FDA 21 CFR 177.2600: Requirements for Repeated Use Rubber Articles in Food.

FDA 21 CFR 177.2600: Compliance for Repeated Use Rubber Articles in Food

Problem Statement

Repeated use rubber articles in food processing face chemical degradation from cleaning agents (e.g., caustic soda) and thermal stress from steam sterilization cycles (up to 120°C). Compression set failure and leaching of harmful compounds are critical concerns.

Material Science Analysis

EPDM rubber excels in this application due to its saturated hydrocarbon backbone. This structure resists oxidation and chemical attack from alkalis and acids. Fluorocarbon elastomers (FKM) fail due to excessive fluorine content, which reacts with caustic agents. Silicone rubber, while thermally stable, exhibits poor compression set resistance under repeated steam cycles.

Technical Specs

• Material: EPDM (Ethylene Propylene Diene Monomer)
• Shore A Hardness: 70 ± 5
• Tensile Strength: 12 MPa
• Elongation at Break: 300%
• Temperature Range: -40°C to 150°C
• Compression Set: 20% (22 hours at 120°C)

Material Comparison

Material	EPDM	FKM	Silicone
Chemical Resistance (Alkali)	Excellent	Poor	Good
Compression Set (%)	20	30	40
Temperature Range (°C)	-40 to 150	-20 to 200	-60 to 200
FDA Compliance	Yes	Yes	Yes

Standard Compliance

RubberQ adheres to IATF 16949 for batch traceability and PPAP documentation. ASTM D2000 ensures material callouts meet FDA 21 CFR 177.2600. ISO 3601 validates sealing performance under repeated use conditions.

CTA

For custom material compound development or IATF 16949 documentation, consult RubberQ's engineering department.