疫苗生产洁净室消毒剂的验证

Validation of disinfectants used in clean rooms of vaccine production

目的根据消毒剂的实际使用方式，验证疫苗生产洁净室4种消毒剂的使用效果，为无菌生产控制提供依据和保障。方法对于洁净室的日常表面消毒，采用2%84消毒液、0.1％新洁尔灭消毒液、1％Minncare杀孢子剂和75％乙醇进行实验室悬液定量杀菌试验、环境获得菌不锈钢载体杀菌试验以及材料耐受性确认。另外，用75％乙醇进行人员手部冲淋消毒现场确认，用84消毒液、新洁尔灭消毒液和杀孢子剂各连续3次消毒后进行洁净室静态环境微生物检测。结果在悬液定量杀菌试验中，新洁尔灭消毒液和乙醇对枯草杆菌黑色变种芽孢菌悬液作用10和20min、84消毒液作用10min，杀灭对数值均〈5．00，未达到标准；其余实验室试验结果均符合规定。在乙醇手部冲淋消毒现场确认中，所有人员五手指印微生物检测均为阴性。洁净室经连续3次84消毒液、新洁尔灭消毒液和Minncare杀孢子剂表面消毒后，静态环境微生物检测均为阴性。结论经过验证，以上4种消毒剂在预定使用条件下均有效，能够较好地控制洁净室的洁净度。

Objective To validate effectiveness of 4 disinfectants used in clean rooms for vaccine production according to their actual usage to provide the basis and guarantee for the control of sterile production. Methods Suspension quantitative germicidal test, stainless steel carrier germicidal test for strains obtained from clean room, and material tolerance verification were performed by 2% 84 disinfectant, 0.1% benzalkonium bromide, 1% Minncare sporicide and 75% ethanol. The hand showering disinfection using 75% ethanol was confirmed on site. The static cleanliness environmental microbial test was performed in the clean room disinfected by 84 disinfectant, benzalkonium bromide or Minncare sporicide for 3 times. Results In the suspension quantitative germicidal test, the logarithm values of benzalkonium bromide and ethanol disinfecting Bacillus subtilis var. niger spores for 10 and 20 min, and 84 disinfectant for 10 min were less than 5.00, not meeting the requirement. The rest results of the laboratory tests all complied with the requirements. The five fingerprint contact plates were all negative after hand showering disinfection using ethanol. The plates for the static cleanliness environmental test in the clean rooms using 84 disinfectant, benzalkonium bromide and Minncare sporicide for surface disinfection were all negative. Conclusion The above 4 disinfectants have good effect under intended conditions, and could effectively control the cleanliness of clean rooms.