Broadley James SingleSense SU600 Operation Manual

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Operation Manual

SingleSense

Single-Use

™

pH Sensor

Model SU600/SU680

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Summary of Contents for Broadley James SingleSense SU600

Page 1 Operation Manual SingleSense Single-Use ™ pH Sensor Model SU600/SU680...
Page 2 Purpose and Scope Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Purpose This manual provides instructions on how to operate Models SU600/SU680 SingleSense™ Single-Use pH Sensor for use with a downstream bioprocess system. Scope This operation manual is for customers who purchase and use Models SU600/SU680 SingleSense™ Single-Use pH Sensor.
Page 3 Compliance Information Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Compliance Broadley-James Corporation confirms Models SU600/SU680 SingleSense™ Single-Use pH Sensor meets the following regulatory and compliance standards: CE Compliant RoHS Compliant REACH Compliant CFR 21-11 Compliant Not applicable BSE/TSE/ADI Compliant USP Class VI Compliant Yes, all wetted parts FDA Material Compliant...
Page 4 Product Description and Symbol Definitions Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Product Description The SU600 and SU680 SingleSense™ Single-Use pH Sensor is designed for installation with a downstream bioprocess system. Definition of Symbols Catalogue number Serial number CE marking Use by date Temperature limit Quantity...
Page 5 Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Table of Contents Operation Overview Step 1: How It Works Step 2: Startup, Calibration, and Operation Step 3: Optional Mid-Run Standardization Check Appendices Appendix A – Buffer Storage Chamber Solution Table Appendix B – Calibration Tag Data Appendix C –...
Page 6 Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Operation Overview Step 3 Step 2 Step 1 Optional Mid-Run Standardization Check Startup, Calibration, and Operation How It Works • Sequence of Optional Mid-Run Standardization • Sequence of Startup, Check • Essential Terms and Calibration, and •...
Page 7 Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Step 1: How It Works • Essential Terms and Definitions • Sensor Description • Cutaway of Operation Information subject to change based on feedback. Draft #4 | 18-Aug-21 | Confidential and Proprietary | 7 OM-082101 R1...
Page 8 1.0 How It Works Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Essential Terms and Definitions The table outlines terms and definitions that are important for the operation process. See the next slide for their location on the sensor and single-use assembly. Term Definition Aseptic connector (optional)
Page 9 1.0 How It Works Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Sensor Description Outlet Dial face Calibration tag Bracket clip Sensor’s VP8 Connector Connector Protective Cap Inlet Switch Figure 1. Sensor description Information subject to change based on feedback. Draft #4| 18-Aug-21 | Confidential and Proprietary | 9 OM-082101 R1...
Page 10 1.0 How It Works Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Single-Use Assembly Description Customer-specified aseptic connector Customer-specified tubing Dial face Outlet Calibration tag Bracket clip Connector Switch protective cap Inlet Blue zip-tie Figure 2. Single-use assembly description Draft #4| 18-Aug-21 | Confidential and Proprietary | 10 Information can be changed subject to feedback.
Page 11 1.0 How It Works Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Mounting to Optional Bracket Mounting bracket (optional) Outlet To mitigate bubbles, we recommend installing the sensor in a vertical position, with the outlet on the top and inlet on the bottom.
Page 12 1.0 How It Works Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Sensor Operation Modes The sensor has two operation modes—measure and calibrate. Use the switch on the dial face to move the sensor between the two positions. Move Switch to the Measure Position Move Switch to the Calibrate Position pH Sensor in Flow Stream pH Sensor in Buffer Storage Chamber...
Page 13 1.0 How It Works Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Cutaways of Sensor Operation Modes Switch to the Calibrate Position Switch to the Measure Position pH Sensor in Buffer Storage Chamber pH Sensor in Flow Stream This illustration shows the pH sensor out of the This illustration shows the pH sensor out of the buffer process solution and measuring the pH of the buffer storage chamber and measuring the pH of the process...
Page 14 Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Step 2: Startup, Calibration, and Operation • Sequence of Startup, Calibration, and Operation • Mount Sensor to Optional Bracket • Connect the Sensor to Instrumentation • Calibrate Sensor Information subject to change based on feedback. Draft #4 | 18-Aug-21 | Confidential and Proprietary | 14 OM-082101 R1...
Page 15 2.0 Startup, Calibration, and Operation Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Sequence of Startup, Calibration, and Operation 1. Confirm the sensor 2. If the sensor is used for cable is connected to control, confirm the pH control your instrumentation. loop is set to HOLD, PAUSE, or OFF.
Page 16 2.0 Startup, Calibration, and Operation Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Mount the sensor onto the optional bracket by snapping it into place. Mounting bracket (optional) Fastener Fastener Bracket clip Bracket clip Figure 6. Installing new sensor to optional mounting bracket Information subject to change based on feedback.
Page 17 2.0 Startup, Calibration, and Operation Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Confirm the sensor is connected to your instrumentation. • Remove the protective cap Connector from the sensor’s VP8 protective cap connector. • Connect the sensor to your pH meter or process control system with the VP8 plug.
Page 18 2.0 Startup, Calibration, and Operation Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Pre-Calibration Precaution If this sensor is used for control, confirm the pH control loop is set to HOLD, PAUSE, or OFF in the control system before calibration. Do not switch the sensor to calibration position if the closed loop control is active.
Page 19 2.0 Startup, Calibration, and Operation Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Calibration: Direct Input of Offset and Slope The Factory Offset is the sensor’s offset (mV at pH 7) when measured at the factory before shipping. 1. Reference the data on the calibration tag.
Page 20 2.0 Startup, Calibration, and Operation Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Calibration (cont.): 1-point Standardization Perform a 1-point standardization. Note: The correct pH value of the sensor’s buffer chamber is indicated on the tag at 25° C. Refer to Appendix A – Storage Buffer Table for a complete chart of storage buffer value versus temperature.
Page 21 2.0 Startup, Calibration, and Operation Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Switch the sensor to the measure position. After completing a 1-point standardization, rotate the switch to the measure position. The pH sensor is now in the flow stream. Outlet Process solution...
Page 22 2.0 Startup, Calibration, and Operation Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Reengage the pH control loop. If this sensor is used for control, take the pH control loop off HOLD, PAUSE, or OFF on the control system. This completes the startup and calibration. The sensor is now operational and measuring the pH of your process.
Page 23 2.0 Startup, Calibration, and Operation Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Operation Checklist  1. Has the sensor been switched to the measure position for full operation?  2. If this sensor is being used for control, is the pH control loop system reengaged after the 1-point standardization check? The startup is complete.
Page 24 Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Step 3: Optional Mid-Run Standardization Check • Sequence of Optional Mid-Run Standardization Check • Switching the pH Sensor Into the Buffer Storage Chamber • Checking the pH Sensor Offset • Switching the pH Sensor Back Into the Flow Stream Information subject to change based on feedback.
Page 25 3.0 Optional Mid-Run Standardization Check Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Sequence of Optional Mid-Run Standardization Check 2. If the sensor is used for control, 1. Confirm the sensor is in pause the pH control loop. the measure position. Do we need this slide? Steps are...
Page 26 3.0 Optional Mid-Run Standardization Check Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Switch the pH Sensor Into the Buffer Storage Chamber 2. Move the switch to the 1. Confirm the sensor is in the calibrate position. measure position. Before you switch to calibrate, pause the pH control loop if the sensor is used for control. Figure 12.
Page 27 3.0 Optional Mid-Run Standardization Check Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Checking the pH Sensor Offset 4. Check the pH value on the calibration tag. The sensor should read within 0.05 pH units of the value on the calibration tag. 5.
Page 28 3.0 Optional Mid-Run Standardization Check Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Switching the pH Sensor Back Into Flow Stream 7. Move the switch back to the measure position. Reengage the pH control loop. Outlet Inlet This completes the optional mid-run standardization check. Figure 14.
Page 29 Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Appendices • Appendix A – Buffer Storage Chamber Solution Table • Appendix B – Calibration Tag Data • Appendix C – Dimensional Drawing of SU600 SingleSense™ Single-Use pH Sensor • Appendix D – Optional Bracket Mounting Information •...
Page 30 Appendices Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Appendix A – Buffer Storage Chamber Solution Table T, ºC Normalized pH (NIST 6.864) This table outlines the 0.0875 0.0589 nominal pH level of the 0.0349 sensor’s buffer storage 0.0156 chamber solution in -0.0114 correlation with -0.0205...
Page 31 Appendices Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Appendix B – Calibration Tag Data Note: The data on the tag is for sample purposes only. The Calibration Data is unique to each sensor. It gives the factory calibration principles and data for each sensor. The Factory Offset is the sensor’s offset (mV at pH 7) when measured at the factory before shipping.
Page 32 Appendices Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Appendix C – Dimensional Drawing of SU600 SingleSense™ Single-Use pH Sensor Figure 16. Dimensional drawing of sensor Placeholder Image. Subject to change. Draft #4 | 18-Aug-21 | Confidential and Proprietary | 32 OM-082101 R1...
Page 33 Appendices Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Appendix D – Optional Bracket Mounting Information Figure 17. Bracket mounting information Placeholder image. Subject to change. Draft #4 | 18-Aug-21 | Confidential and Proprietary | 33 OM-082101 R1...
Page 34 Appendices Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Appendix E – Drawing of Installed SU600 SingleSense™ Single-Use pH Sensor and Optional Bracket Figure 18. Dimensional drawing of installed sensor and bracket Placeholder Image. Subject to change. Draft #4 | 18-Aug-21 | Confidential and Proprietary | 34 OM-082101 R1...
Page 35 Appendices Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Appendix F – Post-installation Dimensions for SU600 SingleSense™ Single-Use pH Sensor Figure 19. Installation dimensions Placeholder Image. Subject to change. Draft #4 | 18-Aug-21 | Confidential and Proprietary | 35 OM-082101 R1...
Page 36 Appendices Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Appendix G – Dimensional Drawing of Single-Use Assembly with Sensor and Aseptic Connectors Placeholder for generic Sanofi drawing with Sanofi name redacted Figure 20. Dimensional drawing of single-use assembly Draft #4 | 18-Aug-21 | Confidential and Proprietary | 36 Information can be changed subject to feedback.
Page 37 Appendices Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Appendix H – Specification Sheet for SU600 SingleSense™ Single-Use pH Sensor Placeholder Draft #4 | 18-Aug-21 | Confidential and Proprietary | 37 Information can be changed subject to feedback. OM-082101 R1...
Page 38 Appendices Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Appendix I – Specification Sheet for SU680 SingleSense™ Single-Use pH Sensor Placeholder Draft #4 | 18-Aug-21 | Confidential and Proprietary | 38 Information can be changed subject to feedback. OM-082101 R1...
Page 39 Appendices Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Appendix J – Purchasing Sheet for SU600 with ⅛ in Barbed Hose Port Need this view but without blue zip ties SU600-01 (⅛ in barb) purchasing sheet Draft #4 | 18-Aug-21 | Confidential and Proprietary | 39 Information can be changed subject to feedback.
Page 40 Appendices Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Appendix J (cont.) – Purchasing Sheet for SU600 with ¼ in Barbed Hose Port SU600-02 (¼ in barb) purchasing sheet Draft #4 | 18-Aug-21 | Confidential and Proprietary | 40 Information can be changed subject to feedback. OM-082101 R1...
Page 41 Appendices Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Appendix J (cont.) – Purchasing Sheet for SU600 with ⅜ in Barbed Hose Port SU600-03 (⅜ in barb) purchasing sheet Draft #4 | 18-Aug-21 | Confidential and Proprietary | 41 Information can be changed subject to feedback. OM-082101 R1...
Page 42 Appendices Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Appendix K – Purchasing Sheet for SU680 with ½ in Barbed Hose Port SU600-11 (½ in barb) purchasing sheet Draft #4 | 18-Aug-21 | Confidential and Proprietary | 42 Information can be changed subject to feedback. OM-082101 R1...
Page 43 Appendices Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Appendix K (cont.) – Purchasing Sheet for SU680 with ¾ in Barbed Hose Port SU600-12 (¾ in barb) purchasing sheet Draft #4 | 18-Aug-21 | Confidential and Proprietary | 43 Information can be changed subject to feedback. OM-082101 R1...
Page 44 Appendices Model SU600/SU680 SingleSense™ Single-Use pH Sensor Operation Manual Appendix K (cont.) – Purchasing Sheet for SU680 with 1 in Barbed Hose Port SU600-13 (1 in barb) purchasing sheet Draft #4 | 18-Aug-21 | Confidential and Proprietary | 44 Information can be changed subject to feedback. OM-082101 R1...

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Singlesenses u680