隧道式烘箱灭菌效果影响因素的考察与风险分析  

Investigation of Influencing Factors and Risk Analysis of Sterilization Effect in Tunnel Oven

作　　者：黎阳 姚辉 窦金丽 许航 LI Yang;YAO Hui;DOU Jinli;XU Hang(Tianjin Academy of Drug Inspection,Tianjin 300070)

机构地区：[1]天津市药品检验研究院,天津300070

出　　处：《中国医药工业杂志》2024年第9期1271-1276,1294,共7页Chinese Journal of Pharmaceuticals

摘　　要：为了全面考察影响隧道式烘箱灭菌效果的因素、加强风险识别,该文分别从微生物、温度分布、气流、水分残留、压差梯度变化等方面进行了研究。结果表明,在隧道式烘箱的冷却段以人工擦拭方式消毒,仍能检出微生物;灭菌段长时间的高温环境会造成悬浮粒子数量增多、西林瓶内应力增大,增大碎瓶和污染风险;洗瓶间的气流变化会对设备的压差平衡带来波动;西林瓶中的水分残留量增大及其上方的挡板高度增加,都会使杀菌热力强度(F_(H))值下降;布置多排探头进行温度验证更能充分地识别出灭菌冷点。在实际生产中,建议在隧道式烘箱的冷却段增加灭菌功能、避免西林瓶在灭菌段长时间停滞、维持洗瓶间气流相对稳定、检查洗瓶机吹气孔的通畅性并保证其排风能力、根据生产中的西林瓶高度选择合适的挡板高度且布置多排探头进行温度验证,以最大程度排除风险隐患,保障药品安全。In order to comprehensively investigate the factors affecting the sterilization effect of the tunnel oven and strengthen the risk identification,this paper studied from the aspects of the microorganisms,temperature distribution,air flow,moisture residue,pressure gradient change,etc.The results showed that the microorganisms could still be detected in the cooling section of the tunnel oven by manual wiping.The high temperature environment in the sterilization section for a long time would increase the number of suspended particles,increase the stress in the bottle,and increase the risk of broken bottle and pollution.The change of air flow between washing bottles would bring fluctuations to the pressure difference balance of the equipment.The increases of residual moisture in the bottle and the height of the baffle above the bottle would decrease the value of the bactericidal thermal strength(F_(H)).Placing multiple rows of probes for temperature verification could more fully identify sterilization cold points.In order to eliminate the risks and hidden dangers to the maximum extent to ensure drug safety,in actual production,it was recommended to increase the sterilization function in the cooling section of the tunnel oven,avoid the long-term stagnation of the bottle in the sterilization section,maintain the relatively stable air flow between the bottle washing room,check the smooth blowhole of the bottle washing machine and ensure its exhaust capacity,select the appropriate baffle height according to the height of the bottle in production,and arrange multiple rows of probes for temperature verification.

关 键 词：隧道式烘箱 无菌药品 药品安全 灭菌效果 风险分析 

分 类 号：TQ460.82[化学工程—制药化工]