FDA Silicone Sheeting & Uncured Compounds
FDA Silicone Sheeting & Uncured Compounds
ElastaPro is a Made in USA manufacturer of FDA 21 CFR 177.2600 solid silicone sheet and uncured silicone compound. These high-purity elastomers meet U.S. Food and Drug Administration (FDA) requirements for rubber articles intended for repeated use in contact with food.
While this regulation establishes critical standards for material purity and low extractable levels, our medical grade silicones also meet USP Class VI, ISO 10993, and European Pharmacopoeia requirements.
Need FDA Silicone Sheeting or Slit Rolls?
We supply continuous roll stock, pre-cut solid sheets, and custom uncured compounds with low minimum order quantities and rapid turnarounds. White and translucent are the most popular FDA silicone colors, but we also offer red, green, gray, blue, and custom colors.
Request a Quote (RFQ)FDA Silicone Product Forms & Capabilities
ElastaPro supplies high-purity FDA silicones in three primary product formats engineered for die-cut converters, gasket fabricators, and custom molders.
1. Solid FDA Silicone Sheeting
Calendered into high-precision, smooth-surface sheets ideal for die-cutting precision sanitary gaskets, diaphragms, and seals used in peristaltic pumps, insulin delivery systems, and food processing machinery.
- Durometers: 10 to 80 Shore A
- Thickness Range: 0.007” to 0.500”
- Standard Widths: Up to 60” wide rolls
- Color Options: Translucent (standard), White, Red, Green, Blue, Gray, and custom color matches
- Surface Finishes: Gloss or Matte (Made-to-Order)
2. FDA Continuous Silicone Rolls
Manufactured in continuous roll stock engineered for automated high-speed conversion, slit-to-width operations, and high-volume gasket stamping.
3. FDA Uncured Silicone Compounda
Pre-mixed, ready-to-mold uncured silicone formulations provided off the mill in rolls or slabs with protective poly liners for compression molding and custom profile extrusion.
Technical Specifications & Cure Systems
Platinum-cured silicone uses an addition-cure system that leaves zero peroxide byproducts, resulting in higher clarity, ultra-low extractables, and superior biocompatibility for pharmaceutical and medical uses.
Peroxide-cured silicone offers strong mechanical properties and cost-effective thermal performance for standard food and beverage sealing.
The table below summarizes the key differences.
Specification Parameter | Platinum-Cured FDA Silicone | Peroxide-Cured FDA Silicone |
Primary Performance Trait | Ultra-low extractables, non-yellowing, maximum clarity. | High mechanical strength, cost-effective high-volume production. |
Operating Temperature | −80°F to +450°F (Intermittent to +500°F) | −80°F to +450°F (Intermittent to +500°F) |
Extractable Byproducts | None (no peroxide residues or off-gassing) | Minimal post-cure off-gassing |
Regulatory Compliance | FDA 21 CFR 177.2600, USP Class VI, ISO 10993 | FDA 21 CFR 177.2600 |
Key Applications | Medical fluid handling, peristaltic pumps, pharmaceutical packaging. | Food processing gaskets, oven door seals, beverage dispensing lines. |
FDA Approved vs. FDA Compliant: Key Differences
Understanding the regulatory distinction between “FDA Approved” and “FDA Compliant” is essential for proper specification in food processing and medical manufacturing:
| Feature | FDA Compliant | FDA Approved |
|---|---|---|
| Scope | Applies to raw materials & components (e.g., silicone sheeting, compounds). | Applies to finished end-use products or devices (e.g., a specific medical device or drug). |
| Mechanism | Formulated using approved ingredients and tested against extractable limits (such as 21 CFR 177.2600). | Evaluated directly by the FDA through formal submittal processes (510(k), PMA, etc.). |
| Agency Role | The FDA does not pre-approve raw raw-materials; manufacturers self-certify or issue a Declaration of Compliance (DoC). | The FDA explicitly reviews and approves the full finished assembly for market entry. |
Note: Compliance with 21 CFR 177.2600 alone does not guarantee suitability or approval for all medical uses. The FDA evaluates medical devices and equipment as complete assemblies. For medical device applications, materials often require additional testing to satisfy standards like USP Class VI and ISO 10993.
Frequently Asked Questions (FAQ) about FDA Silicones
What is FDA silicone rubber?
FDA silicone rubber is a high-purity synthetic elastomer specifically formulated for repeated contact with food, beverages, and sensitive pharmaceutical products. Engineered to comply with FDA Title 21 CFR 177.2600, these food-grade materials resist extreme temperatures, inhibit bacterial growth, and prevent harmful extractables or chemicals from migrating into consumable products.
As a leading U.S. manufacturer of calendered silicone sheeting, ElastaPro Silicone Solutions provides Made-in-the-USA FDA solid silicone sheet, continuous rolls, and uncured compounds engineered to meet rigid sanitary, medical, and industrial processing standards.
What is FDA Title 21 CFR 177.2600 and why does it matter for silicone materials?
FDA Title 21 CFR 177.2600 is the U.S. regulation defining rubber articles—including silicone—permitted for repeated food-contact applications. Materials must meet strict extractables limits when exposed to water and n-hexane to ensure safety.
What types of silicone products can comply with FDA 21 CFR 177.2600?
Silicone sheets, continuous rolls, and uncured compounds can all be formulated to meet 21 CFR 177.2600 requirements.
What testing is required for FDA 21 CFR 177.2600 compliance?
Compliance requires extractables testing in both distilled water and n-hexane under defined time and temperature conditions to confirm migration levels remain within regulatory limits.
Are ElastaPro’s FDA-compliant silicones platinum-cured or peroxide-cured?
Both options are available. Platinum-cured silicones offer lower extractables and higher purity, while peroxide-cured silicones offer excellent mechanical performance for standard food-processing environments.
What temperature range can FDA 21 CFR 177.2600 silicone withstand?
Operating temperatures range from −80°F to +450°F (−62°C to +232°C), with intermittent heat resistance up to 500°F (260°C).
What applications commonly use FDA 21 CFR 177.2600 silicone?
Common uses include food-processing gaskets, oven seals, sanitary seals, conveyor belting, beverage dispensers, dairy processing, and low-extractable medical device components.
What sizes, durometers, and thicknesses are available?
ElastaPro manufactures FDA-compliant silicones in durometers from 10 to 80 Shore A, widths up to 60 inches, and thicknesses from 0.007 to 0.500 inches.
Does FDA 21 CFR 177.2600 compliance guarantee suitability for medical applications?
No. 21 CFR 177.2600 regulates food contact, not medical biocompatibility. For medical or pharmaceutical applications, materials should also meet USP Class VI, ISO 10993, or European Pharmacopoeia standards.
Can ElastaPro provide documentation for regulatory compliance?
Yes. ElastaPro provides a Declaration of Compliance (DoC) certifying that the silicone formulation meets FDA 21 CFR 177.2600 extractable limits.