ASI Completes Validation for Grass Roots Sterile Fill Facility

ASI was contracted to supply technical resources for fast-track validation of a grass roots aseptic fill facility.This biotechnology plant included automated vial filling, lyophilization, blow fill seal, and barrier isolation technology. Working at the direction of a small, highly focused, and dynamic site management team, ASI was able to go from construction to a successful pre-approval inspection in an unheard of 16 months.The FDA pre-approval inspection resulted in zero observations related to validation activities.

Work included validation of the HAVC/BAS systems, all facilities, the water for injection system, all critical utilities, a terminal sterilizer, lyophilizer, Rommelag blow-fill-seal machine, and a fully isolated automated vial line.ASI also assisted in cleaning and process validation activities.