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21 U.S.C. 351, 352, 360b, 371, 374.
40 FR 14031, Mar. 27, 1975, unless otherwise noted.
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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.