Cytiva, 6500-0374C, Allegro™ 3D biocontainer systems

Allegro™ 3D 50 L biocontainer w/ AdvantaFlex biopharmaceutical grade TPE tubing
The Allegro™ 3D systems are single-use systems comprised of biocontainers and tubing assemblies in standard configurations designed and built to speed up the biopharmaceutical production process. They can also be paired with supporting hardware in the form of totes and trolleys to provide maximum flexibility in the processing environment with stackable, maneuverable and collapsible features. The Allegro™ 3D systems and associated hardware are manufactured under a Quality Management System certified to ISO 9001. The Allegro™ biocontainers are 100% leak tested during manufacturing, which takes place in a controlled environment (Class 10,000, grade C). The materials of construction of the Allegro™ biocontainers meet:
• USP <88> Biological reactivity tests in vivo for Class VI - 50°C plastics
• USP <87> Biological reactivity tests in vitro (cytotoxicity)
• ISO 10993 (biological compatibility)
• USP <661>, EP Section 3.1.5 and JP section 61 part 1 (physicochemical tests for plastics)
• USP <85> and EP Section 2.6.14 (endotoxins)
• USP <788> (particulates)
• European directive 85/572/EEC for food contact plastic materials
Film properties and benefits:
Coextruded film, comprising inert polyethylene in the inner Inert polyethylene fluid contact layer Excellent gas barrier properties Superior clarity and flexibility Compatible with a wide range of chemicals and pH Very low level of leachables No animal derived ingredient Applications include: Cell culture media preparation and storage Buffer preparation and storage Product and cell harvesting Intermediate product storage Bulk product storage prior to filling Totes and trollies available for storing and moving the biocontainers available.