EPDM Gaskets for critical pharmaceutical and biotech applications.
James Walker has developed its Elast-O-Pure® EPDM gaskets based on the EP75 Black ethylene-propylene-diene elastomer, to meet the stringent requirements of the pharmaceutical and bioprocessing sectors. Our highly developed pharmaceutical grade of ethylene -propylene – diene elastomer possesses significantly enhanced properties in comparison to other EPDM compounds. Elast-O-Pure® EP75 Black has been independently tested in accordance with, and fully complies with, the requirements of United States Pharmacopoeia (USP) 30 Class VI. When independently tested, following extraction procedures in accordance with USP 381, Elast-O-Pure® EP75 Black demonstrated significant, class-leading performance in comparison to its three main competitors.
To check the adhesion resistance of our Elast-O-Pure® EP75 Black gaskets we have performed customer trials under a steam cleaning regime; subjecting the gaskets to 500 thermal cycles from clean steam at 130°C / 266°F in a line assembly. Each cycle comprised one hour in clean steam and a return to room temperature before re-exposure to steam. On completion of 500 cycles, the assembly was dismantled and the gasket was removed cleanly with no sticking and without leaving any residue on the metal surfaces.
● Compliance with FDA 21 CFR 177.2600.
● Independently tested and certificated to USP Class VI.
● Compounded to give extremely low extractables.
● Long-term dimensional stability with very low compression set, which gives our clamp gaskets excellent long-term sealability.
● Compatibility with a wide range of process chemicals, including acids and alkalis used in CIP systems.
● Excellent resistance to steam — ideal for SIP sterilisation systems.
● Low adhesion to stainless steel — providing clean release and disassembly after long use.
● Exceptionally wide temperature range.
● ADI Free (Animal Derived Ingredient Free)
|Temperature (max)||+135/+275, with excursions to +180/+356 in steam for SIP|
|Elongation at break||130|