Today we would like to talk to you about FDA seals for the food, pharmaceutical and biotechnology industries. If you want to meet your overall quality target, it is imperative that the components of pumps, agitators, valves, filters, mixers and other components that come into contact with process fluids also meet their own quality targets. One of these targets is that they must be FDA-approved materials.
Index
And what is an FDA checkpoint?
A retainer consists of a an elastomer lip that may or may not be protected by a metal casing and normally has a spring that provides sealing tension to the lip.
Of the components that make up the FDA seal, the sealing lip material is the FDA-approved element that must comply with the regulatory code.
Specifically, oil and lubricant compatible thermosetting elastomers such as silicone (VMQ), nitrile (NBR), hydrogenated nitrile (HNBR) and fluoroelastomer (FPM) are governed by FDA CFR 21.177.2600. However, thermoplastic elastomers such as PTFE and restructured PTFE, which are also used for the same purpose, are governed by another FDA regulatory code: CFR 21.177.1550.
FDA seals models
Models available in FDA seals are elements with or without dust cap, with or without stainless steel housing and lip seals, both single inverted and double lip (tandem or back-to-back configurations). Lip seals can have an O-ring as an additional fastening element for their housing. Likewise, the pockets are made of stainless steel, as are the springs. The materials are virgin PTFE and PTFE with additives, such as graphite or glass beads. All of them are FDA-approved materials, resulting in FDA seals.
At Epidor SRT we provide you with FDA seals made of quality materials adapted to your delivery needs.
Find out more about O-rings in materials and about sealing solutions that can be manufactured with FDA-approved materials.