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The Challenge
Pumps used in pharmaceutical, biotechnological and sterile processes are subject to some of
the highest standards and safety requirements worldwide. In addition to ease of operation
they must also provide maximum biological safety without any unfavorable hydraulic
characteristics that could adversely influence sensitive products.
Strict 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 (clean in place) and SIP (sterilization in place) capabilities.
Specific 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.
Pump and process engineers must therefore take special care in selecting appropriate
sealing materials. In addition to hygienic installation and production requirements, they
Pharmaceutical Seals for CIP and SIP | 2
must consider:
The Solution
DuPont Kalrez 6221 perfluoroelastomer parts 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 parts combine the outstanding sealing properties of a perfluoroelastomer
with the attributes of PTFE to help provide an effective solution for processes requiring
minimal contamination, as well as longer sealing life.
The Advantages
The surface finish of Kalrez parts works in harmony with the stainless steel to help provide
an optimum sealing environment for reduced contamination. This is aided by the low
extractable levels of Kalrez seals measured in various chemical environments similar to
those of PTFE.
Gallagher Fluid Seals is your DuPont Kalrez distributor in the northeast and mid-
Atlantic. Feel free to contact us with any questions about Kalrez and how it can benefit
your processes.
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