蒲公英 - 制药技术的传播者 GMP理论的实践者

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[其他] 蒲公英独家网络首发重磅资料:ISPE baseline volume4-Water and Steam System 2

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发表于 2013-6-5 20:15:44 | 显示全部楼层 |阅读模式
     ISPE baseline volume4-Water and Steam System 2《制药用水及蒸汽系统 (第二版) :本指南的英文版出版日期为201112月,是市面上唯一一本用于指导新建水和蒸汽系统按照现行GMP及相关法规和指南进行设计、建造、运行和维护的指南性丛书。具体内容包括设计原理、最终处理选择、储存和分配系统、实验室用水、红锈和不锈钢、调试和确认,以及制药用水系统微生物注意事项等。第二版为如何满足中国新版GMP有关于水和蒸汽系统的要求提供了具体指导原则,具有较高的参考价值和市场推广价值。
资料为本人几经周折收藏的,资源是从ISPE官网下载的原版文件(价值200美元)绝非扫描版本资料是英文版,中文版等得花儿也谢了),现在共享给各位蒲友,走过路过不要错过,天上真的掉馅饼了!有需要的蒲友抓紧时间下载!
本资料只供大家进行技术交流,禁止用于其它的商业用途!
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Table of Contents
1Introduction..........................................................................................................................9
   1.1Background...................................................................................................................................................9
   1.2 Scope of this Guide......................................................................................................................................9
   1.3 Key Topics included in thisGuide...............................................................................................................10
   1.4 GuideStructure...........................................................................................................................................12
2 Key DesignPhilosophies..................................................................................................13
   2.1Introduction.................................................................................................................................................13
   2.2 Pharmacopeial Water and Steam...............................................................................................................13
   2.3 Specification of Pharmaceutical WaterQuality...........................................................................................14
   2.4 Critical ProcessParameters.......................................................................................................................15
   2.5 CGMP ComplianceIssues..........................................................................................................................16
   2.6 Design Range versus OperatingRange.....................................................................................................16
3 Water Options and SystemPlanning...............................................................................19
   3.1Introduction.................................................................................................................................................19
   3.2 Water Quality Options.................................................................................................................................19
   3.3 SystemPlanning.........................................................................................................................................25
   3.4 SystemDesign............................................................................................................................................30
4 PretreatmentOptions........................................................................................................31
   4.1Introduction.................................................................................................................................................31
   4.2 Process Design of Pretreatment.................................................................................................................31
   4.3 Feed Water to Pretreatment Quality: Testing andDocumentation.............................................................. 33
   4.4 Output Water from Pretreatment: Quality of Feed Waterto Final Treatment.............................................. 34
   4.5 Control of Fouling: Removal of Turbidity andParticulates..........................................................................35
   4.6 Control of Scaling: Removal of Hardness andMetals................................................................................37
   4.7 Organic Material andRemoval...................................................................................................................41
   4.8 System Design for Control of MicrobialGrowth..........................................................................................44
   4.9 Removal of Microbial ControlAgents..........................................................................................................46
   4.10 Changes in AnionComposition/Concentration...........................................................................................49
   4.11 The Importance of pH inPretreatment.......................................................................................................51
   4.12 Materials of Construction and ConstructionPractices................................................................................51
   4.13 Water Conservation....................................................................................................................................52
   4.14Summary.....................................................................................................................................................52
5 Final Treatment Options: Non-Compendial Waters,Compendial Purified Water,and Compendial Highly Purified Water......53
   5.1 Introduction.................................................................................................................................................53
   5.2 IonExchange..............................................................................................................................................55
   5.3 ReverseOsmosis........................................................................................................................................61
   5.4 Continuous Electrodeionization (CEDI). 66
   5.5 Polishing and Removal of SpecificContaminations...................................................................................69
6 Final Treatment Options: Water for Injection(WFI)........................................................ 77
   6.1 Introduction.................................................................................................................................................77
   6.2 PharmacopeialIssues................................................................................................................................77
   6.3 General TechnologyDiscussion..................................................................................................................79
   6.4 Process and Systems Description..............................................................................................................83
   6.5 Final Treatment – General System-Wide Controls andInstrumentation.................................................... 90
   6.6 Summary and Technology Comparison......................................................................................................90
7 PharmaceuticalSteam......................................................................................................93
   7.1 Introduction.................................................................................................................................................93
   7.2 Common Steam Terms andDefinitions......................................................................................................93
   7.3 Types ofSteam...........................................................................................................................................94
   7.4 Regulatory and Industry Guidance.............................................................................................................95
   7.5 Background and IndustryPractices............................................................................................................96
   7.6 SystemPlanning.........................................................................................................................................97
   7.7 SteamGeneration.....................................................................................................................................100
   7.8 Steam Attributes and CondensateSampling............................................................................................102
   7.9 Materials ofConstruction..........................................................................................................................103
   7.10Distribution................................................................................................................................................104
8 Storage and DistributionSystems.................................................................................107
   8.1Introduction...............................................................................................................................................107
   8.2Purpose.....................................................................................................................................................107
   8.3 SystemComponents................................................................................................................................107
   8.4 Materials ofConstruction/Finishes............................................................................................................118
   8.5 Microbial ControlConsiderations..............................................................................................................123
   8.6 SystemDesigns........................................................................................................................................124
9 LaboratoryWater.............................................................................................................139
   9.1Introduction...............................................................................................................................................139
   9.2 System DesignConsiderations.................................................................................................................139
   9.3 Determining User Needs..........................................................................................................................140
   9.4 Water PurificationTechnologies................................................................................................................152
   9.5 Laboratory Water SupplyOptions.............................................................................................................152
   9.6Maintenance.............................................................................................................................................161
   9.7 Instruments andCalibration......................................................................................................................161
   9.8 Commissioning and Qualification.............................................................................................................162
10 Rouge and StainlessSteel..............................................................................................165
   10.1 Introduction...............................................................................................................................................165
   10.2 Regulatory Stance....................................................................................................................................166
   10.3 Surface Conditions andTreatments.........................................................................................................167
   10.4 RougeFormation......................................................................................................................................171
   10.5 Rouge Detection(Methodology)...............................................................................................................178
   10.6 Risk Analysis – Rouge and itsRemediation.............................................................................................183
   10.7 Rouge Remediation (Methodology)..........................................................................................................185
   10.8Conclusions..............................................................................................................................................190
   11 Control andInstrumentation...................................................................................................................191
   11.1Introduction...............................................................................................................................................191
   11.2Principles..................................................................................................................................................192
   11.3 General Instrumentation Requirements....................................................................................................193
   11.4 Design Conditions versus OperatingRange.............................................................................................200
   11.5 InstrumentationSpikes.............................................................................................................................201
   11.6 ControlSystems........................................................................................................................................201
   12 Commissioning andQualification..................................................................................205
   12.1Introduction...............................................................................................................................................205
   12.2 Sampling for WaterSystems....................................................................................................................205
   12.3 Sampling for SteamSystems...................................................................................................................206
   12.4 AcceptanceCriteria..................................................................................................................................206
   12.5 Change Control and Maintaining the Qualified Stateof the System......................................................... 208
13 Microbiological Considerations for PharmaceuticalWater Systems......................... 209
   13.1Introduction...............................................................................................................................................209
   13.2 The Microbial Growth Process in High Purity WaterSystems.................................................................. 209
   13.3 Detrimental Effects ofBiofilm....................................................................................................................212
   13.4 Microbial Control Strategies......................................................................................................................214
   13.5 SanitizerChoices......................................................................................................................................220
   13.6 Assessing Microbial ControlSuccess.......................................................................................................235
   13.7 Functional Microbiological Pharmacopeial Compliance...........................................................................239
   13.8 Microbial and Endotoxin Control in Pure SteamSystems........................................................................241
14 Appendix 1 – References................................................................................................243
15 Appendix 2 –Glossary....................................................................................................247
15.1 Acronyms and Abbreviations....................................................................................................................247
15.2Definitions.................................................................................................................................................249

附件下载:
ISPE baseline volume4-Water and Steam System2.pdf (12.45 MB, 下载次数: 10279, 售价: 10 金币)
已有 5 人评分 金币 贡献 收起 理由
admin + 1 + 500 + 3 特殊贡献,实施奖励
巴西木 + 1 + 20 神马都是浮云
了了. + 20 + 1 太感动了!!
陈玉海 + 8 很给力!
蒲公英 + 1 + 20 + 2 就这么大权限了,都给你奖励

总评分:  + 3  金币 + 568  贡献 + 6   查看全部评分

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药徒
发表于 2013-6-5 20:20:11 | 显示全部楼层
抢沙发。哪个牛人敢翻译?
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药徒
发表于 2013-6-5 20:42:14 | 显示全部楼层
我也想看看中文版
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药徒
发表于 2013-6-5 20:48:51 | 显示全部楼层
我就看看里面的图片吧!哈哈哈
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 楼主| 发表于 2013-6-5 20:56:02 | 显示全部楼层
谁都需要中文版本的,目前网络上第二版英文的可下载资料都找不到
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 楼主| 发表于 2013-6-6 08:31:05 | 显示全部楼层
这么好的资料没人要?
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发表于 2013-6-6 08:38:55 | 显示全部楼层
哇塞,太感激了~
蒲公英,万岁!

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库拉赛尅伊姬谷  在蒲公英,没有什么不可能!  详情 回复 发表于 2013-6-6 08:41
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 楼主| 发表于 2013-6-6 08:41:54 | 显示全部楼层
paul3122 发表于 2013-6-6 08:38
哇塞,太感激了~
蒲公英,万岁!

在蒲公英,没有什么不可能
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头像被屏蔽
发表于 2013-6-6 08:44:26 | 显示全部楼层
提示: 作者被禁止或删除 内容自动屏蔽
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药徒
发表于 2013-6-6 08:45:37 | 显示全部楼层
楼主威武,这么强大的资料都可以弄到,多谢楼主的分享精神,蒲公英论坛真不简单!
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药徒
发表于 2013-6-6 08:46:45 | 显示全部楼层
这个算不算特殊贡献?@admin  

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admin  绝对算特殊贡献,奖励  发表于 2013-6-6 10:16
yan1302  绝对算特殊贡献!!!!!  发表于 2013-6-6 08:53
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药徒
发表于 2013-6-6 08:59:31 | 显示全部楼层
好东西  TKS
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发表于 2013-6-6 09:00:13 | 显示全部楼层
库拉赛尅伊姬谷 发表于 2013-6-6 08:41
在蒲公英,没有什么不可能!

感激啊~ 不过ISPE还有很多书籍,俺都找不到网络版的~~如果……嘿嘿……
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药生
发表于 2013-6-6 09:14:14 | 显示全部楼层
感谢楼主的贡献和支持,代表蒲公英人民感谢您,如果有更多的ISPE资料,希望继续贡献

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库拉赛尅伊姬谷  多谢版主,我会继续努力  详情 回复 发表于 2013-6-6 09:16
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 楼主| 发表于 2013-6-6 09:16:59 | 显示全部楼层
蒲公英 发表于 2013-6-6 09:14
感谢楼主的贡献和支持,代表蒲公英人民感谢您,如果有更多的ISPE资料,希望继续贡献

多谢版主,我会继续努力
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药徒
发表于 2013-6-6 09:20:09 | 显示全部楼层
谢谢分享    有中文的么
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药徒
发表于 2013-6-6 09:20:49 | 显示全部楼层
很不错,加油!!!
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药徒
发表于 2013-6-6 09:20:59 | 显示全部楼层
非常感谢提供跟原版资料,论坛应该组织人翻译一下了

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蒲公英  组织一下,作为一个项目,呼叫@samuel  详情 回复 发表于 2013-6-6 09:24
蒲公英  组织一下,作为一个项目,呼叫@samuel  详情 回复 发表于 2013-6-6 09:24
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药徒
发表于 2013-6-6 09:22:24 | 显示全部楼层
楼主太伟大大了,蒲公英网友有福了。
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药生
发表于 2013-6-6 09:24:03 | 显示全部楼层
石头968 发表于 2013-6-6 09:20
非常感谢提供跟原版资料,论坛应该组织人翻译一下了

组织一下,作为一个项目,呼叫@samuel  

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石头968  http://www.ouryao.com/thread-130291-1-1.html这里有倡议书啊 @haohaochifan 还是ISPE板块的版主组织比较好@GmpForEver  详情 回复 发表于 2013-6-6 09:35
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