FDA / ASTM Cure Date Requirments

[NBROWN]

I am in need of the shelf life delivery requirments for the FDA and ASTM Standards. I know the Military requires 85% shelf life remaining on all rubber product upon recipet. Does anyone know what the FDA or ASTM requirments might be?
Thakns in advance.

 

[TheAnswerGuy]

NBROWN,

Everything that I have done in medical (and that is quite a bit) has to have it shelf life validated. Generally through an acellerated aging study. How long that shelf life is, would be determined by how quickly the end user would use the product and guaranteed through your validation study.

Materials used for your product have a lot to do with shelf life.

 

[pg11]

Shelf life of rubber products is very dependent on storge conditions and temperatures. Ideally the components should be stored in a dark, cool storage area. Different polymers have different storage life and subsequent changes in physical properties. The ASTM heat ageing methods are probably as good as anything for specifying requirements.

Peter Goodwin