蒲公英网络独家网络首发：ISPE Good Practice Guide-Process Gases

库拉赛尅伊姬谷

    重磅资料来袭：应蒲友要求@paul3122 ，现将ISPE Good Practice Guide-Process Gases这本书共享，主要内容是指导制药行业所用气体的在实际生产中的应用，资源为ISPE官方网站下载原版文件（价值145美元），绝非扫描版，有需要的蒲友可选择下载。
注：本资料只供大家进行技术交流，禁止用于其它的商业用途！

Table of Contents
1 Introduction.......................................................................................................................... 7
1.1 Purpose.........................................................................................................................................................7
1.2 Scope............................................................................................................................................................7
1.3 Benefits.........................................................................................................................................................7
1.4 Objectives.....................................................................................................................................................8
1.5 Key Concepts...............................................................................................................................................8
1.6 Structure of this Guide................................................................................................................................ 11
2 Development of the User Requirements Documentation.............................................. 13
2.1 Introduction.................................................................................................................................................13
2.2 Process Requirements...............................................................................................................................13
2.3 Defining User Requirements for a Process Gas System............................................................................ 15
2.4 Equipment Performance/Operational and Maintenance Requirements..................................................... 16
2.5 Control/Monitoring System Requirements..................................................................................................17
2.6 Facility.........................................................................................................................................................17
2.7 Reference Documents................................................................................................................................18
2.8 Roles and Responsibilities..........................................................................................................................18
3 Design Options – Process Gas Generation/Supply Systems........................................ 21
3.1 Introduction.................................................................................................................................................21
3.2 Process Gases: Descriptions and Properties............................................................................................. 22
3.3 Process Gases: Typical Applications.......................................................................................................... 24
3.4 Applicable Regulations, Standards, and Codes......................................................................................... 25
3.5 Safe Handling and Storage of Gases.........................................................................................................27
3.6 User Requirements Considerations for Process Gases............................................................................. 33
4 Design Options – Compressed Air Systems................................................................... 37
4.1 Design of Generation of Compressed Air Systems.................................................................................... 37
4.2 Equipment Selection...................................................................................................................................38
4.3 Compressors...............................................................................................................................................38
4.4 Compressed Air System Controls............................................................................................................... 42
4.5 Air Treatment.............................................................................................................................................. 43
4.6 Dryers......................................................................................................................................................... 44
4.7 Compressed Air Filters................................................................................................................................ 48
4.8 Air Receivers............................................................................................................................................... 49
4.9 Traps and Drains........................................................................................................................................50
4.10 Designing for Redundancy.........................................................................................................................51
5 Design Options – Distribution Systems.......................................................................... 53
5.1 Concepts.....................................................................................................................................................53
5.2 Non-Return or Check Valves......................................................................................................................57
5.3 Pressure Reducing Valves..........................................................................................................................57
5.4 Mixing Valves..............................................................................................................................................58
5.5 Filtration......................................................................................................................................................59
5.6 Filters in Compressed Air Systems.............................................................................................................62
5.7 Material Selection.......................................................................................................................................63
6 Design Options – Control and Monitoring Systems....................................................... 69
6.1 Introduction.................................................................................................................................................69
6.2 Control Systems..........................................................................................................................................69
6.3 Monitoring...................................................................................................................................................70
7 Risk Assessment............................................................................................................... 81
7.1 Introduction.................................................................................................................................................81
7.2 Quality Risk Management for Process Gas Systems................................................................................. 82
7.3 Risk Assessment Process...........................................................................................................................83
7.4 Risk Control................................................................................................................................................85
7.5 Risk Assessment Communication..............................................................................................................86
7.6 Risk Review................................................................................................................................................86
8 Final Design....................................................................................................................... 89
8.1 Introduction.................................................................................................................................................89
8.2 Engineering Turnover Package..................................................................................................................89
8.3 Commissioning...........................................................................................................................................91
8.4 Installation and Operational Tests...............................................................................................................93
8.5 Performance Testing................................................................................................................................... 94
8.6 Acceptance and Release............................................................................................................................ 94
9 Operation and Maintenance.............................................................................................. 97
9.1 Maintenance...............................................................................................................................................97
9.2 Calibration...................................................................................................................................................98
10 Appendix 1 – Example of the Development of a Sampling Strategy Based on a
Risk Assessment........................................................................................ 99
10.1 System Description...................................................................................................................................100
10.2 Control Strategy........................................................................................................................................100
10.3 Moisture Content......................................................................................................................................102
10.4 Hydrocarbons/Oil......................................................................................................................................102
10.5 Viable and Non-Viable Particulate............................................................................................................103
10.6 Microbial Levels........................................................................................................................................103
11 Appendix 2 – Risk Assessment Examples.................................................................... 109
12 Appendix 3 – Calibration Strategies...............................................................................113
13 Appendix 4 – Sample User Requirement Specifications..............................................117
14 Appendix 5 – The Effect of System Leakage................................................................ 121
14.1 Minimize Leaks.........................................................................................................................................122
14.2 Pressure/Flow Controllers.........................................................................................................................122
15 Appendix 6 – Nitrogen Gas Generation Systems......................................................... 125
16 Appendix 7 – Miscellaneous Information...................................................................... 129
17 Appendix 8 – References................................................................................................ 135
18 Appendix 9 – Glossary.................................................................................................... 139
18.1 Abbreviations and Acronyms.................................................................................................................... 140
18.2 Definitions................................................................................................................................................. 141

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友情链接：
蒲公英独家网络首发：ISPE Baseline Vol 7-MaPP

麦田.守望

http://docshare01.docshare.tips/files/30141/301413722.pdf

黎明曙光

各位：蒲友下午，这次跟大家分享是

ISPE工艺气体验证指南

有需要就下载吧，我已经把权限降到50了，如果你们还觉得高，我只能呵呵了

库拉赛尅伊姬谷

黎明曙光 发表于 2016-6-28 13:48
各位：蒲友下午，这次跟大家分享是有需要就下载吧，我已经把权限降到50了，如果你们还觉得高，我只能呵呵了 ...

大哥，我给你个建议，在发帖之前搜索一下论坛里边有没有重复的资源，在我发的帖子里还妄称“英文原版第一份”，给附件标上价格，加上权限，我都呵呵了，没有攻击你的意思，看你发的帖子也知道你有很多资源要和大家分享，我只是希望你在发帖时多搜索一下，尽量少给管理员增加没必要的负担，你说不是吗？

黎明曙光

淡莣 发表于 2016-6-28 16:54
英文的，还这么贵，呵呵！~~~

英文原版，论坛第一份

道路漫长黑暗

谢谢分享，不过已经收集到了

库拉赛尅伊姬谷

沙发自己坐！

cph2345

我抢板凳。

红茶.

最近RP爆发啊。。。。。。。。。。

库拉赛尅伊姬谷

好的资源应该能够让更多的而且有需要的人分享到，本人绝不会私自占有

踏雪无痕

收藏起来    谢谢分享

岁寒三友

谢谢分享

仲夏秋夜云

伟大的蒲公英……跪谢楼主

静夜思雨

楼主WV，强烈支持。{:soso_e130:}

windli

不顶不行   

重磅一个接一个

仲夏秋夜云

cph2345 发表于 2013-6-6 16:05
我抢板凳。

你也很强大~

仲夏秋夜云

库拉赛尅伊姬谷 发表于 2013-6-6 16:11
好的资源应该能够让更多的而且有需要的人分享到，本人绝不会私自占有

感谢楼主的感慨，真的

吱吱

威武的楼主，您还有多少重磅炸弹全部投出来吧，向我开炮！

库拉赛尅伊姬谷

仲夏秋夜云 发表于 2013-6-6 16:30
感谢楼主的感慨，真的

版主客气了，我会继续努力

cph2345

仲夏秋夜云 发表于 2013-6-6 16:30
你也很强大~

我只是混日子的，没有版主您强大呀，听了你的培训很是有收获呀。

开羽

服了。。。。。。。

仲夏秋夜云

库拉赛尅伊姬谷 发表于 2013-6-6 16:35
版主客气了，我会继续努力

客气了……生物制品版块也开了资源区，欢迎多多支持，去发发帖……

Eleven

最近人品爆发啊

仲夏秋夜云

cph2345 发表于 2013-6-6 16:38
我只是混日子的，没有版主您强大呀，听了你的培训很是有收获呀。

哎……各有所长，在这个坛子里，我愿意永远做默默拍手、记录的小蒲公英……为你们服务

cph2345

库拉赛尅伊姬谷 发表于 2013-6-6 15:54
沙发自己坐！

楼主有没有这份资料呀，分享一下ISPE Good Practice Guide: Cold Chain Management 。冷链管理的