Articles
New Membrane Technology From Pall Speeds Biotech Drug Processing Flow Rates Up To 50 Percent
March 19, 2004
Pall Corporation (NYSE:PLL) introduces an innovative new filter for drug manufacturers that accelerates flow rates by as much as fifty percent, significantly shortening production cycles. The new Supor® EKV 0.2 micron sterilizing grade filter incorporates Pall's proprietary machV membrane technology and can be used to remove bacteria and other pathogens from buffer solutions, tissue culture media and critical process fluids used for drug production. Biopharmaceutical manufacturers rely on high volumes of these purified solutions to produce the increasing number of biotechnology drugs in the pipeline. The Supor EKV filter with machV technology will enable them to relieve processing bottlenecks so that they can bring safe new drugs to market faster and more economically.The machV membrane technology was first introduced by Pall for use in its laboratory products last year. Its asymmetrical (funnel-shaped) pore design enables removal of large contaminants without impeding flow through the membrane. This new application into full-scale drug production provides biopharmaceutical manufacturers the benefits of increasing throughput, extending filter life and cutting costs.
"The Supor EKV filter breaks the speed record for drug processing and it can significantly accelerate the time to market of new life-saving therapies when used in disposable capsule formats that do not require cleaning validation," says Ed Hoare, President of Pall BioPharmaceuticals. "This new technology facilitates purification of larger volumes of biologicals while also lowering overall production costs."
The Supor machV technology combines a polyethersulfone (PES) membrane with an asymmetric membrane structure that improves the efficiency of particle removal.
The final membrane in the Supor EKV filter provides the security of the depth of a symmetrical 0.2 micron membrane for bacterial removal. Supor EKV cartridges and capsules have been validated to remove Brevundmonas diminuta bacteria at 107cfu /cm2, and are 100 percent integrity tested to conform to current Good Manufacturing Practices (cGMP). Supor EKV filters also provide excellent wettability, which further promotes flow rates and ease of use.
Pall's 10, 20, and 30 inch Supor EKV filters have been engineered with a patented Ultipleat® filter construction for high membrane area and faster flow distribution to ensure economical filtration. The Ultipleat construction also provides a strong filter cartridge, as demonstrated by the ability of a 10-inch Ultipleat filter cartridge to withstand higher pressure differentials (1 bar / 14.5 psi) during steam-in-place compared to traditional pleated filters.
Supor EKV filters are available in cartridge formats as well as in single-use capsules (from 200 cm2 to 1.8 m2). As a single-use capsule, manufacturers will be able to substantially reduce assembly, sterilization, cleaning and cleaning validation sequences since they are discarded after each use. In addition to offering disposability, single-use capsules can be gamma-irradiated. The Supor EKV filter is also available in Pall's NovaSipTM capsule format, the only capsule filter that can be steamed in place.



