§ 213.42 Design and construction features.

(a)(1) Any buildings and facilities used in the manufacture, processing, packing, or holding of a medical gas shall be of adequate design, including having adequate space, for the orderly placement of equipment and materials to prevent mix-ups between: (i) Components; (ii) Incoming designated medical gases; (iii) Medical gas containers and closures; (iv) Labeling; (v) In-process materials; or (vi) Medical gases. (2) Such buildings and facilities shall also allow for adequate cleaning, maintenance, and proper operations. (b)(1) Operations shall be performed within specifically defined areas of adequate size. There shall be separate or defined areas or such other control systems for the firm's operations as are necessary to prevent contamination or mix-ups during the course of the following procedures: (i) Receipt, identification, storage, and withholding from use of components, incoming designated medical gases, medical gas containers and closures, and labeling, pending the appropriate sampling, testing, or examination by the quality unit before release for manufacturing or packaging; (ii) Holding rejected components, incoming designated medical gases, medical gas containers and closures, and labeling before disposition; (iii) Storage of released components, incoming designated medical gases, medical gas containers and closures, and labeling; (iv) Storage of in-process materials; (v) Manufacturing and processing operations; (vi) Packaging and labeling operations; (vii) Quarantine storage before release of medical gases; (viii) Storage of medical gases after release; and (ix) Control and laboratory operations. (2) The flow of components, incoming designated medical gases, medical gas containers and closures, labeling, in-process materials, and medical gases through the buildings and facilities shall be designed to prevent contamination and mix-ups. (c) Any building or facility used in the manufacture, processing, packing, or holding of a medical gas shall be maintained in a clean condition so as to assure the safety, identity, strength, quality, and purity of the medical gas. Written procedures applicable to the maintenance and cleaning of buildings and facilities shall be established and followed.