A guide for Pharmacy Cold Chain Temperature and Relative Humidity Monitoring
Understand the importance of temperature and relative humidity monitoring in a pharmacy.
Temperature and relative humidity monitoring is an essential practice to ensure the safety and effectiveness of the valuable stock of medicines, vaccines and reagents.
It is important that the temperature of the fridges as well as temperature and relative humidity of the rooms storing medicines are checked with accurate data.
According to the best practices, pharmacy storage conditions monitoring, should follow EU Good Distribution Practice (GDP) Guidelines.
Most medicines stored in pharmacy fridges should be kept between 2°C and 8°C, while medicines that can be stored at ambient room temperature should be between 15ºC and + 25ºC with a relative humidity below 65%.
Patient safety and medication efficiency is, of course, the key objective for all those who are involved in the process.
How to check the storage conditions?
Considering the sensitivity of medicines, vaccines or other critical assets to changes in temperature and relative humidity conditions, only continuous and automatic monitoring, provides through real-time information, timely reactions that ensure the quality, safety, and promote high financial savings.
Periodic and manual sampling (daily, bi-daily or even hourly) does not guarantee the detection of occurrences such as door openings, equipment malfunctions (power or breakdown) or others, besides having an increased cost of manual labor, also prone to errors.
Select the appropriate temperature monitoring devices.
Looking forward to assuring a real-time temperature monitoring of the pharmaceutical cold chain equipments, it is recommended to use digital data loggers or continuous temperature monitoring systems. These devices should meet industry standards, such as those set by the FDA and EU, and be validated for accuracy and reliability through an annual calibration process.
Wireless temperature monitoring systems are increasingly used, featuring technologies like up to 10 years lifetime battery-powered sensors with internal memory for data assurance in case of energy outage, easy to install, with no cables neither the need to tamper the equipment to install the sensor.
It is important to choose a device that meets the specific needs of your pharmaceutical operation, such as those related to temperature range, storage capacity, and regulatory requirements.
Sensor data must be automatically sent to a software platform, accessible in real time from any location, thus providing instant and simple access to information at any time, particularly in the event of any occurrence. Omni Channel Monitoring Solutions are preferable, thus providing different ways to access the data, namely through Smartphone apps providing mobility.
Regularly review and update the monitoring system.
Given the critical nature of the application, as it is a 24/7 solution that must assure real time information, with alarming and reporting features, it is extremely relevant to choose a solution with full maintenance, daily backups and updates included, as well as several redundancy levels, in order to ensure its correct operation and availability.
Benefits and Savings
The cold chain monitoring automation process, using a validated solution, increases the Patient and Medical Staff Safety, promotes high savings by automating the manual process and avoid losses in cases of breakage of the cold chain, ensures compliance with existing rules and increases the quality of the whole process.