Accelerated Stability Studies - Duration and Conditions - Class III Medical Device

[raghuramas]

Hello Friends,

Wishes.

I wish to have forum friends great advice before getting in to the process.

My product is medical device (MDD,class III). Due to various commercial reasons my management asked me to extend the shelf life of my product to 5 years. I am planning to do acceletated stability testing at 40 °C for 555 days using Arrehenius theory with Room Temperature 22 °C ( my products are stored at this temperature ). To avoid the time gap is it acceptable to take 2006 - 04 (mfg date) product for this study and age it for 333 days.

Regards,
Raghu

 

[Statistical Steven]

Re: Accelerated Stability Studies - Duration and Conditions - Class III Medical Devic

Hello Friends,

Wishes.

I wish to have forum friends great advice before getting in to the process.

My product is medical device (MDD,class III). Due to various commercial reasons my management asked me to extend the shelf life of my product to 5 years. I am planning to do acceletated stability testing at 40 °C for 555 days using Arrehenius theory with Room Temperature 22 °C ( my products are stored at this temperature ). To avoid the time gap is it acceptable to take 2006 - 04 (mfg date) product for this study and age it for 333 days.

Regards,
Raghu

If I understand you, you have product that has been aged at normal conditions since the manufacturing data. Now you want to put it on accelerated stability after 333 days? Does not sound like the Arrenhenius model will hold for those conditions.

 

[James W]

Re: Accelerated Stability Studies - Duration and Conditions - Class III Medical Devic

Hello Friends,

Wishes.

I wish to have forum friends great advice before getting in to the process.

My product is medical device (MDD,class III). Due to various commercial reasons my management asked me to extend the shelf life of my product to 5 years. I am planning to do acceletated stability testing at 40 °C for 555 days using Arrehenius theory with Room Temperature 22 °C ( my products are stored at this temperature ). To avoid the time gap is it acceptable to take 2006 - 04 (mfg date) product for this study and age it for 333 days.

Regards,
Raghu

Raghu,
Typically when performing shelf-life verification/validation activities, real-time aging and accelerated aging tests are ran simultaneously, as expiration data from accelerated aging results are sufficient until you have the results from the real-time test.

Combining a real-time element and an accelerated aging element so the combined “aged” is equivalent to the 5 years you are seeking is technically sound as long as you will have 5-year real-time data available in 2011 to support your claim. Just remember, per Section 6, Stability Testing of ISO 11607-1, to document your rationale for the real-time/accelerated aging conditions and the test duration.

As a side note, your “time-zero” performance/stability test data should have occurred in 2006-04 if you are using a comparison of “un-aged” versus “aged” in your performance or stability acceptance criteria.

Best regards,
Jim

 

[Alyana]

Re: Accelerated Stability Studies - Duration and Conditions - Class III Medical Device



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?

Dear Steven,

Thanks for your response.
We will be testing for pinholes, visible defects and force at break.

 

[Statistical Steven]

Dear Steven,

Thanks for your response.
We will be testing for pinholes, visible defects and force at break.

The force at break is continuous and lends itself to regression analysis. For pinholes and visible defects you might need to use a logistic regression to identify if the "rate" of defects increases over time.