Silicone (VMQ) O-Rings
High-purity elastomers offering exceptional temperature range, flexibility, and FDA compliance for food, medical, and pharmaceutical applications.
Key Properties & FDA Compliance
- FDA 21 CFR 177.2600: Compliant for repeated food contact applications
- Temperature Range: -60°C to 230°C (-76°F to 446°F) continuous service
- Medical Grade: USP Class VI and ISO 10993 compliant options available
- Odorless/Tasteless: Will not affect product flavor or aroma
- Biocompatibility: Non-toxic and non-allergenic formulations
- Sterilization: Withstands autoclaving, radiation, and chemical sterilization
Silicone Grades & Certifications
Food-Grade Silicone
FDA 21 CFR 177.2600
NSF 51 Certified
3-A Sanitary Standard
Medical-Grade Silicone
USP Class VI
ISO 10993
EU 10/2011 Compliant
Industrial-Grade Silicone
High-Temp Resistant
Enhanced Tear Strength
Custom Hardness Available
Mechanical Properties
| Property | Standard Values | Test Method |
|---|---|---|
| Hardness (Shore A) | 30-80 | ASTM D2240 |
| Tensile Strength (MPa) | 4-10 | ASTM D412 |
| Elongation at Break (%) | 200-700 | ASTM D412 |
| Compression Set (% @ 150°C) | 15-40 | ASTM D395 |
| Tear Resistance (kN/m) | 10-30 | ASTM D624 |
Limitations & Considerations
- Not all silicones are FDA compliant - Must be specifically formulated and certified
- Chemical Resistance: Poor resistance to oils, fuels, and concentrated acids
- Abrasion Resistance: Lower than most other elastomers
- Gas Permeability: High permeability to gases
- Cost: 2-3x more expensive than NBR for industrial grades
FDA-Approved Applications
- Food Processing: Seals for mixers, fillers, and packaging equipment
- Beverage Industry: Seals for bottling lines and dispensing systems
- Dairy Equipment: Milk processing and cheese production seals
- Pharmaceutical: Seals for drug manufacturing equipment
- Medical Devices: Seals for diagnostic equipment and implants
- Cosmetics: Seals for lotion/potion filling machines
Frequently Asked Questions
FDA-compliant silicone must meet 21 CFR 177.2600 regulations, meaning:
- Formulated without toxic additives or fillers
- Passes stringent extraction tests for food contact
- Manufactured under GMP conditions
- Documented traceability of materials
Yes, medical-grade silicone O-rings can withstand repeated autoclaving at 121°C (250°F) or 134°C (273°F) cycles. However:
- Platinum-cured silicones perform better than peroxide-cured
- Expected lifespan is typically 50-100 cycles
- Should be inspected regularly for degradation
- Certification Documents: Must have FDA 21 CFR 177.2600 compliance statement
- Color: Typically white or translucent (non-pigmented)
- Odor: Should be completely odorless
- Markings: May have "FDA" or "NSF" markings on packaging
- Supplier Certification: Reputable suppliers provide material certifications