For the better part of a century, pharmaceutical companies have produced their products through batch manufacturing, a process that typically follows a series of steps separated by hold times, off-site quality checks and complex equipment setup. Because batch manufacturing is a natural evolution from bench size manufacturing and government regulations called for strict product integrity, it became standard practice across pharmaceutical companies.
However, in recent years, experts have started recommending that pharma manufacturers shift to a continuous production model. In many other industries, continuous schedules have already been implemented with impressive results, helping plants increase output and respond quickly when the market changes, among other benefits. It makes sense, then, that the FDA and other government agencies have encouraged pharma plants to consider switching to a continuous approach as well.
A More Efficient Method
Perhaps the most significant advantage of a continuous production model is its increased efficiency. Unlike batch manufacturing, continuous processes don’t require hold times between production steps. Hold times range in length, but for some manufacturers, they involve moving product to other facilities and performing multiple tests to ensure quality. Consistently stopping and starting production also adds more time-consuming steps to the process, which are common sources of delays and human errors. By eliminating or minimizing hold times, continuous manufacturing can cut hours, days, or even weeks from total production time without sacrificing product quality.
It’s worth noting that the transition to continuous production can be logistically challenging, costly, and time-consuming. For certain pharmaceutical processes, there’s also still equipment or technology missing from continuous models that would be needed to complete production. However, the total time savings and revenue increases associated with switching to continuous production has already proven its worth to a number of pharmaceutical companies, including Pfizer and Eli Lilly, who have implemented continuous production at plants in recent years.
Increased Productivity and Flexibility
As is evident in its name, continuous manufacturing naturally allows your plant to produce more product in the same amount of time. There are a multitude of benefits associated with increased output, including more product to sell and distribute, increased availability of the pharmaceuticals, and less chance of a shortage. As the current pandemic has clearly illustrated, it’s critical for patients’ health to have pharmaceuticals widely and quickly available as soon as they’re needed.
Continuous manufacturing also allows for more flexibility within pharmaceutical manufacturing. By building around steady-state processes, many of the variables of traditional batch manufacturing, such as titer, are more tightly controlled. This consistency creates the opportunity for improvements in process efficiency and automation, increasing overall asset utilization and process throughout.
If your organization is considering making the switch to continuous manufacturing, an optimization tool like VirtECS is a key instrument in analyzing the opportunity and impact of switching to a continuous production schedule. If there are potential roadblocks standing in the way, VirtECS will uncover them and help you find the most efficient path forward when creating schedules within this new paradigm. VirtECS has been and continues to be used by several pharmaceutical manufacturers, and over the years, our team has developed a deep understanding of the unique challenges these plants face when optimizing production. If you’re interested in learning more about using VirtECS at your pharmaceutical plant, one of our experts would be happy to chat with you.
