ESI Ultrapure offers a wide range of custom 2D Bags (bioprocess bags) for a variety of applications: preparation, storage and transport of biopharmaceutical solutions. The multi-layer 2D bags are available in a range of volumes between 5 ml and 50 litres.
Single-Use Custom 2D Bag Applications
The Biopharmaceutical Industry has validated two primary polymers for the contact layer of Single-Use bioprocess bags which ESI Ultrapure utilise. The first material is EVA (Ethylene vinyl acetate) which is commonly used for 2D Bags, and Bags for Rocking Platforms. The second and most widely used material is ULDPE (Ultra low density polyethylene) which is used as the contact layer for large 2D bags and 3D Bags. These bioprocess 2D bags are used in the following applications:
Cell culture media preparation and storage
Buffer preparation and storage
Chromatography fraction collection
Intermediate product storage
Bulk product storage prior to filling
Quality Standards of Single Use Bags
All custom single-use bag assemblies are manufactured under a Quality Management System certified to ISO 9001 processes include cGMP standards which are strictly maintained.
Bag assemblies are supplied either gamma sterilized (25kGy – 50kGy) or sterile (SAL 106) in compliance with ISO11137.
100% Leak tested
A Certificate of Compliance (COC) or Certificate of Analysis (COA) is supplied with each bag assembly
All films and components used in the production of these 2D bag assemblies are certified to be Animal Derived Component Free (ADCF)