We can’t control the weather. But Accuristix can manage and monitor the temperature of your products and ensure compliance with all aspects of the revised Guidelines for Environmental Control of Drugs during Storage and Transportation (GUI-0069).
Understanding and controlling temperature exposure during transportation to customer destinations is 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.
The Quality Assurance & Compliance team at Accuristix has invested extensively in environmental control management to help you overcome the many challenges that GUI-0069 brings to your business. Our Temperature Services include calibration, validation, shipping container qualification, product stability, cycling, vibration and transportation lane studies. 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 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.