Digitalization Moves Forward in Pharma Equipment and Processes
2022-03-10
The benefits of digital maturity in pharmaceutical manufacturing were made evident by the COVID-19 pandemic during 2020 and 2021, as the sudden need to develop, manufacture, and distribute treatments and vaccines intersected with travel restrictions, social distancing, and supply chain interruptions. Digital technologies that could meet these new challenges and aid manufacturing scale-up and speed to market, such as automated digital data collection and augmented and virtual reality (AR/VR) remote collaboration tools, were already available and had been adopted by some, but the new demand spurred greater adoption. The need to solve manufacturing challenges gave more companies the incentive to initiate or make further progress on their digital transformation journeys.
In bio/pharmaceutical manufacturing, the application of “Industry 4.0” techologies, such as digitalization, must be aligned with regulatory requirements, including good manufacturing practices (GMPs). The International Society for Pharmaceutical Engineering (ISPE) has trademarked their initiative as Pharma 4.0, also dubbed the “Smart Factory,” and has developed an operating model, which the Pharma 4.0 special interest group notes goes beyond IT to organizational, process, and resource aspects (1).
“There is a cultural aspect to digitalization because it’s a significant investment that results in changes to the operational structure of a facility; it is beneficial when the digitalization comes from the top,” explains Yvonne Duckworth, automation engineer and Industry 4.0 subject matter expert at the CRB Group, a life sciences engineering and construction company. “We are seeing more often that management is driving the adoption of digitalization in new facilities. It is becoming a standard and expected part of facility design.”
In the past five years, pharma manufacturers have been moving toward digital maturity. Assessed using the BioPhorum Group’s Digital Plant Maturity Model (2), some manufacturers are at level 1 (predigital); some are at level 2 (digital silos and islands of automation); many are at level 3 (connected plants) on their way to level 4 (predictive plant with real-time predictive analysis), and others want to adopt some aspects of level 5 (autonomous, adaptive plant), says Duckworth.
Although in past years, digitalization primarily meant moving away from paper-based systems to digital reports that were then printed to electronic or physical paper, a new paradigm enables a jump from Pharma 2.0 paper-based systems to the Pharma 4.0 operator-centric connected plant, said Gilad Langer, industry practice lead at Tulip, which supplies a cloud-based front-line operations platform (3). “This paradigm shift changes the culture and the processes, but doesn’t significantly change the operator’s workflow. Instead, digital apps are built to bring the physical world to the digital world with sensors and cameras, with digital output as the evidence.
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