灯检机HGA站位检测的应用与研究  

Application and Research of HGA Station Detection of Visual Inspection Machine

作　　者：王愚腾 杜雨生 周园 Wang Yuteng;Du Yusheng;Zhou Yuan(Lanzhou Institute of Biological Products Co.,Ltd.,Gansu,730046)

机构地区：[1]兰州生物制品研究所有限责任公司,甘肃730046

出　　处：《当代化工研究》2024年第21期134-137,共4页Modern Chemical Research

摘　　要：目的:冻干疫苗在不破坏原有免疫原性的基础上使该致病微生物无致病性,为避免氧气导致冻干疫苗的降解、药物的失活,需对其真空度进行检测。方法:基于朗伯比尔定律,灯检机使用顶空气体分析法(Headspace Gas Analysis,HGA)对冻干疫苗制品真空度逐瓶检测,针对灯检机HGA站位详述了其硬件调试及参数设定的方法。结果:灯检机HGA检测能力主要由其设备硬件和参数控制,同时还受制品慢散性、温度、湿度、内包材和生产工艺的影响。结论:通过灯检机HGA站位的应用,确保了冻干疫苗制品的密封完整性,保证了冻干疫苗制品的质量。Objective:Freezing-dry vaccine make pathogenic microorganisms non pathogenic without destroying their original immunogenicity.To avoid oxygen induced degradation of freeze-dried vaccines and drug inactivation,it is necessary to test their vacuum degree.Methods:Based on Lambert Beer's law,the visual inspection machine uses headspace gas analysis(HGA)to detect the vacuum degree of freeze-dried vaccine products bottle by bottle.This article describes the hardware debugging and parameter setting methods for the HGA station of the lamp inspection machine.Results:The HGA detection capability of the visual inspection machine is mainly controlled by its equipment hardware and parameters,and is also affected by the slow dispersion of the product,temperature,humidity,secondary packaging materials,and production process.Conclusion:The application of the HGA station of the visual inspection machine ensures the sealing integrity of freeze-dried vaccine products and guarantees the quality of freeze-dried vaccine products.

关 键 词：密封完整性检测 顶空气分析法 疫苗质量 

分 类 号：TQ460.5[化学工程—制药化工]