[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.16]

[Page 95]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, 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 the timeframe specified in the directions for 
use for the blood collecting, processing, and storage system used, 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 cells except 
when a cryoprotective substance or additive solution 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 
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; 66 FR 40890, Aug. 6, 2001]