Sector health

• Thermal characterisation of materials: the overall coefficient of heat transfer K.

To characterise the performances of a container, we determine the overall coefficient of heat transfer K. The lower the K-value (or K-factor), the better a thermal insulator the material is.

If K ≤ 0.4 W/m².°C, the thermal insulation performance is suitable for transporting goods at temperatures above and below zero

If 0.4 W/ m².°C ≤ K ≤ 0.7W/ m².°C, the thermal insulation performance is suitable for transporting goods at temperatures above zero only

The K-factor indicates the insulating performance of a container.

It is measured by a specific testing method which takes account of all the materials in the design of the container and the assembly techniques.

Olivo solutions meet all the international requirements, the criteria defined by the WHO, in terms of insulation and temperature maintenance for all types of transport temperature profile.

• Regulations on insulated containers

The insulated equipment used for temperature-controlled transport is subject to the ATP Agreement.

ATP: Agreement on the International Carriage of Perishable Foodstuffs and on the Special Equipment to be Used for such Carriage. This UN agreement came into force in 1970. It was signed by 48 countries and introduced mutual recognition of certificates. In France, the Order of 20 July 1998 transposed the ATP into French law.

In France, the competent authority mandated by the State to issue ATP certificates is Cémafroid.

In the distribution of temperature-sensitive healthcare products, the ATP is a reference certification even though it is not mandatory.

• Qualification standards

The Good Distribution Practices for medicinal products for human use and pharmaceutical products (Official Bulletin validated by the Order of 30 June 2000) mention the distribution of temperature-sensitive products in general terms and state in particular that “the conditions of storage must be respected at all times, including during transport” and that it is necessary to “protect products subject to particular storage conditions with appropriate packaging and to identify them”.

• Compliance checks

The regulations relating to the ATP impose an annual monitoring audit on manufacturers as well as traceability and manufacturing process repeatability requirements.

Every Olivo insulated and refrigerating container is characterised and checked at regular intervals by approved laboratories which authorise their use and placing in service.

The use of all our solutions is therefore compatible with the HACCP principles.

• Storage temperature

A cold chain logistics solution is chosen according to the storage temperature of the product concerned. The contractual storage temperatures are those specified in the marketing authorisation (MA). However, tolerances will be defined for each type of products. When carrying out the pre-qualification study, it is important to know the permissible limits and the conditions of degradation: threshold, integrative, cumulative.

• Volume

The volume of the products to be transported is a determining factor in the choice of the logistics solution to maintain the cold chain.

The choice of the number of products per package must be studied so as to optimise the cost/safety and weight/volume ratios.

• Destination and duration of transport

The solutions used are configured for specific lengths of time. It is therefore necessary to look at the margins of tolerance on the durations announced and the risks incurred.

Depending on the customer’s needs and objectives, there may be several logistics circuits. These are characterised by segments of different durations and different exposure temperatures. In fact, it is essential to know the ambient conditions during transport and at the destination.

All devices have to be qualified for pharmacy use. Qualification consists of confirming by tests conducted in a laboratory and providing tangible proof that the use of the equipment really does provide the expected results in an approved validation report.

Every piece of insulated equipment must be fitted with a temperature monitoring and control system to ensure that temperature-sensitive healthcare products are unharmed.

The user must ensure that the measuring device is calibrated for the relevant temperature range (standards EN 13485 and EN 13486).

In the logistics of healthcare products, the user has an obligation to guarantee the continuity of the cold chain throughout the period of transit. In order to isolate any risk of temperature excursions, the user must be able to provide temperature recordings for the goods transported.