THE TRANSPORT OF MEDICINES FRANCE-FLORIDA. ECONOMY AND FLEXIBILITY

We have already had the opportunity to learn more about how, in long-distance transport (such as the France-Florida route), intermodal transport is one of the most used solutions. This method of goods handling is extremely flexible, as well as economical, as, by combining different means (road-iron, road-water, road-air etc.) it is possible to benefit from the advantages of each of these transport modes. Without considering that, from an environmental point of view, the reduction in road freight transport translates into a positive environmental impact.

Road, sea, rail, air are segments of the same logistical mechanism which, to be functional, must be able to make the most of its different specificities. The dynamic development of trade has become a factor in the expansion of shipping services not only on European but also intercontinental routes.

The expansion of trade connections between individual countries of the world has contributed to the development of a wide range of shipping services that use modern and flexible solutions in the field of freight transport.

As an international forwarder, Trasauto Logistica has the duty to protect the client and, with this, the final recipient of the goods, managing the details of the transport phase in the best possible way. This principle applies, in particular, to the case of the transport of drugs and biomedical products. Medicines require special care due to the function they are intended for.

The characteristics of intercontinental pharmaceutical transport

Drug and medical device logistics deal with the storage and distribution of medicines. And it is a sector in constant growth and evolution, especially at a regulatory level, for the regulation of storage and transport practices.

Medicines are a fundamental pillar of health care. From treating chronic diseases to controlling pain, these products play a vital role in the lives of many patients.

The transport of medicines is a crucial aspect of the healthcare system and, ensuring that they reach patients safely and effectively, is essential to guarantee their health. These products, therefore, require special storage conditions and rigorous controls. The main characteristics of pharmaceutical logistics are:

• Traceability to quickly identify anomalous or irregular batches
• Storage at controlled temperatures to avoid interruptions in the cold chain
• Quality control to safely store medicines
• Short times to manage urgent deliveries.

 From the moment pharmaceuticals leave the hands of manufacturers until they arrive in pharmacies, every step of the process must be carefully monitored and regulated to ensure the integrity of the product itself.

THE DIFFICULTIES OF TRANSPORTING MEDICINAL PRODUCTS AT CONTROLLED TEMPERATURE. FRANCE-FLORIDA ROUTE, WHAT TO PAY ATTENTION TO?

The shipment to America represented a great challenge for Trasauto Logistica as it involved the transport of pharmaceutical products in summer, a very hot season which therefore required maximum temperature control. A high temperature, as well as a low temperature, can develop toxicological characteristics and accelerate the degradation process of the products.

Pharmaceutical transportation from France to the United States, particularly for the France-Florida route, is a very complex procedure. As with the transport of perishable goods, drugs and medicines also require not only temperature-controlled transport but also two phases that require the utmost attention from the company:

• Preparation at the point of production: there are specific cases in which drugs require a specific temperature and, especially in the summer periods, this caution becomes much more complex
• Packaging: the packaging phase is equally important to prevent the drugs from being impacted or ruined during the transport phase. There are, therefore, special containers for refrigerated transport.

A critical aspect of the transport of medicines is the cold chain management. Many medications are temperature sensitive and must be stored under specific conditions to maintain their effectiveness. The cold chain includes all phases, from production to distribution, in which it is necessary to maintain a controlled temperature.

These are sensitive products that require certain temperatures - between 18° and 22° for medicines and between 2° and 8° for vaccines - and a minimal change in temperature can cause the alteration of the chemical-physical characteristics and therefore the ineffectiveness of the product itself. The insulation of the vehicle, in our case the plane, can be useful for medicines that require temperatures lower than +25-30°C, but in summer it is often above +30°C and it is not always possible to guarantee it, especially on long journeys.

The help of an air conditioner that exchanges air with the transport compartment may be useful. In this way, ideal transport conditions can be maintained. In other cases, however, a specific refrigeration system is required for medicines that require temperatures between +2°C and +8°C and below 0°C. Trasauto Logistica has been dealing with intercontinental transport for over forty years, the company is specialized in the France-Florida route.

AN AIR SHIPMENT OF FRENCH PHARMACEUTICAL PRODUCTS

A “CASE HISTORY” OF A FRANCE-FLORIDA TRANSPORT

One of our French clients, Suzanne R., left France to move to the United States, to Jaksonville, where she decided to open her own chain of pharmacies. She contacted our company because she needed an intercontinental shipment of drugs.

At this point, to ensure full temperature control during transport, fast and efficient transport was necessary. Air transport, combined with road transport, was therefore identified as the preferable choice.

Over 55 tons of pharmaceutical products landed in Washington D.C., after more than 11 hours of flight, on board an air freighter departing from Nantes (FR).

It was an all-cargo charter flight, one of the many intercontinental transports, whose take-off, on 23 July 2022, was scheduled by us at Trasauto Logistica to establish an alternative supply chain to the conventional distribution of medicines, in this case in Americas. The route then continued by road to Jaksonville in Florida, after approximately another 11 hours of travel.

The flight involved the movement of 70 special containers at controlled temperatures (+5°) for a total weight of 55 tons and 330 m³ of goods. Transport was possible thanks to latest generation containers. Able to maintain a constant temperature for the entire duration of the journey, an essential factor if we talk about the transport of pharmaceutical products. Refrigerated containers, in fact, play a fundamental role in ensuring the continuity and integrity of the cold chain.

The diabetes medications included in the shipment are more sensitive to temperature and require rigorous monitoring during storage and transportation to ensure the effectiveness of the insulin.

US FDA: Pharmaceutical Transportation Regulation

In America, all imported products are strictly controlled by the Food and Drug Administration (FDA), a US government agency aimed primarily at protecting public health, guaranteeing the safety and effectiveness of drugs and by the Department of Transportation (DOT). 

FDA regulations are very stringent regarding the transportation of heat-sensitive products and this is something the agency believes is unavoidable. In fact, the Code of Federal Regulations (CFR) Title 21, Section 211.94 (b) states: “Container closure systems shall provide adequate protection against foreseeable external factors, during storage and use, which may cause deterioration or contamination of the pharmaceutical product”.

Some of the highlights of this regulation related to the shipping of pharmaceutical products include:

• Vehicle equipment: ensure that vehicles used for pharmaceutical transport have the necessary technology and equipment. For example, trailers must have temperature control and necessary safety measures
• Transportation Operations: Pharmaceutical transportation companies are required to properly clean a trailer's loading area to prevent cross-contamination. Temperature monitoring and control devices must also be regularly maintained to ensure proper operation
• Staff training: people directly involved in the distribution of pharmaceutical products must receive appropriate training, which must be documented
• Labeling: All pharmaceutical shipping containers must be clearly labeled and marked
• Documentation storage: Transportation and training documentation must be properly preserved and archived.

TRANSPORT OF MEDICINES AND COLD CHAIN. THE FRANCE-FLORIDA ROUTE

In recent years, greater regulatory attention has been paid to good distribution practices, which prescribe how regulated products must be transported. Fortunately, the emergence of GDP has created a robust and viable cold chain to handle temperature-controlled drug shipments.

In intermodal transport, communication between the interested parties is of fundamental importance, in order to guarantee that the load arrives at its destination safely. Freight transport in loading units follows a precise procedure for each transport mode and contract: planning, packaging, shipping and delivery.

Overcoming the difficulties of the Cold Chain. A must for logistics companies

Managing possible risks related to the transportation of medicines has a significant impact on business costs. For air transport alone, IATA, the International Airline Organization, estimates an annual loss of 35 billion dollars due to storage problems of thermolabile drugs. Half is due to the deterioration of goods along the various links of the supply chain.

Therefore, to maintain the cold chain in the context of pharmaceutical logistics, it is necessary to address the friction points related to each phase of transportation. For example, at the exit of refrigerated warehouses, the SAS (Security Airlock System) prevents the goods from suffering sudden changes in temperature or the action of other atmospheric factors.

As for the means of transport that handle medicines, they must be prepared to maintain a specific temperature (they can be isothermal, refrigerated or refrigerated) with active and passive control systems. It is also necessary to monitor the humidity level, atmospheric pressure and impacts when handling the products.

FRANCE-FLORIDA, THE REQUIREMENTS TO BE SATISFIED IN THE MULTIMODAL TRANSPORT OF MEDICINES AND MEDICAL EQUIPMENT

It is very important to underline that, in our case, we opted for combined air-road transport, as some of the pharmaceutical products being shipped could not withstand a longer journey. Reason that led us to exclude the use of cargo ships with special container modules for the management and monitoring of the cold chain. 

The combination of different means of transport remains, in any case, the fastest and most practical solution, as well as the most convenient in relation to the shipping time. The movement on rubber lasts the time to reach the destination after the airway and, more and more often, it’s important to use trucks and means that are characterized by low CO2 emissions with a view to greater sustainability.

Through transport by plane, the load of drugs travels in safe conditions regardless of the weather conditions and there is a greater speed for urgent or particularly bulky or precious loads.

Multimodal transport brings multiple advantages to the pharmacological sector, including:

• Fast shipments: in intermodality, the drugs must not be loaded and unloaded during the change of transport method, which speeds up operations
• Safety of the goods: intermodal transport eliminates the risk of stock leaks. By reducing the handling of loads, it significantly decreases the possibility of damaging the products during exhaust operations
• Flexibility: the combined use of more means of transport for the same journey facilitates the management of shipments. It also allows companies to take advantage of each way, from the enormous skills of merchant ships to the flexibility of road transport.

How to mitigate the safety risks by choosing the type of transport?

Pharmaceutical logistics is in itself complex and delicate since it must guarantee the correct conservation of thermosensitive products during long and articulated shipments.

 Combined intermodal transport combines, in our case, the flexibility of road transport, which is used as the last stage of the route, to the advantage of air transport, to ensure that any location can be reached in sufficiently short times. The correct transport planning is fundamental in order to obtain a compact or fixed stowage.

An inadequate preparation of the load costs the logistics and transport sector over 6 billion dollars a year. It is not only the process of preparation for the load units that affects but also other phases of the process, including:

• Weight distribution
• Load fixing
• Workflow
• Classification and documentation
• Declaration relating to the goods to be transported
• Transfer of the load.

THE INTERMODAL SOLUTION IN THE TRANSPORT OF FRANCE-FLORIDA DRUGS

Transport regulations are one of the most important details to consider when pharmaceutical products are sent. Given the crucial nature of these assets, restrictions must be taken seriously. The rules in force start from the production plant and extend along the entire supply chain up to the shop shelves.

Trasauto Logistica offers a wide range of logistical services useful for the international transport of medicines, equipment and medical equipment, adapting logistical solutions to the needs of each customer.

The company pays particular attention to load safety, therefore the transport is made in compliance with the guidelines of good distribution practices (GDP - Good distribution Practice) and in accordance with international law and the rules established in the field of the commercial circuit of medicines. The transport of medicines is carried out by different means throughout Europe, North Africa, South-East Asia and Central America, as well as in the United States of America and Canada.

Know-How, Expertise and a dense network of partners worldwide make Trasauto Logistica the ideal interlocutor for your transport at controlled temperature. Intermodal transport represents the method of the future and therefore requires an increasingly punctual knowledge regarding import/export and customs administrative assistance.

If, therefore, you have the need to transport perishable goods, such as pharmaceutical or biomedical products, anywhere in the world, just fill out our contact form. The staff will in a very short time to draw up a detailed estimate suitable for determining the sum that you will have to spend so that the transport is completed with maximum efficiency.

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Or for personalized assistance, you can call our offices in Italy at: +39 (0) 828 1818150  or request more information also by e-mail: info@trasauto.com