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Broch Biostat-STR-Flexsafe SBI1509-e Neu

Biorreactores

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0% found this document useful (0 votes)
2K views24 pages

Broch Biostat-STR-Flexsafe SBI1509-e Neu

Biorreactores

Uploaded by

Brian Vasquez
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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BIOSTAT STR® Bioreactors and Flexsafe STR® Bags

A Perfect Match for True Scalability in Single Use


Overview Scalability System Features Automation Bag Concept Film Safety

Single-Use Production Platform


of the Future
The BIOSTAT STR® fully scalable, single-use bioreactor family offers working
volumes from 12.5 L to 2000 L and is based on conventional stirred-tank
design. It is now available in its second generation with improved hardware
design, Flexsafe STR® bags for excellent cell growth and robustness and
single-use, non-invasive biomass monitoring.

Cell Growth
The complete control of our Flexsafe®
bag production process – from the resin
to the final sterilized bag – guarantees
you consistent lot-to-lot cell growth
performance, even of the most sensitive
cell lines.
Scalability
Classic stirred-tank design from the
ambr® 250 to the BIOSTAT STR® 2000.
Simplify your scale-up and scale-down,
reduce risks in your process transfers
and easily switch between reusable and
single-use bioreactors.

Connectivity
Easily connect your BIOSTAT STR® to our
BioPAT® MFCS or third party supervisory
software like DeltaV™. Straightforward
integration into existing automation
infrastructure provides you with data
consistency across scales and throughout
the entire development process.

Continuous Processing
Get the best solution for high-cell ­density,
intensified cultures with combining
­efficient oxygen transfer, mixing and
CO2 stripping with integrated advanced
analytics for high level and automated
monitoring Microcarrier Cultures
®
– BioPAT  ViaMass for viable biomass Benefit from our flexible stirrer and
– BioPAT ® Trace for glucose | lactate sparger options. Successfully grow your
shear sensitive cells on microcarriers
and ensure excellent cell growth
and viability.

DeltaV™ is a trademark of Emerson Process Management.


Service Technical Data

BIOSTAT STR® 2000


Overview Scalability System Features Automation Bag Concept Film Safety

Accelerate Your Development –


Rely on Proven Scalability
Sartorius Stedim Biotech offers classic stirred-tank design in single-use bioreactors,
from ambr® 250 to BIOSTAT STR® 2000.

– Geometrical similarity of vessel design Simplify your scale-up and scale-down studies
– Consistent mixing and gassing strategies Easily switch between reusable and single-use bioreactors
– Reliable single-use sensor platform Mitigate risks during process transfers

ambr® 250 UniVessel® SU 2 L BIOSTAT STR® 50 BIOSTAT STR® 200


100 – 250 mL working volume 0.6 – 2 L working volume 12.5 – 50 L working volume 50 – 200 L working volume

Cell line Development Process Development

– Mammalian, insect and stem cell culture


– High cell density cultures exceeding 150 million cells /mL
– Adherent cell culture on microcarriers
– Low to medium cell density microbial culture
Service Technical Data

Seamless scalability in single use


from early process development
to commercial production

250 mL 2L 50 L 2000 L

BIOSTAT STR® 500 BIOSTAT STR® 1000 BIOSTAT STR® 2000


125 – 500 L working volume 250 – 1,000 L working volume 500 – 2,000 L working volume

Production

– Antibodies and
recombinant proteins
– Vaccines For further details please
– Cell and gene therapy have a look at:
www.sartorius.com/biostat-str
Overview Scalability System Features Automation Bag Concept Film Safety

Advanced Functionality
The BIOSTAT STR® bioreactor system is comprised of a stainless steel bag holder,
with new, improved design, a single-use Flexsafe STR® bag with advanced single use
sensor solutions and a superior control system that can easily be connected to
third party SCADA systems such as Delta V™.

Easy Installation
Even at 2,000 L Scale
Install our bioreactor bags in next to
no time thanks to our large door, the fixed
motor position and an easily accessible
filter holder position. Prevent tube
and cable spaghetti with our cable and
tube management system.

Larger Sensor Window


Increase your sensor and connection
options. Use standard re-usable sensors via
special insertion devices. Connect external
cell retention devices.

Advanced Single-Use Sensors


Run your processes in an intensified, auto-
mated and predictive manner with our
advanced analytics solutions. Use BioPAT ®
ViaMass to monitor cell growth and exert a
tight control onto feeding and harvesting
in intensified processing. With BioPAT ®
Trace you are able to improve your product
titer and quality with controlling and
maintaining a low-glucose concentration.
Service Technical Data

Advanced Aeration Concept


Attain high oxygen transfer rates and
minimize foaming with our innovative
sparging element that combines a 0.8 mm
ring sparger and a 150 μm micro-sparger
with defined hole sizes. Remove excessive
CO2 using a stripping gas flow. Benefit from
optimal gas bubble size and homogeneous
distribution.

Proven Stirrer Design


Achieve excellent fluid flow dynamics –
comparable to classic stirred-tank bioreac-
tors - with two impellers on a magnetically
coupled center-line shaft. Choose between
Rushton and 3-blade segment impeller
designs.

Local Controller with


Full Connectivity
Reduce operator training effort and
mitigate human error with our GAMP
compliant DCU local control platform
and intuitive design of the human machine
interface. Now enabling also straight­
forward integration into 3rd party SCADA
systems including Delta V™.

Increased Double Wall


Cool down your culture harvest at the
end of your process faster than ever due
to the increased heat exhange area of
our bag holder.
Overview Scalability System Features Automation Bag Concept Film Safety

Intuitive and Industry-Proven Local Control


Benefit from our industry-proven, robust and intuitive-use local control platform for our BIOSTAT ® bioreactors, SARTOFLOW ®
crossflow filtration units and FlexAct® configurable systems. Available in its fourth generation, with new, improved features.

– Minimizes training and enables you to start your process right away
– Increases operator flexibility
–M
 itigates human error

Centralized User | Password
Management Utilizing
Windows® Domain Login
Central management of user rights for
your bioprocess equipment has never been
easier – the BIOSTAT STR® can connect
directly to your user management
data implemented on your Microsoft®
server and your user can work with their
well-known user names and passwords.

Import and Export Process


Relevant Settings
Easily store your individual process settings
and user authentication data and transfer
them between BIOSTAT STR® systems.

“ The BIOSTAT STR® smoothly


integrates into your individual
control and IT infrastructure.

Microsoft® and Windows® are registered trademarks of Microsoft Corporation, USA.


Service Technical Data

Integration and Connectivity at Its Best


Our BIOSTAT STR® provides the right interfaces and tools to connect to supervisory control and data acquisition systems (SCADA)
or distributed control systems (DCS ) – regardless if you chose to work with our BioPAT® MFCS as a ready-to-use solution
or connect to your specific company SCADA or DCS solution.

BioPAT® MFCS – Turnkey SCADA Solution


Specialized for bioprocesses, BioPAT® MFCS is designed as a “plug-and-play” tool
for advanced SCADA functionalities. It is ideally suited for capturing, storing
and visualizing process data of all BIOSTAT® and ambr® bioreactors and other process
equipment.

One source bundle with full Sartorius Specifically tailored for Cost-effective & flexible
responsibility and lifecycle concept  biopharmaceutical industry  automation platform

Setpoints | Actuator Access
DCU Modbus fieldbus | DCU OPC interface
Process Values | Alarms
Emerson Process
Siemens Simatic PCS 7 Management DeltaV™
Rockwell Automation

For straightforward integrations of your BIOSTAT STR® into a DeltaV™ network, we provide a Modbus mapping
of your system in digital format. Once imported into your DeltaV™ configuration, it enables you to access process values,
set controller parameters or even access actuators in a direct manner – e.g. pumps or valves.

DeltaV™ is a trademark of Emerson Process Management.


Overview Scalability System Features Automation Bag Concept Film Safety

Conventional Stirred-Tank Design


Ease of Use
Large doors provide easy access for
safe bag installation. Our ease-of-use
concept enables fast and straight­forward
installation even of large-scale bags up
to 2,000 L. The torospherical Flexsafe STR®
bags fit perfectly into the bagholder –
preventing creases and crinkles.

Lifting device for easy installation of 2,000 L bags

Easy Implementation
Flexible Combinations
Gamma-sterilized Flexsafe STR® bags
are ready to use. Sterile connection and
disconnection devices, like our BioWelder®
and BioSealer® can be used for safe
connections and liquid transfer. Needle
free sampling ports allow easy and
convenient sampling without any risk
of contamination.

BioWelder®

Easy and safe installation


of a 2,000 L Flexsafe STR® bag
Watch Video:
www.sartorius.com/biostat-str
Service Technical Data

Geometrical similarity
from 50 L to 2,000 L

d2
h1
= constant 1.8 h1
d1
d2
h1 d2
= constant 0.38
d1
d1
d1

50 L 2,000 L

Configurable Flexsafe STR® Bag Design


The bags feature a 1:4 turndown ratio. Flexsafe STR® bags are individually
configurable, offering multiple options for tubing, connectors, spargers
and agitation devices to cover all process demands. Pre-configured standard bags
are readily available from stock – the choice is all yours.

Tubing Options Choose between silicone and C-Flex® 374 tubing in various
diameters. Internal dip tubes for inoculation or carrier-free
harvesting.
Sparger Type Choose between just using the 0.8 mm ring sparger or the 
150 μm micro-sparger part of our innovative sparging element
or a combination of both.
Impeller Type Choose between two 3-blade segment impellers, two 6-blade
disk impellers (Rushton) or a combination of both.
Connections Choose among Luer, MPC, Opta® sterile connectors and
tube welding.
Sensors Choose between single-use and conventional pH and DO
probes. Monitor viable biomass with our single-use
BioPAT® ViaMass capacitance probe and improve your product
titer, quality and ensure glycolisation homogeneity with our
BioPAT ® Trace.

BioPAT® Trace BioPAT® ViaMass Opta® Connectors


Extensive bioreactor characterization
data on kLa, mixing time and power
input available.
www.sartorius.com/bpi-supplement

C-Flex® is a registered trademark of Saint-Gobain Performance Plastics Corporation.


Overview Scalability System Features Automation Bag Concept Film Safety

New Bag Family

50 L Flexsafe STR® 2,000 L

Safe and Convenient Single-Use Processing


Flexsafe® – One Film Across All Single-Use Applications
Flexsafe® meets your requirements for outstanding robustness and ease of use throughout
all steps of single-use processing – from rocking motion or stirred tank bioreactor cell
culture, through to large-scale mixing to shipping of drug products. In addition, Flexsafe®
reduces time and expense for process validation, extractable and leachable studies,
toxicology assessment and stability studies.

Seed Production 3D Storage & Shipping

1– 200 L total volume 50 – 2,000 L 100 –1,000 L

Flexsafe® RM Flexsafe STR® Flexsafe® 3D Bags


Service Technical Data

One for All


Cell Growth
Flexsafe® ensures excellent and reproducible growth behavior
of the most sensitive production cell lines. The complete control
of our raw materials, the extrusion process and the bag assembly
guarantees consistent lot-to-lot cell growth performance.

We optimized the resin and


minimized the additive package,

Cell Density
Reference: Borosilicate Glass in collaboration with our resin
and film suppliers.
Flexsafe® Bags

Standard Bags Independent labs have confirmed


that Flexsafe® bags are free of
cytotoxic leachables. No bDtBPP
is identified in WFI extracts of
Time Flexsafe® bags.

Robustness
The thickness, strength and flexibility of the new polyethylene
film enhances the mechanical robustness of Flexsafe® – making it
ideal for all bioprocessing applications. The strength of Flexsafe®
significantly reduces the risk of accidental damage to the bag
due to inappropriate handling. Its flexibility enables convenient
installation and self-deployment of the bag in its container.

Bag A

Bag B

Bag C

Flexsafe®

Energy at Break

Assurance of Supply
Flexsafe® provides you with an unprecedented assurance of
supply and enables robust business continuity plans. Our strategic
partnership with resin and film suppliers ensures full traceability
of raw materials and control over the entire manufacturing
process from the resins to the final assembled bags.

Use our Flexsafe STR® bags for clinical


or commercial production of your valuable
antibody, recombinant protein or vaccine.
Team up with our Flexsafe® RM bags
in your seed train. Benefit from the same
PE film material across all of your cell
culture steps. New Flexsafe® Bag Family

Watch Video:
www.sartorius.com/sartorius/en/EUR/flexsafe
Overview Scalability System Features Automation Bag Concept Film Safety

Unparalleled Safety in Single-Use Technology


Unlike stainless steel bioreactors, single-use bioreactors are made, shipped, stored and installed for every run. Therefore, we have
developed a holistic safety concept that governs the entire process from manufacturing to using single-use bioreactor bags to produce
drugs for human use, from end to end. Especially, testing the integrity of bioreactor bags at the point of use, helps to mitigate potential
contamination and biosafety risks. This is even more important for processes requiring higher biosafety levels, e.g. in vaccine production,
where protection of operators and the environment are of great concern.

Bio

Development Production Transportation

– User requirement specification (URS) – ISO 9001-certified production – Innovative packaging concept for safe
–R
 igorous mechanical, chemical and – State-of-the-art quality system accord- transportation and storage
biological testing of components ing to applicable cGMP requirements – Cleanroom compliant packaging
–Q
 ualification of bioreactor bags – Incoming goods inspections – Easy and safe unpacking without
according to applicable guidelines – Qualified components with proven cell cutting objects
–G
 eneration of extractable and culture performance
leachable data – ISO 7 cleanroom bag assembly
– E xtensive application-based robustness – Qualified manufacturing procedures
testing of entire bioreactor bags
– Validated gamma irradiation procedures
– Stringent quality control and product
release

Comprehensive Supporting Documentation Available

Validation Guide
Extractables Guide for Standard Flexsafe STR®
Flexsafe STR® Single-use Stirred Bioreactor Bags Stirred Bioreactor Bags – 50 L to 2000 L

Learn more about our single-use


bioreactor bag qualification approach.

Extractables Guide Validation Guide www.sartorius.com/bpi-supplement


Service Technical Data

safety

Installation Operation Deinstallation

– System designed for convenient – Pressure measurement and control – Aseptic disconnection
installation to reduce operator keeps bag pressure within permissible – Convenient dismantling
manipulation range
– Detailed instruction and video – Single-use exhaust cooler and back-up
installation guide exhaust filter to prevent filter blockage
– Aseptic connector technology – Overheating protection to maintain
– Bag Tester for post-installation, film material properties
point-of-use leak test – Completely closed bag with magnetic
– Tubing and cable management for easy, coupling and single-use sensors
safe and clean set up – Spill containment tray with option
to connect to kill tank

Sartocheck® 4 plus Bag Tester


Post-installation, pre-use testing takes safety to highest level
– Patented techology for non-destructive point-of-use bag test
– Tests the bag and the manual connections simultaneously
– Fully validated, automatic and fast test method based on pressure drop
– F irst bag tester for single-use bioreactors and specifically designed for BIOSTAT STR®

Reduce your risk of batch losses due to operator failures and incorrect handling.

Post-installation bag testing


Watch Video:
http://microsite.sartorius.com/sartocheck/video.html
Overview Scalability System Features Automation Bag Concept Film Safety

Maximized Process Security


To keep your biopharmaceutical process robust and reliable, we provide a comprehensive range of services to ensure the highest
reliability and uptime of your BIOSTAT STR®, regulatory compliance and best quality of results. From installation and qualification
to regular preventative maintenance: Our service team will be happy to assist you on site and will be with you quickly thanks
to our worldwide service network.

Installation and Commissioning Qualification (SAT) Operator Training


Safe and proper operation of your equipment — Compliance with GMP requirements, easy Quality through greater expertise: Sartorius
right from the start integration into your quality management system trains the personnel operating our equipment

Installation Phase
Utilization Phase

Repairs and Spare Parts Maintenance and Contracts Calibration


In the event of service requests, we are Optimal equipment operation and Accurate results in the long term and
quickly at your side with the necessary protection against potential downtimes compliance with regulatory requirements
spare parts — worldwide
Service Technical Data

Service Contracts for the Entire System Lifecycle


With our Bioprocess Service Program, Sartorius offers service contracts to protect your equipment through its entire lifetime.
Based on your specific risk assessment and requirements, you can choose between three Service Level Agreements:
Essential, Advanced and Comprehensive. Protect your BIOSTAT STR® by choosing the appropriate service contract.
For maximum productivity and minimum downtimes.

Essential Advanced Comprehensive


You benefit from: You benefit from: You benefit from:
– A plannable annual maintenance – A plannable annual maintenance – A plannable annual maintenance
– A fast support at the technical helpdesk – Technical helpdesk reaction time within – Technical helpdesk reaction time within
within one business day and priority 8 hours and 72 hours on-site response 4 hours and 48 hours on-site response
on-site-response – In case of repair: labor and travel – In case of repair: all costs are covered
– In case of repair: A discount on all time costs are covered, a discount of 10%
and material based cost elements on spare parts

Reaction time
Reaction time
Reaction
Reaction
timetime

Repair Repair Repair


Repair

h h hhh h h
hh hh

h h hhh h hhh h hh
Maintenance
Maintenance
Maintenance
Maintenance

Essential Essential Essential


Essential
Advanced Advanced Advanced
Advanced
Comprehensive
Comprehensive
Comprehensive
Comprehensive

– Process stability and minimized downtime


Your Benefits – Maximized system uptime, higher profitability
– Optimized total cost of ownership

For further details and the dedicated


datasheets, please have a look at
our website: www.sartorius.com/service
Overview Scalability System Features Automation Bag Concept Film Safety

Technical Specifications

BIOSTAT STR® 50 BIOSTAT STR® 200 BIOSTAT STR® 500 BIOSTAT STR® 1000 BIOSTAT STR® 2000

Bag Holder with TCU


BIOSTAT STR® BIOSTAT STR® BIOSTAT STR® BIOSTAT STR® BIOSTAT STR®
50 200 500 1000 2000
Material AISI 304L stainless steel
Dimensions 588 × 880 ×  788 × 980 ×  1033 × 1380 ×  1225 × 1380 ×  3400 × 2750 × 
W × D × H 1952 mm 1978 mm 2312 mm 2692 mm 3900 mm
23.2 × 34.6 31 × 38.6 ×  40.7 × 54.3 ×  48.2 × 54.3 ×  134 × 108.3 × 
 × 77 in. 78 in. 91 in. 106 in. 153.5 in.
(incl.platform)
Footprint 0.52 m2 0.77 m2 1.43 m2 1.69 m2 9.35 m2
5.6 ft2 8.3 ft2 15.4 ft2 18.2 ft2 100.6 ft2
(incl.platform)
Weight 185 kg 285 kg 575 kg 765 kg 2,045 kg
408 lb 629 lb 1,268 lb 1,687 lb 4,509 lb
(incl.platform)
Packaging 1450 × 1150 ×  1450 × 115 ×  1700 × 1200 ×  1700 × 1500 × 
dimensions 1900 mm 1900 mm 2200 mm 2540 mm
57.1 × 45.3 ×  57.1 × 45.3 ×  67 × 47.2 × 67 × 59 × 100 in.
74.8 in. 74.8 in.  86.6 in.
Installed on skid • • • • •
Double wall • • • • •
Electro-polished • • • • •
Single front door 1 1 1 1 1
Holder for gas filters • • • • •
Viewing window 1 1 1 1 1
Lateral window 2 2 2 2 2
for sensors and ports
Top drive motor • • • • •

• available – not available ( ) optional, needs to be ordered separately


Service Technical Data

Control Tower
BIOSTAT STR® BIOSTAT STR® BIOSTAT STR® BIOSTAT STR® BIOSTAT STR®
50 200 500 1000 2000
Material AISI 304 stainless steel
Dimensions 800 × 910 × 1708 mm 
W × D × H 31.5 × 35.8 × 67.2 in.
Footprint 0.73 m2
7.86 ft2
Weight 182 kg
402 lb
Packaging dimension 1450 × 1150 × 1900 mm 
57.1 × 45.3 × 74.8 in.
Single version • • • • •
Twin version* • • – – –
Installed on skid • • • • •
Color touch screen 19“ 19“ 19“ 19“ 19“
Safety measurement and • • • • •
shut-off
Different user level (•) (•) (•) (•) (•)
log in
Logbook function (•) (•) (•) (•) (•)
Uninterrupted power (•) (•) (•) (•) (•)
supply (UPS) 24 V

BIOSTAT STR® 50 & * Twin configuration to accommodate extra-low space requirements.


BIOSTAT STR® 200 Twin Ideal for seed train and small-scale production.

Facility and Utility Requirements


BIOSTAT STR® BIOSTAT STR® BIOSTAT STR® BIOSTAT STR® BIOSTAT STR®
50 200 500 1000 2000
Power Supply
Power | Frequency | Consumption
208 VAC | 60 Hz | 23 A • • • • •
400 VAC | 50 Hz | 18 A • • • • •

Gas Supply Gas specification according to ISO 8573-1: dry, free of oil and dust
Compressed air (bar) 2 2 2 4 4
Gas pressure O2, N2, CO2 (bar) 2 2 4 4 4

Water Supply
Cooling water – supply pressure (bar) 1.5 1.5 1.5 1.5 2
Drain for water 25 lpm 25 lpm 25 lpm 25 lpm 40 lpm
Temperature min. 8°C min. 8°C min. 8°C min. 8°C min. 8°C
min. 46°F min. 46°F min. 46°F min. 46°F min. 46°F
Degree of hardness max. 12 dH max. 12 dH max. 12 dH max. 12 dH max. 12 dH

Environmental Requirements
Ambient temperature 5 – 40°C
41 – 104°F
Relative humidity range < 85%

• available – not available ( ) optional, needs to be ordered separately

DeltaV™ is a trademark of Emerson Process Management


Overview Scalability System Features Automation Bag Concept Film Safety

Process Control
BIOSTAT STR® BIOSTAT STR® BIOSTAT STR® BIOSTAT STR® BIOSTAT STR®
50 200 500 1000 2000
Agitation Module
Max. stirrer speed* 240 rpm 150 rpm 110 rpm 90 rpm* 70 rpm

Temperature Control Unit


Type Heating | cooling Heating | cooling Heating | cooling Heating | cooling Heating | cooling

Heating kW | cooling HP
Temperature control, double wall 8°C (46°F) above 8°C (46°F) above 8°C (46°F) above 8°C (46°F) above 8°C (46°F) above
cooling water up to cooling water up to cooling water up to cooling water up to cooling water up to
40°C (104°F) 40°C (104°F) 40°C (104°F) 40°C (104°F) 40°C (104°F)
Over-temperature protection • • • • •
Connection to pressure rated • • • • •
cooling water

Aeration Module 4-gas mix (O2, N2, CO2, air) with 3 outlets

Rotameters (Flow Meters)


– Outlets 3 3 3 3 3
– Accuracy of rotameters ± 5% full-scale ± 5% full-scale ± 5% full-scale ± 5% full-scale ± 5% full-scale
For sparger line ring, micro or combi-sparger (O2, N2, CO2, air)
– Flow rates (lpm)** 0.7 – 5.5 1.0 – 23 5.0 – 55 12 – 104 30 – 210
For overlay line (CO2, air)
– Flow rates (lpm)** 0.7 – 5.5 1.0 – 23 5.0 – 55 12 – 104 30 – 210

Mass Flow Controllers (MFC)


– Number of MFCs up to 6 up to 6 up to 6 up to 6 up to 6
– Accuracy of MFC ± 1% full-scale ± 1% full-scale ± 1% full-scale ± 1% full-scale ± 1% full-scale
For sparger line Ring sparger, micro- or combi-sparger (O2, N2, CO2, air)
– Flow rates (lpm)** (0.025 – 5) (0.1 – 20) (0.25 – 50) (0.5 – 100) 1.0 – 200
For overlay line (CO2, air)
– Flow rates (lpm)** (0.025 – 5) (0.1 – 20) (0.25 – 50) (0.5 – 100) 1.0 – 200
Softkey to switch air | O2 between ring • • • • •
and micro-sparger
Advanced DO controller • • • • •

Pump Module
Max. 6 built-in pumps
WM314 fixed speed (1 to 4) (1 to 4) (1 to 4) (1 to 4) (1 to 4)
WM314 speed-controlled (0 to 4) (0 to 4) (0 to 4) (0 to 4) (0 to 4)

External Pumps
Speed-controlled (up to 4) (up to 4) (up to 4) (up to 4) (up to 4)

* Valid for 2 + 3-blade impellers. In case of 1 + 3-blade and 1 + 6-blade impellers, the maximum stirrer speed may be reduced depending on the filling level.
At maximum filling level, the stirrer speed is limited to 70 rpm at 1,000 L scale.
** Alternative lower flow ranges are available upon request.

• available – not available ( ) optional, needs to be ordered separately


Service Technical Data

Process Control Continued


BIOSTAT STR® BIOSTAT STR® BIOSTAT STR® BIOSTAT STR® BIOSTAT STR®
50 200 500 1000 2000

Sensors & Measurement


Temperature probe Pt 100 • • • • •
– Measurement range 0 –150°C 0 –150°C 0 –150°C 0 –150°C 0 –150°C
32 – 302°F 32 – 302°F 32 – 302°F 32 – 302°F 32 – 302°F
pH, single-use • • • • •
– Measurement range 6.0 – 8.0 6.0 – 8.0 6.0 – 8.0 6.0 – 8.0 6.0 – 8.0
– Recalibration function • • • • •
pH, electro-chemical, reusable • • • • •
– Measurement range 4-10 4-10 4-10 4-10 4-10
DO, single-use • • • • •
– Measurement range 0 –110% 0 –110% 0 –110% 0 –110% 0 –110%
– Recalibration function • • • • •
DO optical or polarographic, reusable • • • • •
– Measurement range 0 –100% 0 –100% 0 –100% 0 –100% 0 –100%
Load cells (•) (•) • •  •
Balance substrate (up to 4) (up to 4) (up to 4) (up to 4) (up to 4)
BioPAT ® ViaMass • • * * *
BioPAT ® Trace (Glucose | Lactate sensor) • • • • •
– Accuracy 0.1 g/L 0.1 g/L 0.1 g/L 0.1 g/L 0.1 g/L

Accessories
Ladder | Platform – – (•) (•) (•)
Filter line IN • • • • •
Filter line OUT • • • • •
SU exhaust cooler (•) (•) (•) (•) –
Holder for conventional probes (•) (•) (•) (•) (•)

Communication | Interface of DCU Control Tower


BIOSTAT STR® BIOSTAT STR® BIOSTAT STR® BIOSTAT STR® BIOSTAT STR®
50 200 500 1000 2000
RS232 up to 4 up to 4 4 4 5
Industrial Ethernet • • • • •
Analog IN 4 4 4 4 4
Analog OUT 4 4 4 4 4
DeltaV™ connectivity (•) (•) (•) (•) (•)

®
• available – not available ( ) optional, needs to be ordered separately * coming soon on Flexsafe STR 500 | 1000 | 2000 L

DeltaV™ is a trademark of Emerson Process Management.


Overview Scalability System Features Automation Bag Concept Film Safety

Flexsafe STR® Bags

Geometrical Data of Flexsafe STR® Bags

Flexsafe STR® 50 L 200 L 500 L 1,000 L 2,000 L


Total volume [L] 68 280 700 1,300 2,800
Max. working volume [L] 50 200 500 1,000 2,000
Min. working volume [L] 12.5 50 125 250 500
Turndown ratio 1: 4 1: 4 1: 4 1: 4 1: 4
Bag diameter, d1 [mm] 370 585 815 997 1,295
Bag height, h1 [mm] 666 1,055 1,467 1,800 2,330
Ratio, h1/d1 1.8 1.8 1.8 1.8 1.8
Liquid height, h2 [mm] 480 783 1,005 1,360 1,670
Ratio, h2/d1 1.3 1.34 1.23 1.36 1.29
Impeller diameter, d2 [mm] 143 225 310 379 492
Ratio, d2/d1 0.38 0.38 0.38 0.38 0.38
Distance between impellers [mm] 186 300 403 493 640
Volume bottom impeller, 12.5 50 125 250 395
fully immersed V1 [L]
Volume top impeller, 28 100 245 450 930
touches surface V2 [L]
Volume top impeller, 32 130 330 610 1,240
fully immersed V3 [L]
Bag packaging dimensions 395 × 395 × 1170 |  395 × 595 × 1440 |  764 × 1153 × 1320 |  764 × 1153 × 1440 |  995 × 1195 × 1715 | 
W × D × H (mm | in.) 15.5 × 15.5 × 46 15.5 × 23.4 × 56.7 30.1 × 45.4 × 52 30.1 × 45.4 × 56.7 39.2 × 47 × 67.5

Top Ports

Example of Flexsafe STR® 200 L Basic Configuration


WV Max Pos. Designation Tubing Size | Material Tubing Termination Remarks
A Overlay aeration 1” + 3”, Si(Pt) Opta connector Without spare port
h1 B Substrate line 1 a” + b” MPC quick coupling
d2 C Substrate line 2 a” + b” MPC quick coupling
h2 D Sparger aeration 1” + 3”, Si(Pt) Opta connector Without spare port
WV Min Lateral
Ports E Substrate 3-4 4” + 7/16”, C-Flex®*; a” + b”, C-Flex®* MPC quick coupling 2 lines via Y, dip tube
I, J, K, L F Base addition 8” + 4”, C-Flex®* Clave connector
®
G Antifoam addition 4” + a”, C-Flex * Clave connector
Harvest H Gas out (exhaust) 1” ID, Si(Pt) Opta connector 2 lines via Y
d1 (M)
I Temperature sensor Si(Pt) N/A Reusable sensor (Pt100)
Front View J | K DO | pH Sensor N/A N/A Optical sensor
L Small-volume sampling 8” + 8”, Si(Pt) Clave connector
M Bottom-drain harvest 1” + 3”, C-Flex®* MPC quick coupling
Spare D E H
* C-Flex® is a registered trademark of Saint-Gobain Performance Plastics Corporation.
A G
B F
C Spare

Top View

Example of Flexsafe STR® Bag

DeltaV™ is a trademark of Emerson Process Management.


Service Technical Data

Ordering Information
Description Order No.

BIOSTAT STR® Bioreactor System


System will be configured according to process requirements based on broad choice of configuration options.
Please contact your sales representative.

Flexsafe STR® Single-use Bioreactor Bag


Standard Design
Flexsafe STR® 50 L FRS132668
Flexsafe STR® 200 L FRS132670
Flexsafe STR® 500 L FRS124057
Flexsafe STR® 1,000 L FRS124058
Flexsafe STR® 2,000 L FRS132367
Customer-specific designs: Please contact your sales representative.

Bag Tester Fleece*


For 50 L STR® DZ050L-S2SIT
For 200 L STR® DZ200L-S2SIT
For 500 L STR® DZ500L-S2SIT
For 1,000 L STR® DZ001K-S2SIT
For 2,000 L STR® DZ002K-S2SIT

Accessories
Filter line IN 50 | 200 L DS200L-SBFLI
Filter line OUT 50 | 200 L DS200L-SBFLO
Filter line IN 500 |1,000 L DS001K-SBFLI
Filter line OUT 500 |1,000 L DS001K-SBFLO
Filter line IN 2,000 L DS002K-SBFLI
Filter line OUT 2,000 L DS002K-SBFLO
Lab Cart (STR® 2,000) 1ZG---0032
Lifting device & adapter (STR® 2,000) 2ZG---0009
Autoclave tray for re-usable probes 1ZG---0034

Single-Use Exhaust Cooler


SU exhaust cooler STR® 50 | 200 DS200L---EC
SU exhaust cooler STR® 500 |1,000 DS001K---EC

* Fleece for old bag holder still available – DZ050L-SBSIT, DZ200L-SBSIT, DZ500L-SBSIT, DZ001K-SBSIT

Fleeces for Gen 2 hardware are now available.


Sales and Service Contacts
For further contacts, visit www.sartorius-stedim.com

Europe Americas Asia | Pacific


Germany Italy USA Australia
Sartorius Stedim Biotech GmbH Sartorius Stedim Italy S.r.l. Sartorius Stedim North America Inc. Sartorius Stedim Australia Pty. Ltd.
August-Spindler-Strasse 11 Via dell’Antella, 76/A 5 Orville Drive, Suite 200 Unit 5, 7-11 Rodeo Drive
37079 Goettingen 50012 Antella-Bagno a Ripoli (FI) Bohemia, NY 11716 Dandenong South Vic 3175
Phone +49.551.308.0 Phone +39.055.63.40.41 Toll-Free +1.800.368.7178 Phone +61.3.8762.1800

Sartorius Stedim Systems GmbH Netherlands Argentina China


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34302 Guxhagen Int. A. Ávalos 4251 Trading Co., Ltd.
Phone +31.30.60.25.080
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Phone +49.5665.407.0
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Phone +54.11.4721.0505
France Pudong District
Poland
Sartorius Stedim FMT S.A.S. Shanghai 201210, P.R. China
Sartorius Stedim Poland Sp. z o.o.
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62-025 Kostrzyn
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Phone +48.61.647.38.40 São Bernardo do Campo Sartorius Stedim (Shanghai)
Phone +33.442.845600
CEP 09600-000 - SP- Brasil Trading Co., Ltd.
Beijing Branch Office
Russian Federation Phone +55.11.4362.8900
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LLC “Sartorius Stedim RUS”
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Vasilyevsky Island
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5th line 70, Lit. A
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Libramiento Norte de Tepotzotlan s/n,
Phone +33.442.845600
Phone +7.812.327.53.27 Colonia Barrio Tlacateco,
Municipio de Tepotzotlan, Sartorius Stedim (Shanghai)
Austria Spain Estado de México, Trading Co., Ltd.
Sartorius Stedim Austria GmbH Sartorius Stedim Spain, S.A.U. C.P. 54605 Guangzhou Branch Office
Modecenterstrasse 22 Avda. de la Industria, 32 Room 1105
Phone +52.55.5562.1102
1030 Vienna Edificio PAYMA Xing Guang Ying Jing Building
28108 Alcobendas (Madrid) [email protected] No. 119, Shui Yin Road
Phone +43.1.7965763.18
Yue Xiu District, Guangzhou 510075
Phone +34.913.586.098
Peru Phone +86.20.3836.4193
Belgium
Sartorius Peru S.A.C.
Sartorius Stedim Belgium N.V. Switzerland
Avenue Alberto del Campo 411
Rue Colonel Bourg 105 Sartorius Stedim Switzerland AG India
Floor 12 – The Office
1030 Bruxelles Ringstrasse 24 a Sartorius Stedim India Pvt. Ltd.
15076 – San Isidro, Lima
8317 Tagelswangen #69/2-69/3, NH 48, Jakkasandra
Phone +32.2.756.06.80

Specifications subject to change without notice. Copyright Sartorius Stedim Biotech GmbH. Printed in the EU on paper bleached without chlorine.
Phone +51.1.441 0158 Nelamangala Tq
Phone +41.52.354.36.36
562 123 Bangalore, India
Hungary
Phone +91.80.4350.5250
Sartorius Stedim Hungária Kft. U.K.
Kagyló u. 5 Sartorius Stedim UK Ltd.
2092 Budakeszi Longmead Business Centre Japan
Blenheim Road, Epsom Sartorius Stedim Japan K.K.
Phone +36.23.457.227
Surrey KT19 9 QQ 4th Fl., Daiwa Shinagawa North Bldg.
8-11, Kita-Shinagawa 1-chome
Phone +44.1372.737159
Shinagawa-ku, Tokyo, 140-0001 Japan
Phone +81.3.4331.4300
Ukraine
LLC “Sartorius Stedim RUS”
Post Box 440 “B” Malaysia
01001 Kiev, Ukraine Sartorius Stedim Malaysia Sdn. Bhd.
Lot L3-E-3B, Enterprise 4
Phone +380.44.411.4918
Technology Park Malaysia
Bukit Jalil
57000 Kuala Lumpur, Malaysia
Phone +60.3.8996.0622 Publication No.: SBI1509-e180304 · Order No.: 85034-538-48 · Ver. 03 | 2018

Singapore
Sartorius Stedim Singapore Pte. Ltd.
10 Science Park Rd
The Alpha #02-13/14
Singapore Science Park II
Singapore 117684
Phone +65.6872.3966

South Korea
Sartorius Korea Biotech Co., Ltd.
8th Floor, Solid Space B/D,
PanGyoYeok-Ro 220, BunDang-Gu
SeongNam-Si, GyeongGi-Do, 463-400
Phone +82.31.622.5700

www.sartorius-stedim.com

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