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Home / Materials / Pharma Silicone
Material

Certified Pharma & Food-Grade Silicone O-Rings

FITCO's certified pharma and food-grade silicone range covers platinum-cured, FDA-compliant and USP Class VI compounds for pharmaceutical, biotech, dairy, beverage and food-processing equipment. Compliance claims apply only to the specific compound for which supporting documentation is provided.

When to Select

When Pharma Silicone Should Be Selected

Select certified pharma/food-grade silicone for CIP/SIP process equipment, aseptic filling systems, and any sealing position requiring documented FDA or USP Class VI compliance.

Advantages

Main Advantages

  • Platinum-cured compounds available for minimal extractables
  • Wide temperature flexibility across CIP/SIP cycling
  • FDA and USP Class VI compliant grades subject to documentation
Limitations

Important Limitations

  • Compliance applies only to the exact documented compound — confirm the required regulation at enquiry stage
  • Not suited to hydrocarbon fuel or mineral oil exposure
  • Lower mechanical strength versus FKM/FFKM — static sealing applications only
Applications

Typical Industries

Pharmaceutical & BiotechFood, Beverage & Dairy
Media Compatibility

Suitable & Unsuitable Media

SUITABLE:
CIP/SIP cleaning cycles (compound-specific verification required)Water and steam (compound-specific)Food-contact and pharmaceutical process fluids
UNSUITABLE / REQUIRES VERIFICATION:
Hydrocarbon fuelsMineral oilsConcentrated acids
Technical Data

Hardness, Temperature & Standards

Hardness30–80 Shore A
Temperature Range-60°C to 200°C continuous, 230°C short-term
Relevant Standards / CertificationsFDA 21 CFR 177.2600, USP Class VI, EC 1935/2004, 3-A Sanitary Standard — compliance applies only to the specific compound for which supporting documentation is provided. Please confirm the required regulation when requesting a quotation.
Comparison

Pharma Silicone vs. Alternative Materials

Certified silicone is the default for general hygienic sealing. Where the CIP/SIP fluid list includes aggressive chemistries beyond silicone's resistance, FFKM or FDA/USP-compliant FKM should be evaluated.

Available As

Pharma Silicone Product Types

Pharma Silicone O-Rings

Precision-molded circular seals available across FITCO's full specialty material range.

View O-Rings →

Pharma Silicone Cords

Extruded cord stock in FKM and Silicone — cut, spliced and vulcanized to size.

View Cords →

Pharma Silicone O-Ring Kits

Application-specific seal kits in FKM and Silicone, bundled to equipment BOM or drawing.

View O-Ring Kits →
FAQ

Pharma Silicone Frequently Asked Questions

No. Compliance applies only to the specific compound for which documentation is provided. Confirm the required regulation when requesting a quotation.

Metal-detectable O-rings are available within the certified range — confirm requirement and compound at enquiry.

Send Your Application Details

Share your fluid, temperature, pressure and certification requirement — FITCO will review and propose a suitable Pharma Silicone compound.

Send Your Application Details
Material information is provided for preliminary guidance. Final material selection must consider the complete application, including fluid composition and concentration, temperature, pressure, movement, operating cycle, groove design and applicable regulatory requirements. FITCO helps customers identify suitable sealing materials based on application details; this does not constitute a compatibility guarantee.