TEMPERATURE MAPPING AND GDP-COMPLIANT WAREHOUSE QUALIFICATION
A cold store for air freight shipments was built at the World Cargo Center (WCC) at Leipzig/Halle Airport so that complete aircraft loads of temperature-sensitive goods can be stored. The WCC has direct access to the apron and thus guarantees short transport routes to and from the aircraft as well as to the trucks.
The warehouse area was certified according to the European guideline “Good Distribution Practice” (GDP) at the same time as it was commissioned. This quality system proves compliance with the high standards in the distribution of medicinal products for human use regarding their storage at the site. The cold store, operated by PortGround, can store goods at temperatures of +2°C to +25°C.
The mapping by Rotronic formed the basis for a clean assessment of the climatic conditions in the cold store!
In order to meet the customer requirements of PortGround GmbH as well as the high standards of the Good Distribution Practice (GDP) guideline, Rotronic carried out a winter climate mapping of the new cold rooms. Initial contacts between PortGround GmbH and Rotronic had already existed at the time the storage areas, 20-foot containers as well as parking spaces were to be qualified with the help of a mapping. Talks on the planning and execution of the mapping work were held at that time with the responsible employees. The procedures for the interim storage of sensitive products with regard to the influence of temperature and maintenance of the necessary temperature were discussed in detail with the employees of PortGround GmbH.
To map a warehouse or other storage facility, it is first necessary to identify the risk areas in which risks to product quality arise due to unacceptable violations of temperature and humidity limits. As a result of new findings from discussions with employees of PortGround GmbH and the changed transport volume, separate cold storage rooms were designed and installed.
PortGround GmbH and Rotronic then subjected the new cold rooms to a risk assessment and determined the number and measurement locations of the data loggers to be used.
The control and variability of storage spaces are influenced by a number of factors. Once the risk areas have been identified, a test plan must be developed for the mapping test, describing the following circumstances and the basis for each decision:
Types of data to be generated – e.g. temperature,
relative humidity and their measurement intervals
Number of sensors to be used
Determination of the sensor positions
Duration of the investigation
Summer and winter mapping
Requirements for calibration of the data loggers
Permissible limit values for temperature and
Report generation requirements
Determination of sensor distribution
To this end, the data loggers are positioned in the warehouse in all three dimensions according to a uniform model. In addition, data loggers are then used in critical areas where draughts from loading ramps, heat or cold radiation from external walls, solar heating through windows, heating by lamps, air circulation from traffic or the HVAC system, temperature extremes due to inadequately insulated areas, local influences from room heating and air conditioning systems and draughts from typical activities for warehouse buildings have an effect.
After completion of the test, the Rotronic HW4 software is used to read out the files saved by the data loggers. The HW4 software shows the recorded data and displays the selected results in charts for the mapping report. With all relevant information such as:
Raw data with time and date
Calculated values such as humidity, temperature
minimum, temperature maximum, MKT
The characteristic curves of all data loggers over the test period
The device settings
Date and time of the test
The calibration information
The superposition of the individual sensors can be displayed in a graph to provide a quick overview of possible extremes in temperature and relative humidity. The outside temperature and humidity should also be recorded. Then, for example, a temperature peak can be associated with a time when the gates of the loading ramp were open.
Safe operation of the cold rooms illustrated
After the reports for the evaluation of the mapping were generated, they were evaluated and discussed together with the employees of PortGround GmbH.
A total of 50 HL-1D data loggers were used for recording the data. The temperature curves obtained from the recorded data resulted in recommendations and procedures for operation of the cold rooms. In conclusion, safe operation of the cold rooms could be demonstrated.