Broadley James SingleSense SU600 Manuale utente
Operation Manual
SingleSense™Single-Use
pH Sensor
Model SU600/SU680
Operation Manual
Purpose and Scope
Purpose
This manual provides instructions on how to operate Models SU600/SU680 SingleSense™Single-Use pH
Sensor 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 Sensor.
Precautions
This product is intended for professional use only. Follow your standard operating procedures when using this
product. Do not install 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 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 (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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Information subject to change based on feedback.
Model SU600/SU680 SingleSense™Single-Use pH Sensor
Compliance Information
Compliance
Broadley-James Corporation confirms Models SU600/SU680 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, USP Class VI, ADI-Free Extraction Tested 21CFR, 177.2600, Dimethyl Silicone Rubber, Pt Cure, USP Class VI
Extraction Tested 21CFR, 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 Sensor is designed for installation 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 –Dimensional Drawing of SU600 SingleSense™Single-Use pH Sensor
Appendix D –Optional Bracket Mounting Information
Appendix E –Drawing of Installed SU600 SingleSense™Single-Use pH Sensor and Optional Bracket
Appendix F –Post-installation Dimensions for SU600 SingleSense™Single-Use pH Sensor
Appendix G –Dimensional Drawing of SU600 SingleSense™Single-Use Assembly
Appendix H –Specification Sheets for SU600 SingleSense™Single-Use pH Sensor
Appendix I –Specification Sheets for SU680 SingleSense™Single-Use pH Sensor
Appendix J –Purchasing Sheets for SU600 SingleSense™Single-Use pH Sensor
Appendix K –Purchasing Sheets for SU680 SingleSense™Single-Use pH Sensor
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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
•Sequence of Startup,
Calibration, and
Operation
•Connect the Sensor to
the Control System
•Calibration
•Sequence of Optional
Mid-Run Standardization
Check
•Switching pH Sensor Into
the Buffer Storage
Chamber
•Checking the pH Sensor
Offset
•Switching the pH Sensor
Back Into Flow Stream
Operation Overview
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Model SU600/SU680 SingleSense™Single-Use pH Sensor
Operation Manual
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 bracket
Calibration tag Tag on the sensor’s cable that displays data specific to each sensor (do not remove)
Connector 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
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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Calibration tag
Dial face
Inlet
Outlet
Sensor’s VP8
Connector
Switch
Bracket clip
1.0 How It Works
Connector
Protective Cap
Information subject to change based on feedback.
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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Information can be changed subject to feedback.
Connector
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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