灭菌的方法及注意事项培训讲学
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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
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) testinBaidu Nhomakorabea （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.
Dry Heat: 干热 For depyrogenation and equipment sterilization. The mode of action is protein denaturation
用于去热原和设备灭菌。作用方式是使蛋白质变性
Ethylene Oxide: 氧化乙烯 Primarily for devices. The mode of action is alkylation of nucleic acids. 主要用于设备。作用方式是使核酸烷基化
Product contact surface, personnel, air
产品接触表面，人员，空气
Materials 材料 Water, raw materials. plastic, paper
水，原材料，塑料，纸张
Characteristics of Bioburden 生物负荷特点 Types of microorganisms 微生物类型 Resistance to sterilization process 对无菌工艺的耐受 Number of organisms 有机物数量
产品和/包装上的活性微生物的数量和类型
Mixture of organisms 有机物混合 Indigenous microflora 地方微植物群 Needs to be inactivated by sterilization
需灭菌失活
8
Bioburden
生物负荷
Bioburden Sources 生物负荷来源 Environment 环境
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
Radiation: 辐射 Primarily for devices. The mode of action is DNA strand breakage
主要用于设备。作用方式是使DNA链破坏
Other methods? 其他方法？
7
Bioburden
生物负荷
Definition: 定义
Population of viable microorganisms on or in a product and/or a package
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
3
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.
Sterilization 灭菌
A General Discussion from CGMP Perspective
从CGMP角度的综合讨论
1
Outline 讨论纲要
PART I
Terminology 专业用词的定义 GMP Requirements in The Manufacture of Sterile Pharmaceutical
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
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) testinBaidu Nhomakorabea （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.
Dry Heat: 干热 For depyrogenation and equipment sterilization. The mode of action is protein denaturation
用于去热原和设备灭菌。作用方式是使蛋白质变性
Ethylene Oxide: 氧化乙烯 Primarily for devices. The mode of action is alkylation of nucleic acids. 主要用于设备。作用方式是使核酸烷基化
Product contact surface, personnel, air
产品接触表面，人员，空气
Materials 材料 Water, raw materials. plastic, paper
水，原材料，塑料，纸张
Characteristics of Bioburden 生物负荷特点 Types of microorganisms 微生物类型 Resistance to sterilization process 对无菌工艺的耐受 Number of organisms 有机物数量
产品和/包装上的活性微生物的数量和类型
Mixture of organisms 有机物混合 Indigenous microflora 地方微植物群 Needs to be inactivated by sterilization
需灭菌失活
8
Bioburden
生物负荷
Bioburden Sources 生物负荷来源 Environment 环境
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
Radiation: 辐射 Primarily for devices. The mode of action is DNA strand breakage
主要用于设备。作用方式是使DNA链破坏
Other methods? 其他方法？
7
Bioburden
生物负荷
Definition: 定义
Population of viable microorganisms on or in a product and/or a package
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
3
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.
Sterilization 灭菌
A General Discussion from CGMP Perspective
从CGMP角度的综合讨论
1
Outline 讨论纲要
PART I
Terminology 专业用词的定义 GMP Requirements in The Manufacture of Sterile Pharmaceutical