Product Validation

Kit Performance Validation (2008)

The Pro-CORE Kit is a qualified thermal package for use in shipping biological specimens for 48 hours throughout summer and winter conditions. The container was tested against the 48-hour temperature profiles in ISTA (International Safe Transit Association) Procedure 7D, as well as some extreme flat-line profiles for informational purposes. The container was also evaluated with different configurations of phase-change materials in order to show its ability to maintain varied temperature ranges. The summer and winter studies were performed three times to show that consistent repeatable results were obtained.

Each of the simulated product loads was probed with Thermoprofile data loggers, one for each payload area being used in the packaging configuration depicted below. After the temperatures of product loads stabilized, they were packed into the appropriate cavity of the BPS Insulated Package, along with phase-change material as needed. The shipping container was then closed, sealed, and placed into the environmental chamber programmed to run the temperature profile.

Summer and winter 48-hour temperature profiles used by the manufacturer of the existing CPX system (TCP Reliable, Inc.) to simulate express package shipment environmental conditions, and actual CPX system configuration test results appear below.


Table 1. TCP Reliable summer condition 48-hour test temperature profile.

Step Temperature Set Point Time Duration
0 22°C 4 hrs
2 35°CC 2 hrs
2 30°C 36 hrs
3 35°C 6 hrs

Figure 1. Summer condition test results for the current CPX system. The system fails to maintain temperature below -70°C for more than 24 hours and below -20°C for more than 38 hours.

Table 2. TCP Reliable winter condition 48-hour test temperature profile.

Step Temperature Set Point Time Duration
0 18°CC 4 hrs
2 -10°CCC 2 hrs
2 10°CC 36 hrs
3 – 10°CC 6 hrs

Figure 2. Winter condition test results for the current CPX system. The system maintains temperature below -20°C for 48 hours (deep frozen tissue integrity for biomarker analysis is considered comprised above -20°C). However, temperature climbs above optimal temperature of -70°C after ca. 38 hours. The ambient temperature payload freezes after 48-hours.

The full validation report can be found here.