Table 1 Schedule of the simulation contamination procedure
Day | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
|---|---|---|---|---|---|---|---|---|
Bacterial strain subculturing | Yes | Yes | Yes | Yes | Yes | |||
Inoculum preparation | 106 UFC/cm2 on pads | 106 UFC/cm2 on pads | 106 UFC/cm2 on pads | 106 UFC/cm2 on pads | 106 UFC/cm2 on pads | |||
Medium control | Numeration | |||||||
Packaging sterility control | (Filling) | Numeration | Numeration (unused pack) | Numeration (unused pack) | Numeration (unused pack) | Numeration (unused pack) | Numeration (unused pack) | |
Delivered doses numeration (morning) | 1 dose before simulation | 1st dose 2nd dose | 1st dose 2nd dose | 1st dose 2nd dose | 1st dose 2nd dose | Numeration on 1 g + pack content | ||
Simulation (6 h minimum between each) | Morning | Morning | Morning | Morning | Morning | |||
Afternoon | Afternoon | Afternoon | Afternoon | Afternoon |