Qualification of temperature is known to be an in-depth study, which has been thus designed for the evaluation of various equipment. For this study there are various tests incorporated into it. Temperature Qualification Study is used worldwide for the evaluation of variety of assets such as warehouse, cold room, refrigerator, etc. that are primarily used for the transportation and storage of temperature-sensitive products. Once the study is completed, that particular asset is qualified as fit for maintaining the required level of temperature.
Vacker Maldives offers Temperature and Humidity Mapping studies in sectors such as storage areas and transportation, for regions or areas such as Hithadhoo, Malé, Fuvahmulah, Kulhudhuffushi, Thinadhoo, Naifaru, Hulhumale, etc. In total, four processes comprise the study of temperature qualification. Next process starts only after the completion of the previous one and the processes are as listed below.
1. Design Qualification
This process is specifically for the equipment that is installed in the assets and helps in analyzing whether or not those assets have been properly designed and are capable for the proper functionality of the desired functions. These functions may include attaining and maintaining the sought temperature.
Design qualification process performed by Vacker Maldives in regions such as Malé, Hithadhoo, Kulhudhuffushi, Thinadhoo, Naifaru, Hulhumale, etc., is to analyze any specific items to find out whether it can deliver results in accordance with the specifications and requirements set by the manufacturer. This may involve testing of designs on the basis of general engineering practices and other preliminary requirements of Maldives.
2. Installation Qualification
Installation qualification process, generally known as IQ, assists in the minute examination of all the major components installed in the particular asset. They are well verified and the verification is carried out so as to confirm that all the requirements and specifications are met as set by the manufacturer.
3. Operational Qualification
Operational Qualification Process, generally known as OQ, is designed to assess various methods applied in the operation of the assets along with its major components. It should be considered that operation of the equipment shall not violate the specification as desired by the manufacturer and should also comply with the Standard Operating Procedure (SOP) executed by the user.
4. Performance Qualification
Performance qualification process is the final stage of the qualification study. In this process, all the documents such as calibration certificates, maintenance checklists, operation checklists etc. are thoroughly verified. Vacker Maldives maintains these documents as per the written procedures or SOP. The temperature of the asset needs to be as per the design specification which is evaluated by this process.
Of all the processes, IQ and OQ are considered to be easier to perform and the documentation part is also equally easier. Most of the pharmaceutical manufacturers abide by these requirements and the manufacturer of the equipment helps in undergoing these qualification processes. The final and the most important phase is the performance qualification process which helps to ensure that the asset is in perfect capacity to do the following:
- At higher degree fluctuation in external temperature, the functionality in maintaining the interior temperature as predefined.
- Identification of the hot and cold spots in the assets and then recording them.
- In cases of excursions, estimated time needed to return within the specified range must be determined and thus recorded.
- The impact of power failure on retaining the specific temperature level must be specified by the study.
Cold room temperature qualification
Cold rooms are basically used to store medicines and vaccines and we all know that majority of the medicines and vaccines need to be stored at a temperature range of 2°C to 8°C. Vacker Maldives performs the temperature qualification of cold rooms in regions such as Hithadhoo, Malé, Fuvahmulah, Kulhudhuffushi, Thinadhoo, Naifaru, Hulhumale, etc., that is determined by defining specific protocols and thus testing every equipment that is installed in the cold rooms. The qualification study is carried out by performing IQ, OQ and PQ. The protocol is generated prior to the study which covers attributes needed to be executed during the testing period.
Details of the main equipment, controllers, sensors, etc. are required during the installation qualification process. At the same time, electrical requirement of the cold rooms is also verified. During the operational qualification study, we must:
- Verify the calibration detail of all the components.
- Verify the SOP (Standard operating procedure).
- Verify that all the parts of the temperature controller are fully functional in accordance with the specification of the manufacturer.
- Verify that the alert function is fully operational as desired.
- Observe that the cold room is fully capable of maintaining and controlling temperature under vacant conditions.
- Verify the power failure test in order to identify the duration until the cold room can maintain the desired temperature even during power failures and subsequently identify the recovery time.
- Observe that the cold room is capable of maintaining and controlling temperature under loaded conditions.
- Verify that the loaded room is capable of prompt recovery in case of door opening.
The report provided by Vacker Maldives, along with the protocol of the temperature qualification for cold rooms consists of methodology, results, data analysis and other features for the cold rooms.
Cold rooms’ Temperature & Humidity qualification:
Temperature and humidity qualification refers to testing of both temperature and humidity which is considered for the cold rooms. Testing of humidity is considered equally important as testing of temperature. Vacker Maldives generally carries out these tests in small rooms, walk-in freezers, etc., of regions such as Malé, Hithadhoo, Kulhudhuffushi, Thinadhoo, Naifaru, Hulhumale, etc.
Reefer Trucks’ and Vans’ Temperature qualification
For transporting temperature-sensitive goods, reefer trucks and vans are used. These vehicles follow the functionality of a cold room but the humidity is not tested in such vehicles since it is beyond control. For the actual results, the vehicles must be on roads while testing.
Temperature qualification of active boxes
Electrically refrigerated boxes are known as active boxes and in order to generate actual results, Vacker Maldives tests these boxes both inside the vehicles as well as inside the warehouse. However, other procedures are similar to the ones mentioned above.
Temperature qualification of refrigerators
Even for the refrigerators, the procedures are similar as mentioned above but it is suggested that Data Loggers be used with external sensors and the sensors need to be inserted in glycol bottles.