Broadley James SingleSense SU800 User manual

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

Model SU800 SingleSense™Single-Use pH Sensor
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
Purpose, Scope, and Disclaimers
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.
Disclaimers
Read all instructions prior to installing or operating this product. Save this manual for future reference.
If you do not understand any of the instructions, contact Broadley-James for clarification. If this instruction manual is not the correct manual, contact us at [phone].
Follow all warnings, cautions, and instructions marked on and supplied with the product.
To ensure proper performance, use qualified personnel to install, operate, update, calibrate, and maintain the product.
This product is designed for single use.
Third Party Content
The manual uses the trademarks and names of third parties, including Bedford Industries and Eldon James Corporation. Broadley-James Corporation and users agree that the third parties are not affiliated or partnered with Broadley-James Corporation. The mention of third parties is not an endorsement of any business offering, products, or services.
Broadley-James Corporation is not liable for any products or services of mentioned third parties or any transactions or decisions that may arise from the mention of third parties in this manual for any reason.
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Compliance
Broadley-James Corporation confirms the SingleSense™Single-Use pH Sensor (Model SU800) meets the following EU
directives (including all applicable amendments):
RoHS 3 Directive
Precautions (Placeholder Information)
This device is intended for professional use only. Follow your standard operation procedures when operating this device. Do
not operate the device if it is broken, defective, or otherwise in anon-operational state.

Model SU800 SingleSense™Single-Use pH Sensor
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
Product Description and Symbol Definitions
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
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Catalogue number
Serial number
CE marking
Use-by date
Temperature limit
Quantity

Table of Contents Model SU800 SingleSense™Single-Use pH Sensor
Operation Steps 5
Step 1: Overview 6
Step 2: pH Measurement 9
Step 3: Mid-Run Calibration Check 16
Appendices 21
Appendix A –Specification Sheet
Appendix B –Dimensional Drawing
Appendix C –Storage Buffer Table
Appendix D –Calibration Tag Data
Appendix E –Purchasing Datasheet
Appendix F –Glossary of Terms and Definitions
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
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STEP 1
Sensor Overview
STEP 2
pH Measurement
STEP 3
Mid-Run Calibration Check
Model SU800 SingleSense™Single-Use pH Sensor
•Sensor Description
•How It Works: Sensor
Retracted
•How It Works: Sensor
Inserted
•Connection to
Instrument
•Measurement
•Calibration Check
•Sequence of Procedure
•Breakdown of
Procedure
Operation Steps
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
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Model SU800 SingleSense™Single-Use pH Sensor
Step 1: Overview
•Overview of Sensor
•How It Works: Sensor Retracted
•How It Works: Sensor Inserted
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
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1.0 Overview
1.1 Definitions and Terminology
Model SU800 SingleSense™Single-Use pH Sensor
Figure 1. Sensor terms and definitions
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Lever backward
pH sensor retracted
*create same without red tie*
Lever forward
pH sensor inserted
VP8 connector
Calibration tag
Red safety
zip tie
Storage
chamber
Protruding
bulb
Lever arm

v
1.0 Overview
1.2 How It Works
Model SU800 SingleSense™Single-Use pH Sensor
Figure 2. Sensor retracted and inserted
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Lever backward
pH sensor retracted
Lever forward
pH sensor inserted
Calibration
chamber Buffer solution
Tubular bulb
O-ring seal

Model SU800 SingleSense™Single-Use pH Sensor
Step 2: pH Measurement
•Connect to Instrument
•Check Calibration
•Insert Sensor Into Process Media
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
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1
2.0 Operation Instructions
2.1 Connect the sensor to control automation.
Model SU800 SingleSense™Single-Use pH Sensor
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
Figure 3. Connecting sensor to control automation
Remove and discard any remaining packaging material that may be wrapped around the
sensor and its cable connector.
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Connector
protective cap
Placeholder for isometric cable plug with
side view
*to scale –same iso angle –with
simulated cable connected and added
image (sideview) of VP8 plug*
Simulated BPC bag
*add simulated BPC bag*

1
2.2 Pre-Calibration Procedure
Model SU800 SingleSense™Single-Use pH Sensor
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
2.0 Operation Instructions
•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.
•Before calibration, confirm the pH control loop is set to HOLD, PAUSE, or
OFF in the control system
•There are two ways to calibrate the sensor. Proceed to the next slide.
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1
2.2 Calibration Procedure #1: Direct Input of Offset and Slope
Model SU800 SingleSense™Single-Use pH Sensor
Figure 4. Calibration procedure #1
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
2.0 Operation Instructions
1. Reference the calibration tag.
2. Take the Factory Offset and
Span/slope (mV) information
and input it into the
automation instrument.
3. The pH value should read
within 0.05 pH units of the
values on the calibration tag,
correctly reflecting the buffer
pH.
4. If not, perform a 1-point
standardization (see next
slide).
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1
2.3 Calibration Procedure #2: 1-point pH Standardization
Model SU800 SingleSense™Single-Use pH Sensor
Figure 5. Calibration procedure #2
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
2.0 Operation Instructions
1. 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
temperature.
2. Perform a 1-point
standardization of the
sensor using the pH value
at the appropriate
temperature.
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2.0 Operation Instructions
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.
Text?
Model SU800 SingleSense™Single-Use pH Sensor
Figure 6. Red safety zip tie removal
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
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2.5 Insert the sensor and secure the lever arm.
Need updated image with red zip tie on
bottom image.
Model SU800 SingleSense™Single-Use pH Sensor
Figure 7. Lever arm insertion and securement
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
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•Push until the
handle touches the
silicone tubing.
•An audible click
occurs as the lever
arm is pushed
forward.
2.0 Operation Instructions

1
Model SU800 SingleSense™Single-Use pH Sensor
Step 3: Mid-Run Calibration Check
•Sequence of Procedure
•Sensor Equilibration
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Model SU800 SingleSense™Single-Use pH Sensor
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
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3.0 The Mid-Run Calibration Check
3.1 Sequence of Procedure
Pause the pH control loop
on the BPC control system.
Retract the sensor into
the buffer chamber.
The sensor should now read within 0.05 of the tag
value (approx. 6.7 pH).
Decision Point:
If a 1-point standardization is
necessary, use the sensor’s buffer
reference or a grab sample.
The calibration is complete.
Reinsert the pH sensor.
If the change in pH is more than 0.2 pH
units, reset integral on proportional-
integral-derivative (PiD) parameter to
prevent control oscillations before re-
engaging pH control
5
Calibrating
the Sensor

3.0 The Mid-Run Calibration Check
3.2 How It Works
Model SU800 SingleSense™Single-Use pH Sensor
Figure 8. Steps 1 and 2
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
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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.
*need image without tie*

3.0 The Mid-Run Calibration Check
3.3 How It Works
Model SU800 SingleSense™Single-Use pH Sensor
Figure 9. Steps 3, 4 and 5
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
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4. If the difference is greater than 0.05 pH,
decide whether to recalibrate using the
SU800 buffer chamber pH or a grab
sample pH.
3. Check the pH value on the calibration
tag. The sensor should now read within
0.05 pH of the value on the tag.
5. Calibration complete. Reinsert the
probe.
*need image without tie*

3.0 The Mid-Run Calibration Check
3.2 How It Works
Model SU800 SingleSense™Single-Use pH Sensor
Figure 10. Steps 6 and 7
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
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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.
7. Reengage the pH control.