21 CFR § 213.65 - Equipment construction.
---
identifier: "/us/cfr/t21/s213.65"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 213.65 - Equipment construction."
title_number: 21
title_name: "Food and Drugs"
section_number: "213.65"
section_name: "Equipment construction."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "213"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360b, 360ddd, 360ddd-1, 371, 374."
regulatory_source: "89 FR 51770, June 18, 2024, unless otherwise noted."
cfr_part: "213"
---
# 213.65 Equipment construction.
(a) Equipment shall be constructed so that surfaces that contact components, in-process materials, or medical gases shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the medical gas beyond the official or other established requirements.
(b) Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, containers, closures, in-process materials, or medical gases so as to alter the safety, identity, strength, quality, or purity of the medical gas beyond the official or other established requirements.