Optimizing Pharmaceutical and Life Sciences Manufacturing

The need for equipment maintenance and optimization is ever present. With the demands for faster product availability, modern manufacturing systems are being used to control process conditions and automatically collect data in a secure manner.

For life sciences and pharmaceutical factories, the added compliance requirements, and the race for talent, brings the need for automated asset management systems to the forefront. Manufacturing facilities are a complex ecosystem where management, operations and reliability engineers are juggling many demands: improving batch yields, ensuring optimum condition for manufacturing, improving speed to market, quality, regulatory compliance, and safety. In this challenging environment, solutions are needed to reduce uncertainty, increase reliability in operations while driving down costs, and to maintain regulatory compliance.

What is Asset Performance Management (APM)?

According to professional services firm Gartner: “Asset Performance Management (APM) encompasses the capabilities of data capture, integration, visualization and analytics tied together for the explicit purpose of improving the reliability and availability of physical assets. APM includes the concepts of condition monitoring, predictive forecasting and reliability-centered maintenance (RCM).

APM uses a standardized methodology, data management, pattern recognition, predictive analytics, artificial intelligence, and machine learning to support manufacturing companies to create more productive facilities, improving asset availability while reducing operational costs and risks. As a result, yield improvements, compliance and environmental performance can be seen through the consistent planning and application of APM practices. It also helps to reduce production failures by unifying the enterprise through data intelligence, evidence-based decision making and simplified visibility for underlying performance issues.

Why APM for the pharmaceutical industry?

In the pharmaceutical biologics industry, Asset Performance Management can be applied to improve operational performance. The APM approach standardizes processes that are used to monitor, assess, maintain, and fund the equipment (assets) that are needed to run the business. Creating reliability in the manufacturing process can be achieved by applying automated standard processes to manage wear and tear on equipment and assets.

Here are 6 key advantages of utilizing APM Systems:

Resilient supply chain planning

The global pharmaceutical supply chains did not collapse under the pressure of COVID-19, but the pandemic revealed serious weaknesses in pharmaceutical logistics.

The lean supply chains and just-in-time (JiT) approach cultivated over decades of process improvements are not resilient to sudden shocks or issues with production, caused by events such as unexpected disruptions, supply shortages or lack of qualified talent. As a result, long manufacturing lead times and spikes or drops in demand can cause problems through the near term.

APM strengthens the supply chain by assisting in identifying asset related failures early enough for the failure to not cause production interruptions or other unwanted events. Therefore, APM helps to build resiliency through better planning and efficient inventory management.

Process Control

Process Control

As an industry practice, the quality of pharmaceuticals is defined as one that is pure, correctly identified, effective, and safe to use. To help ensure that this is exactly what customers and patients can expect, pharmaceutical storage requirements for quality control is becoming more stringent.

Overall, the manufacturing industry has relied on process control techniques to reduce the variation in the production process. TQM (Total Quality Management) and 6Sigma processes have taught us that reduction of variation is key to improving reliability in a process environment. To reduce human error in the pharmaceutical manufacturing environment, error proofing, process automation and robotics are employed to achieve repeatable results. Additionally, data collection errors are minimized greatly by automating the data collection process through technology adoption.

Robotics and automation can enhance product compliance and result in less rejections. In addition, robotic systems reduce variation and generate important data automatically that can feed data historians or data lakes. This data can be used to provide real-time analytics, dashboards, and KPI insights in a more efficient manner to enable quicker response time and thereby avoiding larger impacts if the trends are not recognized through local operations personnel.

Improved product traceability and tracking

Improved product traceability and tracking

Pharmaceutical warehousing requirements direct operators to keep written procedures describing the storage conditions for each drug they store. In addition, each drug must have a unique, traceable code that identifies the lot’s status (eg, approved, quarantined, or rejected). Written procedures describing the distribution process for each drug, including recalls, are also required.

With higher product demand, increased production throughput and larger storage facilities will be required. Automation, instrumentation, data historians and digital tools can eliminate routine tasks and paper-based systems thereby improving traceability and productivity.

Driving down compliance-related costs and risks

Driving down compliance-related costs and risks

The cost and risks of non-compliance is a key topic for stakeholders and brand integrity. The impact of non-compliance in life sciences can be severe as it can span quality, performance and profitability. It can also become a very public issue and re-building trust can take many years. To reduce costs and risks, companies are adopting a more strategic, risk-based approach to managing compliance through APM where root-cause analytics are adopted.

Optimizing asset performance and asset utilization

Optimizing asset performance and asset utilization

Under-performing assets reduce operational efficiency, presenting problems such as slower time to market, more lost batches, reduced yields, and safety issues. Reduced asset performance may be the result of insufficient maintenance, repair, inspection, calibration, and other processes that directly affect product quality and employee safety. By improving asset performance, companies can reduce line outputs and other forms of production downtime, drive down costs associated with defects, waste, and over-fill thereby optimizing material yield, and can improve distribution efficiency.

Improving labor efficiency

Improving labor efficiency

Robust asset management systems provide all the information required to execute work orders more efficiently, through digital tablets or online systems, helping to reduce search time and increase actual “wrench time.” For example, an integrated e-catalog and indirect procurement capabilities can help maintenance technicians identify needed repair parts and better ensure they are available when required.

The advantages of integrating an Asset Performance Management system in the pharmaceutical sector are significant. Your production facility may be operating in an efficient manner now, but without APM in place, there is a reasonable expectation that any emerging issue could have a more drastic impact on the bottom line when it occurs.

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