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Identify effective means of detection of particles Understand and
interpret current environmental, GMP and other standards, and
requirements for contamination control Learn the sources and
characteristics of contaminant particles Set up requirements and
test methods for injectable solutions and medical devices Conduct
visual inspections, light extinction particle counting, airborne
particle counting, and environmental monitoring Validate particle
counting instrument systems Sample and collect particulate matter
for analysis 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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