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PLATELET CONCENTRATE

      Caution A filter is to be used in the administration set.

 

Category Human blood and blood products.

         Platelet Concentrate contains the platelets taken from plasma obtained by whole blood collection, by plasmapheresis, or by plateletpheresis, from a single suitable human donor of Whole Blood, 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 plateletpheresis 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 6 to 8 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 90 per cent 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 6.2 during the storage period when kept at the selected storage temperature, the selected storage temperature and corresponding volume of resuspension plasma being 30 ml to 50 ml of plasma for storage at 20º to 24º. It meets the aforementioned requirements for platelet count, pH, and actual plasma volume, when tested 5 days after preparation.

Expiration date The expiration date of Platelet Concentrate processed in a closed system is not more than 5 days after the collection of the original whole blood.

         Platelet Concentrate prepared in an open system shall be used within 4 hours of preparation.

Packaging and storage Platelet Concentrate shall be stored in tightly closed, sterile and pyrogen-free, colourless, transparent plastic containers, at the temperature relevant to the volume of resuspension plasma, either between 20º and 24º (a continuous gentle agitation shall be maintained) or between of 2º and 6º, the latter except during shipment, when the temperature may be between 1º and 10º.

Labelling Complies with the “General Information for Biological Products”, p. 177. In addition, the label on the container states (1) the volume of original plasma present; (2) the kind and volume of anticoagulant solution present in the original plasma; (3) the blood group designation of the source blood; (4) the hour of expiration on the stated expiration date; (5) the names of the adventitious agents tested and the results of the tests (6) where labelled for storage at 20º to 24º, that a continuous gentle agitation shall be maintained that such agitation is optional; (7) that it is to be used as soon as possible and not more than 4 hours after entering the container; (8) that a filter is to be used in the administration set.

Sterility Complies with the “Sterility Test” (Appendix 10.1).

 

MONOGRAPHS • PLATELET CONCENTRATE
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หมายเหตุ / Note : TP II 2011 PAGE 192