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ITT Richter Chooses FDA-Compliant Kalrez® To Seal Ultra-Pure Pharmaceutical Process Pumps

* Copyright for photograph

The pharmaceutical and food processing industries have a critical need for sealing materials of the highest purity and integrity to help eliminate contamination and leakage of sensitive process fluids. However, for engineers managing these processes, oring seals and gaskets are often the weak link.

In response, DuPont Dow Elastomers offers Kalrez® 6230 perfluoroelastomer parts specifically to overcome the performance problems associated with conventional sealing materials when used in such demanding environments. The perfluoroelastomer has demonstrated significantly lower contamination and longer seal life than silicone, EPDM and fluoroelastomers (FKM), the company states.

Effective December 19, 2000, the United States Food and Drug Administration (FDA) affirmed the compliance of Kalrez® 6230 perfluoroelastomer parts for repeated use in contact with food, as stated in Food Contact Substance Notification FCN000101. This notification substantiates DuPont Dow's previous report on the suitability of Kalrez® 6230 in food and pharmaceutical applications.

Kalrez® 6230 has been developed to reduce the risk of leakage of chemicals and ultra-pure water used, for example, during clean-in-place (CIP) and steam-in-place (SIP) cleaning and sterilisation procedures at up to 160°C. According to DuPont Dow, it combines the inertness and purity of PTFE with the outstanding sealing properties of perfluoroelastomer to provide an ideal solution for processes requiring minimal contamination and longer sealing life.

ITT Richter chooses Kalrez® 6230

The properties offered by a Kalrez® perfluoroelastomer oring recently met the stringent performance requirements demanded by ITT Richter in seals for its MNK range of plastics-lined pumps. ITT Richter Chemie-Technik, part of ITT Industries Inc., USA, manufactures pumps, valves, measurement and control devices for corrosive and high-purity process fluids. To resist corrosion and maintain purity, all parts exposed to process fluids have thick linings of fluid-resistant, high-performance plastics materials.

The company selected an oring of Kalrez® 6230 for its MNK magnet pumps to ensure long-term static sealing of corrosive, hazardous, toxic or high-purity media in chemical and pharmaceutical processes. In addition, ITT Richter confirms that the FDA-compliant Kalrez® oring not only resist these conditions, it minimizes absorption, desorption and extractables in extremely sensitive pharmaceutical processes.

Kalrez® 6230 is marketed as an oring, sheets, slabs, and parts produced to customer specifications, and as sterile seals of Kalrez® and stainless steel, manufactured by DuPont Dow in ISO 9001 quality certified facilities. Each item is individually packaged in a bar-coded bag for full traceability.

About DuPont Dow Elastomers

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/Bruce Fritz

Next Article: Article 4: Pharma and Food Process Seal Problems Overcome with FDA-Compliant Kalrez®, Claims DuPont Dow