Cold chain: difference between revisions
Diff·revision 14 → 15·02:16, 7 Aug 2024
Difference between revision 14 and revision 15 of Cold chain. 10 lines changed; the page grew by 1,666 bytes.
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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}} | 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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| + | 33 | The World Health Organization additionally defines a ''controlled temperature chain'' for specified vaccines, permitting a single excursion to ambient temperatures up to 40 °C for a defined period immediately before administration, subject to product-specific stability data and to a monitoring device that records the exposure. It is a deliberate, evidence-supported relaxation of the 2–8 °C requirement rather than a tolerance of failure, and it illustrates that cold-chain requirements are properties of products rather than of logistics.{{r|kartoglu2014}} | |
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| + | 35 | == Monitoring instrumentation == | |
| + | 36 | A cold chain produces a record, and the instrument that produces it determines what the record can support. | |
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| + | 38 | Electronic data loggers are the reference instrument for shipments and for storage. A logger samples a thermistor or thermocouple at a fixed interval, stores time-stamped values in non-volatile memory, and reports either on retrieval or, in connected variants, in near real time. What matters for interpretation is the sampling interval, the accuracy and its temperature dependence, the calibration status, and whether the sensor is in the payload or in the air of the container. A logger taped to the outside of a shipper records the transit environment; a logger buried in the payload records something much closer to what the product experienced, and the two can differ by several degrees for hours.{{r|usp1118}} | |
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| + | 40 | Simpler devices remain in use and answer narrower questions: | |
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| 33 | == References == | 42 | == References == |
| 34 | {{reflist}} | 43 | {{reflist}} |
| 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> | 44 | <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> |
| 36 | <ref name="usp659">United States Pharmacopeia, General Chapter <659>, "Packaging and Storage Requirements". USP–NF, current revision.</ref> | 45 | <ref name="usp659">United States Pharmacopeia, General Chapter <659>, "Packaging and Storage Requirements". USP–NF, current revision.</ref> |
| + | 46 | <ref name="usp1118">United States Pharmacopeia, General Chapter <1118>, "Monitoring Devices — Time, Temperature, and Humidity" (informational). 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> | 47 | <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> |
| 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> | 48 | <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> |