biostat® rm - rocking motion bioreactors · colour coded plugs and socket for easy operation...
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BIOSTAT® RM - Rocking Motion Bioreactors Single-Use Solutions for Screening, Seed & Small Scale Production
Dr. Franziska Faulstich, Product Manager Single-Use Bioreactors, Fermentation Technologies
Page 2
Product Family BIOSTAT® RM
From Basic to Advanced
Applications
BIOSTAT® B with RM 20/50
BIOSTAT® B with RM 200
Flexsafe® RM
Ordering
Content
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No gas permeable membranes for
oxygen transfer
Oxygen transfer and mixing are
accomplished by the principle of
wave-induced motion (WIM)
Bubble free overlay aeration
Low shear stress
Wave Induced Motion
Principle: Wave Induced Motion
Sartorius bioreactor product overview – market leader in fermentation
BIOSTAT® B with RM 200 Rocker
Small Scale Benchtop Pilot/Production
BIOSTAT STR® 50 - 2000 L
Univessel ® SU 2 ambr 250 10 – 250 mL
BIOSTAT® RM 20/50 L
BIOSTAT® RM 200
Single Use Upstream Solution
BIOSTAT® B with RM 20/50 Rocker
BIOSTAT® B with RM 200 Rocker
BIOSTAT® RM 20/50 Basic
BIOSTAT® B with
1 L (0.5 L)
200 L (100 L)
100 L (50 L)
50 L (25 L)
20 L (10 L)
10 L (5 L)
2 L (1 L)
RM 20/50 Rocker
Product Family: BIOSTAT® RM
BIOSTAT RM 20/50 - from Basic to Advanced
BIOSTAT® RM 20/50 Basic
• Cell culture without need for sophisticated control
• Cost effective and fast seed production
• Alternative to roller bottle, spinner flask or T-flask
BIOSTAT® RM 20/50 with BIOSTAT® B control tower
• Fully automated and controlled batch, fed-batch
or high cell density perfusion cultures
• Use of Flexsafe® RM bags with single-use pH, DO and biomass sensors
• Highest cell densities/product yields with ease of use
BIOSTAT® RM
BIOSTAT® RM 20/50 basic - Easy to Use Rocker
Working volume 100 ml to 25 L
Rocking rate: 8–42 ± 1 r/min
Rocking angle: 4-10 ± 0,3 °
Perfectly sized, stand alone bioreactor – unique in the market
Based on well proven principle
No internal mixing or sparger device
Cells
• Mammalian cell culture
• Insect cell culture
• Low to medium density microbial cultures
• Shear sensitive cells such as stem cells
BIOSTAT® RM
Load cells – the weighing solution
Weight measurement integrated in Rocker
Monitoring the fill level of bag precisely even during rocking
Space saving
load cell module
BIOSTAT® RM
Rocker integrated load cells for media weight and level control
• Load cells in rocker determine media weight and drive feed pump
• Harvest with manual control (optional GFC)
• Advantages
Consumes less space
Cost efficient, only load cells required
Keeps media in bag constant – very precise measurement with load cells even when rocking
Load Cells
Fully automated and controlled batch or fed-batch processes
High cell density perfusion process using external cell retention unit
Process Options
Cell culture process options of Biostat® RM systems
Which cells can be cultivated with the BIOSTAT® RM systems?
Mammalian, insect and plant cell culture
Low to medium density microbial cultures
Shear sensitive cells such as stem cells
Cell types
BIOSTAT® RM 20/50 Basic Features
optional gassing module with integrated Air/CO2 mixing
individual control of 2 bags (T, gasfl)
• 3 different user levels • service interval display
lid design with space for filter heater
automatic sample function
load cells
colour touch screen with Trend & Alarm Display colour coded plugs and socket for easy operation
tube and cable organizer
standard Ethernet & Modbus RTU interface optional ProfiBus DP interface guaranteed to work with DeltaV
BIOSTAT® RM
filter heater plugged directly in rocker base
Connections for Data Acquisition and Control
ETHERN
ET
third party data acquisition software
driver supplied by customer
I/O protocol supplied by SSB
driver supplied by customer
BioPAT® MFCS
ProfiBusDB
I/O protocol
supplied by SSB
e.g.
BIOSTAT® RM basic
RS232
BIOSTAT® RM
RS232
Modbus RTU
Besides the core functionality of a real SCADA system, BioPAT® MFCS/win offers a number of additional modules for adaptation to individual requirements
SCADA Software
BioPAT® MFCS/win – SCADA Software for Bioprocess Management
• Recipe control according to ISA-88.01
• 21 CFR Part 11 compliance
• Secure integration into company networks
• Flexible device connection facility via OPC
• Replication Manager for automatic batch transfer
• Logging of alarms and transmission to multimedia
devices
• Integrated Design of Experiments (DoE)*
• Integrated Multivariate Data Analysis (MVDA)*
* powered by UMETRICS
BIOSTAT® RM with BIOSTAT® B controller
One control platform for all
Advanced Control System - BIOSTAT® B with BIOSTAT® RM 20/50
Working volume 100 ml to 25 L
Advanced control of gas mixture and flow rate, filling volume and substrate addition
Applications:
• fully automated and controlled batch culture
• fed-batch culture
• high cell density perfusion culture
BIOSTAT® B Controller with RM
Extra small space requirement
in TWIN configuration
BIOSTAT® B with Rocker
• Basic and advanced solutions
• 4 independent gassing lines
with 4 mass flow controllers
• Perfusion option via connection to external cell retention device, e.g. ATF
(100l & 200l bags with perfusion membrane no longer available)
• Up to 3 media feeds
• Up to 2 gravimetric flow controllers
BIOSTAT® B with Rocker
The BIOSTAT® B – From June 2014 on with RM Rocker
• BIOSTAT® B with RM Rocker is the successor of BIOSTAT® RM Optical and Perfusion
BIOSTAT® B Controller with RM
BIOSTAT® B The Gold Standard of benchtop bioreactors
WM 114 Easy load pumps
12” touch screen with flush housing integration for liquid
protection
Largest installation base worldwide with reference applications for many processes
Controller, software & culture vessels made in-house
Available in single and twin
configurations
Connection to glass and single-use vessels and
Rocker
Various gassing and feeding strategies
available
BIOSTAT® B
UniVessel® UniVessel® SU
Rocker 20/50 Rocker 200
BIOSTAT® B
One control platform for all*
* depending on tower configuration
Storage Dish for accessories
12” touch screen with frameless design for liquid protection
Lifting Handles for easy transportation
BIOSTAT® B
WM 114 Easy load pumps Sensor Field located at the front
BIOSTAT® B
New gassing module old BIOSTAT® RM optical vs. BIOSTAT® RM with BIOSTAT® B
Mixture of
• exclusive flow (air, N2, O2)
• Additive flow (CO2)
• with 2 mass flow controllers
4 independent gassing lines
• with 4 mass flow controllers
• either with DO cascade control or optional advanced DO controller
BIOSTAT® RM with Controller
26 May 2014
New options for media feeds old BIOSTAT® RM optical vs. BIOSTAT® RM with BIOSTAT® B
• No CTO media feed or GFC
• No CTO rocker weight measurement
• No CTO level control
• Up to 3 media feeds
• Up to 2 gravimetric flow controllers
• Load cells integrated in Rocker for media weight and level control
BIOSTAT® RM with Controller
New solution for perfusion old BIOSTAT® RM optical vs. BIOSTAT® RM with BIOSTAT® B
One balance to weigh the feed
One balance to weigh the harvest
No direct measurement of cell culture volume
Load cells in rocker determine media weight and drive feed pump
Harvest with manual control (optional GFC)
Precise solution, but some disadvantages : • Space requirement • Price • Does not detect media loss due to
evaporation
Advantages : • Consumes less space • Cost efficient, only load cells required • Keeps media in bag constant • Very precise measurement with load cells even
when rocking
BIOSTAT® RM with Controller
Features, Advantages & Benefits part 1 Feature Advantage Benefit
Rocking Motion Technology Gentle and efficient mixing. Well established wave-type technology Longest history in single use bioreactors.
Well known to customers and FDA, large number of references.
Highly flexible bag design
Different sizes from 0.1 L to 100 L working volumes, many different connections, with or w/o pH, DO & biomass sensors.
Allows highest flexibility of processes with low consumable costs.
Single use sensors
pH, DO and biomass sensors integrated in the bag, delivered sterilized and pre-calibrated.
Eliminate risk of contamination, reduce calibration effort.
Over Pressure Prevention System Controller measures bag pressure and keeps it below 30 mbar.
Highest possible safety against overpressure. Risk of bag damage by overpressure is eliminated.
Integrated Air/CO2 module for basic rocker (option)
Allows to work with fixed percentage of CO2 (“incubator style”).
Turns rocker into fully functional stand alone unit for simple cultivations.
.
Features, Advantages & Benefits part 2
Feature Advantage Benefit
BIOSTAT® B controller Newest generation of bioreactor control system with full feedback control of all relevant process parameters.
Well known to the industry, easy to use, same controller for many different SSB instruments.
Heating and Cooling option Heating cooling by stainless steel coil on bag holder and thermostat unit in control tower.
Precise temperature control even in high ambient temperatures and lower cultivation temperatures. Possibility to run multiphasic processes.
Touch screen user interface Graphical display for operation and data display.
Easy to use, helps to avoid errors.
Individual control (T, gassing) of two bags on one rocker
Great flexibility: allows different process conditions simultaneously.
Save time and space.
Improved filter heater Better heating efficiency, connects directly into rocker. Monitoring connection of filter heater before start of process.
Even more efficient prevention of filter blockage. Alarm if user forget to plug in heater. Improved process safety.
.
Features, Advantages & Benefits part 3
Feature Advantage Benefit
Modbus RTU and Ethernet port (standard) and Profibus DP (optional)
Allows direct connection to third party software (e.g. historian). I/O protocol supplied by SSB.
Enables integration into facility networks.
New lid design and cable/tube organizer
Space for filter heaters, lid is click-fixed to bag holder. Cables and tubes are neatly organized.
Prevents bending of exhaust tubes, enhances process safety. Prevents “tube spaghetti”.
Color coded plugs and sockets Connection made easy. Enhanced ease of operation.
Electronic angle setting Angle can be set in Rocker display and Tower.
Include angle in automation strategy.
Improved communication between rocker and Tower
Process values, set points, alarms, controller parameters are transferred in both ways.
Enhanced flexibility, enhanced process safety.
Same well-known BIOSTAT® B control tower
Configurability of pumps and MFCs
Available in single & twin configuration
Improved hood design with space for filter heaters
Integrated weight measurement with load cells (optional)
Material of entire system (incl. lab-cart) optimized for use in clean rooms
Highlights
Advanced Control System - BIOSTAT® B with RM Rocker
SSB vs. Competition – Key Differentiators / USPs
BIOSTAT B - Twin setup • we are the only manufacturer who can control two rockers with one control tower • saves space • RM 20/50 only, RM200 – twin BAG configuration
RM 200 • Modular concept allows space saving arrangement • Same well-known Biostat® B control tower as for Biostat RM 20/50 - no special training needed, user
friendly • Configurability of pumps and MFC
Flexsafe Film • Industry leading, proprietary S80 film • Ultimate assurance of supply (Excellent cell growth proven by independent Dechema study)
BioPat® ViaMass • single-use viable biomass sensor • Only single-use wave style bags in market with non-invasive viable biomass measurement
USPs
BIOSTAT® B with RM 200
Next Generation of Rocking Motion Single-Use Bioreactor
Applications of BIOSTAT® RM 200 system
Preclinical and clinical studies - fast protein and cell supply
Large scale seed expansion for large bioreactors, e.g. stirred tank bioreactor
Small scale production of monoclonal antibodies, recombinant proteins and vaccines
cGMP production
BIOSTAT® RM 200
Seed process RM 20 RM 200 STR 2000
BIOSTAT B with RM 200 Rocker
OLD
2007 2015
NEW
• modular design for flexible arrangement
• integrated load cells
• twin bag option
load cells
Old vs. New RM 200
New gassing module
Mixture of
• exclusive flow (air, N2, O2) and
• additive flow (CO2)
• with 2 mass flow controllers
4 independent gassing lines
• with 4 mass flow controllers
• either with DO cascade control or optional
advanced DO controller
Old vs. new RM 200
New options available
• Perfusion option via internal membrane for fully automated continuous processes
• No CTO media feed or gravimetric flow controller option
• No CTO rocker weight measurement option
• No CTO level control option
• Perfusion option via connection to an external cell retention device, e.g. ATF
(100l & 200l bags with perfusion membrane no longer available)
• Up to 3 media feeds
• Up to 2 gravimetric flow controllers
• Rocker integrated load cells for media weight and level control
Old vs. new RM 200
Description of the BIOSTAT® RM 200 system
The system consists of :
BIOSTAT® B control tower
BIOSTAT® RM 200 Rocker
Flexsafe® RM 100 L or 200 L bag(s)
with single use pH & DO sensors
Lab-cart
Working volume from 10 L up to 100 L
Single Bag or Twin Bag Configuration
No basic version of RM 200
Twin Bag Configuration
Single Bag Configuration
Biostat® RM 200
NEW Corporate design
as for BIOSTAT® RM 20/50
Integrated load cells (optional)
Flexible arrangement
Efficient and gentle mixing
No high voltage connection required
CE-marking, UL/CSA (EN61010-1)
Heating or heating/cooling function
(optional)
BIOSTAT® RM 200 - Rocker
BIOSTAT® RM 200 Rocker – the new generation
Rocker: integrated weight measurement
Precisely monitor fill level of bag even during rocking
Space saving
Optional
load cells
New Features
Load cells – the weighing solution
Twin Bag version of the device with two culture bags
different temperatures can be set for the two heating elements
Large opening for sampling
Cable/Tube organizer New hood design with space for filter heater
New Features
Proven DCU controller and software
Control of glass and single-use vessels and Rockers
WM 114 fast load pumps
Various gassing and feeding strategies
Available in single and twin bag configuration
Overpressure control
Feedback control of temperature, pH, DO and agitation (rocker speed & angle)
Connectable to advanced SCADA software, BioPAT® MFCS 4 or BioPAT® MFCS/Win incl. OPC module
BIOSTAT® B
BIOSTAT® B control tower – the gold standard
• Robust platform for controller
• 3 shelves - middle one is adjustable
• incl. 2 baskets for bottles and cable/tube organizer
• Flexible use – for external pumps, feeding bags
• Easy to clean – developed for clean room use
• Made of stainless steel
Lab-Cart
Flexible arrangement with the lab-cart
third
par
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ata
acqu
isiti
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oftw
are
I/O protocol
supplied by SSB
BioPAT® MFCS 4 or BioPAT® MFCS/win
BioPAT® MFCS/win incl. OPC module
OPC
third
par
ty d
ata
acqu
isiti
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oftw
are
OPC
BioPAT® DCU OPC Server.Net
ETHERNET
BIOSTAT® RM 200
Communication
Communication and Data Acquisition
Flexsafe® RM – Disposable Cultivation Bag
Excellent Cell Growth
Robustness
Consistent Quality
S80 FILM Multilayer film structure
The new benchmark PE film represents
optimal combination of cell culture
performance and physico-chemical
properties
Flexsafe® meets the most stringent
customer needs for safer bioprocessing
Flexsafe® RM bags
Flexsafe® RM – bioprocessing bags of Flexsafe® Bag Family
BAG DESIGN
Basic bags
Optical bags with single-use pH, DO and viable biomass sensors
Perfusion bags
TUBING MATERIAL C-Flex® 374 – all tubes weldable Silicone PharMed® Natvar ABL-1222 TPE
BAG SIZES Total volume: 1 L, 2 L, 10 L, 20 L, 50 L,
100 L, 200 L Working volume: 50% of total
volume
PORTS Harvesting Sampling Probes Addition Surface aeration
Flexsafe® RM bags
June 2016 Page 6
Main Competitors – Film Overview Product SSB Flexsafe RM GE Cellbag Meissner FlexGro
Film Flexsafe Bioclear 11 TepoFlex
Working Volume Up to 100L Up to 100L Up to 25L
Online Biomass Measurement Yes No No
Raw material supplier agreements: change notification agreement with film
supplier 10-year contract with film
manufacturer Safety stocks of resin & films for up to 2
years supply Multiple bag mfg & sterillization sites
Yes Yes Yes Yes
Yes No No ?
No No No No
Specifications for resins and additives
– Access to formulation – Control of resin
formulation – Access to polymer and
additives by CAS number
commercially available LLDPE resins
Guarantee forward and backward traceability of every component in biocontainer assembly
Full Control of Extrusion Process Yes No No
Cell Growth Data Tested with 9 different cell lines
1 cell line (CHO DG44) No
EtOH extraction Pure EtOH 112 days, 40 °C
20% EtOH 28 days at 50°C
96% EtOH 90 days, 40°C
How to order the BIOSTAT® RM system?
Quotations are available via your local application specialist and sales representative.
Each quote is generated via our Product Configurator software program for fast turn-around, Sartorius will help you identifying your requirements.
Ordering information
Ordering information
How to order Flexsafe® RM bags?
Article Number Product Description Flexsafe® RM qty per order code
min. order quantity
min. order quantity Article Number Product Description Flexsafe® RM qty per order
code min. order quantity
min. order quantity
Flexsafe® RM Basic bags per box bags box Flexsafe® RM Perfusion bags per box bags box
DFB001L Flexsafe® RM 1L basic (5 pcs) 5 10 2 DFP002L--SM Flexsafe® RM 2L perfusion pro 1,2 µm (3 pcs) 3 3 1
DFB002L Flexsafe® RM 2L basic (5 pcs) 5 5 1 DFP010L--SM Flexsafe® RM 10L perfusion pro 1,2 µm (3 pcs)
3 3 1
DFB002L----01SC Flexsafe® RM 2L basic SC (5 pcs) 5 10 2 DFP020L--SM Flexsafe® RM 20L perfusion pro 1,2 µm (3 pcs)
3 3 1
DFB010L Flexsafe® RM 10L basic (5 pcs) 5 5 1 DFP050L--SM Flexsafe® RM 50L perfusion pro 1,2 µm (3 pcs)
3 3 1
DFB010L----01SC Flexsafe® RM 10L basic SC (5 pcs) 5 10 2 DFP002L--AT Flexsafe® RM 2L perfusion ATF (3 pcs) 3 3 1
DFB020L Flexsafe® RM 20L basic (5 pcs) 5 5 1 DFP010L--AT Flexsafe® RM 10L perfusion ATF (3 pcs) 3 3 1
DFB020L----01SC Flexsafe® RM 20L basic SC (5 pcs) 5 10 2 DFP020L--AT Flexsafe® RM 20L perfusion ATF (3 pcs) 3 3 1
DFB050L Flexsafe® RM 50L basic (5 pcs) 5 5 1 DFP050L--AT Flexsafe® RM 50L perfusion ATF (3 pcs) 3 3 1
DFB050L----01SC Flexsafe® RM 50L basic screw cap (5 pcs) 5 10 2 DFP100L--AT Flexsafe® RM 100L perfusion ATF (2 pcs) 2 4 2
DFB050L----01US Flexsafe® RM 50L basic GE rocker (5 pcs) 5 5 1 DFP200L--AT Flexsafe® RM 200L perfusion ATF (2 pcs) 2 4 2
DFB100L Flexsafe® RM 100L basic (2 pcs) 2 4 2 Flexsafe® RM ViaMass
DFB200L Flexsafe® RM 200L basic (2 pcs) 2 4 2 DFB010L----VM Flexsafe® RM 10L basic Viamass (5 pcs) 5 5 1
Flexsafe® RM Optical DFB020L----VM Flexsafe® RM 20L basic Viamass (5 pcs) 5 5 1
DFO002L Flexsafe® RM 2L optical (5 pcs) 5 5 1 DFB050L----VM Flexsafe RM 50L basic Viamass (5 pcs) 5 5 1
DFO002L----01SC Flexsafe® RM 2L optical SC (5 pcs) 5 10 2 DFO010L----VM Flexsafe® RM 10L optical Viamass (5 pcs) 5 5 1
DFO010L Flexsafe® RM 10L optical (5 pcs) 5 5 1 DFO020L----VM Flexsafe® RM 20L optical Viamass (5 pcs) 5 5 1
DFO010L----01SC Flexsafe® RM 10L optical SC (5 pcs) 5 10 2 DFO050L----VM Flexsafe® RM 50L optical Viamass (5 pcs) 5 5 1
DFO020L Flexsafe® RM 20L optical (5 pcs) 5 5 1 DFO100L----VM Flexsafe® RM 100L opt ViaMass (2 pcs) 2 4 2
DFO020L----01SC Flexsafe® RM 20L optical SC (5 pcs) 5 10 2 DFO200L----VM Flexsafe® RM 200L opt ViaMass (2 pcs) 2 4 2
DFO050L Flexsafe® RM 50L optical (5 pcs) 5 5 1 DFP010L--SMVM Flexsafe® RM 10L perfusion Viamass (3 pcs) 3 3 1
DFO050L----01SC Flexsafe® RM 50L optical SC (5 pcs) 5 10 2 DFP020L--SMVM Flexsafe® RM 20L perfusion Viamass (3 pcs) 3 3 1
DFO100L Flexsafe® RM 100L optical (2 pcs) 2 4 2 DFP050L--SMVM Flexsafe® RM 50L perfusion Viamass (3 pcs) 3 3 1
DFO200L Flexsafe® RM 200L optical (2 pcs) 2 4 2 DFP010L--ATVM Flexsafe® RM 10L ATF Viamass (3 pcs) 3 3 1
Customized design DFP020L--ATVM Flexsafe® RM 20L ATF Viamass (3 pcs) 3 3 1 DFCnnn (customer specific)
Flexsafe® RM customized 10 DFP050L--ATVM Flexsafe® RM 50L ATF Viamass (3 pcs) 3 3 1
DFP100L--ATVM Flexsafe® RM 100L ATF ViaMass (2 pcs) 2 4 2
DFP200L--ATVM Flexsafe® RM 200L ATF ViaMass (2 pcs) 2 4 2
22 June 2016 Page 2
BioPAT ® ViaMass – single-use biomass sensor
• for non-invasive measurement of viable biomass
Art. No Description
DFB010L----VM Flexsafe® RM 10L basic ViaMass (5 pcs)
DFB020L----VM Flexsafe® RM 20L basic ViaMass (5 pcs)
DFB050L----VM Flexsafe® RM 50L basic ViaMass (5 pcs)
DFO010L----VM Flexsafe® RM 10L optical ViaMass (5 pcs)
DFO020L----VM Flexsafe® RM 20L optical ViaMass (5 pcs)
DFO050L----VM Flexsafe® RM 50L optical ViaMass (5 pcs)
DFO100L----VM Flexsafe® RM 100L optical ViaMass (2 pcs)
DFO200L----VM Flexsafe® RM 200L optical ViaMass (2 pcs)
DFP010L--SMVM Flexsafe® RM 10L perf ViaMass (3 pcs)
DFP020L--SMVM Flexsafe® RM 20L perf ViaMass (3 pcs)
DFP050L--SMVM Flexsafe® RM 50L perf ViaMass (3 pcs)
DFP010L--ATVM Flexsafe® RM 10L ATF ViaMass (3 pcs)
DFP020L--ATVM Flexsafe® RM 20L ATF ViaMass (3 pcs)
DFP050L--ATVM Flexsafe® RM 50L ATF ViaMass (3 pcs)
DFP100L--ATVM Flexsafe® RM 100L ATF ViaMass (2 pcs)
DFP200L--ATVM Flexsafe® RM 200L ATF ViaMass (2 pcs)
Page 45
Installation
FAT & SAT
IQ | OQ support & documentation
Calibration services
Spare part sales
Preventive maintenance contracts
Customer-specific maintenance contracts
Instrument repairs
Technical & application support
Practical & technical operator training
Additional Information
Our Services
Page 48
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