Process understanding: for scale-up and manufacture of active ingredients
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| Format: | Elektronisch E-Book |
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Wiley-VCH
2011
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| Beschreibung: | Druckausg. u.d.T.: Process understanding (XVIII, 351 S.) |
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| ISBN: | 9783527637140 |
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| 245 | 1 | 0 | |a Process understanding |b for scale-up and manufacture of active ingredients |c ed. by Ian Houson |
| 250 | |a 1. Aufl. | ||
| 264 | 1 | |a Weinheim |b Wiley-VCH |c 2011 | |
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| 500 | |a Druckausg. u.d.T.: Process understanding (XVIII, 351 S.) | ||
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Datensatz im Suchindex
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IMAGE 1
CONTENTS
1
1.1 1.2
1.3 1.4 1.5
2
2.1 2.2 2.3 2.3.1
2.3.2 2.3.2.1 2.3.3 2.3.3.1 2.3.3.2 2.3.4 2.3.5 2.3.5.1 2.3.5.2 2.3.5.3
2.3.5.4 2.4 2.4.1
PREFACE XV LIST OF CONTRIBUTORS XVII
QUALITY BY DESIGN 1 VINCE MCCURDY HISTORY 1 DEFINING PRODUCT DESIGN
REQUIREMENTS AND CRITICAL QUALITY ATTRIBUTES 3 THE ROLE OF QUALITY RISK
MANAGEMENT IN QBD 6
DESIGN SPACE AND CONTROL STRATEGY 12 QUALITY SYSTEMS 14 REFERENCES 15
ROUTE AND PROCESS SELECTION 17 DAVID]. AGER INTRODUCTION 17 ROUTE
EVALUATION 20 FACTORS TO CONSIDER 24 TIMING 24
COSTS 25 REMOVAL OF A CHROMATOGRAPHY STEP 26 SAFETY, HEALTH, AND
ENVIRONMENT (SHE) 26 SAFER PROCESSES 28
GREEN CHEMISTRY 33 LEGAL 37 OTHER CONSIDERATIONS 38 THROUGHPUT 40
SOLVENTS 42 RAW MATERIALS 43 INTERMEDIATES 43 ROUTE SELECTION 43
SILDENAFIL 48
BIBLIOGRAFISCHE INFORMATIONEN HTTP://D-NB.INFO/1008658790
DIGITALISIERT DURCH
IMAGE 2
VI CONTENTS
2.5
2.5.1 2.5.2 2.5.3 2.6
PROCESS SELECTION 49 PREGABALIN 51 NK1 RECEPTOR ANTAGONIST 53 DATA 55
SUMMARY 56 REFERENCES 57
3 CRITICAL STAGES OF SAFETY ASSESSMENT IN PROCESS DESIGN AND SCALE-UP 59
STEPHEN ROWE 3.1 REACTION SAFETY CONCEPTS 59
3.1.1 WHAT IS THE HAZARD? 60
3.1.2 THE CRITICAL EFFECTS OF SCALE-UP ON THERMAL BEHAVIOR 60 3.1.3
SAFETY FEATURES OF A REACTION 62 3.1.4 STAGES OF SAFETY ASSESSMENT 64
3.2 PRE-LABORATORY SAFETY STUDIES 65
3.2.1 PREDICTING REACTION SAFETY CHARACTERISTICS 65 3.2.2 SELECTING
INHERENTLY SAFER PROCESSING CONDITIONS 68 3.3 THE SYNERGIES OF SAFETY
AND OPTIMIZATION - TOGETHER 69 3.3.1 TESTING OF POTENTIALLY EXPLOSIVE
COMPOUNDS 69
3.3.2 THERMAL STABILITY ASSESSMENT 70 3.3.3 REACTION THERMODYNAMIC,
KINETIC, AND GAS-GENERATION QUANTIFICATION 71 3.3.4 DEVELOPING
FAULT-TOLERANT PROCESSES - BY DESIGN 74
3.4 ESTABLISHING A RELIABLE BASIS OF SAFETY FOR SCALE-UP 75 3.4.1
HAZARDOUS SCENARIO IDENTIFICATION 76 3.4.2 DETERMINING THE CONSEQUENCES
OF HAZARDOUS SCENARIOS 77 3.4.3 EXPERIMENTAL SIMULATION - ADIABATIC
CALORIMETRY 77
3.4.4 SPECIFY AND IMPLEMENT SAFETY MEASURES 79 3.4.5 LARGE-SCALE
PRODUCTION 80 3.5 FLAMMABILITY HAZARDS 80
3.5.1 ASSESSING PILOT-SCALE FLAMMABILITY HAZARDS 82 3.6 SUMMARY 84
REFERENCES 85
4 UNDERSTANDING THE REACTION 87
JOHN ATHERTON, IAN HOUSON, AND MARK TALFORD 4.1 INTRODUCTION 87
4.2 PROCESS COMPLEXITY 88
4.2.1 NUMBER OF PHASES 88
4.2.2 PHYSICAL AND DYNAMIC COMPLEXITY 89 4.2.2.1 LENGTH SCALES 89
4.2.2.2 TIME 90
4.2.2.3 SOLUBILITY 90
4.2.2.4 DENSITY 90
IMAGE 3
CONTENTS VII
4.2.2.5
4.2.2.6 4.2.2.7 4.2.2.8 4.2.3 4.3 4.4 4.5
4.6 4.6.1 4.6.2 4.6.3 4.7
4.7.1 4.8 4.9 4.10
4.11 4.11.1 4.11.2 4.11.3 4.11.4
4.11.5 4.11.6 4.12 4.13 4.13.1
4.13.1.1 4.13.1.2 4.13.1.3
4.13.2 4.13.2.1 4.13.2.2 4.13.2.3 4.14
4.14.1 4.14.2 4.14.3 4.14.4
4.15 4.15.1 4.15.2 4.15.3
4.15.4
RHEOLOGY 90 HEAT TRANSFER 90 MASS TRANSFER/INTERFACIAL AREA 90 MIXING
TIME 91 CHEMICAL COMPLEXITY 91 TOPICS FOR DATA ACQUISITION 91
REACTION PROFILES 92 REACTION PICTURES 93 IONIC EQUILIBRIA AND REACTION
SELECTIVITY 95 NITRATION 95 ACYLATION 96 ASSOCIATION EQUILIBRIA -
LITHIUM DIETHYLAMIDE (LDA) 99
KINETICS 99 ORDER OF REACTION 99 CATALYZED PROCESSES 102 THE
RATE-DETERMINING STEP 102
MIXING IN CHEMICAL REACTORS 105 MIXING THEORY 106 MIXING REGIMES 108
MICROMIXING 109 MACROMIXING 110 MESOMIXING 110
DETERMINING MIXING SENSITIVITY IN THE LABORATORY 111 COMMENTS ON
SCALABILITY OF MIXING 111 MULTIPHASE PROCESSES 112 MASS TRANSFER THEORY
113 EFFECT OF MASS TRANSFER ON CHEMICAL REACTION RATES 114 CHEMICAL
RATE-LIMITED REACTION 114 MASS TRANSFER RATE-LIMITED REACTION 114
SOLUBILITY-LIMITED REACTION 114 PHASE EQUILIBRIA 115 PARTITIONING 115
"SALTING OUT" 115 COMMON ION EFFECT 115 MASS TRANSFER AND MIXING
REQUIREMENTS IN MULTIPHASE
SYSTEMS 116 LIQUID- LIQUID SYSTEMS 116 LIQUID- SOLID SYSTEMS 118
GAS-LIQUID SYSTEMS 118
SOLID-LIQUID-GAS SYSTEMS 119 CONCEPTS OF STRUCTURE AND SCALE FOR
EQUIPMENT SELECTION 120 WHAT DO WE MEAN BY "STRUCTURE"? 120 WHAT IS
"PREDICTABILITY"? 121 WHAT IS "INTENSITY"? 121
SCALES OF STRUCTURE 122
IMAGE 4
VIII CONTENTS
4.15.5 HOW SUSCEPTIBLE TO VARIABILITY IS THE PROCESS; WHEN WOULD
DIFFERENT
EQUIPMENT HELP? 123
4.16 CONCLUSION 124
REFERENCES 125
5 USE OF MODELS TO ENHANCE PROCESS UNDERSTANDING 127 WILFRIED HOFFMANN
5.1 INTRODUCTION 127
5.2 THE PROCESS CHARACTERIZATION ELEMENTS OF A CHEMICAL REACTION 128 5.3
THE IMPACT OF MODELING 130
5.4 UNDERSTANDING THE CHEMISTRY 131
5.4.1 A SIMPLE START 131
5.4.2 GETTING REAL RATE PARAMETERS 132 5.4.3 INTRODUCTION OF TEMPERATURE
DEPENDENCE 135 5.4.4 INCLUDING REACTION HEATS 137 5.4.5 PUTTING ELEMENTS
TOGETHER: LARGE-SCALE SIMULATIONS 138
5.4.6 THERMAL PROCESS SAFETY SIMULATIONS 141 5.5 PHYSICAL RATES (THE
ELEMENTS OF MASS TRANSFER) 144 5.5.1 GAS/LIQUID MASS TRANSFER 145 5.5.2
SOLID/LIQUID MASS TRANSFER 149
5.6 SUMMARY AND OUTLOOK 152
REFERENCES 153
6 SCALE-UP OF CHEMICAL REACTIONS 155
E.HUGH STITT AND MARKJ. H. SIMMONS 6.1 INTRODUCTION 155
6.2 CASE STUDY - BATCH HYDROGENATION 156
6.3 SCALE-UP OF STIRRED TANK REACTORS (STRS) 159 6.3.1 FUNDAMENTALS OF
FLOW REGIMES, TURBULENCE, AND TURBULENT MIXING 160 6.3.1.1 MIXING
MECHANISMS IN LAMINAR FLOWS 161
6.3.1.2 MIXING MECHANISMS IN TURBULENT FLOWS 162 6.3.1.3 ESTIMATING
ENERGY DISSIPATION AND MIXING LENGTH SCALES FROM TURBULENT FLOW FIELDS
164 6.3.2 STIRRED VESSEL DESIGN AND SCALE-UP 366
6.3.2.1 IMPELLER FLOW PATTERNS 167 6.3.2.2 POWER INPUT AND SPECIFIC
ENERGY DISSIPATION RATE 167 6.3.2.3 MIXING TIMES 170 6.4 STIRRED TANK
SCALE-UP 171
6.4.1 CHOICE OF CRITERION FOR SCALE-UP IN TURBULENT FLOW 171 6.4.1.1
CONSTANT MIXING TIME (CONSTANT N) 171 6.4.1.2 "CONSTANT" TURBULENT
MIXING BEHAVIOR (CONSTANT ER) 172
6.4.2 HEAT TRANSFER 172
6.4.3 MULTIPHASE SYSTEMS: SOLID-LIQUID SYSTEMS 174 6.4.3.1 PARTICLE
SUSPENSION AND FLOW PATTERNS 175
IMAGE 5
CONTENTS IX
6.4.3.2 SOLID-LIQUID MASS TRANSFER 177
6.4.4 MULTIPHASE SYSTEMS: GAS-LIQUID SYSTEMS 177 6.4.4.1 POWER
CONSUMPTION 178 6.4.4.2 GAS HOLD-UP AND FLOW PATTERNS 178
6.4.4.3 MASS TRANSFER 179 6.4.5 SUMMARY 180
6.5 CHEMISTRY EFFECTS IN SCALE-UP 181 6.5.1 "FED-BATCH" LIQUID-PHASE
REACTIONS 181 6.5.2 LIQUID-SOLID REACTIONS 182 6.5.3 GAS-LIQUID (-SOLID)
REACTIONS 183
6.5.3.1 GASEOUS REACTANT 183 6.5.3.2 GASEOUS PRODUCT 183 6.5.3.3
CATALYSIS 184
6.5.4 IMPURITIES 184
6.6 ACHIEVING PROCESS UNDERSTANDING FOR REACTOR SCALE-UP 184 6.6.1
CHEMISTRY SCALE-UP SENSITIVITY 185 6.6.2 ON THE ACQUISITION OF RELEVANT
CHEMICAL INFORMATION 186 6.6.3 ON THE ACQUISITION OF RELEVANT REACTOR
DESIGN INFORMATION 187 6.7 REACTOR SELECTION 388
6.7.1 SO WHICH REACTOR CAN I USE? 188 6.7.2 GENERIC DUTY 189
6.7.3 CHARACTERIZING MIXING RATE 189 6.7.4 CHARACTERIZING SOLIDS
SUSPENSION 190 6.7.5 CHARACTERIZING HEAT TRANSFER 190 6.7.6
CHARACTERIZING MASS TRANSFER 191 6.8 EXPLOITING PROCESS UNDERSTANDING IN
SCALE-UP 191 6.8.1 MIXING RATE-LIMITED REACTIONS 392 6.8.2 SOLID-LIQUID
MIXING-LIMITED REACTIONS 193 6.8.3 HEAT-TRANSFER-LIMITED REACTIONS 193
6.8.4 MASS-TRANSFER-LIMITED REACTIONS 194 6.9 CONCLUSIONS 194
REFERENCES 195
7 PROCESS UNDERSTANDING - CRYSTALLIZATION 199 LEROY CRONIN, PHILIP J.
KITSON, AND CHICK C. WILSON 7.1 INTRODUCTION 199
7.1.1 CRYSTAL DEFINITION AND STRUCTURE - CRYSTAL DEFECTS AND BASICS OF
CRYSTAL GROWTH 200 7.1.2 THERMODYNAMICS OF CRYSTALLIZATION 202 7.1.3
KINETICS OF CRYSTAL GROWTH, NUCLEATION 204
7.1.3.1 METASTABLE STATES 206 7.1.4 NUCLEATION AND CRYSTAL GROWTH 206
7.1.4.1 SUPERSATURATION AND METASTABLE ZONE WIDTH 206
7.2 CRYSTALLIZATION PROCESSES 208
7.2.1 CRYSTALLIZATION FROM THE MELT 208
IMAGE 6
X I CONTENTS
7.2.1.1 THE BRIDGMAN METHOD 208
7.2.1.2 THE CZOCHRALSKI METHOD 209 7.2.1.3 CRYSTALLIZATION OF ORGANIC
MATERIALS FROM THE MELT 209 7.2.2 CRYSTALLIZATION FROM SOLUTION 209
7.2.2.1 SINGLE SOLVENT CRYSTALLIZATION 209 7.2.2.2 MULTIPLE SOLVENT
CRYSTALLIZATION 233 7.2.2.3 VAPOR DIFFUSION 232 7.2.3 CRYSTALLIZATION
FROM VAPOR 232
7.3 BATCH CRYSTALLIZATION TECHNIQUES 213 7.3.1 TANK CRYSTALLIZERS 233
7.3.2 CONTINUOUS (FLOW) CRYSTALLIZERS 214 7.3.2.1 CONTINUOUS OSCILLATORY
BAFFLED CRYSTALLIZER 235 7.4 PROCESS CONTROL OF CRYSTALLIZATION 236
7.4.1 CRYSTAL GROWTH RATE AND MORPHOLOGY CONTROL 237
7.4.2 PARTICLE AND CRYSTAL SIZE 217 7.4.3 CRYSTAL PURITY 238
7.4.4 COMPOSITION CONTROL (COCRYSTALLIZATION) 238 7.4.5 POLYMORPHISM
CONTROL 239 7.5 ANALYTICAL TECHNIQUES FOR PRODUCT CHARACTERIZATION 239
7.5.1 FOCUSED BEAM REFLECTANCE MEASUREMENTS AND ATTENUATED TOTAL
REFLECTANCE ULTRA VIOLET 220 7. .5.2 DYNAMIC LIGHT SCATTERING 221 7.5.3
ULTRASOUND METHODS 221
7.5.4 X-RAY METHODS 221
7.5.5 DSC/TGA 223
7.6 CONCLUSIONS 225
ACKNOWLEDGMENTS 225 REFERENCES 225
8 KEY TECHNOLOGIES AND OPPORTUNITIES FOR INNOVATION AT THE DRUG
SUBSTANCE-DRUG PRODUCT INTERFACE 229 COLM CAMPBELL AND BRIAN KEAVENY 8.1
INTRODUCTION 229
8.1.1 THE DRUG SUBSTANCE-DRUG PRODUCT INTERFACE 229 8.1.2 PHYSICAL
CHARACTERISTICS AND BIOAVAILABILITY 231 8.2 OPPORTUNITIES FOR INNOVATION
233
8.2.1 TAILORED APIS 234
8.2.2 PART-FORMULATED APIS 234 8.3 CRYSTALLIZATION 234
8.3.1 SPHERICAL CRYSTALLIZATION 235 8.3.2 ULTRASONIC CRYSTALLIZATION 236
8.3.3 CONTINUOUS CRYSTALLIZATION 237 8.4 SELECTED MANUFACTURING
TECHNOLOGIES AT THE DRUG SUBSTANCE-DRUG
PRODUCT INTERFACE 237
8.4.1 MICRONIZATION 238
IMAGE 7
CONTENTS XI
8.4.1.1 JET MILLING 238
8.4.1.2 SCF PRECIPITATION 239 8.4.1.3 CONTRAST BETWEEN JET MILLED AND IN
SITU MICRONIZED MATERIAL 239 8.4.2 NANONIZATION 240
8.4.2.1 CONTRASTING PERFORMANCE OF MICRO-AND NANOPARTICLES 241 8.4.3
BLENDING 242
8.4.4 ROLLER COMPACTION 243 8.5 ANALYTICAL TECHNIQUES 243
8.5.1 SURFACE/PARTICULATE 244 8.5.1.1 ATOMIC FORCE MICROSCOPY (AFM) 244
8.5.1.2 DYNAMIC VAPOR SORPTION (DVS) 244 8.5.1.3 FOCUSSED ION BEAM (FIB)
244 8.5.1.4 INVERSE GAS CHROMATOGRAPHY (IGC) 245 8.5.1.5 PARTICLE SIZE
245
8.5.1.6 PARTICLE SHAPE 247 8.5.1.7 PYCNOMETRY 247 8.5.1.8 SURFACE AREA
(BET) 247 8.5.1.9 X-RAY TOMOGRAPHY (XRT) 247
8.5.2 BULK 247
8.5.2.1 ANGLE OF REPOSE, CARR'S INDEX, AND HAUSNER RATIO 248 8.5.2.2
DYNAMIC MECHANICAL ANALYSIS (DMA) 249 8.5.2.3 DRY POWDER RHEOLOGY AND
DYNAMIC AVALANCHING 249 8.5.3 BLENDS 251
8.5.3.1 NEAR-IR 251
8.5.3.2 THERMAL EFFUSIVITY 251 8.5.3.3 LASER LIGHT SCATTERING 252 8.6
CONCLUSIONS 252
ACKNOWLEDGMENTS 252 REFERENCES 252
9
9.1 9.2 9.3 9.4 9.4.1 9.4.2
9.4.3 9.4.4 9.4.5 9.4.6
9.4.7
PROCESS UNDERSTANDING REQUIREMENTS IN ESTABLISHED MANUFACTURE 255 DYLAN
JONES INTRODUCTION 255 THE STATUS QUO 256
RISK AND REWARD 257 TERMS AND DEFINITIONS 258 PAT 258
PROCESS UNDERSTANDING, CRITICAL QUALITY ATTRIBUTES, AND CRITICAL PROCESS
PARAMETERS 258 QUALITY BY DESIGN 259 DESIGN SPACE 259
DESIGN SPACE AS APPLIED TO SPECTRAL ANALYZERS 259 FITNESS FOR PURPOSE
259 SPECTRAL ANALYZERS 260
IMAGE 8
XII CONTENTS
9.4.8
9.4.9 9.4.10 9.4.11 9.5 9.5.1 9.5.2 9.5.2.1
9.5.2.2 9.5.2.3 9.5.2.4 9.5.2.5
9.5.3 9.5.3.1 9.5.3.2 9.5.3.3
9.5.4 9.5.5 9.5.5.1 9.5.5.2
9.5.5.3 9.5.5.4 9.5.5.5 9.5.6 9.5.6.1 9.5.6.2
9.5.6.3 9.5.7 9.6 9.6.1
9.6.2 9.6.3 9.6.3.1 9.6.3.2
9.7 9.7.1 9.7.2 9.7.3 9.7.4 9.7.5 9.8 9.8.1 9.8.1.1 9.8.1.2 9.8.1.3
MULTIVARIATE CALIBRATIONS 260 PROCESS CAPABILITY 260 PROCESS KNOWLEDGE
260 CONTINUOUS QUALITY VERIFICATION 260 PROCESS UNDERSTANDING
REQUIREMENTS 263
START WITH THE END IN MIND 263 GENERAL CONSIDERATIONS 262 REGULATORY 262
INFORMATION TECHNOLOGY 262
R&D/ENGINEERING 262 QUALITY ASSURANCE 263 PRODUCTION 263 CHARACTERISTICS
OF CONTINUOUS PROCESSES 263
PHASES OF OPERATION 263 MASS AND ENERGY BALANCE 264 FLUID DYNAMICS 264
MEASURABLE VARIATION IN A PROCESS 264 UNCERTAINTY IN THE ANALYTICAL
MEASUREMENTS 265 ANALYZER DESIGN 265 PRECISION 266
RANGE 266 SAMPLING FREQUENCY 266 SAMPLE SIZE 267 UNDERSTANDING THE
CONTROL SYSTEM 267
LAG 267 OSCILLATIONS 268 TUNING 268 FAILURE MODES AND EFFECTS ANALYSIS
(FMEA) 268
METHOD DEVELOPMENT AND INSTALLATION 269 STARTING ON THE PLANT 269
STARTING IN THE LAB 269 SCALED-DOWN MODELS 270
SIMPLE 270 COMPLEX 270 STATISTICAL PROCESS CONTROL 273 TIME SERIES
CHARTS 272
2D PLOTS 272 PARALLEL COORDINATE GEOMETRY 273 MULTIVARIATE ANALYSIS 274
THE ANALYSIS OF NOISE 274
AUTOMATION 275 BUSINESS DRIVERS FOR AUTOMATION 275 COST BENEFITS 275
MORE CONSISTENT QUALITY 275 IMPROVED COMPLIANCE 276
IMAGE 9
CONTENTS XIII
9.8.2 THE CONTROL PHILOSOPHY 276
9.8.3 SIGNAL CONDITIONING 277 9.8.4 UNIVARIATE CONTROL 277
9.8.5 MODEL PREDICTIVE CONTROL 279 9.9 CONCLUSION 279
REFERENCES 280
10 PLANT DESIGN 283
MARKJ. DICKSON
10.1 INTRODUCTION 283
10.1.1 CAPEX PROJECT PHASES 284 10.1.2 STARTING PLANT DESIGN 286 10.1.3
EQUIPMENT SELECTION 287 10.1.4 ASSETS (EXISTING OR NEW) 289 10.2
DEVELOPING PROCESS CONCEPT TO PLANT CONCEPT 290 10.2.1 PROCESS
INFORMATION 290 10.2.2 PHYSICAL PROPERTIES 292 10.2.3 IMPACT OF
OBSERVATIONS ON DESIGN 293 10.2.4 EQUIPMENT SELECTION DECISIONS IN
PROCESS
DEVELOPMENT 293
10.2.5 COMBINING AND SPLITTING TASKS 293 10.2.6 BATCH VERSUS CONTINUOUS
PROCESSING 295 10.2.7 SUSTAINABILITY 297 10.2.8 THE OPPORTUNITY FOR
INNOVATION 298
10.3 REGULATIONS 298
10.3.1 LEGAL REQUIREMENTS 299 10.3.2 INDUSTRY STANDARDS 299 10.3.3
DEVELOPING THE KNOWLEDGE BASE 300 10.3.4 QUALITY CONTROL 300 10.4
INFRASTRUCTURE DESIGN 301
10.4.1 PLUG'N'PLAY 301
10.5 PORTFOLIO ANALYSIS AND ASSET PLANNING 302 10.5.1 FINDING THE
OPTIMUM PROCESS FOR MY COMPANY 303 10.5.2 AGILE AND/OR LEAN
MANUFACTURING 303 10.5.3 ASSET PLANNING OPTIONS 304 10.5.4 THE CONTRACT
MANUFACTURER 305
11 CONTRACT MANUFACTURE 307
STEVE WOOLLEY
11.1 INTRODUCTION 307
11.2 WHY CONTRACT? 307
11.3 THE CONTRACTOR 308
11.4 THE CLIENT 309
11.4.1 SCOPE REQUIRED BY A CLIENT 309 11.5 TECHNOLOGY TRANSFER 311
IMAGE 10
XIV CONTENTS
11.5.1 PRIOR TO WINNING THE CONTRACT 333
11.5.2 AFTER WINNING THE CONTRACT 332 11.6 WHAT MAKES A GOOD TECHNICAL
PACKAGE? 313 11.7 CLIENT PROCESS UNDERSTANDING 334 11.8 CASE STUDIES 335
11.9 WINNING AND DELIVERING THE PROJECT 316 11.9.1 WINNING THE BUSINESS
316 11.9.2 DELIVERING THE SCOPE 318
11.9.2.1 CASE STUDY 320 11.10 PROJECT TIMING 320
11.11 CHALLENGES OF MULTIPRODUCT PLANT SCHEDULING AGAINST AN UNCERTAIN
BACKGROUND 323 11.12 CONCLUSION 322
12 WHOLE PROCESS DESIGN 323
PAUL SHARRATT
12.1 PROCESS UNDERSTANDING FOR WHOLE PROCESS DESIGN 323 12.1.1 PROCESS
COMPLEXITY AND ITS IMPACT ON DATA NEEDS FOR UNDERSTANDING 327 12.1.2
PROCESS DESIGN PHILOSOPHIES 330
12.2 PROCESS OUTCOMES 330
12.3 ORGANIZATION OF THE DESIGN ACTIVITY 331 12.4 RISK AND UNCERTAINTY
IN WPD 333 12.5 WHOLE PROCESS REPRESENTATIONS 335 12.6 DECISION MAKING
IN WPD 337
12.6.1 DECISIONS ABOUT THE DESIGN ACTIVITY 337 12.6.2 DECISIONS IN
PROCESS DEVELOPMENT 338 12.7 SUMMARY 340
REFERENCES 340
INDEX 343 |
| any_adam_object | 1 |
| author2 | Houson, Ian |
| author2_role | edt |
| author2_variant | i h ih |
| author_facet | Houson, Ian |
| building | Verbundindex |
| bvnumber | BV037403289 |
| classification_rvk | VN 5000 |
| collection | ebook |
| ctrlnum | (OCoLC)812382450 (DE-599)DNB1008658790 |
| dewey-full | 660.28 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 660 - Chemical engineering |
| dewey-raw | 660.28 |
| dewey-search | 660.28 |
| dewey-sort | 3660.28 |
| dewey-tens | 660 - Chemical engineering |
| discipline | Chemie / Pharmazie |
| edition | 1. Aufl. |
| format | Electronic eBook |
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| id | DE-604.BV037403289 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-20T11:08:14Z |
| institution | BVB |
| isbn | 9783527637140 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-022555904 |
| oclc_num | 812382450 |
| open_access_boolean | 1 |
| owner | DE-11 |
| owner_facet | DE-11 |
| physical | 1 Online-Ressource |
| psigel | ebook |
| publishDate | 2011 |
| publishDateSearch | 2011 |
| publishDateSort | 2011 |
| publisher | Wiley-VCH |
| record_format | marc |
| spelling | Process understanding for scale-up and manufacture of active ingredients ed. by Ian Houson 1. Aufl. Weinheim Wiley-VCH 2011 1 Online-Ressource txt rdacontent c rdamedia cr rdacarrier Druckausg. u.d.T.: Process understanding (XVIII, 351 S.) Pharmazeutische Chemie (DE-588)4132158-3 gnd rswk-swf Prozessentwicklung Technik (DE-588)4278925-4 gnd rswk-swf Chemische Verfahrenstechnik (DE-588)4069941-9 gnd rswk-swf Chemische Verfahrenstechnik (DE-588)4069941-9 s Pharmazeutische Chemie (DE-588)4132158-3 s Prozessentwicklung Technik (DE-588)4278925-4 s DE-604 Houson, Ian edt X:MVB text/html http://deposit.dnb.de/cgi-bin/dokserv?id=3620658&prov=M&dok%5Fvar=1&dok%5Fext=htm Verlag kostenfrei Inhaltstext DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=022555904&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Process understanding for scale-up and manufacture of active ingredients Pharmazeutische Chemie (DE-588)4132158-3 gnd Prozessentwicklung Technik (DE-588)4278925-4 gnd Chemische Verfahrenstechnik (DE-588)4069941-9 gnd |
| subject_GND | (DE-588)4132158-3 (DE-588)4278925-4 (DE-588)4069941-9 |
| title | Process understanding for scale-up and manufacture of active ingredients |
| title_auth | Process understanding for scale-up and manufacture of active ingredients |
| title_exact_search | Process understanding for scale-up and manufacture of active ingredients |
| title_full | Process understanding for scale-up and manufacture of active ingredients ed. by Ian Houson |
| title_fullStr | Process understanding for scale-up and manufacture of active ingredients ed. by Ian Houson |
| title_full_unstemmed | Process understanding for scale-up and manufacture of active ingredients ed. by Ian Houson |
| title_short | Process understanding |
| title_sort | process understanding for scale up and manufacture of active ingredients |
| title_sub | for scale-up and manufacture of active ingredients |
| topic | Pharmazeutische Chemie (DE-588)4132158-3 gnd Prozessentwicklung Technik (DE-588)4278925-4 gnd Chemische Verfahrenstechnik (DE-588)4069941-9 gnd |
| topic_facet | Pharmazeutische Chemie Prozessentwicklung Technik Chemische Verfahrenstechnik |
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