Q&A on single-use and multi-use fluid control for biopharma processes

Q&A on single-use and multi-use fluid control for biopharma processes

  • Photo of Biopharma product managers Steriflow and Equilibar

From single-use valves for TFF to a redesigned sanitary safety relief valve, Equilibar and Steriflow have been exploring synergistic ways to combine two distinct technologies to create better fluid control solutions for the biopharmaceutical industry since 2021.

As they prepare for the April 2024 INTERPHEX show in New York City, Single Use Technology Manager Ryan Heffner and Megan Cider Elm, Product Manager for Pharma Multi-Use, took a moment to share what they look forward to at this year’s global conference. Equilibar and Steriflow Valve are divisions of Richards Industrials.

 

Richards Industrials (RI) Q&A with Megan and Ryan:

 

RI: Ryan, you are presenting with colleagues from Endress & Hauser and Arcadis at the Interphex Tech Theater this year. Can you explain more about your topic, Improving WFI Point-of-use with single-use flow control, and give a sneak preview of what attendees can expect to learn?

Ryan: Certainly. This will be an exciting presentation to share with end users, since the focal point will highlight some new technological advancements in the single use space to improve Water-For-Injection (WFI) dispensing while saving floor space and improving clean room workflow efficiency. If you are at Interphex, please Join us at Tech Theater 1 on Tuesday afternoon at 4pm to learn more. We will also have a live demonstration of this technology for visitors to see at our booth 2427.

RI: Biopharmaceutical production facilities continue to expand, and processing techniques are evolving. What are some recent developments in biopharma processing where you have seen our technology offers solutions?

Megan: There are a lot of exciting new medicines coming to the market and many manufacturers have a more critical need to increase their output as demand for their products grows. Interest has grown in our Steriflow Valve solutions for adapting or future-proofing plants to increase output with high turn-down valves that limit the need for upsizing equipment.

Ryan: We are also seeing a lot of innovation in the biopharma market right now in process improvements. Several of our customers are inventing new filtration techniques and process flow paths to support growing interest in continuous manufacturing as well as new modalities like cell & gene therapies. A recent case study we wrote describes how an Equilibar® SDO single-use valve is used in a novel process for single-pass tangential filtration (SP-TFF). In the study, the SDO is automated to maintain precise trans-membrane pressure in a continuous TFF setup.

RI: Preventing unwanted pump push-through flow has been a topic of discussion recently. Can you explain what that is and how our back pressure regulators can help?

Ryan: As customers re-evaluate clean room floorspace management, we see them relocating buffer storage tanks to a floor level above the clean rooms and installing ceiling penetrations for piping down to the process skid. This increased elevation of the supply tank from the process delivery pump creates head pressure at the pump inlet and can result in uncontrolled push-through flow. The Equilibar SDO single use back pressure regulator is the industry’s first single use control valve and can prevent push-through flow. Read more about how the SDO can help here.

Megan: Push-through flow has been an accepted occurrence that creates significant buffer waste when those buffers are stored at higher elevations. Flow through a diaphragm pump occurs even when the pump is off due to the head pressure. Our FDO back pressure regulator, when installed downstream of the pump, is perfectly designed to eliminate push-through flow while also allowing operation of the pump at low RPM’s, which leads to reduction of waste and increased efficiency.

RI: Megan, Steriflow Valve introduced a sanitary safety relief valve (SSRV) into its portfolio last year. Please explain how it is different from what is already available.

Megan: Of course, safety is no less important in a sanitary system than an industrial one, but what often gets overlooked is the need to protect the process from the environment as much as the typical need of protecting the environment from the process. We work with customers who have had to sacrifice batches of product when rupture discs blow. When pressure is exceeded, the disc bursts, as intended, and the pressure is relieved, but the process is exposed. As an alternative, utilizing a sanitary safety relief valve can relieve pressure without exposing the process, thereby preserving the batch and preventing waste.

RI: What are some highlights that this year’s Interphex attendees can expect when they visit your booth?

Megan: This year the Steriflow and Equilibar booth will have more working displays of our products to show how our valves operate in real time and how they respond in different process scenarios. It will be a great opportunity for visitors to speak with our technical experts, watch our demonstrations and look for new ways to improve their process.

Ryan: I think our newest working demo will be very instructive for guests to come and witness. We’ve created a condensed version of a WFI distribution loop to demonstrate key performance advantages our single and multi-use product lines offer. For customers who don’t often dive deep into the fluid mechanics of valve design, it’s a great functional tool that can simply present complex control challenges. Watching will help scientists and engineers envision how these performance features can translate to system benefits.

RI: Are there any new products, solutions, or services that you have been hearing about in the industry that you are eager to learn more about while at Interphex this year?

Megan: There have been a lot of developments with oligonucleotide production due to the increase in demand. I am looking forward to learning more about new challenges manufacturers are facing and how our products may be helpful in these applications.

Ryan: I am excited to connect with customers to learn what process development is going on at their facility. Customers are constantly coming up with creative solutions to re-imagine bioprocessing. I like to learn how their process solutions synergize with the innovations we are designing in the pharmaceutical fluid control space to create the next generation of bioprocessing equipment.

RI: It’s been three years since Richards Industrials added Equilibar to our family of fluid technology brands. What have you seen evolve during this time in terms of access to biopharma fluid control options for Equilibar and Steriflow Valve customers? 

Megan:  The best part of the integration has been improving our capacity to offer customers a wider range of solutions to fit their needs for every application. The Equilibar FDO valve technology brings new capabilities to the Steriflow multi-use portfolio, making it easier to solve even more challenges that our customers are facing. The experienced Steriflow distributors have been able to share the unique FDO technology with many more customers through their network.

Equilibar and Steriflow Valve will once again be in Booth 2427 at  INTERPHEX in The Javits Center in New York City – April 16-18. In addition to Megan and Ryan, the booth will have other experienced engineers to discuss precision fluid control for pharmaceutical systems as well as hands-on demonstrations and sample devices. Please make a note to come by to say hello and ask questions. As always, feel free to contact Equilibar or Steriflow engineers to discuss your fluid control challenges.

Register for Interphex Free at this Link

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