FDA

Food and Drug Administration

Typically in the pharmaceutical applications, there is a requirement for the materials used in the construction of the pump to be FDA-compliant. This applies to the wetted parts and includes the mechanical seal and static seals.

The Food and Drug Administration Department of Health and Human services publish their rules in Title 21 of the Code of Federal Regulations (CFR). The relevant sections are:

Part 177 - Indirect food additives: polymers.

Part 182 - Substances generally recognized as safe.

Part 211 - Current good manufacturing practice for finished pharmaceuticals.