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The pharma industry relies extensively on the trust when it comes to consumers as well as communities. As a result, it remains a very regulated business with stringent quality and also safety standards. Pharma companies are in the present times, facing new business challenges, one of which is the requirement for better asset management.
Customer expectations happen to be on the rise, regulatory compliance has gone on to become tougher, patents are expiring, biosimilars are emerging, alternative treatments are also being created, and more powerful as well as competitive collaborative business models are evolving. The procedure of finding, creating, and supplying safe and effective medicine is now underway at a pace that’s rapid.
Interestingly, technology happens to be advancing at an increasingly rapid pace. The global digital transformation, also known as Pharma 4.0, has had significant implications for the highly regulated industry thereby affecting various business functions. There is, at present, a strong focus as far as utilising data and analytics to enhance quality and efficiency when it comes to production is concerned. Effective asset management becomes even more crucial in this scenario. Machine condition monitoring, which is a very important component of asset management, is now taking a significantly larger role in the pharma landscape.
Asset management in case of digital transformation
Amidst digital transformation and Pharma 4.0 revolutionising the sector, the introduction of new data solutions portfolios has gone on to be highly advantageous. These portfolios enable the collection, storage, and utilisation of reliable, real-time data that’s operational. It is well worth noting that they have become crucial for effective asset management within the industry.
This enables condition monitoring to be executed at an enterprise level, thereby lessening the reliance on proprietary condition-monitoring servers. Analytics can be used to enhance machine health care monitoring by not only tracking alarm limits, trending, as well as event notification, but also by making the process easier to gauge, trustworthy, as well as productive.
Pharma Machine Tracking Differs
Although the specific processes monitored may vary amongst pharmaceutical manufacturers, there are common asset management issues that are unique to the pharma sector vis-à-vis other industries. In a pharmaceutical plant, for example, there are several machines that play an essential part in the manufacturing of medicinal drugs. However, compared to other industries, the machines that are being used in the utilities and HVAC sections of the pharma plant happen to be equally important as the production machines.
Utility systems and machines tracked
Utilities are essential for all pharmaceutical processes and serve as the lifeblood of the plant. The production processes rely entirely when it comes to these utilities.
It is well to be noted that the production will come to a halt if the water pumps, air compressors, or power-generating units are not functioning properly. Hence, it is imperative to continuously monitor these utility assets rather than going for checks periodically. In addition, it is important to note that there are other important machines that are also required to be monitored.
Heating, ventilation, and air conditioning
The HVAC system plays a big role in the pharma plant as its main objective is to regulate the surrounding environment for processes. Additionally, it is worth noting that this function accounts for 50–80% when it comes to total energy consumption.
To avoid potential issues such as contamination, temperature as well as humidity deviations, along with the subsequent consequences of quarantined inventory or lost batches, it is important for the HVAC elements to consistently and reliably keep performing. Even a slight disruption in flow or a temperature that goes beyond the specified range can go on to have detrimental effects in case of a bath, potentially leading to the need for additional processing. While it is true that these losses can be quite costly, it is very important to note that many of them can be prevented through the addressing efficient condition tracking and oversight measures.
The air handling unit- AHU happens to be the most crucial component of the HVAC system as it serves as the core of the system which consistently supplies filtered air to the cleanroom manufacturing area, effectively regulating humidity, temperature, air pressure, as well as contaminant levels without any variations. If the AHU stops working, it can cause significant disruptions to the processes that rely on it, even though it is not directly involved in the manufacturing process because these processes heavily rely on maintaining precise environmental conditions.
If the blower of the AHU fails, it will be essential to halt all processes that rely on the cleanroom. Monitoring this system is of utmost importance in the pharmaceutical plant. However, it is important to acknowledge that there are certain set of challenges associated with it. Variable-speed drive motors- VSD are necessary in the AHU to ensure precise regulation of airflow. This process is similar to other procedures at the plant that also use these motors. Early fault detection and diagnostics for conventional monitoring systems present a challenge, necessitating the use of specialised monitoring techniques.
Production
Pharmaceutical production involves several key processes, including milling, granulation, hot melt extrusion, coating as well as tablet pressing.
Several processes in a pharmaceutical plant are already difficult to execute in a lab environment, but they become even more intricate when it comes to industrial-scale production. Achieving precise temperature control is crucial, especially on an industrial scale. However, it can be tricky to accomplish as certain processes require precise amounts of reagents to be added in order to ensure a proper reaction. If the machinery is not functioning or controlled correctly, improper mixing can lead to the production of failed batches. Maintaining a constant material flow rate is therefore essential to ensuring the proper blending of APIs and excipients.
Asset Management paying off
The pharma industry has recognised the growing significance of asset management as well as reliability in enhancing production while upholding strict safety and product quality norms. Certain condition monitoring solutions are well-suited for data management, early fault detection, and reliable diagnostics.
Pharma customers frequently make the decision to track all critical machines in their plant. This choice is driven by their desire to achieve ultimate benefits for the entire plant, including reduced downtime, lower maintenance costs as well as fewer lost batches. The significant cumulative maintenance cost savings are a result of monitoring numerous machines. Furthermore, the avoidance of lost batches due to machine faults leads to increased cost savings. The system can therefore prove to be worthwhile by preventing just a few batch losses.
