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.
“Single-use disposable technology is a proven alternative solution for the biotech and biopharm industries, offering several significant advantages over standard reusable stainless steel systems,” said Helene Pora, Ph.D., senior director of single-use systems, 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.”
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 new 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. For more information, visit http://www.pall.com/allegro.
About Pall Corporation
Pall Corporation is the global leader in the rapidly growing field of filtration, separation and purification. Pall is organized into two businesses: Life Sciences and Industrial. These businesses provide leading-edge products to meet the demanding needs of customers in biotechnology, pharmaceutical, transfusion medicine, energy, electronics, water purification, aerospace, transportation and broad industrial markets. Total revenues for fiscal year 2008 were $2.6 billion. The company is headquartered in East Hills, New York, and has extensive operations around the world. For more information, visit Pall at http://www.pall.com.
