Food & Pharma Seal Compliance (FDA / USP Class VI)
gioăng cấp thực phẩm / dược phẩm
Also known as: FDA gasket · USP Class VI O-ring · food-grade seal · 3-A Sanitary Standard
Food and pharmaceutical seals must meet FDA 21 CFR 177 (materials in contact with food) and/or USP Class VI (biological testing) — requiring VMQ Silicone, EPDM, or PTFE compounds with certified non-toxic, non-leaching formulations.
Technical Detail
Key compliance frameworks: (1) FDA 21 CFR 177.2600 (rubber articles intended for repeated use with food) — specifies allowed ingredients and extraction limits; VMQ Silicone, EPDM, and PTFE generally comply with correct formulation. (2) USP Class VI — a biological test (implant, systemic injection, intracutaneous) required for pharmaceutical direct-product-contact seals; more stringent than FDA food contact. (3) 3-A Sanitary Standards (USA dairy/food processing) — specify surface finish Ra ≤ 0.8 µm, no crevices, specific elastomer compounds. (4) EU Regulation 1935/2004 (EU food contact materials) — EPDM and VMQ Silicone are listed under Annex I. Approved compounds for Vietnam food/pharma plants: VMQ Silicone 60–70 Shore A (lowest extraction, widest temperature); EPDM 70 Shore A (good for hot water/steam CIP); PTFE-encapsulated O-ring (chemically inert, for aggressive CIP chemicals). NBR and FKM are NOT food-contact approved without specific FDA formulation.
Reference Standards
- FDA 21 CFR 177.2600
- USP Class VI
- 3-A Sanitary Standard 18-03
- EU 1935/2004
Related Terms
- VMQ Silicone (Polydimethylsiloxane Rubber) — VMQ Silicone (polydimethylsiloxane) is a flexible, FDA-compliant elastomer operating from –60°C to +…
- EPDM (Ethylene Propylene Diene Monomer) — EPDM is a synthetic rubber with outstanding resistance to water, steam, ozone, and UV, operating fro…
- PTFE-Encapsulated O-Ring — A PTFE-encapsulated O-ring has a thin PTFE or FEP outer shell (0.2–0.5 mm) over a silicone or FKM co…