The prefilled syringe is composed of a needle tube, a c […]
The prefilled syringe is composed of a needle tube, a cap, a push rod or a piston. Generally speaking, prefilled syringes are mainly sterilized by ethylene oxide sterilization. But there will be residues in ethylene oxide sterilization, so how to detect whether the ethylene oxide residue meets the standard requirements?
The specific method is as follows:
Pre-filled syringe sample preparation: Take this product out of packaging, suck in distilled water of the marked volume (V), and equilibrate at 37°C±1°C for 1 hour.
Preparation of control stock solution: Take a 50ml volumetric flask which is dry outside, add 30ml of water, add a stopper, and weigh to the nearest 0.1mg. Use a syringe to inject 0.6ml of ethylene oxide reference substance (purity greater than 99.7%), shake it gently, then close the stopper, and weigh. The difference between the two weighings is the weight of ethylene oxide. Add water to the mark and dilute this solution to 1g/L as a control stock solution. Dilute it into a solution with an ethylene oxide content of 1 µg/ml as a control solution.
Take 5ml of each of the control solution and the sample and put them in the headspace bottle, and place them at 60°C±1°C for 20 minutes. Inject 1ml of the overhead gas into the gas chromatograph, record the chromatogram, and measure the peak area of the reference substance and the sample. The peak area of the control solution should be greater than the peak area of the sample.
The residual amount of ethylene oxide in the prefilled syringe should be ≤1µg/ml
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