I am looking for any regulatory guideline which defines the usage of the regrind materials in case of plastics, for the medical devices.

The use of virgin material is no doubt the best, but in some cases, I have noted that the manufacturers use upro a maximum of 20 % regrind into virgin material.

Appreciate if any one could help me on -

1. Guidleines for regrinding (preferably FDA)
2. How is the maximum percentage of regrind decided for parts ?


:thanx:

I am looking for any regulatory guideline which defines the usage of the regrind materials in case of plastics, for the medical devices.

The use of virgin material is no doubt the best, but in some cases, I have noted that the manufacturers use upro a maximum of 20 % regrind into virgin material.

Appreciate if any one could help me on -

1. Guidleines for regrinding (preferably FDA)
2. How is the maximum percentage of regrind decided for parts ?




1. I am not aware of any federal guideline about the percentage of reprocessed material. Typically no one in blood contacting or implantable medical devices will allow reground material in their products due to the difficulty in validating the biocompatibility of the material.

I was chosen to be part of a project to establish a regrind procedure for the company, having no real previous injection molding experience I would really appreciate any help or guidelines on this matter. I've done some googling on the matter but nothing really significant came up.

In my years of Quality, I have only seen the customer deceide what percentage he would allow in the remix.

standard for common is no more than 10-15% regrind for standard use.

FDA, I have seen up to 3%

Medical, up to 3-5%

Commerical this is up to the org. to determinded their libility concerns
(25% and UP)

It need to do validation to decide the maximum percentage of regrind.
Normally 20 % is too much and will comprimise the physical & chemical fucntion of plastic. However, for your special device, if the validation results show 20 % still acceptable, e.g. biocompatiblity, color, the physical specifications, there is no excuse to refuse the regrind.

Also check with the resin manufacturer. It has been a while since I worked in injection molding, but I think the material specifications data sheets will have a general guideline of how much regrind is allowable.

Is there a chance that the regrind has been reground more than once? This can be a key issue for failure.