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  #1  
Old 9th March 2008, 07:49 AM
raghuramas raghuramas is offline
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Please Help! Expiry Date of Sutures based on Shelf Life of Raw Materials

Hello Friends,

Lastweek I faced an audit in our premises and one of the observation is explained below.

We get raw material with a shelf life of 2 years. we do sterilization (after manufacturing) and give expiry of 3 years. The auditor asked me how can you give an expiry of 3 years to a product which is produced from 2 years shelf life raw material. I answered him as the finished product is given with the expiry not the raw materials and I tried to justify with the accelerated and real stability reports. But he was not satisfied and I was given with minor NC.

I want to know forum friends opinion in this matter.

Regards,
Raghu

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Old 9th March 2008, 08:25 AM
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Re: Shelf life of raw material and expiry of finish product

We would need more information on the physics involved than you have provided.

The answer would depend on what the shelf life and expiry were based upon. If the expiry is based on a physical property of the raw material that is unchanged by your processing then the auditor has a point. If the expiry has nothing to do with the shelf life, that is, the expiry is based on your processing AND the shelf life only applies to its processability, not its final use, then you have a point.

Please elaborate. Also, is your product a medical product (you mentioned sterilization) governed by agency/regulatory requirements? If it is, we should move this to a more appropriate forum.

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Last edited by Miner; 9th March 2008 at 08:28 AM. Reason: Added last paragraph.
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Old 9th March 2008, 08:39 AM
raghuramas raghuramas is offline
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Re: Shelf life of raw material and expiry of finish product

Dear Miner,

Thank you very much for the reply.

The product concerned is absorbable suture ( class III ). The material absorbs moisture from air and loose its properties. we do all the processing with in 2 days ( in clean room with <RH 20% and 20deg )from the date of opening of the raw material package and do sterilization. (Maximum allowed exposure in open air with RH 60% is 7 days).

We have proven records that the sterilization has only negligible effect on its properties. Most of our final release criteria are based on the physical properties and release 25% more than the reg.reqt.

Hope the info is okay.

Regards,
Raghu
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Old 9th March 2008, 09:39 AM
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Re: Need your opinion for expiry date of sutures based on shelf life of Raw Materials

Hi Raghu,

I have directed your question under this forum to get more responses.

Btw, which was the audit that you referred ?

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Last edited by Ajit Basrur; 9th March 2008 at 09:53 AM.
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Old 9th March 2008, 04:55 PM
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Re: Need your opinion for expiry date of sutures based on shelf life of Raw Materials

IMO it's the two years from the original date of manufacture since nothing in your process changes the material's properties.

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Old 10th March 2008, 03:30 AM
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Re: Expiry Date of Sutures based on Shelf Life of Raw Materials

Unless you have shelf life tests that prove otherwise, I would say two years is the limit.


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Old 10th March 2008, 11:08 AM
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Re: Expiry Date of Sutures based on Shelf Life of Raw Materials

So your subsequent processing and sterilisation "magically" increases the shelf-life of the original product by 50%?

Gert is right, if you can prove (via validation) that the product is good for a longer time, then there is no problem.

I would in addition be asking my supplier where the "two years" lifetime came from in the first place.

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Old 10th March 2008, 05:28 PM
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Re: Expiry Date of Sutures based on Shelf Life of Raw Materials

Quote:
In Reply to Parent Post by Roland Cooke View Post

I would in addition be asking my supplier where the "two years" lifetime came from in the first place.
I agree with the other responses, if your RM's are 2 year expiry then I can't see what you have done to make them last longer unless you have effected a significant chemical change on them.

I think Roland's point is the key to "solving" your problem. Find out what is the basis of the supplier's shelf life. If they just use a convenient, unvalidated, finger-in-the-air approach then you can justify your approach with your accelerated testing etc..

If their shelf life is based on a proper scientific validation then you are playing with fire. Your options in this case are to negotiate the "freshest" product you can get and go with their shelf life.

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