Broch Biostat-STR-Flexsafe SBI1509-e Neu
Broch Biostat-STR-Flexsafe SBI1509-e Neu
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.
– 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
250 mL 2L 50 L 2000 L
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.
– 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.
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.
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®
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
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.
Cell Density
Reference: Borosilicate Glass in collaboration with our resin
and film suppliers.
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.
Watch Video:
www.sartorius.com/sartorius/en/EUR/flexsafe
Overview Scalability System Features Automation Bag Concept Film Safety
Bio
– 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
Validation Guide
Extractables Guide for Standard Flexsafe STR®
Flexsafe STR® Single-use Stirred Bioreactor Bags Stirred Bioreactor Bags – 50 L to 2000 L
safety
– 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
Reduce your risk of batch losses due to operator failures and incorrect handling.
Installation Phase
Utilization Phase
Reaction time
Reaction time
Reaction
Reaction
timetime
h h hhh h h
hh hh
h h hhh h hhh h hh
Maintenance
Maintenance
Maintenance
Maintenance
Technical Specifications
BIOSTAT STR® 50 BIOSTAT STR® 200 BIOSTAT STR® 500 BIOSTAT STR® 1000 BIOSTAT STR® 2000
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
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%
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
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
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.
Accessories
Ladder | Platform – – (•) (•) (•)
Filter line IN • • • • •
Filter line OUT • • • • •
SU exhaust cooler (•) (•) (•) (•) –
Holder for conventional probes (•) (•) (•) (•) (•)
®
• available – not available ( ) optional, needs to be ordered separately * coming soon on Flexsafe STR 500 | 1000 | 2000 L
Top Ports
Top View
Ordering Information
Description Order No.
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
* Fleece for old bag holder still available – DZ050L-SBSIT, DZ200L-SBSIT, DZ500L-SBSIT, DZ001K-SBSIT
Specifications subject to change without notice. Copyright Sartorius Stedim Biotech GmbH. Printed in the EU on paper bleached without chlorine.
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Technology Park Malaysia
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Phone +60.3.8996.0622 Publication No.: SBI1509-e180304 · Order No.: 85034-538-48 · Ver. 03 | 2018
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