[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: 21CFR640.24]

[Page 96-97]
 
                        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 C_Platelets
 
Sec. 640.24  Processing.

    (a) Separation of plasma and platelets and resuspension of the 
platelets shall be in a closed system. Platelets shall not be pooled 
during processing.
    (b) Immediately after collection, the whole blood or plasma shall be 
held in storage between 20 and 24 [deg]C unless it must be transported 
from the collection center to the processing laboratory. During such 
transport, all reasonable methods shall be used to maintain the 
temperature as close as possible to

[[Page 97]]

a range between 20 and 24 [deg]C until it arrives at the processing 
laboratory where it shall be held between 20 and 24 [deg]C until the 
platelets are separated. The platelet concentrate shall be separated 
within 4 hours or within the timeframe specified in the directions for 
use for the blood collecting, processing, and storage system.
    (c) The time and speed of centrifugation must have been demonstrated 
to produce an unclumped product, without visible hemolysis, that yields 
a count of not less than 5.5x10\10\ platelets per unit in at least 75 
percent of the units tested.
    (d) The volume of original plasma used for resuspension of the 
platelets shall be determined by the maintenance of a pH of not less 
than 6.0 during the storage period. The pH shall be measured on a sample 
of platelets which has been stored for the maximum dating period at the 
selected storage temperature. One of the following storage temperatures 
shall be used continuously:
    (1) 20 to 24 [deg]C.
    (2) 1 to 6 [deg]C.
    (e) Final containers used for Platelets shall be colorless and 
transparent to permit visual inspection of the contents; any closure 
shall maintain a hermetic seal and prevent contamination of the 
contents. The container material shall not interact with the contents, 
under the customary conditions of storage and use, in such a manner as 
to have an adverse effect upon the safety, purity, potency, or efficacy 
of the product. At the time of filling, the final container shall be 
marked or identified by number so as to relate it to the donor.

[40 FR 4304, Jan. 29, 1975, as amended at 42 FR 10983, Feb. 25, 1977; 47 
FR 49021, Oct. 29, 1982; 50 FR 4139, Jan. 29, 1985; 63 FR 16685, Apr. 6, 
1998; 64 FR 45372, Aug. 19, 1999; 66 FR 1836, Jan. 10, 2001; 66 FR 
40890, Aug. 6, 2001]