[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: 21CFR640.69]

[Page 110]
 
                        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 G_Source Plasma
 
Sec. 640.69  General requirements.

    (a) Pooling. Two units of Source Plasma from the same donor may be 
pooled if such units are collected during one plasmapheresis procedure: 
Provided, That the pooling is done by a procedure that does not 
introduce a risk of contamination of the red blood cells and, for plasma 
intended for injectable products, gives maximum assurance of a sterile 
container of plasma.
    (1) The pooling of plasma from two or more donors is not permitted 
in the manufacture of Source Plasma intended for manufacturing into 
injectable products.
    (2) The pooling of plasma from two or more donors by the 
manufacturer of Source Plasma intended for manufacturing into 
noninjectable products is permitted: Provided, That the plasma from two 
or more donors is pooled after the plasma has been removed from the red 
blood cells, and after the red blood cell containers are sealed.
    (b) Storage. Immediately after filling, plasma intended for 
manufacturing into injectable products shall be stored at a temperature 
not warmer than -20 [deg]C, except for plasma collected as provided in 
Sec. 640.74. Plasma intended for manufacturing into noninjectable 
products may be stored at temperatures appropriate for the intended use 
of the final product, provided these temperatures are included in the 
Source Plasma license application.
    (c) Inspection. Source Plasma intended for manufacturing into 
injectable products shall be inspected for evidence of thawing at the 
time of issuance, except that inspection of individual plasma containers 
need not be made if the records of continuous monitoring of the storage 
temperature establish that the temperature remained at -20 [deg]C or 
colder. If there is evidence that the storage temperature has not been 
maintained at -20 [deg]C or colder, the plasma may be relabeled and 
issued as provided in Sec. 640.76(a).
    (d) Samples. If samples are provided, they shall meet the following 
standards:
    (1) Prior to filling, all samples shall be marked or identified so 
as to relate them directly to the donor of that unit of plasma.
    (2) All samples shall be filled at the time the final product is 
prepared by the person who prepares the final product.
    (3) All samples shall be representative of the contents of the final 
product or be collected from the donor at the time of filling the 
collection container.
    (4) All samples shall be collected in a manner that does not 
contaminate the contents of the final container.

[38 FR 32089, Nov. 20, 1973, as amended at 41 FR 10769, Mar. 12, 1976; 
41 FR 14367, Apr. 5, 1976; 50 FR 4140, Jan. 29, 1985; 63 FR 16685, Apr. 
6, 1998; 64 FR 45374, Aug. 19, 1999]