Packaging unsterile medical devices

Lenka

Registered
#1
Can anyone help with storage/packaging conditions for unsterile molded parts for intermediate storage so not the finished final product? Does the packaging (foil) has to fulfil any regulatory requirements, e.g. food grade? All standards seem to be related to sterile medica devices.
Thanks for any advice how to handle this,
Lenka
 
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indubioush

Quite Involved in Discussions
#2
A little confused by your question. Is there a risk that these molded parts could be used as a medical device? Are you sending them somewhere or are they sitting in your inventory? Will they be used for further assembly or is the assembly complete? Do you sell components or are you a medical device manufacturer?
 

yodon

Staff member
Super Moderator
#3
Good questions by @indubioush - but it would probably be a good idea anyway to consider risk. Will the packaging do anything to the parts that would in any way impact them (including leaving residues or particulate)? Does the packaging provide adequate protection (from damage or allowing exposure to particulate, etc.) while packaged (and ostensibly shipped around or stored)?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Good answers above. Regarding the explicit question:
Does the packaging (foil) has to fulfil any regulatory requirements, e.g. food grade?
None such explicit that I'm aware of. There are general regulatory requirements related to manufacturing processes (in-process storage included) that would impact indirectly though.

In the context of medical devices, "food grade" is a loosely defined term with questionable applicability. Also don't be misled by vague references to "USP class VI", "ISO 10993" and the likes, in relation to plastic bags etc.

From experience, the top concern about in-process (or final) packaging plastic bags is particulate contamination, typically aggravated by electrostatic charging.
 
Last edited:

Lenka

Registered
#5
Thank you for your answers.
Yes , we are a medical device manufacturer and the parts are just sitting there before being further assembled.
However, as Yodon mentioned we thought the risk of any impact on the parts should be considered (residues from the foil) etc.
But biocomp-testing, such as cytotox seems exaggerated. So do you agree that visual inspection should do?
 

planB

Trusted Information Resource
#6
Lenka,

visual inspection is typically not the method of choice for verifying presence or absence of residuals, but typically chemical material characterisation studies according to ISO 10993-18. You could avoid/complement these by gathering comprehensive foil material data from your supplier, i.e. base material(s), absence/presence of any additives (such as denesting additives, colourants, coatings, ...) and its manufactrung process. In case you succeed in gathering these data comprehensively (i.e without significant "unknowns"), you could also be in a position to assess whether you could exclude any unacceptable risk from residuals, without having to generate additional test data on your won.

BTW, a passed , standalone cytotoxicity test would only tell you that the test material has no cytotoxic potential, not more.

HTH,
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Lenka,

visual inspection is typically not the method of choice for verifying presence or absence of residuals, but typically chemical material characterisation studies according to ISO 10993-18. You could avoid/complement these by gathering comprehensive foil material data from your supplier, i.e. base material(s), absence/presence of any additives (such as denesting additives, colourants, coatings, ...) and its manufactrung process. In case you succeed in gathering these data comprehensively (i.e without significant "unknowns"), you could also be in a position to assess whether you could exclude any unacceptable risk from residuals, without having to generate additional test data on your won.

BTW, a passed , standalone cytotoxicity test would only tell you that the test material has no cytotoxic potential, not more.

HTH,
While this is 100% correct and is important, I'd like to reiterate that from my experience with exactly this kind of scenario (multiple instances), chemical interaction with the container/bag materials is typically NOT the main risk, but rather the particulate cleanliness of such containers. It's also typically much harder to obtain reliable cleanliness information from the supplier (who is seldom the original manufacturer) or the manufacturer. Further, it's near impossible to economically "clean" unclean plastic bags, to an acceptable standard.

If there is any significant biocompatibility impact it's likely to come up in the finished device biological evaluation anyway. Unless the containers/bags have gross issues (which will be fairly easy to pick up early on), I would hardly expect any significant impact on the finished device.
 
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