21 CFR 606.40 - Facilities.
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Facilities shall be maintained in a clean and orderly manner, and shall be of suitable size, construction and location to facilitate adequate cleaning, maintenance and proper operations. The facilities shall:
(1) Private and accurate examinations of individuals to determine their suitability as blood donors.
(2) The withdrawal of blood from donors with minimal risk of contamination, or exposure to activities and equipment unrelated to blood collection.
(4) The quarantine storage of blood or blood components in a designated location pending repetition of those tests that initially gave questionable serological results.
(7) The orderly collection, processing, compatibility testing, storage and distribution of blood and blood components to prevent contamination.
(8) The adequate and proper performance of all steps in plasmapheresis, plateletpheresis and leukapheresis procedures.
(c) Provide adequate, clean, and convenient handwashing facilities for personnel, and adequate, clean, and convenient toilet facilities for donors and personnel. Drains shall be of adequate size and, where connected directly to a sewer, shall be equipped with traps to prevent back-siphonage.
(1) Trash and items used during the collection, processing and compatibility testing of blood and blood components.
Title 21 published on 2013-04-01
no entries appear in the Federal Register after this date.