Jun 8, 2020

The temperature-controlled transport represents the best solution, made obligatory by law, for the movement of perishable goods.

The regulations currently in force (known by the acronym ATP) require, for all goods that need higher or lower temperatures than the environmental ones, the transport at controlled temperature through the use of specially equipped vehicles.

The goods subject to controlled temperature transport are all perishable goods: these are defined as all products that require a certain temperature range to be maintained during storage, loading and transport so that they do not deteriorate.

ATP: what does it mean and what it concerns

The regulations governing the transport and storage of perishable goods were born from the ATP agreement, an acronym of  Accord Transport Perissable, with which, during 1970, the main European States established the key points to be followed in the management of this type of operation.
The agreement, which initially linked France, Germany, Italy, Spain, Russia and Yugoslavia, is currently recognized by as many as 29 nations and defines the following aspects precisely:

  • Technical characteristics of the load compartments of vehicles used for the transport of perishable goods;
  • The temperatures to be observed during transport and treatment of the products.

The means of transport of perishable goods, depending on the specific temperatures required by the foodstuffs to be handled, can be Isothermal, Refrigerators, Refrigerants or Heaters.

Each of these, once put into circulation, must have the appropriate ATP certificate, a document valid for 6 years for new vehicles, renewable every three years until the vehicle reaches the age of 12 years.

The renewal of the certificate may take place at the test centre of an ATP expert. After this deadline, a further renewal may only take place at a higher test station. The technical checks shall, of course, cover the state of wear of the load compartment walls, the functionality of the doors, the tightness of the seals and the effectiveness of the cooling devices, where fitted.

The ATP certificate is internationally recognized and therefore allows companies specialized in the transport of perishable goods to move easily even outside the Italian territory.

Fundamental regulations with regard to controlled temperature transport

ATP regulations require temperature-controlled transport vehicles to have insulated, easily disinfectable and corrosion-resistant walls and load compartments with hermetically sealed doors. In addition, trucks used for the transport of fresh and frozen food must be equipped with special temperature control systems and thermometers.

All vehicles must also receive special Health Authorization, subject to periodic renewal. What is also very important is the type of packaging, in fact incorrect packaging may not allow the temperature of the goods or the correct condition of the product to be maintained.

For all these reasons it is good to look for specialized companies that do not have deficiencies in the management of the cold chain, in order not to incur in loss of profits. 

Temperatures to be used for the transport of medicines

The transport of drugs or medicines is not subject to the rules for perishable goods. These types of products are excluded from the ATP regulations. Instead, there is a specific regulation resulting from the decree of 6 July 1999 issued by the Ministry of Health, which indicates what characteristics the vehicles must have and under what conditions the journey must be carried out.

The means of transport used for the transfer of medicines and drugs must be equipped with all the appropriate equipment to ensure compliance with the temperature and health regulations.

Light insulation is prescribed inside the compartment where the products are placed. Let’s see in detail what are the different temperature ranges to be used in pharmaceutical transport:

  • Cryogenic: from -80°C to -180°C
  • Frozen: -20°C (ideal for transporting biological samples)
  • Refrigerated: from +2°C to +8°C
    (ideal for the transport of pharmaceutical products)
  • Ambient temperature: from +15°C to +25°C
    (ideal for transporting medical devices and instruments).


Conclusions on the reference standard

In Italy, the Ministry of Health, with the Ministerial Decree of 6 July 1999, approved the guidelines on good practice in the distribution of medicinal products for human use.

By issuing this ministerial decree, distribution companies must comply with the Good Distribution Regulations to ensure that medicines are stored and distributed/delivered without altering their characteristics.

Our company, as Exporter, refers to the Circular of the Ministry of Health issued in 2000 and inspired by the EU directive CPMP/QWP609/96, and containing notes explanatory to the Ministerial Decree of 6 July 1999, in particular information on the storage temperature of the products medicines for the transport of goods at controlled temperature.