Temperature Mapping Validation, Study and Qualification

VackerGlobal provides Temperature Mapping Study, Temperature Qualification and Temperature Validation for Cold Chain segments. These are applicable for Pharma and Food segments. We offer various tests & analysis for life sciences, pharmaceutical and food segments. We call these segments as cold chain systems. It involves the segments involved in the manufacture, storage and transportation of temperature-sensitive products.

What is Temperature Mapping Study, Validation & Qualification?

Temperature mapping study analyzes the distribution of temperature and humidity. This test is across the temperature-controlled area under various practical conditions. We carry out these tests to check the uniformity of the temperature within the area. This is applicable for cold rooms, warehouse, refrigerator and vans for transportation. These are for transportation and storage of medicines, vaccines and foods. Please see our video for a detailed understanding.

Assets which need Temperature mapping study, qualification & validation

We cover all the following categories of facilities. These are for storage and transportation of medicines, vaccines, food etc.:

1. Walk-in chillers and freezers for storage purposes.
2. Cold rooms for storage of medicines, typically between 2 to 8°C for medicines.
3. Warehouses for storage of medicines, typically between 15 to 25°C and under 65% RH.
4. Refrigerators for keeping medicines, vaccines etc.
5. Freezers for keeping plasma, medicines etc.
6. Vans and Reefer trucks for transportation of medicines, between 2 to 8°C or 15 to 25°C.
7. Autoclaves and stability chambers which have to generate controlled temperature and humidity.
8. Temperature stability chambers, Temperature & Humidity stability chambers.
9. Cool cells, Thermal boxes, Cold Stores etc. in Airports for Airport logistics for CEIV and IATA certification.

Procedure for Temperature Mapping Study & Temperature Qualification

We study the whole system under various conditions:

1. Empty condition without any loads inside the storage area.
2. The fully loaded condition with 100% loads within the storage area.
3. 60 to 70% loaded condition, in which the area will have loads up to 60 to 70% of the storage area.
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. We test the door opening conditions. This will establish the duration for door opening without affecting the interiors. We independently test all doors.
6. We carry out the startup verification process. This is to find out the duration required to achieve the desired cooling upon startup.

Please read more on Temperature Qualification

Protocol for Temperature Mapping Study, Temperature Qualification & Validation

We carry out the process of temperature mapping study as per the protocol. We issue this before the test for approval by the client. The protocol indicates various details of the assets and methods of various tests. In the protocol, we also consider the usual operating practices of the customer. We incorporate these aspects while carrying out the tests.

Suppose the customer always operates the vehicle at around 50 % load, In such a case, it is ideal that we carry out the test at 50% loaded condition also. Suppose we qualify a vehicle for 2 to 8 Degree Centigrade. This means that the entire storage area of the vehicle will remain within 2 and 8 Degree Celsius. This is subject to the current set of cooling unit, evaporator, sensor, controller etc.

Consider that we qualify a box for 2 to 8 Degree centigrade. This means that the box will remain within 2 and 8 Degree for a certain duration. So the customer should not keep the medicine for a longer duration. Also, we identify critical conditions such as the duration for which you can keep the door open. If there are any suggestions and corrective actions, we state the same in the final report. This process will qualify your Warehouse, Cold Room, Chiller, Vehicle or Boxes. This means that they are suitable for storage and transportation of Food & Medicine.

Temperature mapping study using Bluetooth & WiFi data loggers

In the conventional method of temperature mapping, we use normal data loggers to record the data. After the tests, we remove all data loggers and download the data. The disadvantage is that if there are excursions, we will not notice until we download the data. In the case of corrective actions, the customer has to undertake the corrective actions and carry out the complete test once again. This will result in huge expenditure on cost and time.

In order to overcome this problem, we can use wireless data loggers. We will be using wireless monitoring systems instead of data loggers. There are different types of wireless data loggers. We use Bluetooth data loggers for the same purpose. The data transmission is in real-time through a local server or a cloud-based server. We can monitor the data in real-time.

In the case of excursions of temperature or humidity, it can generate alerts. Upon receiving alerts, the customer can look for problems and can take corrective actions. We can start retesting upon completion of the corrective actions. The data loggers can remain in the same locations while undertaking corrective actions. Thus a huge amount of money and time can be saved in the process.

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

Software validation for temperature monitoring systems

We offer validation of software of temperature  & humidity monitoring systems. For many clients, there is a requirement to validate the software. We can do this after installation by the pharma distributor in their warehouse or cold room. We carry out such validation on software by different manufacturers. Also, we offer validation of software for the temperature tracking system for vehicles. Please see more on our services for software validation.

Video on Temperature mapping study & qualification

Other Products & Services by VackerGlobal:

1. 

   Temperature mapping of Thermal boxes

   Data Loggers for monitoring and recording of temperature and humidity.

2. Wireless, Real-time Temperature monitoring over the internet with Phone, Email and SMS alert.
3. Packaging products covering Thermal blankets, insulation sheets etc.
4. Insulated passive shipping boxes with gel packs.
5. Temperature mapping & Qualification of shipping packages & boxes.
6. Thermal Package testing for testing the thermal withstand capacity.
7. Thermal Profile study for understanding the thermal behaviour under different conditions.
8. Thermal equipment calibration and certification on a periodic basis.
9. Package Integrity testing to test the thermal behaviour of packaging materials.
10. Validation of software for temperature monitoring systems.
11. HVAC validation for Cold Chain warehouses and cold rooms.
12. Complete humidity control using dehumidifiers. We select the dehumidifiers as per the design calculation. We supply and install entire dehumidification systems for warehouses, cold storages etc.
13. Economic Walk-in cold stores for pharma and food storage.

Temperature Qualification

Temperature is a major parameter for qualifying equipment. But, this need not be the only parameter or the main parameter. This depends on the application and type of equipment. In the article, we explain about Temperature Qualification.

What is the Difference between the Mapping study and Qualification?

This is often a subject of confusion which we will like to clarify. In brief terms, qualification is a much more elaborate process than a mapping study. A mapping study only analyzes the distribution of temperature and humidity (if applicable). The result will show whether the distribution is uniform.

Mapping study is only one part of the qualification process. The qualification procedure has a lot of other verification and tests. These are to check whether the installation and operation of all the major equipment are as per specifications. Also, it will check whether they are capable of achieving and maintaining the temperature and humidity.

Suppose we qualify a cold room for 2-8 Deg Centigrade. This will mean that the entire cold room is capable of maintaining the temperature of 2-8°Celsius. All international pharmaceutical companies prefer their distributors to do qualification for critical assets. Such assets include cold rooms, vans, boxes etc.

Temperature qualification study of refrigerated vehicles

Temperature Qualification (and humidity if required) is a bit elaborate process than a mapping study. This involves mapping study as one part of the process. These series of tests are for any temperature and humidity sensitive areas. Temperature Qualification involves complete identification of entire equipment inside the enclosed area. These include chillers, sensors, evaporators, cooling units and dehumidifiers.

We carry out the study of the complete system under various conditions. In a qualification process, we check all major equipment including the cooling units. This includes checking of various parameters and records of this equipment. In a mapping study, we will be checking only the temperature distribution inside the area.

Assets and equipment which need Temperature Qualification

The following are some of the major assets for which the process is applicable and the temperature is one of the main factors:

1. Cold room for keeping medicine, vaccine, food, consumer goods etc.
2. Refrigerators for keeping medicines, vaccines.
3. Freezers below 0°C which keep vaccines, frozen food etc.
4. Cryo Freezers for keeping Cryogenic items.
5. Reefers, refrigerated trucks and vans for transporting medicines over long distances.
6. Vans for transporting medicines for local distribution.
7. Insulated Boxes which keep medicines under controlled temperature for a small duration such as 24 hours.
8. Thermal Insulated Containers which keep medicine with or without auxiliary power.
9. Stability chambers which have controlled temperature and humidity environment.
10. Humidity Chamber having a controlled humidity environment.
11. Incubators (Temperature & Humidity).
12. Clean rooms having controlled temperature, humidity and particle count.
13. Trailer and Trucks, Reefer trucks and refrigerated vehicles. These are for consumer goods, perishable items, FMCG, frozen food, fruits and vegetables.
14. Cool cells, Thermal pallets, thermal pallet covers etc. for Airports to handle medicines and vaccines for CEIV and IATA certification.

Temperature Qualification Process

The process involves a variety of tests as per our protocol specific to each equipment and client. Irrespective of model and type of the tested piece, we prepare the protocol for each device and we test each of them separately. You can see a sample protocol for the qualification process. The process involves the following procedures:

1. Design Qualification (DQ)

    

   The design of the equipment should be adequate to achieve the desired results. The results are not to be defined by the installed equipment. eg. A cold room should maintain a temperature of 2 to 8 Deg Celcius for keeping medicines. Here the desired result is that the temperature should always be within these limits. Hence all the installed equipment should be suitably designed to ensure the same.

2. Installation Qualification (IQ)

   This process involves various checking to test

   1. Verify that the calibration documents are valid for Various components.
   2. Ensure that the client maintains all equipment as per the recommendations of the manufacturer.
   3. Check the procedure to ensure that the client operates the equipment as per the recommended operational procedures of the manufacturer.

3. Operational Qualification (OQ)

   

   Temperature Qualification of Refrigerator

   This procedure involves checking all aspects affecting the operations of the equipment. In this, we check various controlling instruments of the asset. This is to ensure that it is possible to control the asset properly. eg. a Thermostat of a freezer is a controlling instrument. If it is not working properly, it will affect the operation of the asset.

   Temperature mapping study also is generally a part of the procedure.

4. Performance Qualification (PQ)

   The performance of the equipment varies as per the distribution and the type of material kept inside the area. Hence it is important to test the equipment under all such circumstances. The whole process will involve rigorous testing for extreme conditions to ensure the reliability of the same.
   

A typical protocol for Temperature Qualification

An example of a typical protocol  procedure is enclosed at this link: Download typical Protocol

Temperature & Humidity Qualification of a cold room

You may contact us for any specific protocol requirements of different authorities. Examples are SFDA temperature mapping protocol, NHS cold shipment validation protocol etc.

The temperature qualification process of the asset is complete if all the above tests and verification are successful. In such a case, we certify that the asset is suitable for the application. It is possible that a certain deviation or non-conformances happens during the processes. The client has to rectify this and we will carry out a retest. Upon completion of the retest, the process is complete.

Temperature Qualification using Wireless real-time data loggers

Normally we have been using normal data loggers for a qualification process. After conducting all the tests, we remove the data loggers and download the data. Upon analysing the data in our software, we find out whether all the tests were satisfactory. As you are aware there are a lot of tests in a qualification process. It involves the loading of goods by the client as well. If the results are not satisfactory after all these efforts, it will result in a huge loss of time and efforts.

In order to overcome this problem, we can use wireless data loggers for data collection. For small to medium cold rooms, we can use Bluetooth data loggers. These are real-time data loggers which transmit the data continuously to a cloud-based server. We can set alerts for temperature or humidity excursions. Thus we can take corrective actions if we find out any deviations during the test process. If corrective actions do not take a long time, the customer can carry out at the same time. Thereafter we can start the test process once again. This will save a lot of time and efforts.

Temperature mapping study and validation are mainly applicable to the pharmaceutical industry and food/FMCG industry. It helps us to analyze and ensure the uniformity of temperature distribution across all areas of the controlled areas under real-life conditions.

The necessity of Temperature Mapping study

Temperature mapping study is to test whether all areas of your asset maintaining the same temperature as per your requirement. Typically we require temperature mapping study for the following type of assets:

1. Warehouses normally between 15 to 25 Deg C.
2. Cold Room normally maintaining a temperature between 2 to 4 Deg C.
3. Walk-in Chillers or Freezers which will maintain a temperature below zero Degree up to -40 Deg C.
4. Refrigerators which keep medicines normally between 2 to 8 Deg C.
5. Cold Storage for food which may have different temperature ranges.
6. Autoclaves which maintain particular temperature ranges.
7. Humidity chambers which maintain a particular range of humidity.
   

   Temperature mapping study results

8. Refrigerated Vehicle, Van & Reefers which maintain a temperature range such as 2 to 8 Deg C for medical transportation.
9. Thermally insulated passive boxes which maintain temperature for a certain duration.
10. Active refrigerated boxes which are small refrigerators.

We carry out the analysis by analyzing the data under real-time operating conditions. For carrying out a temperature mapping study, we place numerous data loggers in the area. They record the data continuously for a couple of days. We mark the location of such data loggers in a 3D drawing. This will become part of the report.

All operations like loading, unloading, forklift movement etc. will happen as normal. We record all such actions to the extent possible. We analyze all such data and prepare analysis and graphs. Thus we analyze the temperature uniformity across the entire area. We will compare any abnormal variations with the real-time operations that happened at those particular times. We identify hot spots and cold spots in this study and we recommend corrective actions.

Temperature & Humidity Mapping Study

For certain assets, you have to maintain humidity within permitted levels. eg. DHA, Dubai specifies that warehouses storing medicines should maintain humidity below 65% RH. In this case, we have to test the distribution of humidity also along with the temperature. Hence we call it as Temperature & Humidity Mapping study.

We have to carry out the temperature study at least in two climatic conditions ie. Summer and winter. This will provide a detailed analysis of the area across various climatic conditions.

Results of the Temperature Mapping Study

Apart from certification, various recommendation including the following will form part of the report:

1. Are there any hot spots in the enclosed area?  Are they rectifiable? If not, we have to isolate this area. Thus the client does not store sensitive items in this area.
2. If power fails how long the area is safe for the stored goods? This testing helps the customer to understand the required actions in case of a power failure.
3. We can decide the location for placing your Sensors or recording instruments for continuous monitoring.
4. How many people and machinery can occupy the area simultaneously?
5. Any difference in behaviour in Summer and Winter?

Identifying Hot spots and cold spots in a Warehouse, Cold room, walk-in freezer etc.

We determine hot spots and cold spots of the area from the results of the temperature mapping study. As the name indicates, a hot spot means the hottest point inside the area. The cold spot is the coldest recorded point. After identifying the hot spot and cold spot, the client has to install continuously monitor these points using real-time temperature monitoring systems.

What is the difference between Temperature Mapping Study and Validation?

Temperature Mapping study is the study and analysis as explained above. This will provide a detailed analysis report for your enclosed area. This report provides confidence that the area is capable of maintaining the correct temperature.

Validation is mainly applicable to various systems used for controlling and monitoring of the controlled area. Validation of Electronic recording systems is as per 21 CFR part11. This is the process of Validation. The mapping study also may be part of the whole process. The electronic instruments should be as per the international regulations such as 21 CFR Part 11.

Temperature mapping study is known as Thermal mapping study and Temperature validation is known as Thermal validation as well.

What is 21 CFR Part 11?

In general terms, this stipulates compliance of the electronic recording instruments. This is applicable to all manufacturers and distributors of medicines, vaccines and related products.

For life sciences, this refers to the recording of various critical data through all stages of manufacture, storage and distribution of goods so that all recorded data is accurate.

Please see our detailed article on the same: What is 21 CFR Part 11

Related Articles:

1. What is the difference between Qualification and validation in the cold chain?
2. Validation protocol for wireless temperature monitoring
3. Difference between Temperature Mapping Study & Qualification
4. Temperature mapping study and validation
5. Guide to Temperature mapping study & Qualification
   
6. Difference between Temperature Mapping Study & Qualification
7. Top 10 Checklist for Temperature & Humidity Mapping, Validation & Qualification of the cold room, vehicle, warehouse, refrigerator
8. Temperature Mapping Study – Pharmaceutical industry
9. Temperature Mapping & Qualification of Vehicles, Refrigerator, Cold Room, Warehouse, Reefer
10. Temperature mapping study for the FMCG industry
11. Importance of Temperature mapping study in the Middle East
12. What is 21 CFR Part 11?

Case Studies:

1. Case study: Temperature mapping study and qualification of a cold room in Saudi Arabia
2. A case study on a cold room used for storage of medicines can be downloaded at this link: Case study – Medicine room 

Description of services under this category:

1. 1. Service Type: Temperature Mapping Study, qualification & Validation
   2. Areas Served: The United States of America, United Kingdom, Germany, France, The United Arab Emirates, Saudi Arabia (Riyadh, Jeddah, Dammam, Jubail), Qatar, Oman, Bahrain, Kuwait, Kenya, Tanzania, Ethiopia, Rwanda, Uganda, Egypt, Jordan, Lebanon, India, Pakistan.
   3. Service Offer: Temperature Mapping Study, Humidity Control Solutions, Combined Monitoring Systems for Warehouse/Vans/Boxes, Supply & Installation of certified Walk-In Cold Stores.
   4. Provider Name: VackerGlobal, 92438, Deira, Dubai, United Arab Emirates. Tel: +97142661144
   5. Service Description:
      1. Temperature mapping study, Temperature qualification & Temperature validation of warehouses.
      2. Temperature mapping study, Temperature qualification & Temperature validation of walk-in cold rooms.
      3. Temperature mapping study, Temperature qualification & Temperature validation of walk-in freezers.
      4. Temperature mapping study, Temperature qualification & Temperature validation of reefer trucks, refrigerated vans.
      5. Temperature mapping study, Temperature qualification of passive and active thermal insulated boxes.
      6. Temperature validation of passive and active thermal insulated boxes.
      7. Temperature mapping study, Temperature qualification & Temperature validation of autoclaves.
      8. Temperature & Humidity mapping study, Temperature & Humidity qualification of warehouses.
      9. Temperature & Humidity validation of warehouses.
      10. Temperature & Humidity mapping study, Temperature & Humidity qualification of walk-in cold rooms.
      11. Temperature & Humidity validation of walk-in cold rooms.
      12. Temperature & Humidity mapping study, Temperature & Humidity qualification of walk-in freezers.
      13. Temperature & Humidity validation of walk-in freezers.
      14. Temperature & Humidity mapping study, Temperature & Humidity qualification of reefer trucks, refrigerated vans.
      15. Temperature & Humidity validation of reefer trucks, refrigerated vans.
      16. Temperature, Humidity mapping study, Temperature/Humidity qualification of passive and active thermal insulated boxes.
      17. Temperature & Humidity validation of passive and active thermal insulated boxes.
      18. Temperature & Humidity mapping study, Temperature & Humidity qualification of autoclaves.
      19. Temperature & Humidity validation of autoclaves.
      20. Temperature & Humidity mapping study, Temperature & Humidity qualification of clean rooms.
      21. Temperature & Humidity validation of clean rooms.

FAQ on Temperature Mapping study, Temperature qualification and Temperature validation for Cold Chain Management

1. What is a temperature mapping study or a thermal mapping study? Temperature or thermal mapping study is a series of tests on assets used for storage and transportation of medicines, vaccines etc. Typical assets are warehouses, walk-in cold rooms, refrigerators, refrigerated vehicles etc. The purpose of the study is to ensure and certify that all storage and transportation methods are capable of maintaining the specified temperature for medicines and vaccines.
2. What is temperature qualification study? Temperature qualification study is a set of tests and inspections to ensure that cold rooms, vans etc. are suitable for maintaining the specified temperature for medicines and vaccines. This is especially for medicines between 2 to 8°C. In addition to temperature mapping study, all individual temperature control pieces of equipment are tested and verified. Hence a thermal qualification study is more stringent than mapping study.
3. Which assets require thermal mapping study and which ones require qualification study? As a thumb rule, storage facilities such as a warehouse for normal non-critical medicines require only temperature mapping study. All other assets including cold storages, refrigerated vans etc. require a qualification study. However, this also depends on your regulatory authorities as well as the requirements of your medicine manufacturer.
4. What is the validity of a temperature mapping study or qualification study? This depends on various parameters including the age of the HVAC equipment. If the assets are new, the study has to be repeated once every 3 years. For new vehicles with normal running hours, you may do the tests once every 2 years. However, if the vehicles are meant for continuous usage, it is recommended to have the tests once every year. This also depends on regulatory bodies and medicine manufacturers.
5. Is humidity important in a temperature mapping study? For many medicines, humidity is an important storage parameter. Your medicine manufacturer generally specifies the required humidity levels. In most of the cases, the humidity should be below 65% RH. If the humidity limit is a condition for your medicines, you should include humidity also in the mapping study or qualification.
6. How to reduce humidity for a temperature mapping study? If humidity is important for your medicines, you will have to control the humidity. In order to reduce the humidity, you have to use a dehumidifier.
7. How to decide the locations & number of temperature recorders in a warehouse, cold store or refrigerated vehicles? The mapping study report will indicate hot and cold points. This is from the recordings collected during the temperature mapping study. You have to place the continuous recording and alert system at these points. This is mainly for storage and transportation of medicines and vaccines.

Reference documents:

1. WHO standards on Good Distribution Practices for Pharmaceutical Products.
2. FDA standards 21 CFR Part 11 for electronics recorders.

Please contact the nearest office of VackerGlobal for all your requirements on Temperature Mapping Study, Thermal Validation, Qualification Study etc.