07.08.2026
Visual Inspection
One area receiving particular attention is automated optical inspection for pre-filled syringes. Compared with traditional manual inspection, automated systems can provide greater consistency and the ability to detect defects that may be difficult to identify through visual checks alone.
At medac CDMO, Japanese optical inspection machine — the first of its kind in Europe — was introduced in 2024 for automated inspection of pre-filled syringes.
What Makes This System Different
The machine consists of three fully automated modules: denester, optical inspection, and renester. The integrated system is capable of processing up to 24,000 syringes per hour.
Each syringe is inspected individually using a combination of cameras, stopper sensors, and high-voltage leak detection (HVLD) modules. The platform performs 100% container closure integrity testing while simultaneously optical checking.
12 inspection stations with 21 cameras takes 150 pictures for each syringe. System detects defects for particles, glass defects (cracks and scratches), needle and needle shield defects, filling volume deviations, cosmetic defects, stopper positioning deviations, and color variations. Maximal processing time is 250 ms for each camera (to take a picture, send to visual PC, evaluate picture and virtually mark bad syringe for rejection).
The inclusion of HVLD technology reflects the growing use of non-destructive container closure integrity testing methods in sterile manufacturing. Compared with traditional approaches, HVLD enables automated verification of syringe integrity directly within the inspection workflow.
Automated optical inspection is becoming increasingly relevant as manufacturers manage larger production volumes alongside rising regulatory expectations for particulate control, data traceability, and inspection reliability. Unlike manual visual inspection, automated systems apply the same inspection parameters consistently across every unit and batch.
The adoption of high-speed inspection platforms also supports operational efficiency without reducing inspection coverage. At throughput rates of up to 24,000 syringes per hour, systems can maintain full inspection while supporting commercial-scale production demands.
As fill-finish operations continue to evolve, advanced inspection technologies are becoming a more integrated part of quality assurance strategies, particularly for sterile injectable products where defect detection and container integrity remain critical process requirements.
For pharma companies who need to outsource a high-volume injectable to CDMO it helps to create a stable, scalable manufacturing process where quality verification can keep pace with production itself.