The global demand for pharmaceutical products has grown consistently since the turn of the century. Despite the growth in demand and market value, pharmaceutical manufacturing has by and large neglected many of the productivity and efficiency benefits presented by automation systems. Here, George Walker, managing director of pharmaceutical automation specialist Novotek UK and Ireland, explains how pharmaceutical manufacturers can find greater value in their automation layer.
Even prior to 2020’s COVID-19 outbreak and global pandemic, the pharmaceutical industry was one with climbing demand. According to Statista, the global revenues for pharmaceutical companies totalled $1.25 trillion in 2019 — an increase of $46 billion from 2018. Although specific demand figures are difficult to gauge, it’s reasonable to surmise that they would be increasing in line with revenue.
Although revenue has increased three-fold since 2001, many of the automated processes and approaches implemented by pharmaceutical manufacturers have remained the same.
In 2001, the US Food and Drink Administration (FDA) and the EU worked closely together to develop the 2001/83/EC Directive for good manufacturing practice (GMP) and good automated manufacturing practice (GAMP) in the production of pharmaceutical products. A core part of this directive was to ensure safety in drugs by outlining a need for extensive validation and documentation of manufacturing processes and setpoints.
Pharmaceutical manufacturing is a careful and complex series of processes. Once an initial formulation for a product is proven, proportions of biological agents or chemicals must then be correct at scale to preserve the efficacy of the drug as designed, without risks such as adulteration. This involves meticulous control of variables such as ambient temperatures, characteristics of incoming raw materials and dosing levels, as well as conducting routine temperature checks and providing staff with effective protective equipment.
To follow GAMP and comply with the EU Directive, pharmaceutical manufacturers are required to not only validate their processes, but also extensively document the rules around setpoints — such as sensor data, ambient conditions and programmable logic controller (PLC) settings — and evidence that checks are routinely undertaken. If any changes are made to processes or systems that can affect product quality, manufacturers must go through the costly process of re-validating and re-documenting their production.
For many automation engineers, it seems intuitive that these requirements readily lend themselves to digitisation using automation systems such as manufacturing execution systems (MESs) to monitor and control processes. However, many manufacturers misinterpreted the need for repeat validation and documentation as extending to all changes in the control system, not just the ones directly related to production quality. This means even component or equipment health indicators, such as motor speed or temperature, would not be controlled; effectively meaning that automation systems were not used to their fullest. This was further compounded by misinterpretation around electronic batch record (EBR) guidelines.
Effective management can include ensuring that the system is tamper-proof to avoid manipulation of sensor data, locking the server to all but authorised personnel and introducing extensive change control practices that cover all underlying automation systems.
The reality is this is an overcomplication of the EU guidelines that led to many pharmaceutical businesses introducing paper on glass MESs. These systems are effectively MESs without the execution functionality; they are simply a way of digitally recording precisely what was formerly handwritten. Yet because of the expense incurred in introducing these systems, combined with the perceived cost of re-documentation, they are still commonplace.
Today, the EU Directive is better understood and pharmaceutical manufacturers have a clearer idea of what can be done within the guidelines. And due to the amount of years that have elapsed since the introduction of the guidelines, many of the systems are likely to be nearing obsolescence in the coming years. As such, now is the ideal time for manufacturers to look at how they can not only replace their systems, but also improve their capabilities.
For example, now could be a good opportunity to redeploy the automation layer to segment the data that is required for batch records from the data that is collected overall, offering a platform to improve operations. This could be done in multiple ways, but one of the most effective could be to use a server such as Kepware’s KEPServerEX alongside a data historian software that can collect richer data and separate it effectively.
KEPServerEX offers an ideal solution because it provides the required security to satisfy EBR guidelines. KEPServerEX features a user management tool that allows engineers to easily define which users can access different projects and tasks. This restricted access can be limited by certain tags which belong to certain projects, allowing easy distinction between batch record data and operational performance data. In addition, KEPServerEX adds authentication and encryption to its data sources to keep data secure.
Obsolescence is normally a negative for most industries, but in the case of pharmaceutical manufacturing it offers the ideal opportunity to take a more informed, creative approach to process control and automation. If systems need replacing and revalidating anyway, why not look at what you can do better?
Pharmaceutical manufacturers do not need to know the intricacies of modern automation features to plan an overhaul of their current process. Working with specialists like Novotek UK and Ireland allows pharmaceutical companies to get insight into what is possible, once they have first established what they want to achieve while maintaining compliance.
The global pharmaceutical market continues to grow in demand and become more competitive. If system obsolescence is on the horizon, now might be the perfect time to consider how operations can be made more efficient and competitive to provide greater value.