The stakes could not be higher for the end consumers of pharmaceuticals, which is why drug manufacturers operate with the utmost precision. That kind of rigor is arguably even more vital in the segment of the industry known as biopharma, where medicines based on genes, cells, microorganisms, and other “biologics” are produced.
Central to biopharma’s meticulous manufacturing processes is something that might, at first, appear mundane: pipework. Miles and miles of pipes often snake through a single facility, carrying the ingredients and agents necessary for production. The pipework, notes Patrick Leonard, CEO of Smartline, of Dublin, Ireland, and the slopes of those pipes (determined by a multitude of supports) are the heart of the operation.
“Say, for instance, you're dealing with an ingredient that has a short shelf life,” says Leonard. “Biopharma companies need to ensure that all of that ingredient goes all the way down the line, and none of it stays in the pipes.”
Pipe supports might not sound like high-tech equipment, but their positioning assures that the pipelines slope to the exact specifications demanded. Too steep a slope, and too much material might flow; too small a slope, and little pockets of material can be left behind. And, as those pockets degrade inside the pipes, the entire process can become contaminated.
“With these biopharma plants especially,” he explains, “if you've got even a little bit of dirt or anything in the line, it could destroy your batch. A batch can take two to three months to properly ferment and go through the system.”
Another reason for for well engineered slopes: pumping the big, complex, delicate molecules of biopharma can damage them. So transfer from process to process is best done by natural flow.
Recognizing a need in the industry that no one else was filling, in January 2018 Leonard, a mechanical engineer, and his partner, Dave Reddy a Product Development Architect, and veteran in data analytics, launched Smartline—a system designed to help the biopharma industry meet its exquisitely calibrated requirements, while saving companies as much as 40 percent over current costs.
“It’s very much an engineering-based application,” says Leonard, “with a big data front end, and big data capabilities.”
Despite the exactitude required, prior to Smartline, biopharma companies relied more or less upon ad hoc applications to design their pipework and supports in non-integrated silos. That made it difficult to ensure that everything worked together as it should. If one segment of the supports needs adjustment, for example, every other segment of the design will have to be adjusted, to match. Leonard says that the Smartline application automates that tedious and potentially costly process. An adjustment anywhere triggers all the
necessary adjustments in the design to the rest of the line. In fact, all the processes—concept, design, fabrication, implementation, and disposal—operate synergistically under one umbrella in an end-to-end workflow system.
“This product ensures that all these supports will conform to level of detail 400 and 500. It also ties in with BIM [building information management],” says Leonard. “Using our system makes all the components that are managed by our system fully BIM compliant, and that makes it a virtually seamless transition to the client, when the plant gets handed over, to convert our information straight into their data systems.”
As Ireland attracts more and more pharmaceutical companies to its shores, Smartline has been connecting with a number of the local companies that design and construct new facilities for the industry. Leonard is eager to partner with all the players in the field, both in Ireland and beyond.
And, because the system specifies the components needed in an individual application, based on suppliers’ catalogs, and integrates those into its pipework designs, Leonard says that the company is also interested in partnering with new and existing fabrication companies. “All their catalog components can be ported into our application,” he says. “Our application can give them a data wraparound, or a data enabled envelope.”
For more information about Smartline, please visit: www.smartline.ie
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