Temperature plays a pivotal role in administering an effective vaccine to the patient. Depending on the construction of the vaccine, manufacturing method and treatment process - every vaccine product has a specific sensitivity to temperature. Most liquid vaccines require refrigeration and are very sensitive to heat and freezing. Thus, monitoring and managing temperatures of vaccines throughout the supply chain is of utmost important. However some challenges exist, outlined below.
Seasonal vaccines
Large occasional and bulky shipments
NGO's donating and delegating distribution
Delegation of control, end-to-end
temperature monitoring required
Production in low cost countries
shipped to poor countries
Difficult logistics, ad-hoc shipments
Recipient has no training and infrastructure
Need of simple temperature monitoring solution
Pandemic situations
High public interest, emergency timelines, government or military involvement
Government tenders
Cost pressure, buyer takes risk
Various NGO’s under the lead of the World Health Organisation (WHO) have defined standards for vaccine cold chain logistics and temperature monitoring. In close cooperation with UNICEF, BARDA, PATH, MSF, the ICRC and many other NGO’s, the WHO prequalifies devices under defined categories for vaccine data loggers, chemical WHO indicators (Vaccine vial monitor, VVM) as well as electronic shipping indicators.
WHO Category:
Electronic shipping indicators measure temperature every minute and compare them with a pre-programmed defined stability budget (alarm limits and allowed excursion times) reflecting the heat and/or freeze sensitivity of the vaccine being shipped.
WHO Category:
User programmable temperature data loggers are measuring and storing temperature for further download and analysis on a PC or in a cloud database. They are used for monitoring bulk shipments to hubs or for mapping purposes (transport route profiling or mapping of cold rooms, refrigerators or refrigerated vehicles).
WHO Category:
These devices are typically placed with the vaccine load in a vaccine refrigerator. They log the refrigerator temperature at a given interval (e.g. every 10-minutes) for 30 consecutive days on a rolling basis and have the capability to issue alarms locally or via SMS/E-Mail.
WHO / PQS / E006 / TR06.3
WHO / PQS / E006 / TR03.2
Ideal for frozen or ultra-low shipments on dry ice or in cryogenic LN2 containers. Choose from internal or external probe options; and single-use or multi-use. Both data loggers feature multi-level programming with eight alarm levels and PDF reporting
For Cryogenic Containers & Ultra Low Temperatures
Multi-level PDF Logger with internal probe for direct placement in dry ice.
ELPRO has 30+ years of designing monitoring solutions for the life sciences industry. The LIBERO solution family not only provides supply chain visibility and patient safety, but gives you certainty in a highly validated, compliant solution.
ISO 9001 certified
ISO 17025 calibrated
GAMP5 compliant
FDA 21 CFR Part 11 compliant
On-site testing centers, labs and organizations that administer, manage and ship patient test kit samples are required by law to monitor the temperature of the sample. Sample temperature monitoring must occur from the point of collection, during on-site storage, and during shipment to laboratories for analysis. In the short video below, ELPRO temperature monitoring expert Martin demonstrates how to ensure the safety of COVID-19 test kit samples, pharmaceuticals, and patient safety.
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