FloPac 2D/3D Single-use Bag For Biopharmaceuticals

2D/3D biocontainer single-use systems comprised of biocontainers and tubing assemblies designed for applications where biocontainers must be both reliable and flexible.

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 materials
Japanese 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 Plastics
The 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.

Highly transparent biocontainers for easy visual inspection of solutions
Possibility for the end user to input product batch information
Part number and batch number visible on the biocontainers
Improved labelling for optimum traceability
Traceability & Inspection
Ports designed to allow tubing attachments with cable ties or BarbLock fittings
Potential to insert a probe through a ½ in. port
Choice of ¼ in. to ½ in. outlet and inlet connections, with an option for a ¼ in. port for all sizes
Sized to allow filling at nominal volume, even in applications where freezing is required
Shape enables very efficient drainage of the fluid
Design & Usability
Excellent barrier properties
No animal-derived ingredients
Very low levels of extractables and leachables
Compatible with a wide range of chemicals
High clarity and flexibility
Inert low-density polyethylene fluid contact layer
Material & Compatibility

Product Details

FloPac 2D/3D Single-use Bag For Biopharmaceuticals

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