Biocompatibility for Packaging Materials

B

benderspeck

#1
Hi All,

I recently received a question about biocompatibility of our packaging materials for permanent implant device. The question was about how we account for extractables regarding how they could negatively impact the biocompatibility of the device over the shelf life period. I have the basic cytotox, sensitization, irritation data, but nothing that would qualify as extractables.

The material we are using is HDPE, which I know has a lonnnnnggg history (pharmaceuticals/food packaging and implants). However, I can't seem to find the data for it. Any suggestions? (I'm trying to avoid running the extractables study)
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi All,

I recently received a question about biocompatibility of our packaging materials for permanent implant device. The question was about how we account for extractables regarding how they could negatively impact the biocompatibility of the device over the shelf life period. I have the basic cytotox, sensitization, irritation data, but nothing that would qualify as extractables.

The material we are using is HDPE, which I know has a lonnnnnggg history (pharmaceuticals/food packaging and implants). However, I can't seem to find the data for it. Any suggestions? (I'm trying to avoid running the extractables study)
Hi,

1. "HDPE" is too generic - you need to relate to the specific grade you are using.

2. Your first stop for information regarding your packagaing materials shold be your supplier (if they're not the manufacturer then this would be the next stop).

3. "Extractables" doesn't mean too much in biocompatibility terms. Even the tests you mentioned typically involve extraction, i.e. extraction is just a tool. Perhaps the intent was "leachables"?... IMO you should begin with a theoretical analysis / evaluation of the risks - what sort of materials originating in the packaging materials may end up in/on the implant, in what amounts, do they pose significant risks, what is the mechanism of transfer for each etc. Once you have a clear view on these aspects, you can start planning bench testing for quantifying, if necessary. Additional biocompatibility testing is only the last step, and you might actually find out / prove that it's not even necessary.

Cheers,
Ronen.
 
B

blargon

#3
Extractables & leachables studies are more common with pharma (or if your device has a drug component or is a combination device) rather than med device packaging. Extractables are generally substances that can leach into the packaged container under extreme conditions (like elevated temperature, direct exposure to intense sunlight or harsh solvents, assessed in a controlled extractables study), leachables leach from the device / packaging under more normal conditions.

And here's an extended definition*
? Extractables are chemical entities, both organic and inorganic, that will extract from components of a container closure system or device into solvents under controlled conditions. They are used to identify and quantify potential leachables.
? Leachables are chemical entities, both organic and inorganic, that migrate from components of a container closure system or device into a drug product over the course of its shelf-life.
? Leachables are usually present in drug product matrices as complex mixtures at trace levels relative to the active pharmaceutical ingredient (API).

* courtesy of Dr. Frank Moffatt, 'Extractables and leachables in pharma ? A serious issue'

As Ronen mentioned, 'HDPE' is generic, your supplier should be able to advise. They may have done this testing. Extractables from HDPE could be residual solvents, cleaning agent, lubricants..
 

planB

Trusted Information Resource
#4
Benderspeck,

adding to what the previous poster wrote:

It is your final, permanently implantable device that has to be biocompatible, and _not_ your packaging according to ISO 10993-1:2009. You have to demonstrate that at the point of use your _device_ does not cause any biological reactions which are unacceptable - not your packaging.

To this end, you may want to gather "material characterization" data according to ISO 19883-18:2005, both by your own physico-chemical studies (i.e. leachables and extractables) on your device in its final packaging and after having undergone all manufacturing steps (e.g. including terminal sterilization), as well as relevant literature and prior relevant clinical experience.

Literature on you packaging material like (material safety) data sheets listing its exact composition (e.g. additives like colours, stabilizers and plasticizer, release agents, denesting additives) and its manufacturing (e.g. injection molding) will be necessary to support your conclusions drawn from your won leachables/extractables studies performed on your final device.

HTH,

Gerhard
 
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