Lyophilization: introduction and basic principles
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Denver, Colo.
Interpharm Press
1999
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| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XVII, 646 S. Ill., graph. Darst. |
| ISBN: | 1574910817 |
Internformat
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| 100 | 1 | |a Jennings, Thomas A. |e Verfasser |4 aut | |
| 245 | 1 | 0 | |a Lyophilization |b introduction and basic principles |c Thomas A. Jennings |
| 264 | 1 | |a Denver, Colo. |b Interpharm Press |c 1999 | |
| 300 | |a XVII, 646 S. |b Ill., graph. Darst. | ||
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| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 650 | 4 | |a Freeze-drying | |
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Datensatz im Suchindex
| _version_ | 1804128862711316480 |
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| adam_text | LYOPHILIZATION INTRODUCTION AND BASIC PRINCIPLES THOMAS A. JENNINGS
INTERPHARM PRESS DENVER, COLORADO P R E S S CONTENTS PREFACE VII 1.
INTRODUCTION 1 HISTORICAL REVIEW 1 EVOLUTION OF PROCESS AND EQUIPMENT 3
DEFINITION OF LYOPHILIZATION 4 GENERAL DESCRIPTION OF THE PROCESS 4
FORMULATION 4 FREEZING 5 PRIMARY DRYING 6 SECONDARY DRYING 6
CONTAINER-CLOSURE SYSTEM 6 FREEZE-DRYING EQUIPMENT 6 THE FREEZE-DRYING
CHAMBER * THE CONDENSER CHAMBER * THE VACUUM PUMPING SYSTEM PROPERTIES
OF LYOPHILIZED MATERIALS 8 STABILITY 8 LONG-TERM OR REAL-TIME STABILITY
TESTING * ACCELERATED STABILITY TESTING COSMETIC PROPERTIES 9 MOISTURE
10 FREE WATER * BOUND WATER RECONSTITUTION 11 APPLICATIONS 11 HEALTHCARE
INDUSTRY 11 VETERINARY 12 FOOD 12 OTHER APPLICATIONS 12 REFERENCES 13 2.
PRODUCT FORMULATION 15 INTRODUCTION 15 IV LYOPHILIZATION: INTRODUCTION
AND BASIC PRINCIPLES ACTIVE CONSTITUENT 16 SYNTHETIC 16 CISPLATIN *
SODIUM SALT OF [2,3-DICHLORO-4-(METHYLENEBUTYRYL)PHENOX] ACETIC ACID
NATURE DERIVED 17 VACCINES * PROTEINS PHYSICAL STATE 18 SOLVENT SYSTEM *
HUMIDIFICATION * THERMAL TREATMENT OTHER CONSTITUENTS 19 BUFFERS 20 LAW
OF MASS ACTION * DEFINITION OF PH * BUFFER SOLUTION BULKING COMPOUNDS 29
MANNITOL * POLYVINYL PYRROLIDONE * OTHER BULKING AGENTS STABILIZING
AGENTS 33 LAW OF MASS ACTION * EXCIPIENT INDUCED CRYSTALLIZATION OF THE
ACTIVE CONSTITUENT CRYOPROTECTANTS 35 LYOPROTECTANTS 36 SOLVENTS 37
NATURE OF WATER 38 SOLUBILITY AND SOLVATION PROPERTIES OF WATER 39
SOLUBILITY MECHANISM * SOLVATION OTHER SOLVENT SYSTEMS 41
CRYSTALLIZATION OF THE ACTIVE CONSTITUENT * STABILITY OF THE ACTIVE
CONSTITUENT PHYSICAL CHARACTERISTICS 42 COLLIGATIVE PROPERTIES 42
FREEZING-POINT DEPRESSION * OSMOLARITY CONCENTRATION PROPERTIES 44
OPTICAL PARTICULATE MATTER 48 VISIBLE PARTICLES AND MEANS FOR THEIR
DETECTION * SUBVISIBLE PARTICLES AND MEANS FOR THEIR DETECTION * VARIOUS
SOURCES OF EXTRINSIC PARTICULATE MATTER IN A FORMULATION THERMAL
PROPERTIES 52 THE FUNCTION OF THERMAL PROPERTIES 52 EFFECT ON THE COST
OF MANUFACTURING 53 IMPACT ON THE FREEZE-DRYER 53 SYMBOLS 54 REFERENCES
55 3. THE IMPORTANCE OF PROCESS WATER 59 ROLE OF PROCESS WATER IN
LYOPHILIZATION 59 INTRODUCTION 59 PURITY 59 TOTAL SOLIDS * INORGANIC
COMPOUNDS * CONDUCTIVITY * PH MEASURE- MENTS * ORGANIC COMPOUNDS *
MICROBIAL AND ENDOTOXIN LEVELS CONTENTS HYDROGEN BONDING 62 FORMATION 62
IMPACT OF EXCIPIENTS OR IMPURITIES 63 DEGREE OF SUPERCOOLING 64
HETEROGENEOUS NUCLEATION 64 HOMOGENEOUS NUCLEATION 65 RATE OF ICE GROWTH
67 EFFECT ON CAKE STRUCTURE 67 CAKE STRUCTURE WITHOUT EXCIPIENT
INTERACTION * CAKE STRUCTURE WITH EXCIPIENT INTERACTION STRUCTURE OF ICE
71 POLYMORPHIC FORMS OF ICE 72 HEXAGONAL STRUCTURE OF 1^ 73 AFFECT OF
SOLUTES 74 CLATHRATES OR GAS HYDRATES * AMORPHOUS FROZEN WATER
ELECTRICAL CONDUCTIVITY OF ICE 76 DISORDERED SURFACE REGION 77
CONDUCTIVITY OF ICE 78 INTRINSIC CONDUCTIVITY OF ICE * SURFACE
CONDUCTIVITY OF ICE SUMMARY 79 SYMBOLS 80 REFERENCES 81 4. PHASE CHANGES
83 IMPORTANCE OF PHASE CHANGES 83 HOMOGENEOUS AND HETEROGENEOUS SYSTEMS
84 HOMOGENEOUS SYSTEM 84 HETEROGENEOUS SYSTEM 84 CONSTITUENTS AND
COMPONENTS 85 CONSTITUENT 85 COMPONENT 85 INTENSIVE STATE VARIABLES 86
EQUILIBRIUM BETWEEN PHASES 86 DEGREES OF FREEDOM 87 PHASE RULE 87
CLAPERYON-CLAUSIS EQUATION 88 GLASSY STATES 89 FORMULATION 90 LATENT
HEAT OF MELTING 91 GLASS TRANSITION AND COLLAPSE TEMPERATURES 91 SYMBOLS
91 REFERENCES 92 5. THE THERMAL PROPERTIES OF FORMULATIONS 93 NEED FOR
IDENTIFYING THERMAL PROPERTIES 93 VI LYOPHILIZATION: INTRODUCTION AND
BASIC PRINCIPLES REPRODUCIBILITY OF THE FORMULATION 93 RATIONALE FOR THE
FREEZING AND PRIMARY DRYING PROCESSES 94 ICE-LIKE WATER CLUSTERS 94
DEGREE OF SUPERCOOLING 95 EQUILIBRIUM FREEZING TEMPERATURE 95 THE WATER
SYSTEM 95 FORMULATION 96 DEGREE OF CRYSTALLIZATION 97 EUTECTIC
TEMPERATURE 99 DEFINITIONS 100 GIBB S PHASE RULE * FREEZING-POINT
DEPRESSION FREQUENCY OF EUTECTIC POINTS IN FORMULATIONS 101 COLLAPSE
TEMPERATURE 102 INTERSTITIAL MELTING TEMPERATURE 103 ICE MELTING
TEMPERATURE 103 METASTABLE STATES 103 ACTIVATION ENERGY 104 SYMBOLS 105
REFERENCES 106 6. THERMAL ANALYTICAL METHODS 109 INTRODUCTION 109
THERMAL ANALYSIS 109 DESCRIPTION OF THE APPARATUS 110 ANALYTICAL METHOD
111 CONTAINER * CERTIFICATION OF THE THERMOCOUPLES * FILL VOLUME * SETUP
OF THE APPARATUS * COOLING * WARMING INTERPRETATION OF THE DATA 112
COOLING DATA * WARMING DATA SUMMARY AND COMMENTS 114 APPARATUS *
ANALYTICAL METHOD * THERMAL CHARACTERISTICS DIFFERENTIAL THERMAL
ANALYSIS 115 DESCRIPTION OF THE APPARATUS 116 ANALYTICAL METHOD 116
INTERPRETATION OF THE DATA 116 SODIUM CHLORIDE SOLUTION * EARL S
SOLUTION WITH GLUCOSE AND GLYCINE SUMMARY AND COMMENTS 119 APPARATUS *
ANALYTICAL METHOD * THERMAL CHARACTERISTICS * LIMITATIONS DIFFERENTIAL
SCANNING CALORIMETRY 121 DESCRIPTION OF THE APPARATUS 121 HEAT FLUX
DESIGN * NULL-BALANCE SYSTEM * GENERAL CHARACTERISTICS OF DSC SYSTEMS
ANALYTICAL METHOD 124 CALIBRATION AND CERTIFICATION * PREPARATION OF THE
SAMPLE AND REFER- ENCE * FREEZING OF THE SAMPLE * WARMING TEMPERATURE
SCANNING RATE CONTENTS VLL INTERPRETATION OF THE DATA 125 COOLING
THERMOGRAM * WARMING THERMOGRAM SUMMARY AND COMMENTS 129 APPARATUS *
ANALYTICAL METHOD * THERMAL CHARACTERISTICS FREEZING MICROSCOPE 132
DESCRIPTION OF THE APPARATUS AND ANALYTICAL METHOD 132 PHOTOMICROGRAPHY
AND CINEMICROGRAPHY * FREEZE-DRYING MICROSCOPE INTERPRETATION OF THE
OBSERVATIONS 134 FREEZING PROCESS * FREEZE-DRYING DURING WARMING SUMMARY
AND COMMENTS 136 ADVANTAGES OF THE FREEZE-DRYING MICROSCOPE *
LIMITATIONS OF THE FREEZE- DRYING MICROSCOPE ELECTRICAL RESISTANCE 138
INTRODUCTION 138 OHM S LAW * RELATIONSHIP BETWEEN RESISTANCE AND
RESISTIVITY * CONDUCTION MECHANISM * PARKER EFFECT DESCRIPTION OF THE
APPARATUS 142 MULTIELECTRODE SYSTEM * DUAL ELECTRODE SYSTEM * VERTICAL
RESISTIVITY CELL ANALYTICAL METHODS 146 MULTIELECTRODE SYSTEM * DUAL
ELECTRODE SYSTEM * VERTICAL RESISTIVITY CELL INTERPRETATION OF THE DATA
147 MULTIELECTRODE SYSTEM * DUAL ELECTRODE SYSTEM * VERTICAL RESISTIVITY
CELL SUMMARY AND COMMENTS 151 DIELECTRIC ANALYSIS 153 INTRODUCTION 153
DESCRIPTION OF THE APPARATUS 155 ANALYTICAL METHOD 156 PREPARATION OF
THE SAMPLE * TEST METHOD INTERPRETATION OF THE DATA 156 WATER *
RELAXATION TIME * DCC AND TOF METHODS SUMMARY AND COMMENTS 159
THEORETICAL BASIS FOR DEA MEASUREMENTS * APPARATUS * ANALYTICAL METHOD *
INTERPRETATION OF THE DATA D 2 AND DTA ANALYTICAL SYSTEM 162
INTRODUCTION 162 DJ ANALYSIS DESCRIPTION OF THE APPARATUS 165 TEST
CONTAINERS, SENSORS, AND RESISTANCE CELLS * DATA COLLECTION AND COMPUTER
SYSTEM ANALYTICAL METHOD 166 RUN IDENTIFICATION * CALIBRATION * SETUP OF
THE ANALYSIS * COOLING ANALYSIS * WARMING ANALYSIS * PRINTOUT OF DATA
INTERPRETATION OF THE DATA 170 COOLING * WARMING SUMMARY AND COMMENTS
186 APPARATUS * INTERPRETATION OF THE DATA VIII LYOPHILIZATION:
INTRODUCTION AND BASIC PRINCIPLES SYMBOLS . 188 REFERENCES 191 APPENDIX
A: DATA FOR THERMAL PROPERTIES OF A 0.9% NACL SOLUTION DURING COOLING
AND WARMING 193 APPENDIX B: DATA FOR A D 2 AND DTA ANALYSIS OF A 0.9%
(WT/V) NACL SOLUTION 203 APPENDIX C: DATA FOR 3% (WT/V) AND 0.9% NACL
(WT/V) SOLUTION 227 APPENDIX D: DATA FOR A D 2 AND DTA ANALYSIS OF A 3%
LACTOSE SOLUTION 252 7. THE FREEZING PROCESS 261 INTRODUCTION 261
FORMATION OF THE FROZEN MATRIX 262 FORMATION OF ICE CRYSTALS 262 MUSHY
SYSTEM 262 INTERSTITIAL REGION 263 GLASSY STATE * CRYSTALLINE AND GLASSY
STATES * CRYSTALLINE STATE FROZEN MATRIX 266 IMPACT OF THE FILL VOLUME
267 HEAT-TRANSFER RATE 267 HEAT TRANSFER DURING FREEZING 268 FREEZING
FUNCTIONS AND METHODS 270 INTRODUCTION 270 FORMULATION #1 271
FORMULATION #2 274 FORMULATION #3 275 OTHER FREEZING METHODS 276
IMMERSION FREEZING * SNAP FREEZING SYMBOLS 279 REFERENCES 280 8. THE
PRIMARY DRYING PROCESS 283 INTRODUCTION 283 THE FUNCTION OF THE PRIMARY
DRYING PROCESS 283 THE PERCEPTION OF THE PRIMARY DRYING PROCESS 283 THE
SUBLIMATION PROCESS 284 GENERAL ASSUMPTIONS 284 MATRIX TEMPERATURE *
DISORDERED ICE LAYER * FREQUENCY DISTRIBUTION OF ENERGY THE SUBLIMATION
OF ICE 286 SUBLIMATION MODEL BY MAENO AND NISHIMURA * SUBLIMATION MODEL
BY PIKAL, SHAH, SENIOR, AND LANG * RATE OF SUBLIMATION BY LIVESEY AND
ROWE * SUBLIMATION MODEL BY DUSHMAN * EFFECTS OF CHAMBER PRESSURE AND
SHELF-SURFACE TEMPERATURE EFFECT OF CONTAINER CONFIGURATION 292
HEAT-TRANSFER RATE * HEAT TRANSFER BETWEEN THE SHELF SURFACE AND A TRAY
* HEAT TRANSFER BETWEEN THE SHELF SURFACE AND A VIAL CONTENTS IX PRIMARY
DRYING OF A FORMULATION 306 CONFIGURATION OF THE FROZEN MATRIX * THE
EFFECT OF THE INTERSTITIAL REGION ON THE PRIMARY DRYING PROCESS KEY
PROCESS PARAMETERS GENERAL RELATIONSHIP BETWEEN P C , T P , AND T S 313
PRIMARY DRYING INDEPENDENT OF THE BATCH SIZE * SIZE AND MANUFACTURER OF
THE FREEZE-DRYER CHAMBER PRESSURE 314 EFFECT OF LACK OF PRESSURE CONTROL
ON PRIMARY DRYING * IMPACT OF THE NATURE OF THE PRESSURE GAUGE * GAUGE
LOCATION AND DESIGN FEATURES OF THE DRYER * SUMMARY SHELF TEMPERATURE
319 FLUID-SHELF TEMPERATURE * INLET AND OUTLET FLUID TEMPERATURES *
SHELF- SURFACE TEMPERATURE PRODUCT TEMPERATURE 322 THE IMPORTANCE OF
MONITORING T * INDIRECT DETERMINATION OF T P * MANO- METRIC MEASUREMENTS
OF T_ CONDENSER TEMPERATURE 330 HIGH T C VALUES * LOW OPERATING P C
VALUES THE CONDENSER EXAMPLES OF PRIMARY DRYING PROCESSES FORMULATION #1
332 DETERMINATION OF THE OPERATING PARAMETERS FORMULATION #1
FORMULATION #2 334 DETERMINATION OF THE OPERATING PARAMETERS
FORMULATION #2 FORMULATION #3 335 DETERMINATION OF THE OPERATING
PARAMETERS FORMULATION #3 SUMMARY 338 PROCESS MONITORING TECHNIQUES
PRESSURE RISE TEST 339 COMPARATIVE PRESSURE MEASUREMENT 339 DIELECTRIC
MOISTURE SENSOR 340 WINDMILL DEVICE 342 SUMMARY 342 CALORIMETRIC
MEASUREMENT TECHNIQUES INTRODUCTION 343 METHOD FOR MAKING CALORIMETRIC
MEASUREMENTS 313 DESIGN AND CONSTRUCTION OF PRIMARY DRYING PROCESS FOR
PRIMARY DRYING PROCESS FOR PRIMARY DRYING PROCESS FOR 331 339 343 343
DETERMINATION OF Q M * DETERMINATION OF H M T DETERMINATION O/C 0 345
PREPARATION OF THE SENSOR VIAL * MEASUREMENT METHOD * DETERMINATION OF C
O VALUE MEASUREMENT O/Q M AND H M DURING PRIMARY DRYING 346 APPLICATIONS
OF THE FREQUENCY DISTRIBUTION OFC 0 348 SENSORS FOR CALORIMETRIC
MEASUREMENTS * STANDARD DEVIATION SUMMARY 350 X LYOPHILIZATION:
INTRODUCTION AND BASIC PRINCIPLES SYMBOLS 350 REFERENCES 353 9.
SECONDARY DRYING PROCESSES 355 INTRODUCTION 355 ROLE OF THE DRYING
PROCESS 355 HISTORICAL BACKGROUND 355 GENERAL DESCRIPTION OF SECONDARY
DRYING 356 CRITERIA FOR SELECTING SECONDARY DRYING PARAMETERS 356
RESIDUAL MOISTURE AND STABILITY 357 RESIDUAL MOISTURE * BOUND WATER
ABSORPTION, ADSORPTION, AND DESORPTION OF GASES 359 ABSORPTION *
ADSORPTION * DESORPTION MODEL FOR SECONDARY DRYING 363 MODEL * EXAMPLES
OF ADSORPTION OR DESORPTION ISOTHERMS OF LYOPHILIZED PRODUCTS SECONDARY
DRYING PARAMETERS 368 STANDARD OPERATING SECONDARY DRYING PARAMETERS *
CALORIMETRIC MONITOR- ING OF SECONDARY DRYING PROCESS MONITORING
TECHNIQUES 372 PRESSURE RISE TEST 372 DESCRIPTION OF THE TEST METHOD *
COMMENTARY COMPARATIVE PRESSURE SENSORS 373 DESCRIPTION OF THE METHOD *
COMMENTARY HUMIDITY SENSOR 375 DESCRIPTION OF THE METHOD * COMMENTARY
RESIDUAL GAS ANALYSIS 375 DESCRIPTION OF THE ANALYTICAL METHOD *
COMMENTARY PURGE METHOD 376 CALORIMETRIC MEASUREMENTS 377 RESULTS OF
CALORIMETRIC MEASUREMENTS DURING SECONDARY DRYING * COMMENTARY EXAMPLES
OF THE SECONDARY DRYING PROCESS 379 FORMULATION #1 380 SELECTION OF THE
OPERATING PARAMETERS * SECONDARY DRYING FOR FORMULATION #1 *
DETERMINATION OF COMPLETION OF SECONDARY DRYING * STOPPERING OF THE
VIALS * COMMENTARY FORMULATION #2 383 SELECTION OF THE OPERATING
PARAMETERS * SECONDARY DRYING FOR FORMULATION #2 * DETERMINATION OF
COMPLETION OF SECONDARY DRYING FORMULATION #3 386 SELECTION OF THE
OPERATING PARAMETERS * SECONDARY DRYING FOR FORMULATION #3 *
DETERMINATION OF COMPLETION OF SECONDARY DRYING SYMBOLS 390 REFERENCES
391 CONTENTS XI 10. PRODUCT PROPERTIES 393 INTRODUCTION 393 NEED FOR
EVALUATION OF THE LI/OPHILIZED PRODUCT 393 GENERAL OVERVIEW OF THE
CHAPTER 393 GENERAL PHYSICAL PROPERTIES OF THE CAKE * MOISTURE *
RECONSTITUTION * STABILITY PHYSICAL PROPERTIES 395 EFFECTS OF THE
FORMULATION 395 TRANSITION TEMPERATURE * CAKE VOLUME * COLOR * TEXTURE *
CAKE DEN- SITY * SHRINKAGE OR COLLAPSE * PORES * CRYSTALLIZATION *
STRUCTURE * CAKE STRENGTH * FRACTUREABILITY * VIAL BREAKAGE EFFECTS OF
THE LYOPHILIZATION PARAMETERS 405 POTENCY * MATRIX STRUCTURE * BILAYER
STRUCTURE * FROTH OR FOAM * CAKE STRENGTH * CRUST OR GLA/E * COLLAPSE *
MELTBACK * PUFFING * BROWN- ING * EFFECTS OF STORAGE MOISTURE 410
RESIDUAL AND BOUND WATER 410 RESIDUAL MOISTURE AND FREE WATER *
DEPENDENCE ON SURFACE AREA * CHANGE IN THE RESIDUAL MOISTURE CONTENT *
BOUND WATER ANALYTICAL METHODS 412 GRAVIMETRIC ANALYSIS OF BULK
MATERIALS * GRAVIMETRIC ANALYSIS OF LYOPHILIZED PRODUCTS *
THERMOGRAVIMETRIC ANALYSIS * KARL FISCHER METHOD * COULOMETRIC KARL
FISCHER ANALYSIS * COMPARATIVE STUDY OF GRAVIMETRIC, THERMOGRAVIMETRIC,
AND KARL FISCHER MOISTURE ANALYSES * WATER PRESSURE DETERMINATION * HIGH
VACUUM MOISTURE DETERMINATION RECONSTITUTION 426 THE DILUENT 426 PH OF
THE DILUENT * TEMPERATURE * PARTICULATE MATTER * DILUENT FORMULATION
RECONSTITUTION TIME 427 SURFACE AREA AND PHYSICAL PROPERTIES * METHODS
FOR RECONSTITUTION * RELA- TIONSHIP OF LYOPHILIZATION PROCESS AND
RECONSTITUTION * EFFECT OF STORAGE SPECIFICATIONS FOR PARTICULATE MATTER
429 USP LIMITS FOR PARTICULATE MATTER FOR INJECTABLE SOLUTIONS * SOURCES
OF SUBVISIBLE PARTICLES * MEASUREMENT OF PARTICULATE MATTER ADDITIONAL
TESTS OF THE RECONSTITUTED FORMULATION 431 COLLIGATIVE PROPERTIES *
CONCENTRATION PROPERTIES PRODUCT STABILITY 432 INTRODUCTION 432
REAL-TIME STABILITY 432 ACCELERATED DETERMINATION OF STABILITY 432 KEY
PRODUCT PROPERTIES AFFECTING STABILITY 432 STRUCTURE * MOISTURE *
CONTAINER SYSTEM REVIEW OF STATISTICAL METHODS AND CONTROL CHARTS 434
FREQUENCY DISTRIBUTION * ARITHMETIC MEAN * STANDARD DEVIATION REAL-TIME
STABILITY STUDIES 438 MOISTURE CONTENT * PRODUCT STABILITY XII
LYOPHILIZATION: INTRODUCTION AND BASIC PRINCIPLES ACCELERATED STUDIES
443 ARRHENIUS RATE EQUATION * DESCRIPTION OF THE METHOD * GENERAL
REACTION EXPRESSION * RESULTS OF ARRHENIUS ACCELERATED STUDIES SYMBOLS
451 REFERENCES 452 11. VACUUM TECHNOLOGY 457 INTRODUCTION 457 THE NEED
TO UNDERSTAND VACUUM TECHNOLOGY 457 OBJECTIVES OF THE CHAPTER 458
KINETIC THEORY OF GASES 459 POSTULATES 459 GAS PRESSURE 459 UNITS OF
PRESSURE * PARTIAL AND VAPOR PRESSURES MEAN FREE PATH 463 GAS FLOW 465
GENERAL GAS FLOW EXPRESSION * VISCOUS FLOW * MOLECULAR FLOW * EFFECT OF
BENDS ON GAS CONDUCTION VAPOR THROUGHPUT 467 GAS THERMAL CONDUCTIVITY
470 PRESSURE GAUGES 470 U TUBE 470 MCLEOD GAUGE 472 FUNDAMENTAL
PRINCIPLES OF THE MCLEOD GAUGE * OPERATION OF THE MCLEOD GAUGE THERMAL
CONDUCTIVITY GAUGES 474 FUNDAMENTAL PRINCIPLES OF A THERMAL CONDUCTIVITY
GAUGE * OPERATION OF THE THERMOCOUPLE GAUGE * OPERATING OF A PIRANI
GAUGE CAPACITANCE MANOMETER GAUGE 478 CONSTRUCTION OF THE CAPACITANCE
MANOMETER GAUGE * OPERATION OF THE CAPACITANCE MANOMETER GAUGE * ZEROING
OF THE GAUGE RESIDUAL GAS ANALYSIS (RGA) 480 OVERALL INSTRUMENT *
QUADRUPOLE MASS SPECTROMETER * ION FORMATION AND FRAGMENTATION PATTERNS
* PROCEDURE FOR DETERMINING THE PARTIAL PRESSURE OF A GAS VACUUM LEAKS
487 REAL LEAKS 487 STRAIGHT LEAK PATH * SERPENTINE LEAK PATH * MOLECULAR
FLOW LEAK PATHS VIRTUAL LEAKS 490 SUMMARY 490 SYMBOLS 491 REFERENCES 493
12. CONTAINER-CLOSURE SYSTEM 495 INTRODUCTION 495 THE CLOSURE 496
CONTENTS XIII CLOSURE COMPOSITION AND FORMATION 496 POLYMER COMPONENT *
REINFORCING AGENT * OTHER CONSTITUENTS * FORMATION OF THE CLOSURE
PHYSICAL PROPERTIES 498 MODULUS * COMPRESSION SET * DUROMETER HARDNESS *
GLASS TRANSITION TEMPERATURE * VAPOR TRANSPORT PROPERTIES DIFFUSION AND
PERMEATION 501 DIFFUSION * PERMEATION OUTGASSING 504 OUTGASSING OR GAS
PERMEATION * OUTGASSING OF WATER VAPOR * DETERMIN- ING THE OUTGASSING OF
WATER VAPOR * FREQUENCY DISTRIBUTION FOR THE OUT- GASSING OF WATER VAPOR
* OUTGASSING OF OTHER GAS SPECIES FROM CLOSURES CORING 514 CONDITIONS
FOR THE CORING OF CLOSURES * CORE TESTING OF THE CLOSURE SILICONIZATION
OF CLOSURES 516 THE CONTAINER 517 HISTORICAL 517 DISSOLUTION AND
LEACHING OF GLASS 517 DISSOLUTION * LEACHING * GLASS TYPES * CLEANING OF
THE VIALS THE PHYSICAL PROPERTIES OF VIALS 519 EFFECT OF VIAL
CONFIGURATION * MOLDED AND TUBING VIALS * GLASS AMPOULES
CONTAINER-CLOSURE SYSTEM 523 DESCRIPTION OF THE SEALING SYSTEM 523 THE
CRIMPING OPERATION * CONTAINER-CLOSURE SEAL MEASUREMENT OF COMPRESSIVE
FORCES 525 TWIST METHOD * SEAL FORCE MONITOR * WEST SEAL TESTER *
CONSTANT RATE OF STRAIN TESTING * ON-LINE TESTING CONTAINER-CLOSURE
LEAKS 528 BUBBLE TEST 529 STANDARD METHOD * VACUUM BUBBLE TEST PRESSURE
RISE 531 COLOR DYE TEST 533 HELIUM LEAK TESTING 533 VERIFICATION OF THE
HELIUM LEAK TEST FOR A CONTAINER-CLOSURE * DETERMINA- TION OF THE LEAK
RATE FOR AN UNCRIMPED CLOSURE * LEAK RATE FOR A CRIMPED
CONTAINER-CLOSURE SYSTEM GLOW DISCHARGE METHOD 538 NATURE OF THE GLOW
DISCHARGE * ELECTRO-TECHNIC VC-105 AUTOMATIC VACUUM TESTER * EFFECT OF
THE GLOW DISCHARGE ON THE PROPERTIES OF THE LYOPHILIZED CAKE *
COMMENTARY MICROBIAL TRANSPORT TESTS 542 MICROBIAL INGRESS TEST METHOD *
MICROBIAL REGRESS TEST METHOD MISCELLANEOUS TESTS 543 VACUUM/PRESSURE
DECAY * CARBON DIOXIDE TRACER GAS * OXYGEN AS A TRACER GAS AMPOULE SEAL
544 XIV LYOPHILIZATION: INTRODUCTION AND BASIC PRINCIPLES LEAK TESTING
OF AMPOULES 545 WATER BATH * DARK FIELD MICROSCOPY SYMBOLS 545
REFERENCES 547 13. EFFECT OF VACUUM FREEZE-DRYERS*PRESENT AND FUTURE 549
INTRODUCTION 549 IMPACT ON THE LYOPHILIZATION PROCESS 549 IMPACT ON THE
LYOPHILIZED PRODUCT 550 EFFECT ON THE CONTAINER-CLOSURE SYSTEM 550
SAFETY CONSIDERATIONS 551 THE DRYING CHAMBER 551 CHAMBER DESIGN OR
CONFIGURATION 551 CONSTRUCTION 553 MATERIALS * FINISH * INSULATION LEAKS
555 REAL LEAKS * VIRTUAL LEAKS LEAK TESTING 559 DRYER PREPARATION LEAKS
AND THE NATURE OF THE LEAK * SOAP SOLUTION * ACETONE * HELIUM LEAK
TESTING * MASS SPECTROMETER * REFRIGERANT LEAK DETECTION * FLUORESCENCE
DOOR 567 DESIGN AND CONSTRUCTION * THERMAL INSULATION * GORILLA EFFECT
SHELVES 571 CONSTRUCTION * UNUSABLE AND USABLE SHELVES * SPACING * HEAT
TRANSFER * DIRECT EXPANSION * GAS CONDUCTANCE * HEAT-TRANSFER FLUID *
SHELF TEMPERATURE SAFE ENVIRONMENT 580 PARTICULATE MATTER 580 SWAB TEST
* FILTER TEST * COUNTER VAPOR DEPOSITS 582 SWAB TEST * CONTACT ANGLE
CLEANING 584 MANUAL * CLEAN-IN-PLACE * FLOODING * COMMENTARY THE
CONDENSER 586 CONDENSER CONFIGURATION 587 PLATES * COILS CAPACITY 589
CONDENSER TEMPERATURES 589 INTERNAL CONDENSER 590 EXTERNAL CONDENSER 591
ISOLATION VALVE 591 VALVE CONFIGURATION * GAS CONDUCTANCE VACUUM SYSTEM
592 THE NEED FOR A VACUUM SYSTEM 592 CONTENTS XV FORELINE 593
BACKSTREAMING OF OIL VAPORS 593 METHODS FOR DETERMINING BACKSTREAMING *
MEANS FOR ELIMINATING OR PREVENTING BACKSTREAMING GAS BALLAST 598
INSTRUMENTATION 600 VACUUM GAUGES 600 MERCURY MCLEOD GAUGE * PIRANI AND
THERMOCOUPLE GAUGES * CAPACITANCE MANOMETER GAUGE PROCESS CONTROL
SYSTEMS 602 AUTOMATIC RESISTIVITY CONTROL SYSTEM * COMPUTER CONTROL
SYSTEM * TEMPERATURE CONTROL * DATA COLLECTION SYSTEM THE FUTURE OF
LYOPHILIZATION 606 NEIV OBJECTIVES 607 FORMULATION 608 THERMAL
PROPERTIES * CAKE PROPERTIES * STATISTICAL APPROACH * THE SCIENTIFIC
FORUM BATCH VERSES CONTINUOUS 610 THE BATCH SYSTEM * THE CONTINUOUS
SYSTEM * A PROTOTYPE OF A CONTINUOUS FREEZE-DRYER * A COMPARISON OF A
CONVENTIONAL AND A CONTINUOUS DRYER * A COMPARISON OF REQUIRED UTILITIES
* A COMPARISON OF PRODUCTION PARAMETERS AND CAPACITY SYMBOLS 617
REFERENCES 618 INDEX 621
|
| any_adam_object | 1 |
| author | Jennings, Thomas A. |
| author_facet | Jennings, Thomas A. |
| author_role | aut |
| author_sort | Jennings, Thomas A. |
| author_variant | t a j ta taj |
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| callnumber-first | R - Medicine |
| callnumber-label | RS199 |
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| callnumber-search | RS199.F74 |
| callnumber-sort | RS 3199 F74 |
| callnumber-subject | RS - Pharmacy |
| ctrlnum | (OCoLC)40996101 (DE-599)BVBBV014006908 |
| dewey-full | 615/.19 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
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| dewey-search | 615/.19 |
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| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| format | Book |
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| id | DE-604.BV014006908 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T18:55:59Z |
| institution | BVB |
| isbn | 1574910817 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-009589258 |
| oclc_num | 40996101 |
| open_access_boolean | |
| owner | DE-19 DE-BY-UBM |
| owner_facet | DE-19 DE-BY-UBM |
| physical | XVII, 646 S. Ill., graph. Darst. |
| publishDate | 1999 |
| publishDateSearch | 1999 |
| publishDateSort | 1999 |
| publisher | Interpharm Press |
| record_format | marc |
| spelling | Jennings, Thomas A. Verfasser aut Lyophilization introduction and basic principles Thomas A. Jennings Denver, Colo. Interpharm Press 1999 XVII, 646 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Freeze-drying GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009589258&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Jennings, Thomas A. Lyophilization introduction and basic principles Freeze-drying |
| title | Lyophilization introduction and basic principles |
| title_auth | Lyophilization introduction and basic principles |
| title_exact_search | Lyophilization introduction and basic principles |
| title_full | Lyophilization introduction and basic principles Thomas A. Jennings |
| title_fullStr | Lyophilization introduction and basic principles Thomas A. Jennings |
| title_full_unstemmed | Lyophilization introduction and basic principles Thomas A. Jennings |
| title_short | Lyophilization |
| title_sort | lyophilization introduction and basic principles |
| title_sub | introduction and basic principles |
| topic | Freeze-drying |
| topic_facet | Freeze-drying |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009589258&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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