By Sofrigam S.A
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Refrigerated Vehicles and Refrigerated Packaging
Refrigerated vehicles and refrigerated packaging requirements in respect to the logistics and transport of health products under controlled temperature are continually rising. The escalation of requirements is caused by the increasingly stricter regulations and continuous controls of refrigerated vehicles and refrigerated packaging upon cool chain quality. Suppliers of equipment, distributors, service providers and pharmaceutical companies are motivated to constantly improve and to work hard in order to meet the expectations and statutory requirements in addition to safeguarding patient safety within refrigerated vehicles and with actual refrigerated packaging.
Two solutions have been put forward to transport health products, both refrigerated and frozen under controlled temperature – refrigerated vehicles or insulated packaging. The user, presented with above two solutions will have to decide which one is most compatible to transport temperature-sensitive products. The main factors that come into play when determining the correct option are:
• Impact on environment
• Temperature profile
• Distribution and logistics circuit
• Volume of products to be sent
• Temperature range of products
• Qualification and validation of the solution
The above parameters will now be examined to determine their importance in the selection of a solution in regards to the requirements of the cool chain for transporting temperature-controlled products.
Distribution & Logistics Circuit of Medicines
Two types of distribution circuit for human medicines can be identified. To start with, the medicines are transported from the manufacturer’s laboratory to a distribution site belonging to the laboratory or a pharmaceutical agent. Within the hospital circuit, the medicines are then distributed to public or private hospitals. They are sent directly or through a trading group or a wholesale distributor. For the official circuit, the medicines are allocated to retail pharmacies through a wholesale distributor or occasionally directly.
Temperature-controlled transportation or refrigerated vehicles can be arranged from the shipper’s site to the consignees’, directly or using hubs, where sorting is carried out by the grouping and grouping packs. In this situation, packs are transported from the shipper’s site the nearest sorting hubs, from where they are arranged by cosignees’ to geographical zones. The packs are then transported to the ungrouping hubs.
If the transportation process involves refrigerated packaging to be transported by air, packs pass through sorting hubs at airports. Although if transportation is done using static refrigerated packaging, the hubs are not refrigerated – they remain at ambient temperatures (as is the case in international shipping and national distribution over long distances). The hubs must be refrigerated if the transportation is carried out under refrigerated conditions. The distribution and logistics circuit enables an initial choice between both solutions. The use of refrigerated vehicles (generally complete or incomplete) can be modified in the following cases:
• From the manufacturer’s laboratory to the distribution site (normally by full truck)
• In the case of group transport (by full are almost full vehicle), loading and unloading zones and hubs must also be refrigerated to circumvent any break in the cool chain.
Insulated refrigerated packaging for very low temperature shipping, refrigerated by eutectic gel packs or by dry ice to preserve an environment below 30°C, are employed in specific cases, including logistics circuits that include an air transport leg (international shipping and national shipping for long distances), or in the situation where hubs and zones of loading and unloading are not refrigerated. In markedly complex cases, both solutions are combined to ensure the consistency of the cool chain.
Volume to be Sent
Once both solutions can safeguard the necessary temperature range of the products for the specified logistics circuit, the volume of products to be shipped will be the pivotal parameter employed to select the shipping method. The volume parameter has the largest influence in terms of the cost of temperature-controlled transportation than any other.
If the quantity of products does not justify the utilisation of a refrigerated vehicle then refrigerated packaging will be vital. The relocation of heat-sensitive pharmaceutical products from the manufacturer’s laboratory to storage or the distribution site is usually made by a refrigerated vehicle since several temperature sensitive products for several final consignees can be grouped together easily.
The priority of a particular solution can change in accordance with the temperature range of products. Insulated boxes refrigerated by dry ice are employed for very low temperatures (below -30°C). Refrigerated boxes with specific configuration or air-conditioned vehicles are required for products between 15 and 25°C. The accepted tolerances (excursions) outside the temperature range of the transported product can play a pivotal factor when selecting the solution. The manufacturer laboratory stipulates the tolerances subsequent to carrying out stability tests on the product. Accepted tolerances enable the selection of a solution with excursions, for simplicity or for decreased cost. This way, a complex or costly solution without excursions can be averted.
For instance, for temperatures between 2 and 8°C, if the lowest and highest tolerated temperature limits for the product are 1 and 9°C respectively, the user will have to make the decision between refrigerated packaging qualified between 1 and 9°C, with a simple configuration, or alternative refrigerated packaging qualified between 2 and 8°C, with a complicated configuration (weightier, bigger and more costly). The tolerances specified enable the choice of the former option which is easier and less costly.
The temperature profile conveys the sections 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 is subject to the logistics circuit. Open from closed segments can be differentiated as follows:
• For a closed logistics segment, the temperature is controlled or relatively stable, and doesn’t follow the climatic temperature directly. Cold chambers, temperature controlled rooms, storage warehouses, closed vehicles or work are some examples.
• For an open logistics segment, the temperature is not controllable and is not stable since it follows the climatic temperature directly. Open loading, delivery zones and tarmac of an airport are some examples.
In the case of a temperature profile involving open segments that the refrigerated vehicle is unable to reach, refrigerated packaging will be essential due to its autonomy. In specific cases, it can be used in association with air-controlled vehicles.
In the case of a temperature profile that involves both warm and cold segments i.e. below 0°C, the combination of an air-controlled vehicle and refrigerated packaging could be the most effective solution.
Qualification and Validation
The qualification of the methods used to respect the cool chain is essential. This qualification must be done in accordance with current standards. Various guidelines (recommendations, guidelines and standards) have been determined 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, the 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
During the period of time for the establishment of a qualification for refrigerated vehicles for health products, transport companies apply for the ‘Agreement on the transport of perishables and special vehicles to be used for this transport’, which is the ATP agreement in relation to food.
The companies in the cool chain field are aware of the significance of establishing a particular standard, allowing the qualification of refrigerated vehicles for health products, and taking into consideration pharmaceutical requirements. The process for refrigerated vehicle transport is tough to manage since the parameters to be substantiated are numerous and complex. The process will require risk analysis because this process identifies critical points and possible failures. Further to this, analysis will be needed to take corrective actions or preventive measures.
Once the performance qualification of the solution is done then the validation of the overall transport process will take place. The destinations that are chosen for validation of the transport process by refrigerated packaging must be relevant. It is essential that the transport by refrigerated vehicles is continuously controlled in real time.
An important parameter when selecting the best solution is cost. When two solutions meet the required specifications, the solution with the lowest cost will be chosen. The cost of the solution will be related to the global logistics cost for the service provided. The cost will incorporate the price of transport by refrigerated vehicle or the price of refrigerated packaging, in addition to all the costs produced by the preparation and the employment of the solution (sundry expenses, equipment, energy consumption and salaries of the staffs).
The cost of the solution is also subject to the required safety level. The safety margin, must be determined without overestimation, to avert the wasteful requirements which confound the solution and inflate the cost. Good specifications incorporate an optimised solution and decreased cost.
Another factor that should to be analysed in relation to the evaluation of the solution is the impact on the environment. The lifecycle analysis for the same provided service (equivalent result) enables the comparison of the impact on the environment for every solution. This analysis incorporates all systems, all the energy and materials necessary for a certain solution throughout its lifecycle, from the extraction of raw materials through to the treatment at the end of life.
Good Use Practice
For every transport process (static or dynamic), to safeguard the efficiency of the temperature-controlled concept, rules of good practice must be utilised. The main rules in relation to each solution are as follows:
For refrigerated vehicle:
• It is important to stabilise the insulated body of the vehicle at the necessary temperature prior to loading
• If the loading and unloading zones of the vehicle are notrefrigerated the refrigerating unit must be turned during loading and unloading
• Do not place products in the cold air flow of the refrigerating
• When employing a multi-temperature vehicle, products must not touch the separation wall of the compartments unit.
For refrigerated packaging:
• Insulated packaging refrigerated by frozen gel packs should not be stored in a cold room, especially during transit and on arrival. Frozen gel packs must be removed before storage
• The exposure time of the insulated packaging in the open segment must be reduced to the minimum possible
• The validated operating instructions for the preparation and loading must be respected
• For refrigerated packaging, which has two different configurations for summer and for winter, one must make sure of weather forecasts before changing the configuration.
Refrigerated packaging and refrigerated vehicles are resources that complement each other. Individual solutions are adapted for specific cases and for specific stages of the distribution process of medicines. The solution employed must be qualified and need precautions and good use practices to safeguard its efficiency. Refrigerated vehicles are employed for the national distribution of health products in the shape of groupage transport or transport batches. For very low temperatures (below -30°C) insulated boxes (packaging) refrigerated by eutectic gel packs or by dry ice are utilised for international shipping and for long distances in national distribution, since the logistics circuit includes an air transport leg and for the distribution of various volumes (not mastered) of products which do not validate the mobilisation of a refrigerated vehicle. Both methods can be associated in particular cases to safeguard the cool chain environment. Insulated boxes (packaging) minus cold source are joined with refrigerated vehicles to avert a break in cool chain in the transfer and delivery zones or to safeguard the products from the cold air flow (below 2°C) from the refrigerating unit. For more information or to discuss our refrigerated vehicles and refrigerated packaging solutions please contact us directly.