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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:
