Freeze-drying:
Gespeichert in:
| Hauptverfasser: | , |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Weinheim, Germany
Wiley-VCH Verlag GmbH & Co. KGaA
[2018]
|
| Ausgabe: | Third, completely revised and enlarged edition |
| Schlagworte: | |
| Online-Zugang: | http://www.wiley-vch.de/publish/dt/books/ISBN978-3-527-34306-5/ Inhaltsverzeichnis |
| Beschreibung: | xii, 422 Seiten Illustrationen, Diagramme |
| ISBN: | 9783527343065 3527343067 |
Internformat
MARC
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| 003 | DE-604 | ||
| 005 | 20181005 | ||
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| 016 | 7 | |a 1138580635 |2 DE-101 | |
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| 020 | |a 3527343067 |9 3-527-34306-7 | ||
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| 084 | |a 42 |2 sdnb | ||
| 084 | |a CIT 250f |2 stub | ||
| 100 | 1 | |a Haseley, Peter |4 aut | |
| 245 | 1 | 0 | |a Freeze-drying |c Peter Haseley and Georg-Wilhelm Oetjen |
| 250 | |a Third, completely revised and enlarged edition | ||
| 264 | 1 | |a Weinheim, Germany |b Wiley-VCH Verlag GmbH & Co. KGaA |c [2018] | |
| 264 | 4 | |c © 2018 | |
| 300 | |a xii, 422 Seiten |b Illustrationen, Diagramme | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 650 | 4 | |a Freeze-drying | |
| 650 | 0 | 7 | |a Gefriertrocknung |0 (DE-588)4156264-1 |2 gnd |9 rswk-swf |
| 653 | |a Chemical Engineering | ||
| 653 | |a Chemie | ||
| 653 | |a Chemische Verfahrenstechnik | ||
| 653 | |a Chemistry | ||
| 653 | |a Gefriertrocknung | ||
| 653 | |a Grundoperationen d. Pharmazeutischen Verfahrenstechnik | ||
| 653 | |a Industrial Chemistry | ||
| 653 | |a Process Engineering | ||
| 653 | |a Prozesssteuerung | ||
| 653 | |a Technische Chemie | ||
| 653 | |a Technische u. Industrielle Chemie | ||
| 653 | |a Verfahrenstechnik | ||
| 689 | 0 | 0 | |a Gefriertrocknung |0 (DE-588)4156264-1 |D s |
| 689 | 0 | |5 DE-604 | |
| 700 | 1 | |a Oetjen, Georg-Wilhelm |4 aut | |
| 710 | 2 | |a Wiley-VCH |0 (DE-588)16179388-5 |4 pbl | |
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| 776 | 0 | 8 | |i Erscheint auch als |n Online-Ausgabe, ePub |z 978-3-527-80893-9 |
| 776 | 0 | 8 | |i Erscheint auch als |n Online-Ausgabe, Mobi |z 978-3-527-80892-2 |
| 776 | 0 | 8 | |i Erscheint auch als |n Online-Ausgabe, oBook |z 978-3-527-80894-6 |
| 780 | 0 | 0 | |i Vorangegangen ist |z 9783527306206 |
| 856 | 4 | 2 | |m X:MVB |u http://www.wiley-vch.de/publish/dt/books/ISBN978-3-527-34306-5/ |
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| 999 | |a oai:aleph.bib-bvb.de:BVB01-030273639 | ||
Datensatz im Suchindex
| _version_ | 1804178416428122112 |
|---|---|
| adam_text | CONTENTS
PREFACE TO THIRD EDITION AND ACKNOWLEDGMENT IX
PREFACE TO THE SECOND EDITION XI
1 FOUNDATIONS AND PROCESS ENGINEERING 1
1.1 FREEZING 2
1.1.1 AMOUNT OF HEAT, HEAT CONDUCTIVITY, HEAT TRANSFER,
AND COOLING RATE 3
1.1.2 STRUCTURE OF ICE, SOLUTIONS, AND DISPERSIONS 14
1.1.3 INFLUENCE OF EXCIPIENTS 22
1.1.4 FREEZING OF CELLS AND BACTERIA 32
1.1.5 METHODS OF STRUCTURE ANALYSIS 34
1.1.5.1 MEASUREMENTS OF ELECTRICAL RESISTANCE (ER) 34
1.1.5.2 DIFFERENTIAL THERMAL ANALYSIS (DTA) 45
1.1.5.3 CRYOMICROSCOPY 51
1.1.5.4 FREEZE-DRY MICROSCOPY 59
1.1.5.5 DIFFERENTIAL SCANNING CALORIMETRY (DSC) 60
1.1.5.6 NUCLEAR MAGNETIC RESONANCE 68
1.1.5.7 THERMOMECHANICAL ANALYSIS (TMA) 74
1.1.5.8 DIELECTRIC ANALYSIS (DEA) 76
1.1.5.9 XRPD DIFFRACTOMETER-RAMAN SPECTROSCOPY 77
1.1.6 CHANGES OF STRUCTURE IN FREEZING OR FROZEN PRODUCTS 78
1.2 DRYING 79
1.2.1 MAIN DRYING (SUBLIMATION DRYING) 82
1.2.2 SECONDARY DRYING (DESORPTION DRYING) 101
1.2.3 TEMPERATURE AND PRESSURE MEASUREMENT 113
1.2.3.1 WIRELESS TEMPERATURE MEASUREMENT 135
1.2.4 WATER VAPOR TRANSPORT DURING DRYING 136
1.2.4.1 ENDPOINT DETERMINATION OF MAIN AND SECONDARY DRYING 144
1.2.5 COLLAPSE AND RECRYSTALLIZATION 145
1.2.6 DRYING PROCESSES WITHOUT VACUUM 148
1.2.7 MICROWAVE FREEZE-DRYING 149
1.2.8 SPRAY FREEZE-DRYING 150
1.3 STORAGE 150
1.3.1 MEASUREMENT OF THE RESIDUAL MOISTURE CONTENT (RM) 151
1.3.1.1 GRAVIMETRIE METHOD 151
1.3.1.2 KARL FISCHER (KF) METHOD 151
1.3.1.3 THERMOGRAVIMETRY (TG, TG/MS) 153
1.3.1.4 INFRARED SPECTROSCOPY 154
1.3.2 INFLUENCE OF VIAL STOPPERS ON THE RESIDUAL MOISTURE
CONTENT 156
1.3.3 QUALITIES OF THE DRY SUBSTANCES AND THEIR CHANGES 162
REFERENCES 165
2 INSTALLATION AND EQUIPMENT TECHNIQUE 177
2.1 FREEZING INSTALLATION 177
2.1.1 COOLING BY LIQUIDS: SHELL-FREEZING AND SPIN-FREEZING 177
2.1.2 COOLED SURFACES 178
2.1.3 PRODUCT IN THE FLOW OF COLD AIR, FOAMING, AND FREEZING OF EXTRACTS
AND PULPS 179
2.1.4 DROPLET FREEZING IN COLD LIQUIDS 181
2.1.5 FREEZING BY EVAPORATION OF PRODUCT WATER 184
2.1.6 NUCLEATION-ON-DEMAND TECHNOLOGY - CONTROLYO* 184
2.2 COMPONENTS OF A FREEZE-DRYING PLANT 185
2.2.1 INSTALLATIONS FOR FLASKS AND MANIFOLDS 185
2.2.2 DRYING CHAMBERS AND FORMS OF TRAYS 186
2.2.3 SHELVES AND THEIR COOLING AND HEATING 192
2.2.4 WATER VAPOR CONDENSERS 192
2.2.5 REFRIGERATING SYSTEMS AND REFRIGERANTS 201
2.2.6 VACUUM PUMPS 215
2.2.7 INLET VENTING FILTERS 221
2.2.8 VACUUM MEASURING SYSTEMS 224
2.2.9 LEAK RATE DETECTION 229
2.2.10 PROCESS CONTROL SYSTEMS 232
2.2.11 PROBLEMS, FAILURES, AND DEVIATIONS 235
2.3 INSTALLATIONS UP TO 10 KG ICE CAPACITY 238
2.3.1 UNIVERSAL LABORATORY PLANTS 238
2.3.2 PILOT PLANTS 240
2.3.3 MANIPULATORS AND STOPPERING SYSTEMS FOR VIALS 244
2.3.4 CLEANING INSTALLATIONS, STERILIZATION BY STEAM, AND VAPORIZED
HYDROGEN PEROXIDE (VHP) 248
2.4 PRODUCTION PLANTS 264
2.4.1 LOADING AND UNLOADING SYSTEMS 269
2.4.2 WHAT IS AN ISOLATOR? 274
2.4.3 ISOLATORS: VALIDATION OF DECONTAMINATION PROCESSES 280
2.5 PRODUCTION PLANTS FOR FOOD 283
2.5.1 DISCONTINUOUS PLANTS 283
2.5.2 CONTINUOUS PLANTS WITH TRAY TRANSPORT 284
2.5.3 CONTINUOUS PLANTS WITH PRODUCT TRANSPORT BY WIPERS OR BY
VIBRATION 285
2.6 PROCESS AUTOMATION 287
2.6.1 PREREQUISITES FOR PROCESS AND RELATED PLANT AUTOMATION 287
2.6.2 CONTROL OF THE PROCESS AND RELATED PLANT DATA BY THERMODYNAMIC
DATA MEASURED DURING THE PROCESS: THERMODYNAMIC LYOPHILIZATION
CONTROL (TLC) 289
2.6.2.1 CONTROL OF THE PROCESS WITHOUT TEMPERATURE SENSORS IN THE
PRODUCT 289
2.6.2.2 MEASUREMENT OF THE ICE TEMPERATURE AT THE SUBLIMATION FRONT AND
THE
DESORPTION RATE AS PROCESS GUIDES 292
2.623 MEASUREMENT OF THE RESIDUAL MOISTURE CONTENT (RM) DURING THE
PROCESS 302
2.6.2 A THE TRANSFER OF A FREEZE-DRYING PROCESS FROM A PILOT TO A
PRODUCTION
PLANT 304
2.62.5 SUMMARY OF PREREQUISITES, LIMITS, AND SUGGESTIONS FOR AUTOMATED
THERMODYNAMIC LYOPHILIZATION CONTROL 308
REFERENCES 309
FURTHER READING 310
3 PHARMACEUTICAL, BIOLOGICAL, AND MEDICAL PRODUCTS 313
3.1 PROTEINS AND HORMONES 313
3.2 VIRUSES, VACCINES, BACTERIA, AND YEASTS 330
3.3 ANTIBIOTICS, CYTOSTATICS, IBUPROFEN 341
3.4 LIPOSOMES AND NANOPARTICLES 342
3.5 ANTIBODY 350
3.6 TRANSPLANTS, COLLAGEN 351
3.7 FREEZE-DRYING SUBJECT TERMS - OVERVIEW AND SUMMARY 358
REFERENCES 360
4 METAL OXIDES, CERAMIC POWDERS 367
REFERENCES 372
5 TROUBLE SHOOTING 375
5.1 PROLONGED EVACUATION TIME 375
5.2 SUBLIMATION FRONT TEMPERATURE TOO HIGH 376
5.3 SUBLIMATION FRONT TEMPERATURE IRREGULAR 376
5.4 SLOW PRESSURE INCREASE IN THE CHAMBER DURING MAIN DRYING 376
5.5 STOPPERS POP OUT OR SLIDE INTO THE VIALS 377
5.6 TRACES OF HIGHLY VOLATILE SOLVENTS (ACETONE, ETHANOL) 377
5.7 DIFFERENT STRUCTURES OF THE DRIED PRODUCT IN THE CENTER AND BORDER
OF
A SHELF 378
6 REGULATORY ISSUES 379
QUALIFICATION AND VALIDATION OF PROCESSES AND INSTALLATIONS 379
6.1 PAT (PRACTICAL ANALYTICAL TECHNOLOGY) 385
6.2 QUALITY OF THE PRODUCT 388
6.3 DESCRIPTION OF THE PROCESS DEVELOPED FOR MANUFACTURING OF THE
PRODUCT 389
6.4 DESCRIPTION OF PRODUCTION INSTALLATIONS AND THEIR HANDLING 391
6.5 EQUIPMENT PERFORMANCE TESTS 392
6.6 QUALITY OF INSTALLATION TO DOCUMENT THE ABILITY OF EQUIPMENT TO
OPERATE PROCESSES (DESCRIBED IN SECTION 6.3) 395
6.7 DOCUMENTATION OF THE QUALITY OF THE PRODUCTS MANUFACTURED
(IN COMPARISON WITH SECTION 6.2) 396
REFERENCES 396
APPENDIX: ABBREVIATIONS, SYMBOLS, AND UNIT OF MEASURE 399
INDEX 40S
|
| any_adam_object | 1 |
| author | Haseley, Peter Oetjen, Georg-Wilhelm |
| author_facet | Haseley, Peter Oetjen, Georg-Wilhelm |
| author_role | aut aut |
| author_sort | Haseley, Peter |
| author_variant | p h ph g w o gwo |
| building | Verbundindex |
| bvnumber | BV044879381 |
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| callnumber-raw | TP371.6 |
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| dewey-hundreds | 600 - Technology (Applied sciences) 500 - Natural sciences and mathematics |
| dewey-ones | 660 - Chemical engineering 540 - Chemistry and allied sciences |
| dewey-raw | 660/.28426 540 |
| dewey-search | 660/.28426 540 |
| dewey-sort | 3660 528426 |
| dewey-tens | 660 - Chemical engineering 540 - Chemistry and allied sciences |
| discipline | Chemie / Pharmazie Chemie-Ingenieurwesen |
| edition | Third, completely revised and enlarged edition |
| format | Book |
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| id | DE-604.BV044879381 |
| illustrated | Illustrated |
| indexdate | 2024-07-10T08:03:37Z |
| institution | BVB |
| institution_GND | (DE-588)16179388-5 |
| isbn | 9783527343065 3527343067 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-030273639 |
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| owner_facet | DE-M347 DE-29T DE-B768 DE-19 DE-BY-UBM DE-83 |
| physical | xii, 422 Seiten Illustrationen, Diagramme |
| publishDate | 2018 |
| publishDateSearch | 2018 |
| publishDateSort | 2018 |
| publisher | Wiley-VCH Verlag GmbH & Co. KGaA |
| record_format | marc |
| spelling | Haseley, Peter aut Freeze-drying Peter Haseley and Georg-Wilhelm Oetjen Third, completely revised and enlarged edition Weinheim, Germany Wiley-VCH Verlag GmbH & Co. KGaA [2018] © 2018 xii, 422 Seiten Illustrationen, Diagramme txt rdacontent n rdamedia nc rdacarrier Freeze-drying Gefriertrocknung (DE-588)4156264-1 gnd rswk-swf Chemical Engineering Chemie Chemische Verfahrenstechnik Chemistry Gefriertrocknung Grundoperationen d. Pharmazeutischen Verfahrenstechnik Industrial Chemistry Process Engineering Prozesssteuerung Technische Chemie Technische u. Industrielle Chemie Verfahrenstechnik Gefriertrocknung (DE-588)4156264-1 s DE-604 Oetjen, Georg-Wilhelm aut Wiley-VCH (DE-588)16179388-5 pbl Erscheint auch als Online-Ausgabe, ePDF 978-3-527-80891-5 Erscheint auch als Online-Ausgabe, ePub 978-3-527-80893-9 Erscheint auch als Online-Ausgabe, Mobi 978-3-527-80892-2 Erscheint auch als Online-Ausgabe, oBook 978-3-527-80894-6 Vorangegangen ist 9783527306206 X:MVB http://www.wiley-vch.de/publish/dt/books/ISBN978-3-527-34306-5/ DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=030273639&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Haseley, Peter Oetjen, Georg-Wilhelm Freeze-drying Freeze-drying Gefriertrocknung (DE-588)4156264-1 gnd |
| subject_GND | (DE-588)4156264-1 |
| title | Freeze-drying |
| title_auth | Freeze-drying |
| title_exact_search | Freeze-drying |
| title_full | Freeze-drying Peter Haseley and Georg-Wilhelm Oetjen |
| title_fullStr | Freeze-drying Peter Haseley and Georg-Wilhelm Oetjen |
| title_full_unstemmed | Freeze-drying Peter Haseley and Georg-Wilhelm Oetjen |
| title_short | Freeze-drying |
| title_sort | freeze drying |
| topic | Freeze-drying Gefriertrocknung (DE-588)4156264-1 gnd |
| topic_facet | Freeze-drying Gefriertrocknung |
| url | http://www.wiley-vch.de/publish/dt/books/ISBN978-3-527-34306-5/ http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=030273639&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT haseleypeter freezedrying AT oetjengeorgwilhelm freezedrying AT wileyvch freezedrying |