制藥用水系統(tǒng):英文版簡(jiǎn)介，目錄書摘
2021-04-13 09:55
來源：京東
作者：京東
制藥用水系統(tǒng):英文版
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編輯推薦:理念先進(jìn)——由來自全球的制藥專家編寫，結(jié)合ISPE和ASME BPE的理論，準(zhǔn)確、形象地介紹了制藥用水系統(tǒng)的概念與設(shè)計(jì)思路
體系完整——對(duì)制藥用水系統(tǒng)的知識(shí)體系進(jìn)行了全面地梳理；
內(nèi)容實(shí)用——結(jié)合作者多年的實(shí)際工作經(jīng)驗(yàn)，結(jié)合大量工程案例和圖片。
體系完整——對(duì)制藥用水系統(tǒng)的知識(shí)體系進(jìn)行了全面地梳理；
內(nèi)容實(shí)用——結(jié)合作者多年的實(shí)際工作經(jīng)驗(yàn)，結(jié)合大量工程案例和圖片。
內(nèi)容簡(jiǎn)介:《制藥用水系統(tǒng)（英文版）》結(jié)合多年工程實(shí)踐經(jīng)驗(yàn)，對(duì)制藥用水系統(tǒng)進(jìn)行了全面、深入的總結(jié)。
《制藥用水系統(tǒng)（英文版）》大量采用實(shí)際工程案例和圖片，結(jié)合ISPE及ASME BPE的理論經(jīng)驗(yàn)，力求真實(shí)、形象、準(zhǔn)確地介紹制藥用水系統(tǒng)的基本概念和設(shè)計(jì)思路。本書基于“質(zhì)量源于設(shè)計(jì)、預(yù)防微生物污染與預(yù)防顆粒物污染”的理念，重點(diǎn)介紹了制藥用水系統(tǒng)的設(shè)計(jì)、安裝、調(diào)試以及驗(yàn)證的基本原理與具體實(shí)踐。本書還提供了制藥用水系統(tǒng)組成材料的質(zhì)量控制標(biāo)準(zhǔn)，以保證制藥用水系統(tǒng)能穩(wěn)定地為制藥生產(chǎn)提供所需的制藥用水和純蒸汽。
《制藥用水系統(tǒng)（英文版）》適用于制藥行業(yè)從事研究、設(shè)計(jì)、生產(chǎn)制藥用水系統(tǒng)的技術(shù)人員，也可供制藥工程相關(guān)專業(yè)高校師生閱讀參考。
《制藥用水系統(tǒng)（英文版）》大量采用實(shí)際工程案例和圖片，結(jié)合ISPE及ASME BPE的理論經(jīng)驗(yàn)，力求真實(shí)、形象、準(zhǔn)確地介紹制藥用水系統(tǒng)的基本概念和設(shè)計(jì)思路。本書基于“質(zhì)量源于設(shè)計(jì)、預(yù)防微生物污染與預(yù)防顆粒物污染”的理念，重點(diǎn)介紹了制藥用水系統(tǒng)的設(shè)計(jì)、安裝、調(diào)試以及驗(yàn)證的基本原理與具體實(shí)踐。本書還提供了制藥用水系統(tǒng)組成材料的質(zhì)量控制標(biāo)準(zhǔn)，以保證制藥用水系統(tǒng)能穩(wěn)定地為制藥生產(chǎn)提供所需的制藥用水和純蒸汽。
《制藥用水系統(tǒng)（英文版）》適用于制藥行業(yè)從事研究、設(shè)計(jì)、生產(chǎn)制藥用水系統(tǒng)的技術(shù)人員，也可供制藥工程相關(guān)專業(yè)高校師生閱讀參考。
作者簡(jiǎn)介:《制藥用水系統(tǒng)》主編：張功臣，從事GMP合規(guī)性及工程設(shè)計(jì)咨詢多年，畢業(yè)于武漢工程大學(xué)制藥工程專業(yè)及華中科技大學(xué)生物化學(xué)與生物專業(yè)。擁有18年的制藥行業(yè)實(shí)踐經(jīng)驗(yàn)與多項(xiàng)制藥工業(yè)領(lǐng)域?qū)＠?。主要從事制藥行業(yè)潔凈流體工藝系統(tǒng)（制藥用水系統(tǒng)、制藥工藝配液系統(tǒng)、CIP/SIP系統(tǒng)）的設(shè)計(jì)與研發(fā)工作，國(guó)際制藥工程協(xié)會(huì)（ISPE）“水與蒸汽系統(tǒng)”課程特約講師；中國(guó)較早的流體工藝系統(tǒng)模塊化設(shè)計(jì)理念推廣者，中國(guó)較早研發(fā)并實(shí)踐批處理控制（Batch）的生物原液工藝配料系統(tǒng)、智能型大輸液工藝配料系統(tǒng)、智能型脂肪乳注射劑工藝配料系統(tǒng)、智能型栓劑與膏劑工藝配制系統(tǒng)、注射用水過熱水滅菌、熱儲(chǔ)存/旁路常溫循環(huán)的注射用水系統(tǒng)、科學(xué)除銹與鈍化、純化法制備高純水或注射用水、水電解臭氧消毒的應(yīng)用與subloop冷用點(diǎn)降溫模塊化等諸多創(chuàng)新設(shè)計(jì)理念。
目錄:Chapter 1Pharmacopeia and Regulations1
1.1Classification of Pharmaceutical Water1
1.2Composition of Water System3
1.3Pharmacopeia Standards4
1.4GMP Standards12
1.5Key Water Quality Indexes 15
Chapter 2Design Concept21
2.1Prevention of Microbial Contamination21
2.2Prevention of Particles Contamination26
2.3Quality Influencing Factors28
Chapter 3Unit Operation and Components41
3.1Pressure Vessels41
3.2Centrifuge Pumps57
3.3UV Light 82
3.4Filtration Devices93
3.5Valves116
Chapter 4Generation of Purified Water130
4.1Raw water Quality Indexes132
4.2Raw Water Tanks135
4.3Multi-media Filters135
4.4Activated Carbon Filters136
4.5Softening Unit137
4.6Dosing Unit138
4.7Ultrafilter for Pretreatment141
4.8Nanofilter142
4.9Microfilter142
4.10Degasser142
4.11UV Lamp143
4.12RO Unit 143
4.13EDI Unit 146
Chapter 5Generation of Water for Injection150
5.1Pyrogens151
5.2The Distillation Method155
5.3Purification Process164
Chapter 6Storage and Distribution Systems171
6.1Overview171
6.2Decision Flow Chart182
Chapter 7Pharmaceutical Steam Systems193
7.1Overview193
7.2Regulations and Pharmaceutical Steam196
7.3Pure Steam Systems198
Chapter 8Sanitation and Sterilization Technology204
8.1Overview204
8.2Regulatory Requirements for Sterilization205
8.3Basic Principle of Sterilization208
8.4Sanitation Technology211
8.5Sterilization Technology219
Chapter 9Rouge Formation228
9.1Regulatory Viewpoint228
9.2Rouge Classification230
9.3Metal Corrosion232
9.4Rouge Formation237
9.5The Risk of Rouge247
Chapter 10Derouging Stainless Steel Systems261
10.1Cleaning Technologies261
10.2Rouge Remediation Technologies276
10.3Rouge Remediation Quality Control 298
10.4Rouge Remediation Case Study304
10.5Rouge Prevention 312
10.6On-line Analytical Technologies328
Chapter 11Quality Management 333
11.1Quality Control333
11.2Welding Quality Control345
11.3Passivation Quality Control347
11.4Documentation System364
Chapter 12Automatic Control Technology367
12.1Introduction of Automatic Control Technology367
12.2Sensor Technology377
12.3Automatic Control of Unit Operation399
12.4Good Automated Manufacturing Practice406
Chapter 13Validation 410
13.1Basic Concepts 410
13.2Validation of a Pharmaceutical Water Systems 414
13.3Pharmaceutical Steam System Validation426
13.4Application of Quality Risk Management in Pharmaceutical Water Systems 429
Bibliography 437
1.1Classification of Pharmaceutical Water1
1.2Composition of Water System3
1.3Pharmacopeia Standards4
1.4GMP Standards12
1.5Key Water Quality Indexes 15
Chapter 2Design Concept21
2.1Prevention of Microbial Contamination21
2.2Prevention of Particles Contamination26
2.3Quality Influencing Factors28
Chapter 3Unit Operation and Components41
3.1Pressure Vessels41
3.2Centrifuge Pumps57
3.3UV Light 82
3.4Filtration Devices93
3.5Valves116
Chapter 4Generation of Purified Water130
4.1Raw water Quality Indexes132
4.2Raw Water Tanks135
4.3Multi-media Filters135
4.4Activated Carbon Filters136
4.5Softening Unit137
4.6Dosing Unit138
4.7Ultrafilter for Pretreatment141
4.8Nanofilter142
4.9Microfilter142
4.10Degasser142
4.11UV Lamp143
4.12RO Unit 143
4.13EDI Unit 146
Chapter 5Generation of Water for Injection150
5.1Pyrogens151
5.2The Distillation Method155
5.3Purification Process164
Chapter 6Storage and Distribution Systems171
6.1Overview171
6.2Decision Flow Chart182
Chapter 7Pharmaceutical Steam Systems193
7.1Overview193
7.2Regulations and Pharmaceutical Steam196
7.3Pure Steam Systems198
Chapter 8Sanitation and Sterilization Technology204
8.1Overview204
8.2Regulatory Requirements for Sterilization205
8.3Basic Principle of Sterilization208
8.4Sanitation Technology211
8.5Sterilization Technology219
Chapter 9Rouge Formation228
9.1Regulatory Viewpoint228
9.2Rouge Classification230
9.3Metal Corrosion232
9.4Rouge Formation237
9.5The Risk of Rouge247
Chapter 10Derouging Stainless Steel Systems261
10.1Cleaning Technologies261
10.2Rouge Remediation Technologies276
10.3Rouge Remediation Quality Control 298
10.4Rouge Remediation Case Study304
10.5Rouge Prevention 312
10.6On-line Analytical Technologies328
Chapter 11Quality Management 333
11.1Quality Control333
11.2Welding Quality Control345
11.3Passivation Quality Control347
11.4Documentation System364
Chapter 12Automatic Control Technology367
12.1Introduction of Automatic Control Technology367
12.2Sensor Technology377
12.3Automatic Control of Unit Operation399
12.4Good Automated Manufacturing Practice406
Chapter 13Validation 410
13.1Basic Concepts 410
13.2Validation of a Pharmaceutical Water Systems 414
13.3Pharmaceutical Steam System Validation426
13.4Application of Quality Risk Management in Pharmaceutical Water Systems 429
Bibliography 437
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