Warehouse and cold room temperature mapping
|INSTRUMENTS||SCOPE OF QUALIFICATION|
|Temperature chambers – freezers, refrigerators, incubators, termostats, drying ovens, sterilisers, furnaces||-160 °C to +1200 °C|
|Warehouses||from -30 °C|
|Cold room||from -90 °C|
|Baths||-160 °C to +1200 °C|
Every summer and winter, initial temperature mappings in the context of qualification of storage areas and cold rooms are carried out in accordance with the client’s protocol or GDP (Good Distribution Practice) of medicinal products for human use and WHO Technical Report Series, No. 961, Qualification of temperature-controlled storage areas, supplements 7 and 8. In this regard, we use data loggers, internally calibrated on a regular basis with software that complies with FDA CFR Part 11.
Depending on the storage area, in particular, its height and layout, when setting up the loggers, particular attention is paid to critical points, i.e. where external influences can change the temperature within the space.
Temperature mapping should always include both working and non-working days, so that it is possible to conclude how much regular work and other processes affect the temperature within the storage space. In order to be able to propose optimum mapping dates, we always keepi up with medium-term weather forecasts.
Each mapping report includes the mean, minimum and maximum temperature as well as the mean kinetic temperature for each data logger, identification of cold and hot spots, the most stable and unstable spatial spots, as well as a comparison with acceptability criteria and recommendations for further work. Also, enclosed with each report is a sketch of the placement of the data loggers, including raw data printouts, temperature graphs, accredited calibration certificates for all data loggers used as well as our accreditation certificate issued by the Croatian Accreditation Agency.
Temperature mapping of vehicles and transport validation
|INSTRUMENTS||SCOPE OF QUALIFICATION|
|Transport vehicles with temperature-controlled space – trucks and vans||from -30 °C|
|Active tank||from -90 °C|
|Passive tank||from -90 °C|
Temperature mapping in the context of vehicle qualification and transport process validation in a temperature-controlled vehicle space is performed in accordance with WHO Technical Report Series, No. 961, Qualification of refrigerated road vehicles, supplement 11, and GDP (Good Distribution Practice) of medicinal products for human use. Equally to warehouse mapping, the data loggers used, including their software, are in full compliance with FDA CFR Part 11.
Contrary to warehouse mapping, the recommendations of the World Health Organization (WHO) for vehicle mapping state the data loggers should be put in boxes with the products and placed in critical positions. They are placed in the packages prior to loading, ideally a day before, in order to validate the entire process – from the warehouse, to the loading and unloading processes during the transport route. Apart from vehicles, measurements can be performed and transport process validation reports can be made for transport containers as well.
In order to be able to propose optimum mapping dates, we constantly keep up with medium-term weather forecasts, depending on the chosen transport route.
The report for each vehicle is comprised of the mean, minimum and maximum temperatures as well as the mean kinetic temperature for each position, identification of cold and warm points within the vehicle space, the most stable and unstable spatial points, a comparison with regards to acceptability criteria and recommendations for further work. Also, enclosed with each report is a sketch of the data logger positions, raw data printouts, temperature graphs, pre-conditioning time and time of all deliveries, accredited calibration certificates for all data loggers used as well as our own accreditation certificate issued by the Croatian Accreditation Agency.