Sanitary Gasket and Seal Selection Guide

Gaskets and seals are critical components in sanitary connections. The right gasket material ensures leak-free operation, product purity, and compliance with FDA and 3-A standards. This guide covers the most common gasket materials used in sanitary processing and provides selection criteria based on temperature, chemical exposure, and application.

Common Sanitary Gasket Materials

Gasket Selection by Application

Food and Dairy Processing: EPDM is the standard choice — FDA 21 CFR 177.2600 compliant, good chemical resistance to CIP solutions (caustic soda, phosphoric acid), and cost-effective for high-volume use.

Pharmaceutical and Biotech: Silicone or PTFE-encapsulated silicone — must withstand SIP cycles at 121-134°C, be USP Class VI compliant, and minimize extractables. Silicone is preferred for most applications.

Brewing and Beverage: EPDM is standard. For higher-temperature mashing processes, silicone may be specified.

High-Purity / WFI Systems: PTFE or PTFE-encapsulated — minimizes particle shedding and extractables. Must meet USP Class VI and FDA requirements.

Gasket Standards and Dimensions

Sanitary gaskets are manufactured to match ferrule standards: ISO 2852 (tri-clamp), DIN 32676, 3A Sanitary Standards, and SMS 3017. Always specify the standard when ordering gaskets, as dimensions vary between standards for the same nominal size. Gasket sizes match the pipe outer diameter (OD): 1/2" through 6" (DN10 through DN150) in standard sanitary sizes.

When to Replace Gaskets

Replace gaskets every 6-12 months for standard applications. Replace more frequently (3-6 months) for SIP-intensive applications. Signs of wear: visible compression set (flattening), hardening or cracking, leakage, difficulty achieving proper clamp closure. ONEMO stocks replacement gaskets for all standard sizes.

Frequently Asked Questions

Can I mix gasket materials from different manufacturers?

Yes, as long as the gasket matches the ferrule standard (ISO, DIN, 3A) and size. However, we recommend using gaskets from the same manufacturer as the ferrules for optimal fit and performance. ONEMO gaskets are manufactured to match ONEMO ferrule specifications.

What gasket material is best for steam service (SIP)?

Silicone is the most commonly used gasket material for SIP service, with a temperature rating up to 205°C (well above the 121-134°C SIP range). PTFE is also suitable for steam service up to 260°C but requires careful clamping. EPDM has a lower temperature limit (130°C) and may degrade faster with frequent SIP cycles.

Can PTFE gaskets be used with tri-clamp connections?

Yes, but PTFE has lower elasticity than elastomeric gaskets. PTFE gaskets require careful, even clamping and may need re-torquing after thermal cycling. For tri-clamp connections subject to frequent temperature changes, PTFE-encapsulated silicone gaskets offer a better balance of chemical resistance and sealing performance.

How do I prevent gasket contamination in pharmaceutical applications?

Use pharmaceutical-grade (USP Class VI) gaskets, avoid gaskets with metal detectable fillers unless specified, store gaskets in clean, sealed packaging, replace gaskets after each batch changeover in high-purity lines. ONEMO supplies pharmaceutical-grade gaskets with full material certification.

Key Resources

Related Standards

• FDA 21 CFR 177.2600 — Rubber articles for repeated food contact

• USP Class VI — Biological reactivity tests for pharmaceutical materials

• 3-A Sanitary Standards — Gasket material compliance

• ASME BPE-2022 — Gasket dimensions and materials for bio-processing

Related ONEMO Products

• Sanitary Gaskets for Tri-Clamp Connections

• Tri-Clamp Fittings

Related Guides

• Connection Methods Guide

• CIP and SIP Systems Guide