Pharmaceutical Seals for CIP and SIP
Clean in Place Service benefits from Kalrez® O-rings
Hilge-Pumpen AG, Swiss subsidiary of Philipp-Hilge GmbH, Bodenheim, Germany, selected Kalrez® 6221 perfluoroelastomer parts to seal its Euro-Hygia®, Hygiana-HT and Contra pump series, to meet the stringent safety, cleanliness and sterilization requirements demanded by the pharmaceutical, biotechnology and cosmetics industries.
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 must consider:
- Expected sealing life
- Chemical resistance
- CIP and SIP capabilities FDA compliance status.
In view of the demanding purity and performance criteria, Hilge-Pumpen AG selected Kalrez® O-rings to for its Euro-Hygia®, Hygiana-HT and Contra pump to meet the rigorous safety requirements of the pharmaceutical, biotechnology and cosmetics industries.
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 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.