Sartorius AG · XETR:SRT
Sartorius — Technical Presentation (March 2021)
57 slides from Sartorius's technical presentation, March 2021
Slide 1: Biostat D-DCU: Your Fast Lane to Production
Biostat® D-DCU Your “Fast Lane” to Production March 2021
Slide 2: Content
Content Introduction System Overview Hybrid Solution 2
Slide 3: Drivers of Standardization for Stainless Steel Fermentation Systems
Introduction Drivers of Standardization for Stainless Steel Fermentation Systems Key Drivers for Standardization ▪ Optimized and proven design ▪ Simplified and fast project execution ▪ Spare part availability ▪ Trained service technicians close to your operation ▪ Fast delivery ▪ Reduced costs ▪ Qui
Slide 4: Biostat D-DCU Ideal Platform for
Introduction Biostat® D-DCU Ideal Platform for ▪ Process development ▪ Process optimization ▪ Up-scale and down-scale ▪ Production 4
Slide 5: Content
Content Introduction System Overview Hybrid Solution 5
Slide 6: Your Fast Lane to Production
System Overview Biostat® D-DCU Your “Fast Lane” to Production Biostat® D-DCU ▪ Standardized, fully-featured SIP | CIP -System ▪ Microbial and cell culture applications ▪ Process development to production ▪ Single or Twin configuration ▪ Working volumes 10L, 20L, 30L, 50L, 100L, 200L ▪ Hybrid process
Slide 7: System Overview
System Overview Biostat® D-DCU System Overview Supply unit : Open frame design : Thermostat system Control Tower : Gas inlet : Single or Twin configuration : Exhaust : DCU control System Culture vessel : Touch panel : Flat top plate : Integrated gassing system : Bottom agitation system : Integrated
Slide 8: Control Tower
System Overview Biostat® D-DCU Control Tower ▪ Control Tower ▪ Single or Twin Configuration ▪ 19” Color display with touch screen ▪ Industrial PC ▪ Integrated amplifier rack ▪ Integrated Gassing Module : Airflow (Microbial applications) : O2-Enrichment (Microbial applications) : Gas Flow Ratio Contr
Slide 9: Gassing Strategy: Airflow
System Overview Biostat® D-DCU Gassing Strategy “Airflow” ▪ Rotameter for Sparger flow ▪ Intermitted sparging of air controlled by DOT controller ▪ Option: DOT control via mass flow controller 9
Slide 10: Gassing Strategy: O2-Enrichment
System Overview Biostat® D-DCU Gassing Strategy ▪“O2-Enrichment” • Gassing system with O2 enrichment capability via solenoid valve • Rotameter for Total Sparger flow • Intermitted O2 enrichment controlled via DOT controller • Option: Mass Flow Controller for Total Sparger Flow 10
Slide 11: Gassing Strategy: Gas Flow Ratio Control
System Overview Biostat® D-DCU Gassing Strategy Gas Flow Ratio Control” ▪ Air flow gassing system with O2 supplementation capability via mass flow controller for Air and O2 ▪ Continuous gas flow control of Air and Oxygen via DOT controller ▪ Rotameter for Total Sparger flow ▪ O2 Supplementation auto
Slide 12: Gassing Strategy: Advanced Additive Flow
System Overview Biostat® D-DCU Gassing Strategy ▪ Advanced Additive Flow” • Mixing of up to four gases Air, N2, O2 and CO2 • Sparger and Overlay gas outlets • Air, O2, N2, CO2 routed to Sparger, Air routed to Overlay • Intermitted or Continuous gas flow control of Air, O2 and N2 via DOT controller •
Slide 13: Pumps
System Overview Biostat® D-DCU Pumps ▪ Integrated Pumps ▪ Up to 6 integrated peristaltic pumps per vessel - 1 & 2 fixed speed, on/ off controlled - 3 & 4 fixed speed, on/ off controlled or speed controlled - 5 & 6 speed controlled ▪ Watson Marlow pump heads ▪ Available pumps - fixed speed WM 114, 5
Slide 14: Human Machine Interface (HMI)
System Overview Biostat® D-DCU Human Machine Interface (HMI) Human Machine Interface (HMI) ▪ Intuitive to use ▪ Touch panel ▪ 19” TFT display ▪ Swivel-mounted 14
Slide 15: Operation-Main
System Overview Biostat® D-DCU Operation-Main Control Tower –Operation Main ▪ Vessel process value overview at a glance for Twin systems ▪ Unit vessel detail process value overview ▪ Controller status indication manual auto auto cascade 15
Slide 16: Operation-Trend
System Overview Biostat® D-DCU Operation-Trend Control Tower -Operation Trend Display ▪ Up to 8 process variables ▪ Display time selectable : 1 hour : 12 hours : 72 hours ▪ Selectable ranges : for each process value : % value of measurement range ▪ Temporary storage only 16
Slide 17: Operation-Calibration
System Overview Biostat® D-DCU –Control Tower Operation-Calibration Control Tower -Operation Calibration ▪ Single or Group calibration ▪ User guided calibration routines ▪ For pH, DOT, turbidity, redox probes ▪ For pumps (flow totalizer) ▪ For gas solenoids (gas totalizer) 17
Slide 18: Operation-Controller
System Overview Biostat® D-DCU Operation-Controller Control Tower Operation – Controller ▪ Operations : Mode selection : Servo controller selection : Set point changes : Parameter changes * min./ max. out put * PID parameter * Dead band : Alarm setting 18
Slide 19: Operation Advanced DOT Controller
System Overview Biostat® D-DCU Operation Advanced DOT Controller Advanced pO2 Controller ▪ Up to 4 servo controllers ▪ Free user configurable polyline for parallel or sequential control ▪ Starting points are depending on DOT controller output ▪ Selectable starting points 19
Slide 20: Operation-Phases
System Overview Biostat® D-DCU Operation-Phases Control Tower -Operation Phases Sequence control with interlocks for ▪ Sterilization - Full vessel, incl. gas inlet and exhaust line - Empty vessel incl. gas inlet and exhaust line - 4-Valve addition array - Separate Exhaust filter line - Sampling valv
Slide 21: Measurement and Control Capabilities
System Overview Biostat® D-DCU Measurement and Control Capabilities Measurement Control Comments Agitation speed X X Servo drive Temperature X X Controlled via closed loop thermostat system pH_1 & pH_2 X X Controlled via CO2 (Solenoid) or MFC / Acid pump + Base pump (analogue or digital) pO2_1 & pO2
Slide 22: Supply Unit
System Overview Biostat® D-DCU Supply Unit Supply Unit Open frame design with... ▪ Gas inlet and Exhaust line ▪ Thermostat system - Closed-loop pressurized water system with circulation pump and heat exchanger for cooling - Heating : 10-30L: Alternatively via stainless steel heat exchanger (cupper s
Slide 23: Supply Unit Components: 10-30L
System Overview Biostat® D-DCU Supply Unit Components: 10-30L 1 Pressure control valve 2 Sight glass buffer system DMS 3 Temperature control system 3a Pressure compensation vessel 3b Safety valve 3c Circulation pump 3d Heat exchanger 3e Variant: Electrical heating 4 Variant: Dual exhaust filter line
Slide 24: Supply Unit Components: 50-200L
System Overview Biostat® D-DCU Supply Unit Components: 50-200L 1 Pressure control valve 2 Sight glass buffer system DMS 3 Temperature control system 3a Pressure compensation vessel 3b Safety valve 3c Circulation pump 3d Heat exchanger 3e Auxiliary electrical heater 3f Continues controlled steam valv
Slide 25: Gas Inlet
System Overview Biostat® D-DCU Gas Inlet Sparger aeration ▪ Stainless steel filter housing ▪ Bypass line if no Overlay line is installed ▪ Option: WIT ready filter housing Overlay aeration (Cell culture) ▪ Stainless steel filter housing ▪ Option: WIT ready filter housing 25
Slide 26: Exhaust
System Overview Biostat® D-DCU Exhaust Exhaust filter, basic (10-30L only) ▪ Stainless steel filter housing directly mounted on Exhaust cooler ▪ High foam sensor included Exhaust filter line (10-200L) Single filter line or Dual parallel filter line for in process sterilization Stainless steel filter
Slide 27: Exhaust Cooler / Pressure Control Valve
System Overview Biostat® D-DCU Supply Unit Exhaust Cooler / Pressure Control Valve Exhaust Cooler (10-30L) ▪ Mounted on culture vessel lid ▪ Shell and tube heat exchanger Exhaust Cooler (50-200L) ▪ Mounted in piping skid ▪ Shell and tube heat exchanger Pressure control valve ▪ Mounted in piping skid
Slide 28: Culture Vessel
System Overview Biostat® D-DCU Culture Vessel Culture vessel ▪ Vessel with bottom agitation ▪ Working volume 10, 20, 30, 50, 100, 200L ▪ Aspect ratio H : D (total): 2:1 or 3:1 ▪ Jacketed stainless steel vessel with torospherical bottom ▪ Longitudinal viewing window ▪ Vessel fabrication: PED or ASME
Slide 29: Volume Overview
System Overview Biostat® D-DCU Volume Overview Working Volume Total Volume Vessel description [L] [L] 10-2 | 10-3 4,5 – 10 | 3,5 - 10 14 | 15 20-2 | 20-3 5.5 – 20 | 3.5 – 20 29 | 31 30-2 | 30-3 6.5 – 30 | 5.5 – 30 42 | 41 50-2 | 50-3 13 – 50 | 13 - 50 74 | 77 100-2 | 100-3 24 – 100 | 24 - 100 152 |
Slide 30: Culture vessel port overview
System Overview Biostat® D-DCU Culture vessel port overview Description Vessel 10 L 20 L 30L 50 L 100 L 200 L 1 x sight glass for illumination 1 x sight glass for illumination 1 x spare port DN 50 1 x port for Exhaust 1 x port for CIP - connection (2x 200L) Lid 9 x 19 mm port 1 x port for Exhaust Li
Slide 31: Scalability via geometrical similarity
System Overview Biostat® D-DCU Scalability via geometrical similarity Scale 10-2 20-2 30-2 50-2 100-2 200-2 10-3 20-3 30-3 50-3 100-3 200-3 Total volume [L] 14 29 42 74 152 313 15 31 41 77 152 323 Working volume [L] 10 20 30 50 100 200 10 20 30 50 100 200 Min. working volume [L] 3,5 5,5 6,4 13 24 47
Slide 32: Lid Lifting Device
System Overview Biostat® D-DCU Lid Lifting Device Lid lifting device ▪ Available for vessel sizes from 30 – 200L ▪ Pneumatic operated ▪ Swivel and lockable Lid lifting device 200L 32
Slide 33: Agitation Shafts
System Overview Biostat® D-DCU Agitation Shafts Agitation shaft sealing Double mechanical seal w/ buffer fluid system ▪ For microbial and cell culture application ▪ Lubricated by pressurized condensate - Compressed Air pressurization Option: Low level alarm monitoring - Steam pressurization ▪ Sealin
Slide 34: Agitation Motor
System Overview Biostat® D-DCU Agitation Motor Agitation motor ▪ Bottom agitation system ▪ Brushless DC Servomotor ▪ Gear and maintenance free ▪ Easy to clean due to smooth surface 34
Slide 35: Impeller for Microbial Application
System Overview Biostat® D-DCU Impeller for Microbial Application 6-blade disk impeller The 6-blade disk impeller produces a flow which moves radially away from the shaft and has a high energy dissipation density. This impeller breaks up air bubbles effectively and thereby improves oxygen transport
Slide 36: Impeller for Cell Culture Application
System Overview Biostat® D-DCU Impeller for Cell Culture Application 3-blade segment impeller 3-blade segment impellers for cell culture applications, especially for shear sensitive cells and microcarrier cultures. The impeller creates an axial downward flow (upward flow version available as option)
Slide 37: Aeration Devices
System Overview Biostat® D-DCU Aeration Devices Microbial and Cell Culture application ▪ Ring sparger for 25 mm upper side port ▪ Holes from bottom Cell culture application ▪ Micro sparger for 25 mm upper side port ▪ Sintered stainless steel frit 20 µm Ring sparger µ-sparger 37
Slide 38: Addition Devices: Needle Kits
System Overview Biostat® D-DCU Addition Devices: Needle Kits Needle assembly for 19 mm port Product description ▪ For installation 19 mm top plate port ▪ Available as : 1-Channel assembly : 3-Channel assembly Operation: 1. Sterilization in an autoclave together with the addition bottles 2. Steriliza
Slide 39: Addition Devices: SACOVA
System Overview Biostat® D-DCU Addition Devices: SACOVA fety Containment Valve (Sacova) Product description ▪ Sterile valve for a 19 mm top plate port ▪ 1-Channel or 3-Channel assembly available ▪ For tubing 3,2 x 1,6 mm Sacova valve closed ▪ High containment class Operation: 1. Sterilization in an
Slide 40: Addition Devices: 4-Valve Addition Array
System Overview Biostat® D-DCU Addition Devices: 4-Valve Addition Array 4-Valve Addition Array, auto Product description ▪ Automatic resterilizable valve array for 25 mm port ▪ For multiple sterile connections during the process ▪ Perfect fit for connection of bags using BioWelder ▪ High containment
Slide 41: Addition Devices: 4-Valve Addition Array, man
System Overview Biostat® D-DCU Addition Devices: 4 Valve Addition Array, man 4-Valve Addition Array, man Product description ▪ Resterilizable valve array for 25 mm port ▪ Automatic bioreactor, manual vales for steam, condensate and addition ▪ For multiple sterile connections during the process ▪ Per
Slide 42: Sampling
System Overview Biostat® D-DCU Sampling Resterilizable Sampling Valve, Keofit Product description ▪ Resterilizable Keofit sampling valve for TC 50.5 sanitary port ▪ For multiple samplings during the process ▪ Manual steam valve ▪ Incl. Sterile sleeve ▪ Optional: Automatic sterilization via automatic
Slide 43: Containment Sampling
System Overview Biostat® D-DCU Containment Sampling Resterilizable Containment Sampling System Product description ▪ Resterilizable Keofit sampling valve for TC 50.5 sanitary port ▪ For multiple sterile samplings during the process ▪ Manual steam and condensate valves ▪ Containment sampling bottle ▪
Slide 44: Single-use Sampling
System Overview Biostat® D-DCU Single-use Sampling Takeone® Single-use sampling ▪ Aseptic sampling system ▪ Ready to use ▪ NO cleaning, preparation and sterilization ▪ Quickseal®: aseptic tube sealing system ▪ Sampling bag sealed & disconnected in seconds 44
Slide 45: Drain Valve
System Overview Biostat® D-DCU Drain Valve Drain valve Product description ▪ Radial sealed with TC connection ▪ Manual or automatic operated ▪ Sterile sleeve or Condensate line w/ steam trap ▪ Optional: Automatic sterilization via automatic steam and condensate valves or Drain valve (100-200L) trans
Slide 46: Temperature Measurement of Condensate Lines
System Overview Biostat® D-DCU Temperature Measurement of Condensate Lines Temperature measurement of condensate lines • For all relevant condensate lines in sterile area • Contact temperature sensors • Monitoring via Control Tower Contact temperature sensor at addition valve array 46
Slide 47: Transfer Valve Group
System Overview Biostat® D-DCU Transfer Valve Group Transfer valve group (10-30L) ▪ Automatic valves for steam and Condensate lines ▪ Manual transfer valve Transfer valve group (50-200L) ▪ Automatic valves for steam and Condensate lines ▪ Automatic transfer and drain valve Transfer valve group (10-3
Slide 48: Cleaning In Place (CIP)
System Overview Biostat® D-DCU Cleaning In Place (CIP) Cleaning In Place For the use of an external CIP system, culture vessel is used as a batching tank ▪ Available for vessel sizes 10 – 200L ▪ SIP / CIP header ▪ Automatic CIP sequence for: : Culture vessel : Aeration line : Exhaust line : 4-valve
Slide 49: mobile CIP Unit
System Overview Biostat® D-DCU mobile CIP Unit mobile CIP Unit ▪ One system for all vessel sizes (10L – 200L) ▪ High & low conductivity measurement ▪ Pump dry run protection ▪ Up two integrated dosing stations ▪ D-DCU communication interface for automated CIP sequence control 49
Slide 50: Supporting Documentation
System Overview Biostat® D-DCU Supporting Documentation Supporting Documentation Pre-order: ▪ Data sheet ▪ Arrangement plan ▪ Reference P&ID Post-order: ▪ Reference 3D model for room planning ▪ Operating manual ▪ Consumable list ▪ Qualification package - As build P&ID - Material certificates - Funct
Slide 51: Content
Content Introduction System Overview Hybrid Solution 51
Slide 52: Hybrid Solutions
Hybrid Solutions Hybrid Solutions Flexboy® or Flexel® bags can be connected to the BIOSTAT® D-DCU for corrective agent and feed addition to reduce cleaning effort. Together with our media preparation system FlexAct® MP and our cell harvest FlexAct® CH, a completely hybrid upstream process solution c
Slide 53: Common Stainless Steel Bioreactor Design
Hybrid Solutions Common Stainless Steel Bioreactor Design Common stainless steel bioreactor design ▪ Stainless steel storage vessels for corrective agents and feeds ▪ SIP / CIP requirements for all vessels ▪ High Steam / WFI requirements ▪ High capital investment 53
Slide 54: Example of a Hybrid Solution: Stainless Steel Bioreactor with Single-Use Bags
Hybrid Solutions Example of a Hybrid Solution Stainless Steel Bioreactor with Single-Use Bags Advantages ▪ Single-use bags for media storage and harvest ▪ SIP / CIP requirement for bioreactor only ▪ Low Steam / WFI requirements ▪ Fully flexible ▪ Reduced cleaning validation ▪ Lower capital investmen
Slide 55: Example of a Hybrid Solution: How to Connect Single-Use Bags?
Hybrid Solutions Example of a Hybrid Solution How to Connect Single-Use Bags? Tube welding, the easiest way to connect Operation ▪ Autoclave re-usable valve with TPE tubing ▪ SIP of addition / harvest group after connection of the autoclaved valve ▪ Connect TPE tubing from bag and valve by welding v
Slide 56: Biostat D-DCU Hybrid Solutions
Hybrid Solutions Biostat® D-DCU BioSealer ® TPE tube sealer FlexAct ® MP: Media Preparation Flexel ® CH: Cell Harvest Liquid storage bag Sartoclear ® Depth filter Flexboy® BioWelder ® Media storage bag Sartopore ® 2 TPE tube welder Liquid Filter 56
Slide 57: Thank you.
Thank you.