Shelf Life Testing of a Sterile Medical Device

#1
Hallo All

can we declare a shelf life of sterile medical device for atleast six month without performing a shelf life testing. ?
 
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Michael Malis

Quite Involved in Discussions
#3
Hallo All

can we declare a shelf life of sterile medical device for atleast six month without performing a shelf life testing. ?
No you can't.
However, you can use accelarated aging testing.
Accelerated aging technique - exposed products to High Temperature (and sometimes humidity) to similate aging in real time. Based on the temperature that product can take, you may sometimes in short period of time (8 to 12 weeks) get the resluts that would be equival to 1 year of real shelf life. Most companies used a Arrhenius equation to relate the accelerated aging data to ambient aging.

For details see: http://www.devicelink.com/mpb/archive/98/07/002.html
 
C

cclee

#4
For accelerated aging testing one could use:

ASTM F1980-07 : Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

Hope this helps.
 

Ajit Basrur

Staff member
Admin
#5
Hallo All

can we declare a shelf life of sterile medical device for atleast six month without performing a shelf life testing. ?
Simple answer is No.

FDA Guidance Document, Quality System Regulation Labeling Requirements states - expiration dates must reflect the time after final packaging during which the device is fit for its intended use when stored and used per its labeling. The manufacturer should have stability test data which establishes the interval that the device remains fit for use.
 
M

MIREGMGR

#6
Determination of a claimable /compliant shelf life is part of sterile barrier packaging validation. If you don't have any shelf life data, you don't have a complete packaging validation.

A product may go to market based on valid accelerated-aging shelf life data if real-time shelf life testing also is underway. The product's continued marketability is dependent on that real time testing program being completed to the claimed life, and duly passing each benchmark (i.e. annually) along the way.
 

Michael Malis

Quite Involved in Discussions
#7
Determination of a claimable /compliant shelf life is part of sterile barrier packaging validation. If you don't have any shelf life data, you don't have a complete packaging validation.

A product may go to market based on valid accelerated-aging shelf life data if real-time shelf life testing also is underway. The product's continued marketability is dependent on that real time testing program being completed to the claimed life, and duly passing each benchmark (i.e. annually) along the way.
:agree1: Yes - 1. You should have a complete accelerated aging test data done and Acceptable and
2. Real time data is started and monitored at the appropriate intervals (i.e. varified that product information collected so far is still Acceptable). If your product failed at any point in time - you only can claim shelf life for the existing product configuration that is = to the last passing data. For example, if your protocol set up to check the product status every 3 months and you Fail at 15 months , - you only can claim that your product is good for 1 year.
 
L

lhkahler

#8
FDA had a old guidance document that stated that it was "customary" to add 6 months to your real-time stability data to obtain your expiration.

The ASTM F1980-07 standard does not state this, however, the FDA is still allowing this "customary" practice.

Does anyone know if there is an actual standard that states that if you have x months of real-time stability data you can add 6 months to get you x + 6?

Thanks!
 
K

KilgoreTrout

#9
FDA had a old guidance document that stated that it was "customary" to add 6 months to your real-time stability data to obtain your expiration.

The ASTM F1980-07 standard does not state this, however, the FDA is still allowing this "customary" practice.

Does anyone know if there is an actual standard that states that if you have x months of real-time stability data you can add 6 months to get you x + 6?

Thanks!
There is nothing "customary" about the FDA under the current administration. Rules of thumb are the fast track to getting a deficiency letter.

If your device is a PMA device, write up your aging protocol (include accelerated and RT arms), file a RTR request, submit it, and get your protocol approved. That way, shelf life changes can be handled in annual reports rather than in PMA supplements.

Lots of noobs at FDA these days. These are sharp-pencil types with minimal authority. Don't expect them to do anything "customary." They're noobs.
 
O

oskameyer

#10
Once shelf-life is established, what is the regulatory and/or ISO expectation for monitoring shelf-life validity? In other words, am I expected to place a new lot of product on real-time shelf-life study periodically to generate new data to support the established shelf-life? FYI, I am not interested in extending shelf-life in the foreseeable future.
 
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