BIOSTAT B The Gold Standard of Benchtop Bioreactors for Cell and Microbial Culture

BIOSTAT B System Concept

The BIOSTAT B is a fermenter | bioreactor which has been developed specifically for the varied requirements of biotechnological and biopharmaceutical research and development. With several thousand installations worldwide, BIOSTAT B is the most successful autoclavable laboratory fermenter system in its class and is now available in the completely re-developed third generation.

Attributes Simple cleaning through hygienic stainless steel housing Space-saving system concept with connections for one or two culture vessels per control unit Clearly presented graphic user interface with color display and 12 touchscreen Trend display of up to 8 process values with variable display cycles for a quick overview UniVessel culture vessels 1, 2, 5 and 10 liters 2 L single-use, polycarbonate culture vessel for cell cultivation High-performance agitation motor for all applications and UniVessel sizes Specially configured gassing systems for microbial and cell culture Special configuration for the alternate use of a system for fermentation or cell culture Control of agitator speed, pH, DO, temperature, foam, filling level, substrate addition, gas mixture and gas volume Scalable culture vessels Redox and Turbidity measurement Off-gas measurement O2 | CO2 Software for external data aquisition (BioPAT MFCS) UniVessel Glass WM Easy Load Pumps Gassing System

Single or Twin Version

Nothing should come in just one flavor. Various configurations are available for animal, plant and insect cell culture plus microbial fermentation. The system can control one or two vessels, completely independent of each other.

The controller unit can be combined with our stirred glass vessels (UniVessel) or single-use vessels (UniVessel SU). The volumes for our UniVessel range from 1 L through to 2 L and 5 L up to 10 L. The UniVessel SU is available as a 2 L polycarbonate vessel.

12 Touchscreen

Typical Applications
Process development for vaccine, recombinant protein and monoclonal antibody production. Process strategy development in batch, fed-batch, continuous or perfusion mode. Scale-up and scale-down experiments for production scale Seed production in small scale High cell density fermentation Adherent cell culture with microcarriers Low-shear cell culture of sensitive organisms Cultivation of filamentous organisms Biofuel manufacture Dual use for both cell culture as well as for microbial applications, e.g. in academic research The BIOSTAT B, a product of some of the most forward thinking in the biotech industry, can be supplied as a flexible base unit which is utilized in pre-clinical research up to a completely qualified system that meets the requirements of a validated GMP environment.

Agitation Motor

Single-use UniVessel

Sensor and External Device Connections USB Connection

BIOSTAT B Flexibility Configured to Order

Base Unit Single Version

Easy Load Peristaltic Pumps Its as easy as open, insert tube, close, finished. No more pinched fingers or torn gloves. Up to six peristaltic pumps can be connected per vessel.

Connections for Sensors & External Devices All connections for the culture vessels can be made easily with the quick connect couplings. All connections are marked for simple allocation to the culture vessel and as identification in the local control software.

12 Touchscreen with closed frame; protected against splashing water and dust deposits

Control Tower includes the gassing, pump and temperature control module, saving valuable space in the laboratory

Storage Dish helps you organize your workstation

Base Unit Twin Version

Single | Twin Need to operate two culture vessels? No problem. One controller can independently control up to two vessels without requiring any extra space. You can freely choose which volumes and culture vessel types should be combined.

New Standards for InterferenceFree Measurements All laboratory inlets for water and gasses are located on the rear of the unit. Mains connection, Ethernet link and a potential-free (common) alarm contact are also positioned on the rear. Complying with the latest standards, the unit is also shielded with a potential equalisation against electromagnetic currents ensuring interference-free measurements during your cultivation process.

BIOSTAT B Gassing Strategies

A series of flexible gassing options turn the BIOSTAT B into a cross-functional system for the most wide-ranging applications from high cell density fermentation with large oxygen demand up to cell cultures which are especially sensitive to shear stress.

Microbial Applications
Various configurations facilitate gassing with air or oxygen along with the classic O2 Enrichment function. For anaerobic processes, the air inlet can also be used for nitrogen. The standard installed solenoid valves in combination with a rotameter ensure gas supply for simple applications. Optional mass flow controllers provide an exact dosing of the individual gasses ideal for balancing studies in combination with off-gas analysis.

Gas Inlet

Solenoid Valve MFC (max. 2) (max. 2)

Rotameter

Gas Outlet

Air

Sparger

O2

Cell Culture and Multipurpose Applications

Five different gas paths, equipped with solenoid valves and rotameters or with up to four optional mass flow controllers provide the maximum level of flexibility and precision. Optional switching from sparger to headspace (Overlay) gassing for the CO2 path facilitates simulating culture conditions with pH control as in an incubator.
Gas Inlet Solenoid Valve (max. 4) MFC (max. 4) Rotameter Gas Outlet

Headspace

Air O2 N2 CO2
Switching CO2 from Sparger to Headspace

Sparger

DCU Local Control

Since its introduction in the late 80s, up to today we have installed several thousand digital control units (DCU) in leading companies of the pharmaceutical and biotechnological industry. The DCU controller is one of the best proven, most secure and most flexible control solutions both in the upstream and in the downstream process. Thanks to its continuous development, the control platform is now available in the 4th generation and is the standard automation platform for our BIOSTAT bioreactors, SARTOFLOW Crossflow filtration units and FlexAct configurable production solutions.
An intuitive touchscreen is used for local process control of BIOSTAT B:

Gassing Control

Weight Measurement & Gravimetric Flow Control

Process Parameter Overview

Pump Module

Submenus

Overview & Detail View Culture Vessels

Status Display

BioPAT MFCS SCADA Process Control

BioPAT MFCS is the international standard software for the supervisory control and data acquisition of bioprocesses. More than 25 years of experience have left their mark on the current version of BioPAT MFCS. With more than 2,300 installations it is the reliable basis for your individual requirements. Provided standard, we deliver a version for data recording (BioPAT MFCS | lite) with every bioreactor:

Shortcut to Home Menu

Easy Comparison of Historic and Ongoing Processes (e.g. Comparison to Golden Batch)

Alarm List

Navigation & System Overview

System Administration

Innovative Data Analysis & Evaluation

Easy switch from one process unit to the other (if multiple bioreactors are connected)

Flexible Setting of Display Period

Start & Stop Data Aquisition in SQL Database

BioPAT MFCS | win The optional advanced version of BioPAT MFCS includes, along with a genuine SCADA system for reusable and disposable bioprocess applications, a series of add-on modules: Bioprocess optimization with Design of Experiments module (DoE) S88 recipe control Batch control compliant with ANSI | ISA-88.01 21 CFR, Part 11 compatibility Secure integration into company networks Flexible device connection facility through OPC Expanded data logging and data archiving Logging of alarms and transmission to multimedia devices

BIOSTAT B Technical Specifications

Weights Control Tower
Single | Twin ~ 40 | 55 [kg]

Dimensions Control Tower (B + H + T)

Single | Twin 410 + 810 + 520 [mm] 230 V ( 10%), 50 | 60 Hz, power consumption 8 A 120 V ( 10%), 50 | 60 Hz, power consumption 10 A Device protection class IP 21 Potential equalisation Gas supply pressure max. 1.5 barg Dry, oil and dust-free Connection hose coupling d external = 6 mm Water supply pressure max. 2 barg Flow rate max. 4 l/min Temperature min. = 4C Discharge pressureless Connection hose coupling | d external = 10 mm Degree of hardness: max. 12 dH Single-board computer Stainless steel AISI 304 Touchscreen 12 125 dpi Industrial Ethernet 1 bar 1.5 bar

Utility Connections
Power Supply

Gasses

Water

Control Tower
Controller Housing Display Resolution Host communication Potential-free (common) alarm contact Safety valve gasses Water inlet pressure reduction value

Gassing Module
Outlet to culture vessel Hose coupling d external = 6 mm

MO (Microbial)
AIR with O2 Enrichment or Gas Flow Ratio mixing along with anaerobic fermentation; Max. total flow

2-Gas mix with sparger outlet

2 vvm

CC (Cell Culture)
Additive Flow 4-gas (Air, O2, N2, CO2) mixture Flow rates

4-Gas mix with sparger and headspace outlet

0.05 1 vvm

Dual use
Additive Flow 4-gas (Air, O2, N2, CO2) mixture Flow rates

4-Gas mix with sparger and headspace outlet

0.05 2 vvm 5 % FS MO (2 Rotameters): 0.120 lpm CC (5 Rotameters): Sparger: 5 ccm 4.2 lpm | Headspace: 0.1-13 lpm 5 ccm 20 lpm

Rotameter
Precision Various models available Dual use

Mass Flow Controller Optional

AIR | N2, O2 or CO2 calibrated Precision 1 % FS

Various models available Dual use

MO (max. 2 MFCs): 0.03 - 20 slpm CC (max. 4 MFCs): Sparger: 1 sccm 4.2 slpm | Headspace: 0.0310 slpm 1 sccm 20 slpm Power 200 W Power 200 W

Drive Motor
Maintenance-free, quiet direct drive Maintenance-free top drive with magnetic motor coupling

Pump Module
Built-in Pumps
Fixed speed (on | off controlled) Speed 40 rpm Flow rate (tubing wall thickness 1.6 mm) Speed 5 rpm Flow rate (tubing wall thickness 1.6 mm) Speed controlled Speed 0.1-200 rpm Flow rate (tubing wall thickness 1.6 mm) Watson Marlow 114, easy load pump head ID: 1,6 mm: 0,178,4 ml/min ID: 3,2 mm: 0,5628,2 ml/min ID: 1,6 mm: 0,010,7 ml/min ID: 3,2 mm: 0,052,4 ml/min Watson Marlow 114, easy load pump head ID: 1,6 mm 0,0128,0 ml/min ID: 3,2 mm 0,0594,0 ml/min Watson Marlow 120, easy load pump head ID: 1,6 mm: 0,0128,0 ml/min ID: 3,2 mm: 0,0594,0 ml/min

External Pumps
Speed controlled Speed 0.1-200 rpm Flow rate (tubing wall thickness 1.6 mm)

Temperature Control Module

Single-wall Culture Vessels
Electrical heating system with heating sleeve and optional cooling finger Temperature control of 8C above cooling-water inlet temperature up to 60C Heating capacity 1 L | 2 L | 5 L | 10 L Connections to exhaust cooler and cooling finger with quick connect couplings

100 | 170 | 400 | 780 [W]

Double-wall (Jacketed) Culture Vessels

Open thermostat system with circulation pump and automatic cooling water valve Temperature control of 8C above cooling-water inlet temperature up to 80 C Heating capacity 2 + 300 [W] Connections to the culture vessel and exhaust cooler with quick connect couplings

External Signals per Culture Vessel

Balance connection RS-232 External signal input 010 V External pumps 2 2 2

Process Control | Sensors

Rotation speed motor, direct coupling 1 | 2 | 5 | 10 [L] 202.000 | 202.000 | 201.500 | 20800 [rpm] Pt100 with thermowell | 0150C (temperature control 0-80C) | 0.1C Polarographic or optical | 0100 % | 0,1 % Combined measuring electrode | 212 pH | 0,01 pH Electrical conductive sensor, stainless steel, ceramic insulated Anti-foam disk (MO applications): min. stirrer speed 300 rpm | PEEK Electrical conductive sensor, stainless steel, ceramic insulated 1-channel NIR absorption sensor | 06 AU | 0,01 AU Combined measurement with pH sensor | -1.000 1.000 mV | 1mV max. 7 kg | 1 g max. 60 kg | 2 g

Sensor | Measurement range | Display accuracy

Temperature Dissolved oxygen pH Foam control Mechanical foam control Level Turbidity Redox Balance substrate Balance culture vessel

Culture Vessel UniVessel

Autoclavable single-wall or double-wall (jacketed) glass vessel 1 L
Material Sizes [L] Total volume [L] Working volume [L] Top port 19 mm | 12 mm | 6 mm

2L

5L

10 L
10 13 1.5 | 510 5|2|9

Borosilicate glass, stainless steel ISI 316L, EPDM 1 2 5 1.6 3 6,6 0.41 0.62 0.65 3|2|6 3|2|9 3|3|8

UniVessel, single-wall
Weights [kg] Space requirement autoclave [W + H + D mm] Space requirement autoclave, reduced [W + H + D mm]
1

1L
6 200 + 540 + 270

2L
7 230 + 600 + 300 480 + 410 + 300

5L
12 260 + 730 + 340 530 + 510 + 410

10 L
19 330 + 860 + 420 540 + 630 + 420

UniVessel, double-wall
Weights1 [kg] Space requirement autoclave [W + H + D mm] Space requirement autoclave, reduced2 [W + H + D mm]
1 2

1L
7 330 + 540 + 270

2L
8 380 + 600 + 300 480 + 410 + 300

5L
14 410 + 730 + 340 530 + 510 + 410

10 L
23 450 + 860 + 420 540 + 630 + 420

With tripod and head plate, without medium Adapter for exhaust cooler to reduce height in the autoclave optionally available

Possible set-up (freely configurable):

Stirrer shaft with single-mechanical seal and direct coupling Stirrer shaft with single-mechanical seal and magnetic coupling 3-blade segment impeller | 6-blade disc impeller (Rushton) | Paddle impeller Addition bottles: 250 ml | 500 ml | 1000 ml Bottle holder Aeration filter Midisart 2000 | Sartofluor capsules Ring sparger | Micro-sparger | Aeration basket for bubble-free gassing Inoculation port Exhaust cooler Heating blanket for single-wall vessels Cooling finger for single-wall vessels 4-way addition port | 3-way addition port Universal adapter ID 3.2 mm Harvest pipe height adjustable | Harvest pipe bent for complete draining Baffles STT Connector 2 mm | 5 mm Port adapter 19 mm 12 mm Manual sampler Tool set for vessel dismantling Consumables including filters, O-rings and other accessories Spin filter for cell retention in perfusion applications

Culture Vessel UniVessel SU

Single-use vessel made of pre-sterilized polycarbonate for cell culture applications
Total volume [L] Working volume [L] Max. temperature Operating pressure Max. stirrer speed 2.6 0.6-2 50 C < 0.5 barg 400 rpm

Ordering information for connection to BIOSTAT B Control Tower

DUO002LL-SS----V DZ-------MB DZ-------VHB DZ002L---VHI DZ-------FH1 UniVessel SU 2l culture vessel, 2+ pack Motor adapter BIOSTAT B, direct coupling UniVessel SU holder, basic UniVessel SU holder adapter ring 2l Filter heater UniVessel SU

Basic Configurations
The BIOSTAT B is a highly flexible and modular system that can be individually adapted to the demands and requirements of your application. Below please find an overview of the basic equipment which can be expanded with diverse options. Please contact your Sartorius Stedim Field Representative or Application Specialist for additional information.

Microbial Packages Ordering Information

Volume Single Twin Digital controller, color display with touchscreen Control temp, pH, DO, stirrer speed Maintenance-free, quiet motor Storage dish for accessories Gassing module with 2 solenoid valves 2 rotameters for manual flow-rate control (AIR | N2, O2) Software configured for microbial applications 4-stage DO cascade BioPAT MFCS software for data acquisition 2 integrated pumps for pH control (Acid | Base) Temperature control module for double-wall vessels 2 external signals 010V Standard test and documentation Installation set for the gas and water connections Mains cable Double-wall culture vessel Stirrer shaft with single-mechanical seal and direct coupling 2 addition bottles for correction agents Exhaust cooler Aeration filters Rushton impellers Ring Sparger 4-way addition port Inoculation port Harvestpipe, height-adjustable Manual sampler Tool set for vessel dismantling Pt100 temperature sensor pH sensor DO sensor, amperometric 1L RBB1M01L RBB2M01L 2L RBB1M02L RBB2M02L 5L RBB1M05L RBB2M05L 10 L RBB1M10L RBB2M10L

Cell Culture Packages Ordering Information

Volume Single Twin Digital controller, colour display with touchscreen Control temp, pH, DO, stirrer speed Maintenance-free, quiet motor Storage dish for accessories Gassing module with 4 solenoid valves 5 rotameters for manual flow-rate control (AIR Overlay, AIR Sparger, N2, O2, CO2) Software configured for cell culture applications 4-stage DO cascade BioPAT MFCS software for data acquisition 1 integrated pump for pH control (Base) Temperature control module for single-wall vessels 2 external signals 010V Standard test and documentation Installation set for the gas and water connections Mains cable Single-wall culture vessel with tripod Heating blanket 120 | 230 V Stirrer shaft with single-mechanical seal and direct coupling 1 addition bottle for correction agent Exhaust cooler Aeration filters 3-blade segment impeller Micro-sparger 4-way addition port Harvest pipe, height-adjustable Manual sampler Tool set for vessel dismantling Pt100 temperature sensor pH sensor DO sensor, amperometric 1L RBB1C01L RBB2C01L 2L RBB1C02L RBB2C02L 5L RBB1C05L RBB2C05L 10 L RBB1C10L RBB2C10L

Options
Control System Advanced DO controller Flexible switching CO2 from sparger to headspace Software for dual use MO | CC Massflow controller Antifoam control via sensor Mechanical foam destroyer (MO applications) Level control via sensor Weight measurement substrates | culture vessel Gravimetric feed | level control Substrate addition via time profile Redox measurement Turbidity measurement

O2 | CO2 off-gas analysis System IQ | OQ BioPAT MFCS SCADA system Culture Vessel Magnetic coupling for drive motor STT connectors for safe inoculation and media transfer Cooling finger (single-wall culture vessels) Spinfilter for perfusion mode Aeration basket for shear stress sensitive organisms Paddle impeller | Rushton impellers | 3-blade segment impellers Baffles Bottle holder Adapter for height reduction of exhaust cooler for the autoclave Inoculation port Consumables set Double-wall culture vessel UniVessel SU single-use culture vessel (CC applications)

Sales and Service Contacts

For further contacts, visit www.sartorius-stedim.com

Europe
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America
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Specifications subject to change without notice. Printed in Germany on paper that has been bleached without any use of chlorine. | W XX-0000-e07051 Order No.: 00000-000-00 Ver. MM | YYYY Publication No.: SBI1513-e12061 Order No.: 85032-542-70 Ver. 06 | 2012

Phone +91.80.4350.5361 Fax +91.80.4350.5253 Japan Sartorius Stedim Japan K.K. KY Building, 811 Kita Shinagawa 1-chome Shinagawa-ku Tokyo 140-0001 Phone +81.3.3740.5407 Fax +81.3.3740.5406 Malaysia Sartorius Stedim Malaysia Sdn. Bhd. Lot L3-E-3B, Enterprise 4 Technology Park Malaysia Bukit Jalil 57000 Kuala Lumpur Phone +60.3.8996.0622 Fax +60.3.8996.0755 Singapore Sartorius Stedim Singapore Pte. Ltd. 1 Science Park Road, The Capricorn, #05-08A, Singapore Science Park 2 Singapore 117528 Phone +65.6872.3966 Fax +65.6778.2494 South Korea Sartorius Korea Biotech Co., Ltd. 8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-Gu SeongNam-Si, GyeongGi-Do, 463-400

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