At Canada Rubber Group Inc. (CRGI), we are often asked to supply Teflon (PTFE) gaskets for FDA-type applications. These applications involve not only the production of food and food-related products, but also those involving the production of pharmaceuticals, supplements, nutraceuticals, and the like.

Like all gaskets, PTFE gaskets for pharmaceutical applications should possess two characteristics. First, the gasket must be generally regarded as safe. This criterion may be met either through testing or through proven safe use in FDA-type applications. Secondly, the material from which the gasket is made should conform to current FDA or equivalent regulations and directives.

About PTFE Gaskets

PTFE (polytetrafluoroethylene) is a synthetic fluoropolymer of tetrafluoroethylene that has numerous applications. Teflon® is the best known brand name of PTFE-based formulas. Teflon® is a trademark of E. I. du Pont de Nemours and Company (DuPont), the discoverer of the compound.

PTFE gaskets for pharmaceutical applications are often used in pumps, valves, and flanged joints in piping and transfer equipment. Gaskets made from both non-filled and filled PTFE sheet are covered under FDA directives as noted above.

PTFE gasket material combines excellent dielectric properties with a very low coefficient of friction and an ability to service a wide range of operating temperatures, from -400°F to 500°F. A key advantage of PTFE gasket material is that is among the most chemically resistant materials known. The ability to resist chemical attack makes PTFE sheet the material of choice for many pharmaceutical sealing applications.

PTFE Gaskets for Pharmaceutical Applications from CRGI

CRGI can supply expanded PTFE gaskets for pharmaceutical applications which are made from expanded or molded PTFE sheets. PTFE gaskets made from molded sheets include those made from TEALON™ TF1510, TEALON™ TF1570, TEALON™ TF1580, and TEALON™ TF1590. These sheets are manufactured by Teadit North America and were tested to be in conformance with FDA requirement Method 21 CFR177.2260. Gaskets made from these sheets are suitable for food-grade applications.

Expanded PTFE gaskets which CRGI supplies are made from Teadit QUIMFLEX 24SH sheet. This FDA-approved PTFE gasket material is made from 100 per cent multi-directionally expanded PTFE and is dimensionally stable. It is fully conformable to a variety of flange shapes and offers superior performance over conventional PTFE. Expanded PTFE possesses excellent chemical resistance, is resistant to cold flow and creep, and is ideal for limited flange load applications. QUIMFLEX SH will seal all aggressive chemicals over the entire 0-14 pH range except for molten alkali metals and elemental fluorine. Made from 100 per cent virgin PTFE, QUIMFLEX 24SH gaskets not only resist chemical attack, but they will not contaminate or discolor end products.

To find out more about the PTFE gaskets for pharmaceutical applications which CRGI can supply, please contact our sales department at crg@canadarubbergroup.com.

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