Single-Use Biocontainers Reduce Biotech Manufacturing Problems

By LabMedica International staff writers
Posted on 12 Feb 2009
Some of the problems of biotech manufacture have been alleviated with the recent introduction of a line of high quality, single-use biocontainers.

A new line of single-use biocontainers offers significant advantages over reusable stainless steel containers. Produced in 100 to 500-liter sizes, the biocontainers are made from a proprietary polymeric film designed to meet critical performance requirements associated with biotechnology and biopharmaceutical manufacturing. The film comprises inert polyethylene inner and outer layers that sandwich between them a gas-barrier film interlayer of ethylene vinyl alcohol polymer. This ensures that the biocontainers possesses excellent gas barrier properties with high clarity and flexibility. The containers are compatible with a wide range of chemicals, have very low level of leachables, and contain no animal derived ingredients.

Called the Allegro 3D, the biocontainer offers many possible applications, among them cell culture media preparation and storage, buffer preparation and storage, product and cell harvesting, intermediate product storage, and bulk product storage prior to filling.

The Alegro 3D biocontainer from by Pall Life Sciences (East Hill, NY, USA) hosts a sophisticated series of access ports for easy filling, emptying, and monitoring. A stainless steel "tote" or lockable cabinet is used to house the biocontainer in the optimum configuration for complete emptying, and an optional stainless steel trolley is available to help move filled biocontainers around the manufacturing facility.

"Single-use disposable technology is a proven alternative solution for the biotech and biopharm industries, …” said Dr. Helene Pora, senior director of single-use systems at Pall Life Sciences. "Single-use systems provide a greater assurance of sterility and purity by reducing microbial and cross contamination risks. They also reduce capital investment costs for facilities and equipment, costs associated with cleaning and cleaning validation, and they reduce lead times to help get drug products to market faster. In applications that process hazardous materials, such as cytotoxic drugs and potent biological materials, closed disposable systems offer additional protection by isolating operators from potential dangers."

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