Broadley James SingleSense SU800 Operation Manual
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Broadley James SingleSense SU800 Operation Manual

Single-use ph sensor
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Operation Manual
SingleSense
Single-Use
™
pH Sensor
Model SU800
DRAFT #2

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Summary of Contents for Broadley James SingleSense SU800

  • Page 1 Operation Manual SingleSense Single-Use ™ pH Sensor Model SU800 DRAFT #2...
  • Page 2 Purpose, Scope, and Disclaimers Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers Purpose The purpose of this operation manual is a guide on how to operate the SU800 SingleSense™ Single-Use pH Sensor. Scope This operation manual is for customers who purchase and use the SU800 SingleSense™ Single-Use pH Sensor. Compliance Broadley-James Corporation confirms the SingleSense™...
  • Page 3 Product Description and Symbol Definitions Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers Product Description The SU800 SingleSense™ Single-Use pH Sensor is gamma-sterilizable and designed for pre-installation in a single-use bioprocessing container (BPC). Explanation of Symbols on Packaging Labels Catalogue number Serial number CE marking...

  • Page 4: Table Of Contents

    Table of Contents Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers Operation Steps Step 1: Overview Step 2: pH Measurement Step 3: Mid-Run Calibration Check Appendices Appendix A – Specification Sheet Appendix B – Dimensional Drawing Appendix C –...

  • Page 5: Operation Steps

    Operation Steps Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers STEP 2 STEP 3 STEP 1 pH Measurement Mid-Run Calibration Check Sensor Overview • Sensor Description • Connection to • Sequence of Procedure Instrument •...

  • Page 6: Step 1: Overview

    Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers Step 1: Overview • Overview of Sensor • How It Works: Sensor Retracted • How It Works: Sensor Inserted Draft #2| 10-Jun-21 | Confidential and Proprietary | 6 OM-062103 R1...
  • Page 7 1.0 Overview Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers 1.1 Definitions and Terminology Red safety Lever backward zip tie pH sensor retracted *create same without red tie* Calibration tag VP8 connector Lever arm Storage Protruding Lever forward...
  • Page 8 1.0 Overview Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers 1.2 How It Works Calibration chamber Lever backward Buffer solution pH sensor retracted O-ring seal Lever forward pH sensor inserted Tubular bulb Figure 2. Sensor retracted and inserted Draft #2| 10-Jun-21 | Confidential and Proprietary | 8 OM-062103 R1...

  • Page 9: Step 2: Ph Measurement

    Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers Step 2: pH Measurement • Connect to Instrument • Check Calibration • Insert Sensor Into Process Media Draft #2| 10-Jun-21 | Confidential and Proprietary | 9 OM-062103 R1...
  • Page 10 2.0 Operation Instructions Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers 2.1 Connect the sensor to control automation. Placeholder for isometric cable plug with side view *to scale – same iso angle – with simulated cable connected and added image (sideview) of VP8 plug* Connector...
  • Page 11 2.0 Operation Instructions Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers 2.2 Pre-Calibration Procedure • Begin operating the BPC system and allow it to reach operating temperature. • Allow the sensor to equilibrate with the BPC system at its operating temperature for at least two hours.
  • Page 12 2.0 Operation Instructions Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers 2.2 Calibration Procedure #1: Direct Input of Offset and Slope Reference the calibration tag. Take the Factory Offset and Span/slope (mV) information and input it into the automation instrument.
  • Page 13 2.0 Operation Instructions Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers 2.3 Calibration Procedure #2: 1-point pH Standardization The correct pH value of the sensor’s buffer chamber is indicated on the tag. Reference the appendix for a more complete chart of buffer value versus...
  • Page 14 2.0 Operation Instructions Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers 2.4 Remove the red safety zip tie. Need updated image with red zip tie on in top image and being taken off in bottom image.
  • Page 15 2.0 Operation Instructions Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers 2.5 Insert the sensor and secure the lever arm. Need updated image with red zip tie on bottom image. • Push until the handle touches the silicone tubing.

  • Page 16: Step 3: Mid-Run Calibration Check

    Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers Step 3: Mid-Run Calibration Check • Sequence of Procedure • Sensor Equilibration Draft #2| 10-Jun-21 | Confidential and Proprietary | 16 OM-062103 R1...
  • Page 17 3.0 The Mid-Run Calibration Check Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers 3.1 Sequence of Procedure Pause the pH control loop If the change in pH is more than 0.2 pH on the BPC control system. units, reset integral on proportional- integral- derivative (PiD) parameter to prevent control oscillations before re-...
  • Page 18 3.0 The Mid-Run Calibration Check Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers 3.2 How It Works 1. Pause pH control before you retract the sensor. 2. Retract the sensor. The o-ring seal cleans the tubular bulb as it is retracted into the buffer chamber.
  • Page 19 3.0 The Mid-Run Calibration Check Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers 3.3 How It Works 3. Check the pH value on the calibration tag. The sensor should now read within 0.05 pH of the value on the tag. 4.
  • Page 20 3.0 The Mid-Run Calibration Check Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers 3.2 How It Works 6. Caution: If the change in pH is greater than 0.2, reset integral value of PiD control and reset it to 0 before reengaging the pH control.

  • Page 21: Appendices

    Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers Appendices • Appendix A – Specification Sheet • Appendix B – Dimensional Drawing • Appendix C – Storage Buffer Table • Appendix D– Calibration Tag Data •...
  • Page 22 Appendices Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers Appendix A – Specification Sheet Draft #2| 10-Jun-21 | Confidential and Proprietary | 22 OM-062103 R1...

  • Page 23: Appendix B - Dimensional Drawing

    Appendices Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers Appendix B – Dimensional Drawing Placeholder Image. Updated image needed. Figure 11. Dimensional drawing Draft #2| 10-Jun-21 | Confidential and Proprietary | 23 OM-062103 R1...

  • Page 24: Appendix C - Storage Buffer Table

    Appendices Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers Appendix C – Storage Buffer Table T, ºC Normalized pH (NIST 6.864) The following table 0.0875 0.0589 outlines the nominal pH 0.0349 level of the SU800 0.0156 storage solution in -0.0114...

  • Page 25: Appendix D - Calibration Tag Data

    Appendices Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers Appendix D – 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 SU800. The Factory Offset is the sensor’s offset (mV at pH 7) when measured at the factory before shipping.

  • Page 26: Appendix E - Purchasing Datasheet

    Appendices Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers Appendix E – Purchasing Datasheet SingleSense ™ Single-Use pH Sensor Placeholder – Can be changed/edited per feedback. Draft #2| 10-Jun-21 | Confidential and Proprietary | 26 OM-062103 R1...

  • Page 27: Appendix F - Glossary Of Terms And Definitions

    Appendices Model SU800 SingleSense™ Single-Use pH Sensor Operation Manual | Insertion/Retraction Design for Bioprocess Containers Appendix F – Glossary of Terms and Definitions Term Definition Variopin Connector Cap This cap protects the VP8 connector during shipment. The tag contains data specific to each sensor. It is not to be removed. Red Safety Zip Tie The red safety zip tie keeps the lever arm locked in a retracted or operative position.

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Su800-1100-n

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