Studies - Class III Medical Gloves

Alyana said:

Hi Cove,

I need some ideas to carry out accelerated aging of gloves. What would be the best temperatures & time interval to do the study?

Thanks.

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Following ICH Q1 for the accelerated conditions, I would recommend 40C/75%RH at 0, 1, 3 and 6 month time points. What will you be measuring as the response?

Hi, can i use EN 455-4:2009, Annex C - Determination of the shelf life of a significantly modified product which stated

a) After storage at 70 °C for 7 days.
b) After storage for 90 days at 50 °C.

to determine my gloves shelf life of 3 years after all the required tests passed for condition a and b? how about the pouch or packaging of glove? can i use the above condition a and b for package integrity test?

I saw the EN455-4 standard cite Annex B - Guidance on conducting and analyzing accelerated ageing studies use Arrhenius equation. Below derive from Arrhenius equation, right? should i use below for accelerated ageing study? many thanks.

EN 455-4:2009, Annex C is not intended to establish an initial shelf life, but to (quote from C.2) "establish a provisional shelf life for a specified condition of storage and distribution by demonstrating that the modified product does not deteriorate to any greater extent than the original product".

For sterile barrier integrity over shelf life, best refer to EN445-4, section 4.5 together with ISO 11607-1:2019, section 8.3.

Guidance on accelerated aging is most up to date in ASTM1980:2021, which you may want to consider in addition to EN455-4, Annex B. Your example calculation appears to be correct for a targeted shelf life of 1 year. You would have to triple you acc. aging time period from 40 to 120 days in order to substantiate a shelf life of 3 years at a storage temperature of 23°C.

HTH,

My understanding is equally similar as you!! I truly wish we are wrong.......by the way, who will be the right person for us to countercheck the interpretation of EN455 and ISO 11607 on accelerated/shelf life/stability studies?

My example of calculation is based on the accelerated ageing calculator available online which derived from Arrhenius equation. I don't have the latest version of ASTM1980 but i suppose the previous version stated the same conclusion as EN455-4 Annex B whereby my example is my final interpretation from Annex B(decide your shelf life, accelerated temp, ambient temp, Q10) to get the conditioning day required on Chamber.

Ya, before i forget, how about the humidity control on accelerated ageing study? is it stated in the standard? Last time, we used RH50% without any justification.

by the way, who will be the right person for us to countercheck

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In case you are the legal manufacturer, then _you_ are the right and responsible one. You could further double-check with regulators, research on the internet , contact peers, get trained, hire a consultant etc. - this is up to you.

planB said:

In case you are the legal manufacturer, then _you_ are the right and responsible one. You could further double-check with regulators, research on the internet , contact peers, get trained, hire a consultant etc. - this is up to you.

Click to expand...

Please refer below answers from Bing.

Can accelerated ageing test use to determine the shelf life of gloves?

Yes, accelerated ageing tests are used to determine the shelf life of gloves. These tests simulate the effects of ageing on gloves by subjecting them to elevated temperatures for a specific period of time. The test results are then used to determine the shelf life of the gloves.

For example, based upon 7 days ageing at 70°C, the gloves conform to EN455-1 and EN455-2; therefore a shelf life of three years can be applied whilst real-time studies are conducted.

Hi, sorry for reviving this old thread, I have a question bout the interval of testing. While I understand from ICH, for example, it is recommended to have testing interval like 3 months, for the first year, 6 months for the subsequent years and etc. I am wondering on what basis is this testing interval established?

For example, if I am claiming a 1 year shelf life of my product, can I just conduct the characterization of the product, at T0 and after that charge it into the climate chamber and perform the test only 12 months later. As I understand, as long as the testing on 12 month passed, I have no issue to claim for the 1 year shelf life? Probably some would say the frequent testing interval allows manufacturer to terminate the study earlier and rectify the issue, if things go south. But is this the only reason why this testing interval was recommended? Other than this, I cant really understand why this testing interval is recommended.

Remember that ICH Q1 is intended for stability testing of drub substance, not shelf life of devices or packaging. The temperature and humidity conditions specified may not be applicable to devices or packaging. Similarly the test points, every 3 months, are only for drug substance. This is because changes in the drug are expected and having the detail behind these changes is important in characterising the drug.

In most cases, the opposite it true for devices and packaging, you are not expecting to see any changes. There is nothing to stop you testing only at T0 and 12 months, but as you say there is a risk in doing this. an extra data point is beneficial, if only to give confidence. It is also expected that accelerated testing will be backed up with real time testing.

Concurring with @chris1price: ASTM1980 specifically addresses accelerated aging of medical devices, and thus, may be better suited than ICH guidelines unless you have specific reason for following to pharmaceutical guidelines for a medical device.