4A分子筛干燥剂连续使用有效次数试验  

The effective times test for continuous use of 4A molecular sieve desiccant

作　　者：寇文月 王为 马京 张颖欣 董静贞 王娇娇 Kou Wenyue;Wang Wei;Ma Jing;Zhang Yingxin;Dong Jingzhen;Wang Jiaojiao(Department of Quality Control,Beijing Institute of Biological Products Co.,Ltd.,Beijing 100176,China;Department of Quality Assurance,Beijing Institute of Biological Products Co.,Ltd.,Beijing 100176,China;The 1st Department of Vaccine,Beijing Institute of Biological Products Co.,Ltd.,Beijing 100176,China)

机构地区：[1]北京生物制品研究所有限责任公司质量检定室,100176 [2]北京生物制品研究所有限责任公司质量保证部,100176 [3]北京生物制品研究所有限责任公司疫苗一室,100176

出　　处：《国际生物制品学杂志》2020年第1期8-11,共4页International Journal of Biologicals

摘　　要：目的确定同一批次4A分子筛干燥剂连续使用后,能达到预期灭菌除湿效果的有效次数。方法分别对无菌隔离器的手套系统(包括手套、封圈、套袖)以及实验舱和传递舱进行完整性测试。采用同一批次4A分子筛干燥剂连续灭菌除湿3次,通过对过氧化氢气体浓度、分布状态和灭菌效果,以及隔离器内部环境微生物(沉降菌、浮游菌、表面微生物)检测,验证过氧化氢对隔离器的灭菌效果;通过对4A分子筛干燥剂使用前后称重和观察舱内起雾现象,确定4A分子筛达到灭菌除湿效果的有效次数。结果共对8个手套系统进行完整性测试,手套在60 s内的压降差值均<60 Pa;实验舱和传递舱的完整性测试结果表明,小时体积泄漏率为0.04%,每次测量环境温度波动均<0.5℃。过氧化氢指示卡显示,舱内过氧化氢达到灭菌浓度且分布均匀。经生物指示剂检测,过氧化氢能杀灭106以上嗜热脂肪芽孢杆菌。隔离器内部环境微生物检测结果如下,沉降菌为每4小时0菌落形成单位(colony forming unit,CFU)、浮游菌为0 CFU/m3、表面微生物为0 CFU/碟。同一批次4A分子筛干燥剂使用前的重量为3.0005 kg,第1、第2和第3次使用后的重量分别为3.1850、3.3405和3.4515 kg。当同一批次干燥剂连续使用至第3次时,隔离器舱内出现起雾现象。结论同一批次4A分子筛干燥剂可连续使用3次,并达到预期的灭菌除湿效果。ObjectiveTo determine the effective continuous use times of the same batch 4A molecular sieve desiccant in achieving the desired sterilization and dehumidification effect.MethodsThe integrity tests for glove system(including glove,seal ring and sleeve),experimental and transferring chambers of aseptic isolator were conducted separately.The same batch 4A molecular sieve desiccant was continuously used 3 times.The sterilization effect of hydrogen peroxide on the isolator was verified by detecting concentration,distribution and bactericidal effect of hydrogen peroxide gas,and microorganisms(sedimentary bacteria,planktonic bacteria and surface microorganisms)inside the isolator.The effective times of sterilization and dehumidification were determined through weighing 4A molecular sieve before and after use,and observing fogging phenomenon in the chamber.ResultsEight glove systems were subjected to the integrity test,the pressure drop differences were all<60 Pa within 60 s.The integrity test of the experimental and the transferring chambers showed that the hourly volume leakage rate was 0.04%,and the ambient temperature fluctuation was<0.5℃in each measurement.The hydrogen peroxide indicator cards indicated that hydrogen peroxide in the chamber reached sterilization concentration and distributed evenly.More than 106Bacillus stearothermophilus bacteria were killed by hydrogen peroxide as determined by biological indicator test.The detection results of microorganisms inside the isolator were 0 colony forming unit(CFU)/4 h for sedimentary bacteria,0 CFU/m3 for planktonic bacteria,and 0 CFU/dish for surface microorganisms.The weight of the same batch 4A molecular sieve desiccant was 3.0005 kg before use and 3.1850,3.3405 and 3.4515 kg after the first,second and third time use,respectively.When the same batch desiccant was continuously used 3 times,fog appeared in the chamber.ConclusionThe same batch 4A molecular sieve desiccant can achieve the desired sterilization and dehumidification effect for 3 continuous usages.

关 键 词：吸湿剂 无菌隔离器 灭菌 除湿 

分 类 号：V[航空宇航科学技术]