[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: 21CFR640.54]

[Page 93-94]
 
                        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 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 frozen solid within 6 hours after blood 
collection. 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.

[[Page 94]]

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]