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 (949) 829-5555.
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.
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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.
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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
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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
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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
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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
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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
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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
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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
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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
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