Pall Life Sciences

Dec. 11, 2008
Biocontainers Offer Gas Barrier Properties That Support Product Stability

Pall Life Sciences' Allegro 3D biocontainers are specifically designed to enhance the performance of the company’s single-use systems for large-scale biotechnology and pharmaceutical manufacturing applications.

Pall Allegro 3D biocontainers were developed for upstream production and downstream purification applications in the production of biotherapeutic molecules from small clinical batches to high-volume commercial processes that require reliability and flexibility. They are made from a proprietary polymeric film designed to meet critical performance requirements associated with biotechnology and biopharmaceutical manufacturing. These applications include cell culture media preparation and storage, buffer preparation and storage, product and cell harvesting, intermediate product storage and bulk product storage prior to filling.

Available in 100-, 200- and 500-liter sizes, Pall Allegro 3D biocontainers enable rapid and easy scale-up during installation. They maximize product recovery within high-volume processes.

Allegro 3D biocontainers include a sampling port plus two inlet top ports for filling and process monitoring. These configurable inlet ports accommodate a wide range of flow rates. Improved labeling includes part/batch numbers plus an area for product batch information that permits optimum tracking and traceability.

The proprietary coextruded film used to form Allegro 3D biocontainers uses inert polyethylene in the inner and outer layers, sandwiching a gas barrier film interlayer of ethylene vinyl alcohol polymer. These Pall biocontainers offer gas barrier properties that support product stability. The composite film features the highest available clarity of any biocontainer film for enhanced visibility of biocontainer contents. The Allegro film is compatible with a wide range of chemicals, has very low leachable levels and does not contain animal-derived ingredients. When used with Pall’s Allegro systems, the Allegro 3D biocontainers simplify operational scale-up by eliminating film re-evaluation.

The product design also ensures quick and easy integration with Pall’s Kleenpak filter capsules, sterile connectors and other single use components. Positioning them into Pall’s stainless steel stackable totes, which close and lock, reduces the manufacturing footprint. Trolleys can be used for easy mobility. Once filling has started, operators are not required to manipulate the biocontainers, reducing the risk of film puncture and exposure to hazards. Tools and accessories also are not needed. Filling can be managed from the top or bottom, and the Allegro 3D bioctontainer/tote combination allows for efficient drainage.

Pall Allegro 3D biocontainers, totes and trolleys are fully validated for use under Good Manufacturing Practice (GMP) to ensure regulatory compliance. They meet quality construction and manufactured standards. An extensive validation program is conducted for gas barrier, extractables, drainage and handling performance.