The pharma industries lose billions annually because of failures in temperature control. Temperature control is very important in temperature-sensitive products otherwise their potency harms and the product becomes useless.
Are you also dealing in businesses handling fragile or temperature-sensitive pharmaceutical products? Do you vouch for the freezer equipment? Do you feel confident in your unit for no wastage despite of tempered temperature?
Temperature mapping is mandatory if you want to reduce wastage and gain maximum results. Without it, the drugs/ vaccines turn ineffective and result in losing revenue.
Proper temperature mapping verifies the temperature efficacy in storage systems so that the products don’t lose effectiveness at any moment.
Continue reading to know why pharmaceutical temperature mapping is required!
Brief about Pharmaceutical Temperature Mapping
Pharmaceutical temperature mapping is a complete process of recording temperature data through data loggers. This recorded temperature is further monitored and analyzed to keep the products at the right temperature as a little carelessness may turn them useless.
The main purpose of this mapping process remains in identifying hot spots so that the effects of internal temperature can be checked with climate changes. It further helps in better management of vaccine storage.
Temperature Mapping for Pharmaceuticals
The regular practice of temperature mapping in pharma companies is a must. With mapping, the potency of drugs can be secured as it makes sure that every temperature-sensitive product is having the right temperature. The equipment used for climate control or temperature control conditions must have the desired documents in it that display its effectiveness for humidity and temperature stability. The refrigerators, warehouses, test cool rooms, vehicles, everything is required to go through mapping for the desired outcomes.
With mapping, they find those spots that have the greatest differences in temperature by measuring during extreme conditions like winters or summers. It particularly showcases the effectiveness of the system to handle worst cases and work under even negative influences.
This testing should be done at regular intervals and each record is required to be kept that shows clear readings of humidity and temperature. Document these readings on both times, when the equipment is loaded and when it is empty. Also, it is necessary to record the exact readings during a power failure, to know at what time the temperature hikes above the desired range. This temperature mapping and its documentation describe changes in temperature while stocking and door opening.
The temperature mapping consists of the following tests to know the exact condition!
- Uniformity Test of Temperature
To check whether the temperature is the same in every part of the unit, a uniformity test is conducted. Usually, the problems occur in non-medical grade equipment. The outer layer that is more supposed to external weather or sunshine needs to be checked for temperature uniformity.
The uniformity test checks the temperature being the same everywhere in equipment, vehicle, room, vaccine carrier, or anywhere where drugs are preserved.
The windows, airflow, frequent door opening & closing, and many aspects can disturb the temperature levels. Regular monitoring keeps temperature uniform.
- Temperature Monitoring
The temperature is mandatory to check at every interval. Almost every day it should be done so that the products can meet the protocols frequently without any delay. Here monitoring equipment plays a vital role. Some equipment comes with an alarm sound that rings when the temperature is not falling in the set range and quickly informs to check the situation.
- Recovery Testing Temperature
The door opening, window immediacy, and many other aspects may make a huge temperature difference. So it’s necessary to consider what time a cold storage unit takes to get back to the desired temperature range. The top-notch quality equipment does not take time in cooling down in such circumstances and keeping the products within the safety range. With mapping, recovery testing temperature is easy and quick.
Why is Pharmaceutical Temperature Mapping Important?
To verify the efficacy of the complete storage systems whether these are warehouses, refrigerators, or cool rooms, temperature mapping holds utmost importance. For temperature-sensitive products, it is quite imperative to have proper temperature mapping. Here are the reasons why is it so important!
- The mapping draws out the actual difference occurring in temperature within the temperature-controlled system. It occurs in the case of proximity to cooling fans, product quantity, personnel movement, and many other points when the temperature difference may occur. With proper mapping, you can easily locate the exact points where fluctuations in temperature are occurring and work on removing the problem right away.
- The temperature mapping creates conditions for the verification and viability of the systems for maintaining the right temperature. It is done to check what fluctuations occur in case the system is influenced by any internal or external factor. The overall impact of temperature difference is calculated for ensuring that the industry meets standards or not. Any defect or incapability is addressed right away.
- The chamber’s central space maintains equal temperature but the temperature in surrounding areas of fans & corners may differ or fluctuate. Temperature mapping takes into account everything that maintains the temperature of varied spaces.
- For every organization and business that is dealing with fragile products which are temperature sensitive, temperature mapping is essential. Mapping confirms whether the vaccine cold chains and refrigerator systems installed in that are maintaining the acceptable level of temperature for the particular product contained within it or not.
- Mapping supports the ongoing monitoring system of cold chains. After mapping also, monitoring is essential to check the backup systems as well for ensuring the proper functioning in every circumstance.
- Temperature monitoring equipment- what purpose does it serve?
- Temperature mapping is mandatory in case you are manufacturing, storing, or transporting the products (temperature-sensitive) from one place to another. Here temperature sensing or monitoring products make the task even quicker and more convenient. It includes real-time alerts, cloud tracking, and many other aspects all at once.
ZedBlox has the best monitors that include advanced firmware and top-notch technology that is easy to operate and result-oriented. We meet the criteria of all healthcare centers, life sciences, critical industries, hospitals, etc. With temperature mapping, the ZedBlox vaccine carrier box provides desired results in maintaining the right temperature for vaccines or other fragile items being carried within it.
How can it be done?
The external conditions of the building leave a deeper impact on the items being stored within it. So for proper temperature mapping, it is a must to have proper details in concern with the outer conditions. Usually, this mapping is done for the complete year so that the external conditions can be mapped easily & properly. The placement of monitoring systems is also determined with the help of it influencing external conditions.
The mapping of cold rooms and fridges can be done for once just as the outer conditions or external environment is controlled. The fluctuations are required to be taken into consideration and frequent tests are also needed to be conducted.
Load testing is another imperative part. It is done to know the interaction of expected levels of each product with temperature-controlled chambers. It helps us know the viability of the situation and whether the temperature-sensitive product will require cooling or reach the desired condition.
Mapping then verifies the chamber’s capacity to take the load and its capability to cope with maximum load. The effectiveness of chamber operation is necessary. If it operates optimally then it can be said that it has been load tested sufficiently.
Under mapping, the performance of the system is tested properly by checking failures or stimulating the operating system thoroughly. It helps you know whether the system will perform well in case it faces some failures in the equipment.
After completion of temperature mapping, sensors are installed that keep everything under surveillance. Proper monitoring is done on the stable areas for perfect monitoring and troubleshooting of any issue.
All in all, the temperature mapping systems are needed to be planned and documented in the right way. This strategy is reviewed by an independent quality unit. The sensors are required to be placed on doors, cooling fans, products, and at greater heights for better outcomes.
Final Thought
Temperature mapping becomes an essential practice if you want to monitor the right temperature in cold chain units. The temperature-sensitive products require controlled environments where the efficacy of these products remains safe and secure. A proper mapping process provides the details regarding system operations in the right way.
With mapping, the problems can be addressed well on time and after that monitoring equipment can provide the right feedback on system efficiency. For more details, send us your queries! We will be pleased on satisfying you by solving them!