Cold Chain Temperature Mapping Study and qualification

Vacker Arabia 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.

What is Temperature Mapping Study,Validation & Qualification?temperature-mapping-of-warehouse

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, ware house, 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. are need to be covered:

  1. Walk in chillers and freezers
  2. Cold rooms (Typically 2 to 8°C for medicines)

    download-guide-of-temperature-mapping-study-and-qualification

    Download free guide

  3. Warehouses (Typically 15 to 25°C for medicines)
  4. Refrigerators
  5. Freezers
  6. Vans and Reefer trucks (Typically 2 to 8°C or 15 to 25°C for medicines)
  7. Autoclaves

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 needs to be done for any sensitive areas such as temperature-mapping-of-medicine-vanware houses, 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:

  1. Empty condition
  2. Fully loaded condition
  3. 60 to 70% loaded conditiontemperature-mapping-of-medicine-cold-room
  4. Power failure condition to study the duration for which the room will remain
    within limits after a power failure without opening the door
  5. Door opening conditions to find out how long the door can be opened without affecting the interiors. All doors are tested separately
  6. Start up verification process to find out the duration required to achieve the desired cooling upon start up.

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 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.temperature-mapping-study-of-van
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 Ware house, 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 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 

Case study: Temperature mapping study and qualification of a cold room in Saudi Arabia

Video on Temperature mapping study & qualification

Other Products & Services by Vacker UAE & Cryopak USA:

  1. Temperature mapping study and qualification of boxesData Loggers for monitoring and recording
  2. Real time Temperature monitoring over internet with Phone/SMS alert
  3. Packaging products
  4. Insulated passive shipping packages
  5. Qualified shipping packages & boxes
  6. Thermal Package testing
  7. Thermal Profile study
  8. Thermal equipment certification
  9. Package Integrity testing

References:

Importance of Temperature mapping study in the Middle East

Vacker Arabia  supplies product and services for  cold chain temperature mapping and study in Jeddah, Dammam, Riyadh, Jubail and Khobar in Kingdom of Saudi Arabia.



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