Control of Particulate Matter Contamination in Healthcare Manufacturing

ISBN-13: 9781574910728 / Angielski / Twarda / 1999 / 574 str.

Thomas A. Barber; Barber A. Barber

Opis

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.

Spis treści

o Overview
o Sources & Characteristics of Contaminant Particles
o Requirements & Test Methods for Injectable Solutions & Medical Devices
o USP 23

O autorze

Thomas A. Barber