VPHP Monitoring and H2O2 Uptake Data from Process Validation Batches
| Configuration/Batch Number | Event | Time (h:mm) | VPHP Level by Picarro (ppb) | H2O2 Uptake by Amplex (ng/mL) | Reference H2O2 Level [Drug Product Solution Outside the Isolator (ng/mL)] | |
|---|---|---|---|---|---|---|
| 15 mL/0001 | End of Decontamination | 0:00 | NA | |||
| Start of Production | 6:14 | 286 | ||||
| Adjusting Filling Line | 6:24 | 322 | ||||
| Sampling - Vials (Beginning) | 6:57 | 331 | 23 ± 5 | 18 ± 1 | ||
| Interruption—30 min | Open, Filled Vials | 7:43 | 293 | 55 ± 8 | ||
| Sampling—First 5 filling cycles | 36 ± 6 | |||||
| Sampling—Vials (Middle) | 10:26 | 203 | 18 ± 2 | |||
| Sampling—Vials (End) | 14:33 | 152 | 19 ± 5 | |||
| End of Production | 14:49 | 155 | ||||
| 15 mL/0002 | End of Decontamination | 0:00 | 311 | |||
| Start of Production | 6:03 | 284 | ||||
| Adjusting Filling Line | 6:18 | 321 | ||||
| Sampling—Vials (Beginning) | 6:38 | 319 | 39 ± 3 | 14 ± 0 | ||
| Interruption—60 min | Open, Filled Vials | 7:13 | 264 | 59 ± 4 | ||
| Sampling—First 5 filling cycles | 42 ± 13 | |||||
| Sampling—Vials (Middle) | 11:21 | 208 | 35 ± 4 | |||
| Sampling—Vials (End) | 12:34 | 183 | 48 ± 13 | |||
| End of Production | 12:40 | 184 | ||||
| 15 mL/0003 | End of Decontamination | 0:00 | 366 | |||
| Start of Production | 7:02 | 240 | ||||
| Adjusting Filling Line | 7:18 | 266 | ||||
| Sampling—Vials (Beginning) | 7:42 | 277 | 33 ± 4 | 22 ± 1 | ||
| Interruption—15 min | Open, Filled Vials | 8:12 | 254 | 41 ± 4 | ||
| Sampling—First 5 filling cycles | 30 ± 4 | |||||
| Sampling - Vials (Middle) | 18:40 | 105 | 27 ± 2 | |||
| Sampling—Vials (End) | 25:52 | 74 | 30 ± 5 | |||
| End of Production | 32:42 | 55 | ||||
| 21.4 mL/0001 | End of Decontamination | 0:00 | 398 | |||
| Start of Production | 6:02 | 274 | ||||
| Adjusting Filling Line | 6:33 | 324 | ||||
| Sampling—Vials (Beginning) | 7:19 | 288 | 20 ± 1 | 15 ± 1 | ||
| Interruption—30 min | Open, Filled Vials | 8:06 | 273 | 40 ± 3 | ||
| Sampling —First 5 filling cycles | 29 ± 10 | |||||
| Sampling—Vials (Middle) | 12:16 | 188 | 20 ± 1 | |||
| Sampling—Vials (End) | 13:48 | 156 | 20 ± 1 | |||
| End of Production | 14:03 | 153 | ||||
| 21.4 mL/0002 | No Decontamination (Continuing from 20 mL/0001 | NA | NA | |||
| Start of Production | 28:11 | 56 | ||||
| Adjusting Filling Line | 28:19 | 62 | ||||
| Sampling - Vials (Beginning) | 28:57 | 75 | 21 ± 1 | 10 ± 0 | ||
| Interruption—60 min | Open, Filled Vials | 30:52 | 60 | 12 ± 3 | ||
| Sampling—First 5 filling cycles | 22 ± 15 | |||||
| Sampling—Vials (Middle) | 33:12 | 49 | 25 ± 5 | |||
| Sampling—Vials (End) | 34:23 | 51 | 23 ± 2 | |||
| End of Production | 35:00 | 47 | ||||
| 21.4 mL/0003 | End of Decontamination | 0:00 | 322 | |||
| Start of Production | 6:44 | 269 | ||||
| Adjusting Filling Line | 6:56 | 310 | ||||
| Sampling —Vials (Beginning) | 7:25 | 307 | 24 ± 1 | 10 ± 0 | ||
| Interruption—15 min | Open, Filled Vials | 8:03 | 289 | 30 ± 14 | ||
| Sampling—First 5 filling cycles | 17 ± 7 | |||||
| Sampling—Vials (Middle) | 20:23 | 106 | 23 ± 2 | |||
| Sampling—Vials (End) | 26:34 | 76 | 23 ± 3 | |||
| End of Production | 26:47 | 71 | ||||
NA, not applicable.