Introduction
Temperature mapping is done by installing sensors or commonly known as data loggers in different points of a facility or storage. This is to see and monitor the differences in temperature in an area over a set period of time.
The abnormal setting of hot and cold spots could compromise temperature-sensitive goods. Preventing this disaster is the main purpose of temperature mapping. This method could also be used to determine the effects of people interacting with space such as door openings. Temperature mapping helps in understanding the distribution of temperature in every capacity status of storage.
What Needs to be Mapped?
Pharmaceutical temperature mapping can be applied in different equipment or facility. Some examples are large-scale refrigerators or reefers, and incubators. However, it is equally possible to map much larger areas such as those seen in warehouses or cold storage rooms.
You might be wondering why temperature mapping is important and how it affects pharmaceutical matters? Let’s continue further in this article.
How Does it Impact Pharmaceutical Storage?
When it comes to medications, they require specific temperatures during the process. The process of these medications involves going through manufacturing, transportation, and storage. Ideally, the temperature of most medications is between 68°F to 77°F.
The temperature is a crucial factor in pharmaceutical storage. It can directly affect the effectiveness of pharmaceutical products. The temperature could easily trigger a chemical reaction and change the chemical properties of the products.
Health professionals can be unaware of the potential effects on medicines if there is no accurate monitoring and recording of the temperatures. This won’t bode well if taken by a patient. Instead of curing, it might deliver another unwelcomed illness.
Why Pharmaceutical Temperature Mapping is Important?
Generally, businesses with warehouses or storage, particularly pharmaceutical companies are required to apply temperature mapping in their warehouses, cool rooms, vehicles, and refrigerators. Every climate-controlled equipment should have proper documents that state its capacity to maintain a stable temperature and humidity.
Pharmaceutical Temperature mapping can help locate areas that have the largest temperature differences. With what is stated earlier, they are most needed during the summer or winter. This is because both summer and winter are considered to have the worst weather conditions in a year.
There are also a number of why a temperature mapping is important:
- Ensuring your products, consumers, and your finances. Above all others, this is the main reason why investing in temperature mapping is important, especially in the drug and food industry. Temperature mapping can be customized depending on the effects of temperature and humidity on product effectiveness, safety, and overall quality.
- Standards Compliance. In order to proceed with the temperature monitoring, it is important to maintain the standard level of temperature for the given facility.
- The monitoring system installed within the facility must be able to record and document the pharmaceutical temperature mapping process. This will serve as evidence that the results of the mapping process are used to guide monitoring and control.
- HVAC Systems. Through temperature mapping, it can determine if the existing HVAC system has the capacity to control the temperature of the storage. The temperature monitoring must be conducted in extreme conditions to be encountered. This also helps if the system should be is still efficient or needs a replacement already.
- Developing a data-based monitoring system. Having a smart and data-based monitoring system can reduce costs and improves overall productivity. This requires minimal manual intervention. Having a complete understanding of the response of your temperature control systems under non-standard conditions also helps to reduce disruption when issues arise.
Challenges in Pharmaceutical Temperature Mapping?
Aside from the process itself being time-consuming. It is an expensive necessity of a business. The material costs might be minimal, however, that does not reflect the overall expense. Pharmaceutical Temperature Mapping is an expensive procedure for companies and needs to have an allotted budget annually. This procedure would protect and monitor pharmaceutical goods that are worth millions and millions so having this procedure is not an option but a must. The expense of using a monitoring system with integrated alarm functions is small compared to the total value of the products it is protecting and help in minimizing a huge financial loss as much as possible.
What is Uniformity Testing?
This kind of test checks if the temperature is the same in all usable parts of the unit. This means that the drugs stay at the same temperature, whether it’s anywhere in the room, equipment, or vehicle. For non-medical-grade equipment, this is usually a problem.
One example is that an area, depending on the location, maybe warmer or colder if it is exposed to sunshine or an outer wall. Cooling and heating can be interfered with by changes in airflow, HVAC systems, and windows. The temperature can even be changed by frequent opening and closing of doors.
To ensure that the temperature stays the same, companies should set up regular monitoring.
What is Recovery Testing Temperature?
This kind of test will measure how long it takes for a cold storage unit to return to its proper temperature range. Both the door opening and the time for when the door is open influence the regulation of temperature. Within the set safety range, the quality equipment should quickly cool in it.
How About Temperature Monitoring?
The USP guidelines state that the air and product temperature at set intervals must take place at least every 24 hours. Some products require frequent measurements more than others to meet protocols.
It might be a good idea to start investing in monitoring equipment. It has an ability where if the temperature falls out of the pre-set range, it can sound an alarm.
Calibration and Maintenance
Routine maintenance and calibration must have a setup schedule. All temperatures should meet international calibration standards. It is also important every once or twice each year to regularly check and calibrate the monitoring devices.
All calibrations and maintenance procedures must be documented. Routine maintenance must have established protocols. Always ask for a certificate of calibration whenever you buy new equipment.
What is a Temperature Mapping Survey?
This survey can show a good amount of information about your installation. It can detail its dynamics and performance. With this information, you can find out if the performance of your system is working well or if there are any shortcomings.
The survey can reveal a lot of things, such as:
- stratification of the air
- hot and cold-spots
- anomalies in the chilling/heating system
- power outages
- the effects of door-openings
- effects of introducing goods
- presence of personnel
- time-to recovery of the set temperature
AKCP Wireless Wireless Temperature Sensor and Data Logger
Place the NIST calibrated, certified temperature sensor with internal calibration check and failover on your shipment, inside your warehouse or medical refrigerator. Monitor temperature and log data internally. Anytime the sensor is within range of an AKCP Wireless Tunnel™ Gateway (WTG) data is synchronized and uploaded to AKCPro Pharma-Mon Server. Install WTG’s at strategic points through your vaccine cold chain. Connect via WiFi, Ethernet, or cellular data. For live monitoring during transport, such as inside refrigerated trucks, a GPS option is available. Through this visibility of the whole supply chain, you can minimize temperature excursions and ineffective vaccines.
Conclusion
Pharmaceutical temperature mapping can help with pharmaceutical products, so it is important to have general knowledge about it. It helps make sure that storage and temperature mapping guidelines are being complied with. Before placing the temperature monitoring equipment at the proper and designated locations, the storage area must be carefully analyzed to ensure a successful mapping procedure.
If you are in a business where it involves manufacturing, transporting, or storing pharmaceutical products, you must conduct temperature mapping. This is especially true if you also have warehouses, cold stores, fridges, freezers, stability cabinets, etc. This is because temperature-sensitive pharmaceutical products are usually stored.
To summarize, pharmaceutical temperature mapping can be an essential tool in ensuring that the quality of pharmaceuticals is properly maintained.
Reference Links:
https://www.loggershop.co.uk/news/temperature-mapping-needed/
https://incepbio.com/blog/temperature-mapping-storage-areas/
https://pharma-mon.com/drug-storage-monitoring/environment-monitoring-of-pharmaceutical-storage/
https://www.geminidataloggers.com/info/temperature-rh-monitoring-pharmaceutical-warehouse
