Roche Cedex Bio User manual

Cedex Bio Analyzer

User Guide version 3.5

Software version 3.0

Roche Diagnostics

Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5

2

Publication information

Edition notice This publication is intended for operators of the

Cedex Bio Analyzer with the installed software

version 3.0.

Every effort has been made to ensure that all the

information contained in this publication is correct at the

time of publishing. However, the manufacturer of this

product may need to update the publication information

as output of product surveillance activities, leading to a

new version of this publication.

Where to find information The User Assistance contains all information about the

product, including the following:

• Routine operation

• Maintenance

• Safety

• Troubleshooting information

• A software reference

• Configuration information

• Background information

The Safety Guide contains important safety information.

You must read the Safety Guide before operating the

instrument.

The User Guide focuses on routine operation and

maintenance. The chapters are organized according to

the normal operation workflow.

Publication

version

Software version Revision date Change description

1.0 1.0 June 2011 First version

2.0 1.0 September 2011 Editorial corrections

3.0 2.0 July 2012 Hardware improvements.

Adjustments to reflect latest software version (time indication

for running tests and disk space indication).

3.1 2.1 November 2013 The TRL Check feature was introduced.

Minor textual adjustments.

3.2 2.2 April 2016 Product IT Security Risk update.

Upgraded analyzer display, and updates to user interface

design.

3.3 2.2.1.0 December 2017 New feature implemented to recover a damaged database.

3.4 2.3 June 2018 New software update.

3.5 3.0 July 2021 Migration to task-oriented structure and FutureDoc layout.

Implementation of the User Assistance. Updated to include

new functions and features included in SW 3.0. Updated safety

and data security information.

uWhat is new in publication version 3.5 (11)

yRevision history

Roche Diagnostics

Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5

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!

General attention

To avoid serious or fatal injury, ensure that you are

familiar with the analyzer and safety information before

you use the analyzer.

rPay particular attention to all safety precautions.

rAlways follow the instructions in this publication.

rDo not use the instrument in a way that is not

described in this publication.

rStore all publications in a safe and easily retrievable

place.

The Online Help is a context-sensitive feature. For help

information in the Cedex Bio software, choose

the to display Help text that relates to the work area

of the software. The Online Help offers a quick and

convenient way of finding information, such as

explanations of screens, dialog boxes, and on how to

perform particular tasks.

To help you find information quickly, there is a table of

contents at the beginning of the User Assistance and

each chapter. In addition, a complete index can be found

at the end.

Training Do not carry out operation tasks or maintenance actions

unless you have received training from Roche

Diagnostics. Leave tasks that are not described in the

user documentation to trained Roche Service

representatives.

Images The screenshots and hardware images in this publication

have been added exclusively for illustration purposes.

Configurable and variable data in screenshots, such as

tests, results, or path names visible therein must not be

used for laboratory purposes.

Warranty Any customer modification to the analyzer renders the

warranty or service agreement null and void.

For conditions of warranty, contact your local sales

representative or refer to your warranty contract partner.

Always leave software updates to a Roche Service

representative, or perform such updates with their

assistance.

Roche Diagnostics

Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5

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License information Cedex Bio Analyzer software is protected by contract law,

copyright law, and international treaties.

Cedex Bio Analyzer contains a user license between F.

Hoffmann-La Roche Ltd. and a license holder, and only

authorized users may access the software and use it.

Unauthorized use and distribution may result in civil and

criminal penalties.

Open-source and commercial software Cedex Bio Analyzer may include components or modules

of commercial or open-source software. For further

information on the intellectual property and other

warnings, as well as licenses pertaining to the software

programs included in Cedex Bio Analyzer, refer to the

electronic distribution included with this product.

This open-source and commercial software and

Cedex Bio Analyzer as a whole can constitute a device

regulated in accordance with applicable law. For more

detailed information, refer to the User Assistance and

labeling.

Note that the respective authorization is no longer valid

according to the corresponding legislation should any

unauthorized changes be made to Cedex Bio Analyzer.

Trademarks The following trademarks are acknowledged:

CEDEX and ISE are trademarks of Roche.

All other trademarks are the property of their respective

owners.

Feedback Every effort has been made to ensure that this publication

fulfills the intended use. All feedback on any aspect of

this publication is welcome and is considered during

updates. Contact your Roche representative, should you

have any such feedback.

Approvals The Cedex Bio Analyzer meets the requirements laid

down in the following directives:

Directive 2014/30/EU of the European Parliament and

Council of 26. February 2014 relating to electromagnetic

compatibility (EMC).

Directive 2014/35/EU of the European Parliament and

Council of 26. February 2014 relating to electrical

equipment designed for use within certain voltage limits.

Roche Diagnostics

Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5

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Directive 2011/65/EU of the European Parliament and of

the Council of 8 June 2011 on the restriction of the use of

certain hazardous substances in electrical and electronic

equipment.

Compliance with the applicable directive(s) is provided by

means of the Declaration of Conformity.

The following marks demonstrate compliance:

Contact address

Complies with the provisions of the applicable EU

directives.

Issued by Underwriters Laboratories, Inc. (UL) for

Canada and the US.

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Roche Diagnostics

Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5

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Table of contents 7

Roche Diagnostics

Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5

Table of contents

Publication information 2

Contact address 5

Table of contents 7

Intended use 9

Symbols and abbreviations 9

What is new in publication version 3.5 11

System description

1 System overview

System description 17

Hardware description 28

Supported material 69

2 Software overview

Overview of the software 77

Key panels 98

Operation

3 Before operation

Quick Guide: Daily operations 171

Quick Guide: Prepare wizard 176

About preparing the analyzer 179

Checklist: Before operation 181

Starting up and shutting down the analyzer 185

Checking supplies, water, and waste 197

Instrument alarms 218

4 Reagents and consumables

Overview of the reagents and consumables 247

Reagent handling 249

Monitoring reagent status 278

Managing supplies and waste 286

ISE unit 316

5 Calibration

Quick Guide: Performing calibrations 329

Calibration overview 330

Performing calibration and handling calibration

results 333

Calibrator lot change 349

General calibration information 365

6QC

Quick Guide: Performing QCs 377

QC overview 378

Performing a QC order and handling QC

results 379

QC lot change 405

General QC information 415

7 Orders and results

Quick Guide: Ordering and analyzing

samples 421

About the sample tube handling 423

Defining a sample order 426

Adding tests to an order 449

Monitoring the analysis progress 454

Test result validation 457

Printing sample results 490

Retransmitting test results to the host 492

Deleting sample orders 495

Deleting test results 497

8 After operation

Quick Guide: End Shift wizard 501

Checking for unfinished orders 504

Checking for not accepted test results 507

Starting the End Shift wizard 510

Performing the daily backup 513

Exporting the log files 516

Exporting full results data 518

Cleaning up the database 521

9 Maintenance

List of maintenance intervals 525

About the periodic maintenance actions 527

About the maintenance action status 529

Performing maintenance actions 531

Maintenance actions 534

Troubleshooting

10 Troubleshooting

Messages 645

Flags 648

Troubleshooting 674

Glossary

11 Glossary

Index 703

8Table of contents

Roche Diagnostics

Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5

Roche Diagnostics

Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5

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Intended use

The Cedex Bio Analyzer is a continuous random-access

analyzer intended for process control in industrial

biotechnological production processes in pharmaceutical,

biochemical, and food manufacturing companies.

It is intended for determination of a wide range of

analytes in various aqueous solutions such as cell culture

and fermentation media.

For use in quality control/manufacturing process only.

Not for use in human clinical or diagnostic procedures.

Symbols and abbreviations

Product names Except where the context clearly indicated otherwise, the

following product names and descriptors are used.

Symbols used in the publication

Product name Descriptor

Cedex Bio Analyzer analyzer

Cuvette Segment Cuvette segment

Ion selective electrode ISE

Activator Bio Activator

ISE Reference Solution REF

yProduct names

Symbol Explanation

oList item

uRelated topics containing further information

qTip. Extra information on correct use or useful

hints.

rStart of a task

IExtra information within a task

fResult of an action within a task.

cFrequency of a task.

nDuration of a task.

dMaterials that are required for a task.

jPrerequisites of a task.

uTopic. Used in cross-references to topics.

pTask. Used in cross-references to tasks.

wFigure. Used in figure titles and cross-

references to figures.

ySymbols used in the publication

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Symbols used on product

Abbreviations The following abbreviations are used.

yTable. Used in table titles and cross-references

to tables.

zEquation. Used in cross-references to

equations.

kCode example. Used in code titles and cross-

references to codes.

Symbol Explanation

ySymbols used in the publication

Symbol Explanation

Global Trade Item Number.

ySymbols used on product

Abbreviation Definition

ANSI American National Standards

Institute

CAL Calibration

CISPR International Special Committee on

Radio Interference

CL-I Chloride indirect

DRAM Dynamic random access memory

e.g. Exempli gratia – for example

EMC Electromagnetic compatibility

EN European standard

F Solution 1 factor

GUI Graphical user interface

i.e. Id est – that is to say

IEC International Electrical Commission

ISE Ion-Selective Electrode

K-I Potassium indirect

LED Light-emitting diode

LLD Liquid level detection

n/a Not applicable

NA-I Sodium indirect

p.a. Pro analysi

ROM Read only memory

S Slope in mV/dec

SRAM Static random access memory

Std 1/1 First measurement of ISE Solution 1

Std 1/2 Second measurement of ISE

Solution 1

yAbbreviations

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Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5

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Abbreviations for units The following abbreviations for units are used.

What is new in publication version 3.5

New layout and structure Resulting from customer feedback, we have updated the

layout and the structure of this publication to help you

find information easier and perform tasks quicker.

Std 2 Measurement of ISE Solution 2

TRL Test range low (lower limit of

measuring range)

UL Underwriters Laboratories Inc.

Abbreviation Definition

yAbbreviations

Abbreviation Definition

°C Degree centigrade

A Ampère

cm Centimeter

h Hour

Hz Hertz

in Inch

kg Kilogram

kVA Kilo volt-ampere

L Liter

m Meter

MB Megabytes

min Minutes

mL Milliliter

mm Millimeter

mV Measured voltage in millivolt

nm Nanometer

s Second

V Volt

V AC Volt alternating current

V DC Volt direct current

VA Volt-ampère

WWatt

L Microliter

m Micrometer

yAbbreviations for units

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Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5

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New functions and features of Cedex Bio

Software 3.0

New user roles and rights functions. Audit Trail function

introduced. Extended Host Interface provides new

features for the host connection. The Graphical User

Interface has been adapted as needed for the new

features. The Cedex Bio Software is now 21 part 11

compliant.

Roche Diagnostics

Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5

System description

1 System overview

Roche Diagnostics

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Table of contents

System overview 1

In this chapter 1

System description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

About the Cedex Bio Analyzer . . . . . . . . . . . . . . . . 17

About the covers, panels, and service flaps . . . . . 20

About the LEDs and their color indicators . . . . . . 23

About the analyzer main power switch . . . . . . . . . 25

About the open/close cover buttons . . . . . . . . . . . 26

About the user interface . . . . . . . . . . . . . . . . . . . . . 27

Hardware description. . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Analyzer overview. . . . . . . . . . . . . . . . . . . . . . . . . . . 29

About the sample area. . . . . . . . . . . . . . . . . . . . . . . 31

Fluid system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

About the fluid system components . . . . . . . . 32

About the probe . . . . . . . . . . . . . . . . . . . . . . . . . 34

About the rinse station. . . . . . . . . . . . . . . . . . . . 35

About the syringe assembly . . . . . . . . . . . . . . . 36

About internal waste tank . . . . . . . . . . . . . . . . . 37

About the external fluid container connectors 38

About the water container. . . . . . . . . . . . . . . . . 39

About the waste container . . . . . . . . . . . . . . . . 40

About the Cleaner bottle . . . . . . . . . . . . . . . . . . 41

Rotor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

About the rotor . . . . . . . . . . . . . . . . . . . . . . . . . . 42

About the reagent disk . . . . . . . . . . . . . . . . . . . 44

About the reagent disk container. . . . . . . . . . . 46

About the reagent cooler. . . . . . . . . . . . . . . . . . 46

About the cuvette ring . . . . . . . . . . . . . . . . . . . . 47

Transfer unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

About the transfer unit. . . . . . . . . . . . . . . . . . . . 48

About the transfer head. . . . . . . . . . . . . . . . . . . 49

About the hand-held barcode reader . . . . . . . . . . 51

About the printer . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

About the absorbance photometer . . . . . . . . . . . . 54

About the absorbance measuring mode. . . . . . . . 55

About the connectors . . . . . . . . . . . . . . . . . . . . . . . 57

About the fuses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

ISE unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

About the ISE cover and panel . . . . . . . . . . . . . 59

About the ISE main components . . . . . . . . . . . 61

About the ISE measuring mode . . . . . . . . . . . . 63

Technical specifications overview. . . . . . . . . . . . . . 66

Supported material. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

1 System overview

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Table of contents

Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

About the tubes . . . . . . . . . . . . . . . . . . . . . . . . . 69

List of supported tube types . . . . . . . . . . . . . . . 71

Roche Adapter Cup . . . . . . . . . . . . . . . . . . . . . . 72

List of allowed cleaning solutions . . . . . . . . . . . . . 73

List of available accessories and consumables . . 74

1 System overview

Roche Diagnostics

Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5

System overview 17

System description

In this section

About the Cedex Bio Analyzer (17)

About the covers, panels, and service flaps (20)

About the LEDs and their color indicators (23)

About the analyzer main power switch (25)

About the open/close cover buttons (26)

About the user interface (27)

About the Cedex Bio Analyzer

The Cedex Bio Analyzer is a continuous random-access

analyzer intended for metabolite analysis in mammalian

cell cultures and microbial fermentation. The

Cedex Bio Analyzer is a low throughput, bench top

analyzer used in manufacturing and quality control of

pharma biotech environments. Core test parameters

cover sodium, potassium, glucose, lactate, lactate

dehydrogenase, ammonia, glutamine, and glutamate.

It is optimized for a small workload of up to 50 samples

per day, utilizing photometric analysis and an optional

unit for ion selective electrodes (ISE).

The Cedex Bio Analyzer is compliant with 21 CFR Part 11

regulation by default after initial installation of the system

by a Roche Service representative.

WARNING

!

Insufficient knowledge and skills

As an operator, ensure that you know the relevant safety

precaution guidelines and standards and the information

and procedures contained in these instructions.

rDo not carry out operation and maintenance unless

Roche Diagnostics has trained you to do so.

rLeave maintenance, installation, or service that is not

described to trained Roche Service representatives.

rCarefully follow the procedures specified in the

instructions for operation and maintenance.

rFollow laboratory best practices, especially when you

work with biohazardous material.

Features The Cedex Bio Analyzer offers laboratories the following

advantages:

High analytical performance

1 System overview

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Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5

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Efficient operation

• Cooled, exchangeable reagent disks ensure

economical reagent use; disposable cuvette segments

allow for easy cuvette loading and removal.

High reliability, low maintenance

• Innovative "low impact" analyzer design and software-

driven preventive maintenance improves up-time and

reduces maintenance costs.

Adaptable user interface

• The built-in color touchscreen, process-driven

software, and reagent and sample barcode entry

adapts to users of different skills and access levels.

High safety standards

• Built-in safety devices, such as liquid level detection,

tube bottom detection, and cuvette QC anticipate

potential hazards during operation.

Flexible sampling

• 8 on-board sample positions accommodate virtually

any type of sample carrier, and enable continuous

sample placing and removal during operation.

Data management

• Bidirectional RS-232 and USB ports, on-board thermal

printer, and drivers offer the latest in data

management capabilities.

Measuring principles Measurements are performed with an absorbance

photometer and optionally an ISE (ion selective electrode)

module that uses ion selective potentiometer.

The analyzer consists of the following components:

• Analyzer unit

• Control unit

• Fluid system

• Transfer unit

• Sample area

• Reagent storage

• ISE unit

1 System overview

Roche Diagnostics

Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5

System overview 19

Cedex Bio Analyzer

The Cedex Bio Analyzer allows you to measure Na+, K+,

and Cl- in addition to the regular photometric tests.

The main features are:

• Cooled, exchangeable reagent disks

• Easy disposable cuvette segment handling

• Continuous sample placing and removal during

operation

Component Function

Analyzer unit Contains the incubators and photometers, used for making measurements; also contains the

analyzer rotor, which moves the cuvettes for pipetting, mixing, and measuring.

Control unit Controls the analyzer functions.

Fluid system Moves all the fluids used by the analyzer, including water, samples, reagents, liquid waste, and

Cleaner.

Transfer unit Pipettes samples, reagents, and other fluids from their containers into cuvettes for mixing so that

measurements can be performed.

Sample area Includes the area for placing different types of tubes.

Reagent storage Refrigerates and stores the reagent sets for testing.

ISE unit Contains the electrodes and solutions that are used for making measurements. The ISE unit also

contains the ISE tower, which mixes samples and QC materials before measuring.

yComponents of the analyzer

1 System overview

Roche Diagnostics

Cedex Bio Analyzer · Software version 3.0 · User Guide · Version 3.5

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About the covers, panels, and service flaps

All covers, panels, and service flaps must correctly be

mounted and closed during operation.

The following figure shows the removable panels, covers,

and the flaps that can be opened.

wThe Cedex Bio Analyzer

Transfer head cover Provides access to:

• Transfer mechanism

• Probe

q Shut down the operating software and switch off the

analyzer before you open this cover.

Left service flap Provides access to:

• Rinse station

• Tubing

• Internal waste tank

• Initialization plate

ATransfer head cover ERear service flap

BLeft side panel FRight side panel

CLeft service flap GRight service flap

DMain cover HPrinter panel

A

B

C

D

H

G

F

E

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Roche Cedex Bio User manual

Roche Cedex Bio User manual

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