**London**: The biopharma manufacturing sector faces the challenge of maintaining operational efficiency amidst stringent regulations. Innovative technologies, including predictive maintenance and real-time monitoring, are crucial for compliance and performance, driving manufacturers to adopt integrated asset management strategies for success in a competitive landscape.
In the biopharma manufacturing sector, operational efficiency is critical, as delays can affect the progress of vital research and disrupt production pipelines. The challenge of maintaining this efficiency is compounded by the stringent regulatory landscape that governs the industry. Within this framework, both regulatory compliance and precision are paramount, making effective asset maintenance strategies essential for success.
According to the European Pharmaceutical Manufacturer, operations within the biopharma industry must adhere to rigorous guidelines, including Good Practice (GxP) and Good Manufacturing Practices (GMP), as enforced by the Medicines and Healthcare Products Regulatory Agency (MHRA). The separation between a manufacturer’s systems and those of engineering providers can lead to data silos, limiting the insights that engineers can offer regarding asset performance. To encourage a seamless exchange of information, a custom-built integration of Enterprise Asset Management (EAM) and Computerised Maintenance Management Systems (CMMS) is essential.
Recent trends highlighted in a McKinsey report on pharma operations indicate a shift towards the incorporation of digital and analytics tools, which are increasingly becoming crucial in streamlining processes. Integral to this strategy are sensors that monitor the condition of assets in real-time, providing engineers with valuable data on performance indicators such as temperature and vibration levels. For instance, EMCOR UK developed a cost-effective solution for monitoring Local Exhaust Ventilation (LEV) systems aimed at ensuring compliance and operational uptime for laboratory personnel.
The enhancement of data visibility led to the creation of a weekly check-in app that increased oversight of over 1,200 assets in real time. Previously reliant on a CMMS with limited reporting functionality, the new system now allows for comprehensive data analysis, including failure statistics and asset usage insights. By scanning QR codes, scientists can access essential information about the status and maintenance history of the LEV cabinets they utilise.
Furthermore, advancements in digital and predictive maintenance technologies are improving how biopharma manufacturers navigate compliance while enhancing operational efficiency. Predictive maintenance solutions, utilizing AI-driven analytics and IoT sensors, enable early detection of potential asset failures, thus reducing the likelihood of costly unplanned downtimes. Among the innovative technologies emerging in this domain is digital twin technology. Although adoption has been slowed by compliance concerns, digital twins present an opportunity to revolutionise compliance oversight and engineering training by allowing for virtual simulations of maintenance tasks.
A strong collaboration between facilities management providers and pharmaceutical manufacturers is vital to harness the benefits of digitalisation and data analytics. This requires a nuanced understanding of regulatory requirements, asset locations, and maintenance histories to ensure that services align with the strategic objectives of the manufacturer. At EMCOR UK, this integrated approach is evident through their Contract and Asset Management (CAM) strategy, which focuses on meticulous planning, performance optimisation, and ongoing compliance assurance.
EMCOR UK has established a structured process for service delivery that emphasises proactive asset monitoring, real-time tracking of performance, and streamlined maintenance schedules. By aligning service delivery with a manufacturer’s operational needs, the approach fosters a culture of continuous improvement and operational resilience.
To advance the industry as a whole, it is imperative for companies to engage with evolving digital tools and maintain strong partnerships with their facilities management providers. Decision-makers in the pharmaceutical sector are being encouraged to assess their existing asset management strategies and consider the adoption of innovative technologies. Such adjustments promise to enhance regulatory compliance and operational efficiency, positioning biopharma manufacturers for success in a rapidly evolving landscape.
Source: Noah Wire Services
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