Building the pharmaceutical facility that is ready for change

Pharmaceutical manufacturing is becoming harder to predict. Facilities that were once designed around relatively stable products and production models must now accommodate high-volume demand for therapies such as GLP-1 analogues while also preparing for increasingly complex and personalised medicines. At the same time, manufacturers face pressure to reduce costs, strengthen supply resilience and bring new products into production more quickly, all while responding to a persistent cyber threat environment and maintaining quality and regulatory control.

For pharmaceutical manufacturers, digitalisation increasingly must deliver more than automation or the replacement of paper-based processes. The greater opportunity is to create a manufacturing environment able to accommodate changes in products, volumes and processes while maintaining control over how those changes are executed.

Rockwell Automation describes this as the Facility of the Future, but the most important part of the concept is not the technology itself. It is the operating model that technology enables. A future-ready facility needs connected information, adaptable production processes and the ability to demonstrate control continuously rather than assembling evidence retrospectively when it is required.

Recent research suggests the industry is already moving in this direction. Rockwell Automation’s latest life sciences research found that 90 percent of respondents consider digital transformation necessary in response to changes in industrial technology, while 58 percent have implemented smart manufacturing technologies either at scale or across parts of their operations. Yet only 32 percent report effectively using more than half of the data they collect.

The next stage of digital maturity therefore depends less on adding individual technologies and more on connecting what manufacturers already have.

From digital projects to connected manufacturing

Life sciences companies have invested heavily in automation, data platforms and digital tools, but these investments do not automatically create a connected manufacturing environment. Production, quality, engineering and business systems often still operate as separate domains, leaving manufacturers with valuable information that is difficult to combine or use in context.

As manufacturing operations become more complex, the value of connected information grows across every stage of production. Quality teams need timely access to production data, operators need the correct procedures and instructions at the point of execution, and engineering changes must be reflected accurately on the factory floor. At the same time, production records need to provide the traceability required by quality and regulatory teams.

The latest Rockwell Automation State of Smart Manufacturing findings show where investment is heading. Life sciences respondents identify AI and machine learning as the technology expected to have the greatest impact at 46 percent, followed closely by process automation and optimisation at 44 percent. Improving quality is the leading driver behind transformation initiatives at 43 percent, while digitising operations and reducing safety, cybersecurity and compliance risk are also significant priorities.

The challenge is that advanced capabilities such as AI cannot be exploited fully where you have fragmented underlying operations”

The challenge is that advanced capabilities such as AI cannot be exploited fully where you have fragmented underlying operations. If production information lacks context, sits across disconnected systems or requires extensive manual reconciliation, scaling analytics or AI becomes much harder.

This is one reason the manufacturing execution system is becoming increasingly important. Manufacturing Execution System (MES) occupies the operational space between enterprise systems and automation, turning production requirements into controlled execution while capturing what happens during manufacturing.

Making MES part of the operating model

For pharmaceutical manufacturers, MES has traditionally been closely associated with electronic batch recording and the removal of paper from production. Those remain important capabilities, but the role can now be much broader.

FactoryTalk^® PharmaSuite^® MES, for example, combines electronic batch records with resource management, recipe design and execution, weigh-and-dispense workflows and exception management. Production-relevant resources, including materials, equipment and personnel, can be captured within the electronic batch record, while master recipes can be constructed using standard building blocks based around ISA S88 and ISA95 principles.

That changes the value proposition from simply recording production electronically to controlling how production is performed. Role-based interfaces can guide operators step by step through procedures while providing different capabilities to employees responsible for areas such as batch-record development. Review by exception allows quality personnel to concentrate attention on deviations rather than manually reviewing every part of a batch record. PharmaSuite^® is also designed to integrate with both the ERP systems and the automation layer, helping production information move seamlessly between systems rather than being maintained independently in several places.

For manufacturers expanding production or introducing new products, standardisation also has to coexist with flexibility. A rigid MES implementation may solve today’s production problem but make tomorrow’s change more difficult. Configurable workflows and reusable building blocks provide a way to establish common production practices without requiring every facility or process to be identical.

This becomes particularly valuable for organisations operating across EMEA, where manufacturers may need to modernise established facilities while also supporting new production capacity. The objective is not necessarily to replace everything already installed, but to create an architecture in which existing and new systems can participate in a more connected production environment.

Continuous readiness changes the compliance model

Greater connectivity has implications beyond manufacturing efficiency. The digital systems used to execute production increasingly form part of the evidence manufacturers depend upon to demonstrate process control, product quality and data integrity.

Rockwell Automation’s life sciences report uses the term continuous readiness to describe an operating model in which regulatory preparedness is built into day-to-day manufacturing rather than treated as a separate exercise ahead of an inspection or information request. In practice, this means keeping production records, data, controls and audit trails accurate, accessible and up to date so the organisation can demonstrate compliance and process control when required.

MES can make an important contribution because the evidence required later is created during execution. Electronic records, audit trails, production information and exception handling become part of the contemporaneous manufacturing process rather than a separate documentation exercise.

The same foundation can also support digital evidence management. In regulated manufacturing, batch records, deviations, CAPA information, change-control documentation and validation evidence need to be available with the appropriate context for review. Standardised data models and clearer traceability between operational and enterprise systems can make that information easier to trust, retrieve and reuse.

That connection between operational execution and information governance becomes more important as manufacturers begin using AI in regulated environments. Among life sciences organisations already using AI and machine learning, 64 percent expect to expand its use during the next 12 months. Planned applications include quality control, cybersecurity and process optimisation.

AI readiness therefore starts well before an algorithm is deployed”

AI readiness therefore starts well before an algorithm is deployed. Manufacturers first need reliable information about products, processes and production events, together with the governance required to understand where that information came from and how it is being used.

Designing the facility as one system

MES is central to the Facility of the Future, but it cannot deliver that model in isolation. The greater opportunity comes from connecting execution with the technologies that design, control and analyse production.

Digital twin technology such as Emulate3D can allow facilities and production processes to be designed and tested virtually before physical deployment, helping engineering teams identify layout, control and sequencing issues earlier. At the control level, Rockwell Automation’s PlantPAx distributed control system (DCS) provides the platform for managing and coordinating process operations across the facility. Connecting PlantPAx with PharmaSuite^® MES can then improve the flow of production information between the systems responsible for execution and those controlling the underlying process.

The significance of that architecture is its ability to accommodate change. A pharmaceutical facility may need to introduce another product, alter production volumes, adopt a different manufacturing process or bring additional capacity online. If each change requires extensive manual integration between isolated systems, flexibility disappears precisely when the business needs it most.

The Facility of the Future should therefore be understood less as a destination than as an operating capability. It is a facility in which production can evolve without losing the digital thread that connects instructions, execution, quality and evidence.

For pharmaceutical manufacturers, that may ultimately prove more valuable than any individual technology. Digital transformation has already moved beyond experimentation across much of the sector. The question now is whether those investments can be connected closely enough to create manufacturing operations that remain ready as products, technologies and regulatory expectations continue to change.

View Rockwell Automation’s ‘State of the Art Smart Manufacturing’ report, here.