May 2021

40 n MEDICAL & PHARMACEUTICAL May 2021 www.drivesncontrols.com Time for to pharmaceutical firms to rethink automation? E ven before the outbreak of the Covid- 19 pandemic, the pharmaceutical industry was experiencing a boom. According to Statista, global pharmaceutical revenues totalled $1.25 trillion in 2019 – $46bnmore than in 2018. But, although revenues have increased three-fold since 2001, many of the automated processes used by pharmaceutical manufacturers have stayed the same. The US Food and Drink Administration (FDA) and the EU worked together to publish the 2001/83/EC Directive in 2001, covering good manufacturing practice (GMP) and good automatedmanufacturing practice (GAMP) in the production of pharmaceutical goods. A core aim of the directive was to ensure drug safety by outlining a need for extensive validation and documentation of manufacturing processes and setpoints. Pharmaceutical manufacturing is a complex series of processes. Once an initial formulation is proven, the correct proportions of biological agents or chemicals must then be maintained at scale to preserve the efficacy of the drug, avoiding risks such as adulteration. This involves meticulous control of variables such as temperatures, characteristics of incoming raw materials and dosing levels, as well as conducting temperature checks and providing staff with effective protective equipment. To follow GAMP and comply with the EU Directive, pharmaceutical manufacturers not only have to validate their processes, but also have to document the rules around setpoints – such as sensor data, ambient conditions and PLC settings – and evidence that checks are being performed routinely. If any changes are made to processes or systems that could affect product quality, manufacturers must go through the costly process of re-validating and re-documenting their production processes. For many automation engineers, it seems intuitive that these requirements lend themselves to digitisation using technologies such as manufacturing execution systems (MESs) to monitor and control processes. However, many manufacturers have misinterpreted the need for repeat validation and documentation as extending to all changes in the control system, not just the ones related directly to production quality. This means even component or equipment health indicators – such as motor speeds or temperature – would not be controlled, and that automation systems were not being used to their fullest. This was further compounded by misinterpretation around electronic batch record (EBR) guidelines. As part of the EU guidelines, auto-generated data from automation software systems can be used in EBRs, but only if pharmaceutical manufacturers can demonstrate that their data management systems are beingmanaged safely and securely. Effective management can include ensuring that systems are 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 that this is an overcomplication of the EU guidelines that has led to many pharmaceutical businesses introducing paper- on-glass MESs – effectively MESs without the execution functions. They are simply a way of recording digitally what was previously handwritten. Yet, because of the expense incurred in introducing these systems, combined with the perceived cost of re- documentation, they are still common. 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 time that has elapsed since the guidelines were introduced, many of the systems are nearing obsolescence. 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 separate the data that is required for batch records from the total collected data, offering a platform to improve operations. This can be done in several ways, one of the most effective being to use a server – such as Kepware’s KepServerEx – alongside a data historian software that can collect richer data and separate it effectively. Obsolescence is usually 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 technologies to plan an overhaul of their current processes. Having first established what they want to achieve, they can then discuss the possibilities with automation specialists. Nowmight be the perfect time for pharmaceutical manufacturers to consider how they couldmake their operations more efficient and competitive to provide greater value. n Many pharmaceutical manufacturers have neglected the productivity and efficiency benefits of modern automation systems. GeorgeWalker, managing director of pharmaceutical automation specialist, Novotek UK and Ireland, argues that they could benefit by taking a closer look at such systems. Pharmaceutical manufacturers don’t always take full advantage of what automation can offer