Temperature excursion: difference between revisions
Diff·revision 12 → 13·02:44, 19 May 2025
Difference between revision 12 and revision 13 of Temperature excursion. 2 lines changed; the page grew by 318 bytes.
| Revision 12 — 10:29, 14 May 2025 ColdChainCleo (talk) merge two short sections 5,832 bytes ±0 | Revision 13 — 02:44, 19 May 2025 PrepHPLC_Pia (talk) de-orphan 6,150 bytes +318 | ||
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| 26 | An excursion is also not a single class of event. Warming above the labelled range and cooling below it have different mechanisms and are not interchangeable in an assessment, because freezing damage is not governed by the Arrhenius relationship on which the warming arithmetic depends. Guidance for products labelled 2–8 °C accordingly treats a freezing event as a separate category, often with a stricter disposition, and freeze indicators exist precisely because the mean kinetic temperature calculation cannot detect the event.{{r|matthias2007,bhatnagar2007}} | 26 | An excursion is also not a single class of event. Warming above the labelled range and cooling below it have different mechanisms and are not interchangeable in an assessment, because freezing damage is not governed by the Arrhenius relationship on which the warming arithmetic depends. Guidance for products labelled 2–8 °C accordingly treats a freezing event as a separate category, often with a stricter disposition, and freeze indicators exist precisely because the mean kinetic temperature calculation cannot detect the event.{{r|matthias2007,bhatnagar2007}} |
| 27 | 27 | ||
| + | 28 | {{note|The label is the reference. Two vials of chemically identical peptide, one supplied as a licensed medicine and one as a research chemical, may experience the same profile and be subject to entirely different assessments, because only one of them has labelled conditions established by a stability programme.}} | |
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| 28 | == References == | 30 | == References == |
| 29 | {{reflist}} | 31 | {{reflist}} |