21 C.F.R. § 640.64 Collection of blood for Source Plasma.
Title 21 - Food and Drugs
Title 21: Food and Drugs
PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
Subpart G—Source Plasma
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§ 640.64 Collection of blood for Source Plasma.
(a) Supervision. All blood for the collection of Source Plasma shall be drawn from the donor by a qualified licensed physician or by persons under his supervision trained in the procedure.
(b) Blood containers. Blood containers and donor sets shall be pyrogen-free, sterile and identified by lot number. The amount of anticoagulant required for the quantity of blood to be collected shall be in the blood container when it is sterilized.
(c) The anticoagulant solution. The anticoagulant solution shall be sterile and pyrogen-free. One of the following formulas shall be used in the indicated volumes, except that a different formula may be used for plasma for manufacture into noninjectable products if prior written approval is obtained from the Director of the Center for Biologics Evaluation and Research at the time of licensing or in the form of a supplement to the biologics license application for Source Plasma.
(1) Anticoagulant citrate dextrose solution (ACD).
Tri-sodium 22.0 grams. citrate (Na3C6H5O7&mid dot;2H2O)Citric acid 8.0 grams. (C6H8O7· ;H2O)Dextrose 24.5 grams. (C6H12O6H2O)Water for 1,000 milliliters. injection (U.S.P.) to makeVolume per 100 15 milliliters. milliliters blood
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(2) Anticoagulant citrate phosphate dextrose solution (CPD).
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Tri-sodium 26.3 grams. citrate (Na3C6H5O7·2H2O) Citric acid 3.27 grams. (C6H8O7·H2O) Dextrose 25.5 grams. (C6H12O6H2O)Monobasic 2.22 grams. sodium phosphate (NaH2PO4·H2O) Water for 1,000 milliliters. injection (U.S.P.) to makeVolume per 100 14 milliliters. milliliters blood
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(3) Anticoagulant sodium citrate solution.
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Tri-sodium 40 grams. citrate (Na3C6H5O7·2H2O) Water for 1,000 milliliters. injection (U.S.P.) to makeVolume per 100 10 milliliters. milliliters of blood
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(d) Donor identification. Each unit of blood and plasma shall be so marked or identified by number or other symbol so as to relate it directly to the donor.
(e) Prevention of contamination of the blood and plasma. The skin of the donor at the site of phlebotomy shall be prepared thoroughly and carefully by a method that gives maximum assurance of a sterile container of blood. The blood shall be collected, the plasma separated, and the cells returned to the donor by aseptic methods in a sterile system which may be closed, or may be vented if the vent protects the blood cells and plasma against contamination.
[38 FR 32089, Nov. 20, 1973; 39 FR 13632, Apr. 16, 1974, as amended at 41 FR 10768, Mar. 12, 1976; 49 FR 23834, June 8, 1984; 50 FR 4140, Jan. 29, 1985; 55 FR 11013, Mar. 26, 1990; 59 FR 49351, Sept. 28, 1994; 63 FR 16685, Apr. 6, 1998; 64 FR 56453, Oct. 20, 1999]
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