CONTROL & AUTOMATION RETHINKING AUTOMATION
NOVOTEK
Using automation obsolescence as an opportunity for innovation
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 threefold 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 . 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 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 further information , please visit www . novotek . com / uk
40 PECM Issue 48