Real-time monitoring is a critical element of pharmaceutical quality control. A real-time system can generate data trends that confirm product quality maintenance and regulatory compliance. Therefore, it is crucial to put in place the right pharmaceutical refrigerator monitoring system.
Pharmaceutical quality control is a process to ensure consistent product quality in a pharmaceutical lab. Quality control seeks to put in place procedures that either maintain or improve product quality.
There are various quality control processes, including simple substance screening methods like thin layer chromatography and infrared spectroscopy. There are also complex methodologies like using pharmacopeia monographs, all of which work to maintain optimal product quality.
A crucial part of pharmaceutical quality control is real-time temperature monitoring. In a pharmaceutical lab, cold temperatures are crucial for production and storage of pharmaceutical products. Without the right temperature margins, it will be impossible to achieve the required product quality.
ELPRO designs sophisticated temperature monitoring solutions for pharmaceutical labs. These monitoring systems are applicable in cold rooms, refrigerators, cold boxes, and storage warehouses. While other environmental conditions have a bearing on the productivity in a lab, temperature bears the most significant influence, hence the need for real-time temperature monitoring.
Real-Time Refrigerator Monitoring
Pharmaceutical refrigerators are the lab's backbone, providing the right refrigerated conditions for storing drugs, vials, and medicines. Temperature fluctuations can negatively impact product quality by interfering with the chemical composition.
Once the chemical makeup of a pharmaceutical product changes, it becomes unfit for human consumption. It can be challenging to determine defective pharmaceutical products from simple inspections because there is no accompanying physical change. That is why pharmaceutical quality control in the form of temperature monitoring is essential.
Real-time refrigerator monitoring prevents contamination of samples. In the long run, an effective monitoring system will protect the consumer from harmful and low-quality pharmaceuticals. The lab will benefit from improved cost-effectiveness. Since there will be no rejected products, the lab will not incur losses through recalls.
Additionally, pharmaceutical quality control ensures optimal lab productivity by minimizing waste.
Another critical reason for investing in real-time temperature monitoring is the need for continuous compliance. It will not be easy to prove compliance with lab temperature standards and regulations without a monitoring system in place.
Only real-time temperature monitoring provides the necessary temperature logs to show trends and confirm that the temperatures have been within the allowable margin over a certain period.
Setting up an effective pharmaceutical quality control program is a process that needs thorough work and planning. Investing in a reliable and robust temperature monitoring system that can handle the workload during the busiest times of the year is ideal. Before one ventures out to find a real-time monitoring system for your refrigerators, there are important considerations to make.
This article highlights five steps to help choose the right refrigerator temperature monitoring solution.
1. Chart Recording Versus Data Logging
Real-time temperature monitoring requires constant feedback on the prevailing temperatures in the refrigerators. The chart recording setup includes a temperature measurement device attached to a recording chart.
Any temperature variation will cause the recording arm to deviate with a corresponding distance. The deviation reflects on the chart as either a rise or a fall. While chart recorders are easy to install and configure, they need chart replacements. Additionally, the user must physically go to the chart to check the readings and is consequently subject to human error.
Data loggers provide better performance for pharmaceutical quality control. They work by recording temperatures in the refrigerator and storing the data in a local storage device. The user can access the data logs by connecting the device to a computer and downloading the details.
Although data acquisition is continuous in this case, data access is not real-time. ELPRO provides advanced data loggers with connectivity features to overcome the real-time data access limitation.
Depending on the application, wireless IoT devices may be the best choice. These devices connect to the internet in case of multi-location facilities or the local area network in a single location facility. Additionally, they offer user-friendly and effective pharmaceutical quality control because they can connect to cloud storage.
2. Automatic Alerts and Indicators
There are essential features that one should not compromise in a real-time temperature monitoring system. Pharmaceutical quality control relies heavily on real-time data to prove accuracy and compliance. The real-time system should incorporate automatic alerts.
One should also be able to customize the limit indicators to suit the products in your refrigerator. Once the temperature range limits are configured, the monitoring system should generate auto alerts when temperatures exceed any limit. That ensures that the user receives constant updates and can step in to perform amendments where necessary.
A monitoring system must be able to generate automated reports. ELPRO recommends using automatic reports from the ELPRO monitoring solutions to minimize human error and make data analysis easy.
3. Battery Life and Wireless Connectivity
For any real-time monitoring system, long battery life is necessary. Since the sensors will be active 24/7, the battery should accommodate a considerable amount of work before draining. That is especially crucial in case of power failure when the system has to run on battery power.
Without wireless data transfer, there cannot be real-time monitoring. Wireless connectivity options include Bluetooth, internet, and radio frequency, which allow the user to have remote access to data from the monitoring system.
ELPRO temperature monitoring systems have wireless connection capabilities, including connection to the cloud. That way, one can view real-time data from the sensors through an internet-enabled device from a remote location and receive notifications directly to the connected device.
4. Selecting Data Storage Options
Real-time refrigerator monitoring generates data that require storage. Data storage is an integral part of pharmaceutical quality control. Apart from having a secure storage platform, it should provide easy, secure access to data when needed.
There are two data storage options available in the market. One may choose to store data on-site on a local server with connected computers and hard disks. This option has a high upfront cost since one will have to buy all the computing and storage materials and put aside maintenance resources.
An alternative option is cloud storage, which ELPRO highly recommends due to low upfront and maintenance costs. The advantage of cloud storage is that the user only pays for the space they need. It is highly scalable, and the only maintenance costs you incur are subscription fees.
5. Considering Calibration
Over time, even the most accurate monitoring system begins to lose accuracy due to wear and tear. As a result, calibration is a critical part of pharmaceutical quality control measures. Whatever system one chooses for refrigerated temperature control, they must make room for calibration.
That means comparing the output of the system against a certified instrument to determine accuracy and precision. Calibration requires financial and technological resources. Therefore, choose a system that is easy to calibrate.
Other factors come into play in conjunction with the above considerations when setting up a pharmaceutical quality control program. These include the refrigerator-size, the products-specific temperature limits, the available resources, and technological expertise. The kind of monitoring system one chooses should also be customizable to the needs of the lab.