“People are trying to use the information that used to just live in these binders upon binders of paper.” Cytiva’s Kristen Manchester explained how digital transformation has increased data visibility at her company during the Automation Fair At Home Life Sciences Industry Forum.
The life sciences industry has seen some of the swiftest technology shifts due to the effects of the COVID pandemic. Being on the front line of developing products to combat the virus puts these organizations in a unique position. Not only do companies have to deal with the new realities of manufacturing in a social-distancing environment, but these same companies are also responsible for producing the equipment and medicines to battle the virus.
Digital transformation has quickly moved to the forefront to aid these companies in keeping workers safe and expediting product development—not to mention maintaining equipment reliability and streamlining data capture and analytics.
In this week’s Life Sciences Industry Forum at Automation Fair At Home, presented by Rockwell Automation, industry panelists discussed how their organizations are addressing digital transformation amidst a global pandemic.
“We always ask why we are digitalizing something,” said Hooman Hooshiar, director of manufacturing technology at Fresenius Kabi USA. “We are in the middle of our MES (manufacturing execution system) rollout, but we have our sights on some future goals, such as predictive and prescriptive analytics.”
Eliminating the paperwork is also a big advantage of digitalization for highly regulated pharma companies. “We were getting some paperwork three days after the fact,” said Tom Oberbeck, manager, MES, bioMérieux. “We have a need for electronic batch records. We have a need for ERP (enterprise resource planning) systems. We want to get to an area where we’re more predictive.”
It’s possible to fill an entire bookshelf with the paperwork that’s generated for just a few batches in the pharmaceutical industry, emphasized Kristen Manchester, senior product manager, MES and sensors, Cytiva. “We’re on our own journey at the same time we’re helping our customers. From our side, we’re approaching Level 3 of the digital plant maturity model.”
For Cytiva customers, quality and compliance are top priorities. “We are figuring out how to manage those large data sets and how to be able to put tools on top of that to do analytics,” said Manchester. “Of course, there are efficiency benefits in terms of reduced paper. People are trying to use the information that used to just live in these binders upon binders of paper.”
The journey at Thermo Fisher Scientific began years ago with data integrity. “We began looking at all the ways we could reduce risk by taking advantage of the data we had, and could take us from reactive to proactive,” said Chris Binion, director of innovative and immersive technology, Thermo Fisher Scientific. “We wanted not just the reduction, but the replacement of paperwork. We are enabling our employees with superpowers: the ability to access data and look at historical trends. We are marching toward Level 3 and moving beyond that in the future.”
At Fresenius Kabi, operating in a regulated environment creates unique challenges. “The compliance aspect is very important,” noted Hooshiar. “When it comes to technical challenges, because of the advantage of not having to validate again, virtualization is very important to us. We have the highest level of scrutiny, because we’re in pharma, for good reason. All of this infrastructure in plants that we just built could be a single point of failure from a cybersecurity standpoint. How do we achieve cybersecurity in a validated GxP (good practice) environment? We have to deploy special tools. Cyberseucrity needs to have a different approach in a pharmaceutical environment than it does in an office environment.”
The technology is changing so fast, said Binion. “But all of this has to be wrapped in cybersecurity,” he explained. “It’s different than it used to be. Auditors are used to looking at things a certain way. We’ve been taking a risk-based approach, looking at how we’re reducing our risks to our products and our patients. We are enabling our people with the ability to make drugs. We are a zero-defect industry. Everything we do maximizes patient safety and product quality.”
Networking different devices can be a challenge, too. “It’s frustrating from our perspective. We also have a lot of systems in place, but not every system is talking to each other,” said Oberbeck. “We have an ERP system, a QMS (quality management system), and MES. They might not be talking to each other.”
The biggest problem is being open to adopt the new technology, explained Hooshiar. “That change management is sometimes a little challenging,” he said. “We brought the stakeholders in early to the design process. We brought in operators. We bring in the end user of the product.” People are much more open to new technology if they’re introduced to it early in the process, Hooshiar advised.
“The customer needs will drive the outcome,” added Manchester. “In the end, we’ll be delivering a solution that gives them the most impact. Our customers struggle with when to make the investments to put technology in place. There are some concerns to delaying the opening of the facility if you’re putting an MES in place. Will the tools already be out of date? They want to drive down costs and eliminate opportunities for errors. How can we help them grow into it?”
Thermo Fisher Scientific is going deep and then going wide, as Binion explained it. “We spend the first year developing expertise and figuring out the best fit for our company,” he said. “We’ve done kind of like Ikea. We’re building immersive models. If this is your problem, here is the solution, boxed up and ready to go. We’ve looked at how to standardize those solutions and implement them across the Thermo Fischer network. We built a taxonomy for the technology. We look at management and support, and we’ve built a matrix. The main thing that has allowed us to do this is developing use cases. If you want some form of remote tele-presence, what are the expected key performance indicators? Reduced travel and expense, less downtime, fewer employees on the shop floor?”
Everyone knows the world has turned upside down, concluded Binion. “In the early days, we had a backpack prototype with a 360° camera on it, and we used smart phones,” he explained. “We tried just about everything to engage our customers. We had already done some immersive technologies. When COVID hit, we were ready. We were in the process of bringing those to the shop floor. It placed us in a unique opportunity. We were able to pull a robot out of the closet that was six months into deployment and start using it. We were able to react very fast. Everyone needed to be able to connect in new ways. Nothing in the world stayed the same. We had to use immersive technologies to change the way we interact with the world. It has changed our program dramatically. It’s overcoming the fears of adoption and accelerating the digital transformation in our companies.”
The pandemic also changed the healthcare industry, from a business standpoint. “A lot of people have skipped elective surgeries as the pandemic has taken place globally, so we had to switch from products designed for elective surgeries to products related to COVID,” explained Hooshiar. “Automation and flexibility don’t go hand in hand. MES is the place where we can utilize digitalization and respond to markets more quickly.”
With COVID, only essential personnel could be in facilities, explained Oberbeck. “It got interesting really quickly, as far as who is essential,” he recalled. “It turned on a dime this year. What are we doing? How quickly can we get up to speed?”
Cytiva is rethinking the way it interacts with internal teams and the way it provides support to customers. “How can we support factory acceptance tests in a virtual manner?” Manchester cited as an example. “I really do think it will accelerate acceptance of technologies.”
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