Advancing Drug Product Quality Through Automated Visual Inspection And Future-Ready Infrastructure

By Mitsutaka Shirasaki, Principal Scientist, Visual Inspection and Packaging Group, Samsung Biologics

Automated visual inspection (AVI) is increasingly vital for safeguarding quality in injectable medicines, where it enables rapid, consistent identification of defects at scale. As drug formulations and delivery formats become more sophisticated, AVI addresses the inherent shortcomings of manual inspection by improving efficiency, reliability, and reproducibility. To ensure performance and regulatory alignment, programs such as defect kit creation, detection probability studies, and fine-tuning of inspection parameters are essential. The integration of artificial intelligence and advanced digital platforms is further elevating inspection accuracy — capabilities that Samsung Biologics is leveraging as it broadens its portfolio to include antibody-drug conjugates (ADCs) and pre-filled syringes (PFS).

In sterile drug manufacturing, inspection is not optional as it is a regulatory mandate and a critical safeguard for patients. The presence of particulate matter, closure integrity problems, or cosmetic irregularities can have serious consequences for safety, compliance, and market trust. Authorities and pharmacopeial standards worldwide require every finished unit to be inspected, underscoring the central role of this process in drug product release.

As pipelines expand and production volumes rise, traditional manual inspection methods are struggling to keep pace. AVI technologies combine robotics, precision imaging, and sophisticated defect-recognition software to provide a scalable solution. However, adoption requires rigorous qualification to demonstrate that automated systems perform on par with, or better than, experienced human inspectors across a broad range of container types and defect scenarios.

Samsung Biologics has positioned AVI as a cornerstone of its fill/finish operations, rather than a supporting step. Through sustained investment in automation, data-centric validation, and flexible manufacturing infrastructure, the company is establishing new benchmarks for quality control in biologics. Its integrated platform—spanning high-volume production to advanced dosage formats such as ADCs and PFS—reflects a commitment to delivering safe, compliant, and reliable medicines to patients worldwide.