Elast‑O‑Pure^® EP75B

• 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 EP75B has been independently tested in accordance with, and fully complies with, the requirements of United States Pharmacopoeia (USP) 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 EP75B 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.

Our Elast-O-Pure materials are trusted across a wide range of specialised applications in the biopharmaceutical industry:

• Process Connections
  • Elast-O-Pure high purity tri-clamp gaskets and O-rings hygienic are essential for maintaining the integrity of process connections in biopharmaceutical manufacturing. They create leak-proof seals, protecting against contamination and product loss.
• Bioreactors
  • In bioreactors, where sterility is crucial, our high-purity elastomers provide secure vessel sealing, safeguarding the bioprocess and preventing contamination.
• Chromatography Columns
  • For chromatography applications, Elast-O-Pure hygienic seals are key to ensuring the purity and efficiency of the separation process by preventing leaks and contamination.
• Purification Skids
  • These seals are indispensable in purification skids, where they help maintain product purity and ensure smooth, clean operations throughout the processing.
• Vessels
  • Whether for storage or transport, Elast-O-Pure hygienic seals provide airtight, sanitary sealing, ensuring the contents are protected from contamination.
• Filtration
  • In filtration systems, these seals play a critical role in enhancing both reliability and efficiency, ensuring that only the desired particles are retained while contaminants are kept out.
• Single-Use Systems
  • Elast-O-Pure hygienic seals are the ideal choice for single-use systems, offering a reliable and hygienic solution for disposable components in biopharmaceutical processes.

For more information on our highly specialised materials for hygienic (tri-clamp and tri-clover) seals, follow this link.