Environmental Monitoring and Quality Operations in Biomanufacturing 2 Units (AA/AS) 18 lecture hours, 54 lab hours

Catalog description

This course builds on the concepts and laboratory techniques introduced in Biotechnology II: Biomanufacturing and Quality Principles. Students will examine the roles of Environmental Monitoring and Quality Control Microbiology in the context of biomanufacturing to ensuring the safety of biological drug products. Routine facility, personnel, and utilities environmental monitoring plans and procedures will be highlighted in the context of a comprehensive quality system. This course will review detection, analysis, and control of both viable and non-viable contaminants with an emphasis on aseptic technique and interpretation of testing data. This course includes a significant laboratory component which emphasizes the selection of appropriate equipment and procedures for non-viable particle monitoring in air, bioburden assessment of air, water, surfaces, and personnel, microbial identification, endotoxin testing, and aseptic gowning procedures.