[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR226.30]

[Page 145]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 226--CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES--Table of Contents
 
   Subpart B--Construction and Maintenance of Facilities and Equipment
 
Sec. 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.