Vacker Group, UAE provides various tests& analysis for life sciences, pharmaceutical and food segments which involve manufacture, storage and transportation of highly sensitive products generally known as Cold Chain systems.
In brief temperature, mapping study is the process of analyzing the uniform distribution of temperature and humidity across the controlled area under various practical conditions. The study is carried out to check and that the entire area inside a thermally insulated chamber is at the specified temperature at all times. This is carried out mainly for the storage facilities such as cold rooms, warehouse, refrigerator, vans for storage and transportation of medicines, vaccines, foods etc. Please see our video for detailed understanding.
Assets which require Temperature mapping study and Temperature qualification
The following categories of facilities which are used for storage and transportation of medicines, vaccines, food etc. need to be covered:
- Walk in chillers and freezers
- Cold rooms (Typically 2 to 8°C for medicines)
- Warehouses (Typically 15 to 25°C for medicines)
- Vans and Reefer trucks (Typically 2 to 8°C or 15 to 25°C for medicines)
What is Temperature Qualification?
Temperature Qualification (and humidity if required) is a bit elaborate process which also involves mapping study as one part of the process. These series of tests also need to be done for any sensitive areas such as warehouses, refrigerators, freezers, medicine rooms, vehicles, reefers, boxes, containers etc. especially for storage and transportation of medicines and food.
The process of Temperature Qualification involves complete identification of entire equipment involved inside the enclosed area including chillers, sensors, evaporators, cooling units, dehumidifiers etc. and study of the complete system under various conditions.
Tests covered under Temperature Mapping Study & Temperature Qualification
The whole system is studied under various conditions:
- Empty condition
- Fully loaded condition
- 60 to 70% loaded condition
- Power failure condition to study the duration for which the room will remain
within limits after a power failure without opening the door
- Door opening conditions to find out how long the door can be opened without affecting the interiors. All doors are tested separately
- Startup verification process to find out the duration required to achieve the desired cooling upon startup.
Please read more on Temperature Qualification
Protocol for Temperature Mapping Study, Temperature Qualification & Validation
The process of temperature mapping study is carried out as per the protocol issued by us and approved by the client. Apart from the various details of the subject being qualified, the protocol indicates the methodology of various tests to be carried out. While writing the protocol, the usual practices of the customer are also considered and tests are performed accordingly. eg. If a vehicle is always used at around 50 % load, it is ideal that tests are also carried out at 50% loaded condition also.
If a vehicle is qualified for 2 to 8 Degree Centigrade, it is meant that the entire storage area of the vehicle will remain within 2 and 8 Degree Celsius with the current set of cooling unit, evaporator, sensor, controller etc.
If a box is qualified for 2 to 8 Degree Centigrade, it is meant that the box will remain within 2 and 8 Degree for a certain duration and the medicine should not be kept for a longer duration
Also, critical conditions such as the duration for which the door can be kept open etc. will be identified and corrective actions will be indicated in the final report.
This process will qualify your Warehouse, Cold Room, Chiller, Vehicle etc. for storage and transportation of Food, Medicine etc.
Vacker Group carries out these services throughout all Middle East countries such as the United Arab Emirates, Kuwait, Qatar, Oman, Bahrain, Kingdom of Saudi Arabia, Iraq, Jordan etc.
Download documents on Temperature Mapping Study & Temperature qualification
A case study on a cold room used for storage of medicines can be downloaded at this link: Case study – Medicine room
Software validation for temperature monitoring systems
We offer validation of software of temperature &humidity monitoring systems. For may clients, there is a requirement to validate the software after installation by the pharma distributor in their warehouse, cold room etc. We carry out such validation on software supplied by different manufacturers. Also, we offer validation of software for the temeprature tracking system for vehicles.
Video on Temperature mapping study & qualification
Other Products & Services by Vacker UAE & Cryopak USA:
- Data Loggers for monitoring and recording
- Real-time Temperature monitoring over the internet with Phone/SMS alert
- Packaging products
- Insulated passive shipping packages
- Qualified shipping packages & boxes
- Thermal Package testing
- Thermal Profile study
- Thermal equipment certification
- Package Integrity testing
- Validation of softare for temperature monitoring ssytems