New and incumbent biomanufacturing employees

Aseptic processing is utilized to prevent contamination and manufacture sterile products to ensure patient safety. Contamination of these drug products via the introduction of microorganisms, endotoxins, or particulates will lead to product failure, product destruction, and the potential for illness or death of patients and consumers. This course provides the foundational knowledge of aseptic practices required for processing sterile products and maintaining customer safety. In this course, students will be introduced to the regulatory requirements for sterile product manufacturing, the consequences of microbial contamination, and the best practices and behaviors in a cleanroom. Students will be introduced aseptic processing topics such as environmental monitoring, endotoxin testing, cleaning and disinfection, cleanroom design and controls, sterilization processes, aseptic gowning, formulation, and sterile filtration.