Molding Release for Medical Plastic Injection Molded Parts

A

andy.yuan

#1
Dear friends,
Do you know whether it's allowed to use the molding release ( molding relief agent ) for injection plastics parts for Medical device?
Could we use the food or Medical grade molding release for these parts? our parts are for Non implantation medical products, it's used for dentist in patient's mouth.
I need your help urgently.
Thanks a lot.
Best regards,
Andy
 
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M

MIREGMGR

#2
Do you know whether it's allowed to use the molding release ( molding relief agent ) for injection plastics parts for Medical device?
Does your customer have a spec?

If they don't, they should.

What did you do in your process at the point when the customer signed off on acceptability? Changing from that without customer approval generally would be inappropriate, whatever your customer agreement or the customer's specs say.

Could we use the food or Medical grade molding release for these parts?
If you're a supplier to a device maker, it's not appropriate for you to make a decision like this. In particular, you should not be deciding that something is appropriately qualified as "medical grade".

Also note that "medical grade" can have a lot of meanings, some of them useless or misleading with regard to the question you're trying to address.

"Food grade" has no legal relationship to medical uses, and is not an indication of patient safety in such applications. "Food grade" as a qualification for medical applications should be ignored.
 
P

psayers

#3
In our product, an IVD, the molding material contains a release agent within itself. The plastic has been approved by the FDA as usable for medical devices and a extra release agent is not recommended.

I suggest working with the plastic supplier, if the material contains a release agent, to review the mold tooling and the settings before adding an extra release agent. Our supplier found several improvements that eliminated the need for extra release.

Also verify with your customer if altering their specification by adding another compound is OK.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Dear friends,
Do you know whether it's allowed to use the molding release ( molding relief agent ) for injection plastics parts for Medical device?
Could we use the food or Medical grade molding release for these parts? our parts are for Non implantation medical products, it's used for dentist in patient's mouth.
I need your help urgently.
Thanks a lot.
Best regards,
Andy
Hi,

Ignoring for a moment your relations with your clients,

- A substantiated need to add separate mould release agents (not inherent in the base resin) is typically an indication of either poor part design (including base resin grade selection), poor tool design, poor moulding parameters setting(s) and/or control, poor resin quality or lack of sufficient control over it, or any combination of the above.

- Material(s) acceptability for medical devices applications is typically determined not through individual ingredients but through the final result - in as-used state - including the effects of all relevant manufacturing processes (including packaging and sterilisation, as applicable). When a medical device is to be qualified as biocompatible the effects of storage, handling, environmental factors, use factors (for multi-use devices) etc., throughout the device's shelf and use life, should preferably be considered and accounted for.

- Specific biocompatibility requirements and testing recommendations are typically determined by the device's / part's nature of contact with different tissue types, and the (accumulated) duration of contact. ISO 10993-1 is a good starting point in that regard, for most of the leading medical devices regulatory systems (e.g. the USA, the EC etc.).

Cheers,
Ronen.
 

kuyakut

Involved In Discussions
#5
Moldability and part release should be address during the part design stage. Your toolmaker should be able to determine that. Try to look into mold design first before going for a mold release agent. A food grade mold release agent is no a guarantee that can solve your problem it may even create another problem such as shiny mark .


Kuyakut
 
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