ESI Technologies Ltd

Custom 2D Bioprocess Bags

Custom 2D Bioprocess Bags

ESI Ultrapure offer a wide range of custom 2D Bioprocess Bags for a variety of applications. The multi-layer 2D single-use bags are available in a range of volumes between 5 ml and 50 litres.

Product Benefits

All custom single-use bag assemblies are manufactured under a Quality Management System certified to ISO 9001 processes including cGMP standards which are strictly maintained.

• Bag assemblies are supplied either gamma sterilised (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)

Technical Data

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 polyethene) which is used as the contact layer for large 2D bags and 3D Bags.

Application

•    Cell culture media preparation and storage
•    Buffer preparation and storage
•    Product harvesting
•    Chromatography fraction collection
•    Intermediate product storage
•    Bulk product storage before filling
•    Sampling