Kalrez® News 1 - Article 4

Pharma and Food Process Seal Problems Overcome with FDA-Compliant Kalrez®, Claims DuPont Dow

* Copyright for photograph

At TechnoPharm 2001, DuPont Dow Elastomers will highlight FDA-compliant Kalrez® 6221 and Kalrez® 6230 perfluoroelastomer parts developed specifically to seal critical pharmaceutical and food processes, and overcome difficulties associated with conventional seal materials. According to the company, they combine the inertness and cleanliness of PTFE with the outstanding sealing properties of perfluoroelastomer, and have demonstrated significantly lower contamination and longer seal life than silicone, EPDM and fluoroelastomers (FKM).

The suitability of Kalrez® 6221 and Kalrez® 6230 perfluoroelastomer parts for repeated use in contact with food was recently reaffirmed by the United States Food and Drug Administration (FDA) in Food Contact Substance Notification FCN000101.

"This notification requires Kalrez® 6221 and 6230 to meet extractable levels not exceeding 0.2 milligrams per square inch," says Sylvie Bonnel, market manager pharma for DuPont Dow Elastomers in Europe. "In addition to existing compliance with FDA 21CFR177.2600, it reinforces DuPont Dow's determination to exceed standards used by the food and pharmaceutical industries, and provides further confirmation of the low risk of contamination from Kalrez® parts, the long term sealing solution for challenging food and pharmaceutical applications."

Kalrez® 6221 and Kalrez® 6230 perfluoroelastomer parts offer significantly reduced risk of leakage of chemicals and ultra-pure water used, for example, during clean-in-place (CIP) and steam-in-place (SIP) procedures at up to 160°C, the company states. The products are available as O-rings, sheets, slabs, and custom parts, and as sterile seals of Kalrez® and stainless steel, manufactured by DuPont Dow Elastomers in ISO 9001 quality certified facilities. Each item is individually packaged in a bar-coded bag for full traceability.

DuPont Dow Elastomers, a global supplier of specialty elastomers with European headquarters in Geneva, Switzerland, is a joint venture between the DuPont Company and The Dow Chemical Company, with more than US $1 billion in sales. The company is the industry leader in chloroelastomers, ethylene elastomers and fluorinated elastomers, serving the automotive, chemical and pharmaceutical processing, construction, general rubber and wire and cable industries.

Kalrez® is a registered trademark of DuPont.

* © Photographer: United States Department of Agriculture, Agricultural Research Service/Keith Weller

Next Article: Article 3: Latest Semicon Sealing Solutions From Dupont Dow Help Improve Yields, Reduce Cost Of Ownership