CFR — Code of Federal Regulations Title 21 Part 211 Subpart D — Equipment § 211.65 — Equipment construction.

[Code of Federal Regulations]
[Title 21, Volume 4]
[CITE: 21CFR211.65]

TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C – DRUGS: GENERAL
PART 211 — CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart D – Equipment

Sec. 211.65 Equipment construction.
(a) Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product 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, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

As per US Health & Human Services, the information on this page is current as of Mar. 22, 2024.