FEATURE CHEMICALS & PHARMACEUTICALS
Rethinking automation in pharmaceutical processing
George Walker, Managing Director of pharmaceutical automation specialist Novotek UK and Ireland, explains how pharmaceutical manufacturers can find greater value in their automation layer
effectively MES 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.
E
ven before Covid-19 struck, the pharmaceutical industry was a growing business. According to Statista, the global revenues for pharmaceutical companies totalled $1.25 trillion in 2019 — an increase of $46 billion from 2018. Revenue has increased three-fold since 2001, yet many of the automated processes in this industry 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.
GUIDELINES 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)
24 APRIL 2021 | IRISH MANUFACTURING
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 (MES) 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. 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 the data management system is being managed safely and securely. 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 MES. These systems are
CLEARER IDEA Today, the EU Directive is better understood and pharmaceutical manufacturers have a clearer idea of what can be done within the guidelines. With much of the equipment 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, the automation layer can be applied to segment the data required for batch records from the data that is collected overall, which will 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. It provides the required security to satisfy EBR guidelines, and it features a user-management tool that allows engineers to easily define who 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?
Novotek UK
www.novotek.com/uk/ / IRISHMANUFACTURING
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