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Single-Use Systems

How to Profit from a Single-Use Mixing System for Biopharmaceutical Production

| Author / Editor: Dr. Andreas Frerix / Dr. Jörg Kempf

All That, And So Much More

“What makes this unit so nice is that we can work directly with the pumps from Quattroflow,” said van Trier of the Quattro Mix. “We like them because the pumpheads minimize particle shedding, which is very important for biopharmaceutical companies.”

The Quattro Mix system has a very basic, easy-to-understand operating principle. A single-use mixing bag is filled via a Quattroflow pump through a 16-hole mixing plate that is built into the bag. After the proper amount of mixing agent is injected into the mixing bag, the Quattroflow’s pumping action through the mixing plate forces the liquid from the bottom of the bag, up around the outer walls and back down through the mixing plate in the center, where it is recirculated through the pump.

“Together with PSG we have invented a very nice mixing system that’s based on the technology of the Quattroflow pump with the mixing plate inside, and the technology from JM Bioconnect that has all of the parts together to make a nice single-use piece of process equipment,” said van Trier. “Since the Quattroflow pumps have a nice capacity, they can run up to 1,200 liters an hour (or 317 gph), we can mix very well. We can mix liquid/liquid solutions as well as liquid/powder solutions.”

The unique, impeller-free operation of Quattroflow pumps also gives them distinct operational advantages over competitive types of mixing systems. “The challenge for other suppliers of mixing technologies is that most of the mixing systems have a magnetic part on them or they have an impeller,” said van Trier. “Some mixing solutions have magnetic beads so a magnetic part will not work with that application. If you have a mixer inside the bag, that creates the chance for contamination on the impeller since the impeller has to go through the bag. This is something that you don’t have with this type of installation. You have a pre-packed complete unit with the pumphead next to it. You install it as a complete unit, install the disposable pumphead to the motor and start filling with water; basically it’s a plug-and-play unit.”

Reduced Risk of Contamination

The Quattroflow pump is also versatile enough that it can be used to transfer the newly mixed solution from the mixing bag to a storage unit without the need to utilize another pump. This decreases the chance that product contamination will occur.

“In the biopharm industry, single-use has become more and more popular because we want the product to come to market as quickly as possible,” said van Trier. “They don’t want to spend time cleaning because cleaning and validation take a lot of time and also a lot of labor goes into the cleaning cycle. With single-use you don’t have to clean anymore, your operators can just make the product, get a new bag, put it in place and go forward. It’s also cheaper when compared to stainless steel, and after 30 minutes the customer has his liquid perfectly prepared; that’s the aim of the system.”

Additional Information
 
At a Glance: Benefits of Single-Used Pumpheads

On top of all that, JM Bioconnect has turned to another Dover company, CPC, for the connectors that link the mixing systems to the mixing bag and pump. Specifically, the Aseptiquik line of connectors help the Quattro Mix become a completely sterile system with no additional sterilization procedures required.

Currently, JM Bioconnect is offering the Quattro Mix system with mixing-bag capacities of 50, 200, 500, 1,000 and 1,500 liters (13 to 396 gallons). “With this integrated system featuring Quattroflow pumps we eliminate a lot of problems other suppliers have,” van Trier summarized. “Minimal particle generation, elimination of the chance of contamination, elimination of a magnetic field inside the bag, elimination of an extra pump to transfer the fluid to another place. All these things are built into the design of the system.”

* The author is Applications Manager Biotech/Biopharma for Quattroflow Fluid Systems, Almatec, Kamp-Lintfort, Germany.

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