Authorization to use shelf life sensitive materials beyond its valid shelf life...

somashekar

Super Moderator
Staff member
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#1
I am asking industry experts here and more particularly from the medical device industry how they manage the shelflife sensitive materials beyond the valid shelflife when stored scientifically. Can some examples authorization methods be shared which has proved good over time. Any instances where such authorization method has detected that the material is not fit to use beyond a time.
:thanx:
 

Stijloor

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#2
Re: Authorization to use shelf life sensitive materials beyond its valid shelf life..

A Quick Bump!

Can someone help?

Thank you very much!!
 

Ninja

Looking for Reality
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#3
Re: Authorization to use shelf life sensitive materials beyond its valid shelf life..

I am not in medical, but you did ask for wider industry as well.

Shelf life (in my field anyway) tends to be a grey-ish area...meaning that nothing magically happens at 6mnths + 1 day....
As such, many things are still perfectly fine at 7mnths. 6mnths was set as shelf life for/from risk analysis...

At 8mtnhs, if I want to use it I have several options:
1. Toss it out
2. Test it as new to see if it still meets process needs
3. Use it in a small trial batch (essentially a use test)
4. trust it and take my chances

The decision as to which path to take depends on the material and the current situation...it too is a risk analysis.

The resulting approval (numbered as above) are:
1. Approval to dispose (wasted money...triggers a review of stocking levels)
2. Approval to "recertify as new" or use for a single batch
3. Same as 2
4. Approval to use untested...essentially a large scale use test.

All of these are risk management, and approval for use may be documented in a multitude of ways at the discretion of the company (pending outside requirements such as customer agreements and regulatory requirements).

Bottom line, I need to spend extra money to use stuff past shelf life. The approval is on the risk/reward balance. It simply takes the form of material approval.

Is this the type of feedback you are looking for?

ADD: Most frequently for low value material I go with #4. The resulting product is immediately put in quarantine and fully tested.
Most frequently with higher value materials, I go with #2 followed by #3...it costs more to do both, but is a bit safer in respect to outgoing fitness for use.
 

MIREGMGR

Inactive Registered Visitor
#4
Re: Authorization to use shelf life sensitive materials beyond its valid shelf life..

Who determined the original shelflife, and via what method? Do you have evidence that the current reviewer and review-method are qualified to overrule that original determination? Is that evidence such that you'd be comfortable explaining it to your NB auditor and your most regulatorily demanding customer?

If a raw material manufacturer rated it for shelf life, and you bought it without qualification and now you want to use it beyond shelf life, and you can't show that you have a deeper technical understanding of the raw material than its manufacturer and therefore that your technical analysis establishing that it is still good is superior to the manufacturer's shelf life rating...then using it beyond shelf life would be illegitimate, irrespective of your economic desires and needs.
 
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qusys

Quite Involved in Discussions
#5
Re: Authorization to use shelf life sensitive materials beyond its valid shelf life..

I am asking industry experts here and more particularly from the medical device industry how they manage the shelflife sensitive materials beyond the valid shelflife when stored scientifically. Can some examples authorization methods be shared which has proved good over time. Any instances where such authorization method has detected that the material is not fit to use beyond a time.
:thanx:
I agree with what the other Covers wrote in previous posts.
In aby case , obsolete materials should be treated as nonconforming product, because if they are used in production , they might loose their property in case of expired shelf life. From a quality standpoint, no matter if the expiration date is due for one day or one month or more: I also think that the process for material control is not effective, because probably FIFO is not applied or turn of material are not taken in charge.
The usage of this material should be done by means of risk assessment, taken into account to monitor the yield of product done with that expired material.
 

somashekar

Super Moderator
Staff member
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#6
Re: Authorization to use shelf life sensitive materials beyond its valid shelf life..

Is this the type of feedback you are looking for?
Not exactly.
We once had a velcro loop material that was with adhesive backing and shelflife of 12 months from date of packing. Due to business reasons it remained for longer period unused, and when the time came we (we and customer) decided to put a protocol in place to evaluate sample from each pack before use. Fortunately this was getting on to foam material and the test protocol was a peel test. Foam tears when peeled >> Test pass, else fail. and this worked. But there are so many other such material, and when the manufacturer technical service is contacted, they just say to test results to our satisfaction before use with no liability on manufacturer. Loctite for example have some shelflife policy where they say we much contact tech support on phone.
How is this addressed when company use it on there own product. In Auto, Aero, Medical , Electrical industries ?
Its too expensive to put it down the drain, same time the risk management information may fail us due to lack of solid technical background about such material performance.
I am keen to know of company examples how such situations have been effectively handled. Any case studies of success / failure that we can learn from ~~~
 

MIREGMGR

Inactive Registered Visitor
#7
Re: Authorization to use shelf life sensitive materials beyond its valid shelf life..

I described our approach, which in fact applies to PSA hook-and-loop fastener material along with many other limited-shelf-life raw materials that we use in medical disposables and positioners.

If we have evidence that we have technical expertise to in effect overrule the material manufacturer, we can change the shelf life. There may be a process to support that determination, i.e. testing or whatever, and without exception there will be documentation. Otherwise, the material gets scrapped. We think that approach is explicitly required by 21CFR 820.70(h).

The above applies to materials that affect product quality. Hypothetically there could be some material...perhaps a process consumable, or some non-critical process component such as a coating jig...that could be excepted from the 21CFR820.70(h) requirement. At present I don't know of any materials in our system, though, that have a manufacturer declared shelf life and aren't treated by us as affecting product quality.
 

MIREGMGR

Inactive Registered Visitor
#8
Re: Authorization to use shelf life sensitive materials beyond its valid shelf life..

Note BTW that engineering techniques sometimes can be applied to except your storage of limited-shelf-life materials from the conditions under which the manufacturer defines that limited shelf life. PSA materials, for instance, can achieve extended shelf life via (correctly defined, non self defrosting) freezer storage, light exclusion, dry-nitrogen-atmosphere storage, and roll-axis-vertical storage. It's easier to make an engineering argument for extended shelf life if you can show that you've applied justifiable engineering techniques in regard to the relevant aging processes from day one.
 
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