In biopharma manufacturing, every second counts. Like in any industry, operational downtime breeds inefficiency. In the context of manufacturing, it can delay critical research, disrupt production and as a result, impact the people in need of the products developed.  

Regulatory compliance and precision are vital parts of the biopharma industry – making smart, adaptable asset maintenance strategies more than just a nice-to-have, but a strategic advantage. However, that strategy can be difficult to implement among siloed works, requiring customer-focused workplace solutions and a foundation of trust. A fully integrated engineering approach can self-deliver critical services that keep manufacturing spaces compliant, advancing science, and improving lives.  

Stringent compliance 

Within such a highly regulated area, work carried out by engineers needs to meet highly regulated GxP (good practice) and GMP (good manufacturing practices) guidelines, which are overseen and regularly inspected by the Medicines and Healthcare Products Regulatory Agency. These stringent regulations also apply to the Enterprise Asset Management (EAM), Computerised Maintenance Management System (CMMS), and Computer Aided Facilities Management (CAFM) software, which often means that the manufacturer’s systems are separate to the engineering providers’ systems.  

That separation creates data siloes, where the engineering system can predict a more advanced data view on an asset than the customer can – understanding what data needs to be transposed, simplified, and used to benchmark the manufacturer against industry peers is vital. To do that, an overlay is needed from the manufacturer EAM and CAFM software and that of the engineering partner, which relies on a custom-built system made in line with the specifics of the manufacturer in-mind. 

Data-led strategy  

A recent McKinsey report into the future of pharma operations strategy stated that “The pharma industry is facing a multitude of industry-specific and global trends. But a few major trends point to an industry tailwind; one of them is the advancement of digital and analytics tools.” 

Key to that are sensors on assets which engineers can use to glean insight into their condition remotely. This can include temperature and vibration level tracking to determine performance, efficiency and asset longevity. For one of our customers, we developed a low-cost and time-efficient solution for the monitoring of its Local Exhaust Ventilation (LEV) systems. These tools require critical compliance and uptime for the scientists operating them.  

A weekly check-in app system was needed for the customer to increase the visibility and compliance of over 1,200 assets in real-time. The format was previously held within its CMMS, which had limited reporting functionality and would now allow for key data analysis, like that of failure by fault type, or to review the highest use by location.  

By analysing the data collection and understanding what additional data points were required for a daily schedule, we developed a cloud-based spreadsheet solution to collect and hold inspection data for all LEV checks across the site. This solution feeds the data into a set of dashboards that drill down capability to individual sites, allowing targeted analysis on risk data, inspection progress, as well as providing failure statistics.  

From the scientist’s end, this means that whenever they need to use an LEV cabinet, they can scan a QR code and see the status of the machine, when it was last maintained, who by, and what the flow rates are.  

Digital and predictive maintenance 

Advancements in digital and predictive maintenance are helping biopharma companies balance the need for compliance with operational efficiency. Predictive maintenance solutions use AI-driven analytics and IoT sensors to track asset conditions in real-time, allowing for early detection of potential failures before they disrupt operations. These insights can inform proactive maintenance schedules, reducing the likelihood of unplanned downtime while ensuring all assets remain compliant with regulatory standards. 

One promising advancement in this space is digital twin technology. While compliance constraints have slowed its adoption in biopharma, digital twins could revolutionise engineering training and compliance oversight. By creating virtual replicas of critical assets, such as chillers or electrical generators, engineers can simulate maintenance procedures without taking equipment offline. Using virtual reality (VR) technology, maintenance teams can practice complex repair scenarios in a risk-free environment, enhancing preparedness while ensuring uninterrupted operations. Exploring AI-driven digital twins could further strengthen predictive maintenance strategies, improving overall asset performance and regulatory compliance. 

Collaboration  

To take advantage of this data and to develop custom-built systems, a strong understanding of the assets, including their regulatory requirements, location, and maintenance history, needs to feed into a wider ecosystem existing beyond these separate data siloes.  

One huge task is to couple the values and services of our team with those of our customers. Cultural alignment is extremely important – from an FM provider’s end, it means acknowledging that any small adjustments in our work can affect the science carried out by our customers. 

A key example of this is Contract and Asset Management (CAM) strategy, which helps align service delivery with the manufacturer’s strategic objectives. CAM management involves meticulous planning, ongoing compliance assurance, and continuous performance optimisation, ensuring that the FM provider operates in complete synergy with the pharmaceutical organisation’s requirements. 

At EMCOR UK, collaboration goes beyond just service provision – it is embedded in strategic planning and operational execution. This is demonstrated through the 15 elements of Business-As-Usual (BAU) daily delivery, which include proactive asset monitoring, real-time performance tracking, and streamlined maintenance scheduling. By ensuring alignment between service teams and biopharma manufacturers, this structured approach enhances efficiency, maintains compliance, and creates a culture of continuous improvement. 

A well-structured strategic management plan allows for long-term success, helping FM teams to anticipate challenges before they arise. Regular alignment meetings, structured key performance metrics, and shared digital platforms ensure that both parties work towards a common goal – enhancing the efficiency, sustainability, and compliance of pharmaceutical manufacturing environments. 

Engineering innovations cannot simply be a plug and play; they need to be implemented within robust internal and industry governance frameworks. To ensure that process is conducted correctly, trust and confidence are key.  

Summary 

The pharmaceutical industry is at a pivotal moment, where leveraging digital tools and enhancing collaboration can redefine asset management. Organisations that embrace data-driven strategies, predictive maintenance, and cultural alignment with their FM providers will be best positioned to navigate regulatory complexities and operational challenges.  

Now is the time for decision-makers to assess their existing asset management frameworks, explore the potential of emerging technologies like digital twins, and invest in strategic partnerships that prioritise efficiency and compliance. By taking proactive steps today, pharmaceutical manufacturers can build a more resilient and future-ready operational model.