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.
“These events directly showed the payoff of information technology (IT)/operational technology (OT) integration achieved over the last several years, but also revealed that we have an opportunity to do much more,” says Dan UpDyke, strategic marketing manager at Rockwell Automation. “The ability for the industry to pivot and quickly bring new therapies to market highlighted the need for flexible, saleable, and connected manufacturing systems. We have already seen an increase in integrating data and recipe management through a manufacturing execution system (MES) and flexible distributed control systems (DCS),” says UpDyke. “These are technologies that enable faster time to market by reducing the efforts to shift to new products.”
“As an industry, we’ve seen we need to be more efficient and we need to be able to monitor and manage processes remotely from a centralized location. People are focused on process intensification and how to better digitize and automate their processes,” says Merrilee Whitney, head of the BioContinuum Platform at MilliporeSigma, the US and Canada life science business of Merck KGaA.
The pandemic created a higher awareness of the need for digitalization, adds Dirk Wollaert, Vertical Market Pharma at Siemens headquarters in Belgium. Digital technologies were key to the success of the rapid development and rollout of the COVID-19 vaccines, facilitating cross-company collaborations even across national borders. “Globalization and industry standardization to facilitate smoother transition from one production plant to another became more important,” he explains.
Another change that accelerated in the past two years was a transition to the cloud for software solutions and data storage, adds Pamela Docherty, Life Sciences Industry manager at Siemens USA. “The ability to push data from the manufacturing floor to the cloud creates a backbone for digitalization,” she says.
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. Data from equipment and human activities are collected via the industrial Internet of things (IIoT),” explained Langer.
From data to digital twins
Digital tools depend first on good data collection. Having equipment that is set up for data collection and data analytics is becoming increasingly important, says Duckworth. Machine sensors and process analytical technology (PAT) instruments can communicate directly with data collection systems using the IIoT. These large quantities of data are needed for machine learning (ML), including artificial intelligence (AI) systems and digital twins, which are representations of the physical world in the digital world.
Visualizing data in ways that scientists and engineers can use to improve understanding and to optimize processes is also important. Technologies can enable an “end-to-end digital thread of information,” says UpDyke. “Multi-site manufacturing in different markets is pushing the industry towards more connectivity, improved visibility across sites and organizations, and increased knowledge and information sharing that will enable expedited recipe development.”
New England Controls, Inc. (NECI), which partners with Emerson, has developed and deployed new digital tools in the past year that enable access to data sources and aggregation into analytical tools to link the “physical plant” to the “digital plant,” says Michael Cody, director of digital and clinical manufacturing at NECI. Access to data with operational context is crucial for pharma manufacturing facilities, says Cody. “The need to aggregate and analyze data from a variety of data sources is pushing equipment and technology providers to be able to interface and communicate with those digital tools in a meaningful way,” he explains.
Digital twins are a tool being increasingly used in a wide range of scenarios, from engineering optimization of individual pieces of equipment to analysis of full manufacturing systems. Examples from the past year, says Docherty, include digital twins for process development with an innovative mixing application, a representation of a new skid to enable faster fabrication, an offline training system for a continuous direct compression line, and an alerting system to ensure that people were keeping proper distance on the manufacturing floor.
Source : https://www.pharmtech.com/view/digitalization-moves-forward-in-pharma-equipment-and-processes1076