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Pharmaceutical Manufacturing and Packing Sourcer

Chilly Choices

Refrigerated vehicle or refrigerated packaging? Abbes Kacimi at Sofrigam discusses the pros and cons of two popular options for temperature-controlled transport

The requirements of the logistics and transport of health products under controlled temperature are always increasing. This growth is the consequence of progressively stricter regulations and continuous controls over cool chain quality. It is also motivated by the decisions of the participants in the cool chain field for health products in order to improve the quality of their services. Pharmaceutical companies, suppliers of equipment, distributors and service providers are committed to a continuous process of improvement, putting in a lot of effort to meet expectations and statutory requirements, and also to guarantee patient safety.

Two solutions are proposed to transport health products, both refrigerated and frozen under controlled temperature – refrigerated vehicles, or refrigerated and insulated packaging. Given a choice between these two solutions, the user may wonder which is most suited to transport temperature-sensitive products. The main parameters which determine the choice are:

  • Distribution and 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 a solution with respect to the requirements of the cool chain for transporting temperature-controlled products.

DISTRIBUTION & LOGISTICS CIRCUIT OF MEDICINES

We distinguish two types of distribution circuit for human medicines. The medicines are initially transferred from the manufacturer’s laboratory to a distribution site belonging to the laboratory or a pharmaceutical agent. In the hospital circuit, they are then distributed to public and private hospitals, either directly or by way of a trading group or wholesale distributor. In the pharmacy circuit, the medicines are distributed to retail pharmacies by way of a wholesale distributor, or sometimes directly.

Temperature-controlled transportation can be carried out from the shipper’s site to the consignees’, directly or using hubs, where sorting is carried out by the grouping and ungrouping of the packs. In this case, packs are transferred from the shipper’s site to the closest sorting hubs, where they are grouped by consignees’ geographical zones, then transferred to the ungrouping hubs. Distribution is made from these ungrouping hubs in rounds.

If a part of the transportation process is carried out by air, packs pass through sorting hubs at airports. However, if transportation is performed using static refrigerated packaging, the hubs are not refrigerated – they remain at ambient temperature. This is the case in international shipping and national distribution over long distances. If the transportation is carried out under refrigerated conditions, the hubs must be refrigerated. The distribution and logistics circuit allows an initial selection between both solutions.

The use of refrigerated vehicles (generally complete or almost complete) is adapted in the following cases:

  • From the manufacturer’s laboratory to the storage or distribution site (generally by full truck)
  • Transport grouping (by full or almost full vehicle). In this case, loading and unloading zones and hubs must also be refrigerated to avoid any break in the cool chain Insulated packaging refrigerated by eutectic gel packs to maintain products between 2 and 8°C or at -18°C, or by dry ice to maintain products below -30°C, are used in the following cases:
  • For logistics circuits that contain an air transport leg (international and national shipping for long distances) 
  • When hubs and zones of loading and unloading are not refrigerated

In particularly complicated cases, both solutions are combined to be sure of the consistency of the cool chain.

VOLUME TO BE SENT

When 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 used to choose the shipping method. This parameter has a higher impact on the cost of temperature-controlled transportation than any other. If the quantity of products to be transferred does not justify the mobilisation of a refrigerated vehicle, refrigerated packaging will be essential. The transfer of heat-sensitive pharmaceutical products from the manufacturer’s laboratory to storage or to the distribution site is often made by a refrigerated vehicle because several temperature-sensitive products for several final consignees can be grouped together easily.

TEMPERATURE RANGE

The temperature range of products can often promote one solution over the other. For very low temperatures (below -30°C), insulated boxes refrigerated by dry ice are used. Products between 15 and 25°C also require refrigerated boxes with specific configuration, or air-conditioned vehicles. The accepted tolerances (excursions) outside of the temperature range of the transported product can also be decisive when choosing the solution. These tolerances are specified by the manufacturer’s laboratory, after carrying out stability tests on the product. Accepted tolerances allow the choice of solution with excursions, for simplicity or for reduced cost. A complicated or expensive solution without excursions can thus be avoided.

For example, for temperatures between 2 and 8°C, if the low and high tolerated temperature limits for the product are 1 and 9°C respectively, the user will have to choose between refrigerated packaging qualified between 1 and 9°C, with a simple configuration, or another refrigerated packaging qualified between 2 and 8°C, with a complicated configuration (heavier, larger and more expensive). The tolerances specified allow selection of the former, which is simpler and less expensive.

TEMPERATURE PROFILE

The temperature profile expresses the segments of the logistics circuit in the form of couples (duration, temperature), from the shipper’s site (removal of products) to the consignees site (delivery of products). The temperature profile depends on the logistics circuit. We distinguish open from closed segments as follows:

  • In a closed logistics segment, the temperature is controlled or relatively stable, and does not follow the climatic temperature directly. Examples include cold chambers, temperature-controlled rooms, work or storage warehouses and closed vehicles
  • In an open logistics segment, the temperature is not controllable and is not stable because it follows the climatic temperature directly. Examples include the tarmac of an airport and open loading and delivery zones

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

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

QUALIFICATION & VALIDATION

The qualification of the means used to respect the cool chain is mandatory. This qualification must be carried out, according to current standards. Several specifications (standards, recommendations and guidelines) have been established for the qualification of thermal performances of refrigerated packaging for health products:

  • NFS 99-700: Isothermal and refrigerating containers for health products – thermal performance qualification method. This approved French standard is the most complete reference point
  • ASTM D3103-07: Standard Test Method for Thermal Insulation Performance of Distribution Packages, a 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

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

The players in the cool chain field are conscious of the importance of establishing a specific standard, allowing the qualification of refrigerated vehicles for health products, and taking into account pharmaceutical requirements. The refrigerated vehicle transport process is difficult to manage because the parameters to be verified are multiple and complex (transshipment, various transfers, hubs and so on). 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 performance qualification of the solution will be followed by the validation of the overall transport process. 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 time.

COSTS INVOLVED

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

ENVIRONMENTAL IMPACT

The impact on the environment is another parameter to be analysed in the evaluation of a solution. The lifecycle analysis for the same provided service (equivalent result) allows us to compare the impact on the environment for every solution. This analysis integrates all the systems, all the materials and all the energy required for a particular solution throughout its lifecycle, from the extraction of raw materials up to the treatment at the end of life.

GOOD PRACTICES

For each transport process (static or dynamic), 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 as follows:

Refrigerated Vehicles

  • It is necessary to stabilise 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
  • When using a multi-temperature vehicle, products must not touch the separation wall of the compartments

Refrigerated Packaging

  • Insulated packaging refrigerated by frozen gel packs should not be stored in a cold room, particularly during transit and on arrival. Frozen gel packs must be removed before storage
  • For refrigerated packaging, which has two different configurations for summer and for winter, one 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 in the open segment must be reduced to the minimum possible

CONCLUSION

Refrigerated packaging and refrigerated vehicles are not necessarily in competition, but are complementary resources. Each solution is adapted for certain cases and for certain stages of the distribution process of medicines. The solution used must be qualified and requires precautions and good use practices to guarantee its efficiency. Refrigerated vehicles are used for the national distribution of health products, in the form of groupage transport or of transport of batches. Insulated boxes (packaging) refrigerated by eutectic gel packs or dry ice, are used for international shipping and for long distances in national distribution, because the logistics circuit contains an air transport leg, and for the distribution of various volumes (not mastered) of products, which do not justify the mobilisation of a refrigerated vehicle. Both means can be associated in certain cases to guarantee the cool chain environment. Insulated boxes (packaging) without cold source are combined with refrigerated vehicles to avoid a break in the cool chain in the transfer and delivery zones, or to protect the products from the cold air flow (below 2°C) from the refrigerating unit. Air-conditioned or warmed vehicles are combined with refrigerated packaging for temperature profiles containing cold segments and warm segments, or for extreme conditions. 


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Abbes Kacimi is an Engineer in Refrigeration and Air-Conditioning and a teacher of Mathematics and Thermodynamics. Abbes was graduated from Constantine University in 1988. Certified for engineering studies in 1991, he created an engineering department in parallel with his teaching activity. In 2001 to 2002, he attended training at the French Institute of Industrial Refrigeration in Paris and joined Sofrigam. After a role as the head of the Engineering Department, responsible for the development and qualification of cooling containers for pharmaceutical products, Abbes is now the Cold chain Expert. He is also member of several cold chain commissions (such as lIR Commission D2), and Co-author of Practical Guidelines, Cold Chain for Medicines. He has contributed to several projects in France and in Europe, and has published a variety of articles on the cold chain. He is currently preparing a thesis on Project Management.
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