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Fresh Frozen Plasma for Infusion; FFP

Category Human blood and blood products.

         Fresh Frozen Plasma is human plasma that complies with the requirements stated on Individual Plasma Units under Plasma for Fractionation, p. 193, and with the following modifications.

Description When thawed, the preparation may vary in colour from light yellow to green liquid and may be turbid due to the presence of fat.

Warning Fresh Frozen Plasma derived from blood of group O whose sera show the presence of hemolysins should not be transfused to recipients of other groups.

Expiration date When stored under the prescribed condition, the expiration date is not later than 12 months from the date of collection.

Packaging and storage Fresh Frozen Plasma shall be kept in a sterile container, sealed so as to exclude micro-organisms and stored at a temperature not exceeding –18º until required for use, except during any period necessary for transportation providing this period does not exceed 30 minutes. 

Labelling Complies with the “General Information for Biological Products”, p. 177. In addition, the label on the container states (1) the reference number of the donation of the Whole Blood from which the preparation was made; (2) the ABO group and the Rh group of the Whole Blood from which the preparation was made and the specificities of the antisera used in testing; (3) the weight in g of plasma in the container and the nature of the anticoagulant present; (4) that the contents shall not be used if there is any visible evidence of deterioration; (5) that, once thawed, the preparation should be used as soon as possible and, in any case, within 3 hours and that it should not be refrozen; (6) that, whenever possible, Fresh Frozen Plasma derived from ABO compatible blood should be used for transfusion; (7) for preparation obtained from blood of group O, that a test for hemolysins has been carried out and, if a positive result has been obtained, that the blood is safe for transfusion only to recipients belonging to group O; (8) that the transmission of infectious agents cannot be totally excluded when medicinal products prepared from human blood or plasma are administered.

Identification Thaw the preparation at a temperature not exceeding 37º. To 1 ml immediately add 0.2 ml of a 2.5 per cent w/v solution of calcium chloride. Coagulation occurs, which can be accelerated by incubation at 37º.

Hemolysins For Fresh Frozen Plasma derived from blood of group O, carry out the test as described under Blood, Whole, p. 189. Preparations that show the presence of hemolysins should be regarded as safe for transfusion only to recipients belonging to group O.

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