Pharmaceutical particulate matter: analysis and control
Saved in:
| Main Authors: | , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Buffalo Grove, Il.
Interpharm Press
1993
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| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | 531 S. |
| ISBN: | 0935184295 |
Staff View
MARC
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| 264 | 1 | |a Buffalo Grove, Il. |b Interpharm Press |c 1993 | |
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| 650 | 4 | |a Drug Contamination |x prevention & control | |
| 650 | 4 | |a Infusions, Parenteral | |
| 650 | 4 | |a Parenteral solutions |x Analysis | |
| 650 | 4 | |a Parenteral solutions |x Contamination | |
| 650 | 4 | |a Parenteral solutions |x Quality control | |
| 650 | 4 | |a Particles |x Analysis | |
| 650 | 4 | |a Pharmaceutical Preparations |x analysis | |
| 650 | 4 | |a Quality Control | |
| 650 | 4 | |a Technology, Pharmaceutical |x methods | |
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Record in the Search Index
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|---|---|
| adam_text | PHARMACEUTICAL PARTICULATE MATTER ANALYSIS AND CONTROL THOMAS A. BARBER
BAXTER HEALTHCARE ILLUSTRATIONS BY JOHN G. WILLIAMS PHOTOMICROGRAPHY
SECTION BY DAMIAN S. NEUBERGER INTERPHARM PRESS BUFFALO GROVE, IL VLL
PREFACE XV ACKNOWLEDGEMENTS XVII I. INTRODUCTION 1 GMP PRINCIPLES L
COMPENDIAL REQUIREMENTS 4 PARTICLE DISTRIBUTION 5 PARTICULATE MATTER
CONTROL 6 STANDARDS 8 SUMMARY 19 REFERENCES 19 II. VISUAL INSPECTION 22
VISUAL INSPECTION 23 MANUAL INSPECTION 24 REPRODUCIBILITY OF VISUAL
INSPECTION 33 AUTOMATED (MACHINE) INSPECTION 34 APPLICATION OF AUTOMATED
SYSTEMS 44 COMPENDIAL REQUIREMENTS 44 SUMMARY 46 REFERENCES 47 III.
INSTRUMENTAL PARTICLE COUNTING 50 THE COULTER PRINCIPLE 51 LIGHT
EXTINCTION COUNTING 54 LASER VERSUS WHITE LIGHT EXTINCTION SENSORS 59
ERROR SOURCES 70 RECENT DEVELOPMENTS 73 SPECTREX (PHOTOTRON) SYSTEM 75
PARTICLE SIZE STANDARDS 77 EMULSION POLYMERIZATION 78 VLLL SUSPENSION
POLYMERIZATION 79 SWOLLEN EMULSION PROCESS 80 STORAGE AND HANDLING OF
STANDARD PARTICLES 81 USE OF COMMERCIAL STANDARDS 82 USP PARTICLE COUNT
REFERENCE STANDARD 84 ALTERNATIVE COUNT STANDARDS 85 AUTORNATED LIGHT
EXTINCTION COUNTING 87 VALIDATION OF THE ROBOTIC ASSAY 89 OPERATIONAL
VALIDATION 92 VALIDATION OF DATA COLLECTED 93 SUMMARY 96 REFERENCES 96
IV. MICROSCOPY 100 STRUCTURE OF THE COMPOUND MICROSCOPE 102 LENS
ABERRATIONS 103 OBJECTIVE LENSES 107 WORKING DISTANCE OF OBJECTIVES 109
RESOLVING POWER 110 OCULARS (EYEPIECES) 111 CONDENSER LENS 111 REFLECTED
ILLUMINATION 112 DARK-FIELD MICROSCOPY 112 REFRACTIVE IN DEX 114
POLARIZED LIGH T MICROSCOPY 115 INTERFERENCE 116 BIREFRINGENCE AND
EXTINCTION 118 REFRACTIVE INDEX DETERMINATIONS 121 DISPERSION STAINING
122 ISOLATION AND HANDLING OF PARTICLES 123 HOT STAGE METHODS 125
MICROSCOPE CALIBRATION 126 MEASUREMENT OF PARTICLE SIZE 127 TECHNIQUES
FOR MICROSCOPIC PARTICLE COUNTING 129 ENUMERATION OF PARTICLES IN
PARENTERAL PRODUCTS 134 SUMMARY 139 REFERENCES 139 IX V. INSTRUMENTAL
ANALYSIS FOR PARTICLE IDENTIFICATION 143 PARTICLE IDENTIFICATION *
ELECTRON MICROSCOPY 145 TRANSMISSION ELECTRON MICROSCOPY 146
ELECTROMAGNETIC LENSES 149 SCANNING ELECTRON MICROSCOPY 152 APPLICATION
OF X-RAY SPECTROSCOPY 160 ELEMENTAL COMPOSITION ANALYSIS 162 INFRARED
MICROSPECTROPHOTOMETRY 165 MASS SPECTROMETRY 169 LAMMA 169 SECONDARY ION
MASS SPECTROMETRY 172 X-RAY DIFFRACTION CRYSTALLOGRAPHY 177 SUMMARY 183
REFERENCES 183 VI. ENVIRONMENTAL PARTICULATE MATTER MONITORING AND
CONTROL 187 APPLICABLE STANDARDS 189 PRINCIPLES OF HEP A FILTRATION 192
HEPA FILTER PARTICLE RETENTION CHARACTERISTICS 197 IN-USE TESTING OF
HEPA FILTERS 197 ENVIRONMENTAL PARTICLE MONITORING 201 LASER VERSUS
WHITE LIGHT COUNTERS 203 REMOTE PARTICLE MONITORING 208 APPLICATION OF
FEDERAL STANDARD 209-D 212 FEDERAL STANDARD 209-E 215 ISOKINETIC
SAMPLING 219 SAMPLING OF COMPRESSED GASES 223 TUBING TRANSPORT OF
PARTICULATE MATTER SAMPLES 226 LARGE PARTICLE MONITORING 229 PERSONNEL
MONITORING 231 SUMMARY 232 REFERENCES 233 VII. PROCESS- AND
PRODUCT-RELATED PARTICLES 237 PACKAGING MATERIALS 240 SOLUTION AND
FORMULATION COMPONENTS 243 DRY POWDER DRUG MATERIALS 246
PRODUCT-CONTAINER INTERACTIONS 248 PROCESS POINT-GENERATED PARTICULATES
249 PARTICULATE MATTER PROBLEM SOLVING 253 PHILOSOPHICAL CONSIDERATIONS
255 SAMPLING FOR LARGE PARTICLES 259 SUMMARY 260 REFERENCES 261 VIII.
PARTICLE POPULATION ANALYSIS 266 PARTICLE SIZE 268 PARTICLE SHAPE 271
PARTICLE SIZE DISTRIBUTIONS (PARTICLE NUMBER) 281 DISTRIBUTION OF
EXTRANEOUS PARTICLE COUNTS 294 AVERAGE DIAMETERS 294 INSTRUMENTATION AND
METHODS 298 NEPHELOMETRY 303 LASER DIFFRACTION 306 PHOTON CORRELATION
SPECTROSCOPY 309 MICROSCOPY AND IMAGE ANALYSIS 312 SIEVING 318 LIGHT
EXTINCTION COUNTING 323 SEDIMENTATION 328 ADSORPTION AND POROSIMETRY 330
POROSIMETRY 334 APPLICATION OF ADSORPTION AND POROSIMETRY 337 AEROSOL
POPULATION ANALYSIS 338 SUMMARY 344 REFERENCES 345 XI IX. COLLECTION AND
ISOLATION OF PARTICULATE MATTER 350 FILTER STRUCTURE AND APPLICATION 352
RETENTION RATINGS, PORE SIZE, AND POROSITY 359 MECHANISM OF LIQUID
FILTRATION 361 DETERMINATION OF RETENTION RATINGS 364 WETTABILITY AND
REFRACTIVE INDEX 365 FILTRATION APPARATUS 366 COLLECTION OF PARTICLES
FOR ANALYSIS 367 ISOLATION OF PARTICLES FOR IDENTIFICATION 368 POWDER
SAMPLING 371 COLLECTION OF PARTICLES FROM ENVIRONMENTAL AIR 376
MICROSCOPIC ANALYSIS OF AIRBORNE PARTICLES 379 MONITORING OF COMPONENTS
AND PARTS 385 SAMPLING OF CLEAN ROOM GARMENTS 386 TESTING OF CLEAN ROOM
OR SURGICAL GLOVES 389 SUMMARY 390 REFERENCES 390 X. PROCESS CONTROL OF
PARTICULATE MATTER 393 PROCESS DESIGN 394 PROCESS CONTROL 398
STATISTICAL PROCESS CONTROL 399 PROCESS STABILITY AND CAPABILITY 403
CONTROL CHARTING 407 BATCH SAMPLING 420 XL SUMMARY REFERENCES MEDICAL
DEVICES PARENTERAL-TYPE DEVICES SOURCES AND CONTROL OF PARTICULATE
MATTER IN DEVICES 434 PROCESS DESIGN 437 PATIENT CONCERNS 440 428 429
431 433 XLL ANALYSIS OF PARTICULATE MATTER IN DEVICES 442 AUTOLOGOUS
TRANSFUSION DEVICES 448 BLOOD FILTERS 449 CHOICE OF PARTICLE COUNTING
METHODS 449 GMP CONTROL OF DEVICE PARTICULATES 450 CURRENT REGULATORY
ISSUES 453 DEVICE-RELATED 483S 459 DEVICE SPECIFIC PARTICULATE MATTER
ISSUES 460 CONSIDERATION REGARDING PARTICULATE MATTER REQUIREMENTS 461
SAFE MEDICAL DEVICES ACT OF 1990 463 SUMMARY 465 REFERENCES 466 XII.
PATIENT ISSUES RELATED TO PARTICULATE MATTER 470 CIRCULATORY TRANSPORT
471 HUMAN INJURY BY PARTICLES 4 73 ANIMAL STUDIES 474 LIPOSOME RESEARCH
476 INFUSION OF RLOOD-RELATED MATERIALS 478 PHLEBITIS AND PARTICLES 479
CONCLUSIONS REGARDING PATIENT RISK 480 SUMMARY 480 REFERENCES 482
APPENDICES 487 1. PHOTOMICROGRAPHY OF PARTICULATE MATTER 487 SAMPLE
PREPARATION 488 INSTRUMENTATION 489 FILM 493 LIGHT BALANCING FILTERS 495
COLOR COMPENSATING FILTERS 496 POLARIZED LIGHT TECHNIQUES 497
ILLUSTRATIONS 498 XLLL 2. VENDOR AND EQUIPMENT INFORMATION 504 PARTICLE
COUNTERS (AIRBORNE AND SOLUTION) 504 LIGHT EXTINCTION COUNTER SENSORS
505 COUNTER CALIBRATION SOFTWARE 505 CALIBRATION MATERIALS 505 VISUAL
INSPECTION SYSTEMS 506 IMAGE ANALYSIS 506 ELECTRICAL ZONE SENSING
COUNTERS 507 LASER DIFFRACTION PARTICLE ANALYZERS 507 LAMMA
INSTRUMENTATION 507 LIGHT MICROSCOPES 507 X-RAY SPECTROMETERS 508
ELECTRON MICROSCOPES 508 PHOTON CORRELATION SPECTROPHOTOMETERS 509 LASER
LIGHT SCATTERING LIQUID COUNTERS 509 MICRO (SUBMICRON) PARTICLE SAMPLERS
509 MICROFILTRATION SUPPLIES 509 CLEAN ROOM SUPPLIES 509 PARTICLE
ANALYSIS EQUIPMENT (GENERAL) 510 POWDER ANALYSIS EQUIPMENT 510 SECONDARY
ION MASS SPECTROMETERS 511 LABORATORY ROBOTS 511 ADDITIONAL SOURCES OF
SUPPLEMENTAL INFORMATION AND STANDARDS 511 SOFTWARE FOR DATA REDUCTION
513 3. TRADEMARKS 514 INDEX 519 NAME 519 SUBJECT 524 THE COLOR
PHOTOMICROGRAPHS FOUND NEAR THE MIDDLE OF THIS TEXT ARE DESCRIBED ON
PAGES 498 TO 503 IN APPENDIX I.
|
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| illustrated | Not Illustrated |
| indexdate | 2024-07-09T17:28:58Z |
| institution | BVB |
| isbn | 0935184295 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-005976883 |
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| physical | 531 S. |
| publishDate | 1993 |
| publishDateSearch | 1993 |
| publishDateSort | 1993 |
| publisher | Interpharm Press |
| record_format | marc |
| spelling | Barber, Thomas A. Verfasser aut Pharmaceutical particulate matter analysis and control Thomas A. Barber ; Baxter Healthcare Buffalo Grove, Il. Interpharm Press 1993 531 S. txt rdacontent n rdamedia nc rdacarrier Drug Contamination prevention & control Infusions, Parenteral Parenteral solutions Analysis Parenteral solutions Contamination Parenteral solutions Quality control Particles Analysis Pharmaceutical Preparations analysis Quality Control Technology, Pharmaceutical methods Teilchen (DE-588)4059317-4 gnd rswk-swf Teilchen (DE-588)4059317-4 s DE-604 Healthcare, Baxter Verfasser aut GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=005976883&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Barber, Thomas A. Healthcare, Baxter Pharmaceutical particulate matter analysis and control Drug Contamination prevention & control Infusions, Parenteral Parenteral solutions Analysis Parenteral solutions Contamination Parenteral solutions Quality control Particles Analysis Pharmaceutical Preparations analysis Quality Control Technology, Pharmaceutical methods Teilchen (DE-588)4059317-4 gnd |
| subject_GND | (DE-588)4059317-4 |
| title | Pharmaceutical particulate matter analysis and control |
| title_auth | Pharmaceutical particulate matter analysis and control |
| title_exact_search | Pharmaceutical particulate matter analysis and control |
| title_full | Pharmaceutical particulate matter analysis and control Thomas A. Barber ; Baxter Healthcare |
| title_fullStr | Pharmaceutical particulate matter analysis and control Thomas A. Barber ; Baxter Healthcare |
| title_full_unstemmed | Pharmaceutical particulate matter analysis and control Thomas A. Barber ; Baxter Healthcare |
| title_short | Pharmaceutical particulate matter |
| title_sort | pharmaceutical particulate matter analysis and control |
| title_sub | analysis and control |
| topic | Drug Contamination prevention & control Infusions, Parenteral Parenteral solutions Analysis Parenteral solutions Contamination Parenteral solutions Quality control Particles Analysis Pharmaceutical Preparations analysis Quality Control Technology, Pharmaceutical methods Teilchen (DE-588)4059317-4 gnd |
| topic_facet | Drug Contamination prevention & control Infusions, Parenteral Parenteral solutions Analysis Parenteral solutions Contamination Parenteral solutions Quality control Particles Analysis Pharmaceutical Preparations analysis Quality Control Technology, Pharmaceutical methods Teilchen |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=005976883&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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