Broadley James SingleSense SU600 User manual

Operation Manual
SingleSense™Single-Use
pH Sensor
Doc Nbr: OM-082101 R2
Published 28 February 2022
Model SU600/SU680

Operation Manual
Purpose and Scope
Purpose
This manual provides instructions on how to operate Models SU600/SU680 SingleSense™single-use pH
sensors 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 sensors.
Precautions
This product is intended for professional use only. Follow your standard operating procedures when using this
product. Do not use the product if it is broken, defective, or visually damaged.
Disclaimers
Read all instructions prior to installing or operating this product. Save this manual for future reference.
If the instructions in this manual are unclear, contact Broadley-James. If this instruction manual is not for the product ordered, call [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 but not limited to PALL, Eldon James Corporation, Saint-Gobain Biopharm, and Colder. 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.
February 2022 | 2
OM-082101 R2
Model SU600/SU680 SingleSense™Single-Use pH Sensor

Compliance Information
Compliance
Broadley-James Corporation confirms Models SU600/SU680 SingleSense™single-use pH sensors meet the following
regulatory and compliance standards:
CE Compliant Yes
RoHS Compliant Yes
REACH Compliant Yes
CFR 21-11 Compliant Not applicable
BSE/TSE/ADI Compliant Yes
USP Class VI Compliant Yes, all wetted parts
FDA Material Compliant Yes, all wetted parts
Wetted Materials
PEEK: UPS Class VI, ADI-Free, Extraction Tested 21CFR, 177.2600 | Dimethyl Silicone Rubber: Pt Cure, USP Class VI,
Extraction Tested 21 CFR, 177.2600 | EPDM: USP Class VI, FDA Compliant, ADI-Free | Lead-Free Glass | Alumina
Silicate
Full scale extractable and leachable test based on BPOG extractable protocol and USP 665 available upon request.
February 2022 | 3
OM-082101 R2
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Operation Manual

Product Description and Symbol Definitions
Product Description
The SU600 and SU680 SingleSense™single-use pH sensors are designed for operation with a downstream
bioprocess system.
Definition of Symbols
Catalogue number
Serial number
CE marking
Use by date
Temperature limit
Quantity
Caution
February 2022 | 4
OM-082101 R2
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Operation Manual

Table of Contents
Operation Overview 6
Step 1: How It Works 7
Step 2: Startup, Calibration, and Operation 14
Step 3: Optional Mid-Run Standardization Check 24
Appendices 29
Appendix A –Buffer Storage Chamber Solution Table
Appendix B –Calibration Tag Data
Appendix C –Specification Sheets
Appendix D –Purchasing Sheets
February 2022 | 5
OM-082101 R2
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Operation Manual

Step 1
How It Works
Step 2
Startup, Calibration, and Operation Step 3
Optional Mid-Run Standardization Check
•Essential Terms and
Definitions
•Sensor Description
•Cutaway of Operation
•Connect the Sensor to the
Control System
•Calibrate
•Switch the pH Sensor Into
the Buffer Storage Chamber
•Check the pH Sensor Offset
•Switch the pH Sensor Back
Into Flow Stream
Operation Steps
February 2022 | 6
OM-082101 R2
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Operation Manual
Operation Overview

Step 1: How It Works
•Essential Terms and Definitions
•Sensor Description
•Cutaway of Operation
February 2022 | 7
OM-082101 R2
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Operation Manual

1.1 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.
1.0 How It Works
February 2022 | 8
OM-082101 R2
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Operation Manual
Term
Definition
Aseptic connector (optional)
Attaches the sensor to the flow stream
Bracket clip
For attachment to an optional mounting bracket
Calibration tag
Tag on the sensor’s cable that displays data specific to each sensor (do not remove)
Yellow protective cap
Protects the sensor’s VP8 connector during shipment
Dial face
Displays the position of the sensor in either measure or calibrate
Inlet
Allows process solution to pass through the sensor
Mounting bracket (optional)
An optional bracket to mount sensor in a vertical position
Outlet
Allows process solution to flow out of the sensor
Protective barb cover
Disposable cover protecting the barb (not shown)
Sensor’s VP8 connector
Connects the sensor to the control system
Switch
Changes the position of the sensor between measure and calibrate
Tubing
Allows process solution to pass through the flow cell
Zip ties
Secures tubing to inlet and aseptic connector

1.2 Sensor Description
Figure 1. Sensor description
February 2022 | 9
OM-082101 R2
Calibration tag
Dial face
Inlet
Outlet
Sensor’s VP8
Connector
Switch
Bracket clip
1.0 How It Works
Yellow
Protective Cap
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Operation Manual

1.3 Single-Use Assembly Description
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Figure 2. Single-use assembly description
February 2022 | 10
OM-082101 R2
Yellow
protective cap
Calibration tag
Dial face
Outlet
Inlet
Switch
Bracket clip
Customer-specified tubing
Customer-specified aseptic
connector
Blue zip-tie
1.0 How It Works
Operation Manual

Model SU600/SU680 SingleSense™Single-Use pH Sensor
February 2022 | 11
OM-082101 R2
1.4 Mounting to Optional Bracket
To mitigate inline bubbles, the
recommended orientation for installing
the sensor is vertical, with the outlet on
the top and the inlet on the bottom.
Broadley-James offers an optional sensor
bracket for this purpose. Contact
Broadley-James sales for more
information.
Outlet
Inlet
Figure 3. Mounting sensor to optional bracket
Bracket Clip
1.0 How It Works
Operation Manual
Mounting bracket
(optional)

1.5 Sensor Operation Modes
Figure 4. Sensor operation modes
1.0 How It Works
February 2022 | 12
OM-082101 R2
The sensor has two operation modes—measure and calibrate. Use the switch on the dial face to
move the sensor between the two positions.
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Operation Manual
Move Switch to the Measure Position
pH Sensor in Flow Stream Move Switch to the Calibrate Position
pH Sensor in Buffer Storage Chamber

1.6 Cutaways of Sensor Operation Modes
Figure 5. Cutaways of sensor operation modes
Switch to the Measure Position
pH Sensor in Flow Stream
This image shows the pH sensor out of the buffer
storage chamber and measuring the pH of the process
solution.
Switch to the Calibrate Position
pH Sensor in Buffer Storage Chamber
This image shows the pH sensor out of the process
solution and measuring the pH of the buffer storage
chamber.
1.0 How It Works
February 2022 | 13
OM-082101 R2
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Operation Manual
pH sensor in
flow stream
pH sensor in
buffer storage
chamber

Step 2: Startup, Calibration, and Operation
•Sequence of Startup, Calibration, and Operation
•Mount Sensor to Optional Bracket
•Connect the Sensor to Instrumentation
•Calibrate Sensor
February 2022 | 14
OM-082101 R2
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Operation Manual

2.0 Startup, Calibration, and Operation
2.1 Sequence of Startup, Calibration, and Operation
February 2022 | 15
OM-082101 R2
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Operation Manual
Startup,
Calibration,
and
Operation
1. Confirm the sensor
cable is connected to
process instrumentation.
2. If the sensor is used for
control, set the pH control loop
is on HOLD, PAUSE, or OFF.
3. Perform a 1-point
standardization
using the calibration
tag data.
4. Move the switch to
the measure position.
5. Take the pH control loop
off PAUSE if the control
loop was previously set to
HOLD, PAUSE or OFF.

2.2 Mount the sensor onto the optional bracket by snapping it into place.
Figure 6. Installing new sensor to optional mounting bracket
2.0 Startup, Calibration, and Operation
February 2022 | 16
OM-082101 R2
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Operation Manual
Bracket clip
Bracket clip
Fastener
Fastener
Mounting bracket
(optional)

2.3 Confirm the sensor is connected to your instrumentation.
Figure 7. Connecting sensor to instrumentation
•Remove the yellow protective
cap from the sensor’s VP8
connector.
•Connect the sensor to your
pH meter or process control
system with the VP8 plug.
2.0 Startup, Calibration, and Operation
February 2022 | 17
OM-082101 R2
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Operation Manual
Do not touch the connector
pins or change the switch
on the dial face to the
measure position.
Sensor’s VP8
connector
VP8 plug
Yellow
protective cap
Calibration tag
Switch in
calibrate
position

2.4 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 calibrate position if the
closed loop control is active.
2.0 Startup, Calibration, and Operation
Note: Follow your standard operating procedure for sensor calibration.
February 2022 | 18
OM-082101 R2
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Operation Manual

2.4 Calibration: Direct Input of Offset and Slope
Figure 8. Direct input of offset and slope
1. Reference the data on the
calibration tag.
2. Take the Factory Offset and
Span/slope (mV) information and
input it into the process
instrumentation.
Note: The pH value should read within
0.05 pH units of the values on the
calibration tag, correctly reflecting the
buffer storage chamber pH.
See next slide to perform a 1-point
standardization.
2.0 Startup, Calibration, and Operation
The Span/slope (mV) is the sensor’s mV to one pH
units at a given temperature or the percentage of
the theoretical value of the sensor’s millivolts to pH
units at a given temperature.
The Factory Offset is the sensor’s
offset (mV at pH 7) when measured
at the factory before shipping.
February 2022 | 19
OM-082101 R2
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Operation Manual

2.5 Calibration: 1-point Standardization
Figure 9. Calibration: 1-point standardization
Perform a 1-point standardization.
Note: The 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.
This completes the 1-point
standardization process.
2.0 Startup, Calibration, and Operation
The Calibration pH refers to the pH of the buffer
solution inside the sensor at 25° C.
February 2022 | 20
OM-082101 R2
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Operation Manual