REFRIGERATED VEHICLE OR

REFRIGERATED PACKAGING …?

The needs of the logistics and the transport of health

products under controlled temperature do not stop
increasing. This growth is the consequence of more and
more strict regulations, and continuous controls of the cold
chain quality. It is also motivated by the will of the actors, in
the field of the cold chain for health products, to improve the
quality of their services.

The needs of the logistics and the transport of health products under controlled temperature do not
stop increasing. This growth is the consequence of more and more strict regulations, and continuous
controls of the cold chain quality. It is also motivated by the will of the actors, in the field of the cold
chain for health products, to improve the quality of their services.

Pharmaceutical companies, suppliers of equipments, distributors and service providers make a

commitment in a continuous process of improvement, concerning the used means and the applied
procedures. They make a lot of effort to meet the expectations and the statutory requirements, and
also to guarantee the safety for the patients.

Two solutions are proposed to transport health products under controlled temperature (refrigerated
or frozen products):

• Refrigerated vehicles,
• Refrigerated and insulated packaging

Between refrigerated vehicles and refrigerated packaging, the user wonders what is the most
adapted mean to transport temperature sensitive products?

The main parameters which determine the selection of the solution are:
• Distribution logistics circuit,
• Volume of products to be sent,
• Temperature range of products,
• Temperature profile,
• Qualification and validation of the solution,
• Cost,
• Impact on the environment.

Let us examine these parameters and their importance in the selection of the solution allowing the
respect of the cold chain.

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1. Distribution logistics circuit of medicines

We distinguish two types of distribution circuits of medicines for human health:

• Hospital circuit: Medicines are transferred from the manufacturer laboratory to a distribution
site of the laboratory or a pharmaceutical agent. They will be distributed then on hospitals and
private hospitals, directly or by way of a trading group or a wholesaler distributor.

• Officinal circuit: Medicines are transferred from the manufacturer laboratory to a distribution
site of the laboratory or a pharmaceutical agent. They will be distributed then on retail
pharmacies by way of wholesaler distributor and sometimes directly.

For the animal health, medicines are transferred from the manufacturer laboratory to a distribution
site of the laboratory or a pharmaceutical agent. They will be distributed then:
• on veterinary clinics, directly or by way of a veterinary wholesaler, or
• on breeding, by way of a veterinarian or of a pharmacist.

The temperature-controlled transport can be directly made from the shipper’s site to the consignees
site, or by way of hubs where are made the sorting, the grouping and the ungrouping of packs.
In this case, packs are transferred from the shipper’s site to the closest sorting hubs, where they are
grouped by geographical zone of consignees, then transferred to the ungrouping hubs. The
distribution is made from these ungrouping hubs by rounds; each round is constituted by several
consignees.

If a part of the transport is made by air, packs pass in transit by sorting hubs at airports. If the
temperature-controlled transport is made by static refrigerated packaging, hubs are not refrigerated
(ambient temperature hubs). This is the case of the international shipping and the national
distribution for long distances.

If the temperature-controlled transport is made by refrigerated, hubs must be refrigerated.

The distribution logistics circuit allows a first selection between both solutions.

The use of the refrigerated vehicles (generally complete or almost complete), is adapted in the
following cases:
• From the manufacturer laboratory to the storage or distribution site (generally by complete
truck),
• Groupage transport (by complete vehicle or almost complete)

In this case, the zones of loading and unloading and hubs must be also refrigerated to avoid the break
of the cold chain.

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Insulated packaging refrigerated by eutectic gel packs, or by dry ice for the very low-temperature
(below-30°C) are used in the following cases:
• For the logistics circuits containing an air transport (international shipping and national
shipping for long distances),
• If hubs and zones of loading and unloading are not refrigerated,

In certain complicated cases, both solutions are combined to guarantee the cold chain.

2. Volume of products to be sent

When the both solutions can guarantee the required temperature range of products for the specified
logistics circuit, the volume of products to be shipped will be the decisive parameter for the selection
of the solution. This parameter has the higher impact on the cost of the temperature-controlled
transport.

If the quantity of products to be transferred does not justify the mobilization of a refrigerated vehicle,
the refrigerated packaging will be imperative.
The transfer of heat-sensitive pharmaceutical products from the manufacturer laboratory to the
storage or the distribution site is often made by refrigerated vehicle because we can group several
temperature sensitive products for several final consignees.

3. Temperature range of products

The temperature range of products can impose the solution.

• For the very low temperatures (below-30°C) for example we use insulated boxes refrigerated
by dry ice.
• Products between +15 and +25°C also require refrigerated boxes with specific configuration or
air-conditioned vehicles.

The accepted tolerances (excursions) out of the temperature range of the transported product can be
also decisive for the selection of the solution. These tolerances are specified by the manufacturer
laboratory, after performing carrying out stability tests on the product.

Accepted tolerances allow the selection of a solution with excursions, for its simplicity or for its
reduced cost. A complicated or an expensive solution without excursions can be avoided.

Example:
For the temperature range between +2°C and + 8°C, if the low and high tolerated temperature limits
for the product are +1°C and +9°C, the user can have to choose between two solutions:
• A refrigerated packaging qualified between +1°C and +9°C, with a simple configuration, and
• Another refrigerated packaging qualified between +2°C and +8°C, with a complicated
configuration (heavier, more voluminous and more expensive).

The tolerances allow the selection of the first one which is simpler and less expensive.

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4. Temperature profile
The temperature profile express the segments of the logistics circuit in the form of couples (duration,
temperature), since the shipper’s site (removal of products) up to the consignees site (delivery of
products). The temperature profile depends on the logistics circuit.

We distinguish the opened segments and the closed segments:

• In a closed logistic segment, the temperature is controlled or relatively stable and does not
follow directly the climatic temperature. Examples: cold chamber, temperature-controlled room,
work or storage warehouse, closed vehicle…
• In an opened logistic segment, the temperature is not controllable and is not stable because it
follows directly the climatic temperature. Examples: the tarmac of an airport, opened loading
and delivery zones…

For a temperature profile containing opened segments that the refrigerated vehicle cannot reach, the
refrigerated packaging will be imperative thanks to its autonomy. It can be used associated with air-
conditioned vehicle, in certain cases.

For a temperature profile which contains warm segments and cold segments (bellow 0°C for
example), the combination of air-conditioned vehicle and a refrigerated packaging can be the best
solution.

5. Qualification and validation of the solution

The qualification of the performances of the means used to respect the cold chain is an obligation.
This qualification must be carried out, according to the current standards.

Several reference (standards, recommendations and guidelines) specific were established for the
qualification of thermal performances of refrigerated packaging for health products:
• NF S 99-700: « Isothermal and refrigerating containers for health products – Thermal
performance qualification method » This approved French standard is the most complete
reference.
• ASTM D3103-07: « Standard Test Method for Thermal Insulation Performance of Distribution
Packages », US standard.
• ISTA 7D Procedure: « Thermal Controlled Transport Packaging for Parcel Delivery System
Shipment ».
• WHO / IVB / 05.23: « Guidelines on the international packaging and shipping of vaccines ».

Waiting for the establishment of a qualification standard of refrigerated vehicles for health products,
the transport companies apply the ATP agreement « Agreement on the transport of perishables and
special vehicles to be used for this transport », which concerns food.

The actors in the field of the cold chain are conscious of the necessity of establishing a specific
standard allowing the qualification of refrigerated vehicles for health products, taking into account
pharmaceutical requirements. A commission working on this subject identified this need.

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The transport process by refrigerated vehicle is difficult to manage because the parameters to be
verified are multiple and complex (transshipment, various transfers, hubs…). Risk analysis will be
necessary for this process to identify critical points and possible failures, and also to take preventive
measures or corrective actions.

The performances qualification of the solution will be followed by the validation of the overall
transport process, in the real use.
The destinations selected for the validation of the transport process by refrigerated packaging must
be relevant.
The transport by refrigerated vehicles must be continuously controlled, in real use.

6. Cost of the solution

The cost is always a decisive parameter in the selection of the solution. If two concepts meet the
expected specifications (requirements), the solution which has the reduced cost will be selected.
The cost of the solution corresponds to the global logistic cost, for the provided service. This cost
integrates the price of the transport by refrigerated vehicle or the price of the refrigerated packaging,
and all the costs engendered by the preparation and the use of the solution (equipments, energy
consumptions, salaries of the staffs, sundry expenses…).
The cost of the solution also depends on the required safety level. The safety margin must be
estimated without exaggeration, to avoid the useless requirements which complicate the solution and
increase the cost. Well established specifications involve an optimized solution and a reduced cost.

7. Impact on the environment

The impact on the environment is a parameter to be also analyzed in the evaluation of a solution. The
life cycle analysis for the same provided service (equivalent result) allows to compare the impact on
the environment of every solution. This analysis integrates all the systems, all the materials and all the
energy implied for the solution throughout its life cycle, since the extraction of raw materials up to
the treatment at the end of life.

Good use practices

For each transport process (static or dynamic system), rules of good practices and precautions must
be applied, to guarantee the efficiency of the temperature-controlled concept.
The main rules of use for each solution are:

For the refrigerated vehicles:

• It is necessary to stabilize the insulated body of the vehicle at the required temperature before
loading.
• If the loading and unloading zones of the vehicle are not refrigerated the refrigerating unit
must be turned, during loading and unloading.
• Do not place products in the cold air flow of the refrigerating unit.
• In the case of multi-temperature vehicle, products must not touch the separation wall of the
compartments.

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For refrigerated packaging:
• You should not store an insulated packaging refrigerated by frozen gel packs in a cold room, in
particular during the transit and on arrival. Frozen gel packs must be removed before the storage.
• For refrigerated packaging which has two different configurations for summer and for winter,
you must make sure of weather forecasts before changing the configuration.
• The validated operating instructions for the preparation and loading must be respected.
• The exposure time of the insulated packaging at the opened segment must be reduced at the
possible minimum.

8. Conclusion

Refrigerated packaging and refrigerated vehicles are not necessarily in competition but they are
complementary resources.
Each solution is adapted for certain cases and to certain stages of the distribution process of
medicines.

The used solution must be qualified and requires precautions and good use practices to guarantee its
efficiency.

The refrigerated vehicles are used for the national distribution of health products, in the form of
groupage transport or of transport of batches.

The insulated boxes (packaging) refrigerated by eutectic gel packs or by dry ice for the very low-
temperature (below-30°C) are used:
• For the international shipping and for long distances in the national distribution, because the
logistics circuit contains an air transport,
• For the distribution of various volumes (not mastered) of products, or which do not justify the
mobilization of a refrigerated vehicles.
• Both means can be associated in certain cases to guarantee the strict respect for the cold
chain.
• Insulated boxes (packaging) without cold source are combined with refrigerated vehicles to
avoid the break of the cold chain in transfer and delivery zones, or to protect the products from
the cold air flow (below +2°C) of the refrigerating unit.
• Air-conditioned or warmed vehicles are combined with refrigerated packaging, for the
temperature profiles containing cold segments and warm segments or for extreme conditions.

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