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cytiva Xuri W25 Operating Instructions Manual
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cytiva Xuri W25 Operating Instructions Manual

Cell expansion system
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Xuri Cell Expansion System
W25
Operating Instructions
Original instructions
cytiva.com

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Summary of Contents for cytiva Xuri W25

  • Page 1 Xuri Cell Expansion System Operating Instructions Original instructions cytiva.com...
  • Page 2 Table of Contents Table of Contents Introduction ......................4 Important user information ........................5 About this manual ............................6 Associated documentation ........................7 Abbreviations ..............................9 Safety instructions ..................... 11 Safety precautions ............................12 Symbols and abbreviations ........................19 2.2.1 Instrument labels ............................
  • Page 3 Table of Contents 5.2.3 Configure system properties ........................99 5.2.4 Configure system settings ........................101 5.2.5 Start a run ................................ 107 Prepare for cultivation ..........................112 5.3.1 Inflate the Cellbag bioreactor ......................... 113 5.3.2 Adjust pump parameters .......................... 114 5.3.3 Add and equilibrate culture medium ....................
  • Page 4 1 Introduction Introduction About this chapter This chapter contains important user information, the intended use of Xuri™ Cell Expansion System W25, description of safety notices, and regulatory information. In this chapter Section See page Important user information About this manual Associated documentation Abbreviations Xuri Cell Expansion System W25 Operating Instructions 29064612 AD...
  • Page 5 1 Introduction 1.1 Important user information Important user information Read this before operating the product All users must read the entire Operating Instructions before installing, oper- ating or maintaining the product. Always keep the Operating Instructions at hand when operating the product. Do not install, operate, or perform maintenance on the product in any other way than described in the user documentation.
  • Page 6 1 Introduction 1.2 About this manual About this manual Purpose of this manual The Operating Instruction manual provides information needed to install, operate and maintain the product in a safe way. Scope of this manual This manual covers the entire Xuri Cell Expansion System W25, including the main unit (rocker), CBCU and pump, as well as accessories.
  • Page 7 Associated documentation Introduction This section describes the user documentation that is delivered with the product, and how to find related literature that can be downloaded or ordered from Cytiva. User documentation for Xuri Cell Expansion System W25 The table below describes the user documentation for Xuri Cell Expansion System W25, which is available from the Help menu in UNICORN™...
  • Page 8 1 Introduction 1.3 Associated documentation Documentation Main contents UNICORNAdministration and Technical Overview and detailed description of manual network setup and complete software installation. Administration of UNICORN and the UNICORN database. UNICORN Online Help Dialog descriptions for UNICORN CD containing the listed manuals and User Documentation CD translated versions of Xuri Cell Expansion System W25 Operating...
  • Page 9 1 Introduction 1.4 Abbreviations Abbreviations Concepts and abbreviations used in this manual are explained in the table below. Concept/ Explanation Translation abbreviation Cellbag™ The disposable container in The disposable container in bioreactors which the cells are cultured. which the cells are cultured. Dissolved oxygen.
  • Page 10 1 Introduction 1.4 Abbreviations Concept/ Explanation Translation abbreviation The bioreactor The entire system, including The entire system, including system rocker, CBCU, and pump, rocker, CBCU, and pump, together with Cellbag together with Cellbag bioreactor and filter heater. bioreactor and filter heater. UNICORN The software used for control- The software used for control-...
  • Page 11 2 Safety instructions Safety instructions About this chapter This chapter describes safety precautions, labels and symbols that are attached to the equipment. In addition, the chapter describes emergency and recovery procedures. In this chapter Section See page Safety precautions Symbols and abbreviations Emergency procedures Important WARNING...
  • Page 12 2 Safety instructions 2.1 Safety precautions Safety precautions Introduction Xuri Cell Expansion System W25 is powered by mains voltage and handles materials that can be hazardous. Before installing, operating or maintaining the system, you must be aware of the hazards described in this manual. Definitions This user documentation contains safety notices (WARNING, CAUTION, and NOTICE) concerning the safe use of the product.
  • Page 13 2 Safety instructions 2.1 Safety precautions WARNING Accessories. Use only accessories supplied or recommended by Cytiva. WARNING Do not use the product if it is not working properly, or if it has suffered any damage, for example: • damage to the power cord or its plug •...
  • Page 14 WARNING Protective ground. The stand-alone products must always be connected to a grounded power outlet. WARNING Only use grounded power cords delivered or approved by Cytiva. Xuri Cell Expansion System W25 Operating Instructions 29064612 AD...
  • Page 15 2 Safety instructions 2.1 Safety precautions 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.
  • Page 16 2 Safety instructions 2.1 Safety precautions CAUTION Only Cellbag bioreactors approved by Cytiva for the product may be used together with the equipment. CAUTION Heavy object. The filled Cellbag bioreactor is heavy and must be lifted with care. This also applies to optional equipment such as calibration weights.
  • Page 17 WARNING Use only approved parts. Only spare parts and accessories that are approved or supplied by Cytiva may be used for maintaining or servicing the product. Xuri Cell Expansion System W25 Operating Instructions 29064612 AD...
  • Page 18 2 Safety instructions 2.1 Safety precautions CAUTION Falling equipment. Due to pinch and crush hazards, calibration weights should not be stacked on top of each other. Remove cali- bration weights before the power is turned off. CAUTION Hazardous substances. Before maintenance, service and decommissioning, clean the product with an appropriate cleaning agent to remove any hazardous substances.
  • Page 19 2 Safety instructions 2.2 Symbols and abbreviations Symbols and abbreviations About this section This section describes the information on the system label and other safety or regula- tory labels that are attached to the product. In this section Section See page 2.2.1 Instrument labels 2.2.2...
  • Page 20 2 Safety instructions 2.2 Symbols and abbreviations 2.2.1 Instrument labels 2.2.1 Instrument labels Instrument labels The table below describes the different instrument labels and their positions on the different equipment. The instrument label identifies the equipment and shows elec- trical data, regulatory compliance, and warning symbols. Label Position on instrument Xuri Cell Expansion System...
  • Page 21 2 Safety instructions 2.2 Symbols and abbreviations 2.2.2 Safety labels 2.2.2 Safety labels Safety labels on Xuri Cell Expansion System W25 rocker The following symbols can be found on the rocker. Label Description Warning! Read the user documentation before using the system.
  • Page 22 2 Safety instructions 2.2 Symbols and abbreviations 2.2.2 Safety labels Label Description Warning! Indicates a hot surface and that 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.
  • Page 23 2 Safety instructions 2.2 Symbols and abbreviations 2.2.3 Additional labels 2.2.3 Additional labels Additional labels The table below describes the different additional labels and their positions on the different equipment. Label Position on equipment Cellbag label Attached to the cellbag. DO sensor label Attached to the cellbag next to the DO sensor.
  • Page 24 2 Safety instructions 2.3 Emergency procedures Emergency procedures Introduction This section describes how to perform an emergency shutdown of Xuri Cell Expansion System W25. This section also describes the result in the event of power failure or network interruption. WARNING Access to power switch and power cord with plug.
  • Page 25 2 Safety instructions 2.3 Emergency procedures Green light: power is ON. No light: power is OFF. Normal and forced shutdown If the Power button is pressed once, a normal shutdown is performed. If the button is pressed and held, a forced shutdown is performed. The following table describes normal shutdown and forced shutdown.
  • Page 26 2 Safety instructions 2.3 Emergency procedures • The rocker and the CBCU(s) will restart using the same values as before the power interruption. • UNICORN will ask if you want to save or discard the run data collected before the power interruption.
  • Page 27 3 System description System description About this chapter This chapter gives a brief overview of Xuri Cell Expansion System W25. For more detailed information, refer to Xuri Cell Expansion System W25 User Manual. In this chapter Section See page System overview Xuri Cell Expansion System W25 rocker Xuri Cell Expansion W25 CBCU Xuri Cell Expansion W25 Pump...
  • Page 28 (SCADA) system, such as the DeltaV™ control system, using the integrated OPC server. Contact Cytiva for instructions and guidance for OPC. Illustration of the system The illustration below shows the main system units for use in single mode with one Xuri Cell Expansion W25 Pump.
  • Page 29 3 System description 3.1 System overview Part Description Hatch Filter heater Cellbag bioreactor Xuri Cell Expansion W25 Pump Xuri Cell Expansion W25 CBCU Xuri Cell Expansion System W25 rocker Tray Xuri Cell Expansion System W25 Operating Instructions 29064612 AD...
  • Page 30 For specifications of the rocker, refer to the Xuri Cell Expansion System W25 User Manual or the data file for Xuri Cell Expansion System W25, available for download from cytiva.com. Front view of the rocker The illustration below shows the front view of the rocker.
  • Page 31 3 System description 3.2 Xuri Cell Expansion System W25 rocker Part Description Location of adjustable foot Power button The Power button indicates the status of the rocker according to the list below. Light indicator Image Description No light The power is OFF. Green flashing light The rocker is starting up.
  • Page 32 3 System description 3.2 Xuri Cell Expansion System W25 rocker Rear view of the rocker The illustration below shows the rear panel of the rocker. Part Description 15-pin D-sub connector, used for digital and analog I/O signals Filter heater connectors Tray connector UniNet-9 ports USB ports...
  • Page 33 3 System description 3.2 Xuri Cell Expansion System W25 rocker Illustrations of tray and lid Part Description Bag clamp (upper) Bag clamp opener (one in each upper corner) Bag clamp opener (one in each lower corner) Bag clamp (lower) The illustration below shows the rocker with Tray 50 and Lid 50 mounted. Xuri Cell Expansion System W25 Operating Instructions 29064612 AD...
  • Page 34 3 System description 3.2 Xuri Cell Expansion System W25 rocker Part Description Rocker base Tray Tubing exit Hatch Prepare for tilt When the system enters END mode, the tray prepares for tilt if System Settings →Rocker →Prepare for tilt at END is set to Yes. This moves the rocker to the mechanical end position, which is 14 degrees from horizontal.
  • Page 35 3 System description 3.2 Xuri Cell Expansion System W25 rocker Step Action Prepare for tilt as described above or select the largest possible angle in UNICORN. Do not tilt the tray from an angle lower than 12°. Hold the textured grip area on each side of the tray and pull the tray towards you.
  • Page 36 3 System description 3.2 Xuri Cell Expansion System W25 rocker Filter heater The filter heater prevents condensation and clogging of the outlet vent filter on the Cellbag bioreactor. Part Description Filter heater Connector for connection to the rocker Filter heater stand Xuri Cell Expansion System W25 Operating Instructions 29064612 AD...
  • Page 37 , pH and DO. For specifications of the CBCU, refer to the Xuri Cell Expansion System W25 User Manual or the data file for Xuri Cell Expansion System W25, available for download from cytiva.com. Front view of Xuri Cell Expansion W25 CBCU The illustration below shows the front panel of a fully configured CBCU.
  • Page 38 3 System description 3.3 Xuri Cell Expansion W25 CBCU Status LED The status LED indicates the CBCU operating status according to the following table. Light indicator Description Steady green light The CBCU is ready for operation. Green flashing light The CBCU is operating. Red flashing light Indicates an internal error, but the CBCU is still operating.
  • Page 39 3 System description 3.3 Xuri Cell Expansion W25 CBCU The CAN ID is set by turning a switch on the CBCU rear panel (see illustration above). The CAN ID should 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.
  • Page 40 For specifications of the pump, refer to the Xuri Cell Expansion System W25 User Manual or the data file for Xuri Cell Expansion System W25, available for download from cytiva.com. Front view of the pump The illustration below shows the front panel of the pump.
  • Page 41 3 System description 3.4 Xuri Cell Expansion W25 Pump Rear view of the pump The illustration below shows the rear panel of the pump. Part Component Description UniNet-9 port Power connection to the rocker. CAN indicator LED Indicates system connection status. CAN ID switch Shows the unit number of the pump for recognition by the system.
  • Page 42 3 System description 3.5 Cellbag bioreactor Cellbag bioreactor Introduction Cell cultivation is performed inside the Cellbag bioreactor. The Cellbag bioreactor is delivered 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.
  • Page 43 3 System description 3.5 Cellbag bioreactor Part Description Addition port DO bag sensor port, located on the underside of the bag Cellbag rod Clave™ sampling port Addition port Addition/harvest port Note: The inlet and outlet vent filters are distinguished by the pressure control valve on the outlet filter.
  • Page 44 3 System description 3.5 Cellbag bioreactor Part Description Sensor The sensor adapter is located at one end of an optical fiber cable. The adapter optical lens of the fiber cable is located in the center of the sensor adapter. The fiber cable is connected to a sensor reader in the CBCU. The fiber cable is connected to the pH or DO port on the CBCU front panel.
  • Page 45 3 System description 3.6 UNICORN software overview UNICORN software overview This section gives an overview of the general operation of the UNICORN software: a complete package for control, supervision and evaluation of cell cultivation runs. It also describes how to access the help utility that is included in UNICORN. Note: Software illustrations in these instructions are examples, and may differ from your software in some details.
  • Page 46 3 System description 3.6 UNICORN software overview 3.6.1 General UNICORN operation 3.6.1 General UNICORN operation UNICORN modules overview UNICORN consists of four modules: System Control, Evaluation, Administration and Method Editor. The main functions of the modules are described in the table below. Module Main functions System Control...
  • Page 47 3 System description 3.6 UNICORN software overview 3.6.1 General UNICORN operation If you want to... then... select Help →Help for... in the UNICORN module of find information about a UNICORN module interest find information about • press the F1 key with the item of interest selected the item currently and in focus selected and in focus...
  • Page 48 3 System description 3.6 UNICORN software overview 3.6.1 General UNICORN operation If you want to... then... In the Method Editor module: find information about an instruction • open a method • select the instruction of interest in the Instruction box in the Text instruction pane •...
  • Page 49 3 System description 3.6 UNICORN software overview 3.6.2 Administration 3.6.2 Administration Introduction The Administration module is used to manage all functions of the UNICORN soft- ware. Refer to UNICORN Administration and Technical manual for more information. Icons in the Administration module The table below shows the Administration module icons.
  • Page 50 3 System description 3.6 UNICORN software overview 3.6.3 System control 3.6.3 System control Introduction The System Control module is used to start, view, and control a manual or method run. System Control panes As illustrated below, two tabs are available in the System Control module by default. The Process Picture tab allows manual interactions with the system and provides feedback on run parameters.
  • Page 51 3 System description 3.6 UNICORN software overview 3.6.3 System control In dual mode, the process picture shows two Cellbag bioreactors on the rocker picture, with separate control icons for the individually controlled parameters in each bioreactor. Icons for the left-hand bioreactor are in the upper half of the process picture and icons for the right-hand bioreactor in the lower half.
  • Page 52 3 System description 3.6 UNICORN software overview 3.6.3 System control Tip: Label the CBCU and pump units with their CAN ID settings to simplify corre- lation of the physical units with the process picture. In dual mode, place the pumps connected to the left and right Cellbag bioreactors on the left and right sides of the rocker respectively.
  • Page 53 3 System description 3.6 UNICORN software overview 3.6.3 System control If you want to... then... Open the settings for a Click on the left-hand side of the button. function The example below shows the settings for dissolved oxygen, DO. Enter appropriate values in the Settings dialog and click Adjust the settings OK or press enter.
  • Page 54 3 System description 3.6 UNICORN software overview 3.6.3 System control Step Action In the System Control module, select System →Settings. Result: The System Settings dialog opens with the Instructions displayed. An example is shown below. Select the instruction to edit from the list. Click the + symbol to show the instructions for each category.
  • Page 55 3 System description 3.6 UNICORN software overview 3.6.3 System control Step Action In the System Control module: • select Manual →Execute Manual Instructions • use the shortcut Ctrl+M. Result: The Manual instructions dialog opens. In the Manual instructions dialog: a. Click the + symbol to show the instructions for the instruction group that you want to modify.
  • Page 56 3 System description 3.6 UNICORN software overview 3.6.4 Evaluation 3.6.4 Evaluation The Evaluation module is used to evaluate the results from bioreactor runs. Evalua- tion is described in detail in the Xuri Cell Expansion System W25 User Manual and UNICORN Online Help. Xuri Cell Expansion System W25 Operating Instructions 29064612 AD...
  • Page 57 4 Installation Installation About this chapter This chapter provides required information to enable users and service personnel to: • unpack the bioreactor system delivered from the factory • install the system units • install UNICORN 7.x software • edit system properties Read the entire installation chapter before starting to install Xuri Cell Expansion System W25.
  • Page 58 4 Installation 4.1 Site preparation Site preparation About this section This section describes the site planning and the preparations necessary before instal- lation of Xuri Cell Expansion System W25. The purpose is to provide planners and tech- nical staff with the data needed to prepare the laboratory for the installation. In this section Section See page...
  • Page 59 When you receive the delivery boxes • Record on the packing slip if there is any apparent damage on the delivery boxes. Inform your Cytiva representative of any such damage. • Move the delivery boxes to a protected location indoors.
  • Page 60 4 Installation 4.1 Site preparation 4.1.2 Site requirements 4.1.2 Site requirements Space requirements Prepare a clean working area on a stable laboratory bench. The bench must fulfill the following requirements: • Recommended minimum bench space: 80 x 180 cm. • The bench must be clean, level, flat and sufficiently stable to withstand vibration from the rocking.
  • Page 61 4 Installation 4.1 Site preparation 4.1.2 Site requirements Illustration of system setup, dual mode In dual mode, place the Xuri Cell Expansion W25 CBCU and Xuri Cell Expansion W25 Pump units on either side of the rocker to correspond with the L and R designations in the software.
  • Page 62 4 Installation 4.1 Site preparation 4.1.2 Site requirements • 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 Parameter Requirement Allowed location Indoor use only Ambient temperature, operation 15°C to 32°C Relative humidity, operating...
  • Page 63 4 Installation 4.1 Site preparation 4.1.2 Site requirements Noise level • The noise level of the operating bioreactor system is below 65 dBA. • Audio warning signals have a higher noise level than the operating system. Heat output The heat output data is listed in the table below. Component Heat output Bioreactor system, including the rocker unit, CBCU and pump.
  • Page 64 Xuri Cell Expansion System W25 is supplied with UNICORN 7.x, which requires Windows 7. If you wish to use Xuri Cell Expansion System W25 with an earlier version of UNICORN, contact Cytiva for assistance. General computer specifications Installation is supported for Windows 7 Professional, 32-bit or 64-bit, with Service Pack 1 or Windows 10 Professional 64-bit.
  • Page 65 4 Installation 4.1 Site preparation 4.1.3 Client computer specifications • UNICORN is not compatible with the Windows 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.
  • Page 66 4 Installation 4.2 Hardware installation Hardware installation About this section This section describes the installation procedure for Xuri Cell Expansion System W25. In this section Section See page 4.2.1 Unpack the system units 4.2.2 Connect the system components Xuri Cell Expansion System W25 Operating Instructions 29064612 AD...
  • Page 67 4 Installation 4.2 Hardware installation 4.2.1 Unpack the system units 4.2.1 Unpack the system units Unpacking instruction Follow the instructions below to unpack each box and to lift the system units onto the bench. Step Action Place the box on a smooth and flat surface with the correct side facing upwards.
  • Page 68 4 Installation 4.2 Hardware installation 4.2.1 Unpack the system units IP settings for standalone installation For a standalone installation, the 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.
  • Page 69 4 Installation 4.2 Hardware installation 4.2.2 Connect the system components 4.2.2 Connect the system components Connect system units to the rocker Xuri Cell Expansion W25 Pump and Xuri Cell Expansion W25 CBCU units are connected to the rocker with UniNet cables. Power to the units is supplied from the rocker. Follow the instructions below to connect the system units to the rocker.
  • Page 70 Connect a network cable between the Ethernet connector on the rear panel of the rocker and the network. Connect the computer to the network. Contact your Cytiva representative for support on how to establish and configure the network connection. Wireless Connect a WiFi USB adapter to the USB port on the rear panel of the rocker.
  • Page 71 4 Installation 4.2 Hardware installation 4.2.2 Connect the system components Connect to mains power Step Action Connect the supplied power cord between the power inlet on the rear panel of the rocker and a grounded power outlet. Follow the manufacturer's instruction to connect power to computer, monitor and local printer (if used).
  • Page 72 For this system, the IP address is 192.168.1.1. Note: For other types of installations, contact your Cytiva representative for support. This includes network installations when you want to access the Xuri Cell Expansion System W25 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.
  • Page 73 5 Operation Operation About this chapter This chapter describes how to operate Xuri Cell Expansion System W25. In this chapter Section See page Set up the system Start and configure the system Prepare for cultivation Perform cultivation Xuri Cell Expansion System W25 Operating Instructions 29064612 AD...
  • Page 74 5 Operation 5.1 Set up the system Set up the system About this section This section describes how to prepare the bioreactor system for cell cultivation. For illustrations and descriptions of the system, refer to Chapter 3 System description, on page In this section Section...
  • Page 75 5 Operation 5.1 Set up the system 5.1.1 Select the tray and Cellbag bioreactor 5.1.1 Select the tray and Cellbag bioreactor Select the Cellbag bioreactor size and corresponding tray according to application requirements and system configuration. See the table below for guidelines. Culture volume/ Cellbag Tray...
  • Page 76 5 Operation 5.1 Set up the system 5.1.2 Attach and detach tray 5.1.2 Attach and detach tray Introduction This section describes how to attach and detach a tray to and from the rocker platform. These operations should preferably be performed without a Cellbag bioreactor on the tray.
  • Page 77 5 Operation 5.1 Set up the system 5.1.2 Attach and detach tray Step Action Fit the tray on to the rocker platform. The attachment pins on the tray engage with the holes in the platform. Attach the pins on the upper edge first, then slide the tray down making sure that the lower pins engage with the respective holes.
  • Page 78 5 Operation 5.1 Set up the system 5.1.2 Attach and detach tray Step Action Make sure that the connector on the tray is plugged into the tray connector on the back of the rocker platform. Detach tray The tray can be detached from the rocker platform in tilt position and in normal posi- tion.
  • Page 79 5 Operation 5.1 Set up the system 5.1.2 Attach and detach tray Step Action Pull the tray towards you. 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. Xuri Cell Expansion System W25 Operating Instructions 29064612 AD...
  • Page 80 5 Operation 5.1 Set up the system 5.1.3 Prepare pH and DO sensors 5.1.3 Prepare pH and DO sensors Instructions Follow the instructions below to connect the sensor adapters to the pH and DO bag sensor ports. NOTICE Be careful to connect the sensors to the correct ports on Xuri Cell Expansion W25 CBCU.
  • Page 81 5 Operation 5.1 Set up the system 5.1.3 Prepare pH and DO sensors Step Action Attach the sensor adapter, with the optical lens facing the sensor port, by inserting the four pins of the port into the corresponding holes of the adapter.
  • Page 82 5 Operation 5.1 Set up the system 5.1.3 Prepare pH and DO sensors Step Action Place the Cellbag bioreactor on the tray with the optical sensors facing downwards. NOTICE Make sure that the optical fiber cables are not placed between the Cellbag bioreactor and the temperature sensor on the tray.
  • Page 83 5 Operation 5.1 Set up the system 5.1.4 Attach the Cellbag bioreactor 5.1.4 Attach the Cellbag bioreactor Instructions Follow the instructions below to attach the Cellbag bioreactor to the tray. Note: When using a Cellbag bioreactor that only covers half of the tray in single mode, such as a 10 L bag on Tray 20, position the bag on the left side of the tray.
  • Page 84 5 Operation 5.1 Set up the system 5.1.4 Attach the Cellbag bioreactor Step Action If the clamp does not close automatically, gently push the bag clamp opener upwards to secure the upper end of the Cellbag bioreactor. Do not use force. Gently pull on the bioreactor to make sure it is attached.
  • Page 85 5 Operation 5.1 Set up the system 5.1.5 Prepare the pump 5.1.5 Prepare the pump Tubing holder positions The pump head has two different holder positions to accommodate tubing with different sizes. The inner position is for small tubing and the outer position is for large tubing (see Pump tubing sizes, on page 85).
  • Page 86 5 Operation 5.1 Set up the system 5.1.5 Prepare the pump Tubing inner diameter Tubing holder posi- Flow rate range tion (mL/min) Millimetres Inches 1/50 Inner 0.01 to 4.6 1/32 Inner 0.02 to 8.6 1/16 Inner 0.07 to 28 3/32 Inner 0.15 to 58 Inner...
  • Page 87 5 Operation 5.1 Set up the system 5.1.5 Prepare the pump Step Action Press down and move the tubing holder to the required position until it clicks into place. Release the pressure. The tubing holder rises into the new position. Repeat the above steps to adjust the tubing holder on the other side of the pump head.
  • Page 88 5 Operation 5.1 Set up the system 5.1.5 Prepare the pump Step Action Open the flip top of the pump head completely. Check that the tubing holder is adjusted to the correct position for your size of tubing. See instructions above. Place the tubing between the rotor rollers and the track, pressed against the inner wall of the pump head.
  • Page 89 5 Operation 5.1 Set up the system 5.1.5 Prepare the pump Step Action Lower the flip top until it clicks into its fully closed position. Connect inlet and outlet tubing to the Cellbag bioreactor, for example acid, base, feed and harvest/waste. Note: The pumping direction is indicated by the arrow on the pump head.
  • Page 90 5 Operation 5.1 Set up the system 5.1.6 Connect gas to the system 5.1.6 Connect gas to the system Gas mix The Cellbag bioreactor requires gas flow to stay inflated and to provide ventilation. The CBCU enables different gas mixing possibilities. Compressed air or N can be mixed with CO and/or O...
  • Page 91 5 Operation 5.1 Set up the system 5.1.6 Connect gas to the system Step Action Attach the filter heater to the outlet vent filter of the Cellbag bioreactor. In dual mode, make sure that the filter heaters are correctly placed with respect to the left and right bioreactors.
  • Page 92 5 Operation 5.1 Set up the system 5.1.6 Connect gas to the system Step Action Connect tubing from the GAS MIX OUT on the CBCU front panel to the inlet vent filter of the Cellbag bioreactor. , at 1.0 to 1.5 bar to AIR/N2 on the Connect the desired gas source, air or N CBCU rear panel.
  • Page 93 5 Operation 5.1 Set up the system 5.1.6 Connect gas to the system NOTICE Make sure to keep the inlet pressures within the stated limits (1.0 to 1.5 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.
  • Page 94 5 Operation 5.1 Set up the system 5.1.7 Connect the filter heater to the rocker 5.1.7 Connect the filter heater to the rocker Follow the steps below to connect the filter heater(s) to the rocker. Step Action Connect the filter heater cable to the filter heater port on the rocker rear panel.
  • Page 95 5 Operation 5.2 Start and configure the system Start and configure the system About this section This section describes how to start the system, log on to UNICORN, connect the system to UNICORN and configure the system in the software. In this section Section See page...
  • Page 96 5 Operation 5.2 Start and configure the system 5.2.1 Start the system and log on to UNICORN 5.2.1 Start the system and log on to UNICORN Follow the instructions below to start the system and log on to UNICORN. The worksta- tion must have a valid e-license.
  • Page 97 5 Operation 5.2 Start and configure the system 5.2.2 Connect to the system 5.2.2 Connect to the system Follow the instructions below to connect the system to UNICORN. Step Action When the indicator light on the rocker front panel shows a steady green light, click the Connect to Systems icon in the System Control module.
  • Page 98 5 Operation 5.2 Start and configure the system 5.2.2 Connect to the system Step Action In the Connect to Systems dialog: a. Select the system. b. Select Control mode. c. Click OK. Result: The Process Picture appears. Note: The detailed appearance of the process picture will vary according to your system setup.
  • Page 99 The Instrument Configuration is the system specific control software. It is provided on a DVD with the system, and is also available for download. Contact your Cytiva representative if you need help to download the Instrument Configura- tion. Follow the instructions below to edit the system properties.
  • Page 100 5 Operation 5.2 Start and configure the system 5.2.3 Configure system properties Step Action All available components are shown in the Component selection list. a. Click the check-boxes to select or de-select components. b. Make sure the components selected match the units connected to the system.
  • Page 101 5 Operation 5.2 Start and configure the system 5.2.4 Configure system settings 5.2.4 Configure system settings Introduction In System Settings, system parameters are defined, such as: • pump roles, which need to be assigned to the individual pump heads before starting a run;...
  • Page 102 5 Operation 5.2 Start and configure the system 5.2.4 Configure system settings Step Action Assign roles to pump heads according to the requirements of the cultivation process. In single mode, available roles are Acid, Base, Feed1, Harvest, Feed2, Feed3 and Feed4. In dual mode, available roles are Acid, Base, Feed1, Harvest, Feed2, Feed3 for the left and right functions separately, identified by the suffix L and R.
  • Page 103 5 Operation 5.2 Start and configure the system 5.2.4 Configure system settings Step Action Click on alternative pH control deadband mode. Click one of the radio buttons Optimal or Traditional to select mode. Note: The selected mode of deadband cannot be changed during a run. Click OK to confirm the selection.
  • Page 104 5 Operation 5.2 Start and configure the system 5.2.4 Configure system settings Step Action In the Lower dead band field, select the lower limit by clicking the small arrows to the right of the field. The limits are selected in the range of 0.10 to 2.00 pH units.
  • Page 105 5 Operation 5.2 Start and configure the system 5.2.4 Configure system settings Step Action Click Execute to apply the selection. Select transition delays in CO2/Base in optimal mode of pH control Follow the instructions below to select the transition delays in Auto/Manual mode before starting a run.
  • Page 106 5 Operation 5.2 Start and configure the system 5.2.4 Configure system settings Step Action Select System →Manual Instructions in the System Control module. Select DO control (advanced) from the list and click the + symbol to view the available alternatives. Click on alternative DO control (transition delays).
  • Page 107 5 Operation 5.2 Start and configure the system 5.2.5 Start a run 5.2.5 Start a run Introduction This section describes how to start a manual or method-controlled run. Data collection begins when the run starts. For further information on methods, refer to Xuri Cell Expansion System W25 User Manual.
  • Page 108 5 Operation 5.2 Start and configure the system 5.2.5 Start a run Step Action Change the Cellbag settings as required. In dual mode, make sure the settings are correctly entered for both bioreactors. a. Click the Cellbag icon. In dual mode, click the appropriate side of the icon.
  • Page 109 5 Operation 5.2 Start and configure the system 5.2.5 Start a run Step Action On the displayed page in the Start Protocol: a. Type the Result name and click Browse to change the Location of where the result is saved if necessary. b.
  • Page 110 5 Operation 5.2 Start and configure the system 5.2.5 Start a run Step Action In the New Method dialog, select a System. Select one of the predefined method templates. Click OK. Result: The Method Outline pane shows the mandatory Method Settings phase for the chosen method.
  • Page 111 5 Operation 5.2 Start and configure the system 5.2.5 Start a run If you want to... then... 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.
  • Page 112 5 Operation 5.3 Prepare for cultivation Prepare for cultivation About this section This section describes the how to prepare the system for cell cultivation. For illustra- tions and descriptions of the system, refer to Chapter 3 System description, on page In this section Section See page...
  • Page 113 5 Operation 5.3 Prepare for cultivation 5.3.1 Inflate the Cellbag bioreactor 5.3.1 Inflate the Cellbag bioreactor Follow the instructions below to inflate the Cellbag bioreactor. Step Action Make sure that all ports on the Cellbag bioreactor are closed and that inlet and outlet filters are open.
  • Page 114 5 Operation 5.3 Prepare for cultivation 5.3.2 Adjust pump parameters 5.3.2 Adjust pump parameters Follow the instructions below to adjust the pump parameters. Step Action Adjust the pump parameters for each pump under Settings →Cellbag pumps. Enter the Tube inner diameter and if the pump function is acid or base, enter the molarity.
  • Page 115 5 Operation 5.3 Prepare for cultivation 5.3.3 Add and equilibrate culture medium 5.3.3 Add and equilibrate culture medium Tare the scale Tare the scale with all the equipment on the tray, such as lid, Cellbag bioreactor, and filter heater before starting a run. For optimal control, the measured weight should be the same as the weight of the culture.
  • Page 116 5 Operation 5.3 Prepare for cultivation 5.3.3 Add and equilibrate culture medium Add culture medium Follow the instructions below to fill the Cellbagbioreactor with culture medium. Note: The high pressure alarm may be triggered as the bioreactor is filled, depending on gas and liquid flow rates. The alarm may be ignored provided that it is no longer active when filling is complete.
  • Page 117 5 Operation 5.3 Prepare for cultivation 5.3.3 Add and equilibrate culture medium Step Action Set the desired rocking speed and angle in Settings →Rocking in the Process Picture. Start the rocking by clicking the right-hand side of the Rocking button. Note: When using Tray 50, the value of rocking speed multiplied by rocking angle may not exceed 240 (e.g., with a rocking angle of 12°...
  • Page 118 5 Operation 5.3 Prepare for cultivation 5.3.4 Prepare the sensors 5.3.4 Prepare the sensors Important Do not start pH or DO reading until the medium is fully equilibrated to operating condi- tions. The sensors do not give reliable measurements until then. Equilibrate the culture medium with 100% air to calibrate DO sensors for 100% air saturation.
  • Page 119 5 Operation 5.3 Prepare for cultivation 5.3.4 Prepare the sensors Step Action Click OK. Prepare the pH sensor Follow the instructions below to prepare the pH sensor. Note: In dual mode, adjust the sensor calibration on each Cellbag bioreactor separately. Step Action When the medium is equilibrated to operating conditions, move the cursor...
  • Page 120 5 Operation 5.3 Prepare for cultivation 5.3.4 Prepare the sensors Step Action Enter the desired values for Control and Setpoint. Check the Deviation Alarm and set the alarm limits if desired. Click OK. Xuri Cell Expansion System W25 Operating Instructions 29064612 AD...
  • Page 121 5 Operation 5.4 Perform cultivation Perform cultivation About this section This section describes the basics of performing a cultivation. During the cultivation, key parameters are monitored and the settings can be adjusted. In this section Section See page 5.4.1 Inoculate the culture 5.4.2 Monitor and control the run 5.4.3...
  • Page 122 5 Operation 5.4 Perform cultivation 5.4.1 Inoculate the culture 5.4.1 Inoculate the culture Instructions Follow the instructions below to inoculate the Cellbag bioreactor. Note: Make sure that the key culture parameters pH, DO and temperature are stable before inoculation. Step Action Make sure that the inlet tubing and the tubing connected to the inoculum container are clamped.
  • Page 123 5 Operation 5.4 Perform cultivation 5.4.2 Monitor and control the run 5.4.2 Monitor and control the run Introduction You may follow and control the ongoing run in the System Control module. The current system status is shown in the System state panel in the Run Data pane. For example, it may show Ready, Manual Run or Method Run, whether optimal or tradi- tional deadband is used for pH control.
  • Page 124 5 Operation 5.4 Perform cultivation 5.4.2 Monitor and control the run Color Indication White The function is inactive. Gray The function is disabled due to higher level control Green The function is active and is working normally. Orange The function needs attention. Click on the button to open the related settings and to see more information.
  • Page 125 5 Operation 5.4 Perform cultivation 5.4.2 Monitor and control the run The following example shows the Process Picture display when the system is in CO deadband mode. The following example shows the Process Picture display when the system is in CO Base deadband mode.
  • Page 126 5 Operation 5.4 Perform cultivation 5.4.3 End a run 5.4.3 End a run End cultivation and harvest the culture Follow the instructions below to end the run and harvest the culture. Step Action Prepare the harvest vessel. Click the stop button in the toolbar in System Control to stop the run. When asked if you want to end the run, click OK.
  • Page 127 5 Operation 5.4 Perform cultivation 5.4.3 End a run Step Action Follow applicable national and/or local regulations for disposal of the Cellbag bioreactor. Turn off all gas supplies. Shut down the system Follow the instructions below to shut down the system. Step Action Disconnect the software from the system in UNICORN.
  • Page 128 6 Maintenance Maintenance About this chapter This chapter describes the required maintenance procedures for Xuri Cell Expansion System W25. It also gives an overview of the calibration procedures needed for the system to function properly. In this chapter Section See page Calibration Cleaning Cleaning before planned service...
  • Page 129 Tempera- Contact Cytiva service personnel for assistance if needed. Service ture personnel use special equipment to achieve more accurate cali- bration.
  • Page 130 6 Maintenance 6.1 Calibration Calibration instruction Follow the instructions below to perform a calibration. The example is a scale calibra- tion. Note: For OPC users, calibration can be accessed from the manual instruction dialog by selecting the OPC component. Step Action Select System →Calibrate in System Control.
  • Page 131 6 Maintenance 6.2 Cleaning Cleaning Cleaning procedure To prevent microbial or cross contamination, Xuri Cell Expansion System W25 should be cleaned after each cultivation. The system must be turned off and unplugged before cleaning. • Clean the exterior of the system units with a damp cloth and a suitable cleaning agent.
  • Page 132 6 Maintenance 6.3 Cleaning before planned service Cleaning before planned service Cleaning before planned maintenance/service To ensure the protection and safety of service personnel, all equipment and work areas must be clean and free of any hazardous contaminants before a Service Engineer starts maintenance work.
  • Page 133 If the suggested actions in this guide do not solve the problem, or if the problem is not covered by this guide, contact your Cytiva representative for advice. In this chapter...
  • Page 134 7 Troubleshooting 7.1 Xuri Cell Expansion System W25 Xuri Cell Expansion System W25 Alarm messages For many of the problems that may occur, UNICORN displays an alarm message on the screen. Follow the instruction shown to resolve the problem. System units not recognized Error symptom Possible cause Corrective action...
  • Page 135 Rocker is in an error • Check the current alarms. state. • Reset power to the unit. • If you still get motor alarms, contact Cytiva service personnel. Tray is in tilt position. • Make sure that the tray is in normal position.
  • Page 136 • If problem persists, contact Cytiva service personnel. Rocking starts when At the first command None. This is normal. sending another...
  • Page 137 Weight Error symptom Possible cause Corrective action No weight reading. Scale does not func- Contact Cytiva service personnel. tion properly. Incorrect weight The weight distribu- Use the tare functionality and even the weight displayed. tion on the rocker feet distribution according to the instructions in is not even.
  • Page 138 7 Troubleshooting 7.2 Xuri Cell Expansion System W25 rocker Error symptom Possible cause Corrective action Incorrect readings in Cellbag bioreactors Check bioreactor placement. dual mode. not centred on the respective halves of the tray. Tare omitted or incor- Tare the scale before or after filling the Cellbag rectly performed.
  • Page 139 An internal error has occurred, but the Check any warning message and red. CBCU is still operating. follow the instruction. If problem persists, contact Cytiva service personnel. Status LED shows a An internal error has occurred, and the Check any warning message and steady red light.
  • Page 140 Status LED on the An internal error has Check any warning message and follow the pump rear panel occurred, but the instruction. If problem persists, contact Cytiva flashes red. pump is still operating. service personnel. Status LED on the An internal error has...
  • Page 141 7 Troubleshooting 7.5 UNICORN System Control UNICORN System Control User Access Problem description Solution Username and password • The UNICORN administrator should check if the user account is not accepted. locked (for example after too many unsuccessful log on attempts). •...
  • Page 142 7 Troubleshooting 7.5 UNICORN System Control System connections Problem description Solution The connections are not avail- • Check if the system has been deactivated. able, i.e. the selection check- • Check that the power to the system is turned on. box is grayed out.
  • Page 143 For system and component specifications, wetted materials and chemical resistance information, refer to the Xuri Cell Expansion System W25 User Manual, the Xuri Cell Expansion System W25 Product Documentation and the data file for Xuri Cell Expansion System W25, available for download from cytiva.com. In this chapter Section...
  • Page 144 8 Reference information 8.1 Chemical resistance Chemical resistance The chemicals listed below have been approved for use with the bioreactor system. Chemical Concentra- CAS no./EC no. tion Alconox Cleaning/Disinfection DesiDos Cleaning/Disinfection Ethanol Cleaning/Disinfection 75-08-1/200-837-3 Hydrochloric acid pH control 7647-01-0/231-595-7 Isopropanol Cleaning/Disinfection 67-63-0/200-661-7 Klercide...
  • Page 145 Recycling of hazardous substances The product contains hazardous substances. Detailed information is available from your Cytiva representative. Disposal of electrical components Waste electrical and electronic equipment must not be disposed of as unsorted munic- ipal waste and must be collected separately.
  • Page 146 8 Reference information 8.3 Regulatory information Regulatory information Introduction This section lists the regulations and standards that apply to the product. In this section Section See page 8.3.1 Contact information 8.3.2 European Union and European Economic Area 8.3.3 Eurasian Economic Union Евразийский...
  • Page 147 Manufacturing information The table below summarizes the required manufacturing information. Requirement Information Name and address of manufacturer Cytiva Sweden AB Björkgatan 30 SE 751 84 Uppsala Sweden Telephone number of manufacturer + 46 771 400 600 Xuri Cell Expansion System W25 Operating Instructions 29064612 AD...
  • Page 148 8 Reference information 8.3 Regulatory information 8.3.2 European Union and European Economic Area 8.3.2 European Union and European Economic Area Introduction This section describes regulatory information for the European Union and European Economic Area that applies to the equipment. Conformity with EU Directives See the EU Declaration of Conformity for the directives and regulations that apply for the CE marking.
  • Page 149 Presnenskaya nab., 10, fl. 12, pr. III, room 6 Telephone: + 7 495 739 6931 Fax nr: + 7 495 739 6932 E-mail: rucis@cytiva.com Информация о производителе и импортере В следующей таблице приводится сводная информация о производителе и импортере, согласно требованиям Технических регламентов Таможенного союза...
  • Page 150 Пресненская наб., д. 10, эт. 12, пом. III, ком. 6 Телефон: + 7 495 739 6931 Факс: + 7 495 739 6932 Адрес электронной почты: rucis@cytiva.com Description of symbol on the system label Описание обозначения на этикетке системы This Eurasian compliance mark indicates that the product is...
  • Page 151 Note: The user is cautioned that any changes or modifications not expressly approved by Cytiva could void the user’s authority to operate the equip- ment. 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.
  • Page 152 8 Reference information 8.3 Regulatory information 8.3.5 Regulatory statements 8.3.5 Regulatory statements Introduction This section shows regulatory statements that apply to regional requirements. General statement NOTICE This equipment is not intended for use in residential environments and may not provide adequate protection to radio reception in such environments.
  • Page 153 8 Reference information 8.3 Regulatory information 8.3.6 Declaration of Hazardous Substances (DoHS) 8.3.6 Declaration of Hazardous Substances (DoHS) This section describes the information that applies to the product in China. 根据 SJ/T11364-2014《电子电气产品有害物质限制使用标识要求》特提供如下 有关污染控制方面的信息。 The following product pollution control information is provided according to SJ/ T11364-2014 Marking for Restriction of Hazardous Substances caused by electrical and electronic products.
  • Page 154 8 Reference information 8.3 Regulatory information 8.3.6 Declaration of Hazardous Substances (DoHS) 有害物质的名称及含量 Name and Concentration of Hazardous Substances 产品中有害物质的名称及含量 Table of Hazardous Substances’ Name and Concentration 部件名称 有害物质 Compo- Hazardous substance nent name 铅 汞 镉 六价铬 多溴联苯 多溴二苯醚 (Pb) (Hg) (Cd)
  • Page 155 UNICORN 6.3, 7.0 and later versions are technically compatible with all relevant sections of FDA 21 CFR Part 11. A part 11-system assessment checklist is available on request from your local Cytiva representative. Xuri Cell Expansion System W25 Operating Instructions 29064612 AD...
  • Page 156 Service Ticket #: To make the mutual protection and safety of Cytiva service personnel and our customers, all equipment and work areas must be clean and free of any hazardous contaminants before a Service Engineer starts a repair. To avoid delays in the servicing of your equipment, complete this checklist and present it to the Service Engineer upon arrival.
  • Page 157 To make sure the mutual protection and safety of Cytiva personnel, our customers, transportation personnel and our environment, all equipment must be clean and free of any hazardous contaminants before shipping to Cytiva. To avoid delays in the processing of your equipment, complete this checklist and include it with your return.
  • Page 158 Index Index Description, 43 Documentation, 7 Adjustable foot, 31 Dual mode, 9 Description, 31 Administration module, 49 description, 49 icons, 49 Emergency, 24 Ambient environment, 61 procedures, 24 Emergency procedures, 24, 25 Assign pump roles, 101 emergency shutdown, 24 power failure, 25 Environmental conditions, 61 Bioreactor system, 28, 134 Equipment dimensions, 61...
  • Page 159 Index Rear view, 32 Troubleshooting, 135 Manual instructions, 54 Run, 107 Manufacturing information, 147 start, 107 Notes and tips, 6 Safety notices, 12 Safety precautions, 12 introduction, 12 Single mode, 9 On site service, 156 Software overview, 45, 46 software modules, 46 Status LED, 38 CBCU, 38 pH sensor, 43, 80...
  • Page 160 Index connect to system, 97 Log on, 96 Start, 96 System Control module, 50 Uninterruptible power supply (UPS), 26 Xuri Cell Expansion System W25 Operating Instructions 29064612 AD...
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  • Page 162 Cytiva and the Drop logo are trademarks of Global Life Sciences IP Holdco LLC or an affiliate. Cellbag, ReadyMate, UNICORN and Xuri are trademarks of Global Life Sciences Solutions USA LLC or an affiliate doing business as Cytiva. Clave is a trademark of ICU medical Inc, CPC is a trademark of Colder Products Company, DeltaV is a...