[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.54]

[Page 105]
 
                        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 
 
                        Subpart F_Cryoprecipitate
 
Sec. 640.54  Processing.

    (a) Processing the plasma. (1) The plasma shall be separated from 
the red blood cells by centrifugation to obtain essentially cell-free 
plasma.
    (2) The plasma shall be placed in a freezer within 8 hours after 
blood collection or within the timeframe specified in the directions for 
use for the blood collecting, processing, and storage system. A 
combination of dry ice and organic solvent may be used for freezing: 
Provided, That the procedure has been shown not to cause the solvent to 
penetrate the container or leach plasticizer from the container into the 
plasma.
    (3) Immediately after separation and freezing of the plasma, the 
plasma shall be stored and maintained at -18 [deg]C or colder until 
thawing of the plasma for further processing to remove the 
Cryoprecipitated AHF.
    (b) Processing the final product. (1) The Cryoprecipitated AHF shall 
be separated from the plasma by a procedure that has been shown to 
produce an average of no less than 80 units of antihemophilic factor per 
final container.
    (2) No diluent shall be added to the product by the manufacturer 
prior to freezing.
    (3) The final container used for Cryoprecipitated AHF 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 customary conditions of storage and use in such a manner 
as to have an adverse effect upon the safety, purity, potency and 
effectiveness of the product. At the time of filling, the final 
container shall be identified by a number so as to relate it to the 
donor.

[42 FR 21774, Apr. 29, 1977, as amended at 47 FR 15330, Apr. 9, 1982; 50 
FR 4139, Jan. 29, 1985; 64 FR 45373, Aug. 19, 1999; 66 FR 1837, Jan. 10, 
2001; 66 FR 40890, Aug. 6, 2001]