News 1 - Article 5
Chooses FDA-Compliant Kalrez® To Seal Ultra-Pure Pharmaceutical
to Problem Solving Products about Kalrez® o-rings and
Release from DuPont (Formerly named DuPont Dow Elastomers when this article was written)
* Copyright for photograph
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.
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.
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.
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.
Richter chooses Kalrez® 6230
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.
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
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.
DuPont Dow Elastomers
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.
is a registered trademark of DuPont.
© Photographer: United States Department of Agriculture,
Agricultural Research Service/Bruce Fritz
Article: Article 4: Pharma and Food Process Seal Problems Overcome
with FDA-Compliant Kalrez®, Claims DuPont Dow