Control of Particulate Matter Contamination in Healthcare Manufacturing

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CRC Press, Oct 31, 1999 - Medical - 574 pages
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This book offers practical applications addressing the specifics of contamination, including particle origination, characterization, identification, and elimination, with a special focus on quality considerations. Written by an industry expert, this material offers a clear and concise understanding of particle populations and their control in stability, efficacy, and predictability in the manufacture of healthcare products. Complete with a full-color insert of micrographs illustrating commonly encountered particulate matter and over eighty figures, tables, and charts.

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Contents

INTRODUCTION AND OVERVIEW
1
SOURCES AND CHARACTERISTICS OF CONTAMINANT PARTICLES
27
Particle Transport Deposition and Adherence
48
REQUIREMENTS AND TEST METHODS FOR INJECTABLE SOLUTIONS
61
StoppersDraft Amendment to ISO 8871
77
Summary and Conclusion
94
Light Obscuration Test Summary
112
The USP 4788 Microscopic Test
114
Visual Inspection of Medical Devices
271
Light Obscuration Sensors
277
Validation and Count Accuracy
291
Light Obscuration Count Data
300
Error Sources Checklist
307
AIRBORNE PARTICLE COUNTING AND ENVIRONMENTAL MONITORING
319
Lower Detection Limits of LightScattering Instruments
326
Particle Transport and Sample Acquisition
335

Summary
127
Philosophy of Compliance
143
Summary and Conclusion
183
REGULATORY PERSPECTIVES RELATED TO
193
Current Regulatory InterestsDrugs and Injectable Products
199
Environmental Monitoring
205
Preparation for FDA Inspections
213
References
227
General Considerations in Visual Inspection
233
Automated Machine Inspection
255
Essentially FreeThe Concept and the Compendium
261
FDA Expectations for Visual Inspection
268
Remote Systems AnalysisGeneral
344
Sampling of Compressed Gases
353
Summary
359
Polarized Light Microscopy
383
Morphology and Particle Identification
390
Microscope Calibration
398
VALIDATION AND ITS APPLICATION TO PARTICLE COUNTING
409
SAMPLING AND COLLECTION OF PARTICULATE MATTER FOR ANALYSIS
457
APPLICATION AND INUSE TESTING OF HEPA FILTERS
493
SOURCES OF STANDARDS AND DOCUMENTS
535
INDEX
541
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