Sterile medical device expiration date

[Jane1]

hello,

I would appreciate any help with the following topics:

1. if I want to change the expiration date for a medical device (for example from 1 year to 2 years) - what testing is required?

2. can anyone please help interpret this statement from ISO 11607:
6.4.7 When it is demonstrated that the product does not interact with the specified sterile barrier system over time, previously documented data for stability testing shall be sufficient to be in accordance with 6.4.1.

thank you!

 

[shimonv]

Hi Jane,
You have already proved that the sterilisation process works. Now you need to show that the packaging system (combination of the sterile barrier system and protective packaging) holds for a longer period of time, i.e. you need to show that the package integrity and device performance meet the predeterimed specifications after two year.

Shimon

 

[Jane1]

Hi Jane,
You have already proved that the sterilisation process works. Now you need to show that the packaging system (combination of the sterile barrier system and protective packaging) holds for a longer period of time, i.e. you need to show that the package integrity and device performance meet the predeterimed specifications after two year.

Shimon

thank you very much for your reply. could you please direct me to a gauidance\standard were it is stated that for each new\change in expiration date the packaging integrity tests need to be repeated (I'm asking because I want to have a source for showing that it is required not only because of common sense but also by regulation).

 

[shimonv]

The standard does not say explicitly that each change in expiration date warrants a repeat of packaging integrity tests; it couldn't. As you can imagine some changes in expiration date will also require a change in device material.
Every change needs to be evaluated through the change control process. See ISO 11607-2, section 5.7, "Process changes and revalidation":

The AAMI TIR22:2007/A1:2008, section 13.3 says the following:
13.3 Revalidation is often affiliated with design control and the associated change control procedure, the extent of the revalidation chosen will depend on the nature of the change and how it affects the process or device.

The governing principle is found it ISO 11607-1, section 6.1.4 and 6.4 (Especially 6.4.1)

6.1.4 The sterile barrier system shall maintain sterility until the point of use or until the expiry date.

6.4.1 Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.


Good luck!
Shimon

 

[SKM.Sunil]

hello,

I would appreciate any help with the following topics:

1. if I want to change the expiration date for a medical device (for example from 1 year to 2 years) - what testing is required?

2. can anyone please help interpret this statement from ISO 11607:
6.4.7 When it is demonstrated that the product does not interact with the specified sterile barrier system over time, previously documented data for stability testing shall be sufficient to be in accordance with 6.4.1.

thank you!

As your device is sterile....You required to produce "real time stability data"

 

[Ronen E]

@Jane1
Please don't forget that extending the device's expiration involves not only validating the packaging/sterile barrier (11607 etc.) but also validating the extended life of the device itself. You won't find any published standard for that, because there is none, not really. Beware of attempting accelerated ageing based on raised temperature, it doesn't necessarily apply to device ageing.

 

[indubioush]

See ASTM F1980-16 Accelerated Aging of Sterile Barrier Systems.

Even though it is true that you need real-time aging data to prove the shelf life of the device, often companies will do accelerated aging for device and packaging together and submit this data to support a preliminary shelf life pending real-time data.

 

[Ronen E]

See ASTM F1980-16 ... often companies will do accelerated aging for device and packaging together and submit this data to support a preliminary shelf life pending real-time data.

Yes, and often there's very little scientific/engineering substantiation behind that approach (which seems to bother reviewers quite little).
F-1980 specifically states in its title what its purpose is.