GMP谈及无菌概念时,经常涉及sanitization ,aseptic 和 sterile 这三个词汇。这三个词意有相似之处。为了更好地体会它们的区别,特选以下示例,供各位体会。
sanitization
1.the destruction of pathogenic and other kinds of microorganisms 消毒
Equipment shall be cleaned and sanitized at appropriate intervals.
设备应定期清洁消毒。
water sanitization 对水系统清洁消毒
Sanitization of cleanrooms 洁净室消毒
sanitization of equipment 设备消毒
Sanitization Methods 消毒方法
Hot Water Sanitization 热水消毒法
Ozone Sanitization 臭氧消毒法
UV light sanitization 紫外灯消毒法
Chemical Free Sanitization 非化学消毒法
***************************************
Aseptic
1.Free of pathogenic microorganisms 无致病微生物的,无菌的
Aseptic meningitis 无菌性脑膜炎
Aseptic necrosis 无菌性骨坏死
Aseptic Bag 无菌包装袋
Aseptic apple juice 无菌苹果汁
Aseptic Tomato Paste 无菌番茄酱
2.Using methods to protect against infection by pathogenic microorganisms
采用防止致病微生物感染的保护措施。防止病菌交叉污染。
aseptic technigue 无菌术
Aseptic processing 无菌加工
Aseptic manufacturing 无菌制造
aseptic gowning 无菌更衣
aseptic filling 无菌灌装
***************************************
Sterile, Sterilization or Sterilisation
1.Free from live bacteria or other microorganisms 无活的微生物,无菌的。
sterile materials 无菌物料
Sterile Saline Solution 无菌生理盐水
sterilised footwear 无菌鞋具
sterile garments 无菌服装
Sterile Syringes 无菌注射器
sterile filters 无菌滤芯(本身并不一定具有除菌功能,只说明滤芯经过灭菌处理)
2.refers to any process that effectively kills or eliminates transmissible agents (such as fungi, bacteria, viruses, spore forms, etc.) from a surface, equipment, article of food or medication, or biological culture medium. 灭菌的,除菌的过程
Disinfectants should be sterilised prior to use. 消毒剂使用前应进行灭菌
Terminal sterilisation 终端灭菌
Autoclave sterilisation 蒸汽灭菌
Sterilisation of equipment by dry heat 干热灭菌
sterilisation of the API by radiation 辐射灭菌
Fumigation Sterilisation 熏蒸灭菌
Chemical sterilization 化学灭菌
Dry sterilization 干消法,用30-35%的双氧水对容器表面灭菌的方法
terilizing-grade Filters 除菌级滤芯
Sterile Filtration 除菌过滤
3.Not producing or incapable of producing offspring 失去繁殖能力的,绝育的
Sterilization of animals 动物阉割,绝育术