Sports and athleticism sometimes have a tenuous relationship. Sure, there are the freak athletes who dominate their sport: Bo Jackson, Deion Sanders, and Jim Thorpe come to mind, each two-sport stars. But then there are the players who aren’t physical specimens that rise to the top of their profession. Thirty-seven place kickers stand atop the NFL’s all-time scoring leaderboard before you find a player who punched it into the endzone rather than kicked it. Place kickers aren’t usually described as freak athletes, and they’re certainly not what sells tickets. Baseball players are often mocked for not possessing the superhuman physique we’ve come to expect of professional ballplayers. This disconnect between expectation and reality isn’t just a sports phenomenon.
The pharmaceutical industry is critical to human survival. Without medicine, many of the miracles of modern healthcare would not exist. It would follow that the most technically advanced manufacturing processes in the world drive pharma, right? Not necessarily. While the most advanced smart manufacturing technologies, often referred to as Industry 4.0, have been utilized in food & beverage, mining and metals, and more, it has yet to find widespread adoption in pharmaceutical factories. Like sports and athleticism, industry and advanced manufacturing technology haven’t always gone hand-in-hand. And it’s not for a lack of need.
Pharmaceuticals are closely and extensively regulated, of course. So much so, it can be difficult to adopt new technologies. Such change, after all, would likely lead to process revalidation, an undesirable initial result. Plants use specific kinds of equipment that require meticulous inspection, their processes validated in scrupulous detail. Despite the hurdles, smart manufacturing offers incredible upside in terms of supply chain traceability. Upside that is well worth it.
The prior generation of breakthroughs in manufacturing were centered more on the shift from mechanical technology to digital computing and communications. This current shift takes those advances a step further by adding autonomy through artificial intelligence (AI), machine learning (ML), and the internet of things (IoT). In other words, we’re now endeavoring not just to produce massive amounts of data but to digest it into smart decision-making. These autonomous systems seek to improve manufacturing processes and quality assurance to increase productivity, efficiency, and quality while reducing risk and adhering to strict regulations.
What form does this take in “Pharma 4.0”? A more connected factory can better tap in to emerging markets, compete with generics, and optimize its products. Greater visibility leads to globalization that can still align on a local level. Production times can be slashed with access to real-time information.
With the rising need for personalized drugs, smart manufacturing makes it possible for pharmaceutical factories to move away from batch manufacturing in which production is stopped for quality assurance testing. Each time production is stopped, lead times increase and something can go wrong. With the flexibility, precision, and speed new technologies afford us, continuous manufacturing becomes possible.
With continuous manufacturing, substances move nonstop at a single facility, eliminating hold times, reducing the probability of human error and the likelihood of drug shortages.
Extensive raw material traceability plays a major role in smart manufacturing, particularly in the face of the strict regulation of pharmaceuticals. Being able to access data on incoming ingredients, their movement, storage, manufacturing processes, personnel assignments, and more provides critical details beyond whether a batch simply went bad. Now we can trace back problems to specific equipment and use diagnostic information to determine if there was a failure on that machine or with its operator.
With ThinkIQ’s Transformational Intelligence platform, pharmaceutical manufacturers gain access to a complete overview of all operations. From lab to jab, our smart manufacturing technology, including our semantic model and material ledger, dramatically reduces recalls, identifies weaknesses in the plant, and eliminates safety concerns.
A material ledger provides a novel approach to intelligent tracking of material and energy movement and transformations, their associate monetary value, and quality data. It delivers insight that improves yield, quality, safety, compliance, and brand confidence through a fact-based granular, data-centric contextualized view of material flows and related provenance attribute data. We utilize existing IoT infrastructure on which a cyber-physical system can be built to decentralize decision-making in favor of autonomous task-completion of all but the highest-level exceptions. It’s the next generation of smart manufacturing for the most mission-critical industry.
If you’re ready to connect expectation to reality with Pharma 4.0, contact us today. We also have a new selection guide eBook to help you better understand the questions you should be asking. Download your copy today.