Sartorius AG · XETR:SRT
Sartorius — Sartorius Stedim Biotech — Investor Presentation (2020)
57 slides from Sartorius's investor presentation, Jun 27, 2020
Slide 1: BIOSTAT D-DCU: Your Fast Lane to Production
BIOSTAT® D-DCU Your “Fast Lane” to Production
Slide 2: Agenda
Agenda • Introduction • System Overview • Hybrid Solution
Slide 3: Drivers of Standardization for Stainless Steel Fermentation Systems
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 • Quickly up and r
Slide 4: Ideal Platform for Process Development and Production
BIOSTAT® D-DCU Ideal Platform for : • Process development • Process optimization • Up-scale and down-scale • Production
Slide 5: Agenda
Agenda • Introduction • System Overview • Hybrid Solution
Slide 6: Your Fast Lane to Production
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 solutions for u
Slide 7: System Overview
BIOSTAT® D-DCU System Overview Supply unit : Open frame design : Thermostat system : Gas inlet Control Tower : Exhaust : Single or Twin configuration : DCU control System : Touch panel Culture vessel : Integrated gassing system : Flat top plate : Integrated pumps : Bottom agitation system : Working
Slide 8: Control Tower
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 Control (Microbial appl
Slide 9: Gassing Strategy: Airflow
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
Slide 10: Gassing Strategy: O2-Enrichment
BIOSTAT® D-DCU Gassing Strategy “O2-Enrichment” • Gassing system with O2 enrichment capability via solenoid valve Design up to 50 L/min • Rotameter for Total Sparger flow • Intermitted O2 enrichment controlled via DOT controller • Option: Mass Flow Controller for Total Design up to 300 L/min Sparger
Slide 11: Gassing Strategy: Gas Flow Ratio Control
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 automatically contr
Slide 12: Gassing Strategy: Advanced Additive Flow
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 • Intermitted or C
Slide 13: Pumps
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,
Slide 14: Human Machine Interface (HMI)
BIOSTAT® D-DCU Human Machine Interface (HMI) Human Machine Interface (HMI) • Intuitive to use • Touch panel • 19” TFT display • Swivel-mounted
Slide 15: Operation-Main
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
Slide 16: Operation-Trend
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
Slide 17: Operation-Calibration
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)
Slide 18: Operation-Controller
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
Slide 19: Operation Advanced DOT Controller
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
Slide 20: Operation-Phases
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 valve - Darin valve
Slide 21: Measurement and Control Capabilities
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_2 X X Controlle
Slide 22: Supply Unit
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 soldered) or elec
Slide 23: Supply Unit Components: 10-30L
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 5 Exhaust coole
Slide 24: Supply Unit Components: 50-200L
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 valve 4 Exhaust filt
Slide 25: Gas Inlet
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
Slide 26: Exhaust
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 w/ WIT (10-30L) Basic (10-30L) Dual w/ WIT (50 - 200L) Dual parallel filter line for in
Slide 27: Exhaust Cooler / Pressure Control Valve
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 Exhaust cooler (50 – 200L) Pressure control valve Pressure cont
Slide 28: Culture Vessel
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 or China licence
Slide 29: Volume 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 | 152 200-2 | 200-
Slide 30: Culture vessel port 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 Lifting handles 8
Slide 31: Scalability via geometrical similarity
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 2,5 3,5 5,4 13
Slide 32: Lid Lifting Device
BIOSTAT® D-DCU Lid Lifting Device Lid lifting device • Available for vessel sizes from 30 – 200L • Pneumatic operated • Swivel and lockable Dual w/ WIT (10-30L) Basic (10-30L) Lid lifting device 200L
Slide 33: Agitation Shafts
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 • Sealing material: SIC/
Slide 34: Agitation Motor
BIOSTAT® D-DCU Agitation Motor Agitation motor • Bottom agitation system • Brushless DC Servomotor • Gear and maintenance free • Easy to clean due to smooth surface
Slide 35: Impeller for Microbial Application
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 in the liquid ph
Slide 36: Impeller for Cell Culture Application
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) and thereby ach
Slide 37: Aeration Devices
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
Slide 38: Addition Devices: Needle Kits
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. Sterilization of the cult
Slide 39: Addition Devices: SACOVA
BIOSTAT® D-DCU Addition Devices: SACOVA Safety Containment Valve (Sacova) Product description • Sterile valve for a 19 mm top plate port • 1-Channel or 3-Channel assembly available Sacova valve closed • For tubing 3,2 x 1,6 mm • High containment class Operation: 1. Sterilization in an autoclave toge
Slide 40: Addition Devices: 4-Valve Addition Array
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 Manual addition valve
Slide 41: Addition Devices: Valve Addition Array, man
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 • Perfect f
Slide 42: Sampling
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 steam valve
Slide 43: Containment Sampling
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 • Optional: Autom
Slide 44: Single-use Sampling
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
Slide 45: Drain Valve
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 Drain valve (100-200L) • Optional: Automatic sterilization via automatic steam and condensate valves or transfer group
Slide 46: Temperature Measurement of Condensate Lines
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
Slide 47: Transfer Valve Group
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 Transfer valve group (10-30L) • Automatic transfer and drain valve
Slide 48: Cleaning In Place (CIP)
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 addition array,
Slide 49: mobile CIP Unit
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
Slide 50: Supporting Documentation
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 - Functional specificat
Slide 51: Agenda
Agenda • Introduction • System Overview • Hybrid solution
Slide 52: 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 can be installed a
Slide 53: Common Stainless Steel Bioreactor Design
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
Slide 54: Example of a Hybrid Solution: Stainless Steel Bioreactor with Single-Use Bags
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 investment
Slide 55: Example of a Hybrid Solution: How to Connect Single-Use Bags?
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 via e.g. BioWelder
Slide 56: Your Fast Track to a Complete Upstream Solution from Media Prep to Cell Harvest
BIOSTAT® D-DCU Your Fast Track to a Complete Upstream Solution from Media Prep to Cell Harvest FlexAct® MP: Media Preparation Flexel® CH: Cell Harvest Liquid storage bag BioSealer® TPE tube sealer Sartoclear® Depth filter BioWelder® Flexboy® TPE tube welder Media storage bag Sartopore® 2 TAKEONE® Li
Slide 57: Thank you for your attention
“HE: sartorius stedim biotech Thank you for your attention
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