James Walker developed Elast-O-Pure® GF75 Black to meet the stringent requirements of the pharmaceutical and bioprocessing sectors.
It provides excellent resistance to steam and strong mineral acids, and the Total Organic Carbon (TOC) levels are generally lower than PTFE due to the purity of the Viton® polymer.
'O' rings, hygienic clamp gaskets, custom mouldings, and other applications where a USP Class VI material is required that combines long-term fluid sealing capability with excellent resistance to steam or chemical attack.
USP requirements: Independently tested in accordance with, and meets the requirements of United States Pharmacopeia (USP) Class VI. Full reports on the testing against various aspects of compliance are available to customers on request.
•Elast-O-Pure® GF75 Black has been designed in accordance with GFR Title 21 Section 177.2600. FDA food contact compliance for Viton® GF-600S with limitations/specifications for repeated use applications is outlined in Food Contact Notifications (FCN) 510.
•Compounded to give extremely low extractables. When independently tested, folowing extraction procedures in accordance with USP 381, Elast-O-Pure® GF75 Black displayed an average Total Organic Carbon (TOC) value of 8.4. Whilst no upper limit is stipulated in the USP document, this remarkably low TOC value minimises any potential for contamiination.
•Very low compression set - ideally suited to the manufacture of fluid seals where the long-term retention of sealing forces is required.
•Excellent resistance to steam - ideal for SIP processes.
•Outstanding chemical resistance - including CIP media and strong mineral acids.
•Exceptionally clean release from stainless steel after prolonged contact at elevated temperatures.
•Very high working temperature capability: +230°C (+446°F) maximum.
Typical properties of Elast-O-Pure® GF75 Black
Temperature (maximum): +230°C (+446°F)
Temperature (minimum): 0°C (+32°F)
Hardness: 74 IRHD
Tensile strength: 30MPa (4351psi)
Elongation at break: 220%
Compression set, 24 hours @ +200°C/+392°F: 13%
Total Organic Carbon (TOC): 8.4ppm
Industry specific immersion testing
Water for Injection (WFI): 4 weeks at +80°C (+176°F)
Volume change, %: +3.2
Change in tensile strength, %: +4
Change in elongation at break, %: -1.7
Change in hardness, IRHD: -5
CIP 100® (4% by volume in de-ionised water):
4 weeks at +60°C (+140°F)
Volume change, %: +0.9
Change in tensile strength, %: +3.2
Change in elongation at break, %: -6.0
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% by volume in de-ionised water):
4 weeks at +20°C (+68°F)
Volume change, %: +0.4
Change in tensile strength, %: -8.3
Change in elongation at break, %: -7
Change in hardness, IRHD: -2
(CIP 200® is manufactured by Steris - based on phosphoric acid. CIP 200® is a registered trademark of Steris Corporation)
Elast-O-Pure® GF75 Black is available as 'O' rings, hygienic clamp gaskets, custom mouldings, sheet, and precision cut gaskets.
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.