FDA Silicone Sheeting & Uncured Compounds
FDA Silicone in Solid Sheets & Uncured Compound
ElastaPro makes FDA silicone sheeting and uncured compounds for both food and beverage applications and for medical and healthcare applications.
- FDA food grade silicones contain ingredients listed in 21 CFR 177.2600 and are safe for repeated use in contact with food.
- FDA medical grade silicones meet 21 CFR 177.2600 requirements and comply with USP Class VI, ISO 10993, and Ph. Eur. 3.1.9.
All of ElastaPro’s silicones are Made in the USA in accordance with our certified AS9100D and ISO 9001:2015 quality system. We offer a full Certificate of Analysis (COA) with every batch.
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We supply continuous rolls and pre-cut sheets with low minimums and fast lead times.
Request a Quote (RFQ)What is FDA 21 CFR 177.2600?
FDA 21 CFR 177.2600 is a U.S. Food and Drug Administration regulation titled “Rubber articles intended for repeated use.” It establishes comprehensive standards for elastomers (including silicone) used in manufacturing, processing, packaging, and holding equipment.
Rather than targeting finished retail products, the regulation governs the chemical makeup of rubber components by outlining approved lists of base polymers, fillers, curatives, and additives, alongside strict limits on chloroform-soluble extractives to ensure that materials do not leach harmful compounds.
Food and Beverage Applications
In food and beverage applications, this regulation governs sealing surfaces, gaskets, O-rings, valve seats, and fluid-transfer hoses across commercial processing lines, dairy plants, and beverage-dispensing machinery.
Because these components face continuous thermal shifts, food oils, and aggressive clean-in-place (CIP) washdowns, 21 CFR 177.2600 compliance verifies that the rubber will not structurally degrade, harbor bacteria, absorb residues, or alter the taste and safety of consumable goods during repeated service cycles.
Medical and Healthcare Applications
In the medical and healthcare applications, 21 CFR 177.2600 serves as an essential baseline standard for upstream processing and fluid-handling equipment; however, it is formally a food-contact regulation rather than a direct patient-contact biocompatibility standard like USP Class VI or ISO 10993.
Pharmaceutical manufacturing skids, biotech bioreactor seals, peristaltic pump tubing, and cleanroom transfer systems also rely on 177.2600-compliant elastomers to
- guarantee high-purity chemical inertness,
- prevent particulate or chemical contamination of sensitive injectable or ingestible drugs, and
- withstand rigorous repeated steam sterilization.
Important: Compliance with 21 CFR 177.2600 alone does not guarantee suitability or approval for all medical uses. ElastaPro’s medical grade silicones meet 21 CFR 177.2600 requirements, but they also meet USP Class VI, ISO 10993, and Ph. Eur. 3.19.
FDA Silicone Sheeting: Platinum vs. Peroxide Curing
ElastaPro offers two main curing systems for silicone sheeting.
- Platinum curing uses an addition-cure system that leaves zero peroxide byproducts, resulting in higher clarity, ultra-low extractables, and superior biocompatibility.
- Peroxide curing offers strong mechanical properties and cost-effective thermal performance for standard food and beverage sealing.
The table below summarizes the key differences and indicates their suitablity for food and beverage processing or medical and healthcare applications.
| Property or Feature | Platinum Cured | Peroxide Cured |
|---|---|---|
| Advantages | Ultra-low extractables, non-yellowing, maximum clarity | High mechanical strength, cost-effective high-volume production. |
| Operating Temperature | -80F to +450F (Intermittent to +500F) | -80 F to 450 F (Intermittent to +500 F) |
| Extractable Byproducts | None (no peroxide residues or offgassing | Minimal post-cure offgasing |
| Regulatory Compliance | FDA 21 CFR 177.2600 USP Class VI ISO 10993 Ph. Eur. 3.1.9 | FDA 21 CFR 177.2600 |
| Key Applications | Medical fluid handling Peristaltic pumps Pharmaceutical packaging | Food processing gaskets Oven door seals Beverage dispensing lines |
FDA Silicone Uncured Compound: Pre-Catalyzed
In addition to solid silicone sheeting, ElastaPro offers uncured silicone compounds. We provide them off the mill in rolls or slabs with protective poly liners for compression molding and custom profile extrusion.
FDA Approved vs. FDA Compliant
Whether you need FDA silicones for food and beverage or medical and healthcare applications, it’s important to understand the difference between “FDA Approved” and “FDA Compliant”. Some suppliers claim that their materials are FDA approved when this is not actually the case.
ElastaPro’s materials are FDA compliant rather than FDA approved. In part, that’s because the FDA reviews and approves the full finished assembly (such as a medical device) – and ElastaPro is a materials manufacturer rather than a medical device manufacturer.
| 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. |
FDA Silicone Frequently Asked Questions
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.