KSZ620/43B型隧道烘箱在血液制品生产工艺中的应用

Application of KSZ620/43B tunnel oven in production process of blood products

目的:对KSZ620/43B型隧道烘箱进行确认、试运行试验,以验证其是否满足血液制品生产工艺要求。方法:按照《药品生产质量管理规范(2010年修订)》的要求,对KSZ620/43B型隧道烘箱进行设计确认、安装确认、运行确认和性能确认(包括热分布、热穿透和细菌内毒素挑战试验),并通过培养基模拟灌装试验和不同生产规模下的运行情况判定KSZ620/43B型隧道烘箱对中硼硅玻璃输液瓶的干热灭菌效果。结果:KSZ620/43B型隧道烘箱的设计确认、安装确认、运行确认和性能确认均符合要求。连续3批培养基模拟灌装试验的结果均为零污染,3种规模下生产的血液制品无菌检查和热原检查合格率均为100%,KSZ620/43B型隧道烘箱对中硼硅玻璃输液瓶的干热灭菌效果符合《药品生产质量管理规范(2010年修订)》的要求。结论:KSZ620/43B型隧道烘箱能够满足血液制品生产工艺的要求,能够用于血液制品的内包材中硼硅玻璃输液瓶的除菌、除热原。

Objective To carry out confirmation and trial run tests of KSZ620/43B tunnel oven to verify whether it meets the requirements of blood product production process.Methods KSZ620/43B tunnel oven was subjected to confirmation tests for design,installation,operation and performances including heat distribution,heat penetration and bacterial endotoxin challenge in accordance with"Good manufacturing practices for pharmaceutical products(2010 revision)".The dry heat sterilization effect of KSZ620/43B tunnel oven on medium borosilicate glass infusion bottles was determined by culture medium simulation filling test and operation under different production scales.Results The confirmation tests of KSZ620/43B tunnel oven for design,installation,operation and performances all met the desired requirements.The results of three consecutive batches of culture medium simulation filling tests were all zero contamination,and the qualification rates of sterility and pyrogen tests of blood products produced under three scales were 100%.The dry heat sterilization effect of KSZ620/43B tunnel oven on medium borosilicate glass infusion bottles satisfied the requirements of"Good manufacturing practices for pharmaceutical products(2010 revision)".Conclusion KSZ620/43B tunnel oven meets the requirements of the production process of blood products,and can be used to remove bacteria and pyrogen from borosilicate glass infusion bottles in the inner packaging materials of blood products.[Chinese Medical Equipment Journal,2022,43(8):45-49]