Cold chain: difference between revisions
Diff·revision 11 → 12·10:51, 4 Oct 2024
Difference between revision 11 and revision 12 of Cold chain. 2 lines changed; the page grew by 477 bytes.
| Revision 11 — 23:02, 19 Sep 2024 CrossRefCleve (talk) state that a phase-change pack and a gel pack behave differently 10,813 bytes +575 | Revision 12 — 10:51, 4 Oct 2024 FmocFrancis (talk) rm the blanket claim that excursions are harmless 11,290 bytes +477 | ||
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| 63 | | Vaccine vial monitor | Cumulative heat exposure at the individual vial | Freezing exposure | | 63 | | Vaccine vial monitor | Cumulative heat exposure at the individual vial | Freezing exposure | |
| 64 | 64 | ||
| + | 65 | The vaccine vial monitor deserves separate mention because it is attached to the individual container rather than to the shipment, and therefore survives every custody transfer. It is a heat-sensitive label whose inner square darkens progressively; when it matches or exceeds the reference ring the vial is not to be used. Its limitation is definitional: it responds to heat and not to freezing, so a vial that has been frozen presents an unchanged monitor.{{r|kartoglu2014}} | |
| + | 66 | ||
| 65 | === Calibration and traceability === | 67 | === Calibration and traceability === |
| 66 | A temperature record is only as good as the calibration of the instrument that produced it. Compendial guidance on monitoring devices expects calibration traceable to a national metrology institute, at intervals appropriate to the device, and at points within the range of interest rather than only at ambient temperature. A logger calibrated at 25 °C and used at 5 °C may carry an error larger than its stated accuracy.{{r|usp1118}} | 68 | A temperature record is only as good as the calibration of the instrument that produced it. Compendial guidance on monitoring devices expects calibration traceable to a national metrology institute, at intervals appropriate to the device, and at points within the range of interest rather than only at ambient temperature. A logger calibrated at 25 °C and used at 5 °C may carry an error larger than its stated accuracy.{{r|usp1118}} |