Despite the challenges involved, the opportunity to make step change operational improvements is encouraging life sciences companies to embark on control system modernisation projects well before parts become hard to source and the system impacts productivity (usually the prerequisites). We speak with Emerson’s Rob Spilsbury and Albina Pace about how modern control systems support improved traceability, compliance and production efficiency, and how innovative software tools can help life sciences companies to reduce project time, cost and risk.
In the past, has there been some reluctance by life sciences companies to modernise the control system?
Rob Spilsbury: In general, due to the impact on operations and potential strain on internal resources, life sciences companies have avoided modernising their control system until it has truly reached the end of its operating life. When hardware parts became difficult to source and the general health of the system impacted availability and productivity, that would tip the balance and a modernisation plan would then become essential. Increasingly, however, life sciences companies see control system modernisation as an opportunity to make step change operational improvements. There is a desire to reduce production variability and increase both flexibility and efficiency and these can be achieved through a modern control system. We are seeing a genuine change in attitude from control system engineers from that of having the unwanted task of updating the control system to searching for control system functionality and capabilities that help them achieve performance improvements.
Albina Pace: I would say that it is not so much a reluctance to modernise the control system, but more an understanding of the challenges of performing a system migration that may have held companies back. Those yet to update their control system understand the benefits of doing so and are carefully evaluating the appropriate point at which to make an investment. Replacing control systems can be a daunting task that requires significant planning and execution capability. To help life sciences companies, Emerson provides a free-of-charge report, specific to their existing control system, that outlines the work required to migrate to the DeltaV™ Distributed Control System (DCS). Using Emerson’s DeltaV REVAMP software, the configuration of their existing control system is analysed. Artificial intelligence identifies patterns of common configuration in the legacy system and maps these patterns to standard function blocks, or a library of basic control strategies. From this analysis, a detailed configuration report is provided, focused on areas such as I/O, function blocks, logic diagrams and system interconnections. The report helps companies understand how much standardisation and configuration is required and can form the basis of a DCS modernisation project strategy. If you would like to get a free report, simply complete this form.
What are pharmaceutical manufacturers trying to achieve?
Albina Pace: The industry is embracing software solutions that eradicate manual and paper-based approaches, support faster technology transfer and help accelerate products to market. Life sciences companies now want end-to-end digital manufacturing solutions that provide greater visibility and transparency across their organisation, including their production and supply chain.
Rob Spilsbury: Life sciences companies are at different points in the plant digital maturity model. Most have transitioned from paper-based and manual processes, but you will find many with islands of automation and some manual processes still in place. Organisations are now moving closer to having fully connected plants, with vertical integration of control system, manufacturing execution system and enterprise resource planning. A modern control system is essential, not only helping to coordinate sophisticated operations across the plant, but improving data management. The aim is for optimised, efficient and consistent production, with minimal operator interventions that might introduce variability impacting quality. The control system must also help to simplify data management, supporting fully automated electronic record-keeping for improved traceability and streamlined audit trails.
What benefits do modern control systems provide life sciences?
Albina Pace: An obvious example is the possibility to perform real-time release to support more efficient quality assurance procedures. Real-time release testing is an advanced approach to quality control. This enables pharmaceutical products to be evaluated using `in-process’ data gathered during the manufacturing process. This is where a modern control system can provide a huge advantage. Spectral Process Analytic Technology can now be integrated into the DeltaV DCS. This helps to eradicate the need for lab testing for quality validation purposes. By adding real-time spectral analysis and creating a closed loop verification process, this can help prevent potential delays of days or weeks.
Another way control systems are supporting greater production efficiency is by providing the ability to predict end of batch quality. Rather than producing a batch and then discovering afterwards that there was variability or an error that may impact quality, a modern control system can identify faults in the batch process in real time. DeltaV Batch Analytics performs a multivariate analysis using models from historical batch production. Any deviation is flagged, which enables operators to make immediate corrections. This can prevent lost batches, and the time and costs associated with that.
Rob Spilsbury: Life sciences companies need access to meaningful real-time and historical production data. DeltaV Batch software provides fully automated electronic batch record-keeping that helps to streamline the audit trail and ensure that manufacturers follow cGMP. By storing historical data, automatic batch and process event capture and system configuration, this improves traceability and helps to ensure compliance. Albina earlier touched on the need for greater visibility across life sciences organisations. Control systems generate, collect and aggregate vast amounts of valuable production and operational data, which can be used for much more than just process control. The DeltaV Edge Environment is helping to simplify and maximise secure access to production data by on-premises and cloud-hosted enterprise software applications. Rather than let data sit within the control system, and wait for it to be accessed, DeltaV Edge Environment works by using a data provider to consolidate different data types. An encrypted, outbound-only data flow to an edge node provides airtight protection that bypasses firewalls and the Purdue model. The edge node creates a high-accuracy, high-resolution control system data replica. Authorised users then have constant access to near real-time data without the risk of them accessing the control system.
For more information about the benefits life sciences organisations can realise through the implementation of a modern control system, visit our website.
Albina Pace, Industry Sales Director, Life Sciences Europe at Emerson
Rob Spilsbury, Senior Sales Director, Control System Modernisation at Emerson
