Art. 2 Protocol bij de Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong, zoals gewijzigd

Dried Human Plasma is prepared by drying the supernatant fluids which are separated by centrifuging or by sedimentation from quantities of Whole Human Blood. During preparation no antiseptic or bacteriostatic or other substance shall be added. Dried Human Plasma shall be obtained by freeze-drying or by any other method which will avoid denaturation of proteins. The dried product shall be readily soluble in a quantity of water equal to the volume of the liquid from which the substance was prepared. The protein concentration of the solution thus obtained must not be less than 45 gram per litre, and must not show visible evidence of the products of haemolysis. The haemaglutinin titre shall not be greater than 1:32. Donations shown to contain dangerous levels of iso-haemolysins (determined using a sample of fresh serum) or any immune haemaglutinins shall be excluded. Unless the plasma is pooled and frozen within 48 hours of collecting the blood, the sterility of each unit shall be tested by culturing not less than 10 ml. Pools shown to contain dangerous levels of immune haemaglutinins or of iso-haemolysins shall be excluded. To avoid untoward effects due to the products of bacterial growth in the plasma no individual donation shall be used if there is any evidence of bacterial contamination, and the sterility of each pool shall be tested by culturing not less than 10 ml. To minimize the risk of transmitting serum hepatitis, plasma should be prepared from pools which should contain not more than twelve donations, or by any other method that has been shown to diminish the risk in comparable manner. Solubility in water - Add a quantity of water equal to the volume of the liquid from which the sample was prepared; the substance dissolves completely within 10 minutes at 15° to 20° C. Identification - Dissolve a known quantity of the product in a volume of water equal to the volume of the liquid from which it was prepared; the solution passes the following tests: by precipitation tests with specific antisera, it must be shown to contain only human plasma proteins; to 1 ml add a suitable amount of thrombin or calcium chloride; coagulation occurs, which can be accelerated by incubation at 37° C. Loss of mass on drying - When dried over phosphorus pentoxide at a pressure not exceeding 0.02 mm of mercury for 24 hours, Dried Human Plasma must not lose more than 0.5% of its weight. Sterility - The final product, after reconstitution, shall be sterile when examined by a suitable bacteriological method. Storage - Dried Human Plasma must be kept in an atmosphere of nitrogen or in a vacuum in a sterile container sealed so as to exclude micro-organisms and, as far as possible, moisture, protected from light and stored at a temperature below 20° C. Labelling - The label on the container shall give all the information shown on the model label (Annex 3).

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