Filtration in the pharmaceutical industry

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Sprache:English
Veröffentlicht: New York u.a. Dekker 1987
Schriftenreihe:Advances in parenteral sciences 3.
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Datensatz im Suchindex

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adam_text FILTRATION IN THE PHARMACEUTICAL INDUSTRY THEODORE H. MELTZER CAPITOLA CONSULTING CO. ARLINGTON, VIRGINIA AND SENIOR CONSULTANT BRUNSWICK TECHNETICS (FILTERITE CORP.) TIMONIUM, MARYLAND WITH CONTRIBUTIONS BY ERIC W. BLAKIE, F. RAYMOND GABLER, HARWOOD GREEN, HYMAN B. KATZ, JULIUS Z. KNAPP, ALVIN LIEBERMAN, DAVID S. LINTON, ROSALIE M. MANDARO MARCEL DEKKER, INC. NEW YORK * BASEL CONTENTS SERIES I INTRODUCTION V FOREWORD VII PREFACE IX CONTRIBUTORS XIX PART I FILTERS 1 1 DEPTH FILTERS, PARTICLES, AND FILTER RATINGS 3 1.1 FILTRATION 3 1.2 DEPTH-TYPE FILTERS 8 1.3 FILTER-MEDIUM MIGRATION 31 1.4 DIFFERENTIAL PRESSURE EFFECTS ON THE FILTRATION PROCESS 37 » 1.5 DEPTH FILTER/MEMBRANE COMPARISONS 38 1.6 PREFILTER ACTION 39 1.7 NOMINAL AND ABSOLUTE RATINGS 40 1.8 PARTICLES 41 1.9 FILTER PERMEABILITY 50 1.10 FILTER CAPACITY 52 1.11 PARTICLE DEFORMABILITY 58 REFERENCES 58 2 MEMBRANE POROSITY: ITS ORIGINS AND MODIFICATIONS 61 2.1 OVERVIEW OF MEMBRANE POROSITY 61 2.2 TRACK-ETCH MEMBRANES 62 2.3 POROUS POLYTETRAFLUOROETHYLENE 66 2.4 GENESIS OF POROSITY IN SOLUTION-CAST FILMS 70 2.5 PHASE-INVERSION MEMBRANES 76 2.6 PORE COLLAPSE 79 2.7 CLEARING OF MEMBRANE 80 2.8 ORIENTATION EFFECTS 80 XI CONTENTS 2.9 INFLUENCES ON TENSILE AND ELONGATION PROPERTIES 83 2.10 MEMBRANE VARIABILITY IN MANUFACTURE 85 REFERENCES 85 3 FILTER POROSITY CHARACTERISTICS 87 3.1 NUMERICAL PORE DIMENSIONS 87 3.2 PORE-SIZE DISTRIBUTION 100 3.3 PORE SHAPES 122 3.4 IMPLICATION OF THE LARGEST PORE 127 3.5 IMPLICATIONS OF BREADTH OF PORE-SIZE DISTRIBUTIONS 128 3.6 ANISOTROPIC PORE STRUCTURES 133 3.7 EFFECT OF PORE LENGTH ON FLOW AND RETENTION 138 REFERENCES 13 9 4 FILTER/FLUID INTERACTIONS 143 4.1 SCOPE OF CONSIDERED INTERACTIONS 143 4.2 EXTRACTABLES 143 4.3 STRUCTURAL COMPATIBILITIES 159 4.4 ADSORPTIVE REMOVAL OF PREPARATIONAL COMPONENTS BY FILTERS 174 REFERENCES 178 5 CHARGE-MODIFIED DEPTH FILTERS: CATIONIC-CHARGE- MODIFIED NYLON MEMBRANES 183 ROSALIE M. MANDARO 5.1 OVERVIEW 183 5.2 DEPTH FILTER MATERIALS 183 5.3 TYPICAL AND ATYPICAL PROPERTIES OF DEPTH FILTERS 184 5.4 ASBESTOS*THE FIRST CMD FILTER 184 5.5 DEVELOPMENT OF NONASBESTOS DEPTH FILTERS 186 5.6 USE OF CMD FILTERS IN BLOOD FRACTIONATION 187 5.7 MEASUREMENT OF SURFACE.CHARGE DENSITY ON CMD FILTERS 187 5.8 CMD FILTER USE IN PHARMACEUTICAL PROCESSING 194 5.9 CONCLUSIONS: CHARGE-MODIFIED DEPTH FILTERS 196 5.10 CATIONIC CHARGE-MODIFIED NYLON MEMBRANES 197 5.11 CONCLUSIONS: CATION CHARGE-MODIFIED NYLON MEMBRANES 205 REFERENCES 206 6 QUALITY ASSURANCE OF FILTERS FOR FLUID CLARIFICATION 209 HYMAN B. KATZ 6.1 INTRODUCTION 209 6.2 PRODUCT DEVELOPMENT 209 6.3 MANUFACTURING 211 6.4 CONTAMINATION CONTROL 213 6.5 CLEANLINESS LEVELS 214 6.6 PERFORMANCE TESTING 216 6.7 TECHNICAL SUPPORT 218 REFERENCES 218 CONTENTS XIII 7 THE INTEGRITY TESTS 219 7.1 INTRODUCTION 219 7.2 BUBBLE POINT AND ORGANISM RETENTION 220 7.3 CAUSES OF BUBBLE-POINT DEVIATIONS 227 7.4 BUBBLE-POINT PROTOCOL 248 7.5 MEASUREMENT AT ROBUST AIR FLOWS 251 7.6 BUBBLE-POINT TESTING AT FIXED AIR PRESSURE LEVELS 253 7.7 POLYMER CONTRIBUTION TO BUBBLE-POINT VALUES 25 5 7.8 SIGNIFICANCE OF THE WILLIAMS STRUCTURE 260 7.9 THE KNEE REGION OF THE CURVE 263 7.10 DIFFUSIVE AIR FLOW AS INTEGRITY INDICATOR 266 7.11 EFFECTS OF MEMBRANE ANISOTROPY 274 7.12 SINGLE-POINT INTEGRITY TEST MEASUREMENT 275 7.13 SENSITIVITY OF DIFFUSIVE AIR FLOWS 278 7.14 PRESSURE-HOLD TEST 279 7.15 SENSITIVITY OF INTEGRITY TESTS 281 7.16 WATER INTRUSION TEST 282 7.17 INITIAL INTEGRITY TEST 284 7.18 AUTOMATED INTEGRITY TESTING DEVICES 286 7.19 FLOW RATIO TEST 290 7.20 CONCLUSIONS 292 REFERENCES 2 93 PART II FILTRATION 299 8 FILTRATIVE PARTICLE REMOVAL FROM LIQUIDS 299 8.1 PARTICLE TRAPPING MECHANISMS 299 8.2 ADSORPTIVE SEQUESTRATION 301 8.3 THE MODELING OF FILTER BLOCKING 324 8.4 PRACTICAL IMPLICATIONS OF ADSORPTIVE SEQUESTRATION 330 8.5 RELIABILITY OF ADSORPTIVE SEQUESTRATIONS 332 8.6 SUMMARY OF TRAPPING FORCES AND THEIR LOCI 336 8.7 THE STERILIZING FILTER * 337 8.8 RETENTION OF LATEX SPHERES 350 REFERENCES 363 9 FILTRATIVE PARTICLE REMOVAL FROM CASES 369 9.1 INTRODUCTION 369 9.2 FERMENTATION AIR FILTERS 369 9.3 VENT FILTERS 373 9.4 SERVICE AIR FILTRATION 374 9.5 MECHANISMS OPERATIVE IN GAS FILTRATIONS 374 9.6 HYDROPHOBICITY 387 9.7 STEAM STERILIZABILITY 387 9.8 INTEGRITY TESTING 389 9.9 MULTIPLE STEAMINGS 390 9.10 CRITERIA FOR AIR FILTERS 391 9.11 SIZING OF VENT FILTERS 391 9.12 VALIDATION OF AIR FILTERS 391 9.13 SUMMARY OF GAS FILTRATION 400 XIV CONTENTS 9.14 STEAM 401 REFERENCES 406 10 FLOW AND PRESSURE, FILTER SIZING, AND FILTER SYSTEM DESIGN 409 HARWOOD GREEN AND THEODORE H. MELTZER 10.1 INFLUENCES ON FLOW 409 10.2 PRESSURE CONSIDERATIONS 410 10.3 CONSTANT-PRESSURE FILTRATIONS 413 10.4 CONSUMPTION OF FILTER CAPACITY 416 10.5 CONSTANT-FLOW FILTRATIONS 420 10.6 MANUFACTURERS CATALOG INFORMATION 420 10.7 THE UTILIZATION OF FLOW DECAY MEASUREMENTS 421 10.8 SIZING PREFILTER/FINAL FILTER COMBINATIONS 434 10.9 DESIGN CONSIDERATIONS 450 REFERENCES 452 11 PRINCIPLES OF TANGENTIAL FLOW FILTRATION: APPLICATIONS TO BIOLOGICAL PROCESSING 453 F. RAYMOND GABLER 11.1 INTRODUCTION 453 11.2 FILTER TYPES USED IN TANGENTIAL FLOW 454 11.3 MICROPOROUS MEMBRANES AND SECONDARY LAYER FORMATION 456 11.4 DEFINITION OF TERMS 457 11.5 THEORY OF TANGENTIAL FLOW FILTRATION 459 11.6 PRACTICAL ASPECTS OF TANGENTIAL FLOW FILTRATION 460 11.7 CONCENTRATION POLARIZATION 466 11.8 DETERMINING OPTIMUM OPERATING PARAMETERS VIA TOTAL RECYCLE 468 11.9 MEMBRANE FOULING 473 11.10 PARTICULATE LOADING 475 11.11 TANGENTIAL FLOW APPLICATIONS 476 11.12 TANGENTIAL FLOW EQUIPMENT 486 11.13 SUMMARY 488 REFERENCES 488 PART III PARTICLES 491 12 VIABLE/NONVIABLE PARTICLE AND PYROGEN RETENTION 493 12.1 PARENTERAL REQUIREMENTS 493 12.2 STERILIZATION BY FILTRATION 494 12.3 STERILIZING FILTER EVALUATION 509 12.4 OTHER-THAN STERILIZING GRADE FILTERS 514 12.5 STERILITY TESTING 518 12.6 DETERMINATION OF BIOBURDEN 524 12.7 DEPYROGENATION 525 12.8 PARTICULATE MATERIAL 527 12.9 FILTER VALIDATION 531 12.10 GROW-THROUGH 537 REFERENCES 541 CONTENTS XV 13 DETECTION AND MEASUREMENT OF PARTICLES IN BULK PHARMACEUTICAL LIQUIDS 545 ALVIN LIEBERMAN 13.1 DEFINITION OF SCOPE 545 13.2 SAMPLE HANDLING PROBLEMS 546 13.3 PARTICLE MEASUREMENT METHODS FOR PHARMACEUTICAL LIQUIDS 557 13.4 ELECTRONIC OPERATION 575 13.5 LIQUID FEEDERS AND FLOW CONTROLS 577 13.6 OPERATING PARAMETERS FOR OPTICAL PARTICLE COUNTERS 579 13.7 LIQUID FLOW RATE EFFECTS 581 13.8 CALIBRATION BASES 581 13.9 DILUTION EFFECTS 581 13.10 MEASUREMENT PROCEDURES 582 13.11 CALCULATION OF RESULTS 583 13.12 CONCLUSIONS 584 REFERENCES 584 14 DETECTION AND MEASUREMENT OF PARTICLES IN SEALED CONTAINERS 587 JULIUS I. KNAPP 14.1 INTRODUCTION 587 14.2 ANALYTICAL AND VISUAL PHARMACEUTICAL PARTICULATE STANDARDS 589 14.3 VISIBLE PARTICULATE SOURCES 590 14.4 VIAL STOPPERS: A MAJOR PARTICULATE SOURCE 590 14.5 PHYSIOLOGICAL EFFECT OF PARTICIPATES IN PARENTERAL PRODUCTS 595 14.6 THE PROBABILISTIC INSPECTION 600 14.7 A PROBABILISTIC EVALUATION OF THE VISUAL INSPECTION FOR PARTICULATES 602 14.8 EFFECT OF CONTAINER CLARITY ON VISUAL PARTICULATE INSPECTION 604 14.9 REJECTION RATE ANALYSIS BY HISTOGRAM SHOWING DISTRIBUTION OF VISUAL PARTICULATE REJECTS 605 14.10 VISUAL INSPECTION REJECT RATE UNMASKED AS A MORTALITY TABLE EFFECT 605 14.11 RELATIONSHIPS OF REJECTION PROBABILITY AND REJECTS IN A NORMAL PARENTERAL PRODUCTION BATCH 607 14.12 EFFECT OF SECOND OR CULL INSPECTION OF FINAL REJECT DISTRIBUTION IN A NORMAL PARENTERAL PRODUCTION BATCH 607 14.13 TRANSFORMATION OF RULE-OF-THUMB QUALITY CATEGORIES INTO PROBABILISTICALLY DEFINED REGIONS 607 14.14 INSPECTION SECURITY EVALUATED WITH THE REJECTION ZONE EFFICIENCY (RZE) PARAMETER 612 14.15 ACCEPT/REJECT DISCRIMINATION EVALUATED WITH THE REJECT RATE IN THE ACCEPT AND GRAY ZONE (RAG) PARAMETER 615 XVI CONTENTS 14.16 THE SCIENCE OF VISUAL INSPECTION 615 14.17 EFFECT ON THE 50% DETECTABILITY RESPONSE OF A TARGET WHEN CONTRAST AND BACKGROUND LUMINANCE ARE VARIED IN TIME-LIMITED TRIALS 617 14.18 REVIEW OF BIOPHYSICS VISION EXPERIMENTS SUPPORTING AND EXTENDING PARTICULATE INSPECTION EXPERIMENTS RESULTS 618 14.19 IES LIGHTING RECOMMENDATIONS FOR VARIOUS VISUAL TASKS 622 14.20 INSPECTOR SELECTION AND VALIDATION 623 14.21 BOOTSTRAP INSPECTOR SELECTION UNDER ACTUAL INSPECTION CONDITIONS USING RZE AND RAG 629 14.22 DURABILITY OF RZE AND RAG DETERMINATIONS FOR A VALIDATED INSPECTOR GROUP 632 14.23 DURABILITY OF INDIVIDUAL AND GROUP RZE AND RAG PARAMETERS 633 14.24 THE CORE VALIDATION PROBLEM FOR VISUAL AND OPTICAL INSPECTION 634 14.25 COMPARISON OF DIFFERENT PROBABILISTIC INSPECTION TECHNIQUES 634 14.26 TWO-DIMENSIONAL REJECTION PROBABILITY DISTRIBUTION 638 14.27 APPLICATION OF THE MANUAL INSPECTION PERFORMANCE YARDSTICK 640 14.28 OBJECTIVE STANDARDS 644 14.29 HOLOGRAMMIC EVALUATION OF AUTOMATED AND VISUAL INSPECTION PERFORMANCE 647 14.30 VISIBILITY REGION BOUNDARIES FOR ACTUAL PARTICULATES IN PARENTERAL PRODUCTS 656 14.31 ACCURACY LIMITATIONS IMPOSED BY SAMPLING INSPECTION PROCEDURES 657 14.32 UHLIR S MODEL OF PARTICULATE INSPECTION 658 14.33 A PRACTICAL COST-EFFECTIVE INSPECTION VALIDATION PROCEDURE 661 14.34 INSPECTION SYSTEMS: PRACTICAL CONSIDERATIONS 699 14.35 OBJECTIVE PHYSICAL CRITERIA VALIDATIONS 704 14.36 COMMERCIAL SYSTEMS 705 REFERENCES 705 15 PUMP TYPES AND THEIR SELECTION 709 DAVID S. LINTON 15.1 INTRODUCTION 709 15.2 DEFINITION OF TERMS 709 15.3 PUMP PARAMETERS 713 15.4 MATERIALS OF COMPOSITON 714 15.5 STERILIZATION OF PUMPS 715 15.6 TYPES OF PUMPS 717 15.7 SUMMARY 725 REFERENCE 726 16 FILTER AND FILTER HOLDER/HOUSING DESIGN 727 16.1 GENERAL FILTER HOLDER/HOUSING DESIGN 727 16.2 DISK VERSUS CARTRIDGE CONFIGURATION 770 CONTENTS XVII 16.3 FILTER CARTRIDGES 772 16.4 STERILIZATION OF FILTER AND HOLDER 780 16.5 DISPOSABLE FILTER DEVICES 784 REFERENCES 787 PART V PRACTICAL FILTRATION APPLICATIONS 789 17 WATER PURIFICATION 791 17.1 GRADES OF WATER 791 17.2 VARIOUS WATER PURIFICATION TREATMENTS 795 17.3 OVERVIEW OF WATER PURIFICATION 809 17.4 DEIONIZATION BY ION-EXCHANGE REACTIONS 811 17.5 REVERSE OSMOSIS 838 17.6 ULTRAFILTRATION MEMBRANES 854 17.7 ULTRAVIOLET IRRADIATION OF WATER 855 17.8 ELECTRODIALYSIS 858 17.9 DISTILLATION OF WATER 860 17.10 USE OF FILTERS IN WATER PURIFICATION 882 17.11 WATER STORAGE AND DISTRIBUTION 885 17.12 WATER FOR INJECTION INSTALLATIONS 897 REFERENCES 913 18 PYROGENS, AND THE DEPYROGENATION OF SOLUTIONS WITH ULTRAFILTRATION MEMBRANES 919 F. RAYMOND GABLER 18.1 BIOCHEMISTRY OF BACTERIAL PYROGENS 919 18.2 CLASSICAL METHODS OF REMOVING PYROGENS 922 18.3 REMOVING PYROGENS WITH ULTRAFILTRATION MEMBRANE FILTERS 923 18.4 SCALING UP A UF SYSTEM FROM LABORATORY TO PRODUCTION 936 18.5 SUMMARY ! 938 REFERENCES 938 19 THEORY AND PRACTICE OF COMPRESSED AIR FILTRATION AND STERILIZATION IN THE PRODUCTION OF ANTIBIOTICS 941 ERIC W. BLAKIE 19.1 INTRODUCTION 941 19.2 COMPRESSED AIR CONTAMINATION 942 19.3 PREFILTRATION 945 19.4 THE COMPRESSED AIR STERILIZATION FILTER 945 19.5 FILTRATION THEORY 950 19.6 THE MODERN AIR STERILIZATION CARTRIDGE 952 19.7 FILTER HOUSINGS 954 19.8 PERFORMANCE COMPARISON 957 19.9 FILTER SELECTION AND SIZING 962 19.10 INSTALLATION 964 19.11 STEAM STERILIZATION 967 19.12 IN SITU STEAM STERILIZATION PROCEDURE 967 19.13 PROBLEM AREAS 968 19.14 FILTER CARTRIDGE LIFE 968 19.15 INTEGRITY TESTING 970 XVIII , CONTENTS 19.16 MICROBIAL TESTING 974 19.17 CONCLUSION 977 REFERENCES 978 20 FILTRATION IN THE PHARMACEUTICAL PROCESSING PRACTICES 979 20.1 REGULATORY FUNCTIONS 979 20.2 CLEANLINESS OF PEOPLE AND FACILITIES 982 20.3 STERILIZATION OF FILTERS 983 20.4 REPEATED ADVICE CONCERNING FILTRATION 986 20.5 LARGE-VOLUME PARENTERALS 986 20.6 SMALL-VOLUME PARENTERALS 996 20.7 OPHTHALMIC PREPARATIONS 1003 20.8 ANTIBIOTICS 1008 20.9 SPECIFIC ELABORATIONS 1018 20.10 BLOOD, PLASMA, AND SERUM 1021 20.11 TISSUE CULTURE MEDIUM FILTRATION 1040 20.12 FILTRATION IN VACCINES PREPARATION 1045 REFERENCES 1051 POSTSCRIPT 1055 PRESENT STATUS 1055 FUTURE DEVELOPMENTS 1055 BASIS FOR PREDICTION 1057 AUTHOR INDEX 1059 SUBJECT INDEX 1069
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spelling Filtration in the pharmaceutical industry Theodore H. Meltzer ...
New York u.a. Dekker 1987
XIX, 1091 S. Ill., graph. Darst.
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Advances in parenteral sciences 3.
Literaturangaben
Filtration
Pharmacie - Technique
Drug Industry
Filters and filtration
Pharmacy Technique
Filtration (DE-588)4017164-4 gnd rswk-swf
Pharmazeutische Industrie (DE-588)4045696-1 gnd rswk-swf
Pharmazeutische Technologie (DE-588)4045699-7 gnd rswk-swf
Pharmazeutische Technologie (DE-588)4045699-7 s
Filtration (DE-588)4017164-4 s
DE-604
Pharmazeutische Industrie (DE-588)4045696-1 s
Meltzer, Theodore H. Sonstige oth
Advances in parenteral sciences 3. (DE-604)BV000021432 3.
GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=000629164&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis
spellingShingle Filtration in the pharmaceutical industry
Advances in parenteral sciences
Filtration
Pharmacie - Technique
Drug Industry
Filters and filtration
Pharmacy Technique
Filtration (DE-588)4017164-4 gnd
Pharmazeutische Industrie (DE-588)4045696-1 gnd
Pharmazeutische Technologie (DE-588)4045699-7 gnd
subject_GND (DE-588)4017164-4
(DE-588)4045696-1
(DE-588)4045699-7
title Filtration in the pharmaceutical industry
title_auth Filtration in the pharmaceutical industry
title_exact_search Filtration in the pharmaceutical industry
title_full Filtration in the pharmaceutical industry Theodore H. Meltzer ...
title_fullStr Filtration in the pharmaceutical industry Theodore H. Meltzer ...
title_full_unstemmed Filtration in the pharmaceutical industry Theodore H. Meltzer ...
title_short Filtration in the pharmaceutical industry
title_sort filtration in the pharmaceutical industry
topic Filtration
Pharmacie - Technique
Drug Industry
Filters and filtration
Pharmacy Technique
Filtration (DE-588)4017164-4 gnd
Pharmazeutische Industrie (DE-588)4045696-1 gnd
Pharmazeutische Technologie (DE-588)4045699-7 gnd
topic_facet Filtration
Pharmacie - Technique
Drug Industry
Filters and filtration
Pharmacy Technique
Pharmazeutische Industrie
Pharmazeutische Technologie
url http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=000629164&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA
volume_link (DE-604)BV000021432
work_keys_str_mv AT meltzertheodoreh filtrationinthepharmaceuticalindustry