When transporting samples, it is imperative that items are moved in accordance with a variety of regulations, and that the method of transportation retains the samples? integrity. Abbes Kacimi, cold chain expertise manager at Sofrigam, explains how the Clinibox range of packaging can ensure the safe transit of controlled substances.

Thousands of samples of human or animal origin are collected and sent around the world every day by pharmaceutical companies, nursing homes, diagnostic laboratories and research centres. They are collected as part of medical tests, clinical trials, surveillance studies and various other tests. The results of clinical trials are crucial for market authorisation dossiers submitted by pharmaceutical companies to the relevant authorities.

Samples must be transported in accordance with IATA regulations for the air transport of dangerous goods and with the European agreement concerning the international carriage of dangerous goods by road (ADR). Temperature-sensitive samples must, for their part, be transported in full compliance with the cold chain, on which their effectiveness depends. Depending on their stability, they are transported at 2-8°C (or 2-4°C) or below -18°C. To guarantee the cold chain, laboratories, depositories and CRO units use cooling packaging. For home treatment, qualified insulated bags are used to transport heat-sensitive products. Samples such as blood and skin are transported in UN 3373 insulated packaging from the collection site (hospitals or laboratories) to analysis laboratories.

UN 3373 packaging: transport of class B biological substances
The ADR and IATA regulations for air and road transport of infectious substances which may contain pathogens are based on UN recommendations. Category A infectious substances, regulated by UN 2814 and UN 2900, are those that can cause permanent disability or fatal illness in humans or animals. Category B infectious substances are those that are not classified as category A. UN 3373 packaging consists of three layers:

• leak-proof primary packaging (container) that contains the substance
• secondary packaging, which is resistant and leak-proof, protecting one or more primary containers wrapped in an absorbent material enough to absorb all liquid in case of leakage
• outer packaging that protects its contents and which guarantees the cold chain if necessary.

Each primary container must not exceed 1L for liquids or 1kg for solids. The maximum amount of category B biological substance transported in a package is 4L for liquids or 4kg for solids. The package must be properly marked, labelled and accompanied by shipping documents.

Clinibox: new range of packaging for clinical trials
Sofrigam has developed a range of UN 3373 packaging for clinical trials. The Clinibox range of packaging ensures secure temperature-controlled transport for clinical trials (clinical samples, diagnostic specimens or category B biological substances). It guarantees compliance with the regulations for the transport of dangerous goods (IATA and ADR) and the respect of the cold chain.

Sofrigam produces packaging for category B infectious substances

These UN 3373 transport kits consist of VIAL 650 pouches (secondary packaging) and a refrigerated box (outer packaging). The VIAL 650 pouch is 95kPa certified, by an IATA-approved laboratory. It is divided into several separate compartments pre-equipped with the absorbent material. Tubes are directly placed in these compartments, complying with the requirements of separation and protection against spillage.

The insulated boxes are made of rigid polyurethane panels, and refrigerated as required by eutectic gel packs or dry ice. They are tested and qualified by Sofrigam's partner Ater Métrologie laboratory, according to ISTA 7E and NF S 99-700 standards for thermal performance. They have also successfully passed drop tests from a minimum height of 1.2m.

The Clinibox packaging range covers temperatures 2-8°C or below -18°C, for durations from 24 to 96 hours.