WHY USE
We manage the entire process from start to finish and provide an audit-ready temperature mapping protocol and report with all supporting evidence customised for your facility or area, selecting hot spots and cold spots for temperature monitoring, pivot positions and showing the desired acceptance criteria have been achieved.
Using our proprietary methods and software, we provide an audit-ready report, with detailed analysis of the data, interpretation and recommendations. All mapping activities are conducted in line with local and global standards. All our recording devices are calibrated to National Standards, on an annual basis.
DO YOU NEED MORE THAN JUST TEMPREATURE MAPPING DATA?
We don’t just map your environment we provide critical guidance to ensure
compliance or assist in fixing technical issues and work with you in the
corrective action process.
- Warehouses (15 °C to 25 °C)
- Freezers (-20 °C to -80 °C)
- Fridge and Cold-rooms (2°C to 8 °C)
- Insulated Containers (2°C to 8 °C)
- Air Freight Shipments (2°C to 8 °C) to local and international locations
- Refrigerated and Temperature Controlled Vehicles
- Reefer Containers
- Hot Tunnels and Stability Chambers
- Most other mapping requirements
SIX KEY ELEMENTS OF A
QUALITY TEMPRATURE MAPPING
EXERCISE:
- Assess the environment – prior to temperature mapping to ensure the equipment passes the temperature mapping (current set point, temperature monitoring data, when was the last service, etc.)
- Data integrity – ensuring that data collected from temperature loggers is traceable and complies to data integrity principles.
- Measuring and Recording Equipment – Wired, wireless or Bluetooth loggers? Ensure the use of correct devices for the environment – operating range, accuracy, device resolution.
- More than just data – the results collected from the temperature mapping; exercise should be analysed including observations and recommendations to assess trends, as well as Hot Spots and Cold Spots for temperature monitoring locations.
- Quality and Technical Probe Review – An independent Quality review should be conducted to ensure that appropriate procedures have been executed, key records are available and data integrity has been maintained. Furthermore a Technical review should interpret the results of the mapping and provide observations and recommendations.
- Calibration – Data loggers used for the mapping exercise should be calibrated at 3 points (which should cover the range of the unit being mapped), the calibration should be traceable to national standards. Factory calibration should be avoided..
REGULATORY OVERVIEW
SAHPRA
South African Health Products Regulatory Authority
Good Wholesale Practice for Wholesalers – 2016
SAPC
South African Pharmacy Council
Good Pharmacy Practice – 2017
14.3.3. All warehouses should be temperature mapped over a period of at least one year to determine the temperature distribution under seasonal extremes.
2.3.5.3. (c)The storage area must be kept clean. Internal air temperature distribution must be mapped on installation of the storage area while empty and thereafter fully stocked. This must be done annually under conditions of normal use. Thermolabile pharmaceutical products must not be stored in areas shown by temperature mapping to present a risk (e.g. in the airflow from the refrigeration unit).