Aseptic Techniques for Bioprocessing

Effective utilization of aseptic bioprocessing techniques is required to maintain product sterility and integrity throughout its lifecycle. Critical and controlled bioprocessing areas help to maintain sterility of a biological product during the manufacturing process and help protect the end-user. Biologically-derived drug products cannot be treated with terminal sterilization methods. Anything that may come in contact with the product or interrupt the sterile field is a source of contamination, and these sources may include personnel, equipment, instruments, waste, raw materials, etc. Personnel must conduct aseptic processes deliberately and methodically to avoid introducing contaminants into the system. This hands-on course teaches best practices for working in critical processing areas and Class 5 biological safety cabinets. Participants conduct basic gowning and de-gowning, proper entrance and exiting, learn behaviors that minimize turbulence and the generation of particulates, and take measures to reduce the likelihood of contamination.