Challenges and Strategies for Implementing Automated Visual Inspection for Biopharmaceuticals

Manufacture of sterile parenteral drug products involves a series of unit operations (1) and aseptic processing conducted under strict requirements with respect to product quality. The manufacturing process is designed and validated to address such requirements and to ensure supply of safe and efficacious products. Visually inspecting each filled and sealed container for foreign contaminants or particulates ensures that these high standards are met and the final drug product is safe for patient use (2).

The United States Pharmacopeia (USP) provides guidance with respect to the inspection process for injectable drug products (2, 3). According to USP General Chapter <1>, the injection process shall be designed and qualified to ensure that every lot of all parenteral preparations is essentially free from visible particulates and every container whose contents shows evidence of visible particulates shall be rejected. Two methods are primarily employed by the pharmaceutical industry to address the need for visual inspection of filled and sealed containers: manual visual inspection (MVI) relying on human capability and machine based automated visual inspection (AVI).