Cold chain (revision 2)
Old revision·12:42, 19 Jun 2024·CommaCarys
| Cold chain | |
|---|---|
| Scope | Manufacture, warehousing, freight, last mile, end use |
| Principal controlled variable | Temperature |
| Principal monitoring device | Electronic temperature data logger |
| Principal documented output | A continuous temperature record with custody points |
| Topic infobox · conventions | |
A cold chain is an unbroken sequence of temperature-controlled storage, handling and transport operations that maintains a temperature-sensitive product within its labelled storage conditions from the point of manufacture to the point of use. The term is used both for the physical arrangement — refrigerated rooms, insulated shippers, coolant, vehicles — and for the documentary system of records and custody transfers that demonstrates the arrangement worked.[1]
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 agonists, most of which are labelled for storage at 2–8 °C before first use.[2]
Storage classes and their definitions
[edit]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.[3][1]
| !Term | Range | Notes |
|---|---|---|
| Freezer | −25 to −10 °C | Not the same as a domestic freezer, which may run colder |
| Cold | 2–8 °C | The range meant by "refrigerated" on a label |
| Cool | 8–15 °C | Seldom used on modern labelling |
| Controlled cold temperature | 2–8 °C, with permitted excursions between −20 and 25 °C | Excursions are bounded in duration and by mean kinetic temperature |
| Controlled room temperature | 20–25 °C, excursions 15–30 °C permitted, mean kinetic temperature not above 25 °C | The permitted excursion band is part of the definition |
| Warm | 30–40 °C | |
| Excessive heat | above 40 °C |
References
- ^ a b 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.
- ^ Lloyd J, Cheyne J. "The origins of the vaccine cold chain and a glimpse of the future." Vaccine 35(17):2115–2120 (2017).
- ^ United States Pharmacopeia, General Chapter <659>, "Packaging and Storage Requirements". USP–NF, current revision.