Standard for Ethylene Oxide Residues in Vaccine Bottles

With the gradual advancement of the national compulsory immunization plan, veterinary vaccines have received more attention, and the quality of vaccine bottles used for vaccine packaging has also attracted attention. Relevant standards have been formulated and detailed regulations have been made for the testing items involved in vaccine bottles. , The residual amount of ethylene oxide is one of them.

vaccine bottle

Ethylene oxide residue is a kind of active chemical disinfectant. Because of its strong ability to penetrate deep and good sterilization effect, it is widely used in the sterilization of medicine packaging. However, ethylene oxide itself is a toxic gas, and the sterilized product will have a certain amount of residue. If it cannot be fully volatilized, the residual toxicity will cause harm to animals when it reaches a certain amount. Therefore, vaccine bottles sterilized by ethylene oxide need to be tested for their residual amount to determine the safety of the veterinary packaging.

Regarding the residual amount of ethylene oxide, it is described in detail in the standard T/CVDA 3-2019 "Polypropylene Bottles for Veterinary Liquid Vaccines":

Sample preparation: Take this product out of packaging, 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 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℃±1℃ to equilibrate for 20 minutes. Take 1ml of the headspace gas and inject it 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 should be ≤1µg/ml.

The quality of the vaccine bottle is a direct factor to ensure the effectiveness and safety of the vaccine and to ensure the immune effect of the animal. The residual ethylene oxide is only one of its quality standards. To meet the standard requirements, the manufacturer of the vaccine bottle needs to As the top priority of production, high-standard packaging is used to promote the healthy development of animal husbandry.