Manufacturing: Enterprise Asset Management

There are usually two parameters important to pharmaceutical manufacturers: time and money. Is everything still on schedule? And are they still on budget? They need non-stop insight

Market pressures such as globalisation, the ageing workforce and sustainability have created a critical inflection point for pharmaceutical manufacturing businesses. This nexus of forces means that efficiency, uptime and cost control are now urgent survival strategies. Enterprise asset management (EAM) is the big technology enabler for streamlining processes. These solutions play a pivotal role in the digital transformation and achieving operational efficiency for pharmaceutical manufacturers and, in turn, enhances their financial resilience and competitive posture.

It goes without saying that regulatory compliance is a daily requirement in the pharmaceutical sector. Yet, manufacturers must also cost-effectively manage and maintain production assets and other equipment to meet ever-evolving market demands. This challenge can span everything from specialised production machinery and measurement devices to changing a light bulb. While regulation is meant to be an enabler, it can sometimes make even the simplest of tasks arduous.

Unplanned downtime is highly disruptive, often caused by mechanical failures that proper maintenance can prevent. In fact, on average, large facilities lose 27 hours a month to machine failures at the cost of $532,000 for each hour of unplanned downtime.1 Production shutdowns can result from product contamination, with improper maintenance activities being potential contaminant sources. Non-compliance with regulations can also bring business to a screeching halt.

There’s much to be gained from streamlining processes. Controlling costs and maximising uptime is fundamentally important in the pharmaceutical sector, but there must be a balance between production assets being kept running – to avoid output and income losses – and the optimisation of maintenance processes and asset performance. However, while investing in optimising maintenance processes and asset performance does come at a cost, the resultant reduction in downtime, material costs and energy consumption make these investments justifiable. A good maintenance strategy is not only important for asset longevity, but it supports cost-effective investment in replacements.

In the pharmaceutical sector, the uptime of critical assets and associated cost control varies markedly. Primary production, involving active pharmaceutical ingredients (APIs), faces stricter regulations and higher stakes for compliance failures than secondary production, which includes filling and packaging. For high-value, patented products, uptime and batch loss prevention are critical, while cost control is crucial for off-patent products competing with low-cost manufacturers. Large life sciences companies are often balancing the needs of factories focused on uptime, with those competing on price.

Maintenance strategies must therefore include timely servicing, part replacements and adjustments, before faults become failures. Condition-based and predictive maintenance go a long way in avoiding unnecessary impediments, but regulatory compliance often demands routine preventive maintenance at more regular intervals. Coordination with production needs is essential, necessitating close communication and information sharing.

One of the most common challenges is a lack of a holistic view of assets, with information spread across unconnected systems. This fragmentation hampers data collection, problem-solving and performance benchmarking.

The adoption of mobile technology, connectivity and cloud solutions has huge potential for improving streamlined operations. Many organisations still use slow, error-prone paper processes instead of digital, instantaneous solutions. Pharmaceutical manufacturers can benefit from cloud access and remote asset management, because it saves them time and helps to avoid contamination.

To minimise cross-contamination, companies often separate primary and secondary production sites, with self-contained buildings for each product. Maintenance procedures are detailed and rigid, requiring a lengthy and often elaborate management of change process for any modifications. Regulation is a significant challenge in pharmaceutical manufacturing maintenance. Regular calibration of instruments to ensure accuracy and hygiene, while assessing contamination risks and impact on product quality. Maintenance activities must follow stringent controlled procedures, especially in cleanroom environments, where even minor interventions can cause substantial disruption. These regulations also vary by country, which can add numerous complexities. Manufacturers must comply with local, national and international regulations, ensuring traceability and documentation of all materials and activities, which are predominantly maintenance related. Production needs can change rapidly, as seen during the COVID-19 vaccine rollout. Agility is essential for pharmaceutical manufacturers, yet regulations can often slow them down.

Predicting future needs and ensuring flexible production capacity involves significant investment risk and requires strategic planning supported by robust data.

Poor communication and information sharing across teams severely threatens uptime. Couple this with both ageing assets and an ageing workforce, and it becomes painstakingly clear: improving cooperation and knowledge retention is crucial for future-proofing operations and responding to unprecedented events.

EAM (enterprise asset management) systems consolidate all data and functions related to an organisation’s assets onto a ‘single source of the truth’, easy-to-use platform. This integration eliminates wasteful duplication, offers a clear overview of activities, costs and issues, and promotes a coordinated approach to operations. EAM systems also enable efficient data correlation, analysis and utilisation, quickly offering extensive insights which allow the organisation to make well-informed decisions that enhance business performance.

For pharmaceutical companies, EAM software is particularly beneficial as it automates compliance in asset management and maintenance. It integrates controlled procedures and regulatory requirements, providing a comprehensive audit trail. EAM far exceeds basic maintenance management software. The best systems offer complete asset optimisation and management solutions, handling the entire asset life cycle from design to decommissioning. This includes planning, optimising, executing and tracking all maintenance activities. The software addresses key questions about asset longevity, inspection schedules and refurbishment or replacement timing. This intelligence bolsters both short-term and long-term planning, ensuring continuous compliance and future business success. Some EAM systems even feature a modular structure, allowing businesses to select the necessary modules and functions, with the flexibility to add more later. The best systems are customisable to meet specific needs and can often integrate with existing systems.

Cloud-based EAM systems offer easy access to information and functions for authorised users from any location via smartphones, tablets, laptops or desktops. Reporting an issue becomes faster and more reliable with self-service functionality for technicians, who can receive and input information directly through simple interfaces. This reduces communication errors from misinterpreted calls, lost notes and other discrepancies. Providing employees flexible access to tools, the ability to configure their own user experience and insights they need anytime and anywhere – for instance via mobile EAM – is important because mutual alignment between maintenance, safety and operations can be a competitive differentiator for pharmaceutical manufacturers.

Wearables are growing increasingly popular in the pharmaceutical sector. They are useful for visualising and confirming steps recommended when undertaking various tasks. It facilitates hands-free maintenance, decreases inspection time and assists in detecting errors. Creating a ‘hub and spoke’ process for remote and automated diagnostics, has the added advantage of fewer skills being required in-person, on the frontline, and increases the productivity of valuable human resources. More importantly, it has a positive impact on worker safety and injury rates.

In other areas of EAM innovation, digital twins and predictive modelling are enabling a virtual representation of a real-world system along with its real-time data, to help manufacturers make better business streamlining decisions. Internet of Things (IoT)-enabled assets also support automated, predictive maintenance scenarios, delivering both efficiency gains and cost savings. Artificial intelligence (AI) is also enabling industrial businesses to gain an unprecedented level of insight into their operations.

Asset-intensive companies like pharmaceutical manufacturers can no longer ignore the importance of addressing environmental, social and governance (ESG) challenges and sustainability reporting. By leveraging EAM, companies can optimise their operations, reduce waste and energy consumption, and minimise their environmental footprint. Importantly, it allows companies to monitor and track their asset performance, ensuring that they are operating efficiently and sustainably. With EAM, companies can identify areas for improvement and implement strategies to enhance their ESG performance.

Streamlining processes in the pharmaceutical manufacturing sector means addressing extensive and complex regulatory requirements rapidly changing production needs and high financial risks. Efforts to simplify can be hindered by poor visibility and correlation of data on asset-related activities, issues, performance and costs. This often stems largely from use of unconnected information systems.

Modular EAM software integrates controlled procedures and regulatory requirements, ensuring all maintenance actions are compliant and fully documented. Industry-specific systems not only help control current costs but also provide the quantifiable data and insight needed to shape a dynamic, long-term asset plan. This empowers organisations to make well-informed, strategic decisions on asset investment, which can be revisited and adjusted as circumstances change. EAM integrates and streamlines various divisions of an organisation, from maintenance teams to financial and human resources management. This is a huge transformation in reducing organisational complexity. Couple it with efficient mobile, connected and cloud-based technologies and the benefits proliferate.

References
1. https://marketscale.com/industries/engineering-andconstruction/whats-the-true-cost-of-machine-downtime/