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Tube Pumps Have Limitations
Recently, Rentschler has invested several million euros into a complete disposable manufacturing line with single-use process equipment that is used for cell cultivation and the purification of the target molecules. For this project Rentschler installed fully automated single-use filtration systems from Pall Life Sciences.
These filtration systems are complex pieces of machinery designed to be ultra-sensitive to the needs of the manufacturer and able to operate within precise process limits. They also need to be extremely flexible so that a wide range of products can be manufactured, ranging from monoclonal antibodies to cytotoxins. Their job is to separate the desired end-product from any impurities that it might contain.
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Taking Pumps to Virus Filtration
An example is a virus-filtration process used in the production of antibodies. The pore size of the filtration medium must be so small that only the antibodies can penetrate it, while still possessing the ability to effectively retain virus particles. To maintain the validation of the process, the transfer pumps used for the filtration must keep the pressures and flowrates within narrow limits.
“Most pumps that have been used in these applications are tube pumps,” says Laukel. “These pumps are good if you have to transfer small quantities like 10 or 100 l (3–30 gallons) at a time, but as the pumping application gets more complex and more demanding they are not the best choice for me.”
That’s because the pumping of very sensitive pharmaceutical components, especially in virus-filtration applications, demands that the pump produce very low levels of pulsation while still maintaining and controlling discharge pressures and flow rates. “With tube pumps, when you perform filtration and you have tight specification, the pulsation is maybe a problem,” says Laukel. “Also, with tube pumps you can have mechanical stress created when pumping that can be a problem for the product.”
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