Cold chain: difference between revisions
Diff·revision 18 → 19·13:10, 28 Aug 2024
Difference between revision 18 and revision 19 of Cold chain. 4 lines changed; the page grew by 927 bytes.
| Revision 18 — 12:57, 22 Aug 2024 MassSpecMarv (talk) clarify whether figure is gross or net mass 7,610 bytes +778 | Revision 19 — 13:10, 28 Aug 2024 MolarMassMaeve (talk) undo good-faith edit: the source does not say this 8,537 bytes +927 | ||
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| 19 | Two properties distinguish a cold chain from ordinary logistics. It is a chain in the strict sense that its integrity is set by its weakest link rather than by an average: an hour on an unshaded loading dock is not offset by a week of correct refrigeration. And its principal failure is invisible on inspection, because temperature-mediated degradation of a peptide or protein product generally produces no visible change. This combination is why monitoring instrumentation, rather than examination of the product, carries the evidentiary burden.{{r|kartoglu2014}} | 19 | Two properties distinguish a cold chain from ordinary logistics. It is a chain in the strict sense that its integrity is set by its weakest link rather than by an average: an hour on an unshaded loading dock is not offset by a week of correct refrigeration. And its principal failure is invisible on inspection, because temperature-mediated degradation of a peptide or protein product generally produces no visible change. This combination is why monitoring instrumentation, rather than examination of the product, carries the evidentiary burden.{{r|kartoglu2014}} |
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| + | 21 | The commonest documented failure of pharmaceutical cold chains is not overheating but inadvertent freezing. Systematic reviews of vaccine distribution have repeatedly found freezing exposure in the majority of studies examining shipments and storage, in high-income and low-income settings alike, and have identified it as more prevalent than heat exposure. Freezing is more damaging than mild warming for many liquid biological products and is not detectable after the fact by inspection.{{r|matthias2007,hanson2017}} | |
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| 21 | == Storage classes and their definitions == | 23 | == Storage classes and their definitions == |
| 22 | Labelled storage statements draw on compendial definitions rather than on plain language, and the definitions are narrower than everyday usage suggests. USP General Chapter <659> defines the terms used on United States labelling, and the European Pharmacopoeia and WHO guidance use closely comparable ranges.{{r|usp659,whotrs961}} | 24 | Labelled storage statements draw on compendial definitions rather than on plain language, and the definitions are narrower than everyday usage suggests. USP General Chapter <659> defines the terms used on United States labelling, and the European Pharmacopoeia and WHO guidance use closely comparable ranges.{{r|usp659,whotrs961}} |
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| 55 | <ref name="usp659">United States Pharmacopeia, General Chapter <659>, "Packaging and Storage Requirements". USP–NF, current revision.</ref> | 57 | <ref name="usp659">United States Pharmacopeia, General Chapter <659>, "Packaging and Storage Requirements". USP–NF, current revision.</ref> |
| 56 | <ref name="usp1118">United States Pharmacopeia, General Chapter <1118>, "Monitoring Devices — Time, Temperature, and Humidity" (informational). USP–NF, current revision.</ref> | 58 | <ref name="usp1118">United States Pharmacopeia, General Chapter <1118>, "Monitoring Devices — Time, Temperature, and Humidity" (informational). USP–NF, current revision.</ref> |
| + | 59 | <ref name="matthias2007">Matthias DM, Robertson J, Garrison MM, Newland S, Nelson C. "Freezing temperatures in the vaccine cold chain: a systematic literature review." ''Vaccine'' 25(20):3980–3986 (2007).</ref> | |
| + | 60 | <ref name="hanson2017">Hanson CM, George AM, Sawadogo A, Schreiber B. "Is freezing in the vaccine cold chain an ongoing issue? A literature review." ''Vaccine'' 35(17):2127–2133 (2017).</ref> | |
| 57 | <ref name="kartoglu2014">Kartoglu U, Milstien J. "Tools and approaches to ensure quality of vaccines throughout the cold chain." ''Expert Review of Vaccines'' 13(7):843–854 (2014).</ref> | 61 | <ref name="kartoglu2014">Kartoglu U, Milstien J. "Tools and approaches to ensure quality of vaccines throughout the cold chain." ''Expert Review of Vaccines'' 13(7):843–854 (2014).</ref> |
| 58 | <ref name="lloyd2017">Lloyd J, Cheyne J. "The origins of the vaccine cold chain and a glimpse of the future." ''Vaccine'' 35(17):2115–2120 (2017).</ref> | 62 | <ref name="lloyd2017">Lloyd J, Cheyne J. "The origins of the vaccine cold chain and a glimpse of the future." ''Vaccine'' 35(17):2115–2120 (2017).</ref> |