2107 LE (Low Extractable) Products
Building on the experience of Newman 2107, 2107LE is setting a new standard for Biopharmaceutical applications. Specifically designed to protect the process, the product and the patient. With 10% of the extractables (LE = Low Extractables) of normal EPDM, 2107LE provides the added benefits of an extended temperature range, easier installation and removal, better equipment support and a longer lifetime while in process. Fully synthetic, 2107LE complies with a multitude of international regulations, standards and customer requirements (e.g. FDA, USP, EU, EP, REACH, RoHS I and II, ICH Q3D Residual Solvents and Elemental Impurities, Free of ADI, Latex, BPA, Phthalates, etc.). 2107LE also meets global requirements for biopharmaceutical processing.
Compatible with CIP, SIP, WFI and Processing areas:
- Lower Extractables
- 10X less than conventional formulations
- Longer Service Life
- Little to no wear after 500 pure steam exposure cycles (ASME BPE Appendix K)
- Better dimensional stability
- Little to no intrusion into the process stream
- Easier Maintenance
- 2107LE EPDM sanitary gaskets disassemble after long periods of exposure with little effort (static friction) and no residue on fittings
- 2107LE supports the weight of equipment better and holds tubing in alignment better than other compounds, all without cracking or tearing
Post Cure
Newman an EPDM, FDA, and Rubber Gasket Manufacturer, process provides for a second step in the vulcanization (the curing process of raw rubber) process for high-end elastomer parts, called post-curing. This provides stronger parts and drives off unwanted residual materials from the curing process. As a result, the parts have lower extractables and leachables, greater resistance to compression set, and greater tensile strength and modulus. It increases performance of the part.
Newman's compounds are specially formulated for high performance. Resisting the temptation to use high amounts of cheap fillers that cause a seal to fail earlier, Newman compounds are designed to last: to give long, reliable, and robust service.
Contact our Specialists at Newman
Newman Sanitary Gasket Company’s mission is to continually grow in our ability to meet our customers’ needs and improve our capabilities. We strive for excellence in quality, service, supply, distribution, and product development and performance. You can count on Newman Sanitary Gasket Company as your number one provider for all your gasket needs.
Selecting the Right Compound
When selecting the right compound for your sealing application, several factors should influence your decision making, including chemistry, the fluids processed, temperatures and pressures, cleaning and sterilization, and regulatory and standard specifications, such as USP and FDA.
Specification sheets and more detailed chemical resistant charts are available from Newman. Newman's expertise is available in case assistance is required in selecting the most suitable compound.
We guarantee highest quality sanitary elastomer parts available on the market.
Quality Assurance
Rigorous Testing
Inspection
Newman Sanitary Gasket Company is a leading manufacturer of FDA and USP Class VI seals for High Purity Process applications such as the Pharmaceutical, Food & Beverage and Dairy industries. Newman Diaphragms provides world class replacement diaphragms for ITT®, Gemü®, Saunders® and Aquasyn® valves.