Articles
New Disposable Manifolded Filtration Systems From Pall Provide Ease Of Use, Reduce Biopharm Process Cleaning Requirements
March 22, 2004
East Hills, NY -- Pall Corporation's (NYSE: PLL) disposable manifolded capsule filter systems provide increased security, while saving time and money. Security is increased since disposable systems are used once and discarded, so the risk of cross contamination is eliminated. Time is saved since the disposable units can be used out of box without assembly, and cleaning is not required. The labor cost is reduced, since process steps for assembly and cleaning are not required. Processing costs are further reduced, since water and cleaning chemical usage is reduced.Disposable filter capsules can be pre-bundled as a fully integrated single use filtration system with the added benefit of pre-sterilization. They can be manifolded in parallel for processing large volumes, or in series for pre to final filtration arrangements.
Because a variety of filters can be used in the assemblies, a number of process operations can be accomplished with a single manifolded system. For example, a multi-round capsule assembly of Preflow® filters can be used for cell removal, and further clarification can be accomplished using a 0.45 micron Fluorodyne® II DBLP filter next in the series. The unique flexibility of these systems can meet most process requirements. For example the aseptic filtration can be included using a 0.2 micron Supor® EKV PES filter, or a single (or a series) of 0.1 micron Fluorodyne II DJL filters can be used.
Applications for these systems include single process applications, such as a virus filtration step, or for a series of filtration steps. The single use capsule filters used in the disposable manifolded systems can be sterilized by gamma irradiation and this further simplifies process requirements by eliminating the need for autoclave or steam in place operations. Systems are supplied fully assembled and pre-sterilized, which not only saves assembly, cleaning and sterilization time, but it also significantly reduces the chances for operator error.
"Cleaning validation can be a costly and time consuming aspect of drug development," said Ed Hoare, President of Pall BioPharmaceuticals. "Furthermore, because these systems can be scaled to meet process volume requirements, Pall's disposable manifold filtration approach gives biopharmaceutical companies a unique competitive advantage that can be applied to every phase of the drug development process."



