We developed a validated automated visual inspection system over 16 weeks: (1) Multi-Camera Inspection Station -- designed a 5-camera inspection station integrated into the filling line: two cameras for particulate detection (backlighting the vial and capturing images while the vial was spun to mobilize particles), one camera for container integrity (high-resolution imaging of the vial body, neck, and crimp seal), one camera for fill volume (side-profile imaging with reference mark detection), and one camera for label inspection (high-resolution label reading with OCR verification against batch specifications).
(2) Defect Detection Models -- trained convolutional neural networks for each defect category: particulate detection (trained on 45,000 annotated vial images including clean vials and vials with various particle types and sizes), container defect detection (trained on 22,000 images including intact vials and vials with cracks, chips, and seal irregularities), fill volume assessment (trained on 15,000 images covering the acceptable fill range and common underfill/overfill conditions), and label quality verification (OCR with verification against batch-specific print specifications). (3) GAMP 5 Validation -- the system was validated following GAMP 5 software category 5 (custom application) requirements: design qualification (DQ) documenting requirements and design decisions, installation qualification (IQ) verifying hardware and software installation, operational qualification (OQ) testing system performance under normal operating conditions with known defect samples, and performance qualification (PQ) comparing automated inspection against manual inspection on production batches.
PQ included a statistical study comparing defect detection rates: 10,000 vials inspected by both human inspectors and the automated system. (4) Electronic Batch Records -- inspection results were recorded electronically with each vial's inspection outcome, defect classification, inspection timestamp, and camera images of rejected vials. This electronic documentation eliminated paper records and provided complete traceability for HPRA inspection. (5) Reject Handling -- defective vials were automatically diverted to a reject station with categorized collection bins (particulate, container defect, fill volume, label). Reject vials were retained for quality review, enabling correlation analysis and root cause investigation for recurring defect types.