Single-Use Systems How to Profit from a Single-Use Mixing System for Biopharmaceutical Production
The challenges are many in the production of biopharmaceuticals. The only way that critical mixing applications can be completed successfully is if the proper equipment, from pumps to bags to hoses to connectors, is utilized. Learn about a single-use mixing system which combines special quaternary (four-piston) diaphragm pumps with the biopharmaceutical expertise of single-use systems.
Two decades ago, friends and colleagues, Mark van Trier and John van der Veeken, set out to form their own biopharmaceutical trade company, the result of which was JM Separations, which they headquartered in Tilburg, The Netherlands. Over the years, the company’s mission has evolved and JM Separations has become an engineering and design firm for the biopharmaceutical industry. “Over time we had more and more of a passion to have our own manufacturing, our own products, our own engineering team and supply the customer with process solutions,” said van Trier, and “We really want to help customers with our solutions,” added van der Veeken.
In recent years, the duo observed the industry-wide growth of single-use equipment and especially pumps in biopharmaceutical processes and identified that as an enabling technology that they could offer their customers. They believed these pumps were a better manufacturing solution because of the low cost compared to permanent stainless-steel pumping systems and the simultaneous ability to ensure the necessary level of high-purity production that is required. Specifically, they felt they could fill a niche where batch-mixing operations could be performed and enhanced through the use of single-use pumping equipment.
For a solution, they reached to the past, in this case, to former colleague Frank Glabiszewski, who had worked with van Trier and van der Veeken in the early 1990s. Since then, however, Glabiszewski had, with partner Josef Zitron, invented the positive displacement quaternary (four-piston) diaphragm pumping principle and founded Quattroflow Fluid System in Germany. In 2012, Quattroflow was acquired by the Dover Corporation’s PSG. PSG has subsequently integrated the manufacture of Quattroflow pumps into the operations of its Almatec subsidiary, which is headquartered in Kamp-Lintfort, Germany.
“In 2010, we started working with Frank Glabiszewski of Quattroflow to build a mixing system,” said van Trier. In 2013, he said, “I think I have the solution for you.” That solution, which would come to be called the Quattro Mix Single-Use Mixing System, and also prompted JM Separations to create a new division named JM Bioconnect, features a Quattroflow Quaternary (Four-Piston) Diaphragm Pump used to circulate the liquids and solids in a mixing bag in order to achieve the necessary mix and dilution rates, all within an optimized time frame.
Human Heart as Model
The main benefit of using Quattroflow pumps in biopharmaceutical-mixing applications is its form of operation: the four-piston diaphragms are driven one after another by a connector plate, which moves back and forth out of its central position in a stroke that is generated by an eccentric shaft, with the length of the stroke determined by the angle of the eccentricity. In other words, the Quattroflow technology has been modeled on the operation of the human heart with its four pumping chambers and check valves keeping product flow constantly moving forward.
The Quattroflow’s pump chambers contain no rotating parts that can be subject to friction, meaning that there is minimal operational heat buildup that can compromise the product. This mode of operation also means that the pumps can run dry, are self-priming and produce little shear because of low slip. In addition, they offer low-pulsation and leak-free operation. Quattroflow pumps also have some of the highest turndown capabilities in the industry, which ensures that the pump’s operation does not adversely affect repeatability and production rates.