What Single-use Pump is Best for Biologics Production?

 

Manufacturing biologics is a delicate process that requires precise design and optimized equipment to run efficiently and effectively. Choosing the wrong equipment

for the application can put product quality at risk, resulting in frequent and expensive maintenance, and can even cause product contamination which can ruin the entire batch. Knowing which single-use pump specifically, is the best for biologics, is key to avoiding these costly issues. First, it’s essential to understand whether a single-use or multi-use pump is best for the application. Narrowing down to a specific pump is a matter of analyzing the options and weighing the pros and cons of each. 

For all biologic production processes, single-use equipment is becoming the standard best-practice. This is due primarily to the cost savings they offer. Specifically, the advantages of single-use equipment include: 

  • Decreased cleaning and maintenance expenses: single-use equipment inherently requires no cleaning, all parts which come in contact with the biologic products are easy to replace between batches.
  • Shortened downtime during production line changeover: most single-use equipment, and single-use pumps specifically, are designed to be switched over rapidly, in as little as 30 seconds.
  • Reduced risk for batch or product contamination, increased production, and facility flexibility: single-use pumps are switched over between batches. The opportunity for contaminants to be introduced into the process is dramatically decreased, ensuring enhanced quality integrity even in a multi-product manufacturing operation.
     
  • Lowered initial capital, overhead and operating costs: single-use pumps typically cost less than traditional, stainless steel equipment. 

These factors combine to provide a competitive advantage for all manufacturing operations, and especially for contract development and manufacturing organizations (CDMOs) or multi-product facilities.  

The question, then, is which single-use pump is best for biologics manufacturing? To maintain product integrity, pumps must offer constant, low-slip, low-shear, low-pulsing flow. If the pumps do not meet these requirements, severe damage can be done to the biologics being handled as well as filter membranes or other media. 

Traditionally, the main pump types are peristaltic (hose) pumps, lobe pumps, centrifugal pumps, and piston pumps. There are issues associated with each type. Neither lobe pumps nor piston pumps are currently offered in a single-use variety, so they’re quickly eliminated. Peristaltic pumps often do not meet the pressure requirements of biologic production facilities and are known to cause contamination and flow issues due to material degradation and release. Centrifugal pumps are available in single-use varieties, but the maintenance of this type of equipment can be complicated and costly. Additionally, centrifugal pumps demonstrate poor flow control and can cause high-shear conditions and damaging heat build-up.

An alternate pump type has been introduced to the market that stands above the rest, meeting all pump performance requirements while still being single-useQuattroflow, a part of Pump Solutions Group (PSG) developed a single-use quaternary diaphragm pump specifically, for pharmaceutical and biotech applications. Modeled after the human heart, the four diaphragms move in sequence, keeping the biologic product always in motion at the specified rate. There are no rotating parts to cause friction, and the pumps are built to maintain flow integrity even under challenging conditions. 

For all biologic applications, the single-use quaternary diaphragm pump has become the go-to solution and the gold standard for Chromatography, Virus Filtration, and Tangential Flow Filtration (TFF). Uncompromising flow and operational quality, paired with the cost advantages associated with single-use equipment, show that innovative improvements to biologic production processes are possible and that the “traditional” solutions are not always the best. 

Learn more about how Liquidyne Process Technologies and Quattroflow Pumps can help support your biologics manufacturing by contacting us today! 

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What’s the Top Pump for Biologic Manufacturing?

 

Choosing a pump for biologics or pharmaceutical manufacturing can be a daunting process. There are close to 50 different, overlapping technology options that meet at least some of the needs for any given application. Narrowing down the field and picking the best pump involves understanding the risks involved with handling sensitive materials and the equipment options available. 

Top Biopharmaceutical Pumps - Quattroflow

Is the application concerned with high purity and sterility? Does it require high or low flow volume? Is the material sensitive to materials compatibility issues? What about heat and shear sensitivity? For most biologic manufacturing these questions can vary slightly but they tend to share the same requirement: pumps must operate with minimal impact on the material they are moving.

Additionally, it’s essential to understand whether single-use or multi-use equipment is necessary for facility flexibility and cost savings. Single-use technologies can reduce significant financial and operational risks associated with biologics manufacturing. And, while single-use pumps reduce downtime and increase batch consistency, the best pump may need to handle both single-use and multi-use configurations. 

With all these factors in mind, what pump types are on the market, and what are the main concerns associated with each? 

Peristaltic (Hose) Pumps: fluid is moved through a tube, via compression and release, by a rotor. Known to have limitations around flow and pressure, these pumps may also release contaminants into the product stream as the hose breaks down over time. While they are appropriate for some applications they are not necessarily the best choice for biologics. 

 Lobe Pumps: fluid is moved through the space created between two lobes as they rotate. With no single-use option available, these pumps can be costly to set up and maintain. Additionally, they tend to experience slippage and leakage as well as increasing the risk of external contamination and heat damage. Depending on the application these pumps can do significant harm to the manufacturing process and should be used only after careful consideration. 

 Centrifugal Pumps: fluid is moved by an impeller rotating. Because they are not positive displacement there is a risk of losing flow control if there’s a change to discharge conditions. Centrifugal pumps may also require expensive and time-consuming maintenance to replace the single-use components involved. They can also cause heat buildup and other issues that lead to biologic product damage or contamination. As a result, they are not commonly used in pharmaceutical processes at this time. 

 Piston Pumps: fluid is moved by piston generated suction and pressure. There are no widely available single-use choices for piston pumps at this time. This is because they are generally mechanically complex, which can lead to higher maintenance costs and manufacturing quality concerns due to equipment malfunction. They are also not a top choice for biologic production. 

 Quaternary Diaphragm Pumps: fluid is moved by four-pistons working together to enable a heartbeat-like, gentle flow. Brought to the market by Quattroflow, these pumps represent a significant improvement to pump technology. Single-use quaternary diaphragm pumps are sterile, efficient, and simple to maintain. They are available in a variety of sizes, accommodating high or low flow and pressure situations without risking damage to sensitive biologics. For facilities that require stainless steel equipment, multi-use pumps are available or single-use pumps can easily be converted over. 

 Quaternary diaphragm pumps are the clear best pump choice in biologic manufacturing. While there are advantages to each pump type there are also costly downsides. The quaternary diaphragm pumps are designed to have little to no impact on pumped materials while having a significant, beneficial impact on operating costs. This is truly a best-case scenario for most biologic manufacturing facilities. 

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Pump Technology for Biopharma, Pushing Towards Innovation

 

Innovation is critical for improving processes and reducing costs in all industries. In pharmaceutical manufacturing, sensitive and sophisticated equipment is necessary to maintain the quality and consistency of biologics. While most pump technology is well established, there have been some recent advancements that are worth noting in the overall approach to pumping equipment and individual improvements to peristaltic, positive displacement, magnetic drive, and diaphragm pump technologies.  

One of the most significant advancements may be the trend towards single-use technologies. With considerations towards efficiency, reliability, cost savings, facility flexibility, and operational improvements, single-use technologies have been adopted by the vast majority of manufacturing facilities for at least one product line. Single-use pumps decrease cleaning and maintenance expenses, shorten the down-time required during production line changeover and significantly decrease the contamination risks associated with multi-batch or multi-use facilities. This provides a substantial competitive advantage for all biologics manufacturing, especially for contract developing and manufacturing organizations (CDMOs) and multi-product operations.  

Most pumps are also getting an Internet of Things (IoT) upgrade. More pumps with sensors and data feedback are on the market today than ever before. One particular company is designing smart pump skids with sensors and automation. These can be customized for each application.  

Peristaltic pump manufacturers are working to improve the design and adapt to the single-use trend. These pumps, which historically have had issues with pressure, flow, and tube degradation, are being upgraded to handle a broader range of pressures and sensitive products. New tube materials are also being developed to limit the contamination and operational issues associated with tubing disintegrating into the production stream.  

External circumferential piston (ECP) pumps are a new variety of positive displacement pumps. They are different from lobe pumps in that they have three rotors rather than two. This makes them more reliable, less prone to pulsing issues, and able to handle prolonged site shutdown without costly maintenance. ECP pumps are not available for single-use applications and may struggle with broader adoption as a result.  

Magnetic drive pumps have been on the market for some time but have only recently become a viable option for biologic production. The main issue with the use of these pumps has been related to heat build-up and flow control. Modern sealless magnetic drive pumps are designed to have fewer leak risks, and their re-engineered components show improved reliability and fewer flow disruptions. Single-use options have also been introduced to the market.  

Quaternary diaphragm pumps, developed and produced by Quattroflow, may be the biggest innovation in recent pump technology. These pumps are perfectly engineered for single-use or multi-use applications. The unique design is modeled after the human heart. The fluid is moved through chambers in sequence by four diaphragms. This keeps the biologic product always in motion at the ideal flow rate with no risk of leakage, friction, or heat build-up. Quaternary diaphragm pumps are available in a wide range of sizes and accommodate high or low flow and pressure environments without harming delicate biologic products.  

It is rare that new technology, in direct competition with established solutions, is introduced and widely accepted. The industry’s response to the quaternary diaphragm pump, however, has been almost universally positive. Many engineers insist that there is no competition for the quaternary diaphragm pump on the market for modern biologics and biopharma manufacturing. As Quattroflow continues to release new models and improve its original concept, these pumps will likely become the gold standard. 

Learn more about how Liquidyne Process Technologies and how Quattroflow Pumps can help support your biologics manufacturing by contacting us today! 

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Saint Gobain Change Notice: Extruded Platinum Cured Tubing – ID, OD and/or Wall measurement equipment change

 

Scope of Change:

Product names and item numbers will not change. The affected parts number are: SG Beaverton Part# All SG Beaverton Platinum Cured extruded finished goods and all finished goods containing Platinum Cured extruded product that are 0.9” diameter OD or smaller are within scope of this change.

Not in Scope:

Any platinum cured tubing that is 0.9” larger in diameter will not be in scope in this change.

Change Description:

Saint-Gobain Beaverton (SGB) is in the process of revising how the ID, OD and/or Wall of extruded platinum cured tubing is measured. Currently, the ID, OD and/or Wall measurements within the Extrusion and Packaging departments are measured using Optical Comparators. Keyence IM-7020 measurement devices will replace the existing Optical Comparators.

Change Impact / Risk Assessment:

Risk is low:

  •  There is no potential impact on the validated state of ID, OD and/or Wall measurements.
  • There is no potential impact on regulatory filings.
  • There is no potential impact on production or product quality.
  • There is no potential impact to environmental, health and safety. Implementation Date: SGB is proposing to implement the Keyence IM-7020 measurement devices to replace the existing Optical Comparators in the Extrusion and Packaging departments by the end of Q3-2020.

Next Steps:

Please take this opportunity to contact the Customer Service Team or your Saint-Gobain District Sales Manager should you have any questions / concerns.

John A. Steichen Quality Engineer Saint-Gobain, Beaverton, MI

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CPC Biopharma Change Notice: New Facility and Redundant Cleanroom Manufacturing Space

 

Description of Change

CPC is building a new facility in Roseville, Minn. This facility will contain a redundant ISO Class 7 manufacturing cleanroom for biopharma product lines. This facility also will become the new shipping location for all CPC products, which will be reflected on future Letters of Certification.

Affected Products

All CPC biopharma product lines. See Appendix A for affected products.

Reason for Change

To accommodate CPC’s continued growth and to provide redundant cleanroom manufacturing.

Implementation Date

The new facility is expected to be completed Q3 2020. The redundant manufacturing cleanroom is expected to be operational Q4 2020.

Additional Information

As noted above, the new cleanroom will provide redundant manufacturing. CPC’s current biopharma cleanroom facility will continue to operate without change. This will ensure supply of product while the new cleanroom is being built and commissioned. There will be no interruptions of supply while the new facility is being qualified. After the new cleanroom is fully operational, the two cleanrooms will continue to operate simultaneously, which provides continued assurance of supply and capacity to grow in the future.

CPC will continue with quality system certifications to ISO 9001:2015 and ISO 13485:2016. All new manufacturing equipment qualified in the new cleanroom will go through CPC’s IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) validation process. The new ISO 7 cleanroom will be certified to ISO 14644 and 14698 standards. Following certification CPC will undergo a third party audit in alignment with the BPOG/RX360 single use joint audit program.

For additional information or questions, please email CPC at nick.johnson@cpcworldwide.com.

Appendix A

 

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Work in Biopharma? Why You Should Adopt Single-Use Assemblies & Technology

 

The adoption of single-use assemblies and technology in life sciences has skyrocketed in the past decade and most projections of the

single-use-clean-room
Liquidyne Process Technologies, Inc has the only ISO-certified cleanroom in Colorado.

industry don’t predict a slowdown in that growth any time soon. In fact, the global market for single-use technology is projected to grow from $2.74 billion in 2017 to $13.23 billion by 2026.

 Why is there such a growing demand for single-use solutions in life sciences operations?
“One thing we know we can point to are advances in single-use technology,” says Chris Couper, President, and founder of Liquidyne. “Single-use tubing and filters have been available for several years. Advances in those products, and the development of single-use solutions in other parts of the manufacturing process– like pumping solutions and bioreactors– have greatly sped adoption.”
The benefits of single-use solutions to life sciences manufacturers come down to considerations of cost, time, quality, and manufacturing size.

Cost Savings Benefits of Single-Use
Single-use bioprocessing systems help manufacturers eliminate the significant costs of cleaning and validating pumps and systems. When transitioning from one batch to another, system operators must clean all parts in the production process and validate that they have been sterilized before manufacturing can resume. Single-use products eliminate the need for cleaning those parts by providing clean-room certified parts for quick and easy replacement. Not only does this reduce labor costs that would be spent on cleaning these systems, but it cuts down on your operation’s water use and downtime creating more benefits for your bottom line.

Single-Use Products Reduce Downtime
Being able to quickly replace used parts for sterilized parts significantly reduces downtime in the manufacturing process. Cleaning stainless steel is both cost-consuming and time-consuming. Stainless steel systems can take weeks to sterilize, but single-use suites can be production-ready in days.

single use at work in biopharma
Single-use assemblies at work in biopharma.

 Single-use products, like the EZ-Set Pump Chamber Replacing System from QuattroFlow, are built to be replaced in as little as 30 seconds, all without special tools or torque wrenches. Single-use enables quick changeovers between lots and increases utilization time, increasing the capacity of the facility.

Quality Control
In life sciences, ensuring product precision and purity is essential, hence the time and labor consumptive activities of cleaning and validating. For single-use assemblies and components that validation is dependent on the supplier. Single-use solutions are supposed to be ready-made for manufacturing. At Liquidyne, our disposable and single-use assemblies are produced in the only state-of-the-art, ISO-certified clean room in the state of Colorado. Single-use components eliminate the chance for cross-batch or cross-product contamination helping you deliver a quality-controlled product with every production cycle.

 Single-Use Suites Make Cents for Niche Manufacturers
Single-use products can enable efficiencies for manufacturers of all sizes, but one reason demand and adoption have increased in recent years reflect advancements in the biopharma industry at large. Biopharma manufacturing yields have improved as technology gets more precise, which reduces production volumes and makes smaller, single-use suites more practical. Single-use assemblies in biopharma are perfect for operations at this scale as it’s simple to set up and reduces downtime and costs between batches.

In need of a single-use solution?
We provide an array of pre-built and custom single-use assemblies and disposable components. Contact us today for a custom quote or to learn more about single-use technology and how we can improve your life sciences operations. 

 

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READY TO PUMP OUT BETTER RESULTS?

 

Meet Quattroflow’s new QF30SU and EZ-Set Pump Chamber Replacing System

Quattroflow™ recently released two new products to help you achieve your fluid handling needs. Learn more about these new releases here and contact your Liquidyne rep for product and ordering information.

The QF30SU is the new tool for your chromatography, TFF and virus filtration needs. This low flow (1 mlpm) single-use diaphragm pump is retrofittable on QF150 drives, has linear flow performance and 500:1 turn-down ratio.

Next up, the upgraded Quattroflow EZ-Set Pump Chamber Replacing System allows you to replace your single-use pump chamber in 30 seconds or less without the use of special tools or torque wrenches. Available now for new pumps by adding “EZ” to the pump code or for existing standard Quattroflow single-use pumps by replacing the pump chamber, pressure plate and shaft bearing kit.

Contact us to learn more about these new products from Quattroflow and other top-of-the-line tools for your fluid transfer needs.

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Skunk the competition, not your beer.

 

Mettler Toledo’s new InTap Portable DO Sensor offers extremely high measurement, accuracy and long term stability at trace levels DO.

Keeping oxygen out of your beer is key to maintaining your brew’s quality and flavor. Optical dissolved oxygen measurement technology is your first line of defense against unwelcome oxygen and preventing your beer from being “skunked”. The new InTap portable analyzer with an internal optical DO sensor from Mettler Toledo is designed for at-line measurement of beer during or after filtration and prior to filling. It is also the perfect reference instrument for calibrating installed in-line optical DO sensors that measure at the lowest oxygen ranges.

For mid-size breweries, InTap can support the transition from off-line DO measurement to in-line measurement, with a portable, lower-cost system.

  • Accurate calibration reference or temporary replacement system 
  • Simple, touchscreen operation
  • Robust design and easy maintenance
  • Convenient and Flexible DO Monitoring and Calibration
  • Prevents Human Error in On-Line Sensor Calibration
  • Measurement Point Tracking Simplifies Documentation

Contact us to schedule your demo today.

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Celebrating 25 Years of Fluid Management

 

INNOVATIVE FLUID MANAGEMENT, HANDLING AND CONTROL

A Note from our Founder & President, Chris Couper

2018 marks Liquidyne’s 25th Anniversary; a milestone that has me reflecting on our last quarter century of business. In 1993, with a background in Bioengineering, I left the lab world to create solutions to issues in fluid handling and measurement which I had experienced. I was now supporting the very people I worked with! There was a lack of customized solutions in the marketplace so I set to work collaborating with suppliers and customers to redefine how fluid management and handling products were created. Liquidyne launched that year and thanks to the blossoming field of biotech, we quickly grew out of my garage and into a new facility.

Pumps, Valves, Tubing, Hoses and a Clean Room All Under One Roof

In 2004, Liquidyne acquired our first company which allowed s to purchase a larger facility. Under one roof, we could now offer fluid transfer design, custom tanking, and a variety of sanitary products to get fluids from point A to point B including pumpsvalvestubinghoses and instruments to provide valuable data.

As our product lines grew and Liquidyne became a go-to company for integrated solutions we realized many of our customers could benefit by using custom tube sets and kitting of parts built in a Class 10,000 production room.

Our clean room — the first in the Rocky Mountain Region — was 3rd party tested and certified and up and running by January 2007. This has allowed us to service requests for custom designs in single-use/disposable products increasing our understanding and capacity to support our custom processes.
High Expectations and The Highest Level of Quality

The funny thing is, once we grew to this level, the expectations we placed on ourselves also grew — and it’s all about quality. We’ve hired a Quality Manager and refreshed our Quality Management System. I’m proud to report that in November 2017 we were awarded our certification of having a QMS compliant to ISO9001:2015.

It is our promise that we will provide the very best level of service to each and every prospect and customer. Whether you already know us or want to get to know us, we are here for you.

Thanks to each and every past and present employee and customer, I look forward to the next 25 years!
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