Freezers and Refrigerators

Refrigerators are used to maintain drug producttemperature between the limitsdefined on the product label. Typically, refrigeration unitsoperate at 5±3°C. Freezer temperatures may vary and typically range from −25°C to −10°C. Regulations require that these systems be periodically mapped to ensure that they continue to fulfill their intended purpose.

Mapping can be performed using various technologies. The XpertVal thermocouple-based system is a cost-effective solution. It is particularly useful when real-time data is needed at a fast rate. It also covers the widesttemperature range of all systems. The GDP temperature loggers provide standard data logger capabilities, simplifying installation and reducing the associated labor. The GMP temperature loggers provide an expanded temperature range suitable for low-temperature applications. The GMP RF temperature loggers add real-time wireless data capabilities useful when performing open door testing, recovery testing and power failure simulations.

All our temperature data collection systems can be pre-calibrated and post-verified in-situ using dry blocks and traceable reference probes. Also, the analysis tools included in the XpertLog® software make it easy to apply pre-configured acceptance criteria to a data set to obtain a pass or fail result. This reduces human error in the interpretation of results and ensures data integrity. The statistics report automatically identifies the coldest and warmest locations from the mapping data. The software can also calculate mean kinetic temperature (MKT), when applicable. All our thermal validation systems use the XpertLog® software which our customers rely upon for their most critical applications.

Products suitable for Freezers and Refrigerators: