2D/3D biocontainer single-use systems comprised of biocontainers and tubing assemblies designed for applications where biocontainers must be both reliable and flexible. Inert low density polyethylene fluid contact layer High clarity and flexibility Compatible with a wide range of chemicals Very low level of extractables and leachables No animal derived ingredients Excellent barrier properties The 2D biocontainers are available from 50 mL up to 50 L. For applications where larger volumes need to be processed (> 50 L), 3D biocontainers are available. The materials of construction are identical throughout the whole product range, thus allowing for easy scale-up and qualification.
Sampling
Filling set
Bulk product storage prior to filling
Intermediate product storage
Fraction pooling
Chromatography fraction collection
Buffer preparation and storage
Product harvesting
Cell culture media preparation and storage
European Directive 85/572/EEC for food-contact plastic materialsJapanese Pharmacopoeia (Section 61, Part 1)European Pharmacopoeia (Section 3.1.5)USP 661 (Physicochemical tests for plastics)ISO 10993 (Biological compatibility)USP 87 (Cytotoxicity)Biological reactivity in vivo for Class VI – 50°C PlasticsThe materials of construction of the biocontainers meet the following standards and regulations:Biocontainers are produced in a controlled environment (Class 10,000, Grade C).Trolleys, trays, and biocontainers are manufactured under a Quality Management System certified to ISO 9001.Biocontainers are 100% leak tested.
Inert low density polyethylene fluid contact layerHigh clarity and flexibilityCompatible with a wide range of chemicalsVery low level of extractables and leachablesNo animal derived ingredientsExcellent barrier properties
