E002: Refrigerated Vehicles
The products in this category include refrigerated vehicles of various sizes used for transporting vaccines and other temperature-sensitive biologicals, as well as related variations and options.
A refrigerated vehicle is a road transport vehicle such as a van, truck or semi-trailer whose isolated, thermostatically controlled cargo compartment is maintained at a temperature different (lower or higher) than the external ambient conditions.
Details regarding the products included in each sub-category of E002, as well as guidelines, performance specifications and verification protocols for this category, can be accessed through the drop-down sections below.
IMD-PQS Category E002 product data sheets are available for view, download and comparison here.
Refrigerated vehicles include vans, trucks and semi-trailers that have an insulated, thermostatically controlled cargo compartment and a dedicated refrigeration unit capable of maintaining a controlled temperature range.
Vans and small trucks typically have refrigeration units powered directly by the vehicle's engine. Larger trucks and semi-trailers have independent, diesel-powered refrigeration units. Both types may also have electrical backup so that they can be plugged into the main electric grid when parked.
Further guidance on how to transport vaccines using refrigerated vehicles is provided in WHO Technical Report Series, No. 961, Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products, Supplement 12: Temperature controlled transport operations by road and by air (May 2015).
Guidance on the loading and operating of refrigerated vehicles is available in the generic operating procedure E7-05: Loading and operating refrigerated vehicles, issued by WHO's Effective Vaccines Management Initiative. National immunization programmes should review and adapt this guidance to the national vaccine handling procedure and to standardize procedures when using refrigerated vehicles.
Temperature monitoring devices (TMDs) are a key component of a quality-assured, temperature-controlled transport system. TMDs are specified in the IMD-PQS performance specification E002/RV01.3: Refrigerated vehicles.
Guidance for the choice of appropriate refrigerated vehicles is forthcoming from WHO.
End-users of insulated containers and their procurement agents are advised to consider the following points when choosing vaccine storage equipment from this category:
- For each vehicle used to deliver vaccines, the routine trips must be mapped, recording the destinations, the typical time needed to complete the journey either as a "loop trip" or a "there-and-back trip" and, if needed, the location of power outlets 415/230-volt sockets for emergency back-up cooling. The time each vehicle will require to compete the delivery route should be estimated. (See WHO Technical Report Series, No. 961, Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products, Supplement 14: Transport route profiling qualification (May 2015)).
- Any load sharing with vaccines and other temperature sensitive products should be agreed, as part of an integrated supply chain implementation. (See, for example, Optimize: Tunisia Report (April 2013) and a discussion facilitated by WHO, UNICEF and the GAVI Alliance (3 January 2014).
- Future load volumes should be estimated to the extent possible. See the Vaccine volume calculator 2012 and the Vaccine volume calculator manual.
- It is always important to adhere to the proper loading protocol of refrigerated vehicles, including any requirements to maintain a minimum distance from ceiling, walls and cooling units.
- During route planning and selection of refrigerated transport vehicles, it is important to verify that each vehicle will not only provide the net storage capacity needed for all the distribution points on a single route but also meet the needs of the operating environment. (See WHO Technical Report Series, No. 961, Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products, Supplement 12: Temperature controlled transport operations by road and by air (May 2015).) When transporting by truck it is also important to estimate the weight of vaccine shipments to ensure that the maximum load limit of a vehicle is not exceeded and that roadway restrictions are observed to avoid delays or problems at checkpoints.
Calculate net storage capacity by multiplying the gross volume by the standard utilization factor of 0.67.
Performance specification
PQS performance specification E002/RV01.3: Refrigerated vehicles
Verification protocol
PQS type-examination protocol E002/RV01-VP.3: Refrigerated vehicles
Guidance for manufacturers/suppliers
Guidelines on the international packaging and shipping of vaccines
IMD-PQS Guidelines for Prequalification Holders