Platelet Concentrate
»Platelet Concentrate conforms to the regulations of the federal Food and Drug Administration concerning biologics (640.20to 640.27)(see Biologics á1041ñ).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 4hours 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 5.5×1010platelets per unit in not less than 75percent of the units tested,and the volume of original plasma used for resuspension of the separated platelets is such that the product has a pHof not less than 6during the storage period when kept at the selected storage temperature,the selected storage temperature and corresponding volume of resuspension plasma being either 30mLto 50mLof plasma for storage at 20
to 24,or 20mLto 30mLof plasma for storage at 1to 6.It meets the aforementioned requirements for platelet count,pH,and actual plasma volume,when tested 72hours after preparation.
to 24,or 20mLto 30mLof plasma for storage at 1to 6.It meets the aforementioned requirements for platelet count,pH,and actual plasma volume,when tested 72hours after preparation.
Packaging and storage—
Preserve in hermetic containers of colorless,transparent,sterile,pyrogen-free Type Ior Type IIglass,or of a suitable plastic material (see Transfusion and Infusion Assemblies á161ñ).Preserve at the temperature relevant to the volume of resuspension plasma,either between 20and 24or between 1and 6,the latter except during shipment,when the temperature may be between 1and 10.
and 24or between 1and 6,the latter except during shipment,when the temperature may be between 1and 10.
Expiration time—
The expiration time is not more than 72hours from the time of collection of the source material.
Labeling—
In addition to the labeling requirements of Whole Blood applicable to this product,label it to state the volume of original plasma present,the kind and volume of anticoagulant solution present in the original plasma,the blood group designation of the source blood,and the hour of expiration on the stated expiration date.Where labeled for storage at 20to 24,label it also to state that a continuous gentle agitation shall be maintained,or where labeled for storage at 1to 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 Bsurface 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 4hours 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.
to 24,label it also to state that a continuous gentle agitation shall be maintained,or where labeled for storage at 1to 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 Bsurface 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 4hours 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.
Auxiliary Information—
Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(BBP)Blood and Blood Products
USP28–NF23Page 1570
Phone Number:1-301-816-8339