Pre-acceptance controls | Pre-defined specification | Validation run | Final specification | ||||
---|---|---|---|---|---|---|---|
#01 | #02 | #03 | #04 | ||||
Accompanying documents | Present | Present (4/4 batches) | C | ||||
Bag identificative | Anonym, univocal code | Anonym, univocal code (4/4 batches) | C | ||||
Volume harvested | To be set | 58 mL | 71 mL | 54 mL | 58 mL | ≥ 50 mL | |
Transportation mean temperature [range] | To be set (transport at controlled temperature in refrigerated container with ice packs and validated data logger) | Not available | 0.4 °C [− 3.9–13.1] | 5.3 °C [4.0–24.6] | 3.1 °C [2.2–6.7] | 2–8 °C | |
Time from harvesting | Up to 12 h from the completion of collection to receipt at the manipulation site | 06h53 | 03h59 | 04h51 | 04h08 | ≤ 12 h | |
State of the collection bag | Intact and appropriately sealed | Intact and appropriately sealed (4/4 batches) | C | ||||
BacT/ALERT aerobic | Sterile | Sterile (4/4 batches) | C | ||||
BacT/ALERT anaerobic | Sterile | Sterile (4/4 batches) | C |