We offer the services of temperature mapping study and Temperature qualification study for temperature-controlled assets such as warehouses, cold storage rooms, cool cells, reefer trucks, vans, thermally insulated boxes etc. used for storage and transportation of medicines and vaccines. We offer our services for the pharmaceutical and food industry, Logistics, medicine distribution, Air cargo and 3PL segments. We offer all variations of these tests such as temperature stability study, temperature validation study, temperature & humidity mapping & qualification etc.
This article explains the procedures and guidelines used by us for our services of temperature mapping study, Temperature qualification study and thermal validation.
There are different kinds of medicines and vaccines, which we store and transport under controlled temperatures. The majority of these medicines and vaccines are under two categories viz. Those, which require storage between 2 to 8 Degree Centigrade, and those stored between 15 to 25°C. Also, there are many vaccines that need storage in sub-zero freezers.
For the efficacy of medicine, it is important that we have to store and transport the goods at the recommended temperature limits. If the medicine or vaccine goes above these temperature limits, it loses the medicinal properties. More importantly, the products will not show any indication of this degradation. In such cases, the ultimate distributor and user will be unaware of the efficacy of the medicine.
We are discussing the medicines generally stored in warehouses, cold rooms, or refrigerators. And we transport the same in boxes, vans, reefers, and containers.
The whole set of study is to analyze the temperature distribution in a warehouse, cold room, refrigerator, active boxes, passive boxes, van or reefer trucks. This to find out whether the temperature inside such a facility is always under the specified temperature levels.
Table of Contents (TOC)
- Temperature Mapping Study / Temperature & Humidity Mapping study
- Temperature Mapping Study / Temperature distribution analysis
- What is the temperature and humidity mapping study?
- Documentation required prior to commencement of a mapping study
- What is Protocol or SOP for a mapping study?
- What are the acceptance criteria for the mapping study?
- How to decide the sampling interval of data collection for the mapping study?
- How to use the results of the temperature mapping study?
- Temperature mapping study / Temperature & Humidity mapping study for various assets
- What are the tests for temperature mapping study of Reefer trucks & vans?
- What are the tests for temperature mapping study of a warehouse?
- Temperature mapping study of Cold room
- What are the tests for temperature mapping study of a refrigerator?
- What are the tests for temperature mapping study of a shipping box?
- What are the reports generated in the Temperature Mapping study?
- What is the Temperature Qualification study? (or Temperature & Humidity Qualification study)
- What is the difference between the Temperature mapping study and a Temperature qualification study?
- How to decide whether you need a Temperature Mapping study or a Temperature Qualification Study?
- Do you require a Temperature qualification study or Temperature and humidity qualification?
- What are the advantages of a Temperature qualification study over a mapping study?
- Documentation required prior to commencement of a qualification process
- Reports of a Temperature qualification study
- How to carry out a temperature qualification study for storage and transportation of medicines and vaccines?
- Reasons for failure of a Mapping study
- Reasons for failure of a Qualification study
- How to improve the results of the test and eliminate chances of failure?
- What is Thermal Validation? What is the difference from Qualifications?
- Documents related to Mapping study & Qualification
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Temperature Mapping Study / Temperature & Humidity Mapping study
This article briefs about mapping study for Temperature & Humidity.
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Temperature Mapping Study / Temperature distribution analysis
Firstly we will explain about temperature mapping study and thereafter about temperature & humidity distribution.
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Why would you require a Temperature Mapping Study (aka Temperature Distribution study)?
This is for warehouses, cold rooms, vehicles, refrigerators etc. for storage and transportation of medicines, vaccines etc. These are a series of tests to ensure and certify that the temperature distribution inside the area is within the specified limits at all times. Also from the study, you will be able to identify any weak areas. The study also indicates the location and number of temperature recorders for the asset.
If you are into the manufacturing, transportation, storage, or distribution of medicines and vaccines, you would like to know more about the temperature mapping study. In all these cases you store your medicine inside an enclosed temperature-controlled area. These include warehouse, cold room, temperature-controlled van, reefer truck, refrigerator, insulated boxes, etc.
In such cases, you need to ensure that the temperature inside the enclosed area is within the desired limits. eg. you want to keep the medicine between 2 to 8 °C and you are keeping inside a cold room. How do you ensure that the entire cold room is between these temperature limits? You might be keeping the medicine at one shelf inside the cold room. You will not have any idea whether this particular place is within the limits. Generally, you will have a temperature display unit in front of the cold room. This display unit takes the reading from a sensor placed inside the room. This display picks up the temperature just from one sensor placed at a certain location at any place probably near the return duct. Also, the cooling unit may have its switch ON and OFF cycles based on this temperature. This might be indicating a temperature between 2 and 8 °C. Most of us tend to believe that this displayed temperature is the temperature across the entire cold room.
However, visualize various shelves and corners of the cold room. This is around the entire room and of course far away from this particular sensor. How do you know that your medicine is a particular shelf is within the temperature limits?
How does a third party like an auditor can check whether the entire cold room is under the correct temperature?
How can you ensure that the display at the front door is exact in relation to the corresponding sensor?
How do you know about the variations when a door is opened?
The sensor might be far away from the door and hence may not reflect any variation. However, it really happens that the area near the door suddenly goes above 8°C. You would like to know the ideal duration for which you can keep a door opened. This will help you to write a proper Standard Operating Procedure (SOP).
We can evaluate all these factors only through a temperature mapping study.
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How do we carry out a temperature mapping study?
In principle, a temperature mapping study involves recording the temperature of the cold room, warehouse, or any such asset under various conditions. We have to collect the data for days or weeks as per the nature of the asset. The vendor who carries out the mapping study places numerous temperature data loggers inside the testing area to record the data continuously. Depending on the nature of the property, they have to test for the following conditions:
- Testing under empty conditions to analyze the distribution of temperature when there are no loads in the area. This may not be possible at all times, since you may not be able to remove the loads from a warehouse or cold room. However, for a new property, it is ideal to carry out this test. For vehicles, it is important to do an empty test.
- Testing under 60% loaded condition to analyze the distribution when the area is loaded up to 60% of full capacity. You can decide any other loaded condition such as 70%, 80%, etc. depending on your normal usage. Eg. If your cold room always loaded to almost 80%, you may do a test at this condition.
- Testing under 100% loaded condition to analyze the distribution when the area is loaded in full capacity.
- Door opening test to understand the effects on temperature during and after a door opening. You may carry out for different duration such as door opening for 1 minute, 3 minutes, 5 minutes, 10 minutes, etc.
- Power failure test to analyze the effects in the event of a power failure. The main purpose of this test is to find out how long you can keep the medicines inside the area in case of a power failure.
- Startup test to check the time required for stabilizing the temperature inside the area. This is especially important for vehicles.
- Recovery test to check the time taken for temperature recovery after a door opening.
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What is the temperature and humidity mapping study?
The methodology is the same as a temperature mapping study. However, in this case, we are analyzing humidity distribution as well. This is especially important if you are storing goods that specify a certain humidity level. Eg. Many pharmaceutical manufacturers specify that the storage area should have a maximum humidity level of 65%. In such a case, you need to study humidity distribution. The acceptance criteria will be that humidity does not exceed 65%.
If you have already installed dehumidifiers to control humidity, the vendor has to note the settings of the same to compare against the actual results. Nowadays for many of the storage areas, humidity also is important and hence we recommend Temperature & Humidity distribution for such areas.
If you find that the humidity is above the required limits, you may have to install dehumidifiers. We will have to carry out a repeat mapping study after the installation of dehumidifiers.
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Do you require a temperature mapping or temperature & humidity mapping?
As mentioned earlier, this needs to be decided by the manufacturer of the medicines or as per your internal quality policy. For a warehouse, generally, it is preferred that humidity also be included in the study. External ambient conditions directly affect a warehouse. For a cold room, the humidity can go to extremely high levels of up to 100% because of its nature of the operation. Generally, the door of the cold room opens to a warehouse which is at a higher temperature. Since the cold room is at a lower temperature, it will attract the moisture and hence will always have higher humidity. Hence irrespective of the medicine being kept in the cold room, it is ideal that the cold room is analyzed for humidity as well. However, you can decide this based on the goods that you are storing in the area.
We generally recommend temperature and humidity mapping study for warehouses and cold rooms. For vans, reefers, refrigerators, and boxes, only a temperature mapping study is sufficient unless otherwise specified. For reefers, vans, and refrigerators it is difficult to control the humidity. You cannot install a dehumidifier as well. Hence, even if you carry out a humidity mapping study you may not be able to implement any methods to reduce the humidity.
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What is the recommended humidity level for the storage of medicines?
This generally depends on the type of medicine and the packaging being kept in the storage area either for a cold room or warehouse. Hence this is generally recommended by medicine manufacturers. Generally, most of the manufacturers are recommending that the humidity should be maintained under a maximum limit of 65% under all conditions.
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How to reduce the humidity for cold rooms and warehouses for medicine storage?
You may have to use a dehumidifier to reduce humidity levels. These are electrical devices that absorb humidity from the air and convert it into water. We can drain the water manually or automatically. In the automatic method, there is a drainage pipe for removing the water from an external outlet. In the manual method, a tray collects the water and we have to empty the tray periodically.
In order to decide the capacity of dehumidifiers, special calculations are required. We require details such as present temperature, humidity, desired humidity, size of the room, etc. You may contact us for free assistance for this calculation.
Generally, for warehouses, desiccant type, and for cold rooms, rotary type dehumidifiers have to be used.
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Documentation required prior to commencement of a mapping study
The customer has to provide the layout drawing of the asset including details and locations of cooling units and dehumidifiers if any. The drawings should include the racks.
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What is Protocol or SOP for a mapping study?
A Protocol or SOP for temperature mapping study is a detailed set of procedures. This will be different based on the type of asset, size of the asset, country, etc. We carry out the entire sequence of test procedures as per this protocol.
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What are the acceptance criteria for the mapping study?
The results of the distribution study will be either pass or fail. Also, it can fail or pass with some deviations. We define the criteria for acceptance of the study in the protocol before the commencement of the tests. Typical criteria defined in the protocol are listed below:
- All readings of the individual data loggers should be within 2 to 8°C during the entire test, except for 30 minutes after a door opening.
- Mean Kinetic value should be within desired limits (We do not encourage this criterion unless insisted by the client. However we will indicate the value in our reports)
- During door opening tests, the values should be within limits and should return to normalcy within 30 minutes after closing the door.
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How to decide the sampling interval of data collection for the mapping study?
Sampling interval is the frequency of data recording of the data loggers. This is as per the type of the asset and the temperature range. The sampling interval is the frequency of data recording of the data loggers. Generally, programming options are available in the data loggers for intervals such as 10seconds, 30 seconds, 1 minute, etc. If the sampling interval of a temperature data logger is 5 minutes it means that the temperature is recorded every 5 minutes.
The sampling interval of data collection should be kept ideally as follows for a temperature mapping study:
- 3 minutes for 2-8 °C assets such as cold rooms, vehicles, boxes, refrigerators, etc.
- 5 minutes for 15-25°C vehicles.
- 5 minutes for warehouses maintained at 15-25 °C
This is mainly based on the goods to be stored inside the asset. Eg. If a medicine that should not go above 8°C for 2 minutes is stored inside a refrigerator, it means that you should keep a sampling interval of at least 1 minute. For medicine that is permitted to go above 8°C for 10 minutes, a sampling interval of 3 minutes is sufficient.
This also depends on the range of temperatures. 2-8 °C is a very narrow range and can go above this range even for minor fluctuations. Hence ideally a sampling interval should not be more than 3 minutes.
For a warehouse, 15-25 °C is a wider range and the rise in temperature will be slow. Hence, a sampling interval of 10 minutes also might be sufficient. However, we generally use 5 minutes intervals.
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How to use the results of the temperature mapping study?
From the summary of the reports of a temperature mapping study, we will be able to understand the behavior pattern of the asset. Examples are the time for which we can open the door. Another example is the duration for which the medicines can be safe in the event of a power failure. The following details will be useful for your practical applications
- We will identify hot and cold points. You have to place your continuous monitoring devices at these Hot and cold points.
- The report will indicate the duration within which the temperature will exceed the permitted levels upon the door opening. eg. if such duration is 5 minutes, you should take care that the door opening should be a maximum of 5 minutes. You can include the same in your Standard operating procedure (SOP).
- The report will indicate the duration within which the temperature will exceed the permitted levels in the event of power failure. So in case of a power failure, you should not open the door and should be in closed condition if you expect that power will be restored within such a duration. If you do not expect power restoration within such a duration the medicines should be shifted to an alternate facility such as a temperature-controlled van or reefer.
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Temperature mapping study / Temperature & Humidity mapping study for various assets
Brief details of the study for various kind of assets are detailed hereunder
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What are the tests for temperature mapping study of Reefer trucks & vans?
We recommend the distribution analysis, power failure test, door opening test, and start-up test for all types of vehicles.
- Distribution analysis under empty conditions (24 hours).
- Distribution analysis under 60% loaded conditions (24 hours).
- Distribution analysis under full load conditions (24 hours).
- Power failure test.
- Door opening test.
- Start-up test.
Small vans are for local distribution and generally, the maximum journey is for 8-10 hours. For such vans, the duration of empty and loaded tests will be 12 hours instead of 24 hours. However, reefer trucks are for longer journeys and hence we recommend at least 24 hours of each test. The idea is to test under normal operating conditions.
The client can decide the percentage loading as per his usual loading pattern.
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What are the tests for temperature mapping study of a warehouse?
For a warehouse, temperature and humidity distribution and door openingpatterns are carried out as part of a temperature mapping study.
- Temperature and humidity distribution analysis are carried out under loaded conditions.
- Door opening tests to analyze the effects.
For an existing warehouse, it will be difficult to carry out other tests such as empty tests, power failure tests, etc. since it may be difficult to remove the existing goods from the warehouse. For a warehouse, the distribution analysis is carried typically for 7-14 days. The tests should also include holidays so that the patterns can be analyzed.
The sampling interval of data collection should be kept ideally at 5-10 minutes.
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What are the tests for temperature mapping study of Cold room for medicine storage?
For all type of cold rooms, we recommenddistribution analysis, power failure test, dooropening test, recovery tests and start up tests.The details are as below:
- Distribution analysis under empty conditions (24 hours).
- Distribution analysis under 60% loaded conditions (24 hours).
- Distribution analysis under full load conditions (24 hours).
- Power failure test.
- Door opening test for different durations such as 1 minute, 3 minutes, 5 minutes and 10 minutes.
- Recovery tests.
The percentage loading can be decided by the client as per his usual loading pattern. The sampling interval will be generally kept at 3 minutes.
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What are the tests for temperature mapping study of a medical refrigerator?
For medical refrigerators, we recommend distribution analysis, power failure test, and door opening test. The details are below:
- Distribution analysis under empty conditions (24 hours).
- Distribution analysis under 60% loaded conditions (24 hours).
- Power failure test.
- Door opening test (for different durations such as 60 seconds, 120 seconds, 180 seconds, etc., since for a refrigerator the door opening will be more frequent compared to other assets).
The percentage loading can be decided by the client as per his usual loading pattern. The sampling interval will be generally kept at 1-2 minutes.
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What are the tests for temperature mapping study of a medicine/vaccine shipping box?
For a refrigerated shipping box, distribution analysis, power failure tests, door-opening tests, and start-up tests. The details are below:
- Distribution analysis under empty conditions (24 hours).
- Distribution analysis under 60% loaded conditions (24 hours).
- Power failure test (for active cooling boxes).
- Door opening test for different durations.
- For active boxes, the tests will be conducted inside a van as well as inside a warehouse.
The percentage loading can be decided by the client as per his usual loading pattern. The sampling interval will be generally kept at 3 minutes.
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What are the reports generated in the Temperature Mapping study?
The reports of a mapping study will include the following details:
- Temperature distribution – Pass /Fail.
- Humidity distribution – Pass /Fail.
- Hot and cold points of the asset. These will be the hottest and coldest points of the area. Real-time continuous monitoring systems need to be placed in these areas.
- Analytical graphs for all the tests.
- Any recommendations for improvement.
- Required Time to reach the desired temperature after startup.
- Duration for which the temperature remains within the limits after a power failure.
- Duration within which the temperature exceeds the limits during a door opening.
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What is the Temperature Qualification study? (or Temperature & Humidity Qualification study)
Temperature qualification study is all procedures of temperature mapping study combined with verification of various equipment. It is a very detailed sequence of tests and analysis including verification of active components such as cooling units, sensors, etc. After these series of test and verification, the asset is certified to be qualified for achieving and maintaining the desired levels of temperature and humidity levels. The various tests covered under the qualification process, in general, are as under:
- Design qualification process (DQ) – to verify the equipment are designed to generate the desired temperature and humidity conditions
- Installation qualification process (IQ) – To verify whether the installation is carried out as per the design and as per the installation procedures recommended by the respective manufacturers of critical equipment.
- Operation qualification process (OQ)– To verify that the operations are carried out as per the recommended procedures of the manufacturers of the critical equipment
- Performance Qualification (PQ) to verify the performance of the entire system. This includes temperature and humidity mapping study.
- Document verification – To verify whether all documents are maintained by the user including SOP, calibration certificates, etc.
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What is the difference between the Temperature mapping study and a Temperature qualification study?
In a temperature mapping study, only the distribution of temperature & humidity is analyzed. This study makes sure that the distribution is always within the permitted range of temperature and humidity as applicable. However the mapping study does not check various criteria such as SOP, whether the installation has been done correctly, whether the machines are working as per the design, whether written procedures are maintained, whether these written procedures are sufficient etc. All such parameters are covered in a temperature qualification study.
A temperature qualification study includes a mapping study, but not vice versa.
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How to decide whether you need a Temperature Mapping study or a Temperature Qualification Study?
If you want to check only the distribution of temperature & humidity, a mapping study is sufficient. If you want to check whether the whole asset is designed, installed, and operated correctly, it is desirable to carry out a temperature qualification study.
A qualification study is considered to be more of international acceptance. An auditor from another part of the world may not be familiar with various installation and operational parameters of the asset. If an asset is qualified the asset is considered to be a fully satisfactory system.
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Do you require a Temperature qualification study or Temperature and humidity qualification?
Please see our explanation for a similar query under the temperature mapping study.
If your major parameter is only the temperature, then you may limit it to a temperature qualification study. If you also require humidity, a temperature & humidity qualification study will be required.
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What are the advantages of a Temperature qualification study over a mapping study?
The temperature qualification study is considered more of international acceptance. So if your clients and suppliers are from various countries, you may go for a qualification study. As an example, each country has its own type of design, installation, and operation procedures for a cold room. Hence your client from another country may not be familiar with such parameters in your country. If a temperature qualification study is carried out on this cold room, the client need not check any details at all since the cold room is fully qualified to ensure full compliance to keep a temperature between 2-8°C.
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Documentation required prior to commencement of a qualification process
Prior to the commencement of a temperature qualification study, we require the following document/details from the customer.
- The customer has to provide the layout drawing of the asset.
- All details of cooling units such as serial nos., details of sensors, operation manuals, design drawings etc. have to be provided.
- Similar details of dehumidifiers also have to be provided.
- All details of temperature monitoring systems (if any) to be provided.
Based on these documents we will prepare a protocol for review and approval by the customer.
We will carry out the tests based on this protocol.
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Reports of a Temperature qualification study
The reports of a temperature qualification study will contain the following details in general. Please note these may vary depending on the nature of the asset.
- Design qualification process – Pass or Fail.
- Installation qualification process – Pass or Fail.
- Operation qualification process – Pass or Fail.
- Performance qualification process – Pass or Fail.
- Document verification – Pass or Fail.
- Power failure test results.
- Recovery test results.
- Start-up test results.
- Hot and cold points.
- Deviation if any.
- Recommendations.
- Corrective actions.
If all the above tests are passed satisfactorily during the temperature qualification study, we issue a certificate indicating that the asset is fully qualified. The details of the asset will be indicated in the certificate.
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How to carry out a temperature qualification study for storage and transportation of medicines and vaccines?
For a complete qualification study, we will inspect and verify all active components such as cooling systems, sensors, recording systems, etc. This is in addition to the temperature mapping study. This section briefly describes the method of qualification study for certain assets. You may once again note that a mapping study is part of a qualification study. But the qualifications process involves certain other procedures as explained in previous sections.
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How to carry out the qualification of a box
The box is one such item that will require a qualification because the box goes through daily tough handling and hence a mapping study alone will not be sufficient to test its efficiency. Also for boxes, we recommend a shorter validity of one year for a qualification. As the box goes through tougher conditions, it is preferred to have the qualification done once every year.
Active boxes
For active boxes, qualification includes the following:
- Define a Thermal profile based on general operating conditions.
- Test the box against this thermal profile.
- Check installation and operation of the cooling units.
- Verify the calibration of the sensors and the cooling units.
Passive box
For passive boxes, there are not many tests compared to active boxes.
For passive boxes, generally, qualification needs to be done only on a sample piece and not on every box. Especially there are many types of single-use passive boxes and hence one from each design need to be qualified to prove the efficiency of the box.
In order to carry out the study more efficiently, it is desirable to know the operating environment conditions that the box undergoes for each customer.
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How to carry out temperature qualification of a Cold Room for medicines and vaccines?
For a cold room, we very all cooling units, sensors, calibration reports, maintenance procedures, SOPs, etc. This is in addition to the temperature mapping study. The following verifications will be done.
- Verify the calibration records.
- Check the installation of the cooling units, sensors, location of sensors.
- Check the entire operation of the cooling units, control panel, and associated circuitries.
- Check the maintenance procedures of the cooling units.
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How to carry out temperature qualification of a refrigerated Van or reefer for medicines and vaccines?
For a van or reefer, we inspect and verify the cooling units, sensors, calibration records, controllers, SOP, etc. This is in addition to a temperature mapping study. The following verifications need to be done.
- Verify the calibration records.
- Check the installation of the cooling units, sensors, location of sensors.
- Check the entire operation of the cooling units, control panel, and associated circuitries.
- Check the maintenance procedures of the cooling units.
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Reasons for failure of a Mapping study
Common reasons for the failure of a temperature mapping study or a humidity mapping study are listed here:
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Reasons for failure of mapping study of a van
We are mentioning of small and medium-sized vans. There are many reasons for the failure of these vehicles during a temperature mapping study and temperature qualification. The main ones are listed here:
- The temperature shown in the display unit of the cooling unit may not be matching with actual inside temperature. Probably the sensor reading is not correct. This can happen for many reasons. Over a period of time, the accuracy of the sensor may be lost. Eg. the display unit might be showing 5°C and the driver will be confident that the cold cabin is at 5°C. However, it is possible that the inside temperature is at 7°C. In order to avoid such a situation place a data logger next to the sensor of the cooling unit and record for a few hours. Set the cooling unit at the desired temperature. After a couple of hours download the data and analyze. The graph will be in continuous up and down cycles. Check the highest and lowest temperature of these cycles. If these values are close to the setpoint, it means that the sensor and display unit is working correctly. Eg. if the setpoint is 5°C, the highest and lowest readings should be 7°C & 4°C. (This varies based on the type of cooling unit, programmed setting of upper and lower cut off limits etc. However, this will give an indication of the correlation between the displayed temperature and actual sensor temperature.
- Temperature goes to extreme low and high points at all cycles. Eg. The setpoint is 5°C. However, the temperature goes regularly to 9°C and 3°C regularly. This happened because the cooling unit is programmed accordingly. ie. It has a high cut off at 4°C above the setpoint and low cut off of 2°C below the set point. This can be programmed for 2°C for both high and low cut off points. Thereafter the higher & lower cut off will be 7 & 3°C respectively. (This feature is based on the manufacturer and models of the cooling unit)
- The temperature on one end of the vehicle goes beyond limits. This happens mainly in Reefer trucks since the cooling unit and fan are one end and the reefer is very long. It is possible that the other end of the cold cabin is not properly receiving the air. If the fan unit is not producing strong airflow this may happen. Otherwise, airflow ducts will have to be provided from the cooling unit to the other end of the reefer. Thus the air will be divided through multiple ducts and distributed at the front and rear end of the vehicle.
- Temperature goes high at certain points during the loaded test. This may happen mainly due to limited airflow. During a loaded test (and during actual loaded conditions), goods should not be placed directly in front of the airflow. Also, sufficient space should be left on all sides and on the top for efficient airflow.
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Reasons for failure of mapping study of a cold room
General reasons for the failure of a cold room are as under:
- The display unit fixed at the outside of the cold room may not be displaying the correct temperature of the cold room.
- The loading and distribution of the shelves may not be uniform thus hindering proper airflow.
- Humidity may be higher than the permitted levels.
- The positioning of the cooling units may not be in perfect location thus affecting uniform distribution.
- Defrost cycle is not programmed properly. Eg. If you have two cooing units, the defrost cycle of the two units should not coincide.
- Air curtains may be required at the doors.
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Reasons for failure of mapping study of a Warehouse
For warehouses the most common reasons for failure are:
- The number of cooling units or the capacity of the cooling units may not be sufficient.
- The location of the ducts may not be proper.
- Humidity may be higher than desired levels.
- Air curtains may be required to control the inflow of ambient air.
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What is the validity period of a temperature mapping study and temperature qualification study?
There are no fixed rules applicable to the validity of these test results. However, for a new facility, we suggest that the study report can be considered valid for a period of 3 years.
If any modifications are carried out related to shape and layout of the asset, modification or replacement of cooling units, rearrangement of racks etc., the original report cannot be considered valid. The reasoning is that any of these changes will affect the distribution of temperature and humidity.
For new vans, we suggest to carry out the mapping study once every 2 years. However, for old vehicles, it is better to carry out the study once a year. This is because the performance of vehicles is very much affected by the age of the vehicle.
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Reasons for failure of a Qualification study
Even if a mapping study is successful, the qualification may fail for other reasons. Few of the major reasons are listed here. Such reasons are pointed out as deviations in the report and most of the minor deviations can be closed after rectifications. However, sometimes it may happen that the deviation might be major and may require major rectifications and retesting for successful qualification.
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Reasons for failure of qualification study of a van
Major reasons for the failure of a van are:
- Failure to maintain proper calibration reports.
- Control panel of the cooling unit of the van is not working properly.
- The equipment is not installed as per the manufacturer’s recommendation.
- The equipment is not operated as per manufacturer’s recommendation.
- There are no clear written instructions to the operators for the proper operation of the vehicle.
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Reasons for failure of qualification of a cold room
Major reasons for the failure of a cold room are:
- Failure to maintain proper calibration reports.
- Control panel of the cooling unit including the condenser, the evaporator of the cold room is not working properly.
- The equipment is not installed as per the manufacturer’s recommendation.
- The equipment is not operated as per manufacturer’s recommendation.
- There are no clear written instructions to the operators for the proper operation of the cold room.
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Reasons for failure of qualification of a passive box
Major reasons for the failure of a passive box are:
- Proper written procedures are not available for instructions of operation.
- Proper identification including serial numbers is not available.
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Reasons for failure of qualification of an active box
Major reasons for the failure of a passive box are:
- Failure to maintain proper calibration reports.
- Control panel of the cooling unit including the condenser, the evaporator of the cold room is not working properly.
- The equipment is not operated as per manufacturer’s recommendation.
- There are no clear written instructions to the operators for the proper operation of the box.
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How to improve the results of the test and eliminate chances of failure?
It is ideal that before carrying out the actual study, you may carry out a trial study with few numbers of data loggers to analyze the data. This trial study will help you to evaluate major problems if any. For all contracts being undertaken by us, we carry out a trial study before the commencement of the actual test. This will save valuable time and money for the customer.
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Advantages of a trial study
The major advantage of conducting a trial study are:
- Saving time and money – After conducting a full test you may end up with some deviations. In such case you will have to carry out a retest after undertaking the corrective actions. By this time you may be in the midst of a climate change and hence will have to wait for the next season. If a trial study is planned properly, this can be avoided.
- Correct settings for cooling units – sometimes just by changing the settings of the cooling units you may have better results. You may not have noticed this so far because your current recording devices were not placed at the correct hot and cold points.
- The requirement of dehumidifier – In many cases humidity distribution was not properly analyzed and hence may require installation of dehumidifiers. This is a process involving time and money and hence if understood at the proper stage, suitable actions can be undertaken.
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How to carry out a temperature mapping trial study?
Before commencing the actual tests, we will send you some data loggers for placing at certain locations as per the drawings. The data need to be collected for a certain duration and the data loggers have to be returned. We will analyze the data and will provide suitable recommendations. Generally, we include one trial study in our scope to assist customers (To be finalized at the time of finalizing the order)
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What is Thermal Validation? What is the difference from Qualification?
Thermal Validation is the process of testing a sequence of activities. Consider an example of dispatching a medicine from one location to another location regularly. This will involve multiple assets such as a cold room, thermal box, vehicle, etc. We can test the whole procedure and validate the whole process. Often confused with Qualification and often used interchangeably. It may not cause a problem while the terms validation is qualification is used interchangeably. We have seen especially the following terms being used:
- Validation of boxes – This is generally the qualification of the boxes only unless defined separately. If the data logger used in the boxes need to be validated, that is a separate procedure and is not covered under the qualification of the box. Please seed, e & f under this section for more details.
- Validation of cold rooms – This also refer to qualification only. If the data logger or real-time monitoring system used in the cold room need to be validated, that is a separate procedure and is not covered under the qualification of the cold room. Please see d, e & f under this section for more details.
- Validation of vans, reefers etc.– This also refers to qualification only. If the data logger or real-time monitoring system used in the vehicle need to be validated, that is a separate procedure and is not covered under the qualification of the van or reefer. Please see d, e & f under this section for more details.
- Validation of real-time temperature monitoring system – This is not part of the qualification and is done separately. In simple terms real-time monitoring system consists of electronic components, software, cloud server, local server etc. and it needs to be verified that all such components are working correctly ensuring correct recording and readings across all these channels. Also, this has to meet CFR Part 11 standards. This whole process is known as validation of the system. Once the system is validated, you can be sure that the readings produced at different points of the hardware and software are all the same.
- Validation of a data logger – This also is in line with Sl. d above, but applicable for the data logger and its software
- Validation of software used to monitor the system- This also is in line with d & e above. This is generally applicable for any software, but in our context, we are referring to any software used for monitoring of temperature or humidity. Eg. If a customer is using disposable data loggers (or any other data loggers) regularly, the report is generated using its software. The software is installed on a computer. Now how do we know as a user that the software is correctly producing all reports from the data logger? If there is an error in the software, the readings and reports will not be correct. If the software is validated, we can be sure that the reports are 100% correct. In this is a onetime procedure for the software, until a major revision is carried out.
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Documents related to Mapping study & Qualification
- Case study of a temperature qualification study in a cold room: http://bit.ly/case-study-temperature-mapping
- Protocol / SOP for Temperature qualification study of cold room: http://bit.ly/temperature-mapping-protocol-sop
NB: For ease of understanding, we generally mentioned temperature throughout the article. However, all mentions about Temperature mapping study are equally applicable for Temperature & Humidity mapping as well. Similarly, all mentions of a Temperature qualification study are equally applicable for Temperature & Humidity qualification study.
Also, temperature mapping study is known as Temperature distribution analysis.
How to carry out a temperature mapping study for storage and transportation of medicines and vaccines?
- Obtain the layout of storage areas of the warehouse, cold room, reefer truck etc
- Based on the application and storage temperature, decide on the number of data loggers.
- Mark the locations of the data loggers in the layout drawing.
- Program the data loggers and place them in the locations.
- Start the recording of the data loggers and the testing process as per the procedure.
- Upon completion of the test process, download the data from the data loggers.
- Prepare a detailed temperature mapping report based on the downloaded data.
Our services on temperature mapping study for storage & transportation of medicines & vaccines
- Service Type: Temperature Mapping Study during storage & transportation of medicines & vaccines for warehouses, cold rooms and vehicles of pharma distributors, shipping companies, air cargo operators, airport storage facilities and 3PL companies.
- 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.
- Service Offer: Temperature Mapping Study & Qualification along with FDA compliant temperature monitoring system.
- Provider Name: VackerGlobal, 92438, Deira, Dubai, United Arab Emirates. Tel: +97142661144
- Service Description:
- Consultancy services for design and installation of Cold Chain management for storage and transportation of medicines and vaccines.
- Temperature mapping study and qualification of warehouses for storage medicines.
- Temperature mapping study and qualification of cold rooms and walk-in freezers for storage of medicines & vaccines.
- Temperature mapping study and qualification of medical refrigerators for the storage of medicines & vaccines.
- Temperature mapping study and qualification of passive boxes for storage or transportation medicines.
- Temperature mapping study and qualification of active boxes for transportation medicines.
- Temperature mapping study and qualification of reefer trucks for transportation medicines.
- Temperature mapping study and qualification of refrigerated vans for transportation medicines.
- Temperature mapping study and qualification of refrigerated vans for transportation medicines.
- Temperature mapping study and qualification for Cold Chain Management.
We offer the services of temperature mapping study and Temperature qualification study in the Asian region mainly in the United Arab Emirates, Kingdom of Saudi Arabia, Qatar, Oman, Bahrain, Oman, Iraq, Iran, Lebanon, Jordan, India, Pakistan, Bangladesh, Sri Lanka, Singapore, Hong Kong, Myanmar, Vietnam, Thailand, South Korea, Japan, Mongolia, Malaysia, Indonesia and Philipines.
The countries covered by us under the African continent are South Africa, Nigeria, Tanzania, Kenya, Ethiopia, Ghana, Rwanda, Uganda, Morocco and Djibouti.
We offer all our services of temperature mapping study and Temperature qualification study across the world including the USA, UK, Europe, Asia, Middle East and Africa.
If you require free assistance on your Cold Chain Management requirements, please contact us