News 1 - Article 10
Pharmaceutical Pumps Benefit From O-Rings of Kalrez®
2002, Birmingham, UK, May 21-23, 2002, DuPont Dow Elastomers - Stand
to Problem Solving Products about Kalrez® o-rings and
seals. Call (303) 758-2728 for instant help with your sealing
Release from DuPont (Formerly named DuPont Dow Elastomers when this article was written)
Hygiana-HT and Contra series pumps manufactured by Hilge-Pumpen
AG are fitted with O-rings of DuPont Dow Elastomers Kalrez®
6221 perfluoroelastomer to meet stringent safety, cleanliness,
sterilization, chemical resistance and seal life requirements
demanded by the pharmaceutical, biotechnology and cosmetics
Copyright for photograph
AG, Swiss subsidiary of Philipp-Hilge GmbH, Bodenheim, Germany,
has selected Kalrez® 6221 perfluoroelastomer parts to seal its
Euro-Hygia®, Hygiana-HT and Contra pump series, to meet stringent
safety, cleanliness, sterilization, chemical resistance and seal
life requirements demanded by the pharmaceutical, biotechnology
and cosmetics industries.
used in pharmaceutical, biotechnological and sterile processes are
subject to the highest standards and safety requirements worldwide.
In addition to ease of operation they must also provide maximum
biological safety without any unfavourable hydraulic characteristics
that could adversely influence sensitive products.
compliance is required with standards set by the FDA, GMP and 3A-Sanitary.
In Europe the draft "DIN EN 12462 Biotechnology" sets
out performance criteria for pumps in terms of cleanability and
sterilization, leakage, materials and their surfaces, and design
details in relation to CIP (cleaning in place) and SIP (sterilization
in place) capabilities.
and process engineers must therefore take special care in selecting
appropriate sealing materials. In addition to hygienic installation
and production requirements, they must consider expected sealing
life, chemical resistance, CIP and SIP capabilities, and FDA compliance
6221 perfluoroelastomer parts, products of DuPont Dow Elastomers,
comply with FDA requirements for repeated use in food contact with
extractable levels below 0.2 milligrams per square inch, and meet
stringent requirements for pharmaceutical and high-purity chemical
applications. The perfluoroelastomer parts are specified to reduce
the risk of leakage of chemicals and ultra-pure water used, for
example, during CIP and SIP procedures at temperatures up to 160°C.
Kalrez® combines the outstanding sealing properties of a perfluoroelastomer
with the inertness and purity of PTFE to provide an effective solution
for processes requiring minimal contamination, as well as longer
attention must also be paid to the surface roughness of pump construction
materials in order to reduce bacterial growth to an absolute minimum
and facilitate cleaning processes. Stainless steel used in the pump
is therefore carefully selected and electrochemically finished to
achieve a smooth, almost particle-free surface.
surface finish of Kalrez® perfluoroelastomer parts works in
harmony with the stainless steel to provide an optimum sealing environment
for reduced contamination. This is aided by the extremely low extractable
levels of Kalrez® seals measured in various chemical environments
- similar to those of PTFE.
view of the demanding purity and performance criteria, Hilge-Pumpen
AG selected O-rings of Kalrez® perfluoroelastomer to help ensure
that its Euro-Hygia®, Hygiana-HT and Contra pump meet the rigorous
safety requirements of the pharmaceutical, biotechnology and cosmetics
6221 is marketed as a white O-ring, slabs, and parts produced to
customer specifications, manufactured by DuPont Dow Elastomers in
ISO 9001 quality certified facilities. Each item is separately packaged
with bar coding to ensure 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.
is a trademark of Philipp-Hilge GmbH.
© Photographer: DuPont Performance Elastomers
Article: Article 9: DuPont Dow Elastomers Extends Capabilities Of
Kalrez® Wet And Dry Process Seals At Semicon 2002