ReadyToProcess WAVE 25 データファイル
Contents
1. GE Healthcare Bio Sciences AB Bj rkgatan 30 751 84 Uppsala Sweden Code number 28 9880 00 29 0442 13 29 0442 16 29 0440 81 29 0320 05 29 0469 18 29 0205 51 29 0203 55 29 0444 72 29 0444 73 29 0444 74 29 0444 75 29 0444 76 29 0444 77 29 0444 71 28 9841 89 imagination at work Related literature UNICORN 6 3 Manual Package UNICORN 6 control software data file Code number 29 0234 67 28 9573 46 Disposable Cellbag bioreactors for WAVE Bioreactor systems data file Validation Support File UNICORN 6 3 20 9511 36 11 0029 94 GE imagination at work and GE monogram are trademarks of General Electric Company Cellbag ReadyToProcess ReadyToProcess WAVE and UNICORN are trademarks of GE Healthcare companies DeltaV is a trademark of Emerson Electric Co Windows and Windows XP are registered trademarks of Microsoft Corporation Any use of UNICORN software is subject to GE Healthcare Standard Software End User License Agreement for Life Sciences Software Products A copy of this Standard Software End User License Agreement is available on request Cellbag bioreactors with integrated optical sensors are sold under a sublicense from Sartorius Stedim Biotech under US patent numbers 6 673 532 7 041 493 and or its foreign equivalents 2013 General Electric Company All rights reserved First published Jun 2013 All goods and services are sold subject to the terms and conditions of sale of th2. AB Cellbag bioreactors Cellbag bioreactors are single use bags for the noninvasive mixing of culture medium and cells during cultivation Fig 8 Cellbag bioreactors require no sterilization or cleaning steps The disposable bioreactors provide a suitable environment for cell growth while minimizing the cross contamination risk The bags are manufactured from multilayer laminated clear USP Class VI plastics and are easily connected to the full suite of ReadyToProcess cell culture purification and fluid handling products The selection of Cellbag bioreactors is listed in Table 2 For more information about Cellbag bioreactors see data fille 28 9511 36 Optical DO sensor embedded in bag Air outlet filter Optional ee Air inlet filter Inoculation harvest lines m pH sensor embedded in bag Cellbag rod Optional tubing Needleless a sampling port Fig 8 Presentation of typical Cellbag bioreactor fittings Table 2 Selection of Cellbag bioreactor sizes Cellbag bioreactor Working volume Cellbag 2 L 300 mLto 1L Cellbag 10 L 500 mL to 5L Cellbag 20 L 1to10L Cellbag 22 L 1to 10L Cellbag 50 L SOL All Cellbag bioreactor sizes are available with internal perfusion filter for perfusion cultures and or can be equipped with single use optical pH pHOPT and DO DOOPT lI sensors t Cellbag bioreactors with optical sensors require 300 mL minimal working volume Depending on application and con
3. ReadyToProcess Pump 25 Peristaltic pump a e en Client computer Tray ReadyToProcess WAVE 25 rocker ReadyToProcess CBCU Installed with Rocker temperature sensors Gas flow mix controller UNICORN software scale embedded controller pH and DO sensors and dual hard drives System setup and integration of subunits ReadyToProcess WAVE 25 rocker ReadyToProcess Pump 25 e Acid base flow e Rocking e Feed harvest flow ae e Weight a a e Media addition measurement e Temperature UNICORN software measurement Administration ReadyToProcess CBCU System control Method editor e Gas flow mix Controller with dual hard drives e pH measurement Evaluation e DO measurement ees I pe nk Sad UNICORN SCADA database not included UNICORN software E mail At home or within notifications enterprise network Fig 2 ReadyToProcess WAVE 25 system overview The System Control module on the client computer is used to start and monitor the cultivation process One UNICORN client can control up to three ReadyToProcess WAVE 25 systems simultaneously SCADA supervisory control and data acquisition OPC open platform communications LAN local area network 2 29 0566 95 AB System overview ReadyToProcess WAVE 25 system components The ReadyToProcess WAVE 25 system consists of a rocker a gas mixer and a pump all operated by the UNICORN software installed on a client computer The rocker
4. distribution between the load cells also on nonlevel surfaces for increased precision of the weight measurement 4 29 0566 95 AB Data storage and communication All run data and control parameters are stored on two independent mirrored solid state drives integrated in the rocker Thus once cultivation has been started and data from the instrument modules have been collected the run can continue without the need for a network connection The use of two solid state drives enables culturing without losing any data even if only one drive is functional After a run data is stored in a UNICORN database on an external computer For facilitated integration into a larger manufacturing operation the rocker also contains software for enabling direct communication with the system via an open platform communication OPC link ReadyToProcess CBCU The ReadyToProcess CBCU gas mixer is a compact unit with multiple functions The unit is primarily used for providing gas to the culture and for monitoring of pH and DO The unit contains a controller for mass flow sensors for gas pressure and O and CO concentrations and transmitters for pH and DO Table 1 Three CBCU configurations are available e CO O and pH e CO O and DO COO pH ana DO The most suitable CBCU configuration will depend on the specific application Table 1 ReadyToProcess CBCU gas mixer overview Feature CO 0 air mix controller Description Depending
5. on systems having the same instrument and component configuration System control The System Control module is used to connect to the system as well as to start view and control a run Fig 7 Default parameter values for an instrument can be viewed and edited in the System Settings dialog before a run is started or during an ongoing run using manual instructions It is also possible to connect to other systems The user friendly and intuitive Process Picture pane enables manual interaction with the system and provides status of the run parameters Data is shown in the process picture but can also be viewed as curves in the Charts tab and as numerical values in the Run Data pane Curves and information about the run are saved in a database which can be opened in the Evaluation module The default view shows the most commonly curves used The user may customize which curves to display and the color and style of the displayed curves Fig 7 Monitoring and controlling all aspects of the culture is managed through the user friendly interface Evaluation In the Evaluation module content of the result files can be viewed analyzed and compiled as reports Reports can be customized saved and printed Automation of process parameters in pH and DO control The UNICORN software automatically sets the desired PID control parameters based on Cellbag bioreactor size and gas flow set point The system also adapts the parameters durin
6. on the configuration air is mixed with CO and or O according to the set points Nitrogen may be used instead of air for maintaining a low oxygen environment for near anaerobic applications Gas flow controller The gas mix flow is measured and controlled by a mass flow controller MFC A correct volumetric flow is achieved by compensation for CO concentration Quick filling of gas into the Cellbag bioreactor enabled by the fast fill function Significantly reduces start up time An alarm will inform the user if pressure sensors detect under or overpressure at the gas inlets or within the Cellbag bioreactor pH The pH is measured with optical pH sensors measurement preinstalled in Cellbag bioreactors of pHOPT type The sensor is connected to the CBCU via an optical fiber cable DO The DO level is measured with optical DO sensors measurement preinstalled in Cellbag bioreactors of DOOPT type The sensor is connected to the CBCU via an optical fiber cable ReadyToProcess Pump 25 The ReadyToProcess Pump 25 is a peristaltic unit incorporating two roller pumps for feed harvest and PH control The pump design makes tubing installation convenient and easy Tubing sizes from 0 5 mm 1 50 to 4 8 mm 3 16 internal diameter can be used to support flow rates from 0 07 to 100 mL min Flow rate is regulated by weight feedback from the scale and is controlled by automatic adjustments of the pump speed Manual adjustment of
7. 5 gives 29 0566 95 AB 3 an almost constant speed throughout the rocking cycle whereas the highest setting 100 gives a faster speed in the middle of the cycle and slower at the turning points Fig 6 A lower percent setting will give a more aggressive mixing with higher gas transfer rates A higher setting will result in a smoother wave suitable for more delicate applications such as adherent cultivation on microcarriers Rocking profile 15 10 10 Angle An Oo Ww O 0 5 1 0 1 5 2 0 2 5 3 0 Time s 20 10 10 Angular velocity s O 20 O 0 5 1 0 1 5 2 0 2 5 3 0 Time s Rocking profile 100 10 Angle n o o 10 ie 0 5 1 0 1 5 2 0 2 5 3 0 Time s 20 10 10 Angular velocity s O 20 O 0 5 1 0 1 5 2 0 2 5 3 0 Time s Fig 6 A user defined rocking motion can be selected in UNICORN system control software The wave can be aggressive or gentle with subsequent impact on mixing and gas transfer in the culture Weight measurement Load cells integrated in the rocker provide accurate and continuous weight measurement of the culture and eliminate the need for external scales The load cells communicate with the system control function for proper media handling and for tailored regulation of pH and temperature The weight measurement functionality is also used for automatic calibration of the pump in perfusion cultures Adjustable feet enables equal weight
8. GE Healthcare Life Sciences Data file 29 0566 95 AB ReadyToProcess ReadyToProcess WAVE 25 The single use ReadyToProcess WAVE 25 bioreactor system is a reliable and intuitive cell culture device for working volumes up to 25 L Fig 1 The system is based on a well known rocking technology that provides mixing and aeration to the culture which is maintained in an inflated disposable Cellbag bioreactor cultivation chamber With ReadyToProcess WAVE 25 the rocking technology is enhanced with features such as advanced sensors and intelligent control strategies System operation is easily managed via the intuitive and user friendly UNICORN system control software The system is designed for fast installation and convenient handling and delivers a reliable and accurate performance suitable for research process development and manufacturing operations ReadyToProcess WAVE 25 offers the following benefits e Robust and reliable performance e Intelligent and accurate process control e Designed for ease of use e Suitable for manufacturing in a regulated environment System benefits Robust and reliable performance ReadyToProcess WAVE 25 is designed to make hardware consumables and software work together in an integrated manner The system has been tested in real applications for reliable performance To decrease the risk for data losses the system comprises dual mirrored solid state drives for data storage Inte
9. Rocking speed control range 2 to 40 rom Rocking angle control range 2 to 12 Rocking motion control range 15 to 100 Media weight control range 0 5 to 25 kg Scale absolute accuracy 0 050 1 of load kg Temperature sensor Pt100 Class A Temperature measurement range 2 C to 50 C Temperature control range ambient temperature 5 C to 40 C Temperature control accuracy excl measurement error 0 2 C 1 When cultivating in a 50 L Cellbag bioreactor at maximum working volume of 25 L rocking speed and angle multiplied should not exceed 240 rpm degrees For example if the rocking angle is set to 12 degrees the rocking speed should not be set higher than 20 rpm ReadyToProcess CBCU Gas flow control range 50 to 1000 mL min Total gas flow accuracy reference flow setpoint 10 3 of read value mL min Fast fill flow 3 L min CO control range 0 to 15 CO CO measurement accuracy at 5 CO 0 5 CO when mixed only with air N CO control accuracy versus setpoint 0 4 CO O control range 0 to 50 O when mixed with N 21 to 50 O when mixed with air O measurement accuracy 0 6 1 of read value O within 0 to 50 O when mixed only with air N O control accuracy versus setpoint 0 6 O pH measurement range DH 4 5 to 8 5 PH control range PH 6 0 to 8 0 pH measurement accuracy 0 05 pH within 0 25 pH from offset calibration pH 0 1 pH within 0 25 to 0 5
10. d Active processes can be locked to enable unattended operations without the risk of unauthorized interference All records are stored in a single unalterable database including results and extended run documentation Additional validation support includes comprehensive documentation on control system validation as well as IQ OQ services Available validation support documentation includes e Detailed description of the development model used for UNICORN software e 21CFR Part 11 system assessment in checklist format e Audit report and 21 CFR Part 11 conclusion on functionality by an external independent expert Networking capabilities UNICORN software operates in Windows XP and Windows 7 environments and the network ability allows real time control from a remote or local computer Communication is Ethernet based and each instrument is controlled by a dedicated instrument server One database can be connected to 32 systems and up to three instruments can be controlled simultaneously from one UNICORN client Results are saved locally in the rocker during the run and then stored on the database server Because results and instructions are saved locally on the embedded drives a run can continue even in the event of a network communication failure UNICORN software can be integrated in a supervisory control and data acquisition SCADA system such as the Emerson DeltaV control system using the UNICORN OPC server 6 29 0566 95
11. e company within GE Healthcare which supplies them A copy of these terms and conditions is available on request Contact your local GE Healthcare representative for the most current information GE Healthcare UK Limited Amersham Place Little Chalfont Buckinghamshire HP7 9NA UK GE Healthcare Europe GmbH Munzinger Strasse 5 D 79111 Freiburg Germany GE Healthcare Bio Sciences Corp 800 Centennial Avenue P O Box 1327 Piscataway NJ 08855 1327 USA GE Healthcare Japan Corporation Sanken Bldg 3 25 1 Hyakunincho Shinjuku ku Tokyo 169 0073 Japan 29 0566 95 AB 09 2013
12. figuration it might be possible to cultivate below the recommended minimum volume However it is highly recommended to stay above this volume for applications that require high agitation and pH and DO control The temperature pH and DO sensors need to be submerged in liquid throughout the complete rocking cycle to function correctly System specifications System specifications are listed in Table 3 Table 3 ReadyToProcess WAVE 25 system specifications General system specifications Control system UNICORN 6 3 2 or later version Dimensions W x H x D Rocker 404 x 205 x 560 mm Tray 10 475 x 60 x 430 mm Tray 20 740 x 70 x 480 mm Tray 50 800 x 70 x 610 mm Lid 10 475 x 230 x 430 mm Lid 20 740 x 245 x 480 mm Lid 50 800 x 260 x 610 mm CBCU 276x117 x 360 mm Pump 25 275x115 x 280 mm Weight Rocker 24 0 kg Tray 10 4 5 kg Tray 20 7 3 kg Tray 50 9 5 kg Lid 10 1 7 kg Lid 20 3 3 kg Lid 50 3 9 kg CBCU 4 8 kg Pump 25 3 8 kg Power supply 100 to 240 V 50 to 60 Hz Power consumption 1500 VA Enclosure protective class IP 21 Gas supply Normal capacity Fast fill capacity External air supply 1 0 to 1 5 bar 1 3 L min 3 5 L min External CO supply 1 0 to 1 5 bar 0 2 L min 0 5 L min External O supply 1 0 to 1 5 bar 0 7 L min 1 7 L min Environmental aspects Operating ambient temperature range 15 C to 32 C Operating humidity range 20 to 80 relative humidity noncondensing ReadyToProcess WAVE 25 rocker
13. g the run for optimization to reach a new set point or to maintain a current set point Proportional integral derivative Alarms notifications and data logging The UNICORN software allows easy access to all operations data and alarm conditions A dynamic graphical user interface shows the real time status of the run while data are automatically saved From the UNICORN software the system is easily configured to trigger an alarm when certain conditions are met Individual deviation alarms can be set for all essential parameters heating gas flow CO pH and DO The regulation of alarm sensitivity and delay is defined by the user If such an alarm condition is triggered the part of the system generating the alarm is highlighted in the graphical user interface and an alarm dialog is displayed The alarm dialog displays information about the alarm such as date and time of occurrence as well as a help text describing the cause of the alarm and how to solve the problem The system is easily configured to send email notifications of alarms and errors 29 0566 95 AB 5 Regulatory readiness The ReadyToProcess WAVE 25 system is suitable for biomanufacturing of regulated products under various Quality Management Systems The use of UNICORN software in 21 CFR Part 11 and GAMP 5 compliant manner enables use of the system in a regulated environment Individual user access permissions can be set and individual users are password protecte
14. is the main unit and is used together with a tray and a disposable Cellbag bioreactor The rocker has multiple functions amongst them heating culture mixing and weight measurement The gas mixer delivers gas of a defined composition to the culture and is used together with the optical sensors of the Cellbag bioreactor for online control of culture pH and DO Liquid is delivered accurately to the culture by ReadyToProcess Pump 25 The pump unit has a flow range covering multiple applications from additions of feed and base to perfusion culturing An overview of the ReadyToProcess WAVE 25 system is shown in Figure 2 The individual components are described in detail below ReadyToProcess WAVE 25 rocker The rocker is the main hardware unit of the system and provides mixing through the rocking reliable temperature measurement from integrated sensors and accurate weight measurement from integrated load cells The ergonomic design makes handling convenient and easy The ability to handle the bioreactor in a tilt position facilitates sampling and harvest Fig 3 The minimal footprint facilitates placement when space is limited A B Fig 3 A ReadyToProcess WAVE 25 in tilt position B The ergonomic design makes activities such as sampling and harvest convenient and easy Trays and lids Trays are available in three different sizes for culturing of up to 5 L 10 L and 25 L The trays are easily attached to the rocker
15. lligent and accurate process control The system is equipped with advanced sensors and automated controllers for temperature liquid handling pH and dissolved oxygen DO The system dynamics have been methodically characterized and the results used to create a library of predefined control parameters tailored for different Fig 1 ReadyToProcess WAVE 25 bioreactor system cultivation volumes The system can automatically determine suitable parameters for a run a feature that facilitates fast start up and enables accurate and stable control Easy to use ReadyToProcess WAVE 25 system is designed for ease of use Cellbag bioreactor attachment is straightforward and system operation is conveniently managed with the UNICORN software with menus and process pictures that are easily accessible and interpretable The harvest operation is facilitated by an innovative tilt function that omits the need for heavy lifting Suitable for manufacturing in a regulated environment ReadyToProcess WAVE 25 is designed to meet the demands and standards that are required in a regulated environment The documentation is extensive and includes material certificates system specifications installation and operational qualification IQ OQ protocols and a detailed user manual The UNICORN software is suitable for use in a manner that complies with 21 CFR Part 11 and Good Automated Manufacturing Practice GAMP 5 Lid Graphical user interface
16. pH from offset calibration OH control accuracy versus setpoint 0 05 pH DO measurement range 0 to 250 air saturation 5 air saturation excl atmospheric pressure variations DO measurement accuracy DO control range 0 to 100 air saturation ReadyToProcess Pump 25 0 1 to 144 L d 0 07 to 100 mL min Pump flow rate range 0 1 5 of read value mL min after calibration Pump flow accuracy Accumulated pumped volume accuracy 10 of measured volume i d 0 5 to 4 8 mm 1 50 to 3 16 wall thickness 1 6 mm 1 16 Supported tubing dimensions Applications ReadyToProcess WAVE 25 is designed for a variety of cell culture applications involving mammalian insect and plant cells e Batch culture e Fed batch culture e Perfusion culture e Cultivation of adherent cells 29 0566 95 AB 7 Ordering information Product ReadyToProcess WAVE 25 Description Rocker ReadyToProcess CBCU pH Gas flow mix and pH ReadyToProcess CBCU DO Gas flow mix and DO ReadyToProcess CBCU Full Gas flow mix pH and DO ReadyToProcess Pump 25 Pump UNICORN 6 3 2 WrkStn pure BP Software and license UNICORN 6 3 Remote License UNICORN 6 3 Dry license Tray 10 Tray 20 Tray 50 Lid 10 Lid 20 Lid 50 Filter heater Bag sensor adaptor 2 5 m assembly Fiber cable for pH and DO control For local office contact information visit www gelifesciences com contact www gelifesciences com upstream
17. the flow rate is also possible Media handling and perfusion using calibrated pumps Calibration of pumps can be performed manually or automatically during an ongoing perfusion process Automatic calibration is possible for flow rates above 3 5 L d and is easily managed by entering the tubing diameter Automated pH control To minimize fluctuations in pH during adjustments with CO base or acid base the flow rate of the acid base pumps needs to be rigorously monitored The ReadyToProcess WAVE 25 system uses combined information from the load cells the current process pH value the pump tubing diameter and the acid base molarity for calculation of the needed flow rate during the run UNICORN software UNICORN system control software consists of four modules Administration Method Editor System Control and Evaluation A comprehensive help tool is also included Administration The Administration module is used to administer all functions of the UNICORN software Available functions include user and email setup controlling access to groups and network users defining and editing system properties database management and logging records of usage and activity Method editor Instructions to control a bioreactor run can be defined in a method The Method Editor module is used to create edit save and work with methods An existing method can be changed to simplify the editing process Individual changes can be saved for later use
18. when in the tilt position A snap lock mechanism allows Cellbag bioreactors to be correctly installed and rapidly changed Fig 4 To protect light sensitive components of the culture medium and to prolong the life of the optical sensors lids are available for all tray sizes Snap locks Fig 4 The tray has an easy lock mechanism for convenient and proper attachment of Cellbag bioreactors Temperature control Reliable efficient and evenly distributed heating is provided by the tray heater plate The temperature measurement is managed by sensors integrated in the rocker base unit Fig 5 To minimize the risk for overheating heating is only enabled when the rocker is in motion For an accurate stable and fast temperature control the heater power output is automatically adjusted based on the Cellbag bioreactor size and the media volume Temperature sensors Fig 5 Integrated temperature sensors for convenient handling and reliable temperature control Mixing and gas transfer The adjustable rocking parameters are speed angle and motion The parameter settings in combination with the cell culture volume affect the mixing and gas transfer rate in the Cellbag bioreactor The speed parameter determines the number of rocking cycles per minute and the angle parameter relates to the tray s degree of tilting at the turning points The motion parameter determines the acceleration profile The lowest motion parameter setting 1
Download Pdf Manuals
Related Search