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Elast‑O‑Pure® EP75

USP Class VI, EPDM elastomer specifically formulated for biopharmaceutical applications.

TYPICAL APPLICATIONS
  • Biopharmaceutical

Our highly developed pharmaceutical grade of ethylene - propylene - diene elastomer possesses significantly enhanced properties in comparison to other EPDM compounds.

  • Compliance with FDA 21 CFR 177.2600
  • Independently tested and certificated to USP Class VI
  • Tested to and compliant with the physicochemical test regime of USP <381> 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)

Elast-O-Pure EP75 has been independently tested in accordance with, and fully complies with, the requirements of United States Pharmacopoeia (USP) 30 Class VI.

Full reports of the testing against the various aspects of compliance are available to customers on request.

To check the adhesion resistance of our Elast-O-Pure EP75 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.

Standard components - including O-rings and hygienic clamp seals - to any size, shape and international standard.

Complex custom shapes by precision moulding. Full materials traceability provided for all items; an attribute that is highly desirable for critical applications.

Expert to Expert

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