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
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
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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
Operation Manual | Insertion/Retraction Design for Bioprocess Containers
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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*