Microbial contamination inside of aseptic processing rooms represents a grave product risk. Supporting areas such as rooms dedicated to donning the sterile gowns can play a role in maintaining the inner core microbial free. The construction of modern cleanrooms and HVAC systems provide a substantially microbial free air when properly designed; but those principles are not fully and consistently applied to gowning rooms.

Download the accompanying presentation, "A GMP Roadmap for Aseptic Processing," presented at IVT's Aseptic Processing, Environmental Monitoring, Cleaning Validation Conference.