Description Elast-O-Pure EP75 Black is an ethylene-propylene (EPDM) synthetic rubber compounded in-house by James Walker specifically for use in pharmaceutical and bioprocessing environments. It is black in colour.
It meets the stringent requirements of the pharmaceutical and bioprocessing industries, and is backed by our ten years' experience of successful supply of the material to these particular sectors.
Typical applications 'O' rings, hygienic clamp gaskets, and other applications where a USP 28 Class VI material is needed that combines long-term fluid sealing capability with resistance to steam or chemical attack.
Specifications Independently tested in accordance with, and certificated to United States Pharmacopoeia (USP) 28 Class VI. Full reports of the testing against the various aspects of compliance are available to customers on request.
Special features
Compliant with FDA 21 CFR 177.2600.
The total organic carbon (TOC) content, or the amount of water-extractable materials, is just 20% of the level typically found in EPDM materials of this class.
Very low compression set, making it ideal for 'O' rings, hygienic clamp gaskets and other items where long-term retention of sealing forces is required.
Exceptional resistance to steam, so it is ideally suited to SIP sterilisation processes. It displays very low swell and minimal loss of mechanical properties after repeated steam cycling.
Excellent resistance to chemicals, including acid and alkaline cleaners used in Clean-In-Place (CIP) systems.
Resistant to aggressive water (WFI) systems.
Excellent release properties from stainless steel after prolonged contact at elevated temperature.
Typical properties of Elast-O-Pure EP75 Black
Temperature (maximum): +135°C (+275°F), with excursions in steam to +180°C (+356°F) for SIP Temperature (minimum): -40°C (-40°F) Hardness: 76 IRHD Tensile strength: 16MPa (2320psi) Elongation at break: 130% Compression set, 168 hours @ +100°C (+212°F) : 6% Compression set, 168 hours @ +125°C (+257°F) typical autoclave temperature: 11% Total organic carbon (TOC): 13.4ppm (whilst there is no upper TOC limit stated in USP 661, this figure compares favourably with the typical value for PTFE of 12ppm)
Industry specific immersion testing
Purified water: 4 weeks at +125°C (+257°F) Volume change, %: +2.7 Change in tensile strength, %: +48 Change in elongation at break, %: +7 Charge in hardness, IRHD: -1
Water For Injection (WFI): 4 weeks at +80°C (+176°F) Volume change, %: +1.9 Change in tensile strength, %: +8.5 Change in elongation at break, %: +11 Change in hardness, IRHD: -2
CIP 100® (4% by volume in de-ionised water): 4 weeks at +60°C (+140°F) Volume change, %: +2.6 Change in tensile strength, %: -9.7 Change in elongation at break, %: -7 Change in hardness, IRHD: -2 (CIP 100® is manufactured by Steris - based on potassium hydroxide. CIP 100® is a registered trademark of Steris Corporation)
CIP 200® (4% volume in de-ionised water) 4 weeks at +20°C (+68°F) Volume change, %: +0.1 Change in tensile strength, %: -24 Change in elongation at break, %: -16 Change in hardness, IRHD: 0 (CIP 200® is manufactured by Steris - based on phosphoric acid. CIP 200® is a registered trademark of Steris Corporation)
How supplied Elast-O-Pure EP75 Black is available as 'O' rings, hygienic clamp gaskets, custom mouldings, sheet, and precision cut gaskets.
Hygienic clamp gaskets are supplied in size ranges including: BS4825 part 3, 1991; BS4825 Non-Standard; BS Schedule 5 Pipe; BS Schedule 40; ISO 2852; ISO 1127; ISO 2037; Mini Series Ultra Bore. Lipped and lipless versions are available. Custom sizes manufactured to order.
We are also willing to partner with equipment manufacturers in the pharmaceutical and bioprocessing sectors to develop, prototype and evaluate materials and/or specific components for custom applications.
