new biostat cplus internal presentation -...

BIOSTAT® Cplus

The SIP Stainless Steel Fermenter|Bioreactor for Your Lab

Internal Presentation

Main Changes New BIOSTAT® CplusProduct Changes

- DFC controller replaced by DCU control platform

- up to 4 MFC for Additive Flow gassing strategy with up to 4 integrated pumps

- VP sensor connectors for pH and DO

- Optical DO sensor (Visiferm) available

- M12 connectors for external inputs, external feed pump connection etc.

- Substrate software controller not part of standard software function

- Software feature “unused integrated pump can be configured as substrate pump”not available

- Gas Flow Ration software controller not available -> configure “Advanced DO controller” instead

- More software features: Advanced DO Controller, Culture Vessel Pressure Hold Sequence and Gravimetric Feed Control available as option

Changes

Main Changes New BIOSTAT® CplusProduct Changes

Discontinued:

– 2L working volume culture vessel

– “Exclusive Flow” gassing strategy

– Bubble-free aeration

Changes

Main Changes New BIOSTAT® CplusConfigurator Changes

- Configurator structure harmonized with BIOSTAT® B and D-DCU

- Customer get what is configured in the configuratore.g. Substrate controller no longer part of standard software scope

- Steam and condensate tubing's are not listed as separate item in the quote -> Now included under “Sterilization” e.g. “manual sterilization sampling valve”

- Only one MO entry, selection in the “pO2 control” “Gassing strategy”-> O2-Enrichment or Gasflow Ratio

- New entry Dual Use. Additive Flow gassing strategy with free configurable gassing rates and vessel accessories

- Qualification now in the configurator

New Basic Configurations (BC) not include sampling valve, high foam kit, casters, tray for storage bottles, motor holder and foam measurement and control

Changes

Contents

1

2

A Profile of Sartorius

BIOSTAT® Cplus3

Bioprocess Solutions Division

Competition Overview4

Sartorius Runs Three Divisions

Sartorius Group

Industrial WeighingLab Products & ServicesBioprocess Solutions


Global Presence

30.06.2012 Sales Production


Contents

1

2


BIOSTAT® Cplus3



Our Portfolio

Bioprocess Solutions

Filtration

FluidManagement

Fermentation

Purification

IntegratedSolutions

Service

The Widest Product Portfolio Along Biopharma’s Process Chain


Leading Worldwide Market Positions

Filtration

amongTOP 3Fermentation

#1 Fluid Management

#1


Our Solutions for Your Process...

... in Upstream Processing (fermentation, cell cultivation, media and buffer preparation)



... in Downstream Processing (depth filtration, crossflow filtration, virus filtration, freeze & thaw)



... in Engineering


Contents

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BIOSTAT® Cplus3



BIOSTAT® Cplus - SIP stainless steel fermenter|bioreactor

Fits in your labEconomic integration in existing infrastructure. Choice of steam or electrical heating for operation and culture vessel sterilization

Advanced process control and intuitive operation DCU control platform for Advanced DO Control, Gravimetric feeding and touch screen operation

Compact and movable Minimum lab space requirement and casters for easy relocation

Excellent safety Automatic sequences for culture vessel sterilization and pressure hold test and a maintenance free agitation motor

Introduction

The BIOSTAT® C Family Tree

1992-2008 2008-08/2013 from August 2013BIOSTAT® C BIOSTAT® Cplus New BIOSTAT® Cplus

- Largest installation base worldwide with reference applications for many processes

- Very experienced service and application specialists for local support

- Trainings and seminars for cell culture and fermentation

- NEW with DCU control platform and new additional features

BIOSTAT® Cplus

Product feature BIOSTAT® Cplus New BIOSTAT® Cplus

Operation/ Display 10” Touch screen 10” Touch screen

Integrated amplifiers max. 7 Up to 12

Interface for optical DO sensor No Yes

Sensor connectors pH | DO DIN | Lemo V8 | V8

Gassing system Integrated, MO: O2-Enrichment, Gasflow Ratio CC: Exclusive Flow, Additive Flow

IntegratedMO: O2-Enrichment, Gasflow Ratio CC: Additive Flow

Mass Flow Controller - max. 2 MFC (dedicated position) - Up to 4 MFC per Vessel (freely selectable)

Pumps Integrated: up 4 (ACID, BASE, FOAM, LEVEL) 2 external substrate pumps

Integrated: up to 4, Total: up to 6 4 x digital (ACID, BASE, FOAM, LEVEL) or2 x digital + 2 x analogue (Feed) and 2 external substrate pumps (shared output w/ internal pumps)

Vessel design 5L – 30 L (2L discontinued)

System qualification yes yes

Gravimetric Feed Control Via BioPAT® MFCS/win only Up to 2

Culture vessel pressure hold sequence

No Yes (Option)

Advanced pO2 Control No Yes (Option)

BIOSTAT® Cplus vs. NEW BIOSTAT® Cplus at a glance...

BIOSTAT® Cplus

Gassing system

BIOSTAT® Cplus

Intuitive Touch Screen

Motor holder

Casters

Resterilizable bottom seat valve

High foam sensor

Sampling bottle

Resterilizable sampling valve

Culture vessel

25 mm port for resterilizabale addition valve

Agitation motor

Up to 4 integrated pump

Fluid buffer system for double mechanical seal

Removable bottle tray

Temperature control systemChoice of electrical or steam heating

Exhaust filter

Supply unit

Control unit

BIOSTAT® Cplus

Lift lifting crane

Motor holder

Casters

Accessories for easy handling

Safety shut down of aeration and agitation OOHigh-Foam

Control of internal unused or additional optional peristaltic pump (internal or external)

O-Substrate A & B feeding

For integration of external device, i.e.BioPAT® Xgas-X3 x External Signal

Manual or automaticOOPressure

Maintenance free, low noise XXAgitation speed

OOVessel weight

Weight indication of feeding bottleOOGravimetric feed control

O

-

X

X

X

X

Control

For Foam or Level control; user selectionXFoam|Level

Free selectable OMFC 1 ...4

MO: Controlled via agitation speed; O2 supplementation; Aeration rate; Substrate CC: Controlled via O2/ N2 supplementation, agitation speed, Aeration rate, Substrate

XpO2

Controlled via CO2/ Acid + BaseXpH

O

X

Measurement

Redox and Turbidity

Closed loop pressurized water systemChoice of electrical or steam heating

Temperature

Comments

Overview Measurement and Control capabilities

BIOSTAT® Cplus

DCU control software

BIOSTAT® Cplus

Process time

Process time

Weight measurement & Gravimetric Feed control

Pumps

Process parameter

Main menus Shut down & Status

DO Control – CASCADE (standard)

− 4 stage, freely configurable

− Setting of min. / max. for each cascade

− PID parameters freely adjustable

− Next cascade is activated once prior one has reached its max.

− e.g.

C1: Nitrogen Flow

C2: Air Flow

C3: O2 Flow

C4: Stirrer Speed

BIOSTAT® Cplus

Advanced DO Control (option)

− Parallel activation of multiple controllers

− Max. flexibility for advanced process development

− Based on DO controller output up to five parameters can be activated at the same time

− e.g.

Increase O2 flow & decrease AIR flow while total flow is kept constant

Increase flow rate & stirrer speed at the same time

BIOSTAT® Cplus

Culture vessel pressure hold sequence (option)

− Automatic pressure hold test for the culture vessel

− Adjustable time, test and process pressure

− Monitoring of the pressure characteristics on the Trend display or SCADA system

− Requires pressure measurement and automatic pressure control valve

BIOSTAT® Cplus

“O2-Enrichment”

– Air flow gassing system with O2 Supplementation capability via 3/2-way solenoid valve

– Rotameter for Total Sparger flow

– O2 Supplementation automaticallycontrolled via pO2 controller

– Optional Mass Flow Controller for Total Sparger Flow

Control unitGassing system “O2-Enrichment”

BIOSTAT® Cplus

“Gas Flow Ratio”

- Air flow gassing system with O2 Supplementation capability via mass flow controller for Air and O2

- Rotameter for Total Sparger flow

- O2 Supplementation automaticallycontrolled via pO2 controller

Control unit Gassing system “Gas Flow Ratio”

BIOSTAT® Cplus

“Additive Flow”

- 4-Gasmixing system gasmixing of Air, N2, O2 and CO2

- Individual Rotameter

- Overlay flow and Sparger aerationOverlay: Air only Sparger: Air, O2, N2 and CO2 automatically controlled via pH/ pO2 controller

- up to 4 optional Mass Flow Controller for

Control unit Gassing System “Additive Flow”

BIOSTAT® Cplus

Agitation motor

Agitation motor

• Brushless DC Servomotor

• Gear and maintenance free

• Motor performance : 2L & 5L 500 W 20-1500 rpm : 10 & 15L 800 W 20-1000 rpm : 20 & 30 L 1200 W 20-600 rpm

BIOSTAT® Cplus

Supply Unit 2L & 5L, Benchtop

Open frame design with...• Frame for culture vessel• Console for control unit • Thermostat system

: Closed-loop pressurized water system with circulation pumpand heat exchanger for cooling

: Heating Alternatively via stainless steel heat exchanger (cupper soldered) orelectrical heating cartridge

• Temperature control range : 8 °C above cooling water up to 90 °C

• Sterilization temperature : up to 130 °C

Supply Unit

BIOSTAT® Cplus

Supply Unit 10-30L, Floor standing

Open frame design with...

• Frame for culture vessel

• Console for control unit

• Thermostat system: Closed-loop pressurized water system with circulation pump

and heat exchanger for cooling: HeatingAlternatively via stainless steel heat exchanger (cupper soldered) orelectrical heating cartridge

: OptionalStainless steel heat exchanger (stainless steel welded) for use with clean steam

• Temperature control range : 8 °C above cooling water up to 90 °C

• Sterilization temperature : up to 130 °C

Supply Unit

BIOSTAT® Cplus

- Storage bottle support (Floor stand version only)

- Storage bottles 500 ml or 1000 ml

- Motor holder

- Installation kit

- NTP connection kit

- Casters (Floor stand version only)

- Recirculation cooler FRIGOMIX® 2000 (230 VAC only)

and installation kit

- Top plate lifting device (manual operated) (Floor stand version only)

Supply unit accessories

BIOSTAT® Cplus

Culture vessel 5L

- Vessel with top agitation

- Working volume 5L

- Aspect ratio H : D (total): 2:1

- Jacketed stainless steel vessel with torospherical bottom and upper glass cylinder

- Vessel fabrication: PED

- Material: Product side: stainless steel 1.4435 (AISI 316L) ,

EPDM, borosilicate glass

others: 1.4301 (AISI 304)

: Surface: internal: Ra <= 0,5, electropolished

external: glass beads blasted, electropolished

Culture vessel

BIOSTAT® Cplus

Culture vessel 10L - 30 L

- Vessel with top agitation

- Working volume 10, 15, 20, 30 L

- 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

- Material: Product side: stainless steel 1.4435 (AISI 316L) ,

EPDM, borosilicate glass

others: 1.4301 (AISI 304)

: Surface: internal: Ra <= 0,5, electropolished

external: glass beads blasted, electropolished

Culture vessel

BIOSTAT® Cplus

Culture vessel Volume overview

429 – 30 | 6 – 3030-2 | 30-3

307,5 – 20 | 5,5 – 2020-2 | 20-3

225,5 – 15 | 5.0 - 1515-2 | 15-3

154,5 – 10 | 3,5 - 1010-2 | 10-3

6.81.6 - 55-2

Total Volume [L]

Working Volume[L]

Vessel description

BIOSTAT® Cplus

6554 | 54Top plate ports 19 mm

11111Bottom

55555Lower side ports (25 mm port) incl. 1 x 12 mm port for Pt100

3333-Upper side ports (25 mm port)ASME vessel addition port for bursting disc

Sparger inlet, Exhaust cooler, agitation, sight glass for illumination (10-30 L), safety valve (PED vessel only)

Top plate port (fixed installations)

30 L20 L15 L10 L

2:1 | 3:15 LDescription Vessel

Culture vessel Port overview

BIOSTAT® Cplus

Culture vessel equipment

• 4 x baffle, removable

• Exhaust cooler

• Light glass Ø 25 mm in lid, with removable lamp (10l – 30 L only)

• Safety valve, ASME vessel with bursting disc

• Temperature sensor Pt 100

• Combined harvesting/sampling valve

BIOSTAT® Cplus

Agitation shaft sealing

Single mechanical seal

• Lubricated by condensate/aerosol in head space

• Sealing material: ceramic/carbon

Double mechanical seal

• Lubricated by pressurized condensate

• Sealing material: ceramic/carbon

• Condensate vessel with viewing window

• High containment class

Culture vessel accessories

BIOSTAT® Cplus

Vessel accessories: 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 phase. At the same time, high local shear forces are also generated which can have a negative influence on the growth of shear-stress-sensitive organisms (cell cultures, filament-producing fungi).

BIOSTAT® Cplus

Vessel accessories: Impeller for cell culture application

3-blade segment impeller

3-blade segment impeller

3-blade segment impellers are specifically designed for use in culturing of cells sensitive to shear stresses and especially for cell cultures immobilized in suspension or on microcarriers. The impeller creates an axial direction of flow and thereby achieves homogenous and thorough mixing of the culture medium while minimizing shearing forces.

BIOSTAT® Cplus

Vessel accessories: Aeration devices direct aeration

Microbial applications

• Ring sparger for 19 mm top plate port

Cell culture applications

• Micro sparger for 19 mm top plate port

• Sintered stainless steel frit 20 μmRing sparger μ-sparger

BIOSTAT® Cplus

30.06.2012 Page 51

DO Sensor Hamilton (standard) or Mettler (optional)Clark or Optical electrode

pH SensorHamilton (standard) or Mettler (optional)

Foam & Level sensorConductive probes

Temperature sensorPt100 sensor with sleeve

Sensors & Connections

BIOSTAT® Cplus

30.06.2012 Page 52

Redox sensor Combined pH & Redox sensor Hamilton (standard) or Mettler (optional)

Turbidity (cell density) sensor On-line measurement of cell growth and biomassReduction of sampling frequency and bench analysesAbsorption based

Sensors & Connections

BIOSTAT® Cplus

Vessel accessories: Addition devices

Needle assembly for 19 mm portProduct description

• For installation 19 mm top plate port

• Available as : 1-Channel assembly with 4 x 1 mm needle for tubing 1.6 x 1.6 mm with sterile sleeve

: 1-Channel assembly with 6 x 0.5 mm needlefor tubing 3.2 x 1.6 mm with sterile sleeve

: 3-Channel assembly with 8 x 1 mm needlefor tubing 1.6 x 1.6 mm with sterile sleeve

Operation:

1. Sterilization in an autoclave together with the addition bottles

2. Sterilization of the culture vessel with septum/ blind plug assembly

3. Remove septum bind plug and tne sterile sleeve of the needle and pierce the septum with the needle

BIOSTAT® Cplus


Safety 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


Operation:

1. Sterilization in an autoclave together with the addition bottle or connected C-flex tubing using a BioWelder for sterile connection

2. After autoclaving installation in the culture vessel and sterilization together with the culture vessel

Sacova valve open

Sacova valve closed

BIOSTAT® Cplus


Steam line APC 19

Steam line

Condensate Line

APC 25

Condensateline

Resterilizable Addition Valve (AP19 & APC25)

Product description

• Resterilizable valve for 19 or 25 mm port

• For multiple sterile connections during the process

• For tubing 3,2 x 1,6 mm


Operation:

1. APC19 & APC25 are installed in culture vessel

2. Sterlization together with culture vessel

3. Sterilization by autoclave of addition bottles with valve assembly

4. After autoclaving connection of valve assembly to culture vessel and sterlization by steaming of connection line

autoclave valveassembly

autoclave valveassembly

BIOSTAT® Cplus

Vessel accessories: Sampling

Resterilizable Sampling Valve (SVC 25)

Product description

• Resterilizable sampling valve 25 mm port

• For multiple sterile samplings during the process

• Incl. Sterile sleeve

• Optional: Sampling bottle with valve assemblyStainless steel kill tank for contaminated condensate

Steam line

Sampling valveSVC 25

Condensate line

Sampling bottlewith valve assembly(optional)

BIOSTAT® Cplus

Vessel accessories: Sampling Schematic overview SVC 25 with kill tank

BIOSTAT® Cplus

The perfusion system with internal spin filter is needed for the continuous medium exchange at long-term cultivation. Internal Spinfilter are mounted on the agiation shaft. Our recommendation for mesh sizes are as follow:

Mesh size 20 μm: Suspension cells

Mesh size 40 μm: aggregate-forming cells

Mesh size 75 μm: Micro carrier cultivations

Vessel accessoriesPerfusion via Spinfilter

BIOSTAT® Cplus

Vessel accessories: Perfusion via SpinfilterSchematic Drawing of a Cell Culture Bioreactor for Perfusion of Medium

BIOSTAT® Cplus

Vessel accessories: Miscellaneous

- Vessel pressure gauge; -1/+3 bar

- Empty vessel sterilization

- Blind plug for 19 mm Blind plug 25 mm port

- Kill tank

- Sampling bottle for SVC 25

- Autoclavable storage bottles 0.5 – 50 L

BIOSTAT® Cplus

30.06.2012 Page 37

BioPAT® MFCS | win – SCADA Software

Besides the core functionality of a real SCADA system BioPAT® MFCS/win offers a number of additional modules for adaptation to individual requirements:

- Bioprocess optimization with Design of Experiments module (DoE)

– S88 recipe control

– Batch control compliant with ANSI | ISA-88.01

– 21 CFR, Part 11 compatibility

– Secure integration into company networks

– Flexible device connection facility through OPC

– Expanded data logging and data archiving

– Logging of alarms and transmission to multimedia devices

SCADA Software

30.06.2012 Page 61

Our Services

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

Service

Sartorius bioreactors are built to last for a decade (& more)-> You will enjoy many years of high performance

We set high standards to sell excellent - quality products-> You will receive only quality and innovative technologies with your Sartorius product

We are represented worldwide -> You‘ll always have a Sartorius contact to talk to directly in your country

Application Specialists–> Are available globally to help you with your processes and eliminate any obstacles you encounter

Value Products for Value Customers

Values

Contents

1

2


BIOSTAT® Cplus

4


Competition Overview

3

Price

System performance

BioFlo 510BioBench

Techfors-S

BIOSTAT® Cplus

Competition overview

BIOSTAT® Cplus

BIOSTAT® Cplus Applikon BioBench


BIOSTAT® Cplus

Electrical heating for operation Steam required for vessel sterilization

Choice of steam heating or electrical heating operation and sterilization

Open loop standard: Closed loop option Closed loop pressurized water temp. control system

Touch screen displayTouch screen display

2:1 onlyVessel aspect H:D ratio 3:1 and 2:1 (2&5L 2:1 only)

Central jacket onlyFully jacketed vessel

Local controller and PC based SCADA systemLocal controller and PC based SCADA system

Vessel volume WV 5L, 10L, 20LVessel volume WV 2L, 5L, 10L, 15L, 20L, 30L

Top driven agitation system Top driven agitation system

Process control for agitation speed, Temp., pH, pO2, feed controllerOptional: Pressure, Vessel weight

Process control for Agitation speed, Temp., pH, pO2; Foam|Level; 2 x Substrate feed controller; High Foam:Optional up to 2 MFC, Vessel weight, Pressure Redox (M), Turbidity (M), 2 x feeding bottle weight

Open frame supply unit integrated controller designOpen-frame with integrated Control Tower design

Applikon BioBenchBIOSTAT® Cplus


BIOSTAT® Cplus

BIOSTAT® Cplus Infors Techfors-S


BIOSTAT® Cplus

Open loopClosed loop pressurized water temp. control system

Electrical heating for operation Steam required for vessel sterilization

Choice of steam heating or electrical heating operation and sterilization

Jacketed vessel, no upper side portsFully jacketed vessel, 3 upper side ports

Top driven agitation systemTop driven agitation system

Vessel volume WV 5L, 10L, 20LVessel volume WV 2L, 5L, 10L, 15L, 20L, 30L

PC based integrated control and SCADA software Local controller and PC based SCADA system



Process control for Agitation speed, Temp., pH, pO2; Optional: Foam|Level; Substrate feed controller, Vessel weight, Pressure, MFC

Process control for Agitation speed, Temp., pH, pO2; Foam|Level; 2 x Substrate feed controller; High Foam:Optional up to 2 MFC, Vessel weight, Pressure Redox (M), Turbidity (M), 2 x feeding bottle weight

Open-frame with integrated Control Tower designOpen-frame with integrated Control Tower design

Infors Techfors-SBIOSTAT® C plus


BIOSTAT® Cplus

BIOSTAT® Cplus NBS BioFlo® 510


BIOSTAT® Cplus

Steam required for vessel sterilization and operationChoice of steam heating or electrical heating operation and sterilization

Open loop standard: Closed loop option Closed loop pressurized water temp. control system



full jacket Fully jacketed vessel

Local controller and PC based SCADA systemLocal controller and PC based SCADA system

Vessel volume WV 16L, 32LVessel volume WV 2L, 5L, 10L, 15L, 20L, 30L

Top driven agitation system Top driven agitation system

Process control for agitation speed, Temp., pH, pO2, Gas Flow Control, feed controller, vessel weightOption: Redox, Pressure,

Process control for Agitation speed, Temp., pH, pO2; Foam|Level; 2 x Substrate feed controller; High Foam:Optional up to 2 MFC, Vessel weight, Pressure, Redox (M), Turbidity (M), 2 x feeding bottle weight

Open frame supply unit integrated controller designOpen-frame with integrated Control Tower design

NBS BioFlo® 510BIOSTAT® C plus


BIOSTAT® Cplus

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