Solutions for USP Class VI Applications
As a critical wearing component in all USP systems, choosing a poor gasket material or a poor gasket design can result in:
- Excessive maintenance costs
- Unexpected process downtime
- Product contamination or rework
- Lost batches
- Costly investigations
Class VI Gasket Material Options
|Compound||Temperature Range||Recommended Applications||Performance Properties|
|EPDM||Varies by Grade: -55°F (-48°C) to 275°F (135°C), short term to 325°F (163°C)||Processing Areas, CIP, Purified Water Systems, Ozone-treated Water||
|Viton™ (fluorocarbon rubber)||Varies by Grade: Typical: -2°F (18°C to 450°F (232°C), short term to 550-600°F (287-315°C)||CIP, Many food applications||
|Teflon™ (fluoropolymer)||-110°F (-78°C) to 450°F (232°C), short term to 500°F (260°C)||Strong acids and Bases, Continuous Steam, High purity Processes. Use in applications where the temperature is fairly constant.||
|Silicone||Varies by Grade: Typical: -80°F (-62°C) to 350°F (176°C), short term to 400°F)||Single-use applications, downstream applications||
|Silverback™ (50/50 blend °F PTFE and 316 stainless steel)||-110°F (-80°C) to 400°F (204°C), short term to 420°F (215°C)||Steam Applications, low temperature applications, constant temperature applications.||
USP Class IV Gasket Application
Newman has the materials, the designs, and the expertise to help you and your USP Class VI Gasket Application.
For over 45 years, Newman has made high-purity processing our sole business. Our high-quality USP Class VI gaskets are specifically designed to meet the stringent requirements of the pharmaceutical, biopharmaceutical, and biotechnology industries. We have the biopharmaceutical gaskets you need for:
- Purified Water Systems
- 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 gaskets you need.
Class VI Gasket Benefits
As process conditions in high-purity systems and applications become more severe, hygienic seals must meet the need for greater seal integrity while maintaining process purity. Our full line of precision fit Class VI gaskets combine excellent chemical, steam, and thermal resistance, exceptional mechanical performance, and unmatched seal performance for longer service life, fewer leaks, and reduced maintenance.
The following are key benefits and features of our full line of USP Class VI gaskets:
- Quality: Use only our time-tested, proprietary materials that meet are chemically pure and meet the highest sanitary standards.
- Reliability: Rigorous in-house performance testing and third-party verification demonstrates long-term durability and excellent and predictable performance.
- Accountability: We control all materials, processes, and products in manufacturing our Class VI gaskets under the ISO 9001:2008 Certified umbrella.
- Traceability: Fully batch traceable at the part level so you know the exact style, size, composition, and provenance of every Newman Class VI gasket.
- Cleanability: Precise finishes and smoother surfaces provide better cleanability and sterilization.
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 to protect their valuable processes, products and patients.
Our full line of precision Class VI gaskets combine outstanding physical properties, chemical, steam, and thermal resistance. With our long proven track record in the most challenging of applications, our customers rest assured in the fact that they are working with quality products that they can trust in.
Newman USP Class VI Gaskets 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 gaskets 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 gasket is fully batch traceable so the exact origin of every Newman Class VI gasket 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 Gasket’s Class VI gaskets meet the stringent standards for purity:
- S. 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 Gasket Material
When selecting the right hygienic gasket 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.
Our material specific pages can help you choose which of Newman Gasket’s Class VI compounds is right for you.