Cold chain: difference between revisions

Diff·revision 3 → 4·07:07, 4 Jul 2024

Difference between revision 3 and revision 4 of Cold chain. 6 lines changed; the page grew by 1,480 bytes.

Revision 3 — 23:26, 26 Jun 2024 CRP_Cormac (talk) correct the freezer temperature range given for long-term storage 3,648 bytes ±0	Revision 4 — 07:07, 4 Jul 2024 CrudePeptidePearl (talk) expand §Distribution outside regulated channels 5,128 bytes +1,480
11	The 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}}	11	The 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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+		13	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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13	== Storage classes and their definitions ==	15	== Storage classes and their definitions ==
14	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}}	16	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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27	Two features of this table are consequential and routinely missed. ''Controlled room temperature'' is not a synonym for whatever temperature a room happens to be; it is a specification with a permitted excursion band and a mean kinetic temperature ceiling, and a warehouse that averages 27 °C does not satisfy it. And the definitions of controlled cold and controlled room temperature both build permitted excursions into the definition itself, so a brief departure from the nominal band is not automatically an excursion in the regulatory sense — a distinction developed at [[Temperature excursion]].{{r\|usp659}}	29	Two features of this table are consequential and routinely missed. ''Controlled room temperature'' is not a synonym for whatever temperature a room happens to be; it is a specification with a permitted excursion band and a mean kinetic temperature ceiling, and a warehouse that averages 27 °C does not satisfy it. And the definitions of controlled cold and controlled room temperature both build permitted excursions into the definition itself, so a brief departure from the nominal band is not automatically an excursion in the regulatory sense — a distinction developed at [[Temperature excursion]].{{r\|usp659}}
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+		31	Storage statements for the compounds covered on this wiki cluster in two groups. Manufactured injectable [[GLP-1 receptor agonist\|GLP-1 receptor agonists]] are labelled for cold storage before first use, with an in-use period at higher temperature after first use. Lyophilised research peptides are commonly accompanied by a recommendation of frozen or cold storage for long-term holding and a statement that the dry material tolerates ambient transit, a combination whose physical basis is set out at [[Lyophilisation]] and whose evidential basis is generally absent.{{r\|ich_q1a}}
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29	== References ==	33	== References ==
30	{{reflist}}	34	{{reflist}}
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>	35	<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>	36	<ref name="usp659">United States Pharmacopeia, General Chapter <659>, "Packaging and Storage Requirements". USP–NF, current revision.</ref>
+		37	<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>	38	<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>
+		39	<ref name="ich_q1a">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003).</ref>
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35	{{DEFAULTSORT:Cold chain}}	41	{{DEFAULTSORT:Cold chain}}