Cold chain: difference between revisions
Diff·revision 46 → 47·17:14, 7 Mar 2025
Difference between revision 46 and revision 47 of Cold chain. 2 lines changed; the page grew by 32 bytes.
| Revision 46 — 08:38, 28 Feb 2025 SemaglutideSasha (talk) add hatnote 18,768 bytes ±0 | Revision 47 — 17:14, 7 Mar 2025 MolarMassMaeve (talk) hedge overclaim 18,800 bytes +32 | ||
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| 103 | Three cautions attach to the statistic and are stated in the compendial guidance itself. It presumes a single Arrhenius-behaved degradation pathway with the assumed activation energy; where the real activation energy differs materially, the calculated value misrepresents the exposure. It is meaningless for freezing damage, which is not an Arrhenius process. And it is a summary, so it cannot substitute for the profile when the question is whether a specific threshold was crossed.{{r|usp1079,ich_q1a}} | 103 | Three cautions attach to the statistic and are stated in the compendial guidance itself. It presumes a single Arrhenius-behaved degradation pathway with the assumed activation energy; where the real activation energy differs materially, the calculated value misrepresents the exposure. It is meaningless for freezing damage, which is not an Arrhenius process. And it is a summary, so it cannot substitute for the profile when the question is whether a specific threshold was crossed.{{r|usp1079,ich_q1a}} |
| 104 | 104 | ||
| + | 105 | {{main|Temperature excursion}} | |
| + | 106 | ||
| 105 | == Packaging and qualification == | 107 | == Packaging and qualification == |
| 106 | Between controlled environments, the product travels inside a package that must maintain its internal temperature without external power. The performance of such a passive shipper is a designed property, qualified against defined ambient profiles, and it is specific to a payload. | 108 | Between controlled environments, the product travels inside a package that must maintain its internal temperature without external power. The performance of such a passive shipper is a designed property, qualified against defined ambient profiles, and it is specific to a payload. |