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Difference between Temperature Mapping study & Temperature Validation for Ware house, cold room, refrigerator, reefer, freezer, vehicle etc.

Difference between Temperature mapping and validation | United Arab Emirates

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Vacker Group carries out Temperature Mapping and Validation Study across all Middle East countries including UAE, Saudi Arabia, Kuwait, Qatar, Oman, Bahrain, Iraq, Jordan, Lebanon and India. Also we provide various Temperature Monitoring Devices and Solutions such as data loggers, software, recorders etc. for all type of Industrial and Commercial applications. We are Authorized distributor for Cryopak, USA for their various products including the data loggers marketed under the brand name Escort What is Temperature Mapping Study? We have already explained in detail about Temperature mapping study in another video for which you can click on the link at the bottom of this screen In a nutshell this is a detailed study of your temperature controlled areas such as ware house, cold room, vehicle, chiller room, refrigerator etc. to analyze whether the temperature across the entire area remains within the permitted levels under all operating conditions. The study will be carried out in different climatic conditions of a year to ascertain uniformity. The result of a temperature mapping study is a report indicating numerous readings and graphs and recommendations. What is Temperature Validation Study? There is a misconception that Temperature mapping study and validation study are the same. However the fact is that Temperature mapping study does not include validation, but validation includes temperature mapping. The mapping study can be carried out by any party and even by the customers for their own facilities. However the test results are not considered to be a certification and hence may not be acceptable internationally to various other parties involved in the cold chain including manufacturers of the medicines, your suppliers and customers. However the validation process is carried out to meet the requirements of International regulations such as 21 CFR Part 11. This regulation requires that Drug makers, Biotech manufacturers, Distributors etc. should implement controls, including audits & system validations The customer has no means to check the credentials of the Mapping Study including: Is the study done as per procedure approved by any third party? Are the results of the study accurate? Are the recommendations of the study accurate? Will the test report be acceptable to your suppliers and customers? However a validation process is as per International regulations and is widely accepted The result of Validation Study is a certification which is internationally valid. Such a Certification can be issued only after a Temperature Validation study is carried out by internationally accredited companies Vacker Group (carries out Temperature Mapping and Validation services. The Validation is carried out by internationally accredited companies associated with Vacker Vacker Group provides these services in the entire Middle East countries including United Arab Emirates, Kuwait, Oman, Qatar, Kingdom of Saudi Arabia, Iraq and Jordan

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Page 1: Difference between Temperature mapping and validation | United Arab Emirates

Difference between Temperature Mapping study & Temperature

Validation for

Ware house, cold room, refrigerator, reefer, freezer, vehicle etc.

Page 2: Difference between Temperature mapping and validation | United Arab Emirates

About us:About us:Head quartered in Dubai, UAE

Activities:1. Automation

2. Temperature Monitoring Products, Services & Solutions

Operates: UAE, KSA, Kuwait, Qatar, Oman, Bahrain, Iraq & India

Authorized Distributor for Cryopak, USA (www.cryopak.com)

Page 3: Difference between Temperature mapping and validation | United Arab Emirates

If you are involved in manufacture, storage or transportation of temperature sensitive products, please contact us for a free

consultation

[email protected]@[email protected]@vackerglobal.com

[email protected]@[email protected]@vackerglobal.com

Page 4: Difference between Temperature mapping and validation | United Arab Emirates

This has been already explained in detail in another youtube video for which you can click on the link at the bottom of this screen

What is Temperature Mapping Study?

Page 5: Difference between Temperature mapping and validation | United Arab Emirates

In a nutshell this is a detailed study of your temperature controlled areas such as ware house, cold room, vehicle, chiller room, refrigerator etc. to analyze whether the temperature across the entire area remains within the permitted levels under all operating conditions.

What is Temperature Mapping Study?

Page 6: Difference between Temperature mapping and validation | United Arab Emirates

The study will be carried out in different climatic conditions of a year to ascertain uniformity.The result of a temperature mapping study is a report indicating numerous readings and graphs and recommendations.

What is Temperature Mapping Study?

Page 7: Difference between Temperature mapping and validation | United Arab Emirates

There is a misconception that Temperature mapping study and validation study are the same. However the fact is that Temperature mapping study does not include validation, but validation includes temperature mapping.

What is Temperature Validation?

Page 8: Difference between Temperature mapping and validation | United Arab Emirates

What is Temperature Validation?

certification and hence may not be acceptable internationally to various other parties involved in the cold chain including manufacturers of the medicines, your suppliers and customers.

The mapping study can be carried out by any party and even by the customers for their own facilities. However the test results are not considered to be a

Page 9: Difference between Temperature mapping and validation | United Arab Emirates

What is Temperature Validation?However the validation process is carried out to meet the requirements of International regulations such as 21 CFR Part 11.

This regulation requires that Drug makers, Biotech manufacturers, Distributors etc. should implement controls, including audits & system validations

Page 10: Difference between Temperature mapping and validation | United Arab Emirates

The customer has no means to check the credentials of the Mapping Study including:a. Is the study done as per procedure approved by any third party.b. Are the results of the study accurate.c. Are the recommendations of the study accurate?d. Will the test report be acceptable to your suppliers and customers?However a validation process is as per International regulations and is widely accepted

What is Temperature Validation?

Page 11: Difference between Temperature mapping and validation | United Arab Emirates

The result of Validation Study is a certification which is internationally valid. Such a Certification can be issued only after a Temperature Validation study is carried out by Internationally accredited companies

What is Temperature Validation?

Page 12: Difference between Temperature mapping and validation | United Arab Emirates

Vacker Group carries out Temperature Mapping and Validation services. The Validation is carried out by Internationally accredited companies associated with Vacker

Page 13: Difference between Temperature mapping and validation | United Arab Emirates

Vacker Group provides these services in the entire Middle East countries including United Arab Emirates, Kuwait, Oman, Qatar, Kingdom of Saudi Arabia, Iraq and Jordan

Page 14: Difference between Temperature mapping and validation | United Arab Emirates

This whole study will give you This whole study will give you certification that your Ware house, certification that your Ware house, Cold Room, Chiller, Vehicle etc. are Cold Room, Chiller, Vehicle etc. are safe for storage / transportation of safe for storage / transportation of

Food, Medicine etc.Food, Medicine etc.Please contact us for a free Please contact us for a free

[email protected]@vackerglobal.com

[email protected]@[email protected]@vackerglobal.com

[email protected]@vackerglobal.com

Page 15: Difference between Temperature mapping and validation | United Arab Emirates

Other Services:Other Services:Real Time Monitoring & Recording with AlertThis is for warehouses, cold rooms, chiller rooms etc.Features:•Computer connectivity is not essential•8000 recordings on the device•Web based free software. Any number of devices across different locations can be connected•Full battery back up•Phone call/SMS/Email alert to 8 operators if temperature exceeds limits •Power failure, Water leakage, Compressor failure etc. can be connected to Phone call alert•Operated with SIM cardPlease see video channel :Please see video channel : http://www.youtube.com/vackerglobal http://www.youtube.com/vackerglobal

Page 16: Difference between Temperature mapping and validation | United Arab Emirates

Other Services:Other Services:USB type Data Logger (disposable/reusable)These are for transportation of food, medicines etc.Features:•4 temperature alarm limits can be

programmed•4 LEDs will indicate whether the

temperature has crossed the limits•8000 readings•‘Start’ and ‘Stop’ buttons for recording•pdf report generated upon inserting into a computer. No software required.•Reports available in pdf, Excel & text formatsPlease see video channel:Please see video channel:http://www.youtube.com/vackerglobalhttp://www.youtube.com/vackerglobal

Page 17: Difference between Temperature mapping and validation | United Arab Emirates

Other Services:Other Services:Temperature recorder with printer for vehiclesThese are for printing reports from the vehicle itselfFeatures:•30,000 readings can be stored•Computer connection not required

except for data download.•Can be mounted in the cabin and

sensors drawn to the freezer compartment•Alert levels can be programmed•Powered by 12 V Battery of the vehicle•Oldest data will be automatically erased when memory full

Page 18: Difference between Temperature mapping and validation | United Arab Emirates

Other Services:Other Services:Temperature & Humidity recorder with displayThese are for warehouses, cold rooms as well as for transportation.Features:•4 Programmable threshold limits•4 LEDs will indicate whether the temperature/humidity crossed the limits•High, Low and average readings will be shown on screen•IP Rating : IP65•Single use and Multiuse models are available

Page 19: Difference between Temperature mapping and validation | United Arab Emirates

Other Services:Other Services:Egg Shaped Data LoggerThis data logger is for monitoring during storage, transportation and incubation of Eggs. Features:•Memory : 16,000 readings•Range : -20° C to +60° C•Interval: 5 seconds to 255 minutes

Page 20: Difference between Temperature mapping and validation | United Arab Emirates

www.vackerglobal.comwww.temperaturemonitoringuae.com

Corporate Office:Suite 306, RKM BuildingNext to Al Qiyada Metro StationHor Al Anz, DeiraDubaiUnited Arab EmiratesTel: +971 42 66 11 44Fax: +971 42 66 11 55Email : [email protected]