---
kind: "section"
citation: "21 C.F.R. § 226.30"
title: "21"
number: "226.30"
heading: "Equipment."
url: "https://uscodex.org/cfr/21/226.30"
---

# §226.30. Equipment.


Equipment used for the manufacture, processing, packaging, bulk shipment, labeling, holding, or control of Type A medicated article(s) or their components shall be maintained in a clean and orderly manner and shall be of suitable design, size, construction, and location to facilitate maintenance and operation for its intended purpose. The equipment shall:

- (a) Be so constructed that any surfaces that come into contact with Type A medicated article(s) are suitable, in that they are not reactive, additive, or absorptive to an extent that significantly affects the identity, strength, quality, or purity of the Type A medicated article(s) or its components.
- (b) Be so constructed that any substance required for the operation of the equipment, such as lubricants, coolants, etc., may be employed without hazard of becoming an unsafe additive to the Type A medicated article(s).
- (c) Be constructed to facilitate adjustment, cleaning, and maintenance, and to assure uniformity of production and reliability of control procedures and to assure the exclusion from Type A medicated article(s) of contamination, including cross-contamination from manufacturing operations.
- (d) Be suitably grounded electrically to prevent lack of uniform mixing due to electrically charged particles.
- (e) **Be of suitable size and accuracy for use in any intended measuring, mixing, or weighing operations.**

## Notes

### Authority

Authority: 21 U.S.C. 351, 352, 360b, 371, 374.

### Source

Source: 40 FR 14031, Mar. 27, 1975, unless otherwise noted.