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Related Topic Tags
retest date, shelf life, stability (measurement system or device)
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  #1  
Old 23rd September 2009, 03:42 PM
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Please Help! WANTED: Product Stability Protocol - absorbable (resorbable) polymeric resins

I don't want to "reinvent the wheel" on this one. I have ICH documents for Stability Testing of New Drug Substance and Products that I am reading now...seems like someone who has more experience with this than I might be willing to share a template...I realize many variables exist depending on anticipated storage conditions and shelf-life expectations. My current case involves absorbable (resorbable) polymeric resins, sensitive to temperature and humidity in particular. These resins can be used as "excipients" by customers, so we need to establish shelf-life and retest dates.

PS I am in US...whatever climatic zone that is I or II, I think.

Last edited by WisdomseekerSC; 23rd September 2009 at 03:50 PM.

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Old 24th September 2009, 05:36 AM
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Re: WANTED: Product Stability Protocol

any responses ?

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Old 24th September 2009, 07:34 AM
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Re: WANTED: Product Stability Protocol

Are you intending to market this product as an excipient in a medicinal drug product?
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Old 24th September 2009, 07:55 AM
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Caution Re: WANTED: Product Stability Protocol

Our current thoughts are to use the resins for our own extrusion processes. We do not incorporate any pharmaceuticals into any of our materials. Since we are a contract manufacturer, providing the resin itself to our medical device customers is a possibility. I am trying to be proactive here and prepare for future potential (or at least be knowledgible of the requirements that we may need to consider prior to making such a business decision).
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Old 24th September 2009, 12:46 PM
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Re: WANTED: Product Stability Protocol - absorbable (resorbable) polymeric resins

The ICH document for Stability Testing of New Drug Substance and Products is mainly geared towards stability testing of active ingredients that will be used in a medicine and the stability testing of the actual medicinal product ..

be midfuil that the purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.

The choice of test conditions defined in this guideline is based on an analysis of the effects of climatic conditions in the three regions of the EC, Japan and the United States. The main ICH guideline addresses climatic zones I and II.
The principle has been established that stability information generated in any one of the three regions of the EC, Japan and the United States would be mutually acceptable to the other two regions,

This guide refers to other zones http://www.emea.europa.eu/pdfs/human/ich/042102en.pdf

I have a template but it is geared towards medicines and I do not think it would be of much use for you as a resin as you would possibly need a different stability protocol/test design

As a start I would use the temperature and humidity levels oultined in the ICH guidance -- I am not sure if there is an ISO or international standard for testing of stability of plastics or resins
Thanks to EamonnJohn for your informative Post and/or Attachment!
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Old 24th September 2009, 12:56 PM
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Re: WANTED: Product Stability Protocol - absorbable (resorbable) polymeric resins

Quote:
In Reply to Parent Post by WisdomseekerSC View Post

I don't want to "reinvent the wheel" on this one. I have ICH documents for Stability Testing of New Drug Substance and Products that I am reading now...seems like someone who has more experience with this than I might be willing to share a template...I realize many variables exist depending on anticipated storage conditions and shelf-life expectations. My current case involves absorbable (resorbable) polymeric resins, sensitive to temperature and humidity in particular. These resins can be used as "excipients" by customers, so we need to establish shelf-life and retest dates.

PS I am in US...whatever climatic zone that is I or II, I think.
Can you be more specific ?

Yes, USA comes in Stability Climate Zone I and II.

I do not think that resins can be used as excipients - the excipients are used as inactives in Pharmaceuticals and are edible. I think what you meant was that resins could be used as Pharmaceutical containers to contain the medicinal prodiuct, right ?

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Old 24th September 2009, 03:39 PM
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Re: WANTED: Product Stability Protocol - absorbable (resorbable) polymeric resins

Are you looking for an accelerated aging model? Will this resin be ultimately used as a medical device? Is this material hydrolytically broken down?

I would check out ASTM F1635 - Standard Test Method for In Vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

This is the procedure I followed for all aging studies of our resorbable (PLA) devices.
Thanks to mcmana for your informative Post and/or Attachment!
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Old 24th September 2009, 03:55 PM
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Read This! Re: WANTED: Product Stability Protocol - absorbable (resorbable) polymeric resins

Well...absorbable polymeric resin is often used for drug delivery, to provide slow-release formulations...as the polymer degrades the drug is released. The polymeric resins can be produced in gel forms for injectables, and solids encased in capsules or pressed into tablets. Other resins are further processed into extruded forms like monofilmanent or multifilaments fibers for sutures, or tube configurations. Some are braided and knitted for fabric meshes or espun into non-woven sheets. Others are molded into parts. We test and classify ours as non-active implantable class VI plastics. The new technology and applications are a jump forward in the medical arena!

Anyway, the resins degrade by-design and have a limited shelf life. Although packaged in an inert, vacuum sealed foil pouch protected from moisture, the storage environment needs to be guarded to ensure the resin doesn't degrade prematurely prior to use...thus the need for stability studies to establish shelf life. I have not been able to find any specific guidelines that apply to our materials so far in my searches...I don't want to be overlooking something that may pertain to our situation.

Of course I realize the finished device manufacturer needs to conduct their own studies on the completely assembled device in the final packaging...but we have some responsibility to ensure our component performs as expected when made and packaged in our facility and stored prior to further processing by us or our customers. I just need alittle more light to see my way thru this new territory.
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