Good pharmaceutical freeze-drying practice:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Buffalo Grove, IL
Interpharm Press
1997
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XV, 303 S. Ill., graph. Darst. |
| ISBN: | 1574910310 |
Internformat
MARC
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| 245 | 1 | 0 | |a Good pharmaceutical freeze-drying practice |c ed.: Peter Cameron |
| 264 | 1 | |a Buffalo Grove, IL |b Interpharm Press |c 1997 | |
| 300 | |a XV, 303 S. |b Ill., graph. Darst. | ||
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| 650 | 4 | |a Drugs |x Drying | |
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Datensatz im Suchindex
| _version_ | 1804128862685102080 |
|---|---|
| adam_text | GOOD PHARMACEUTICAL FREEZE-DRYING PRACTICE EDITOR PETER CAMERON
CONTRIBUTORS L. DAVID BUTLER PETER CAMERON KEVIN KINNARNEY PETER MONGER
KEVIN MURGATROYD INTERPHARM PRESS, INC. BUFFALO GROVE, IL CONTENTS
PREFACE XIII 1. THE FREEZE DRYING PROCESS 1 KEVIN MURGATROYD ADVANTAGES
OF FREEZE DRYING 2 RETENTION OF ACTIVITY 3 RETENTION OF FORM 3
EASEOFRECONSTITUTION 4 LONG SHELF LIFE 4 ACCURATE DOSING 4 STERILE
MANUFACTURE 4 DISADVANTAGES OF FREEZE DRYING 5 BATCH PROCESS 5 SPEED 5
CAPITAL COST 5 OPERATING COSTS 6 TARGET PRODUCT CHARACTERISTICS 6 III IV
CONTENTS TARGET PRODUCTS 7 THE THREE STAGES OF FREEZE DRYING 8 VACUUM
UNITS 10 MATTER STATES 11 SATURATED VAPOUR PRESSURE 12 FREEZING 14
PRIMARY DRYING 23 SECONDARY DRYING 34 ANCILLARY FUNCTIONS 38
STERILISATION 38 DEFROSTING 39 CLEANING/CLP 41 LOADING/UNLOADING 43
BACKFILLING 46 STOPPERING 47 AERATION 47 PROBLEM AREAS 48 PRODUCT
PROBLEMS 48 PRODUCT PROBE PLACEMENT 53 SOLVENTS 55 CONCLUSION 57 2. THE
FREEZE DRYER AND FREEZE DRYER DESIGN 59 KEVIN MURGATROYD THE
PHARMACEUTICAL FREEZE DRYER 62 FREEZE DRYER COMPONENTS 64 THE DRYING
CHAMBER 64 THE CHAMBER DOOR 69 CONTENTS V THE CHAMBER ISOLATION VALVE 80
THE ICE CONDENSER 81 THE SHELF STACK 87 FREEZE DRYER SYSTEMS 93 THE
STOPPERING SYSTEM 93 THE FLUID CIRCULATION SYSTEM 101 THE REFRIGERATION
SYSTEM 105 THE VACUUM SYSTEM 111 THE PIPEWORK SYSTEM 115 THE PNEUMATIC
SYSTEM 122 CONCLUSION 122 3. FREEZER DRYER INSTRUMENTATION AND CONTROL
125 KEVIN MURGATROYD INSTRUMENTATION 126 PRESSURE MEASUREMENT AND
PRESSURE SENSORS 126 TEMPERATURE MEASUREMENT AND TEMPERATURE SENSORS 131
THE CONTROL SYSTEM 135 MANUAL CONTROL SYSTEMS 137 HARDWIRED CONTROL
SYSTEMS 139 MICROPROCESSOR CONTROL SYSTEMS 140 , PC-BASED CONTROL
SYSTEMS 143 BACKUP SYSTEMS 151 CHART RECORDER 152 NETWORKS 153
INTERLOCKS 153 CONCLUSION 154 VI CONTENTS 4. REGULATORY ISSUES: A
EUROPEAN PERSPECTIVE 155 PETER MONGER THE LEGISLATIVE BACKGROUND 155
PRACTICAL IMPLEMENTATION 158 DESIGN CONSIDERATIONS 158 STERILISATION 158
OTHER DESIGN CONSIDERATIONS 165 OPERATIONAL CONSIDERATIONS 168 FREEZE
DRYER SITING AND WORK FLOW 168 LOADING AND UNLOADING 169 LEAK TESTING
169 CALIBRATION AND MAINTENANCE 170 REFERENCES 170 5. REGULATORY ISSUES:
AN AMERICAN PERSPECTIVE 171 L. DAVID BUTLER FORMULATION OF THE BULK
PRODUCT 171 BIOBURDEN CONTROL 171 HOLDING TIMES FOR BULK SOLUTIONS 173
FILLING THE PRODUCT INTO PARTIALLY STOPPERED VIALS 173 FILLING AND
TRANSPORTATION OF VIALS 173 MANUAL STOPPERING 174 ENVIRONMENTAL
MONITORING 174 MEDIA SIMULATIONS 175 FILL VOLUME CONTROL 175 BULK DRYING
176 CONTENTS VII LYOPHILIZATION CYCLE, CONTROLS, AND VALIDATION 176
CYCLE DEVELOPMENT 176 LEAK RATE TESTING 177 MECHANICAL FAILURES 177
LYOPHILIZATION PROCESS CONTROL 178 STERILIZATION OF LYOPHILIZERS 178
FILTER INTEGRITY TESTING 179 VALIDATION OF COMPUTERIZED CONTROL SYSTEMS
179 LYOPHILIZATION CYCLE VALIDATION 180 LYOPHILIZER DESIGN AND
STERILIZATION 180 STERILIZATION AND STERILITY ASSURANCE 180
BACKSTREAMING 182 FINISHED PRODUCT TESTING 182 DOSE UNIFORMITY TESTING
182 MOISTURE TESTING 183 STABILITY TESTING 183 STERILITY TESTING 183
FINISHED PRODUCT INSPECTION 183 CONCLUSIONS 184 ACKNOWLEDGMENTS 185 6.
FREEZE DRYER STERILISATION 187 KEVIN KINNARNEY SANITATION/STERILISATION
METHODS 187 DISINFECTANTS 187 GASES 188 HYDROGEN PEROXIDE VAPOUR 189
STEAM 190 DESIGN OF THE FREEZE DRYER TO ALLOW STERILISATION 191 VIII
CONTENTS VALVES 194 VALIDATION 195 STERILISATION CYCLE 198 ROUTINE
OPERATION 201 ROUTINE MAINTENANCE 202 STEAM QUALITY 203 7. LEAK RATE
TESTING 205 KEVIN KINNARNEY SOURCES OF LEAKS PLANT SPECIFICATION LEAK
TYPES TESTING THE LEAK-UP RATE LEAK RATE 212 ROUTINE OPERATION AND
TESTING LEAK DETECTION CONCLUSIONS 206 207 208 209 213 213 214 8. INLET
FILTER INTEGRITY TESTING 217 PETER CAMERON FILTER TYPES 218 FILTER
INSTALLATION 219 TESTING FREQUENCY 220 TEST EVALUATION 220 REPRODUCIBLE
220 VALIDATION 221 SAFE AND PRACTICAL LIMITS 221 CONTENTS IX REGULATORY
APPROVAL 221 NONDESTRUCTIVE OR CONTAMINATING 222 DRYNESS 222 SAFETY 222
PRACTICALITY 222 IN SITU TESTING 222 POSTSTERILISATION 223 AVAILABLE
TESTS 223 TH E DIFFUSIVE FLO W TEST 223 BUBBLE POINT TEST 226
WATER-BASED INTEGRITY TEST 227 AEROSOL CHALLENGE INTEGRITY TEST 230
SUMMARY 233 DIFFUSIVE FLOW TEST 234 BUBBLE POINT TEST 234 WATER-BASED
INTEGRITY TEST 234 AEROSOL CHALLENGE TEST 235 REFERENCES 235 9. FREEZE
DRYER VALIDATION 237 PETER MONGER WHAT IS VALIDATION AND WHY IS IT
NECESSARY? 237 THE VALIDATION PROCESS 238 VALIDATION MASTER PLAN 238
VALIDATION PROTOCOL 239 VALIDATION REPORTS 239 THE VALIDATION LIFE CYCLE
239 DESIGN QUALIFICATION 240 INSTALLATION QUALIFICATION 243 X CONTENTS
OPERATIONAL QUALIFICATION 244 PERFORMANCE QUALIFICATION 251 REVALIDATION
AND CHANGE CONTROL 255 REFERENCE 258 10. CYCLE OPTIMISATION AND PROCESS
TRANSFER 259 KEVIN KINNARNEY CYCLE OPTIMISATION 261 TECHNOLOGY TRANSFER
263 PROCESS 263 LOADING PLANT 264 FREEZING 265 PRIMARY DRYING 265
SECONDARY DRYING 268 TESTING 268 SUMMARY 269 11. CFC REPLACEMENT 271
KEVIN MURGATROYD THE REFRIGERANTS 272 CHEMISTRY 272 PROPERTIES 273
CLASSIFICATION 273 THE ENVIRONMENTAL IMPACT 274 HISTORY 274 THE OZONE
LAYER 274 THE GREENHOUSE EFFECT 275 THE IMPACT OF REFRIGERANTS 276
CONTENTS XI THE LEGISLATION 278 HISTORY 278 IMPLICATIONS 279 THE FREEZE
DRYER 280 IMPLICATIONS 280 ALTERNATIVE REFRIGERANTS 280 OILS 282 SEALS
283 FILTER DRYERS 284 LEAK DETECTION 284 LIQUID NITROGEN 284 FREEZE
DRYER MODIFICATIONS 285 FORMULATION 286 REPLACEMENT STRATEGY 286
RECOMMENDED READING 289 INDEX 291 COMMISSIONED IN THE UK BY SUE HORWOOD
OF MEDI-TECH. PUBLICA- TIONS LIMITED, STORRINGTON, WEST SUSSEX, ON
BEHALF OF INTERPHARM PRESS, INC., USA. GENERAL SCIENTIFIC ADVISOR: ROBIN
N. STEPHENS, MANAGER OF INTERNATIONAL REGULATORY AFFAIRS AND CLINICAL
RESEARCH, AVE INC., UK
|
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| discipline | Medizin |
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| indexdate | 2024-07-09T18:55:59Z |
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| isbn | 1574910310 |
| language | English |
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| spelling | Good pharmaceutical freeze-drying practice ed.: Peter Cameron Buffalo Grove, IL Interpharm Press 1997 XV, 303 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Drugs Drying Freeze-drying Cameron, Peter Sonstige oth GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009589235&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Good pharmaceutical freeze-drying practice Drugs Drying Freeze-drying |
| title | Good pharmaceutical freeze-drying practice |
| title_auth | Good pharmaceutical freeze-drying practice |
| title_exact_search | Good pharmaceutical freeze-drying practice |
| title_full | Good pharmaceutical freeze-drying practice ed.: Peter Cameron |
| title_fullStr | Good pharmaceutical freeze-drying practice ed.: Peter Cameron |
| title_full_unstemmed | Good pharmaceutical freeze-drying practice ed.: Peter Cameron |
| title_short | Good pharmaceutical freeze-drying practice |
| title_sort | good pharmaceutical freeze drying practice |
| topic | Drugs Drying Freeze-drying |
| topic_facet | Drugs Drying Freeze-drying |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009589235&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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