BIOne Single-use Bioreactor System

Description

Distek's BIOne Single-use Bioreactor System is designed to adapt standard glass bioreactor vessels into disposable, pre-sterilized platforms. The system centers on a gamma-irradiated disposable assembly comprising a headplate permanently welded to a multi-layered polymer liner. This assembly is placed inside a non-sterile glass support vessel; when filled with media, the liner expands to assume the vessel's interior geometry. It is available for working volumes of 2, 5, or 10 liters, with total capacities of 3 or 7 liters depending on the configuration. Sterility assurance is provided by gamma irradiation at a dose between 25 kGy and 40 kGy. Design features include ports for non-invasive dissolved oxygen and optional pH sensors, multiple sparging options (flute, micro, or open pipe), and compatibility with pitched blade impellers. The liner is constructed from USP Class VI compliant, animal component-free materials: an outer LDPE layer for durability, a middle EVOH barrier layer, and an inner ULDPE product contact layer. This system is intended for applications like mammalian cell culture and aims to use materials analogous to larger-scale single-use bioreactors to aid in process scalability.