Custom 2D Bioprocess Bags

Single Use Assembly Benefits

High-Quality, Custom Single-Use Bag Assemblies: Manufactured for Safety and Reliability

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 10^{6) 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)

Single Use Assembly Technical Data

Validated Polymers for Safe and Efficient Bioprocessing Bags

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), used as the contact layer for large 2D bags and 3D Bags.

Single Use Assembly 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

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