Inspection Procedures for Disposable Syringes for Drug Dispensing
4. Capacity tolerance
4.1 Use an electronic balance with an accuracy of 0.1mg to weigh the empty glass, absorb 20 ± 5 ℃ distilled water to the scale capacity (V0, select any point between the range of more than or less than half of the nominal capacity), discharge bubbles, and ensure that the half moon shaped water surface of the water is flush with the end of the cone head cavity. At the same time, the edge of the reference line is tangent to the lower edge of the graduation line, and then discharge all the water.
4.2 Weigh the glass again, and the difference between the two is the actual capacity.
4.3 When equal to or greater than half of the nominal capacity
Calculation formula=
4.4 When less than half of the nominal capacity
Calculation formula=V0-V1
4.5 The calculation results shall comply with Table 1.
5. Residual capacity
Use an electronic balance with an accuracy of 0.1 mg to weigh the empty dispenser, draw 20 ℃± 5 ℃ distilled water to the nominal volume scale line, discharge bubbles and ensure that the half moon shaped water surface of the water is flush with the end of the cone head cavity, then discharge all the water to make the reference line coincide with the zero line, wipe the outer surface of the dispenser dry, and weigh the dispenser again. The difference between the two is the residual amount, and the result should conform to the provisions in Table 1.
6. Dispensing needle
a. The smoothness of side hole needle tube
Under the water pressure of no more than 100Kpa, the flow shall not be less than 80% of the flow under the same conditions of needle tubes with the same outer diameter and the minimum inner diameter specified in the length GB18457
b. Particulate pollution
Take 5 disposable drug needles to prepare the eluent. Under the static pressure of 1m, make the eluent flow through 100ml of each of the 5 disposable drug needles respectively. Collect 500ml eluent in total, and take 500ml of the other as the blank control solution. The pollution index of side hole needle shall not exceed 90
c. Piercing debris
Put 25 stoppers of injection bottles on 25 injection bottles containing half of the filtered water, and seal the bottles with a capper. Each bottle stopper shall be punctured for four times at different positions in the puncture area with medicine. After the fourth puncture, the debris in the channel shall be discharged into the injection bottle with a flushing method or a patenting device. After 100 punctures, the cap or plug of the injection bottle shall be opened so that the liquid contained in each bottle flows through a filter membrane. Observe the falling chips on the film at a distance of 25cm from the film. The number of falling chips generated every 100 times shall not exceed 3.
Post time: Sep-30-2022
