Silicone Gasket for Tri‑Clamp Pharma Boiler Connections
Our silicone gasket for tri clamp pharma boiler connections delivers the reliability required in sterile steam and heat‑transfer systems. Engineered from high‑purity, FDA‑compliant silicone, the gasket creates a leak‑tight seal that withstands repeated sterilization cycles, high‑temperature excursions, and aggressive cleaning agents. Designed for seamless integration with standard 316 L stainless‑steel tri‑clamp flanges, it enables pharmaceutical manufacturers to maintain process integrity while meeting stringent validation requirements.
Key Technical Specifications
| Parameter | Typical Range | Notes |
|---|---|---|
| Material Grade | Medical‑grade silicone (FDA USP <305>) | Low extractables, biocompatible |
| Operating Temperature | -40 °C to +250 °C | Continuous; short‑term up to +300 °C |
| Compression Set (after 70 h @ 150 °C) | ≤ 25 % | Ensures long‑term sealing |
| Hardness (Shore A) | 40 – 60 | Optimized for tri‑clamp torque |
| Standard Size | ½”, ¾”, 1”, 1½”, 2” (custom sizes on request) | Fits ANSI/ASME B16.5 clamps |
*Typical specifications are customizable per order to match exact flange dimensions and process requirements.*
Installation Guide – Quick Reference
- 1. Verify flange cleanliness – remove all debris, oil, and residual cleaning agents.
- 2. Align the silicone gasket centrally on the flange face; ensure the embossed orientation (if any) faces upward.
- 3. Apply the recommended torque (typically 30–45 Nm for ½”–2” clamps) using a calibrated torque wrench.
- 4. Conduct a hydrostatic pressure test at 1.5 × the design pressure to confirm seal integrity.
- 5. Document the installation in the equipment validation file – include part number, batch code, and test results.
The gasket can be reused after a thorough visual inspection and a leak test; however, many users elect to replace it with each scheduled shutdown to guarantee compliance with GMP guidelines.
Frequently Asked Questions
What is the minimum order quantity (MOQ) for custom‑size gaskets?
Our standard MOQ is 250 pcs for off‑the‑shelf sizes. For engineered dimensions, the MOQ can be as low as 50 pcs, depending on tooling requirements.
Can the gasket be sterilized using autoclave cycles?
Yes. The silicone formulation tolerates repeated autoclave cycles at 121 °C for up to 30 minutes without significant compression set.
What certifications does the product meet?
Our gaskets are compliant with FDA USP <305>, ISO 10993‑1 for biocompatibility, and meet the EU Regulation (EC) No 1935/2004 on materials in contact with food‑stuffs.
What is the typical lead time for a first‑time order?
Standard stock items ship within 15 business days. Engineered runs require 30–45 days after final design approval.
Ready to secure a reliable seal for your pharmaceutical boiler system? Contact our engineering team today to discuss specifications, request a sample, or obtain a formal quotation.
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