Temperature Mapping Study – Pharmaceutical industry

Importance of Temperature mapping study in the Middle East

The Middle East countries go through extreme climatic conditions with temperature crossing 50 Degree Centigrade during peak of Cold room temperature mappingsummer. The external temperature and atmospheric conditions affect the temperature of ware houses, cold room, vans, trucks, reefers etc. which are used for storage and distribution of medicines. The Middle East countries referred here are generally United Arab Emirates, Saudi Arabia, Qatar, Kuwait, Oman, Bahrain, Iran, Iraq etc.

Regulatory requirement of Temperature mapping study in the Middle East

While this is not a regulatory requirement in most of these countries, it is desirable for most of the pharmaceutical manufacturers and distributors that a study is carried out atleast once in every three years. The reason for recommending once in three years is that various critical parameters inside the enclosed area keep on changing including the performance of the cooling units. Also the number and arrangement of storage racks are changed many times which are not advisable after carrying out a mapping study. Even adding a small rack will have its own effects in uniform temperature distribution. Such a study need to be carried out for entire cold chain including ware houses, cold room, vans, trucks, Temperature mappingreefers etc.

Do you require Temperature mapping study for your facilities?

How do you decide whether you need to carry out the study for your facilities? If you are dealing with manufacture, storage and transportation of temperature sensitive products such as medicines, vaccines, frozen or fresh food items etc., you need to ensure that the products are always within the specified temperature levels at all stages.

Temperature & Humidity Mapping study of Warehouse

A warehouse is affected extremely by the climatic conditions and hence it is extremely important and essential that the mapping study is carried out in different climatic conditions such as summer and winter in the Middle East. Aware house is typically studies for 7 days continuously in both the seasons. It is practically difficult to carry out ware house study under different loading conditions such as empty and full loaded conditions because the goods in the ware house will have to be moved outside. This is generally possible only if the study is carried out immediately upon construction of the ware house. A ware house is generally studied for a temperature range of 15 to 23 Deg C

Temperature & Humidity Mapping Study of Cold Room

A cold room is very sensitive since the temperature has to be always maintained between 2 and 8 Deg C. Humidity has to be maintained within a limit of 70% if not specified other wise by the medicine manufacturers.  Any corner of  the room should not exceed these temperature levels and hence the mapping is very elaborate in ascertaining the practical conditions. The test is done under two loaded conditions viz. Partial and fully loaded conditions. Various tests done are:

  • Power failure test to determine the duration for which the temperature will be maintained if power fails
  • Temperature recovery test to determine the time taken to reach the specified time limits after a power failure
  • Door opening test to determine the duration for which a door can be kept opened without affecting the inside temperature
  • Mapping of Partially loaded (typically 60-70%) cold room
  • Mapping of Fully loaded cold room

Temperature & Humidity Mapping Study of Vans , Reefers & trucks

The vehicles are always on the move under loaded conditions and the inside parameters cannot be monitored to a great extent. HenceReefer truck temperature mapping it is very important to analyse the inside conditions for all practical conditions and certify the vehicle. Various tests done are:

  • Power failure test to determine the duration for which the temperature will be maintained if power fails
  • Temperature recovery test to determine the time taken to reach the specified time limits after a power failure
  • Door opening test to determine the duration for which a door can be kept opened without affecting the inside temperature
  • Mapping of empty vehicle
  • Mapping of Partially loaded (typically 60-70%) vehicle
  • Mapping of Fully loaded vehicle

Protocol & SOP for Mapping study of Reefer truck with Thermoking

A brief of a typical procedure for a 40 ft. reefer truck fitted with Thermoking cooling unit can be viewed here 

Case Study : Mapping Study and Qualification of Reefer truck

This case study explains the mapping study and qualification carried out on a Reefer truck in Dubai.

Summary of Project

Project Code of Vacker LLC Xxxxxxxxxxxxxxx
Client Name xxxxxxxxxxxxxxxxxxxxx
Dubai
United Arab Emirates
Asset Type Truck for transportation of Pharmaceutical Products
Asset Description Reefer TruckManufacturer: MammutCooling Unit : ThermokingIdentification no. xxxxxxxxxxxxxxxxxCooling Unit : Thermoking Sl.No. xxxxxxxxxxxxxxx
Size of the vehicle in meters (LxWxH) 13.2 x 2.5 x 2.615
Temperature Range to be mapped 2- 8 Deg C Mapping Study
Low Limit 2° C
High Limit 8° C
Set point: 4° C15-25 Deg C Mapping Study
Low Limit 15° C
High Limit 25° C
Set point: 19° C
Duration 2- 8 Deg C Mapping Study17 hours – Empty
12 hours – 60% loaded
16 hours – 100% loaded15-25 Deg C Mapping Study17 hours – Fully loaded
12 hours – 60% loaded
16 hours – 100% loaded
Mapping Type Operational Test 1.0 ; System Start up verification
Operational Test 2.0 ; Empty Load Test
Operational Test 3.0 ; Partial Load Test
Operational Test 4.0 ; Fully Loaded Test
Operational Test 5.0 ; Door opening Test
Operational Test 6.0 ; Power Failure Verification
Operational Test 7.0 ; Temperature Recovery
Date of Test xxxxxxxxxxxxxxxx2014
Place of Test Yard of xxxxxxxxxxxxxxxxxxx at Jabel Ali Free Zone, Dubai, UAE
Test carried out by: xxxxx Vacker LLC

Test was carried out as per summary indicated above. All results were satisfactory. Brief details are as under:

Summary of results : 2- 8 Deg C Mapping Studydata-logger-for-temperature-mapping-study

1.       Summary of Operational Test 1.0 ; System Start up verification:

Power switched ON and Door closed at : xxxxxxxxx , 14:36:02 hours
Time taken for first data logger to reach below 8 ° C from Ambient : 36 Minutes
Time taken for all data loggers to reach below 8 ° C from Ambient: 48 Minutes

 2.    Summary of Operational Test 2.0 ; Empty Load Test:

Empty load test started after stabilization at : xxxxxxxxx , 16:24:02 hours
Empty load stopped at : xxxxxxxxx, 09:33:02 hours (Total 17 hours)
Result : All data loggers remained within the range throughout the test

3.    Summary of Operational Test 3.0 ; Partial Load Test:

Empty load test started after stabilization at : xxxxxxx , 12:00:02 noondata-logger-placement-for-mapping-study
Empty load stopped at : xxxxxxxx, 16:18:02 hours (Total 4 hours)
Result : All data loggers remained within the range throughout the test

4.    Summary of Operational Test 4.0 ; Fully Loaded Test:

Fully load test started after stabilization at : xxxxxxxxx , 18:09:02 hrs
Fully load test stopped at : xxxxxxxxx, 09:54:02 hrs (Total 16 hours)
Result : All data loggers remained within the range throughout the test

 5.    Summary of Operational Test 5.0 ; Door opening Test:

Door opened at : xxxxxxxxxxx , 14:27:02 hours
Time taken for first data logger to reach above 8 ° C : 3 Minutes
Time taken for all data loggers to reach above 8 ° C : 6 Minutes

6.    Summary of Operational Test 6.0 ; Power Failure Verification:cooling-unit-used-in-reefer

Power switched OFF  at : xxxxxxxxx , 10:06:02 hours
Time taken for first data logger to reach above 8 ° C : 21 Minutes
Time taken for all data loggers to reach above 8 ° C : 42 Minutes

7.    Summary of Operational Test 7.0 ; Temperature Recovery:

Power switched OFF  at : xxxxxxxxx , 11:36:02 hours
Time taken for first data logger to reach below 8 ° C : 33 Minutes
Time taken for all data loggers to reach below 8 ° C : 54 Minutes

Detailed report and graph of the mapping study are enclosed here

Related articles on Temperature mapping study
  1. Temperature mapping study and validation
  2. Guide on Temperature mapping study & Qualification
  3. Reasons for failure of mapping study of a cold room
  4. Difference between Temperature Mapping Study & Qualification
  5. Top 10 Checklist for Temperature & Humidity Mapping, Validation & Qualification of cold room, vehicle, warehouse, refrigerator
  6. Temperature Mapping & Qualification of Vehicles, Refrigerator, Cold Room, Ware house, Reefer
Posted in Temperature Mapping, Temperature Mapping & Validation, temperature qualification Tagged with: , , , , , , , , , , , , ,

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