Disposable Syringes – Appendix 2

Disposable Syringes - Appendix II

1. Bacterial endotoxin test:

1.1 Test preparation:

The vessels used in the test need to be treated. The common method is to dry bake at 180 ℃ for 2 hours. Microbial contamination shall be prevented during test operation.

Water for bacterial endotoxin test refers to sterilized water for injection that does not produce condensation reaction with LAL reagent with sensitivity of 0.03EU/ml or higher under 37 ℃± 1 ℃ for 24 hours.

1.2 Test method:

Take 8 original ampoules of 0.1 ml/piece of lysate lysate, 2 of which are added with 0.1 ml of test solution as the test tube, and 2 of which are added with 0.1 ml of 2.0 made of the working standard of bacterial endotoxin with water for bacterial endotoxin test λ The concentration of endotoxin solution is used as the positive control tube. Add 0.1ml of bacterial endotoxin test water to 2 tubes as the negative control tube. Add 0.1ml of test article positive control solution to 2 tubes λ Concentration of endotoxin solution] as the positive control tube of the test article. Gently mix the solution in the test tube, close the nozzle, vertically put it into a 37 ℃± 1 ℃ water bath box, and gently take it out after 60 ± 2min of heat preservation. Avoid false positive results caused by vibration during heat preservation and tube taking.

Result judgment:

Gently take out the test tube and slowly turn it upside down for 1800. If the gel in the tube is not deformed and does not slip from the tube wall, it is a positive result and recorded as (+); If the gel cannot be kept intact and slips from the tube wall, the negative result is recorded as (-).