Cold Chain Temperature Monitoring Guidance
Basic unit:
N/A
Estimated Price:
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Specification
In order to maintain vaccine quality, it is essential to monitor the temperature of vaccines throughout the supply chain. Temperature monitoring devices are used to keep track of the temperature to which the vaccines and diluents are exposed. Based on the data from these devices, important decisions may be made.
Temperature monitoring devices and routines are used during every storage and during every transportation stage until the vaccine is administered to the recipient. Depending on the supply chain level (central store, intermediary store or outreach and transportation container) different monitoring devices are used.
Most of the WHO pre-qualified vaccines can be kept at cold temperature, +2 to + 8 Celsius. (see attachment 1).
In regards to COVID19 vaccines, most of them can be kept and transported at Cold temperature; Pfizer must be kept for storage and transport deep-frozen (-80 to -60 C) and Moderna at frozen temperature, -25 to -15 C for storage and up to one month at cold temperature, meanwhile AstraZeneca can be stored at cold temperature.
Other vaccines available:
See attachment 2 for detailed temperature requirements for COVID vaccines.
Attachment 2: COVID19_Vacc_CC_Summary_Info.xlsx
The stability of a cold chain depends on strict adherence to protocols, the use of combined monitoring devices and a dedicated and trained staff.
Cold chain breach
Cold chain breach or failure is defined when the temperature of the cold chain equipment (cold room, fridge, cold box, etc) has gone beyond the accepted threshold. When vaccines or other medical products with temperature requirements are exposed, it is called a cold chain excursion and demands a specific protocol. Please refer to the Cold Chain Breach solution at the catalogue (to be developed).
Types of Temperature monitoring devices:
Analogic Thermometer
Called also Stem thermometer. They are usually alcohol-based and they should be used as back up since it gives only an instantaneous temperature reading.
Solvoz: Thermometer, Alcohol, Moeller, -40 to 50 Deg C Temperature Range. Solvoz
Chemical
Also called markers or phase-change indicators. They are the most accessible and easy to use, they are based in a chemical impregnated onto a paperboard that changes its appearance under a certain temperature. There are two types of chemical indicators:
Threshold Type chemical indicators provide a signal only when exposed to temperatures higher than (ascending indicator) or lower than (descending indicator) a predetermined threshold temperature. They are irreversible (thus, single-use) and are suitable for high or low temperatures. Solvoz
Progressive type chemical indicators register multiple events in a cumulative way. Whenever the threshold temperature is exceeded the reaction is activated and the indicator starts to change. Further temperature violations increase the change process. The indicator for this type of device usually takes the form of a progressive colour change along a paper strip.
Cold Chain Monitor (CCM) Card: Paper-based temperature monitoring device which changes colour irreversibly and at a constant rate. Indicator strips are attached to a card on which instructions for use are printed.
Solvoz: Cold Chain Monitor, 12 x 15 cm, Card, Chemical Mode of Operation, Visual Alarm, Passive Device Power Source, ISO 9001:2015 Certified Solvoz
Vaccine Vial Monitor (VVM): Heat-sensitive label that gradually and irreversibly changes colour as the vaccine is exposed to heat. It warns the health worker when a vial should be discarded because the vaccine is likely to have been degraded by exposure to heat.
Solvoz: Vaccine Vial Monitor, Type 14, Chemical Mode of Operation, -30 to +50 Deg C Temperature Range, 76 mm Core Size, ISO 9001:2008 Certified Solvoz
Electronic:
- Electronic Freeze Indicators - used to check if vaccines are exposed to freezing temperatures during storage or transport. The alarm indicator is triggered and displayed (changing from a “√” to an “X”) if exposed to temperatures lower than -0.5 °C for a continuous period of 60 minutes.
Solvoz: Freezing Indicator, Electronic, Freeze-tag Brand Solvoz
- Electronic Shipping Indicators - more sophisticated devices that show if a product has been exposed to temperatures beyond the assigned alarm settings. They record the temperature at regular intervals during a certain period (normally not exceeding 20 days due to memory overflow). They have a digital display that reflects if the vaccine being shipped crossed the alarm thresholds.
- Data loggers: Used mainly in cold rooms and refrigerators. Data loggers are battery-operated devices that measure and store data for a period of time. The time limit is the device memory. Some data logger models display the data instantly on an LCD screen while some others require data to be downloaded by USB or cable to a computer for later analysis.
Solvoz: Temperature Data Logger, User-Programmable, 8.5 x 5.4 x 0.85 cm, Polycarbonate, Electronic Mode of Operation, -40 to +85 Deg C Temperature Range. Solvoz
- Remote temperatures monitor devices are instruments that can provide remotely the data register and alarm, depending of the set up by the user. There are several types, depending on the communication protocol used.:
a) GSM
Remote Temperature Monitoring Device, Electronic Mode of Operation, -10 to 55 Deg C Temperature Range, GSM, Acoustic Alarm - Custom n° 3985 Solvoz
b) Bluetooth
Remote Temperature Monitoring Device, Electronic Mode of Operation, -10 to 55 Deg C Temperature Range, Bluetooth, Acoustic Alarm - Custom n° 3982 Solvoz
c) WIFI
Remote Temperature Monitoring Device, Electronic Mode of Operation, -10 to 55 Deg C Temperature Range, WI-FI, Acoustic Alarm - Custom n° 3996 Solvoz
d) Wired
Remote Temperature Monitoring Device, Electronic Mode of Operation, -10 to 55 Deg C Temperature Range, Wired, Acoustic Alarm - Custom n° 3994 Solvoz
Management of temperature monitoring.
According to WHO recommendations, it is better to have a combination of devices, listing as a minimum:
When items are being shipped, the monitoring devices should be checked at arrival. Possible breaches must be properly recorded and reported (refer to Cold chain breach).
For storing, daily check-up of temperature should be implemented by dedicated staff; beginning and end of the day is a recommended time interval. The record should be done in a Temperature Monitoring chart, usually attached to the fridge or freezer.
Download "Vaccine Refrigerator/Freezer Temperature Chart Template" | Templateroller
Sources:
-MSF Catalogue:
Preliminary remarks (msfcatalogues.azurewebsites.net)
-Logistics Cluster: Logistics Operational Guide
-WHO: Temperature Sensitivity of Vaccines
-CDC: Product Information Guide for COVID-19 Vaccines and Associated Products
http://publichealth.lacounty.gov/acd/docs/COVID-19VaccineProductInfoGuide.pdf