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.
This article briefs about mapping study for Temperature & Humidity.
Firstly we will explain about temperature mapping study and thereafter about temperature & humidity distribution.
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.
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:
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.
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.
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.
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.
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.
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.
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:
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:
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.
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
Brief details of the study for various kind of assets are detailed hereunder
We recommend the distribution analysis, power failure test, door opening test, and start-up test for all types of vehicles.
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.
For a warehouse, temperature and humidity distribution and door openingpatterns are carried out as part of a temperature mapping study.
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.
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:
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.
For medical refrigerators, we recommend distribution analysis, power failure test, and door opening test. The details are below:
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.
For a refrigerated shipping box, distribution analysis, power failure tests, door-opening tests, and start-up tests. The details are below:
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.
The reports of a mapping study will include the following details:
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:
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.
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.
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.
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.
Prior to the commencement of a temperature qualification study, we require the following document/details from the customer.
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.
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.
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.
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.
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:
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.
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.
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.
Common reasons for the failure of a temperature mapping study or a humidity mapping study are listed here:
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:
General reasons for the failure of a cold room are as under:
For warehouses the most common reasons for failure are:
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.
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.
Major reasons for the failure of a van are:
Major reasons for the failure of a cold room are:
Major reasons for the failure of a passive box are:
Major reasons for the failure of a passive box are:
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.
The major advantage of conducting a trial study are:
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)
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:
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.
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