Table of Contents Warnings ........................... 6 Hazard Icons ........................6 Danger Levels ........................6 System Overview ........................7 Introduction ........................7 Equipment Overview ......................8 Site Requirements ........................9 Responsibilities ........................9 Size and Weight of Equipment ................... 9 Space Requirements for Equipment Operation ..............9 Power Requirements......................
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5.2.3. GMP On ..........................33 Quick Start Experiment / Batch – from a Pall Default Recipe ........... 34 5.3.1. Running an Experiment / Batch from a Pall Default Recipe ..........34 5.3.2. Calibration ..........................34 5.3.3. Control Element Parameter Setting ..................34 5.3.4.
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7.2.2. View ............................. 59 7.2.3. Data Export .......................... 59 7.2.4. Viewing and Printing a Report ..................... 60 7.2.5. Export via CSV ........................60 Alarms, Diagnostics and Troubleshooting ................61 Alarm Log ........................61 Alarm Screen Description ....................61 8.2.1. Setpoint Alarms ........................62 8.2.2.
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Pall bioreactor connected to the mPath bioreactor control tower should be read in addition to this IFU. It is important to work with your IT department if connecting Pall Link and mPath bioreactor control towers to your local network. Please consult the Pall IT Technical Note reference USD 3222 and review requirements for static IP addresses for the mPath bioreactor control tower and bench top Pall Link server.
If the equipment or the packaging in which the equipment is supplied is damaged on receipt do not attempt to install or use the equipment, but instead contact Pall Corporation for advice. DO NOT use the equipment in any way other than is stated in this manual. Doing so could result in personal injury and damage to the equipment.
(SCADA) platform where the user can remotely view and control their bioreactor from a network enabled device. Access to full features of Pall Link is dependent on the IT environment in which the software is installed. For further details, consult the Pall IT Technical Advisory Note reference USD 3222.
Equipment Overview Figure 1: mPath bioreactor control tower; (1) peristaltic pumps; (2) LED pump status (on selected models); (3) system alarm status illumination; (4) emergency stop; (5) tablet dock and (6) bioreactor connection panel...
A Pall engineer will be responsible for installing and commissioning the hardware to ensure that it is properly installed and operational. The user is responsible for ensuring that the workspace is prepared in advance to allow the Pall engineer to carry out the installation efficiently.
2 (29 psi) to 6 bar (87 psi) or below as mass flow controllers are sensitive to dirt and pressure spikes. Gases from local compressors or generators must be filtered and dried. It is recommended that Pall sub-micron filters are installed in each gas line. ® Recommended: Pall Gaskleen GLF6101FP4 filters.
6 mm OD (for each gas) The optional with PN CCTOOLKIT1 supplied by Pall includes tubing and tubing connectors to enable the easy installation of the hardware and connection of gas lines. Environment ALERT! Risk of damage to equipment! This equipment was designed for indoor use only (ambient temperatures of +16 °C to...
Hardware Overview Figure 2: mPath bioreactor control tower – see key below Item Description Peristaltic pumps. Three variable speed Watson Marlow 314D pump heads are located Only on part on the front of the control tower. These pumps are designed to operate numbers: with tubing bore sizes in the range 0.5 mm to 8 mm MPATHBRXPS2P3...
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To allow external air to be drawn into the mPath control tower for cooling Product label Product and safety information Bioreactor connections Connectors that allow a variety of Pall range laboratory scale bioreactors to interface with the mPath control tower Ground For peripheral equipment requiring a ground connection Gas inlets...
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Figure 4: Product safety label Figure 5: Side panel – see key below...
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Item Description Gas outlets The control tower provides two gas outlets (Primary and Secondary) which provide a controlled flow/mixture of the inlet gases: Primary provides gas mixes of CO , Air/N and O Secondary provides gas mixes of CO and Air/N Tablet charging A USB charging port that can be used to charge a docked tablet is connection...
Pall Link server as shown by the options above. Perform the same task with the Pall Link server. Connect CAT6 Ethernet patch cable to the Ethernet port located at the rear of the unit to the appropriate network point.
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Option 3 Figure 8: Network communication options From the instructions in the Pall IT Technical Advisory Note reference USD 3222, the Pall bioreactor installation specialist will use the IP address set by your IT department to configure the mPath bioreactor control tower.
The Pall Link server along with each bioreactor control tower require a unique static IP address when networked. All IP addresses must be within the same domain range. When adding new control towers to an existing Pall Link system, ensure domain ranges match.
Connect the communication cable to the Pall Comms port. iCELLis Nano bioreactor – Connect the docking station communication cable to Pall Power and connect the Modbus cable to the Modbus port on the rear panel of the mPath control tower.
4.4.4. Side Panel Connections Ensure single-use bioreactor vessel is installed before proceeding. Please refer to the respective product installation guide for detailed instructions on the required connections. Connect all required inputs and outputs at this point. Allegro XRS 25 bioreactor system Xpansion multiplate bioreactor system iCELLis Nano bioreactor system PadReactor Mini bioreactor system...
The Pall engineer will then ensure the Pall Link server is set with the IP address provided. Note: The Pall Link server does not need to be next to the mPath control tower. It is only required to be on the same network as the control tower.
If you have multiple mPath bioreactor control towers you can add them now by repeating the instructions above. 4.7 Connecting to the Bioreactor System When the bioreactor has been connected to the control tower, follow the steps below to establish Pall Link communications between the mPath control tower and the chosen bioreactor. Step 1 ...
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Enter a name for your bioreactor in the name option box. To add password access specific to this bioreactor, click the “Yes” tick box and enter in the password of choice. To add specific user access to this bioreactor, click the “Yes”...
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Figure 15: Scaling of I/O The Allegro XRS 25 bioreactor temperature input has a default offset of +0.5 °C because the PT100 which monitors fluid temperature is outside of the biocontainer. At 25 L the distance between the PT100 and the fluid inside the biocontainer causes a temperature offset of 0.5 °C.
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Navigate to the User Configurable I/O tab by pressing “NEXT” or selecting the User Configurable I/O tab. (If no additional I/O are being added proceed to Step 5). *A full I/O list can be found in Appendix C. Step 4 – Creating User Configurable I/O (Inputs/Outputs) These ports can be used to connect inputs such as sensors or switches and outputs such as additional pumps or balances.
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Figure 16: PadReactor Mini bioreactor user I/O configuration Step 5 Figure 17: Overview configuration The Overview Configuration screen allows customization of the appearance of selected display boxes. Display boxes can be moved around and resized to meet the user’s needs by: o Clicking the display box and dragging it.
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Figure 18: Configuration of control elements Reordering of the control elements within the display boxes can be achieved via the Process Overview screen once an experiment/batch has been started. Once customization is complete, press “NEXT” or select the Summary tab to complete bioreactor set up.
Editing and Deleting Control Towers and Bioreactors 4.8.1. Editing a Previously Created Bioreactor Control Tower Navigate to the control tower set up screen via the Configuration tab. Press “SELECT” on the control tower you wish to edit. Make the changes required and press “SAVE”.
If fluid is spilt on the equipment, disconnect the equipment from the electrical supply via the cord supplied. Wipe the fluid off the equipment using a dry cloth. If it is believed that fluid has entered the equipment, then contact Pall for advice.
This mode allows Pall Link to be either set up with user roles which have specific rights or to be open to all created users. Upon receipt of Pall Link, GMP mode is set to off. Pall Link has 3 default users created, Administrator, Operator 1 and Supervisor 1.
5.2.1. Adding / Deleting Users The administrator user can only be used to add, edit or delete users. To create a new user: Navigate to the “User Management” tab via “Configuration”. Press the green ‘+’ button on the right-hand side to open the “Add User” screen. Figure 21: Adding users ...
To edit an existing user: Double click on the user name or press the edit icon to open the selected user. The password and user roles can be changed but the user name cannot. Click the “Save” button to save the changes. To delete an existing user: ...
For more details, refer to the table in Appendix D for full list of user rights. Quick Start Experiment / Batch – from a Pall Default Recipe The mPath bioreactor control tower software has been designed to allow as much or as little customization as the user wishes.
Figure 24: Control element parameter settings 5.3.4. Trending To display data, select the Process Tab and navigate to the Trends tab. The Trends tab displays customizable trending explained below. o The “All Tags” tab allows the user to trend any parameter. o Select from the drop down filter the parameters required.
Stop or run a live trend Toggle between real time or calendar view Click this button to export trended data Note: Trending live data for a batch/experiment which has been running for many days can cause delays when loading the data to the trend screen. To prevent this press the “Stop” button at the top of the trend screen and select the data to trend.
Operation Configuring Recipes Recipes allow the user to run experiments/batches using customized control loops, parameters, alarms and trends. Control loops, setpoints, alarm values and trend parameters are all created within the recipe manager. The software holds default recipes which can be used once the bioreactor and control tower have been installed.
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The value is saved by pressing “enter”. The value can be changed by re-selecting the box; entering a new value and pressing “enter”. Below is a table describing each parameter. Table 8: I/O Values screen displays overview Parameter Description Setpoints Units...
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User configurable. Minimum time that the ‘alarm off’ condition Alarms High high/ high/ low/low low alarm Off needs to be met before the alarm transitions to the untriggered delay state in milliseconds User configurable. Minimum time that the ‘alarm on’ condition Alarms High high/ high/ low/low low alarm On...
Step 5 – Completion The user will be given four options: o Save (The recipe will save and return the user to the recipe manager). o Save and schedule* (Scheduling opens a calendar view with a pop up prompting the user to plan a time to run the recipe at a later date). o Save and Run (Saves the recipe and opens up a check screen before an experiment/batch will begin).
Starting an Experiment / Batch Experiments / batches may be scheduled for the future or started immediately. In Section 5.3 and 6.1 the options to do a quick start based on a default recipe or after new recipe creation was already described. Here is described how to schedule and start a default recipe, a recipe which has been saved or that has been saved and scheduled during the recipe creation process.
Figure 26: Schedule view Click “Schedule New Batch”. A pop up will appear. (Not required if save and schedule was chosen when creating a recipe). Figure 27: Schedule new batch pop up Select a recipe from the drop down list. (Note: Only recipes that have been created will appear here).
6.2.3. Deleting a Schedule Experiment / Batch To delete a scheduled entry, click on the experiment/batch and click “Remove Batch”. A confirmation pop up will appear asking to confirm deletion. An experiment/batch cannot be deleted once it has been started. 6.2.4.
Calibration Sensors, pumps and internal load cells may all be calibrated. For specific calibration guidance linked to a particular bioreactor, please consult the corresponding bioreactor IFU. When in Process Overview, select the parameter that requires calibration and then select the I/O calibration tab from the pop up window or select the I/O Calibration tab found within the Process tab.
The offset box will display the offset value. Electrochemical DO is also a two-point calibration. Navigate to “Process” followed by “I/O Calibration”. Select Electrochemical DO from the list on the left-hand side of the screen. Take an offline DO measurement and enter the value into “Calibrate 0%” box. ...
Monitoring a Running Experiment / Batch The Process tab links to the following tabs: Overview, Phases, I/O Calibration and Trends. 6.4.1. Overview Screen Figure 29: Process overview screen The layout of the main window is displayed as configured when the bioreactor was created. If changes to the layout of the screen are required please refer to step 5 in Section 4.7 or to reorder the layout of Inputs, Outputs, Gas Handling or User Configurable press the icon...
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Bioreactor Inputs Pop Up Figure 30: Bioreactor inputs pop up Description Setpoint – User editable. Details Process Value – This is the value that is being read by the sensor. Details Output – Percentage power used when attached to a control loop Details Details Visual indicator bar.
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Bioreactor Outputs Pop Up Figure 31: Bioreactor output pop up Description Setpoint – User editable. Details Process Value – The value being read by the sensor. Details Details Visual indicator bar. Control Loop – Input minimum and maximum allows the user to define what Details percentage of the loop is used for this parameter.
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Gas Handing Pop Up Figure 32: Gas handling pop up Description Setpoint – User editable Details Process Value – The value being read by the sensor. Details Details Visual indicator bar. Control Loop – Input minimum and maximum allows the user to define what Details percentage of the loop is used for this parameter.
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Primary Gas Pop Up The Primary gas pop up screen shows a visual representation of the gas mixes flowing out of the primary gas port. Figure 33: Gas handling – primary pop up Description Gas Outlet – Shows pressure and total flow through the primary port Details Gas Outlet –...
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Secondary Pop Up Figure 34: Gas handling – secondary pop up The Secondary gas pop up screen shows a visual representation of gas mixes flowing out of the secondary gas port. Description Gas Outlet – Shows pressure and total flow being passed through the Details primary port.
Bioreactor Image Pop Up Figure 35: Bioreactor details Clicking on the bioreactor image will open a pop up window to allow users to reset, reboot or shut down the system. Note Pressing Complete Rest “ON” will set all setpoints to a default and will set all control to off.
6.4.4. Trends The trends tab displays trends previously created in a recipe as well a fully customizable trending options explained below. Navigate to “Process” and then click the “Trends” button. Figure 37: Trend screen The “All Tags” tab allows the user to trend any parameter selected when a recipe was created.
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Table 9: Trends display button overview Button Functionality Filter option to filter the list showing potential parameters to trend. Toggle between all the trends on one graph or split into multiple graphs. Click this button and then click the trend line to add a vertical read line to the trend.
The control of pH, Dissolved Oxygen and Temperature are achieved using a proportional, integral and derivative (PID) controller. Default control parameters have been set by Pall using Pall standard operating procedures and representative cell lines. If your cell line has consumption and production dynamics which vary significantly from the cell lines used in tuning then custom tuning may be required.
Important: When creating negative control loops ensure a negative value is written to the input minimum and maximum parameters. These parameters can be set by the user in the recipe to suit the needs of the experiment/batch. A single parameter control loop does not need to be 0 - 100% if the user does not require full use of that output.
Negative control – First control parameter 0% minimum and -33% maximum. Second control parameter -33% minimum and -66% maximum. Third control parameter -66% minimum and -100% maximum. The percentages allow the control tower to switch control parameters if the desired setpoint cannot be reached using the initial control parameter.
Like DO, pH can be controlled by positive and negative control parameters to a setpoint with a common deadband. The deadband is equidistant to the setpoint. pH will be controlled by 2 sets of P,I and D parameters. One set for the acidic setpoint (positive side of the deadband from the setpoint) and one set for the basic setpoint (negative side of the deadband from the setpoint).
It is possible to export all data points if none of the parameter boxes are selected from the left of the graph. Note: after a long batch run the vast amount of data collected may cause Pall Link and Excel to perform slowly. ...
Raw – Raw data recorded when data points are changing. If data points are changing the log rate is approx. every 5 seconds. Select an option then select a save location. 7.2.4. Viewing and Printing a Report A report is a printable document, time stamped detailing experimental/batch information including: experiment/batch name, description, control tower name, bioreactor name, start and end dates, phase durations, trended data, alarm log, comments and audit logs etc.
Alarms, Diagnostics and Troubleshooting Alarm Log During an experiment/batch the status ring encircling the face of the control tower will change color depending on the status of the experiment/batch. Figure 44: LED light ring colors If there is an alarm detected: ...
The alarm log displays current alarms, general alarm status and historical alarms in three tabs. The screen is set out in a tabular format showing the alarm name, priority, active time and current state. Within the current alarms tab there is an acknowledge button which allows the user to acknowledge each alarm.
System alarms will present when issues occur which are not related to user set alarms in a recipe, for example, loss of communication between control tower and Pall Link computer. System alarms will display a flashing magenta color status ring on the control tower front and header bar on screen.
If an alarm is present and the bioreactor is deleted from the Pall Link software, the alarm will remain on the control tower. To remove this alarm, navigate to the process overview screen, click the bioreactor image and press complete Rest “ON”.
Figure 49: Alarm status screen Once all alarms are suppressed the Pall Link Server top banner will turn blue and present “OK” and the LED light ring will also display blue. The Process Overview screen will show a bell icon, depicting that the alarm is suppressed.
Figure 52: Diagnostic screen The screen is a visual representation showing the OPC UA server status, the number of people logged into Pall Link, software versions of Pall Link and the PLC and the performance of the server computer along with its databases.
Press “Save” after editing or confirming IP addresses, port configuration and CX number in control tower setup. If the connection remains faulted contact your IT department to check the IP address of the control tower and Pall Link server computer. Loss of communication to Check the status of the OPC UA server.
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Window and re-open it again. When the mPath controller is attached to a LAN network with the Pall Link server also on the LAN, with a tablet to view the HMI, the network and Wi-Fi speed will impact the performance.
Pall provides maintenance and repairs for all bioreactor systems, including preventive maintenance services. Please consult datasheet USD 3078: Pall Single-Use Bioreactor Systems Support and Maintenance Services on www.pall.com or contact your Pall sales representative. In order to keep the bioreactor system up and running a minimum of one preventive maintenance a year is recommended.
Yes, support for remote desktop and mobile clients Remote operation through Pall Link SCADA software Standalone operation No, requires Pall Link SCADA software for operation 6 mm push to connect fittings Gas connections 6 mm OD pneumatic tubing Gas flow control...
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External pump support Up to 4 via user configurable I/O Sensors Single use sensors (on selected Integrated PreSens – 1 pH / 1 DO models) Pt100 Temperature Gas input, 4 input lines Pressure Gas output / biocontainer pressure, 2 output lines 3 biocontainer load cells;...
11. Technical Assistance and Important Contact Details The mPath bioreactor control tower is manufactured by: Pall Portsmouth for Pall international SARL, Avenue de Tivoli 3, 1700 Fribourg Switzerland. For technical assistance, please contact: Corporate Headquarters European Headquarters Asia-Pacific Headquarters 25 Harbor Park Drive...
Appendix A: Abbreviations Dissolved Oxygen Inputs and Outputs Instructions for use Isopropyl alcohol MSDS Material safety data sheet Potential of Hydrogen SCADA Supervisory Control and Data Acquisition User Interface Canadian Standards Association Human-Machine Interface Hertz Inner Diameter Input/Output Outer Diameter Proportional Integral Derivative Process Variable Revolutions per minute...
Pall Link server supplied. If the Pall Link server supplied is connected to a local area network or a wider area network which allows traffic, enter the IP address of the Pall Link server into the browser of your networked device.
Appendix C: I/O List Table shows the full I/O list and the default I/O (ticked) in Pall Link as per bioreactor. Description Allegro Xpansion iCELLis PadReactor XRS 25 Multiplate Nano Mini Bioreactor Bioreactor Bioreactor Bioreactor 6 mm gas supply to primary outlet.
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Description Allegro Xpansion iCELLis PadReactor XRS 25 Multiplate Nano Mini Bioreactor Bioreactor Bioreactor Bioreactor 6 mm Gas supply to primary outlet. Nano Filter Heater 0-24 V Nano MAG Stirrer Internal connection. Measured in rpm Nano Peltier Internal connection. Measured in %. Nano Pump 1 Pump speed measured in rpm.
Appendix D: User Management (Default List) Access Control OFF - Non GMP Use Access Control ON - GMP Use Generic Username / Password Combination at Pall Link launch All changes require password entry to confirm on save. DEFAULT OPERATOR SUPERVISOR ADMINISTRATOR...
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Access Control OFF - Non GMP Use Access Control ON - GMP Use Generic Username / Password Combination at Pall Link launch All changes require password entry to confirm on save. DEFAULT PALL OPERATOR SUPERVISOR ADMINISTRATOR (logged OPERATOR SUPERVISOR ADMINISTRATOR...
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"UCI 3 Voltage – Item Label Name" + Low Low Input_Object (UCI 3 - Voltage) Alarm LowLow "UCI 3 Voltage – Item Label Name" + Low Input_Object (UCI 3 - Voltage) Alarm Low "UCI 3 Voltage – Item Label Name" + High Input_Object (UCI 3 - Voltage) Alarm High "UCI 3 Voltage –...
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Dissolved Oxygen Probe Temperature High High – Input_Object (EC_DO_T) Alarm HighHigh Electrochemical Sensor Low Low – Biomass Input_Object (BIOMASS) Alarm LowLow Low – Biomass Input_Object (BIOMASS) Alarm Low High – Biomass Input_Object (BIOMASS) Alarm High High High – Biomass Input_Object (BIOMASS) Alarm HighHigh Low Low –...
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Module Primary CO2 Valve PV1 Failed to Close – Gas Handling GHM Status Alarm Module Primary O2 Valve PV2 Failed to Open – Gas Handling Module GHM Status Alarm O2 Valve PV2 Failed to Close – Gas Handling Module GHM Status Alarm Air / N2 Valve PV3 Failed to Open –...
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Primary Outlet Pressure High – Gas Handling Module GHM Outlet Pressure Alarm High Primary Outlet Pressure High High – Gas Handling GHM Outlet Pressure Alarm HighHigh Module Secondary Outlet Pressure Low Low – Gas Handling GHM Outlet Pressure Alarm High Module Secondary Outlet Pressure Low –...
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+1 516 484 5400 phone Sweden, Switzerland, Taiwan, Thailand, the United Kingdom, the United States, and biopharm@pall.com e-mail Venezuela. Distributors in all major industrial areas of the world. To locate the Pall office or distributor nearest you, visit www.pall.com/contact. European Headquarters...
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