Sample Risk Assessments
| Status Quo | Scenario A | Scenario B | |
|---|---|---|---|
| [Study Data Not Utilized] | [Study Data Utilized] | [Study Data Utilized] | |
| (1000 ea, 100 mL vial) | (1000 ea, 100 mL vial) | (1000 ea, 100 mL vial) | |
| Subzero exposure | −5 °C for 8 h | −5 °C for 8 h | −12 °C for 5 h |
| Degree hours (dh) exposure | 40 | 40 | 60 |
| Degree hours required for freeze (Table III) | 62.92 | 62.92 | 62.92 |
| Chance of entire supercooling (sc) events (Figure 2) | Unknown | 90% | 50% |
| Chance of benign supercooling events (Figure 2) | Unknown | 10% | ∼50% |
| Rough % freeze, assuming no supercooling (Table III) | Unknown | 79% Insufficient energy required for freeze | ∼100% Sufficient energy required for freeze |
| Vials at risk | Unknown | 1000 − 90% = 100 100 vials expected to experience benign sc events. | 1000 − ∼50% = ∼500 500 vials expected to experience benign sc events. |
| Comments | Lack of data to justify or quantify severity of risk. | The benign sc events add even more confidence as the material in the super cooled state is not actively changing phase. As such, we can estimate that the 79% figure serves an absolute worst case, with the real % of freeze below estimated. | As dh exposure increases, we observe fewer entire sc events. This translates to a higher figure of at risk. Coupled with the vials receiving sufficient energy to freeze, this scenario represents one of moderate risk. |
| Estimated risk of vial breakage | Unknown/High | Minimal | Moderate |