Study of the detection of visible particles in 10 mL type I moulded glass vials by three methods including manual, semi-automated performed by two operators (#1, #2) and automated visual inspection devices
| Operating condition | Vials | Visible particles inspection | ||||
| Manual | Semi-automated | Automated | ||||
| #1 | #2 | #1 | #2 | |||
| No cleanroom ISO 9 Woven cotton/polyester unsterile outfit without gloves | Unwashed and unwrapped | |||||
| Vial 5.1 to 5.5 | Bad | Bad | Bad | Bad | 5 Bad – 0 Good | |
| Cleanroom D ISO 8 Unwoven carbon/polyester sterile cleanroom outfit with sterile gloves | Washed and unwrapped | |||||
| Vial 6.1 | Good | Good | Good | Good | 5 Good – 0 Bad | |
| Vial 6.2 | Good | Good | Good | Good | 5 Good – 0 Bad | |
| Vial 6.3 | Good | Good | Good | Good | 5 Good – 0 Bad | |
| Vial 6.4 | Good | Good | Good | Good | 5 Good – 0 Bad | |
| Vial 6.5 | Bad | Bad | Bad | Bad | 5 Bad – 0 Good | |
| Cleanroom D ISO 8 Unwoven cellulose/polyester sterile cleanroom outfit with sterile gloves | Washed, depyrogenated and unwrapped | |||||
| Vial 7.1 | Good | Good | Good | Good | 5 Good – 0 Bad | |
| Vial 7.2 | Good | Good | Good | Good | 5 Good – 0 Bad | |
| Vial 7.3 | Good | Good | Good | Good | 1 Good – 4 Bad | |
| Vial 7.4 | Bad | Bad | Bad | Bad | 5 Bad – 0 Good | |
| Vial 7.5 | Bad | Bad | Bad | Bad | 5 Bad – 0 Good | |
| Cleanroom C ISO 7 Unwoven carbon/polyester sterile cleanroom outfit with sterile gloves | Washed and wrapped | |||||
| Vial 8.1 | Good | Good | Good | Good | 5 Good – 0 Bad | |
| Vial 8.2 | Good | Good | Good | Good | 4 Good – 1 Bad | |
| Vial 8.3 | Bad | Bad | Bad | Bad | 5 Bad – 0 Good | |
| Vial 8.4 | Bad | Bad | Bad | Bad | 5 Bad – 0 Good | |
| Vial 8.5 | Bad | Bad | Bad | Bad | 2 Bad – 3 Good | |
Good: No defect detected.
Bad: One or more defects detected.
For the washed vials, one set was bagged, the other was filled directly at the end of washing. The vials were successfully inspected five times by an automated visual inspection device.