[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR606.40]

[Page 44]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS--Table of Contents
 
                     Subpart C--Plant and Facilities
 
Sec. 606.40  Facilities.


    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:
    (a) Provide adequate space for the following when applicable:
    (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.
    (3) The storage of blood or blood components pending completion of 
tests.
    (4) The quarantine storage of blood or blood components in a 
designated location pending repetition of those tests that initially 
gave questionable serological results.
    (5) The storage of finished products prior to distribution.
    (6) The quarantine storage, handling and disposition of products and 
reagents not suitable for use.
    (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.
    (9) The orderly conduction of all packaging, labeling and other 
finishing operations.
    (b) Provide adequate lighting, ventilation and screening of open 
windows and doors.
    (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.
    (d) Provide for safe and sanitary disposal for the following:
    (1) Trash and items used during the collection, processing and 
compatibility testing of blood and blood components.
    (2) Blood and blood components not suitable for use or distribution.