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USP Class VI O-Rings

High-purity processing in the pharmaceutical, biopharmaceutical, and biotechnology industries require the unique standards of biocompatibility, purity and reliability. As a critical wearing component in all USP systems, choosing a poor O-ring material or a poor O-ring design can result in:

  • Excessive maintenance costs
  • Unexpected process downtime
  • Product contamination or rework
  • Lost batches
  • Costly investigations

Newman has the materials, the designs, and the expertise to help you and your USP Class VI O-ring Application.

High-Quality Class VI Gaskets

For over 45 years, Newman has made high-purity processing our sole business. Our high-quality USP Class VI gaskets and O-rings are specifically designed to meet the stringent requirements of the pharmaceutical, biopharmaceutical, and biotechnology industries. We have the O-rings you need for:

  • Purified Water Systems
    • Ambient/Hot
    • Heat/Chemical/Other sterilization methods
  • Clean-in-Place (CIP) Distribution Systems
  • Steam-in-Place (SIP) Pure Steam Distribution Systems
  • Processing Areas
  • Purification and Filling Areas
  • Single-use or Multi-use

Inside or outside of the sterile envelope, upstream or downstream, Newman has the full range of USP O-rings you need.

Certified Around the World

High purity, hygienic seals have been the only focus of Newman Sanitary Gasket Company since its inception, because of this we have invested heavily in both the evolution and support of these industries.   Newman Gasket is a leader in developing the industry’s standards and requirements. The world’s biopharmaceutical plants know and trust Newman materials and designs for their valuable processes, products and patients.

Our full line of precision Class VI O-rings combine outstanding physical properties, chemical, steam, and thermal resistance. With our O-ring’s proven track record in the most challenging of applications our customers can rest assured that they are working with a quality product that they can trust in.

[Links to chemical resistance charts, physical properties and general materials selection table]

Newman USP Class VI O-Rings combine:

  • Materials: Our time-tested, engineered, proprietary materials that are certified the world over to meet the highest industry standards.
  • Design: Newman designs reflect decades of experience in the design of cleanable, drainable, user friendly O-rings that perform day-in and day-out.
  • Reliability: Rigorous in-house performance testing with third-party verification and our reputation demonstrate long-term durability and predictable performance.
  • Control: Newman is the manufacturer of its seals, we exercise complete control over, material formulation, processes, and production, falling under our ISO 9001:2015 Certified umbrella.
  • Traceability: Every USP Class VI O-ring is fully batch traceable so the exact origin of every Newman Class VI O-ring in your system is in our database.

High-Purity Compounds for High-Purity Processing

When it comes to high-purity, Newman has the compounds, processes, and expertise to ensure your product streams are better protected against the risk of contamination. Our compounds are specifically formulated for applications requiring the highest purity and sanitary standards. Newman Gasket’s proprietary compounds are already used by bio-processing industries worldwide. With our seals our customers are able to produce the purest pharmaceuticals, demonstrating decades of proven industry leading performance.

We currently have many compounds that meet the criteria for Class VI certification including — Silicone, Viton™, EPDM, Silverback™, and Teflon™. Every compound undergoes rigorous testing to ensure the highest quality sanitary elastomers on the market. We manufacture and control all our compounds, processes, and products, all of our products are fully batch traceable.

Newman’s Class VI O-Rings meet the stringent standards for purity:

  • US. Pharmacopeia Class VI Certification
  • US Pharmacopeia, Class VI, Section 87 Biological Reactivity Tests, in vitro.
  • US Pharmacopeia, Class VI, Section 88 Biological Reactivity Test, in vivo
  • CFR Title 21 Section 177.2600
  • ASME-BPE Standards
  • EHEDG Hygienic Design Criteria (Second Edition, 2004)
  • Cytotoxicity Criteria
  • Complies to EC Regulations (Nos 1935/2004, 2023/2006 and 10/2011)
  • European CPMP Guideline (CPMP/BWP/1230/98)
    • TSE Free (Transmitting Animal Spongiform Encephalopathy)
    • BSE Free (Bovine Spongiform Encephalopathy)
  • ADI Free (Animal Derived Ingredient)
  • BPA Free (Bisphenol A)
  • Latex Free
  • Gluten Free
  • Lactose Free
  • Melamine Free
  • Cyanuric Free
  • Mercury Free
  • Phthalates are not intentionally added

Selecting the Right Class VI O-Ring Material

When selecting the right hygienic O-Ring for your high-purity system or application, several factors should influence your decision making, including chemistry, type of materials processed, process temperature and pressure, programed maintenance cycles, and regulatory specifications, such as USP Class VI and FDA.

The following table gives general guidelines to help you determine which types of compounds to consider for your application.  Our material specific pages can help you choose which of Newman’s Class VI compounds is right for you.

Class VI O-Ring Material Options

Compound Temperature Range Recommended Applications Performance Properties
EPDM   -55oF to 275oF (short term to 325oF)   -48oC to 135oC (short term to 162oC) Processing areas, CIP, WFI and ozone-treated water , vacuum service, applications with thermal cycling.  Pumps and agitators
  • Excellent ozone, heat, cold, steam, abrasion, acid, base and radiation resistance.
  • Good tear resistance.
  • Good tensile strength -   Available in 2017 and 2107LE (Low Extractable) EPDM
Viton™ (fluorocarbon rubber)   Also available: Viton™ GF and ETP -2oF to 450oF (short term to 600oF)   -18oC to 232oC (short term to 315 oC)   High Temperature and Non-aqueous applications. Vacuum service, pumps and agitators
  • Excellent ozone, heat, steam, and both petroleum and vegetable oil resistance
  • Good cold, tear, abrasion, acid, base (depends on grade), and flame resistance
  • Good tensile strength
Teflon™ (fluoropolymer)   -110oF to 450oF   -78oC to 232 oC   Strong acids and bases, High and low temperatures. Continuous Steam applications.
  • Excellent heat, cold, steam, tear,  acid, base, petroleum oil, flame, and vegetable oil resistance
  • Excellent tensile strength
  • Poor resistance to thermal cycling and radiation.

Silicone  
-80oF to 450oF (short term to 400oF)   -62oC to 232oC (short term to 204 oC) Single-use, gamma sterilization, downstream applications, fill and finish.
  • Excellent ozone, heat, cold, and  resistance
  • Good resistance to steam, mild acids and  bases, and some oils
  • Good tensile strength
  • Platinum or Peroxide Cured
Silverback™ (50/50 blend of PTFE and 316 stainless steel) -110oF to 450oF   -78oC to 232 oC   Pure steam distribution lines and continuous temperature applications. Excellent ozone, heat, cold, steam, tear, abrasion, acid, base, petroleum oil, flame, and vegetable resistance Excellent tensile strength Better creep and cold flow resistance to Teflon
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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.

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Address
P.O. Box 222 Lebanon, OH 45036
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