For temperature sensitive pharmaceutical products with stringent Health Canada GUI-0069 requirements, it is critical that the temperature of all the areas where they may be stored are controlled and documented.
Understanding and controlling temperature exposure during transportation to customer destinations is also a critical component of GUI-0069 compliance. Even minor variations in temperature can affect the quality of the drug, cause medications to become ineffective or completely spoil a product.
Accuristix has made significant investments in the area of temperature mapping, shipping container qualification, transportation lane studies and calibration, and developing in-house expertise for GUI-0069 compliance. Our services include designing the study protocol, execution and preparing a detailed report with actionable recommendations. We also have comprehensive transportation temperature data for destinations across Canada.
The objectives of an Accuristix Temperature study include:
Mapping temperature variations within all the areas where temperature sensitive products may be stored or temporarily held during transit (e.g., warehouses, packing areas, loading bays, cold and freezer rooms)
Documenting high and low temperature fluctuations that may be caused by environmental control systems (e.g., heating, cooling and ventilation)
Identifying potential issues that may cause temperature variations
Proposing the best places to locate or re-locate temperature sensors
Understanding how seasonality and various transportation modes used to reach destinations across Canada can impact product temperature exposure
Recommending any remedial actions needed to overcome the issues identified
With the addition of a 16 cu.ft. environmental chamber in 2020, we also offer shipping container testing capabilities through temperature and humidity cycling. Accuristix can design and test a shipping container to meet your product labelled conditions and GUI-0069 requirements. The addition of this chamber also allows us to calibrate temperature sensors and loggers.