灭菌的方法及注意事项
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对无菌和/或无热原的每批药品应进行相应的实验室测试以确定 其与符合要求。测试程序应有书面文件并遵照执行。
6
Sterilization Methods
灭菌方法
Moist Heat: 湿热 For drugs and devices. The mode of action is protein denaturation. 用于药品和设备。作用方式是使蛋白质变性
Dry Heat: 干热 For depyrogenation and equipment sterilization. The mode of action is protein denaturation
Sterilization 灭菌
A General Discussion from CGMP Perspective
从CGMP角度的综合讨论
1 1
Outline 讨论纲要
PART I
Terminology 专业用词的定义 GMP Requirements in The Manufacture of Sterile Pharmaceutical
应该建立并执行用于阻止无菌药品被致病菌污染的相关书面程序。
这些程序应包括任何无菌工艺的验证。
5
Code Federal Regulation
美国联邦法规
211.167(a) testing （a）测试
For each batch of drug product purporting to be sterile and/or pyrogen-free, there shall be appropriate laboratory testing to determine conformance to such requirements. The test procedures shall be in writing and shall be followed.
4
Code Federal Regulation
美国联邦法规
211.113(a) and (b) sterilization 灭菌 (a) Appropriate written procedures, designed to prevent
objectionable microorganisms in drug products not required to be sterile, shall be established and followed. 应该建立并执行用于防止非无菌药品被致病菌污染的相关书面程序。 (b) Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include validation of any sterilization process.
Products 无菌药品生产过程中GMP的基本要求
PART II
Facility Design 生产设施的设计 HVAC System 空调系统 Environmental Monitoring (EM) 环境的监视 Pharmaceutical Water 制药用水 Cleaning/Sanitation 清洁消毒 Personnel 无菌区操作人员
(d) Standards or specifications, methods of testing, and, where indicated, methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug product containers and closures. 应建立并执行对药品容器和密封系统的规格或质量标准，测试方法，清 洁方法，灭菌和除热原过程的相关书面程序。
3
Code Federal Regulation
美国联邦法规
211.84(c)(3) sterile equipment 灭菌设备 Sterile equipment and aseptic sampling twk.baidu.comchniques shall be used
when necessary 必要时应使用灭菌设备和无菌取样技术。
211.94(c) and (d) sterilized
(c) Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use. 药品容器和密封系统应清洁并根据药品的性质和要求，进行灭菌，除 热原过程以确保预期的用途。
PART III
Methods of sterilization 灭菌方法 Sterile Production and validation 无菌生产和验证 The Trend of Sterile Production 无菌产品生产趋势
2
Presentation Outline
概要
US Regulations 美国法规 Moist Heat Sterilization 湿热灭菌 Dry Heat/Depyrogenation 干热/去热原法 Sterilization Process Validation 灭菌工艺验证 Other Sterilization Methods 其他灭菌方法
6
Sterilization Methods
灭菌方法
Moist Heat: 湿热 For drugs and devices. The mode of action is protein denaturation. 用于药品和设备。作用方式是使蛋白质变性
Dry Heat: 干热 For depyrogenation and equipment sterilization. The mode of action is protein denaturation
Sterilization 灭菌
A General Discussion from CGMP Perspective
从CGMP角度的综合讨论
1 1
Outline 讨论纲要
PART I
Terminology 专业用词的定义 GMP Requirements in The Manufacture of Sterile Pharmaceutical
应该建立并执行用于阻止无菌药品被致病菌污染的相关书面程序。
这些程序应包括任何无菌工艺的验证。
5
Code Federal Regulation
美国联邦法规
211.167(a) testing （a）测试
For each batch of drug product purporting to be sterile and/or pyrogen-free, there shall be appropriate laboratory testing to determine conformance to such requirements. The test procedures shall be in writing and shall be followed.
4
Code Federal Regulation
美国联邦法规
211.113(a) and (b) sterilization 灭菌 (a) Appropriate written procedures, designed to prevent
objectionable microorganisms in drug products not required to be sterile, shall be established and followed. 应该建立并执行用于防止非无菌药品被致病菌污染的相关书面程序。 (b) Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include validation of any sterilization process.
Products 无菌药品生产过程中GMP的基本要求
PART II
Facility Design 生产设施的设计 HVAC System 空调系统 Environmental Monitoring (EM) 环境的监视 Pharmaceutical Water 制药用水 Cleaning/Sanitation 清洁消毒 Personnel 无菌区操作人员
(d) Standards or specifications, methods of testing, and, where indicated, methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug product containers and closures. 应建立并执行对药品容器和密封系统的规格或质量标准，测试方法，清 洁方法，灭菌和除热原过程的相关书面程序。
3
Code Federal Regulation
美国联邦法规
211.84(c)(3) sterile equipment 灭菌设备 Sterile equipment and aseptic sampling twk.baidu.comchniques shall be used
when necessary 必要时应使用灭菌设备和无菌取样技术。
211.94(c) and (d) sterilized
(c) Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use. 药品容器和密封系统应清洁并根据药品的性质和要求，进行灭菌，除 热原过程以确保预期的用途。
PART III
Methods of sterilization 灭菌方法 Sterile Production and validation 无菌生产和验证 The Trend of Sterile Production 无菌产品生产趋势
2
Presentation Outline
概要
US Regulations 美国法规 Moist Heat Sterilization 湿热灭菌 Dry Heat/Depyrogenation 干热/去热原法 Sterilization Process Validation 灭菌工艺验证 Other Sterilization Methods 其他灭菌方法