May. 12, 2021
Ethylene oxide has a very strong sterilization ability and is suitable for the sterilization of many products. This sterilization method is generally used in plastic veterinary packaging. However, there will be a certain amount of ethylene oxide residue during the sterilization process, and the excessive amount of residue will affect animal health. Therefore, the detection of ethylene oxide residue for veterinary syringe has become a necessary inspection item.
Regarding the limit of the residual amount of ethylene oxide in veterinary syringes, the specifications of each country are different. Some countries choose the limit specification of mg/device, and some countries choose the limit specification of ppm (μg/g). Most of Europe and America The country’s prevailing norm is the ISO norm. In China, the regulations on the residual amount of ethylene oxide in syringes refer to the standard of T/CVDA 1-2019 "Pre-filled Plastic Breast Injector for Veterinary Use". The specific detection methods are as follows:
Sample preparation: Take this product out of the package, suck in distilled water with 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 externally dry, 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, cover the bottle 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 place them in the top empty bottle, and place them at 60°C±1°C for 20 minutes to equilibrate. 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 syringe should be ≤1µg/ml.
Veterinary drug packaging plays a protective role for drugs and is also the basis for the healthy development of animal husbandry. The detection of residues on ethylene oxide sterilized packages such as veterinary syringe is an effective measure to ensure that the packages are qualified and improve the therapeutic effect of drugs.