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1041
). It contains the platelets taken from plasma obtained by whole blood collection, by plasma pheresis, or by platelet pheresis, from a single suitable human donor of whole blood; or from a plasma pheresis donor; or from a platelet pheresis donor who meets the criteria described in the product license application (in which case the collection procedure is as described therein), except where a licensed physician has determined that the recipient is to be transfused with the platelets from a specific donor (in which case the platelet pheresis procedure is performed under the supervision of a licensed physician who is aware of the health status of the donor and has certified that the donor's health permits such procedure). In all cases, the collection of source material is made by a single, uninterrupted venipuncture with minimal damage to and manipulation of the donor's tissue. Concentrate consists of such platelets suspended in a specified volume of the original plasma, the separation of plasma and resuspension of the platelets being done in a closed system, within 4 hours of collection of the whole blood or plasma. The separation of platelets is by a procedure shown to yield an unclumped product without visible hemolysis, with a content of not less than 5.5 × 1010 platelets per unit in not less than 75 percent of the units tested, and the volume of original plasma used for resuspension of the separated platelets is such that the product has a pH of not less than 6 during the storage period when kept at the selected storage temperature, the selected storage temperature and corresponding volume of resuspension plasma being either 30 mL to 50 mL of plasma for storage at 20
to 24, or 20 mL to 30 mL of plasma for storage at 1 to 6. It meets the aforementioned requirements for platelet count, pH, and actual plasma volume, when tested 72 hours after preparation.161). Preserve at the temperature relevant to the volume of resuspension plasma, either between 20 and 24 or between 1 and 6, the latter except during shipment, when the temperature may be between 1 and 10.
to 24, label it also to state that a continuous gentle agitation shall be maintained, or where labeled for storage at 1 to 6, to state that such agitation is optional. Label it also with the type and result of a serologic test for syphilis, or to indicate that it was nonreactive in such test; with the type and result of a test for hepatitis B surface antigen, or to indicate that it was nonreactive in such test; with a warning that it is to be used as soon as possible but not more than 4 hours after entering the container; to state that a filter is to be used in the administration equipment; and to state that the instruction circular provided is to be consulted for directions for use.
467:
meets the requirements.