Latex in packaging

#1
Hello everyone,

Our supplier declare our cardboard in carton can contains latex (CAS 25085-39-6 and CAS 9003-55-8 - SBR latex).

The cardboard is in contact with our implant device. Is it sufficient if we prove that no leachable is on the device and can't come into contact with the patient?
We perfomed all chemical analysis on the product (GC-MS, UPLC/MS, ICP/MS)

Thanks in advance
Elodie
 
Last edited:
Elsmar Forum Sponsor

planB

Super Moderator
#2
Elodie,

if you have demonstrated a latex-"free" [1] state of your _final_ product (as getting in contact with the patient), your rationale might be acceptable. This implies, though, that you have demonstrated validity of your analytical approach, e.g. including your extraction scheme, and the analytical LOQ (limit of quantification).

In case your supplier discloses the amount of contained latex, you could support your case by estimating the worst-case carry-over of latex to your device - in case the result of this calculation does not exceed the toxicological threshld of concern for latex.

Some additional food for thought:
1) "Latex" is a trigger word for (implantable) medical devices and usually you try to avoid this material in your system if not absolutely required, even though you seem to use a synthetic rubber and not natural latex,
2) Cardboard is not the first choice for direct-contacting packaging materials of implantable devices.

Thus, it might be less tedious to replace your packaging materials instead of trying to built and maintain a defense line for why you use latex.

HTH,



[1] with a caveat from this FDA guidance: "FDA finds that the use of statements, such as “latex-free,” “does not contain latex,” or other similar labeling statements are, at this time, not scientifically supportable."
 

chris1price

Trusted Information Resource
#4
Please remember the risk is not only transfer to the product, it is also the risk to anyone handles the packaging. Just opening the carton may lead to an adverse effect.
 
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