Syringe assembly machine and the medical perfusion devi […]
Syringe assembly machine and the medical perfusion device assembly is composed of a needle tube, a tube cap, a push rod or a piston, and each plastic component is produced by an injection molding process. The infuser is generally sterilized with ethylene oxide. Ethylene oxide will produce residue after sterilization. The residual amount of ethylene oxide should be ≤1µg / ml before the product can be used.
Method for detecting the residual amount of ethylene oxide in the infuser: sample preparation: remove the packaging from this product, inhale the distilled water of the indicated volume (V), and equilibrate for 1 hour at 37 ℃ ± 1 ℃
Control stock solution preparation: Take a 50ml volumetric flask dried externally, add 30ml of water, add a stopper, and weigh to the nearest 0.1mg. Inject 0.6ml of ethylene oxide reference substance (purity greater than 99.7%) with a syringe, shake gently, then cap the stopper, weigh, and the difference between the two weights is the weight of ethylene oxide. Add water to the mark and dilute this solution to 1 g / L as a control stock solution. The solution diluted to 1µg / ml of ethylene oxide was used as a control solution.
Take 5ml each of the control solution and the sample and place it in a headspace vial, and put them under the conditions of 60 ℃ ± 1 ℃ and equilibrate for 20 minutes. Separately, take 1ml of liquid above the liquid and inject it into the meteorological chromatograph, record the chromatogram, and measure the peak areas of the reference substance and the sample. The peak area of the control solution should be greater than the peak area of the sample.
