Broadley James SingleSense SU800 User manual

Operation Manual
SingleSense™Single-Use
pH Sensor
Model SU800

Model SU800 SingleSense™Single-Use pH Sensor
Operation Manual
Purpose and Scope
Purpose
This manual provides instructions on how to operate the SU800 SingleSense™Single-Use pH Sensor for use
with a bioprocess container (BPC).
Scope
This manual is for customers who purchase and use the SU800 SingleSense™Single-Use pH Sensor.
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 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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Model SU800 SingleSense™Single-Use pH Sensor
Compliance Information
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Compliance
Broadley-James Corporation confirms Model SU800 SingleSense™Single-Use pH Sensor meets 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.
Operation Manual

Model SU800 SingleSense™Single-Use pH Sensor
Product Description and Symbol Definitions
Product Description
The SU800 SingleSense™Single-Use pH Sensor is gamma sterilizable and designed for use with a BPC.
Definition of Symbols
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Catalogue number
Serial number
CE marking
Use by date
Temperature limit
Quantity
Caution
Operation Manual

Table of Contents
Model SU800 SingleSense™Single-Use pH Sensor
Operation Overview 6
Step 1: How It Works 7
Step 2: Startup, Calibration, and Operation 11
Step 3: Mid-Run Standardization Check 22
Appendices 27
Appendix A –Dimensional Drawing of Sensor
Appendix B –Buffer Storage Chamber Solution Table
Appendix C –Calibration Tag Data
Appendix D –Specification Sheet
Appendix E –Purchasing Sheet
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Operation Manual

Step 1
How It Works
Step 2
Startup, Calibration, and Operation
Step 3
Optional Mid-Run Standardization Check
Model SU800 SingleSense™Single-Use pH Sensor
•Essential Terms and
Definitions
•Sensor Description
•Cutaway of Operation
•Connect the Sensor to the
BPC Control System
•Temperature Check
•Calibration
•Remove Red Safety Zip Tie
•Retraction into the Buffer
Storage Chamber
•Checking the Sensor Offset
•Reinsertion of Sensor
Operation Steps
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Operation Manual
Operation Overview

Model SU800 SingleSense™Single-Use pH Sensor
Step 1: How It Works
•Essential Terms and Definitions
•Sensor Description
•Cutaway of Operation
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Operation Manual

Model SU800 SingleSense™Single-Use pH Sensor
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1.1 Essential Terms and Definitions
This table outlines terms and definitions important for the operation process. See the next slide for their
location on the sensor.
Term Definition
Buffer storage chamber Houses and protects the glass pH sensor within the sensor body
Calibration tag Tag on the sensor’s cable that displays data specific to each sensor (do not remove)
Connector protective cap Protects the VP8 connector during shipment
Glass pH sensor Measures the pH of the buffer storage chamber when in the lever arm is in the back
position and the process media when the lever arm is in the forward position
Lever arm Retracts and inserts the glass pH sensor
Lever arm back position Glass pH sensor is retracted into the buffer storage chamber when the lever arm is in
the back position
Lever arm forward position Glass pH sensor is inserted into the process media and is measuring the process
media’s pH when the lever arm is in the forward position
Removable red safety zip tie Designed to keep the sensor in the retracted position for shipment
Sensor’s VP8 connector Links the sensor to the BPC control system
1.0 How It Works
Operation Manual

1.2 Sensor Description
Model SU800 SingleSense™Single-Use pH Sensor
Figure 1. Sensor description
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Sensor’s VP8
connector
Calibration tag
Removable
red safety
zip tie
Buffer
storage
chamber Glass pH
sensor
Lever arm
back
position
Lever arm
forward
position
Lever Arm Back
pH Sensor Retracted
Lever Arm Forward
pH Sensor Inserted
1.0 How It Works
Operation Manual

1.3 Cutaway of Operation
Model SU800 SingleSense™Single-Use pH Sensor
Figure 2. Lever arm back and forward
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Lever Arm Back
pH Sensor Retracted Into
Buffer Storage Chamber
The glass pH sensor is out of the process
media and measuring the buffer storage
chamber pH.
Lever Arm Forward
pH Sensor Inserted Into BPC
The glass pH sensor is inserted into the
process media and measuring the pH of
the process media.
Buffer storage
chamber
Process
media
Glass pH
sensor
O-ring
seal
1.0 How It Works
Operation Manual

Model SU800 SingleSense™Single-Use pH Sensor
Step 2: Startup, Calibration, and Operation
•Sequence of Startup, Calibration, and Operation
•Connect the Sensor to the BPC Control System
•Temperature Check
•Calibration
•Remove the Red Safety Zip Tie
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Operation Manual

Model SU800 SingleSense™Single-Use pH Sensor
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2.0 Startup, Calibration, and Operation
2.1 Sequence of Startup, Calibration, and Operation
1. Connect the sensor to
the BPC control system.
2. Bring BPC, process media, and the
sensor to operating temperature.
3. Before calibration, confirm the
pH control loop is set to HOLD,
PAUSE, or OFF in the BPC control
system.
5. Remove the
red safety zip tie
after calibration.
6. Push the lever arm
forward to begin
measuring the pH of
the process media.
7. Take the pH control
loop off PAUSE on the
BPC control system.
Startup,
Calibration,
and Operation 4. Calibration: Input tag information
into the BPC control system. Then,
perform a 1-point standardization
with the sensor inside the buffer
storage chamber.
Operation Manual

2.2 Connect the sensor to the BPC control system.
Model SU800 SingleSense™Single-Use pH Sensor
Figure 3. Connecting sensor to BPC control system
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BPC control system
VP8 cable plug
SU800 installed into an Eldon
James barbed port with
simulated BPC
•Remove the yellow protective connector cap
from the variopin connector.
•Do not touch the connector pins.
•Connect the sensor to the BPC control system
with the VP8 plug.
Note: Part of the BPC is simulated in the image.
2.0 Startup, Calibration, and Operation
Operation Manual
Connector protective cap
Connector pins

2.3 Bring the process media to operating temperature.
•Bring the process
media to operating
temperature (37°C).
•Allow the sensor to
reach thermal
equilibrium with the
process media.
Model SU800 SingleSense™Single-Use pH Sensor
Figure 4. Process media at operating temperature
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37° C
2.0 Startup, Calibration, and Operation
Operation Manual

2.4 Pre-calibration Precaution
Model SU800 SingleSense™Single-Use pH Sensor
Before calibration, confirm the pH control loop is set
to HOLD, PAUSE, or OFF in the BPC control system.
Do not retract the sensor if the closed loop control is
active.
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2.0 Startup, Calibration, and Operation
Note: Follow your standard operating procedure for sensor calibration.
Operation Manual

2.5 Calibration: Direct Input of Offset and Slope
Model SU800 SingleSense™Single-Use pH Sensor
Figure 5. 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.
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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.
Operation Manual

2.6 Calibration: 1-point Standardization
Model SU800 SingleSense™Single-Use pH Sensor
Figure 6. Calibration: 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 B –Storage
Buffer Table for a complete chart
of storage buffer value versus
temperature.
This completes the 1-point
standardization process.
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2.0 Startup, Calibration, and Operation
The Calibration pH refers to the pH of the buffer
solution inside the sensor at 37°C.
Operation Manual

2.7 Remove the red safety zip tie.
Model SU800 SingleSense™Single-Use pH Sensor
Figure 7. Red safety zip tie removed
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2.0 Startup, Calibration, and Operation
•Tools are not needed to
remove the zip tie.
•Pull red safety zip tie in
opposite directions. The
zip tie will separate
along a prescored line.
Note: Do not push the lever
arm forward until you are
ready to operate.
Operation Manual

2.8 Insert the pH sensor into the process media.
Model SU800 SingleSense™Single-Use pH Sensor
Figure 8. Lever arm inserted and secured
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•Push the lever arm forward until
the handle touches the silicone
tubing. The glass pH sensor will
insert into the process media.
•An audible click may occur as the
lever arm is pushed forward.
Note: Securing the lever arm in
forward position with a red safety zip
tie as shown is recommended to
prevent accidental retraction. Add a
lockout tag per your standard
operating procedures.
2.0 Startup, Calibration, and Operation
Operation Manual

2.9 Reactivate the pH control loop.
Model SU800 SingleSense™Single-Use pH Sensor
The pH control loop can be taken off HOLD, PAUSE,
or OFF and made active again after the glass pH
sensor has been inserted into the BPC media.
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2.0 Startup, Calibration, and Operation
Operation Manual