Cold chain: difference between revisions
Diff·revision 8 → 9·05:42, 12 Jul 2024
Difference between revision 8 and revision 9 of Cold chain. 3 lines changed; the page grew by 725 bytes.
| Revision 8 — 03:27, 6 Jul 2024 CDMO_Caradoc (talk) rm unsourced claim per PP:V 4,403 bytes +755 | Revision 9 — 05:42, 12 Jul 2024 UnitsUrsula (talk) update infobox 5,128 bytes +725 | ||
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| 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}} | 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}} |
| 30 | 30 | ||
| + | 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}} | |
| + | 32 | ||
| 31 | == References == | 33 | == References == |
| 32 | {{reflist}} | 34 | {{reflist}} |
| ⋮ | ⋮ | ||
| 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> | 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> |
| 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> | 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> | |
| 37 | 40 | ||
| 38 | {{DEFAULTSORT:Cold chain}} | 41 | {{DEFAULTSORT:Cold chain}} |