SILICONE gaskets 2

[leonzio]

has the FDA given some prescription regarding the use of the silicone as material of the gaskets in the WFI loop?

 

[quark]

Couldn't exactly get your question. Food grade silicon has been widely used for WFI application (found no problems during audits). You can very well go for EPDM and PTFE also.

Regards,

 

[WingTipHsu]

FDA doesn't approve materials of construction unless you are making a medical device and the material is implanted. Silicon happens to be highly permeable to oxygen. You may wish to consider a sanitary EPDM/PTFE envelope gasket.

FYI, the "moral equivalent" of (incorrectly) so-called "FDA-approved" materials would be something akin to USP Class V or Class VI implantation results. Personally, I prefer to use certificates of analysis for traceability purposes in case an FDA inspector asks.

Refer to this site:

http://www.newmangasket.com/