[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: 21CFR640.16]

[Page 88-89]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS--Table of Contents
 
                       Subpart B--Red Blood Cells
 
Sec. 640.16   Processing.

    (a) Separation. Within 21 days from date of blood collection (within 
35 days from date of blood collection when CPDA-1 solution is used as 
the anticoagulant), Red Blood Cells may be prepared either by 
centrifugation done in a manner that will not tend to increase the 
temperature of the blood or by normal undisturbed sedimentation. A 
portion of the plasma sufficient to insure optimal cell preservation 
shall be left with the red blood cells except when a cryoprotective 
substance is added for prolonged storage.
    (b) Sterile system. All surfaces that come in contact with the red 
cells shall be sterile and pyrogen-free.
    (c) Final containers. Final containers used for Red Blood Cells 
shall be the original blood containers unless the method of processing 
requires a different container. The final container shall meet the 
requirements for blood containers prescribed in Sec. 640.2(c). At the 
time of filing, if a different container is used, it shall be marked or

[[Page 89]]

identified by number or other symbol so as to relate it to the donor of 
that unit of red cells.

[38 FR 32089, Nov. 20, 1973, as amended at 43 FR 34460, Aug. 4, 1978; 50 
FR 4139, Jan. 29, 1985; 64 FR 45372, Aug. 19, 1999; 66 FR 1836, Jan. 10, 
2001]