Medical device label storage conditions

[Chiara G]

Hi all,
I've looked through the forum but I could not find an answer to this.
I'm in the process of establishing a protocol for shelf-life validation of the sterile barrier system and medical device and I was reading through ASTM F1980-21.
In the scope section, I came across this sentence:

1.7 The data obtained from accelerated aging studies is not to be used as a manner of establishing label storage conditions for sterile barrier systems.

I'm not a native speaker, so I'm not sure if I'm interpreting this correctly.
Does it say that I cannot use results of accelerated ageing to provide storage conditions for my packaged device?
If this is the case, how should I establish storage condition?

Any help will be appreciated!

 

[emili]

do you have real time aging study undergone simutaneously?

 

[planB]

Chiara,

ASTM F1980 changed quite significantly in its latest revision, including in the title, i.e. its scope - screenshot from the red-line version:



The new section 1.7 means that you cannot establish your actual storage conditions (e.g. in terms of humidity during storage) based on results of accelerated aging studies. These studies are performed pursuant with section 1.2: substantiate your shelf life labelling until real-time data is available.

Storage conditions depend on your product characteristics, including its packaging. You may want to evaluate the safety and performance characteristics of your product that are prone to degradation over the labelled shelf life in case of certain environmental conditions.

HTH,

 

[chris1price]

I think what they are saying is conditions of time and temperature you use for accelerated aging of the sterile barrier will not be the same ones you would use for label storage and thus wont be valid for labels.

 

[indubioush]

Third Opinion: They really messed up on this wording. I am a native English speaker, and I'm very confused about what they are trying to say. Regardless, you should not establish any storage conditions based on accelerated aging data. Your storage conditions should be established prior to doing accelerated aging studies.

 

[Yvonne]

Hi all, I have another questions regarding the storage conditions. If the storage condition is set at 0°C to 30°C, how should I verify the storage condition? Can I verify it by placing the sample at 0°C and 30°C according to the real-time aging period ?

 

[indubioush]

That is a pretty wide range. You are basically saying that your product can freeze, be at refrigerated temperatures, or be at room temperature. What are the temperature extremes you actually expect your product to undergo? You can either store samples at the "worst case" conditions, or you can store two sample sets at low and high temperatures. But first, you need to think about your customer requirements and the materials that go into your product, and determine what your storage conditions will be.

For product that is expected to be stored in a climate controlled location after distribution, storing your aging samples at your climate controlled facility could be sufficient.

 

[Dan H S]

If the storage facility is not climate controlled are you expected to prove that you can achieve the storage conditions you state on your label, is monitoring storage temperatures sufficient?

 

[Billy Milly]

1- Yes, if it is prescribed, you need to demonstrate control.
2- If temperature is the only prescribed storage condition, than yes.

 

[Chiara G]

The new section 1.7 means that you cannot establish your actual storage conditions (e.g. in terms of humidity during storage) based on results of accelerated aging studies. These studies are performed pursuant with section 1.2: substantiate your shelf life labelling until real-time data is available.

Third Opinion: They really messed up on this wording. I am a native English speaker, and I'm very confused about what they are trying to say. Regardless, you should not establish any storage conditions based on accelerated aging data. Your storage conditions should be established prior to doing accelerated aging studies.

So basically I have to decide beforehand T e RH for product storage and then design my accelerated study accordingly.
Obtained data have to be used to support the conditions (already) claimed on the label.
Correct?

On this topic I have a couple more questions.
Let's say I want to allow my customer to store devices as follows
at 25 for 1 year
or
at 4°C for 2 years

1) How could I design an accelerated study to cover both conditions?
2) Would it make sense to use T=50°C to simulate a real condition of storage of T=4°C ?