Detection scheme for residual ethylene oxide in medical surgical masks

Background of the plan

In 2020, novel coronavirus pneumonia broke out in China. For a while, the whole country worked together to fight against the epidemic. At this time, masks became the D line of defense for us to fight against the epidemic, and masks in all parts of the country fell into a temporary shortage. While all mask manufacturers worked overtime to manufacture masks, what they needed to do was not only to meet the requirements in production quantity, but also to provide quality assurance. Therefore, the determination of ethylene oxide residue in masks was particularly important.

Scheme Introduction

Ethylene oxide (EO) is a broad-spectrum low-temperature sterilizer that can kill various microorganisms, including spores, tuberculosis bacteria, bacteria, viruses, fungi, etc., at room temperature. Simultaneously EOIt has strong penetrability and can penetrate micropores to the corresponding depth inside the product, greatly improving the sterilization effect. Currently, most sterile medical device manufacturers commonly use ethylene oxide sterilization. However, while killing microorganisms, the residual ethylene oxide in medical devices can cause a certain degree of harm to the user's body. Through animal experimentsThis indicates that ethylene oxide not only has acute toxicity, but also has allergenic, mutagenic, and carcinogenic effects.

According to GB/T 16886.7-2015 "Biological evaluation of medical devices - Part 7: Residual ethylene oxide sterilization" and GB/T 14233.1-2008 "Methods for inspection of medical infusion, transfusion, and injection equipment - Part 1: Chemical analysis methods",YY 0469-2011 Medical Surgical MasksThe method for detecting residual ethylene oxide in medical masks has been specified. Referring to the above standards, our company uses an automatic headspace sampler in combination with a GC-2020 gas chromatograph to conduct experiments on residual ethylene oxide, providing a comprehensive, efficient, and accurate solution.