Mixing System for Bioprocess

The BIOne Mixing System offers laboratory scientists a sophisticated, yet reliable and user-friendly small volume mixing platform for a diverse range of cell-free mixing applications. Built on the proven technology of the flagship BIOne 1250 Bioprocessing Controller, the BIOne Mixing System delivers precise and accurate agitation and temperature control while supporting seamless integration with advanced process analytical technologies for enhanced monitoring and optimization.

Key Features

• Reliable mixing performance — Consistent mixing and temperature control across single-use and autoclavable vessels
• Magnetic drive agitation — Supports robust scale-down models under demanding process conditions
• Versatile applications — Supports variety of cell-free applications, from Enzymatic and mRNA reactions to buffer and media prep, filtrate collection, and final fill
• Automated process control — Fully automated control of mixing speed, pH, and temperature
• Comprehensive monitoring — Continuous data capture for trending and analysis
• PAT integration ready — Supports additional sensors for conductivity, turbidity, pressure, and more
• Intuitive touchscreen interface — Designed for fast learning and ease of operation

Specifications

Category	Specification
Bioreactor Interface	12.1” (30 cm) Capacitive touch screen
Remote Access	Remote viewing and control with optional OPC license
Data Storage	Over 30 days of local data storage & trending
Bioreactor Working Volume Range	Autoclavable glass: 0.75L - 10L Single-use: 0.9L - 10L
Agitation Type	Magnetic drive
Agitation Range	Autoclavable glass / SUF: 15 - 1250 RPM up to 5L, 15 - 900 RPM in 10L Single-use bioreactor (SUB): 15 - 450 RPM
Gas Control	Unavailable
Temperature Control	Autoclavable glass: 4°C with chiller to 80°C Single-use: 4°C with chiller to 60°C
Temperature Resolution	0.1°C
DO Measurement	Analog or optical (measurement only)
DO Control Range	0 - 200% (measurement only)
pH Measurement	Analog or optical
pH Control Range	pH 2 - 12
Redox Measurement	Analog
Redox Control Range	(-) 2000mV - (+) 2000mV
Pumps	1 variable speed pump. Tubing range from 0.8mm ID to 6.4mm ID

The BIOne Single-Use Bioreactor (SUB) is assembled in Distek’s ISO 7 cleanroom with USP Class VI, animal derivative-free materials, gamma sterilized, and ready to use out of the box — no cleaning, assembly, or autoclaving required. Available in 2L, 5L, and 10L. Well characterized based on k_La, P/V, and tip speed, simplifying the tech transfer and scale-up process.Suited for monoclonal antibody production in CHO, AAV and lentiviral vectors in SF9 and HEK293, adherent and aggregate stem cells, and mRNA.

Key Features

• Ready-to-use — Gamma sterilized, assembled in Distek’s ISO 7 cleanroom with USP Class VI materials; no cleaning, assembly, or autoclaving required
• Animal derivative-free — Triple-layered low antioxidant liner: outer layer (LDPE), middle barrier layer (EVOH), contact layer (ULDPE)
• Agnostic design — Compatible with most bioprocessing controllers and most manufacturers’ glass vessels
• Configurable sensor connections — Standard headplate with ports for non-invasive DO (polarographic or optical), optional integrated single-use pH probe, optional non-invasive optical pH, and PG-13.5 universal sensor ports
• Configurable below the headplate — Single or dual pitched blade impellers; flute, microsparger, or open pipe sparger options
• Perfusion-ready — Compatible with Repligen® ATF perfusion tubing

BIOne SUB materials are rated for use in processes at temperatures up to 60°C (exception of Hamilton Single-Use pH probe, with a maximum operational temperature definition of 50°C). Structural Integrity Testing completed for operations up to 60°C. Leachable and Extractables Testing completed at 40°C.

Specifications

Category	Specification
Working Volume (Maximum)	2L SUB: 2L 5L SUB: 5L 10L SUB: 10L
Working Volume (Minimum)	2L SUB: 0.9L 5L SUB: 1.7L 10L SUB: 2.5L
Operating Temperature Range	4°C to 60°C
Operating Pressure (Maximum)	5 psig (0.0345 mPa)
Agitation Range	15 to 450 rpm
Impeller Type	Single or dual pitched blade
Impeller Diameter	2L SUB: 1.78" 5L SUB: 2.36" 10L SUB: 3.12"
Impeller Power Number	1.5
Gamma Irradiated	25 to 40 kGy

Distek, Inc. has been helping science improve lives for 50 years, designing and manufacturing benchtop bioprocessing solutions for the pharmaceutical, biotechnology, and life science industries. The BIOne product line is a family of controllers, single-use bioreactors, single-use fermentors, and mixing systems built for cell culture, cell-free, and microbial fermentation applications at the bench.