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11.4 SETS FOR THE TRANSFUSION OF HUMAN BLOOD AND BLOOD COMPONENTS

11.4 SETS FOR THE TRANSFUSION OF HUMAN BLOOD AND BLOOD COMPONENTS

           Sets for the transfusion of human blood and blood components consist principally of plastic tubing to which are fitted the parts necessary to enable the set to be used for transfusion in the appropriate manner. The sets include a closure-piercing device, a blood filter, a drip chamber, a flow regulator, and a Luer connector. Provision to allow an injection to be made into the transfusion line during use is also usually included. When the sets are to be used with containers requiring an air filter, this may be incorporated in the closurepiercing device or a separate air-inlet device may be used. The chamber enclosing the blood filter, the drip chamber and the main tubing are transparent.

           All parts of the set that may be in contact with blood and blood components are sterile and pyrogen-free. The sets are not to be resterilized or reused. Each set is presented in an individual package that maintains the sterility of the contents.

           Sets for the transfusion of human blood and blood components are manufactured in accordance with the requirements of good manufacturing practice for medical devices. The materials chosen and the design of the set are such as to ensure the absence of hemolytic effects. Carry out the following test on sterilized sets.

           Acidity or alkalinity Make a closed circulation system from three sets and a 300-ml borosilicate-glass vessel. Fit a thermostat device to the vessel so that the temperature of the liquid in the vessel is maintained at 37º±1º. Circulate 250 ml of Sterile Water for Injection through the system in the direction used for transfusion for 2 hours at a rate of 1 litre per hour using for example a peristaltic pump applied to a piece of suitable silicone tubing as short as possible. Collect the whole of the solution and allow to cool (solution A). To 25.0 ml of solution A add 0.15 ml of a solution containing 0.1 per cent w/v of bromothymol blue, 0.02 per cent w/v of methyl red and 0.2 per cent w/v of phenolphthalein in ethanol. Not more than 0.5 ml of 0.01 M sodium hydroxide VS is required to change the colour of the solution to blue. To a further 25.0 ml of solution A add 0.2 ml of methyl orange TS. Not more than 0.5 ml of 0.01 M hydrochloric acid VS is required to begin the change in colour of the indicator.

           Clarity and colour of solution Solution A is clear (Appendix 4.1) and colourless (Appendix 4.2).

           Flow rate Using a complete set with the flow regulator fully open, pass 50 ml of a solution having a viscosity of 3 mPa.s (a 3.3 per cent w/v solution of polyethylene glycol 4000 at 20º is suitable) under a static head of 1 m. The time taken for the passage of the solution is not more than 90 seconds.

           Light absorption The absorbance of solution A is not more than 0.30 at any wavelength in the range 230 to 250 nm and not more than 0.15 at any wavelength in the range 251 to 360 nm (Appendix 2.2).

           Resistance to pressure Make tight the extremities of the set and any air-inlet device. Connect the set to a compressed air outlet fitted with a pressure regulator. Immerse the set in a tank of water at 20º to 23º. Apply progressively an excess pressure of 100 kPa (750 Torr) and maintain for 1 minute. No air bubble escapes from the set.

           Transparency Prepare an eightfold dilution of the suspension prepared for Standard of opalescence (Method I, Appendix 4.1) for sets having tubing with an external diameter of less than 5 mm and a 16-fold dilution of the suspension for sets having tubing with an external diameter equal to or greater than 5 mm. The opalescence and presence of bubbles of the diluted suspension are discernible when it is circulated through the set, as compared with a set from the same batch filled with water.

           Ethylene oxide Not more than 10 ppm if the label states that ethylene oxide has been used for sterilization, using the following method. Carry out the determination as described in the “Gas Chromatography” (Appendix 3.4) using the following gaseous solutions. For solution A, remove the set from the packaging and weigh. Cut the set into pieces with a maximum dimension of 1 cm and place the pieces in a 250- to 500-ml vial containing 150 ml of dimethylacetamide. Close the vial with a suitable stopper and secure the stopper. Place the vial in an oven at 70º±1º for 16 hours. Remove 1 ml of the hot gas from the vial and inject it onto the column. Prepare solution B under a ventilated hood as follows. Place 50 ml of dimethylacetamide in a 50-ml vial, stopper, secure the stopper, and weigh to the nearest 0.1 mg. Fill a 50-ml polyethylene or polypropylene syringe with gaseous ethylene oxide, and allow the gas to remain in contact with the syringe for about 3 minutes, empty the syringe, and fill again with 50 ml of gaseous ethylene oxide. Fit a hypodermic needle to the syringe and reduce the volume of gas in the syringe from 50 ml to 25 ml. Inject the remaining 25 ml of gas slowly into the vial, shaking gently and avoiding contact between the needle and the dimethylacetamide. Weigh the vial again. The increase in weight is 45 to 60 mg. Using this increase in weight calculate the exact concentration of the solution (about 1 g per litre).

           Prepare a calibration curve using a series of seven vials of the same type as that used in the preparation of solution A, each containing 150 ml of dimethylacetamide. Introduce respectively 0, 0.05, 0.10, 0.20, 0.50, 1.00, and 2.00 ml of solution B, that is, about 0, 50, 100, 200, 500, 1000, and 2000 μg of ethylene oxide. Stopper the vials, secure the stoppers and place the vials in an oven at 70º±1º for 16 hours. Inject 1 ml of the hot gas from each vial onto the column and prepare a calibration curve from the heights of the peaks and the weight of ethylene oxide in each flask.

           The chromatographic procedure may be carried out using (a) a stainless steel column (1.5 m × 6.4 mm) packed with silanized diatomaceous support coated with 30 per cent w/w of polyethylene glycol 1500 and maintained at 40º; (b) helium as the carrier gas with a flow rate of 20 ml per minute and (c) an inlet port temperature of 100º and a detector temperature of 150º. Verify the absence of peaks interfering with the ethylene oxide peak by carrying out the test using an unsterilized set or using the chromatographic procedure prescribed above but using a column such as a stainless steel column (3 m × 3.2 mm) packed with silanized diatomaceous support coated with 20 per cent w/w of triscyanoethoxypropane and maintained at 60º.

           Calculate the weight of ethylene oxide in the vial used in the preparation of solution A from the calibration curve prepared as described above and from the height of the peak obtained in the chromatogram obtained with solution A.

           Extraneous particles Using the normal inlet, fill the set with a 0.01 per cent w/v solution of sodium dodecyl sulfate previously filtered through a sintered-glass filter (pore size 10 to 16 μm) and heated to 37º. Collect the liquid through the normal outlet. When examined under suitable conditions of visibility, the liquid is clear and practically free from visible particles and filaments. (It is assumed that particles and filaments with a diameter equal to or greater than 50 μm are visible to the naked eye.)

           Reducing substances Carry out the test within 4 hours of preparing solution A. To 20.0 ml of solution A, add 1 ml of 1 M sulfuric acid and 20.0 ml of 0.002 M potassium permanganate VS and boil for 3 minutes. Cool immediately, add 1 g of potassium iodide and titrate with 0.01 M sodium thiosulfate VS using 0.25 ml of starch TS as indicator. Repeat the operation using 20 ml of Sterile Water for Injection. The difference between the titration volumes is not more than 2.0 ml.

           Residue on evaporation Evaporate 50.0 ml of solution A to dryness on a water-bath and dry to constant weight at 100º to 105º. Repeat the operation using 50.0 ml of Sterile Water for Injection. The difference between the weights of the residues is not more than 1.5 mg.

           Sterility Comply with the “Sterility Test” (Appendix 10.1) with the following modifications.

            If the sets are stated to be sterile internally only, pass 50 ml of buffered sodium chloride-peptone solution pH 7.0 through the set and use to carry out the test by Method I: Membrane filtration.

            If the sets are stated to be sterile both internally and externally, open the packaging using aseptic precautions. When carrying out the test by Method I: Membrane filtration, place the set or its components in a suitable container containing a sufficient quantity of buffered sodium chloride-peptone solution pH 7.0 to allow total rinsing for 10 minutes. When carrying out the test by Method II: Direct inoculation, place the set or its components in a suitable container containing a sufficient quantity of the culture medium to ensure complete immersion.

            Pyrogens Connect together five sets and pass through the assembly 250 ml of pyrogen-free sodium chloride TS with a flow rate not exceeding 10 ml per minute. Collect the solution aseptically in a pyrogenfree container. The solution complies with the “Pyrogen Test” (Appendix 8.2), using 10 ml of the solution per kg of the rabbit’s weight.

            Labelling The label states, where appropriate, that the set has been sterilized using ethylene oxide. 

APPENDICES • 11.4 SETS FOR THE TRANSFUSION OF HUMAN BLOOD AND BLOOD COMPONENTS
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หมายเหตุ / Note : TP II 2011 PAGE 656-658