Sanitary Tri-Clamp Gaskets (Bulk Manufacturing & Supply)
In hygienic processing, the gasket is the single most critical failure point. A compromised seal leads to product leakage, bacterial ingress, or batch contamination due to extractables. Sunhyings manufactures Sanitary Tri-Clamp Gaskets using strictly validated compounds that resist compression set and chemical degradation. Whether your system runs high-temperature SIP (Steam-In-Place) cycles or aggressive CIP caustics, we provide the correct elastomeric profile to ensure a flush, crevice-free seal. We offer contract manufacturing capacities for OEMs requiring specific durometers, color-coding, or detectability.
- Compliance: FDA 21 CFR 177.2600 & USP Class VI.
- Materials: 100% Virgin PTFE, Platinum-Cured Silicone, EPDM.
- Traceability: Lot-numbered batches with material certificates.
- Design: Flanged (lipped) options for easy alignment.
- Inventory: High-volume stock for 1/2" to 12" sizes.
- Supply: OEM/ODM branding & bulk packaging available.
Technical Specifications
Product Name
Sanitary Tri-Clamp Gasket (Standard & Flanged)
Origin
Manufactured by Sunhy (China)
Material Types
EPDM (Black), PTFE (White/Teflon®), Silicone (Platinum Cured/Clear), FKM (Viton®), Buna-N
Tolerance Class
Temperature Range
Size Range
1/2″ (DN10) to 12″ (DN300)
Regulatory Compliance
FDA 21 CFR 177.2600, USP Class VI (Biocompatibility), ADI Free (Animal Derived Ingredient Free)
Supply Capability
Wholesale Crates, Individual Bagging, Private Label
Standards Compliance
ASME BPE, 3A Sanitary Standards (18-03), ISO 2852, DIN 32676
1. Managing Thermal Expansion & “Cold Flow” Engineers often face leaks after thermal cycling (heating/cooling). Standard PTFE (Teflon) gaskets are rigid and susceptible to “cold flow” (creep), losing seal integrity after temperature shifts. For systems with frequent temperature fluctuations, we recommend PTFE Envelope (Sandwich) gaskets or Platinum-Cured Silicone, which retain elasticity and memory better than solid PTFE.
2. Chemical Compatibility (CIP/SIP)
EPDM: The industry standard for steam (SIP) and hot water. Excellent resistance to acids/alkalis but fails upon contact with fats, oils, or hydrocarbons (swells and degrades).
FKM (Viton®): The engineer’s choice for oil-based products, fats, and aggressive acids at high temperatures.
Buna-N: Cost-effective for petroleum-based fluids but has lower temperature limits.
3. Minimizing Extractables (Pharma Grade) For pharmaceutical OEMs, “leachables” are a major liability. Our Platinum-Cured Silicone and Class VI PTFE gaskets are post-cured to remove volatile organic compounds (VOCs), ensuring zero taste/odor transfer to the final product. Every batch is tested to meet USP Class VI biocompatibility standards.
Note: The “Flange OD” matches the ferrule face. Verify the ID (Internal Diameter) matches your tubing to prevent flow restriction.
| Size (Tube OD) | Flange OD (A) | ID (EPDM/Silicone) | ID (PTFE) | Thickness (Standard) |
| 0.50″ / 0.75″ | 25.0 mm | 10.0 mm / 16.0 mm | 9.9 mm / 15.9 mm | 4.8 mm |
| 1.00″ | 50.5 mm | 22.2 mm | 22.1 mm | 4.8 mm |
| 1.50″ | 50.5 mm | 34.9 mm | 34.8 mm | 4.8 mm |
| 2.00″ | 64.0 mm | 47.6 mm | 47.5 mm | 4.8 mm |
| 2.50″ | 77.5 mm | 60.3 mm | 60.2 mm | 4.8 mm |
| 3.00″ | 91.0 mm | 73.0 mm | 72.9 mm | 4.8 mm |
| 4.00″ | 119.0 mm | 97.6 mm | 97.4 mm | 4.8 mm |
1. Torque & Compression Control
The Problem: Overtightening is the #1 cause of gasket failure. Crushing an elastomer gasket (like EPDM/Silicone) causes it to intrude into the pipe ID, creating a dam where bacteria grow.
The Fix: Tighten the clamp wing-nut until “finger tight,” then apply 1/2 to 1 full turn max. For high-pressure lines using bolted clamps, adhere to a specific torque (e.g., 25 in-lbs for EPDM).
2. Flanged vs. Unflanged Alignment
Recommendation: For difficult-to-reach installations or vertical lines, specify Flanged (Lipped) gaskets. The small outer lip snaps over the ferrule face, holding the gasket in perfect concentric alignment during assembly, preventing the “gasket slip” that leads to leaks.
3. Replacement Intervals
Gaskets are consumables. In active steam lines, EPDM gaskets harden and crack over time. Establishing a Preventative Maintenance (PM) schedule to replace gaskets every 6-12 months prevents emergency shutdowns.
Related Products
FAQ
What is the best Tri-Clamp gasket material for high-temperature steam?
EPDM and PTFE are the best choices for steam applications. EPDM offers superior sealing performance and flexibility at temperatures up to 140°C (284°F) for continuous steam. For higher temperatures (up to 230°C/446°F), High-Temp PTFE or Envelope gaskets are required, though they are harder to seal.
What is the difference between flanged and non-flanged Tri-Clamp gaskets?
A flanged gasket (or lipped gasket) has a small outer rim that wraps around the ferrule flange edge. This feature holds the gasket in place during assembly, ensuring perfect alignment and preventing the operator from having to hold the gasket manually while tightening the clamp.
How often should sanitary gaskets be replaced?
Gaskets should be inspected during every disassembly. In continuous process lines (CIP/SIP), a standard replacement interval is every 6 to 12 months. Immediate replacement is mandatory if the gasket shows signs of cracking, hardening, permanent deformation (compression set), or swelling.
Do you offer USP Class VI certificates for pharmaceutical validation?
Yes. As a B2B supplier for critical industries, we provide full compliance documentation packages, including FDA 21 CFR 177.2600 statements and USP Class VI biocompatibility certification for our Silicone, EPDM, and PTFE compounds upon request.
Why is my PTFE gasket leaking even after tightening?
PTFE is a rigid plastic that does not have the “memory” of rubber. It requires higher torque to seal and is susceptible to “cold flow” (changing shape under pressure/temp). If leaks persist, check if the ferrule faces are misaligned, or switch to a PTFE Envelope Gasket (EPDM core) which combines the chemical resistance of PTFE with the sealing flexibility of rubber.