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In a Covid world, what’s next for pharmaceutical manufacturing?

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Giuseppe Menin, industry manager for Pharmaceuticals at COPA-DATA, and member of the International Society for Pharmaceutical Engineering (ISPE) 4.0 Plug & Produce working group, explains why the pharmaceutical industry is shifting from a systems-oriented architecture to service-oriented.

As Covid-19 was declared a pandemic in March 2020, the pharmaceutical sector needed to adapt – and fast. Within a matter of months, there were over 1,000 clinical trials ongoing and 167 vaccine projects were underway by the end of August. The pharmaceutical industry takes action fast, but the industry’s manufacturing realm has not always kept pace. 

Pharmaceutical’s plant architecture has remained relatively unchanged in the last few decades. Regardless of the rapid rate of development in drugs and medicine, pharmaceutical manufacturing sites typically operate with legacy equipment and use traditional automation architectures.

Often, this architecture uses separate levels of automation for different types of systems. Whether that’s business applications like enterprise resource planning (ERP) or product lifecycle management (PLM), or MES or processing monitoring applications, like SCADA software. Typically, these systems will operate in their own silos. However, it doesn’t need to be this way.

Pharma architectures

With complex regulatory requirements, the pharmaceutical industry is certainly more risk-averse than other sectors – hence the hesitation to deploy new technologies and shift from the status quo. However, while traditional automation architecture may be tried-and-tested, it simply isn’t optimal for the modern pharmaceutical industry.

Let’s say a plant operative wants to remove potential wastages from production. This could be related to energy, ingredient or mechanical waste. To determine areas in which waste is occurring, the operative would need to extract subsets of data from different systems, such as the manufacturing execution system (MES), Laboratory Instruments Management System (LIMS), ERP and SCADA.

To determine where waste is occurring, an operator would need to take multiple steps between laboratories, production and enterprise space to gather all of this information. Typically, an engineer wouldn’t be familiar with all of these areas – production engineers, for instance, aren’t expected to understand datasets from a laboratory and vice versa.

In an ideal world this data would be integrated into a harmonised interface, providing the operative with a ready-made method to spot areas of waste. What’s more, this should ideally be visualised in a way that anyone could understand. Whether that person works in engineering, product development, purchasing or even the administration side of the business.

There are already technologies that enable some integration for pharmaceutical manufacturers, but this rarely offers the flexibility outlined above. Instead, these might be suited for factory floor workers only, or just for enterprise staff.

In truth, the industry needs a shift from this architecture type and a move to a services-oriented structure where integration is the rule, not the exception.

What is service-oriented architecture?

A service-oriented architecture describes a plant that operates as a grid of modular micro services – all of which can integrate with each other when necessary. Consider it like making a meal in a kitchen. While you may know exactly where to find your ingredients and equipment, the process of collecting these items from separate areas of the kitchen is far more long winded than having access to a pre-laid buffet. Much like our aforementioned waste identification example.

By choosing a buffet of data, as enabled by the service-oriented approach, pharmaceutical manufacturers can reap considerable benefits. The model allows for more flexibility, by enabling the quick assembly and disassembly of systems in the architecture.

It also enables better scalability than previous models by ensuring that the data can be reorganised and presented in a way that’s beneficial to whoever is looking at it. Returning to our earlier example, an operator wouldn’t need to visit the laboratory, offices and production space to collect data. Instead, the data can be distributed in various services and accessed from a single interface.

Importantly for the pharmaceutical industry, this model also ensures that all actions are compliant with the relevant regulations. This way, our operator’s actions to reduce waste won’t have a detrimental impact on the products compliance against certain standards.

This element couldn’t be more crucial for the pharmaceutical industry. As the sector has spent much of the last year advancing the fast development of a vaccine, ensuring production is compliant with the necessary regulations – while reducing inefficiencies and wastages – has been crucial.

As the pandemic has demonstrated, the pharmaceutical industry moves fast, and the technologies used in pharmaceutical manufacturing should be advancing too. The ISPE Pharma 4.0 initiative is working to ensure this happens. The group is designing new architectures to accompany the pharmaceutical sector towards more flexible, interoperable and sustainable production.

Pharmaceutical manufacturers must embrace a paradigm shift in how automation architectures are traditionally constructed to keep pace with the industry’s product development, moving away from a system-oriented world into a services-oriented architecture.

Giuseppe Menin

Industry Manager for Pharmaceuticals at COPA-DATA

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