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Cold chain: difference between revisions

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11The concept originates in vaccine distribution, where it was developed from the 1970s onward as part of expanded immunisation programmes, and it retains much of that vocabulary. It has since been generalised to any product whose labelled storage conditions are narrower than ambient, including insulin and the [[GLP-1 receptor agonist|GLP-1 receptor agonists]], most of which are labelled for storage at 2–8 °C before first use.{{r|lloyd2017}}11The concept originates in vaccine distribution, where it was developed from the 1970s onward as part of expanded immunisation programmes, and it retains much of that vocabulary. It has since been generalised to any product whose labelled storage conditions are narrower than ambient, including insulin and the [[GLP-1 receptor agonist|GLP-1 receptor agonists]], most of which are labelled for storage at 2–8 °C before first use.{{r|lloyd2017}}
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+13Two 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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13== Storage classes and their definitions ==15== Storage classes and their definitions ==
14Labelled 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}}16Labelled 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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31<ref name="whotrs961">World Health Organization. "Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products." ''WHO Technical Report Series'' No. 961, Annex 9 (2011), with associated technical supplements.</ref>33<ref name="whotrs961">World Health Organization. "Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products." ''WHO Technical Report Series'' No. 961, Annex 9 (2011), with associated technical supplements.</ref>
32<ref name="usp659">United States Pharmacopeia, General Chapter <659>, "Packaging and Storage Requirements". USP–NF, current revision.</ref>34<ref name="usp659">United States Pharmacopeia, General Chapter <659>, "Packaging and Storage Requirements". USP–NF, current revision.</ref>
+35<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>
33<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>36<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>
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