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www.temperaturemonitoringuae.com
Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal Group
Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 11 55 Our offices : UAE (Corp. Office), India, Oman , Kuwait, USA
email:sales.uae@vackerglobal.com www.vackerglobal.com
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 summer. 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,reefers
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
www.temperaturemonitoringuae.com
Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal Group
Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 11 55 Our offices : UAE (Corp. Office), India, Oman , Kuwait, USA
email:sales.uae@vackerglobal.com www.vackerglobal.com
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. Hence 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
at our website
Case Study : Mapping Study and Qualification of Reefer truck
Project Code of Vacker
LLC Xxxxxxxxxxxxxxx
www.temperaturemonitoringuae.com
Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal Group
Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 11 55 Our offices : UAE (Corp. Office), India, Oman , Kuwait, USA
email:sales.uae@vackerglobal.com www.vackerglobal.com
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. Hence 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
at our website
Case Study : Mapping Study and Qualification of Reefer truck
Project Code of Vacker
LLC Xxxxxxxxxxxxxxx
www.temperaturemonitoringuae.com
Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal Group
Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 11 55 Our offices : UAE (Corp. Office), India, Oman , Kuwait, USA
email:sales.uae@vackerglobal.com www.vackerglobal.com
Test was carried out as per summary indicated above. All results were satisfactory. Brief details are as
under:
Summary : 2- 8 Deg C 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 noon
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:
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
www.temperaturemonitoringuae.com
Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal Group
Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 11 55 Our offices : UAE (Corp. Office), India, Oman , Kuwait, USA
email:sales.uae@vackerglobal.com www.vackerglobal.com
Detailed report and graph of the mapping study are available at our website
Please read more:
http://www.temperaturemonitoringuae.com/services/temperature-mapping-validation/cold-
chain-temperature-mapping/
http://www.temperaturemonitoringuae.com/services/temperature-qualification/

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Importance of Temperature mapping study in the Middle East

  • 1. www.temperaturemonitoringuae.com Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal Group Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 11 55 Our offices : UAE (Corp. Office), India, Oman , Kuwait, USA email:sales.uae@vackerglobal.com www.vackerglobal.com 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 summer. 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,reefers 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
  • 2. www.temperaturemonitoringuae.com Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal Group Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 11 55 Our offices : UAE (Corp. Office), India, Oman , Kuwait, USA email:sales.uae@vackerglobal.com www.vackerglobal.com 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. Hence 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 at our website Case Study : Mapping Study and Qualification of Reefer truck Project Code of Vacker LLC Xxxxxxxxxxxxxxx
  • 3. www.temperaturemonitoringuae.com Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal Group Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 11 55 Our offices : UAE (Corp. Office), India, Oman , Kuwait, USA email:sales.uae@vackerglobal.com www.vackerglobal.com 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. Hence 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 at our website Case Study : Mapping Study and Qualification of Reefer truck Project Code of Vacker LLC Xxxxxxxxxxxxxxx
  • 4. www.temperaturemonitoringuae.com Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal Group Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 11 55 Our offices : UAE (Corp. Office), India, Oman , Kuwait, USA email:sales.uae@vackerglobal.com www.vackerglobal.com Test was carried out as per summary indicated above. All results were satisfactory. Brief details are as under: Summary : 2- 8 Deg C 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 noon 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: 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
  • 5. www.temperaturemonitoringuae.com Vacker LLC l PO Box 92438 l Dubai l UAE Part of VackerGlobal Group Phone : (+971) 4 2 66 11 44 l Fax : (+971) 4 2 66 11 55 Our offices : UAE (Corp. Office), India, Oman , Kuwait, USA email:sales.uae@vackerglobal.com www.vackerglobal.com Detailed report and graph of the mapping study are available at our website Please read more: http://www.temperaturemonitoringuae.com/services/temperature-mapping-validation/cold- chain-temperature-mapping/ http://www.temperaturemonitoringuae.com/services/temperature-qualification/