Isothermal cases qualified by the suppliers: are-they suitable for the transport of heat-sensitive cytotoxic preparations?

Introduction and objective
The transport of cytotoxic preparations is a risky step, particularly in the context of subcontracting, which entails greater logistical constraints. To guarantee compliance with the cold chain, isothermal cases qualified by the suppliers can be used.
The objective of this study was to qualify the 2-hour routing of heat-sensitive cytotoxic preparations for the implementation of a subcontract.

Materials and methods
Temperatures were measured in isothermal cases by a temperature recorder (T°C) or inside the bags with a probe thermometer (T°B). The cases were placed at 25±2°C, empty or containing 0.9% sodium chloride bags prepared at 5±3°C (same filling volume), with T°M or T°P measurements on 3 locations (high, middle, low). An operational qualification in 3 steps was carried out for 3 models of isothermal cases:
1- empty cases, T°C measurements over 8.5h;
2- cases filled with bags, T°C measurements over 8.5h;
3- cases filled with bags, T°B measurements at 30 minutes, 1h, 1.5h and 2h.
The best performing case was tested under stressed conditions (at 35±2°C) using the same procedures as for step 3. Each test was repeated 3 times.

Results
During the no-load tests, the T°C was in conformity (5±3°C) on average during 6.85±1.28h for model 1, 6.47±1.10h for model 2 and 8.38±0.03h for model 3. For the tests with filling, the T°C closest to the eutectics was compliant during 8.43±0.08h, 5.52±3.90h and 8.43±0h respectively for models 1, 2 and 3. The T°C furthest from the eutectics was compliant for 5.77±1.47h, 0.02±0h and 0.02±0h for models 1, 2 and 3.
The T°B was maintained at 5±3°C for all pockets for at least 1.5h with model 1, 2h with model 3 and less than 30 minutes for model 2. Under stressed conditions, model 3 allows the T°P to be maintained at 5±3°C for 1.5h.

Discussion and conclusion
No-load tests showed that the temperature was maintained for much less time than that announced by the suppliers: 18h for model 1 and 8 h for model 2. The cases are actually designed for the transport of samples. Tests with bags show that temperature retention is better when the bag is placed as close as possible to the eutectics. The results of the measurements inside the bags show that model 3 has a better conservation time at 5±3°C compatible with the estimated transport time and acceptable for high temperatures. Nevertheless, the tests should be continued to validate the circuit for intra-hospital transport with repeated openings.

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