Earlier this year, Equilibar launched the Single Use Technology (SUT) division to meet the fast-evolving fluid control needs of the pharmaceutical industry. Ryan Heffner, PE, was named Single Use Technology Manager, leading a team of professionals focused on developing and refining products for this emerging market.
The following is a brief Q&A with Ryan to explain why Equilibar chose to focus on single use and to share technical trends in the pharmaceutical industry, including Pharma 4.0™.
First off, can you explain why there is such a strong emphasis on single use devices in the pharmaceutical industry right now?
The Single Use space in biopharmaceutical manufacturing holds great promise for the future while also providing real savings today. It’s extremely far-reaching and has multiple advantages.
Here are just a few examples–
- From a humanitarian view, there’s an entirely new set of drug companies using single use as a platform to create manufacturing sites with an impactful vision to deliver medicine to remote areas of the planet and avoid transportation infrastructure limitations.
- While COVID taught us that supply chain sourcing of single use components has limitations, new drug manufacturing methods continue to benefit greatly from systems that are optimized to fit.
- The elimination of Clean in Place and Steam in Place (CIP/SIP) requirements for single use systems offers attractive economic benefit. In turn, this savings is driving companies to create specific single use systems in response to new manufacturing methods and needs.
- Finally, while most people don’t equate single use with environmental benefit, there is a positive environmental impact related to the significant reduction of water consumed due to the lack of CIP / SIP.
We’ve been hearing the term Pharma 4.0™ quite a bit lately. What exactly does this mean? Do you have an example of what a Pharma 4.0 process looks like in the real world?
Pharma 4.0™ refers to the initiative of the International Society for Pharmaceutical Engineering that encourages the automation of devices to gather more insight about process data and to gain more control over versatile systems that can produce a variety of drug products. It can be thought of as the 4th industrial revolution for pharmaceutical manufacturing, with the digital age and the adoption of digital controls over pharmaceutical systems preceding it. In addition to implementing automation of hardware, companies are beginning to utilize increased processer capabilities to employ machine learning as methods for systems to self-identify errors and adapt hardware settings to improve system metrics over run time.
The best current example of this is more on the plant operation side, with contract development and manufacturing companies utilizing Pharma 4.0 for entire plant operation optimization. Hardware companies like Equilibar also have a part to play by offering hardware controls that integrate with this trend, and we can also offer more data in the form of self-optimizing hardware.
Equilibar’s first single use product—the SDO back pressure regulator—recently won a rather prestigious award. Can you share the details on that? Were you surprised to receive this award?
Certainly. The Pharma Innovation Award was recently awarded to the Equilibar SDO valve product line by Pharma Manufacturing magazine. The SDO is the first wetted single use valve in the pharmaceutical manufacturing space, so the benefits of Equilibar’s technology—extreme precision, easy automation, flexible flow rate capabilities, etc–are expanded to many new systems. The SDO line has the ability to transform single use systems, with wide-reaching impact for improved tangential flow filtration, chromatography, and gradient elution buffer preparation, which all correlate to improvements in drug manufacturing as a whole.
I was actually surprised that we won this award. In the past, I tended to think that to win a pharmaceutical manufacturing award you had to present something complex that has an exotic use. In this case, the elegance and simplicity of the Equilibar SDO product line enables it to contribute in a way that helps all types of systems, which is pretty cool.
Tell us about the SUT team and why Equilibar decided to create a separate division:
The SUT team is a major investment by Equilibar to highlight that we are dedicated to focusing on growing our brand in the single use space. The team includes engineers, technicians, and a supply chain specialist, and they are all top players. It’s personally exciting to me, of course, but our customers are also excited to invest in this solution for the next round of single use manufacturing systems. We see a lot of potential for our R&D skills to bring products to the single use market.
The SUT division is still quite new. Looking ahead, what do you foresee as it grows and matures?
We will continue to improve and hone our knowledge about the single use industry and launch products that support the industry in ways that we can contribute–precision pressure, flow, conductivity, pulsation, and other methods. We’ve invested in a supply chain that will support our path to market speed. In the future continue to expect new devices from Equilibar to solve the challenges of single use fluid management.
For more information about fluid control for complex pharmaceutical applications, please see Ryan’s recent article in Process Instrumentation magazine. And as always, feel free to contact Ryan or one of our application engineers about your unique fluid control challenge.