Silicone Gaskets

Silicone Gaskets and O-rings

James Walker Elast-O-Pure® Sil70 Translucent elastomer has been developed by James Walker to meet the stringent requirements of the pharmaceutical and bio-processing sectors.

 

Product Description

Silicone gaskets are preferred for a wide range of pharmaceutical and biotech applications because silicone does not readily support microbiological growth. It is therefore ideal for use in clean environments and the manufacture of medical devices.  Elast-O-Pure® SIL70 Translucent is available in a hardness grade of 70 IRHD, making it suitable for a wide variety of fluid sealing duties, including ‘O’ rings and hygienic clamp seals.  James Walker Elast-O-Pure® SIL70 Translucent is a platinum-cured grade of silicone (VMQ) elastomer that has been developed by James Walker to meet the stringent requirements of the pharmaceutical and bioprocessing sectors.  At James Walker we not only manufacture elastomeric components; we also formulate and compound our own materials, giving us total control over every stage of the manufacturing process.  By formulating specifically for bio-pharmaceutical use we make sure that our compounds are designed to minimize leachables and extractables without affecting performance and, unlike component manufacturers purchasing ready-made compounds off the open market, we are able to trace and verify every ingredient.  The Elast-O-Pure® platinum-cured pharmaceutical grade of silicone is available in a hardness grade of 70 IRHD, making it suitable for a wide variety of fluid sealing duties. Our confidence in promoting this material is based on over thirty years of successful supply into the pharmaceutical and bio-processing industries.

Special features

  • Compliant with FDA 21 CFR 177.2600.
  • ADI-free material (no Animal Derived Ingredients – ADCF).
  • Non-toxic.
  • Translucent.
  • High temperature resistance – up to 200°C (392°F) constant with dry heat.
  • Low levels of the extractables that can leach from material to promote contamination in a pharmaceurical process.
  • Excellent resistance to steam. Ideal for sterilisation with SIP systems at up to 130°C (266°F).
  • Excellent chemical resistance, including acid and alkali cleaners used in CIP systems.
  • Resistant to aggressive water in WFI systems at up to 80°C (176°F).
  • Excellent release properties from stainless steel after prolonged contact at elevated temperatures.

Independently tested in accordance with, and certificated to United States Pharmacopeia (USP) Class VI. Full reports of testing against the various aspects of compliance are available to customers on request.

Typical properties of Elast-O-Pure® SIL70 Translucent
PropertyUnit
Value
Hardness IRHD
73
Tensile Strength MPa
9.6
Elongation at break %
600
Compression set,
24 Hrs @ 100°C
%
6.5
Compression set,
24 Hrs @ 125°C
%
7.5

How supplied

Elast-O-Pure® SIL70 Translucent is supplied as standard components – incuding ‘O’ rings, hygienic clamp seals and precision-cut gaskets – to any size, shape and international standard, as well as in sheet form. Complex custom shapes are manufactured by precision moulding. Full materials traceability is provided for all items.

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.

Clink the link to download the PDF
pdficon_largeEP Sil70 final 5 2 2009
pdficon_large51802_James_Walker_PharmaSeal_2011_2.2
pdficon_large53629_JW_Total_Material_Traceability_Biopharmaceutical_6pp_web
pdficon_largeElast-O-Pure Sil70 translucent Statement of Compliance v1 16.02 PL&PS