[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: 21CFR640.24] [Page 90] 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 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 donor clinic to the processing laboratory. During such transport, all reasonable methods shall be used to maintain the temperature as close as possible to 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 after the collection of the unit of whole blood or plasma. (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 5.5 x 10 1 0 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]