Many medicinal product transports in express logistics (3.5 to 7.5 tonnes) must meet more stringent temperature requirements today than they did in the past. In practice, the regulations set forth in the EU GDP Guidelines (Good Distribution Practice) give rise to many questions. The ATP classification of foodstuff transports in particular is frequently given as the minimum standard. However, on closer scrutiny this practice raises questions that could be answered with special heating and cooling equipment.
ATP classifications regulate the international transport of perishable foodstuffs. In the absence of other qualifications they are also used for the transport of temperature-sensitive medicinal products.
The ATP agreement divides the modes of transport into classes based on their suitability for the foodstuffs to be transported. The most commonly used classifications are:
The three letters describe:
Details are given in Figure 1.
|Example: FRC||Example: FNA|
|C: heated equipment|
|F: mechanically refrigerated unit||F||F|
|R: refrigerated equipment|
|N: K coefficient ≤ 0.70 W/m2K, normally insulated equip.||N|
|R: K coefficient ≤ 0.40 W/m2K, heavily insulated equip.||R|
|A: +12° C to 0° C|
|B: +12° C to -10° C||C|
|C: +12° C to -20° C|
Figure 1: Nomenclature for ATP classifications
Thus, a lorry classified as FRC has a mechanically refrigerated unit and heavy insulation and it is suitable for transporting foodstuffs at temperatures down to -20° C. However, it does not have heated equipment.
The medicinal product sector differs from the field of foodstuff transports in that temperature ranges of +2° C to +8° C and +15° C to +25° C are often required. In addition, as yet there are few products that must be stored frozen at temperatures below -18° C. Figure 2 shows that the ATP classifications are not adequate for the field of pharmaceuticals. Classification as FRC or FNA does indicate that a refrigeration unit is at hand; however, there is no heated equipment. A winter transport at temperatures below freezing would require heated equipment for the transport classes of +2° C to +8° C and +15° C to +25° C.
ATP certification is issued by the competent authorities of the EU countries. In Germany, this authority is represented by the ATP inspection stations for new vehicles. An ATP inspection has the following characteristic elements:
Figure 2: Cooling ranges: ATP and medicinal products
In Chapters 3.3, 9.2 and 9.4 the GDP Guidelines call for qualification of the equipment used for the transport.
Chapter 9.4, Section 4 states:
“If temperature-controlled vehicles are used, the temperature monitoring equipment used during transport should be maintained and calibrated at regular intervals. Temperature mapping under representative conditions should be carried out and should take into account seasonal variations.”
Performance qualification (PQ) can provide reliable information relating to these requirements. During the qualification of each means of transport evidence must be provided that these requirements are also met in practice.
Essential elements of this process are:
Practical comparison: This can be compared with the qualification of storage containers in manufacturing medicinal products. A prototype check is not accepted for GMP-compliant manufacturing and is seldom considered. An individual check is more reliable than that of a prototype or model.
Selecting means of transport solely on the basis of ATP classes can pose a risk for transporting medicinal products. A more detailed specification is imperative.
Perhaps ATP classifications are preferred in practice since they are
For example, vehicles with the ATP classification FRC have powerful mechanically refrigerated equipment, but in the winter they often have great difficulties meeting the strict temperature requirements for medicinal products in the positive temperature range (see above).
On the other hand, medicinal product vehicles with thermal units often are not ATP certified as these specialised vehicles are not used for the carriage of foodstuffs. As compared with ATP modes of transport, such vehicles generally have strong heating and cooling capacities. Therefore, they meet requirements not only in sensitive winter operations, but also in the summer. But this must be proven in an appropriate qualification process. Since these manufacturers do not outfit transport vehicles for foodstuffs there is no need for costly ATP certification, nor would this be necessary or reasonable.
Temperature-controlled transports are still a critical subject. ATP certification alone seldom meets requirements for transports of medicinal products. Every pharmaceutical company must answer the following questions specifically for that company’s products and transports:
The answers to the above questions should be taken into account when carriers and transport-container suppliers are being selected. If you do not deal with these questions, they may come up during a future official inspection. You should then make certain that you have the appropriate answers.
 ATP is an abbreviation derived from the French term: “Accord relatif aux transports internationaux de denrées périssables et aux engins spéciaux à utilisier pour ces transports,” meaning “Agreement on the International Carriage of Perishable Foodstuffs and on the Special Equipment to Use for such Carriage”.
Editor in Chief
Maas & Peihter AG, Schopfheim, Germany