Study of the detection of visible defects by a semi-automated visual inspection device and detection of particles by particle counting following the analysis of five production lots of 50 mL and 10 mL
| Compounded sterile preparations | Ethanol 95% | Ethanol 30% | AP ISO | Cisatracurium besilate 5 mg/mL | Pancuronium bromide 2 mg/mL |
| Batch | |||||
| Volume of unit (ml) | 50 | 10 | 50 | 50 | 10 |
| Number of units | 229 | 288 | 300 | 309 | 544 |
| Visible defects >50 µm | |||||
| Fibres | 40 (17.4%) | 8 (2.8%) | 7 (2.3%) | 2 (0.6%) | 7 (1.3%) |
| Particles | 21 (9.2%) | 7 (2.4%) | 4 (1.3%) | 2 (0.6%) | 5 (0.9%) |
| Altered packaging | 0 | 0 | 3 (1%) | 0 | 3 (0.5%) |
| Total | 61 (26.6%) | 15 (5.2%) | 14 (4.6%) | 4 (1.2%) | 15 (2.7%) |
| Sub-visible particles | |||||
| 10 µm (< 6 000 particles/vial) | 17 | 139 | 45 | 105 | 38 |
| 25 µm (< 600 particles/vial) | 1 | 13 | 1 | 65 | 0 |
AP ISO is a mixture of glucose 25 mg/mL and sodium chloride 2 mg/mL used as neonatal rehydration solution.
The term “altered packaging” encompasses a range of defects, including broken vials or lifted caps.