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