Study of the detection sensitivity of visible particles in water-containing vials with and without defects by three methods including manual, semi-automated and automated visual inspection devices
| Inspection parameters | Manual | Semi-automated | Automated | |||
| 50 mL | 10 mL | 50 mL | 10 mL | 50 mL | 10 mL | |
| Number of operators | 3 | 3 | 3 | 3 | 1 | 1 |
| Number of vials inspected | 8 | 8 | 8 | 8 | 8 | 8 |
| Number of inspections | 1 | 1 | 1 | 1 | 30 | 30 |
| Total number of inspections | 24 | 24 | 24 | 24 | 240 | 240 |
| Total inspection of defect-free vials | 9 | 9 | 9 | 9 | 90 | 90 |
| Total inspection of defective vials | 15 | 15 | 15 | 15 | 150 | 150 |
| False positive (%) | 0 | 0 | 0 | 0 | 22 | 42 |
| False negative (%) | 0 | 0 | 0 | 0 | 23 | 95 |
| Unit specific error rate (%) | ||||||
| Vial #12 and #33 - Glass particles ≥600 µm | 0 | 0 | 0 | 0 | 0 | 100 |
| Vial #13 and #34 - Glass particles 224 µm | 0 | 0 | 0 | 0 | 0 | 100 |
| Vial #10 and #32 - Stopper fragments | 0 | 0 | 0 | 0 | 0 | 100 |
| Vial #6 and #30 - Fibres | 0 | 0 | 0 | 0 | 43 | 83 |
| Vial #7 and #31 - Fibres | 0 | 0 | 0 | 0 | 70 | 90 |
| Vial #1 and #27 No defects | 0 | 0 | 0 | 0 | 0 | 0 |
| Vial #2 and #28 No defects | 0 | 0 | 0 | 0 | 17 | 53 |
| Vial #3 and #29 No defects | 0 | 0 | 0 | 0 | 50 | 73 |
| Overall accuracy (%) | 100 | 100 | 100 | 100 | 78 | 25 |
| Overall error rate (%) | 0 | 0 | 0 | 0 | 22 | 75 |
The study was performed on 50 mL and 10 mL type I moulded or drawn 16 glass vials, respectively.