Kalrez® O-Rings and Seals

Pharmaceutical and Food Handling Applications

FDA Statement of Compliance

* Copyright for photograph

On Dec. 19, 2000, the United States Food and Drug administration (FDA) confirmed the compliance of Kalrez® 6221, 6230 and 6230A perfluoroelastomer parts for repeated use in contact with food by publication of Food Contact Notification (FCN) 000101. FDA’s Food Contact Substance Notification process, described in section 409(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 348(h)), is the primary method by which the FDA authorizes the use of food additives that are food contact substances. FCN 000101 requires Kalrez® 6221, 6230 and 6230A to meet extractable levels not to exceed 0.2 mg/in2. This provides further assurance of the low risk of contamination from Kalrez® parts. On page 2 is an excerpt from FCN 000101, the FDA’s official notification to DuPont Performance Elastomers, that designates constituents of Kalrez® 6221, 6230 and 6230A as suitable for repeated use in contact with food.

Kalrez® 6221, 6230 and 6230A parts also comply with the requirements in U.S. FDA regulation 21 CFR 177.2600 and the extractive requirements of 21 CFR 177.2400(d)(1).

Kalrez® 6221, 6230 and 6230A also have been tested in accordance with the United States Pharmacopeia Class VI (USP Class VI) testing protocol and meet the test requirements of a USP Class VI polymer.¹)

Migration and USP Class VI testing was performed by an external testing facility in compliance with 21 CFR, Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies.

CAUTION: Do not use in medical applications involving permanent implantation in the human body. For other medical applications, discuss with us.

The information set forth herein is furnished free of charge and is based on technical data that DuPont Performance Elastomers and Problem Solving Products, Inc. believe to be reliable. It is intended for use by persons having technical skill, at their own discretion and risk. Handling precaution information is given with the understanding that those using it will satisfy themselves that their particular conditions of use present no health or safety hazards. Since conditions of product use and disposal are outside of our control, we make no warranties, express or implied, and assume no liability in connection with any use of this information. As with any material, evaluation of any compound under end-use conditions prior to specification is essential. Nothing herein is to be taken as a license to operate or a recommendation to infringe on any patents. While the information presented here is accurate at the time of publication, specifications can change. Check with us before making a decision about which product to use.

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Kalrez® is a registered trademark of DuPont Performance Elastomers

* © Photographer: United States Department of Agriculture, Agricultural Research Service/Scott Bauer