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GE ReadyToProcess WAVE 25, Руководство по эксплуатации

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3.5

Cellbag bioreactor

Introduction

Cell cultivation is performed inside the Cellbag bioreactor. The Cellbag bioreactor is de-
livered gamma irradiated and ready for use. It is intended for single use only and should
be discarded after use.

Cellbag bioreactor options

The Cellbag bioreactors are available in different configurations, of varying sizes and
equipped with various ports. Cellbag bioreactors with internal cell retention filters are
available for perfusion culture. If required, it is possible to customize the Cellbag biore-
actors. The following bag sizes are available for ReadyToProcess WAVE 25:

•

2 L

•

10 L

•

20 L (single mode only)

•

22 L

•

50 L (single mode only)

58

ReadyToProcess WAVE 25 Operating Instructions 29009597 AD

3 System description

3.5 Cellbag bioreactor

Содержание ReadyToProcess WAVE 25

Страница 1: ...ReadyToProcess WAVE 25 Operating Instructions Original instructions ...

Страница 2: ...Page intentionally left blank ...

Страница 3: ...s DoHS 41 3 System description 42 3 1 System overview 44 3 2 ReadyToProcess WAVE 25 rocker 52 3 3 ReadyToProcess CBCU 55 3 4 ReadyToProcess Pump 25 58 3 5 Cellbag bioreactor 61 3 6 UNICORN software overview 62 3 6 1 General UNICORN operation 65 3 6 2 Administration 66 3 6 3 System control 72 3 6 4 Evaluation 73 4 Installation 74 4 1 Site preparation 75 4 1 1 Delivery and storage 76 4 1 2 Site requ...

Страница 4: ...3 1 Inflate the Cellbag bioreactor 137 5 3 2 Adjust pump parameters 138 5 3 3 Add and equilibrate culture medium 141 5 3 4 Prepare the sensors 144 5 4 Perform cultivation 145 5 4 1 Inoculate the culture 146 5 4 2 Monitor the run 148 5 4 3 End a run 150 6 Maintenance 151 6 1 Calibration 153 6 2 Cleaning 154 6 3 Cleaning before planned service 155 7 Troubleshooting 156 7 1 ReadyToProcess WAVE 25 sys...

Страница 5: ...n of safety notices and regulatory information In this chapter This chapter contains the following sections See page Section 6 1 1 About this manual 7 1 2 Important user information 9 1 3 Regulatory information 15 1 4 Important concepts 16 1 5 User documentation ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 5 1 Introduction ...

Страница 6: ...raphical conventions Software items are identified in the text by bold italic text A colon separates menu levels thus File Open refers to the Open command in the File menu Hardware controls indicators and connections are identified in the text by bold text for example Power switch Text entries that UNICORN generates or that the user must type are represented by a monospacedtypeface forexample Prog...

Страница 7: ... equipment for cell cultivation The system may not be used for clinical or diag nostic purposes Prerequisites In order to follow this manual and use the system in the intended manner it is important that you have a general understanding of how the client computer and Microsoft Win dows operating systems work you are acquainted with the use of general laboratory equipment and with handling of biolo...

Страница 8: ...s situation which if not avoided could result in minor or moderate injury It is important not to pro ceed until all stated conditions are met and clearly understood NOTICE NOTICE indicates instructions that must be followed to avoid damage to the product or other equipment Notes and tips A note is used to indicate information that is important for trouble free and optimal use of the product Note A...

Страница 9: ...information Information Requirement GE Healthcare Bio Sciences AB Name and address of manufacturer Björkgatan 30 SE 751 84 Uppsala Sweden In this section See page Section 10 1 3 1 EU Directives 11 1 3 2 Eurasian Customs Union 12 1 3 3 Regulations for USA and Canada 13 1 3 4 Other regulations and standards ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 9 1 Introduction 1 3 Regulatory inf...

Страница 10: ...ic Compatibility EMC Directive 2014 30 EU Low Voltage Directive LVD 2014 35 EU Restriction of Hazardous Substances RoHS Directive 2011 65 EU CE marking The CE marking and the corresponding EU Declaration of Conformity is valid for the in strument when it is used according to the Operating Instructions or user manuals and used in the same state as it was delivered from GE except for alterations des...

Страница 11: ...ion Requirement See Manufacturing information Name and address of manufacturer Telephone 46 771 400 600 Telephone number of manufacturer GE Healthcare LLC Importer and or company for obtain ing information about importer GE Healthcare Life Sciences Presnenskaya nab 10C 12th floor RU 123 317 Moscow Russian Federation Telephone 1 7 495 411 9714 Fax nr 7 495 739 6932 Email LSrus ge com ReadyToProcess...

Страница 12: ...n The user is cautioned that any changes or modifications not expressly approved by GE could void the user s authority to operate the equipment Note This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to part 15 of the FCC Rules These limits are designed to provide rea sonable protection against harmful interference when the equipment is operate...

Страница 13: ...surement control and laboratory use Part 1 General requirements EN 61010 1 IEC 61010 1 UL 61010 1 CAN CSA C22 2 No 61010 1 Particular requirements for laboratory equipment for the heating of materials IEC EN 61010 2 010 Electrical Equipment for Measurement Control and Laboratory Use EMC requirements Part 1 General re quirements EN 61326 1 Emission according to CISPR 11 Group 1 class A NOTICE This ...

Страница 14: ...tible with all relevant sections of FDA 21 CFR Part 11 A part 11 system assessment checklist is available on request from your local GE repre sentative 14 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 1 Introduction 1 3 Regulatory information 1 3 4 Other regulations and standards ...

Страница 15: ...he two bioreactors Dual mode Optical sensor for pH measurement Attached to pH configured Cellbag bioreactors pH sensor Control unit for gas mix pH and DO control ReadyToProcess CBCU The pump ReadyToProcess Pump 25 The rocker ReadyToProcess WAVE 25 rocker Tray for Cellbag mounted on the rocker Different tray sizes are available for different culture capacities Tray The entire bioreactor system incl...

Страница 16: ...CORN 7 0 system control functions method creation and handling together with evaluation and presentation of data ReadyToProcess WAVE 25 System Handbook Brief instructions providing an overview of how to run the system ReadyToProcess WAVE 25 Cue Card Overview and detailed description of network setup and complete software installation Administration of UNICORN and the UNICORN database UNICORN Admin...

Страница 17: ...nstalling operating or maintaining the product all users must read and understand the entire contents of this chapter to become aware of the hazards involved In this chapter This chapter contains the following sections See page Section 18 2 1 Safety precautions 26 2 2 Labels 35 2 3 Emergency procedures 38 2 4 Recycling information 39 2 5 Declaration of Hazardous Substances DoHS ReadyToProcess WAVE...

Страница 18: ...the following categories General precautions Flammable liquids and explosive environment Personal protection Installing and moving the equipment Power supply System operation Maintenance Some of the safety precautions in this chapter concern situations that are described in other manuals General precautions WARNING Do not operate the product in any other way than described in the user documentatio...

Страница 19: ...be installedand used according to the manufacturer s instructions Flammable liquids and explosive environment WARNING ReadyToProcess WAVE 25 is not designed to handle flammable liquids WARNING ReadyToProcess WAVE 25 is not approved for work in a potentially explosive atmosphere Personal protection WARNING Always use appropriate Personal Protective Equipment PPE during operation and maintenance of ...

Страница 20: ...ce for biosafety Installing and moving the equipment CAUTION Heavy object Because of the significant weight of ReadyToProcess WAVE 25 rocker assistance from another person is highly recom mended when lifting or moving the equipment Use the handles on the sides of the rocker when possible Do not lift ReadyToProcess WAVE 25 rocker with tray attached CAUTION Due to the size and weight of Tray 50 at l...

Страница 21: ...d power cords delivered or approved by GE WARNING Access to power switch and power cord with plug Do not block access to the power switch and power cord The power switch must always be easy to access The power cord with plug must always be easy to disconnect WARNING Disconnect power Always disconnect power from the equipment before connecting the ReadyToProcess WAVE 25 units to any other instrumen...

Страница 22: ...s leakage always switch off all gas supplies when the system is not in use WARNING Fire hazard O2 leakage in combination with heat may cause igni tion To avoid O2 leakages make sure that the pressure over the gas connections does not exceed 1 5 bar the gas connections are tightly secured Visually inspect the inlet tubing regularly CAUTION Only Cellbag bioreactors approved by GE for ReadyToProcess ...

Страница 23: ...ocker base and tray CAUTION Pinch hazard Be careful not to trap any fingers between the rocker platform and tray when repositioning Tray 10 from tilt posi tion Move the tray by firmly gripping both sides of the tray CAUTION Pinch hazard Moving parts in ProductName7 Do not open any pump head flip tops during operation CAUTION Falling equipment To prevent the bioreactor system units from accidentall...

Страница 24: ...wer from the instrument before performing any maintenance task WARNING Always clean the equipment in a well ventilated area Never immerse any part of the equipment in liquid or spray liquid on the equipment Always make sure that the equipment is completely dry before connecting to a mains power source Make sure to follow all environmental health and safety guidelines pertaining to the materials us...

Страница 25: ...tion weights before the power is turned off CAUTION Hazardous substances Before maintenance service and decom missioning clean the ReadyToProcess WAVE 25 system with an appropriate cleaning agent to remove any hazardous substances ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 25 2 Safety instructions 2 1 Safety precautions ...

Страница 26: ...es of labels found on various parts of the system For information about marking of the client computer equipment refer to the manufacturer s instructions In this section See page Section 27 2 2 1 Instrument labels 31 2 2 2 Safety labels 33 2 2 3 Additional labels 26 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 2 Safety instructions 2 2 Labels ...

Страница 27: ...form Filter heater label The following illustration shows an example of the label attached to the filter heater 29044471 Filter Heater Code no 29036750 Mfg Year YYYY MM Voltage 32 V DC Max Power 4 W Made in Sweden GE Healthcare Bio Sciences AB 751 84 Uppsala Sweden ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 27 2 Safety instructions 2 2 Labels 2 2 1 Instrument labels ...

Страница 28: ...nstrument label on the CBCU is located on the underside of the unit The illustration below is an example of the label attachedto a CBCU with full configuration Corresponding labels are attached to the CBCU units with alternative configurations 28 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 2 Safety instructions 2 2 Labels 2 2 1 Instrument labels ...

Страница 29: ...ed separately Please contact an authorized represen tative of the manufacturer for information concerning the de commissioning of equipment This symbol indicates that the product contains hazardous materials in excess of the limits established by the Chinese standard GB T 26572 Requirements for Concentration Limits for Certain Hazardous Substances in Electrical and Electronic Products This symbol ...

Страница 30: ... 61010 1 Electrical requirements Voltage Voltage VAC Voltage VDC Frequency Hz Max power VA Frequency Max Power Degree of protection provided by the enclosure Protection Class Year YYYY and month MM of manufacture Mfg Year CAN ICES 1 NMB 1 indicates that this product complies with the Canadian standard ICES 001 concerning technical require ments relative to radiated noise emissions from Industrial ...

Страница 31: ...hat care must be taken to avoid injury Safety labels on ReadyToProcess Pump 25 The following symbols can be found on the pump Description Label Warning Indicates a risk for fingers getting caught between moving parts in the pump and that care must be taken to avoid injury Safety labels on filter heater The following symbols can be found on the filter heater Description Label Warning Indicates a ho...

Страница 32: ...hat care must be exer cised to prevent injury LEFT indicates the left side of the tray Warning Indicates a hot surface and that care must be exer cised to prevent injury RIGHT indicates the right side of the tray 32 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 2 Safety instructions 2 2 Labels 2 2 2 Safety labels ...

Страница 33: ...of the label attached to the cellbag Illustration of DO sensor label The following image is an example of the DO sensor label attached to the cellbag next to the DO sensor ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 33 2 Safety instructions 2 2 Labels 2 2 3 Additional labels ...

Страница 34: ... attached to the optical fiber cable of the DO sensor The following image shows the label to be attached to the optical fiber cable of the pH sensor Illustration of pump head label The following image shows the label attached to the pump head The label indicates the pumping direction of the pump 34 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 2 Safety instructions 2 2 Labels 2 2 3 Add...

Страница 35: ...plug must always be easy to disconnect Emergency shutdown In an emergency situation stop the run in one of the following ways Stop the run from System Control by clicking the Stop icon if UNICORN is in control of the system Result The current run is ended and the instrument will go to Ready state indicating that it is ready for a new run or Switch off power by pressing the Power button on the rock...

Страница 36: ...shutting down the instrument Normal shutdown press the Power button once All processes are stopped The instrument is shut down immediately Forced shutdown press and hold the Power button Power failure The result of a power failure or emergency shutdown depends on which unit is affected will result in Power failure to The run is interrupted immediately The data collected before the power failure is...

Страница 37: ... same values as before the power inerruption UNICORN will ask if you want to save or discard the run data collected before the power interruption Data collection media control and regulation of pH and DO must be reinitiated manually by reconnecting to the system and starting a new run Note Uninterruptible power supply UPS A UPS can postpone power failure which allows time for a controlled shut dow...

Страница 38: ...ed according to national and local environmental regulations Recycling of hazardous substances The product contains hazardous substances Detailed information is available from your GE representative Disposal of electrical components Waste electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately Please contact an authorized representat...

Страница 39: ...riendly Use Period EFUP which indicates the period during which the hazardous substances contained in electrical and elec tronic products will not leak or mutate under normal operating conditions so that the use of such electrical and electronic products will not result in any severe environmen tal pollution any bodily injury or damage to any assets The unit of the period is Year In order to maint...

Страница 40: ...在GB T26572规定的限量要求以下 X 表示该有害物质至少在该部件的某一均质材料中的含量超出 GB T 26572规定的限量要 求 此表所列数据为发布时所能获得的最佳信息 0 Indicates that this hazardous substance contained in all of the homogeneous materials for this part is below the limit requirement in GB T 26572 X Indicates that this hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirement in GB T 26572 Data...

Страница 41: ...WAVE 25 System Handbook In this chapter This chapter contains the following sections See page Section 42 3 1 System overview 44 3 2 ReadyToProcess WAVE 25 rocker 52 3 3 ReadyToProcess CBCU 55 3 4 ReadyToProcess Pump 25 58 3 5 Cellbag bioreactor 61 3 6 UNICORN software overview ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 41 3 System description ...

Страница 42: ...as flow and gas mixing possibilities In single mode the system supports culture in one Cellbag bioreactor at one time The rocker is connected to one ReadyToProcess CBCU and up to three ReadyToProcess Pump 25 units In dual mode the system supports culture in two Cellbag bioreactors placed on the same tray The rocker is connected to up to two ReadyToProcess CBCU units and up to three ReadyToProcess ...

Страница 43: ... two Cellbag bioreactors independently Both single and dual modes can support up to three ReadyToProcess Pump 25 units 1 4 3 2 5 8 7 6 Description Part Hatch 1 Filter heater 2 Cellbag bioreactor 3 ReadyToProcess Pump 25 4 ReadyToProcess CBCU 5 ReadyToProcess WAVE 25 rocker 6 Tray 7 Lid 8 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 43 3 System description 3 1 System overview ...

Страница 44: ...ag bioreactors in dual mode The rocker also contains an embedded microprocessor which allows the system to be controlled independently of the performance of the connected network and client computer For specifications of the rocker refer to the ReadyToProcess WAVE 25 System Handbook or the data file for ReadyToProcess WAVE 25 available for download from www gelifesciences com wave Front view of th...

Страница 45: ...iption Image Light indicator The power is OFF No light The rocker is starting up Green flashing light The power is ON and the rocker is opera tional Green steady light The rocker failed to connect to other components in the system Red flashing light Indicates an error of the rocker Red steady light ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 45 3 System description 3 2 ReadyToProcess...

Страница 46: ...The illustration below shows the rear panel of the rocker 1 2 4 3 5 6 7 Description Part 15 pin D sub connector used for digital and analog I O signals 1 Filter heater connectors 2 Tray connector 3 UniNet 9 ports 4 USB ports 5 Ethernet connector 6 Power connector Note The rocker is fitted with internal electrical fuses that are not user replaceable 7 46 ReadyToProcess WAVE 25 Operating Instruction...

Страница 47: ...ion below shows the rocker with Tray 50 attached 1 2 3 4 Description Part Bag clamp upper 1 Bag clamp opener one in each upper corner 2 Bag clamp opener one in each lower corner 3 Bag clamp lower 4 The illustration below shows the rocker with Tray 50 and Lid 50 mounted ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 47 3 System description 3 2 ReadyToProcess WAVE 25 rocker ...

Страница 48: ...5 4 3 2 1 Description Part Rocker base 1 Lid 2 Tray 3 Tubing exit 4 Hatch 5 48 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 3 System description 3 2 ReadyToProcess WAVE 25 rocker ...

Страница 49: ...ng and after cell cultivation it is possible to position the tray with the attached Cellbag bioreac tor s into an upright position called tilt position Follow the instructions below to put the tray into tilt position The tray is shown without attached Cellbag bioreactor in the images below NOTICE Take care when tilting the rocker tray with full Cellbag bioreactor s attached Action Step Prepare for...

Страница 50: ...you 2 The illustration below shows the tilt position Filter heater The filter heater prevents condensation and clogging of the outlet vent filter on the Cellbag bioreactor 1 2 3 50 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 3 System description 3 2 ReadyToProcess WAVE 25 rocker ...

Страница 51: ...iption Part Filter heater 1 Connector for connection to the rocker 2 Filter heater stand 3 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 51 3 System description 3 2 ReadyToProcess WAVE 25 rocker ...

Страница 52: ...d pH ReadyToProcess CBCU DO CO2 O2 and DO ReadyToProcess CBCU Full CO2 O2 pH and DO For specifications of the CBCU refer to the ReadyToProcess WAVE 25 System Handbook or the data file for ReadyToProcess WAVE 25 available for download from www gelifesciences com wave Front view of ReadyToProcess CBCU The illustration below shows the front panel of a fully configured CBCU The configuration of your C...

Страница 53: ...ollowing table Description Light indicator The CBCU is ready for operation Steady green light The CBCU is operating Green flashing light Indicates an internal error but the CBCU is still operating Red flashing light Indicates an internal error and the CBCU is not operating Steady red light Rear view of ReadyToProcess CBCU The illustration below shows the rear panel of a fully configured CBCU 1 2 3...

Страница 54: ...d always be set to position 1 for use in single mode For dual mode set the CAN ID to 1 for the CBCU connected to the left Cellbag bioreactor and to 2 for the CBCU connected to the right Cellbag bioreactor Tubing and connectors Tubing and connectors for gas flow as listed below are delivered with the ReadyToProcess CBCU Tubing and connectors for liquid flow must be obtained separately Tubing Length...

Страница 55: ...cifications of the pump refer to the ReadyToProcess WAVE 25 System Handbook or the data file for ReadyToProcess WAVE 25 available for download from www gelifesciences com wave Front view of the pump The illustration below shows the front panel of the pump 1 2 3 Description Part Pump head flip top 1 Pump head 2 Status LEDs for pumping function per pump head 3 ReadyToProcess WAVE 25 Operating Instru...

Страница 56: ...shing light Indicates an internal error and the pump is not operating properly Steady red light Rear view of the pump The illustration below shows the rear panel of the pump 3 2 1 Description Component Part Power connection to the rocker UniNet 9 port 1 Indicates system connection status CAN indicator LED 2 Shows the unit number of the pump for recognition by the system CAN ID switch 3 56 ReadyToP...

Страница 57: ... panel see illustration above The switch has four CAN ID positions marked 1 2 3 and 4 respectively The CAN ID should be set to position 1 for the first pump position 2 for the second pump and so on The pumps are identified in UNICORN by their CAN ID Label each pump unit with its CAN ID to simplify identification of the physical pump Tip ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 57 ...

Страница 58: ...actors are available in different configurations of varying sizes and equipped with various ports Cellbag bioreactors with internal cell retention filters are available for perfusion culture If required it is possible to customize the Cellbag biore actors The following bag sizes are available for ReadyToProcess WAVE 25 2 L 10 L 20 L single mode only 22 L 50 L single mode only 58 ReadyToProcess WAV...

Страница 59: ...erside of the bag 1 Outlet vent filter with pressure control valve 2 Inlet vent filter 3 Addition port 4 DO bag sensor port located on the underside of the bag 5 Cellbag rod 6 Clave sampling port 7 Addition port 8 Addition harvest port 9 The inlet and outlet vent filters are distinguished by the pressure control valve on the outlet filter Note ReadyToProcess WAVE 25 Operating Instructions 29009597...

Страница 60: ...eactor The actual sensor white yellow for pH pink black for DO is located in the center 1 of the sensor port see image below Bag sensor port The sensor adapter is attached to the sensor port by the four pins 2 1 2 The sensor adapter is located at one end of an optical fiber cable The optical lens of the fiber cable is located in the center of the sensor adapter The fiber cable is connected to a se...

Страница 61: ...ss the help utility that is included in UNICORN This section contains the following subsections See page Section 62 3 6 1 General UNICORN operation 65 3 6 2 Administration 66 3 6 3 System control 72 3 6 4 Evaluation Software illustrations in these instructions are examples and may differ from your software in some details Note ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 61 3 System d...

Страница 62: ...s Evaluation Perform user and system setup system log and database administration Administration Create and edit methods Method Editor Enter a UNICORN module To enter a module click the Taskbar button of the module of interest or choose the module of interest in the Tools menu in any of the other software modules The illustration below shows the Tools menu of the Evaluation module 62 ReadyToProces...

Страница 63: ...ble of contents pane expand the headings of interest to navigate the content structure click the heading of interest to open a section navigate the online help select Help Help for in any of the UNICORN modules see illustration above in the Search pane enter the term of interest in the input field click the Search button search for a specific term in the online help select Help Help for in any of ...

Страница 64: ...e Text instruction pane press the F1 key In the System Control module select Manual Execute Manual Instructions expand a heading and select the instruction of interest press the F1 key or click the Help icon in the dialog 64 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 3 System description 3 6 UNICORN software overview 3 6 1 General UNICORN operation ...

Страница 65: ...ss to UNICORN Access Groups and Network Users is used to manage access groups and network users E mail Setup is used to set up an e mail account for automated system messages UNICORN and System Log provides the system administrator with records of usage and activity System Properties is used to define the system and edit system properties Database Management is used for maintenance of the database...

Страница 66: ...run data can be displayed either as separate tabs or as docked panes in the same window Refer to Section 5 4 Perform cultivation on page 144 for information on how to perform a run To get more information than is shown in the Process Picture select View Run Data to open the Run Data pane which presents current data in numerical values Tip Items in the process picture reflect the components include...

Страница 67: ...e shown on the left and right sides of the tray in the process picture To avoid confusion place the physical CBCU units on the left and right sides of the tray as viewed from the front of the rocker Connections between the Cellbag bioreactor s and the respective monitor and active control units are indicated by connection lines in the process picture Pump units are identified in the process pictur...

Страница 68: ...he Process Picture pane in the following ways then If you want to Hold the cursor over the right hand side of the button and turn Reading and or Control on or off as required You can only switch the Control setting if Reading is on and you cannot turn Reading off if Control is on Activate or deactivate pH and DO measure ment and control Click on the right hand side of the button The text on the bu...

Страница 69: ...on The example below shows the settings for dissolved oxy gen DO Enter appropriate values in the Settings dialog and click OK or press enter Adjust the settings ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 69 3 System description 3 6 UNICORN software overview 3 6 3 System control ...

Страница 70: ...n structions for each category The instructions in each category differ depend ing on the instrument configuration 2 Select settings and choose parameter values for the selected instruction Click OK Settings will apply until they are changed 3 To return to the default values defined in the instrument configuration click Set Parameters To Strategy Default Values 4 Manual instructions It is possible...

Страница 71: ...t an instruction and click Insert Repeat for several instructions Note To update parameter fields during run check the Auto update box 3 To perform the instructions click Execute 4 Run data The Run Data pane shows the current values of some parameters for example rocking motion and accumulated time To change the Run Data display select View Run Data right click in the Run Data pane and select Run ...

Страница 72: ...e results from bioreactor runs Evaluation is described in detail in the ReadyToProcess WAVE 25 System Handbook and UNICORN Online Help 72 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 3 System description 3 6 UNICORN software overview 3 6 4 Evaluation ...

Страница 73: ...he rocker contains load cells for weight measurements and should be handled with extra care Do not place the rocker on any parts that may move Avoid exposing the load cells to lateral forces such as pushing the unit sideways on the bench which may cause dis turbances in the measurement or damage the load cells In this chapter This chapter contains the following sections See page Section 74 4 1 Sit...

Страница 74: ...E 25 The purpose is to provide planners and technical staff with the data needed to prepare the laboratory for the installation In this section See page Section 75 4 1 1 Delivery and storage 76 4 1 2 Site requirements 81 4 1 3 Client computer specifications 74 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 4 Installation 4 1 Site preparation ...

Страница 75: ...a protected location indoors Storage requirements The delivery boxes should be stored in a protected location indoors The following storage requirements must be fulfilled for the unopened boxes Allowed range Parameter 25 C to 50 C Ambient temperature storage 5 to 95 non condensing Humidity storage ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 75 4 Installation 4 1 Site preparation 4 1 ...

Страница 76: ...eight reading The bench must be able to support the total weight of the system including the filled Cellbag bioreactor See Equipment dimensions and weight on page 78 If other op tional instruments are installed their weights must also be included Do not place soft material paper sheets or similar under the system as this may block the ventilation inlet WARNING Access to power cord Do not block acc...

Страница 77: ...peration in single mode Illustration of system setup dual mode In dual mode place the ReadyToProcess CBCU and ReadyToProcess Pump 25 units on either side of the rocker to correspond with the L and R designations in the software ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 77 4 Installation 4 1 Site preparation 4 1 2 Site requirements ...

Страница 78: ...ollowing general requirements must be fulfilled The room must have forced ventilation adapted for use of CO2 O2 and N2 The system units should not be exposed to sources of heat such as direct sunlight The installation site must comply with the following specifications Environmental requirements Requirement Parameter Indoor use only Allowed location 15 C to 32 C Ambient temperature operation 20 to ...

Страница 79: ...ameter 100 to 120 V AC 10 Supply voltage 200 to 240 V AC 10 50 60 Hz Frequency Overvoltage category II Transient overvoltages 1500 VA Max power EU or US plug outlet fused or protected by equivalent circuit breaker UK mains cable available on request Mains connection 2 m Extension cables may be used if re quired Length of mains cable WARNING Protective ground The product must always be connected to...

Страница 80: ...pump Gas supply The table below lists the gas supply required for each installed CBCU Flow L min Fast fill mode Flow L min Normal mode Pressure bar Gas 3 5 1 3 1 0 to 1 5 Compressedair N2 0 5 0 2 1 0 to 1 5 CO2 1 7 0 7 1 0 to 1 5 O2 80 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 4 Installation 4 1 Site preparation 4 1 2 Site requirements ...

Страница 81: ...stallation Database Server UNICORN Client 500 MB 12 GB 6 GB 6 GB Min free disk space 2 GB 3 GB 3 GB 3 GB Min availableRAM NTFS NTFS NTFS NTFS Disc format Intel Dual Core or faster Intel Dual Core or faster Intel Dual Core or faster Intel Dual Core or faster Architecture Note UNICORN is tested using the English U S Code 1033 operating system language version Using other language versions of the ope...

Страница 82: ...dows 7 feature High DPI Aware ness which allows the graphic user interface to be scaled The interface scale must remain at 100 to avoid issues with clipping and misaligning of parts of the UNICORN user interface Normally the scale is set at 100 by default 82 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 4 Installation 4 1 Site preparation 4 1 3 Client computer specifications ...

Страница 83: ...ibes the installation procedure for ReadyToProcess WAVE 25 In this section See page Section 84 4 2 1 Unpack the system units 86 4 2 2 Connect the system components ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 83 4 Installation 4 2 Hardware installation ...

Страница 84: ...er has a scale function load cells and should therefore be handled with extra care The rocker shall not be placed on any parts that may move Avoid exposing the load cells to lateral forces such as pushing it sideways on the bench which may cause distur bances in the measurement or damage the load cells CAUTION Heavy object Because of the significant weight of ReadyToProcess WAVE 25 rocker assistan...

Страница 85: ...e client computer s network card that is connected to the rocker should have the static IP 192 168 1 3 Refer to UNICORN Administration and Technical manual Appendix D for instructions on how to change these settings NOTICE Any computerused with the equipmentshall comply with IEC 60950 and be installed and used according to the manufacturer s instruc tions ReadyToProcess WAVE 25 Operating Instructi...

Страница 86: ...nel of the rocker Action Step Connect the ReadyToProcess CBCU unit s to the rocker 1 1 Connect the supplied UniNet cable between the UniNet 9 port on the CBCU rear panel see Rear view of ReadyToProcess CBCU on page 53 and the first available UniNet 9 port on the rocker rear panel Up to two ReadyToProcess CBCU units are used for operation in dual mode 2 For single mode set the CAN ID switch on the ...

Страница 87: ... mode one connected to each filter heater port Note The filter heater connector snaps into place in the socket to prevent it from being disconnected by a sudden pull To release the connector pull the con nector sleeve away from the socket Jumpers Insert jumpers into any unused UniNet 9 ports on the rocker Jumpers are provided with the system Connect to network or computer The system can be connect...

Страница 88: ...ins power Action Step Connect the supplied power cord between the power inlet on the rear panel of the rocker and a grounded power outlet 1 Follow the manufacturer s instruction to connect power to computer monitor and local printer if used 2 Prepare gas tubing Tubing for gas connections Tygon E3603 and silicone see Tubing and connectors on page 54 is supplied with the ReadyToProcess CBCU For gas ...

Страница 89: ...he gas mix sources to the CBCU 1 Insert a CPC tubing connector into one end of each piece 2 For the tubing used to connect the CBCU to the Cellbag bioreactor connect the end without the CPC connector to the silicone tubing using the supplied reducer connector 3 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 89 4 Installation 4 2 Hardware installation 4 2 2 Connect the system components ...

Страница 90: ...installations when you want to access the ReadyToProcess WAVE 25 system from several client computers or control more than one system from a single computer or to run the system from a third party controller Note Additional information about software installation and configuration is available in the UNICORN Administration and Technical manual In this section See page Section 91 4 3 1 Install UNIC...

Страница 91: ...orize that the UNICORN software installation is properly licensed License server For general technical specifications for UNICORN 7 0 computers refer to Sec tion 4 1 3 Client computer specifications on page 81 Note Installation procedure Action Step Insert the installation disk into your DVD drive 1 If the installation program does not start automatically open the DVD in Windows Explorer and doubl...

Страница 92: ...ll be com pleted correctly Destination folder Select data storage locations for backup and archive storage Data storage The backup folder is used for back up copies of the database automatically taken every night Backup material can be recov ered to any UNICORN cell cultivation database The archive folder is used to move old data and recover space in the database Archived material can only be retr...

Страница 93: ...ow Report to view an installation summary report Before the system can be used you will need to configure an e license and define a system These functions are accessed from the Configure eLicense and Define System buttons in the Installation completed dialog and are described in the following sections in this chapter ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 93 4 Installation 4 3 S...

Страница 94: ... used on any workstation in a network Remote license A dry license is a floating license that can be used on any computer in a network for all functionality except connecting to an instrument Dry license Before you start Access Code Before you can retrieve an e license from the GE software e licensing web site you must have received an Access Code with your software or via courier mail Without thi...

Страница 95: ...nnect to the instrument 2 Make a note of the Physical Address Note The physical address is a 6 digit hexadecimal number with the digits sepa rated by hyphens e g F0 1F AF 3E 42 1A You can omit the hyphens if you wish 3 Tip If you type the address into a text editor or similar program you can copy it the the Windows clipboard you cannot copy text from the Command Prompt window 1 In Windows XP click...

Страница 96: ... cards in the computer follow the steps described in Computer Ethernet address on page 95 to find the correct address Do not click Copy to Clipboard Note When activating additional licenses always use the Ethernet address for the network card on the computer where the license server software is in stalled Do not use the Ethernet addresses on additional client computers 96 ReadyToProcess WAVE 25 Op...

Страница 97: ...Healthcare software elicensing web site opens in your web browser Enter your access code see Access Code on page 94 and click Login 3 Result The Operations Portal opens ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 97 4 Installation 4 3 Software installation 4 3 2 Configure an e license ...

Страница 98: ... Enter the data requested Items marked with a red dot are mandatory If for some reason the e license cannot be saved to a file during the configuration select the option Ship to Email or Ship to Address Nor mally this will not be necessary Check whether you want to receive software updates and information about related products Click the Next button to proceed to the next page 3 Click Add New Host...

Страница 99: ...o proceed Check that the information displayed in the manage entitlements page is correct then click Generate 6 Result The License summary page opens On the License summary page select the check box for your license and click Save to File 7 Save the license file in a safe location Click Complete and Logout to close the software e licensing web site 8 ReadyToProcess WAVE 25 Operating Instructions 2...

Страница 100: ...ick Open to transfer the search path to the file into the e License Configuration dialog Click the Configure e License button 2 Result A confirmation dialog opens showing that the configuration has been successful Click OK in the confirmationdialog then close the Configure e License dialog 3 100 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 4 Installation 4 3 Software installation 4 3 ...

Страница 101: ...figuration dropdown menu Tip The list includes all instrument configurations currently in the UNICORN database If your configuration is not included Insert the instrument configuration disk in your DVD ROM drive Click the Import button and navigate to the configuration zip file on the disk Select the appropriate configuration file The Define System dialog changes and the Connect by option differs ...

Страница 102: ...owered on and connected to the client computer 2 Click the Connection Test button Result The connection between the instrument server station and the instru ment is verified 5 Click the Define System button 6 Result The system definition settings are saved and the new system is added in the System Properties dialog as an active system It is recommended that you restart the rocker before the system...

Страница 103: ... WAVE 25 In this chapter This chapter contains the following sections See page Section 104 5 1 Set up the system 123 5 2 Start and configure the system 135 5 3 Prepare for cultivation 144 5 4 Perform cultivation ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 103 5 Operation ...

Страница 104: ...pter 3 System description on page41 In this section See page Section 105 5 1 1 Select the tray and Cellbag bioreactor 106 5 1 2 Attach and detach tray 109 5 1 3 Prepare pH and DO sensors 112 5 1 4 Attach the Cellbag bioreactor 114 5 1 5 Prepare the pump 119 5 1 6 Connect gas to the system 104 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 5 Operation 5 1 Set up the system ...

Страница 105: ...0 50 5 to 25 To use a 20 L or 50 L Cellbag bioreactor the system must be configured for single mode Note Depending on application and configuration 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 ...

Страница 106: ...ns are recommended for installing the tray Attach tray The tray can be attached to the rocker platform in tilt position and in normal position Tilt position is recommended as described in the instructions below Action Step Tilt the rocker platform by pulling the upper edge towards you 1 Lift the tray into the same angle as the rocker platform 2 106 ReadyToProcess WAVE 25 Operating Instructions 290...

Страница 107: ...t the lower pins engage with the respec tive holes Note Make sure that the holes for the temperature sensors on the rocker platform fit into the holes in the tray 3 Make sure that the connector on the tray is plugged into the tray connector on the back of the rocker platform 4 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 107 5 Operation 5 1 Set up the system 5 1 2 Attach and detach tr...

Страница 108: ...e of the tray and slide it upwards so that the attachment pins on the tray disengage from the holes in the rocker platform 1 Pull the tray towards you 2 Note If the tray is detached with the rocker in normal position you will need to lift the tray by the upper edge before sliding it away from you 108 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 5 Operation 5 1 Set up the system 5 1 2 ...

Страница 109: ... respectively Action Step Remove the Cellbag bioreactor from its protective cover bag 1 NOTICE Exposure to intense light will cause deterioration of the optical sensors on the Cellbag bioreactor To avoid unnecessary light exposure remove the protective cover bag just prior to use Place the Cellbag bioreactor on a steady surface with the bag sensor ports facing upwards 2 The optical sensor spots ha...

Страница 110: ...ogonal directions Select the most convenient direction Rotate the sensor adapter clockwise to fix the pins on the sensor port to the adapter A distinct click will indicate that the adapter is securely fastened 4 Note When rotating the sensor adapter make sure not to exert any force on the fiber cable 110 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 5 Operation 5 1 Set up the system 5 ...

Страница 111: ...track of the optical fiber cables mark the cables with the supplied stickers 6 Bundle the optical fiber cables on one side of the tray Fit the lid and make sure the tubing and cables are placed in the tubing exit See Illustrations of tray and lid on page 47 7 Connect the pH sensor cable to the pH port on the CBCU front panel 8 Connect the DO sensor cable to the DO port on the CBCU front panel 9 Re...

Страница 112: ...ting pad Weight measurement resolution will be compromised if the bioreactor is not correctly placed Note Action Step Push the bag clamp openers in the upper corners of the tray downwards This opens the upper bag clamps Note For a Cellbag bioreactor that covers the whole tray open both bag clamps In dual mode or with a bioreactor that covers only half the tray only one clamp needs to be opened 1 I...

Страница 113: ...Repeat the above steps to attach the lower Cellbag rod to completely secure the Cellbag bioreactor on the tray 4 Mount the lid on top of the tray 5 NOTICE Keep the Cellbag bioreactor covered with the lid throughout the cultivation to protect the optical sen sors from excessive light exposure ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 113 5 Operation 5 1 Set up the system 5 1 4 Attac...

Страница 114: ...sition for large tubing Inner position for small tubing Pump tubing sizes The table below lists tubing sizes supported by ReadyToProcess Pump 25 with the range of flow rates provided by each size The wall thickness of the tubing should be 1 6 mm 1 16 Pump tubing is not supplied with the system Suitable tubing must be pur chased separately Note 114 ReadyToProcess WAVE 25 Operating Instructions 2900...

Страница 115: ...d tubing life Using smaller tubing with the tubing holder in its outer position will not secure the tubing correctly and may lead to rupture Adjust tubing holder position Use a pointed tool such as a ball pen to adjust the tubing holder positions on both sides of the pump head Follow the instructions below to change the tubing holder position Action Step Make sure that the pump is not running 1 Op...

Страница 116: ...sition is the same on both sides of the pump head NOTICE Make sure that the tubing holder position is not caught in between the inner or outer position as this may cause erroneous flow rates and abnormal tube wear Load tubing Follow the instructions below to load tubing in the pump head and connect tubing to the Cellbag bioreactor Action Step Make sure that the pump is switched off 1 116 ReadyToPr...

Страница 117: ...d to the correct position for your size of tubing See instructions above 3 Place the tubing between the rotor rollers and the track pressed against the inner wall of the pump head 4 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 117 5 Operation 5 1 Set up the system 5 1 5 Prepare the pump ...

Страница 118: ...nect inlet and outlet tubing to the Cellbag bioreactor for example acid base feed and harvest 6 The pumping direction is indicated by the arrow on the pump head Note 118 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 5 Operation 5 1 Set up the system 5 1 5 Prepare the pump ...

Страница 119: ... N2 is connected to AIR N2 on the CBCU CO2 and O2 are connected to CO2 IN and O2 IN respectively on the CBCU rear panel NOTICE In dual mode be careful to connect the air and gas for the left and right Cellbag bioreactors to the correct CBCU This is easier if the respective CBCU units are placed on the left and right sides of the rocker respectively ReadyToProcess WAVE 25 Operating Instructions 290...

Страница 120: ...ect to the left and right bioreactors Note The inlet and outlet vent filters are distinguished by the pressure control valve on the outlet filter indicated by an arrow in the illustration below Do not at tach the filter heater to the inlet vent filter 1 The image below shows the filter heater mounted on the stand on the Cellbag bioreactor 120 ReadyToProcess WAVE 25 Operating Instructions 29009597 ...

Страница 121: ...t 1 0 to 1 5 bar to AIR N2 on the CBCU rear panel 3 If applicable connect the CO2 gas source at 1 0 to 1 5 bar to CO2 IN on the CBCU rear panel 4 If applicable connect the O2 gas source at at 1 0 to 1 5 bar to O2 IN on the CBCU rear panel 5 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 121 5 Operation 5 1 Set up the system 5 1 6 Connect gas to the system ...

Страница 122: ...5 bar Excessive pressure may cause internal tubing to loosen NOTICE An unsteady inlet pressure will affect the speed of the gas flow and also the gas mix 122 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 5 Operation 5 1 Set up the system 5 1 6 Connect gas to the system ...

Страница 123: ...configure the system in the software In this section See page Section 124 5 2 1 Start the system and log on to UNICORN 125 5 2 2 Connect to the system 127 5 2 3 Configure system properties 129 5 2 4 Configure system settings 131 5 2 5 Start a run ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 123 5 Operation 5 2 Start and configure the system ...

Страница 124: ...NICORN Access cre dentials are assigned by your UNICORN administrator According to the properties of your user account you may be able to select an Access Group 3 Note If Use Windows Authentication is checked you may log on using your Win dows username and password Press the Power switch to start the rocker 4 Result The Power button flashes green during start up and then lights steadily when the r...

Страница 125: ...indicator light on the rocker front panel shows a steady green light click the Connect to Systems icon in the System Control module Result The Connect to Systems dialog opens 1 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 125 5 Operation 5 2 Start and configure the system 5 2 2 Connect to the system ...

Страница 126: ... The detailed appearance of the process picture will vary according to your system setup Tip If UNICORN is unable to connect to the selected system see Section 7 5 UNICORN System Control on page 163 126 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 5 Operation 5 2 Start and configure the system 5 2 2 Connect to the system ...

Страница 127: ...DVD with the system and is also available for download Contact your GE rep resentative if you need help to download the Instrument Configuration Follow the instructions below to edit the system properties Action Step Open the Administration module in the Tools menu 1 Click System Properties Select your system in the System Properties dialog and click Edit Note Only systems that are switched on and...

Страница 128: ...heck boxes to select or de select components Make sure the components selected match the units connected to the system Click OK to apply the changes 4 128 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 5 Operation 5 2 Start and configure the system 5 2 3 Configure system properties ...

Страница 129: ...and or DO sensors should be reset at the end of the run whether rocking gas mix and temperature control should be resumed on restart after power loss whether voltage or current should be used for analog inputs Follow the instructions below to assign pump roles See System settings on page 70 for general instructions on how to configure the system settings Action Step Select System Settings in the S...

Страница 130: ...ase L to separate pump heads for the left Cellbag bioreactor and Acid R and Base R to separate pump heads for the right bioreactor For media addition in dual mode assign Feed1 L to a pump head for the left Cellbag bioreactor and Feed1 R to a pump head for the right biore actor A given pump role cannot be assigned to more than one pump head If a role that is already assigned to a pump head is given...

Страница 131: ...rts For further information on methods refer to ReadyToProcess WAVE 25 System Handbook Pressing the Power button on the rocker while the rocker is switched on will shut down the system and stop any ongoing run Note ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 131 5 Operation 5 2 Start and configure the system 5 2 5 Start a run ...

Страница 132: ...ioreactors 1 1 Click the Cellbag icon In dual mode click the appropriate side of the icon 2 If pH and or DO control will be used enter the appropriate calibration data printed on the Cellbag label 3 Click OK Result The Start Protocol dialog for the manual run opens 132 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 5 Operation 5 2 Start and configure the system 5 2 5 Start a run ...

Страница 133: ...structions below to start a method run The system can be controlled manually from the Process Picture after the method run has been started Tip Action Step Open the System Control moduleand clickthe icon Open Method Navigator 1 Result The Method Navigator pane opens Select the method to run and click the Run icon 2 Result The Start Protocol dialog for the method run opens ReadyToProcess WAVE 25 Op...

Страница 134: ...g and data logging and an acoustic end signal sounds and End is displayed in the Run Log This also applies when ending a manual run then If you want to click the Hold icon temporarily hold the method Note When a method is put on hold the system control is maintained but no new instructions are given click the Continue icon resume a method run Note An ended method cannot be continued click the End ...

Страница 135: ...tions of the system refer to Chapter 3 System description on page 41 In this section See page Section 136 5 3 1 Inflate the Cellbag bioreactor 137 5 3 2 Adjust pump parameters 138 5 3 3 Add and equilibrate culture medium 141 5 3 4 Prepare the sensors ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 135 5 Operation 5 3 Prepare for cultivation ...

Страница 136: ... flow from the Process Picture in System Control 2 Enable Fast fill This will maximize the gas flow during the first 20 minutes Note Fast fill is disabled in the illustration below 3 Turn on Gas flow from the Process Picture by pressing the right hand side of the Gas flow button 4 Result The Cellbag is inflated 136 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 5 Operation 5 3 Prepare f...

Страница 137: ...acid base control is tuned with NaOH and HCl If you are using acid or base with a different pK value you should set the Molarity parameter to the equivalent molarity of NaOH or HCl for optimal pH control If you are preparing a perfusion cultivation enable auto calibration or cali brate the feed and harvest pumps to reach optimal precision 2 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD...

Страница 138: ... below to tare the scale Action Step Set the rocker stop angle to 0 and check that the tray is in a horizontal po sition 1 Open Settings Weight from the Process Picture in System Control 2 In dual mode the weights of the two bioreactors are displayed separately Check that the weight distribution is even by reading the weight percentage values for the rocker feet The values should not differ more t...

Страница 139: ...olume of medium into the Cellbag bioreactor using a pump or gravity flow Tip To automatically fill the bag to a desired weight use Media Addition from Settings Media control in the Process Picture 2 Check if there are visible gas bubbles on the optical sensors See pH reading and DO reading respectively in Section 7 3 ReadyToProcess CBCU on page 161 for advice on how to remove bubbles Note Such bub...

Страница 140: ...esired gas flow in Settings Gas control Gas flow in the Process Picture Start the gas flow by clicking the right hand side of the Gas flow button 2 If applicable turn on CO2 mixing by clicking the right hand side of the CO2 button in the Process Picture 3 Set the required temperature setpoint 4 Click the right hand side of the Temp button to start heating 5 Equilibrate the medium for at least 2 ho...

Страница 141: ...tion and disturb the weight measurement Prepare the DO sensor Follow the instructions below to prepare the DO sensor In dual mode adjust the sensor calibration on each Cellbag bioreactor sepa rately Note Action Step When the medium is equilibrated to operating conditions move the cursor over the DO sensor icon in the Process Picture and set Reading On in the menu that appears 1 Wait until the valu...

Страница 142: ...et in Settings Rock ing Sampling Pause and at an angle set in Settings Rocking Sampling Stop angle in the Process Picture Take a sample to verify that the pH value shown by the system matches the pH measured with a calibrated reference instrument If the deviation is larger than approximately 0 5 pH units make sure that no air bubble is present 3 For instructions on how to remove air bubbles see tr...

Страница 143: ...0 Enter the desired values for Control and Setpoint Check the Deviation Alarm and set the alarm limits if desired 11 Click OK 12 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 143 5 Operation 5 3 Prepare for cultivation 5 3 4 Prepare the sensors ...

Страница 144: ...vation During the cultivation key parameters are monitored and the settings can be adjusted In this section See page Section 145 5 4 1 Inoculate the culture 146 5 4 2 Monitor the run 148 5 4 3 End a run 144 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 5 Operation 5 4 Perform cultivation ...

Страница 145: ...g connected to the inoculum container are clamped 1 Using sterile techniques connect tubing from the inoculum container to the inlet tubing using e g tube fusing equipment or a ReadyMate connector 2 Unclamp the inlet tubing and inoculum container tubing 3 Transfer the desired volume of inoculum into the bag using a pump or gravity flow 4 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 14...

Страница 146: ...cture The Process Picture displays the real time process parameters during a run and can be used to control the run An example of the Process Picture is shown in the illustration below Details vary according to the system configuration The button colors indicate the current state of the respective function as shown in the table below 146 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 5 ...

Страница 147: ...he function needs attention Click on the button to open the related settings and to see more information Orange The function is not working properly Click on the button to open the related settings and to see an explanation of the problem Red ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 147 5 Operation 5 4 Perform cultivation 5 4 2 Monitor the run ...

Страница 148: ...on 3 Connect tubing from the Cellbag bioreactor to the harvest vessel 4 Empty the Cellbag bioreactor using a pump or gravity flow 5 Disconnect the tubing from the Cellbag bioreactor to the harvest vessel 6 Procedures after harvest Follow the instructions below when the cultivation is finished and the culture is harvested Action Step Clamp off the inlet and outlet vent filters of the Cellbag biorea...

Страница 149: ...n Step Disconnect the software from the system in UNICORN 1 Press the power button on the rocker front panel The light flashes green while shutting down Note If the rocker fails to shut down keep the power button pressed in more than 4 seconds to force a shutdown 2 Clean the bioreactor system units 3 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 149 5 Operation 5 4 Perform cultivation ...

Страница 150: ...r in UNICORN keeps track of the usage of different components and shows alerts when it is time for maintenance and service For detailed information about the maintenancemanager refer to UNICORN Administration and Technical manual In this chapter This chapter contains the following sections See page Section 151 6 1 Calibration 153 6 2 Cleaning 154 6 3 Cleaning before planned service 150 ReadyToProc...

Страница 151: ...justment during cultivation if required When required Perform the following calibrations when required or at least once a year Instruction Calibration Contact GE service personnel for assistance if needed Note Scale calibration is recommended after moving the rocker or when the load is changed considerably For Calibrate High point use a weight that is as close as possible to the load that will be ...

Страница 152: ...n Step Select System Calibrate in System Control 1 Result The Calibration dialog opens Select the appropriate monitor in the Monitor to calibrate drop down menu 2 Follow the instructions in the right hand field and enter the correct values in the Calibration procedure field and click Calibrate for each value 3 Close the Calibration dialog 4 152 ReadyToProcess WAVE 25 Operating Instructions 2900959...

Страница 153: ...ing agent Make sure to clean the temperature sensor arms on the underside of the rocker platform If dirt accumulates in these arms they may not function properly which could cause incorrect temperature regulation Recommended cleaning agents All system units can be cleaned with ethanol isopropanol and Virkon at suitable con centrations Refer to Section 8 1 Chemical resistance on page 166 ReadyToPro...

Страница 154: ...n the On Site Service Health and Safety Declaration Form or the Health and Safety Declaration Form for Product Return or Servicing depending on whether the instrument is going to be serviced on site or returned for service respectively Copy the form you need from Section 8 2 Health and Safety Declaration Form on page167 or print it from the PDF file available on the User Documentation CD 154 Ready...

Страница 155: ...oProcess WAVE 25 System Handbook do not solve the problem or if the problem is not covered by these guides contact your GE representative for advice In this chapter This chapter contains the following sections See page Section 156 7 1 ReadyToProcess WAVE 25 system 157 7 2 ReadyToProcess WAVE 25 rocker 161 7 3 ReadyToProcess CBCU 162 7 4 ReadyToProcess Pump 25 163 7 5 UNICORN System Control ReadyTo...

Страница 156: ...e 57 for details Each pump must have a unique CAN ID value The system must be switched off before the CAN ID is changed and then restarted Incorrect pump CAN ID Pump not recognized by UNICORN Click Edit in System Properties in the Administra tion module and add the pump as a component Pump is not selected as a component Reposition the connectors or insert jumpers in the unused positions between th...

Страница 157: ...f you still get motor alarms contact GE service personnel Rocker is in an error state Rocker is not rocking Make sure that the tray is in normal position If this does not help contact GE service person nel Tray is in tilt position Locate and remove the restricting object Rocker is mechanically restricted from moving Rocker stops rocking Incorrect rocking angle This is normal when DO control is ena...

Страница 158: ...and follow the instructions If problem persists contact GE service personnel An internal error has occured in the embed ded computer of the rocker Wait one minute If the system still does not shut down keep pressing the power button to force system shut down If problem persists contact GE service person nel Theembeddedcomput er of the rocker fails to shut down System does not shut down when the po...

Страница 159: ... shown in the Process Picture matches the actual weight of the cul ture medium If not tare the scale with the weight of the content in the Cellbag entered as Net Weight Incorrect weight mea surement Make sure that there is enough culture medi um in the Cellbag bioreactor to cover the temperature sensor also when the rocker is rocking Check that no crease with resulting air pocket has formed on the...

Страница 160: ...ck that no tubing is pulling on the Cellbag bioreactor during rocking Check that the movement of the rocker is not obstructed Mechanical obstruc tions to the rocker Calibrate the scale See Section 6 1 Calibration on page151 If needed contactGE service personnel Scale needs calibration Check bioreactor placement Cellbag bioreactors not centred on the respec tive halves of the tray Incorrect reading...

Страница 161: ...perating Status LED flashes red Checkanywarningmessageandfollowtheinstruc tion If problem persists contact GE service person nel An internal error has occurred andtheCBCU is not operating Status LED shows a steady red light Contact GE service personnel An internal error has occurred andtheCBCU is not operating proper ly Note This is normal the first seconds during power up CAN indicator LED flashe...

Страница 162: ...arningmessageandfollowtheinstruc tion If problem persists contact GE service person nel An internal error has occurred and the pump is not operating Status LED on the pump rear panelshows a steady red light Contact GE service personnel An internal error has occurred and the pump is not operating properly Note This is normal the first seconds during power up CAN indicator LED flashes 162 ReadyToPro...

Страница 163: ...d cannot be entered Access to UNICORN functions Solution Problem description Check that no other user has a control mode connection Check that you have access rights to control the system manually The Execute manual instruction menu com mand in the System Control module is gray This means that you can establisha connection but cannot control the system 1 Open the MadCap help viewer from the Window...

Страница 164: ... off and log on again for access rights changes to be applied A system is not available when you attempt to establish a connection Check that the rocker power button shows a steady green light Check that the computer from which you try to establish a connection is logged on to the network Check that the limit of five simultaneous connections to the system has not been exceeded Check the firewall s...

Страница 165: ...ce information refer to the ReadyToProcess WAVE 25 System Handbook the ReadyToProcess WAVE 25 Product Documentation and the data file for ReadyToProcess WAVE 25 available for download from www gelifesciences com wave In this chapter This chapter contains the following sections See page Section 166 8 1 Chemical resistance 167 8 2 Health and Safety Declaration Form ReadyToProcess WAVE 25 Operating I...

Страница 166: ...3 0 200 661 7 Cleaning Disinfection 70 Isopropanol N A Cleaning Disinfection N A Klercide N A Testing 10 PBS solution 144 55 8 205 633 8 pH control 7 5 Sodium bicarbonate 497 19 8 207 838 8 pH control 1 M Sodium carbonate 7647 14 5 231 598 3 Testing 5 M Sodium chloride 1310 73 2 215 185 5 pH control 1 M Sodium hydroxide 7681 52 9 231 668 3 Cleaning Disinfection 1 Sodium hypochlorite N A Cleaning D...

Страница 167: ...orothersuitablesurvey Adequate space andclearance is providedto allowsafe access forinstrumentservice repairor installation Insome cases this mayrequirecustomerto move equipmentfrom normaloperatinglocation prior to GE arrival Consumables suchas columns orgels have beenremovedor isolatedfromthe instrument andfrom any areathat may impede access tothe instrument All buffer waste vessels are labeled E...

Страница 168: ...hazardous biological substances pleasespecify OtherHazardous Chemicals please specify Equipment must be decontaminatedpriortoservice return Pleaseprovide atelephone number whereGE cancontact youfor additionalinformationconcerningthe system equipment Telephone No Liquid and orgas in equipment is Water Ethanol None empty Argon Helium Nitrogen Liquid Nitrogen Other please specify Equipment type Produ...

Страница 169: ... Component specification equipment dimensions 78 equipment weight 78 D Define a system At installation 101 Documentation 16 DO sensor Connect 109 Description 60 Dual mode 15 E e license 94 Emergency procedures emergency shutdown 35 power failure 36 Environmental conditions 78 Equipment dimensions 78 Equipment weight 78 F FCC compliance 12 G Gas mix Connect 120 Description 119 H Help utility 63 J J...

Страница 170: ...types of e licenses 94 Software overview 61 software modules 62 Space requirements 76 Standards 13 Status LED CBCU 53 Status LEDs Pump 56 System Control module description 66 manual instructions 70 process picture 146 run data 71 system settings 70 System properties edit a definition 127 System recommendations computer specifications 81 System settings 70 129 T Tilt position 49 Tray Attach 106 Det...

Страница 171: ...Page intentionally left blank ...

Страница 172: ...s Standard Software End User License Agreement is available on request UNICORN 7 2009 2017 General Electric Company 2013 2017 General Electric Company First published Jun 2013 All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them A copy of these terms and conditions is available on request Contact your local GE Healthcar...

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