Table 4.
Evaluated parameter | Method | Acceptance criteria | Results | ||
---|---|---|---|---|---|
Replicate 1 | Replicate 2 | Replicate 3 | |||
Temperature | Data logger | -70 to -80 °C | Maintaining temperature integrity (h) | ||
16 | 15 | 16 | |||
Leaking | Visual inspection | Negative | Negative | Negative | Negative |
Packaging | Visual inspection | Intact | Intact | Intact | Intact |
Viability | Hemocytometer | ≥ 90% | 96% | 98% | 96% |
Sterility (aerobic, anaerobic, and fungi) | Culture | Negative | Negative | Negative | Negative |
*Box dimensions: 29 × 16 × 12 cm3 internal size and 33 × 20 × 17 cm3 external size