EG Xcellerex XDUO 2500 User manual

Xcellerex™XDUO 2500 Mixer
Operating Instructions
Original instructions

Table of Contents
51 Introduction ..........................................................................................................
61.1 About this manual ................................................................................................................................
71.2 Important user information .............................................................................................................
91.3 Regulatory information ......................................................................................................................
101.3.1 EU directives .....................................................................................................................................
111.3.2 Eurasian Customs Union ............................................................................................................
121.3.3 Regulations for USA and Canada ...........................................................................................
131.3.4 Korean regulatory information ................................................................................................
141.3.5 Other regulations and standards ............................................................................................
151.4 Abbreviations ..........................................................................................................................................
172 Safety instructions ...............................................................................................
182.1 Safety precautions ...............................................................................................................................
272.2 Labels .........................................................................................................................................................
312.3 Emergency procedures ......................................................................................................................
322.3.1 System power switch and Emergency Stop button .......................................................
342.3.2 Emergency shutdown ..................................................................................................................
382.3.3 Power or communication failure .............................................................................................
402.4 Interlocks ..................................................................................................................................................
412.5 Security levels .........................................................................................................................................
422.6 Recycling information .........................................................................................................................
442.7 Declaration of Hazardous Substances (DoHS) ........................................................................
463 System description ..............................................................................................
473.1 Safety system .........................................................................................................................................
493.2 System overview ...................................................................................................................................
503.2.1 System hardware ...........................................................................................................................
523.2.2 System options ...............................................................................................................................
543.2.3 System connectivity ......................................................................................................................
553.3 Mixer vessel components .................................................................................................................
563.3.1 Mixer vessel ......................................................................................................................................
623.3.2 I/O Cabinet ........................................................................................................................................
653.3.3 Agitators ............................................................................................................................................
693.3.4 Load cells ...........................................................................................................................................
713.3.5 Pumps .................................................................................................................................................
733.4 XDUO 2500 Mixer control ..................................................................................................................
743.4.1 XDUO 2500 Mixer automation and control ........................................................................
763.4.2 Local control panel ........................................................................................................................
773.4.3 Data access ......................................................................................................................................
783.5 Temperature control unit ..................................................................................................................
793.6 Disposable components ....................................................................................................................
803.6.1 Disposable bag assembly ...........................................................................................................
853.6.2 Probe sheath assembly ...............................................................................................................
874 User interface .......................................................................................................
884.1 General description .............................................................................................................................
2 Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH
Table of Contents

954.2 Adjustment and control screens ...................................................................................................
984.3 Alarm screens .........................................................................................................................................
994.3.1 Alarm overview screen ................................................................................................................
1004.3.2 Alarm configuration screens .....................................................................................................
1024.4 pH and conductivity overview screen .........................................................................................
1044.5 Detail screens .........................................................................................................................................
1054.5.1 Agitator screens ..............................................................................................................................
1094.5.2 pH screens ........................................................................................................................................
1134.5.3 Conductivity screen .......................................................................................................................
1144.5.4 Temperature screens ....................................................................................................................
1184.6 Transmitter Offsets screen .............................................................................................................
1194.7 Trend screens .........................................................................................................................................
1215 Installation ............................................................................................................
1225.1 Safety precautions ...............................................................................................................................
1245.2 Site requirements ..................................................................................................................................
1285.3 Installation of the system .................................................................................................................
1305.4 Install accessories ................................................................................................................................
1345.5 Connect temperature control unit ................................................................................................
1416 Preparation ...........................................................................................................
1426.1 Safety precautions ...............................................................................................................................
1436.2 Stabilize the mixer vessel ..................................................................................................................
1446.2.1 Use jacking bolts ............................................................................................................................
1506.2.2 Use leveling feet ..............................................................................................................................
1536.3 Prepare the disposable bag .............................................................................................................
1546.3.1 Unpack the disposable bag assembly ..................................................................................
1626.3.2 Install the disposable bag ..........................................................................................................
1756.4 Prepare and install the probes .......................................................................................................
1766.4.1 Calibrate the pH probe ................................................................................................................
1816.4.2 Prepare the conductivity probe ................................................................................................
1836.4.3 Autoclave probe sheath assembly .........................................................................................
1866.4.4 Insert probes into the disposable bag ..................................................................................
2006.5 Prepare the pumps ..............................................................................................................................
2047 Operation ..............................................................................................................
2057.1 Safety precautions ...............................................................................................................................
2077.2 Start up the system .............................................................................................................................
2127.3 Operate agitator motors ...................................................................................................................
2197.4 Prepare the pump ................................................................................................................................
2217.5 Control the pH ........................................................................................................................................
2257.6 Control the temperature ...................................................................................................................
2297.7 Manage mixer weight .........................................................................................................................
2317.8 Add liquid contents ..............................................................................................................................
2377.9 Add solid contents ................................................................................................................................
2417.10 Finish a batch run .................................................................................................................................
2427.10.1 Collect the product ........................................................................................................................
2437.10.2 Remove the disposable bag ......................................................................................................
Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH 3
Table of Contents

2477.10.3 Shut down the system .................................................................................................................
2488 Maintenance .........................................................................................................
2498.1 Safety precautions ...............................................................................................................................
2508.2 Maintenance schedules .....................................................................................................................
2538.3 Lock-Out / Tag-Out (LOTO): turn-off procedure ......................................................................
2558.4 Lock-Out / Tag-Out (LOTO): turn-on procedure ......................................................................
2578.5 Cleaning ....................................................................................................................................................
2598.6 Hardware maintenance ....................................................................................................................
2638.7 Storage, moving and reinstallation ..............................................................................................
2649 Troubleshooting ...................................................................................................
2659.1 Agitation ....................................................................................................................................................
2679.2 Burst disc ..................................................................................................................................................
2689.3 FlexFactory connectivity ...................................................................................................................
2699.4 Local control panel ..............................................................................................................................
2709.5 pH equilibrium ........................................................................................................................................
2719.6 pH/Conductivity monitoring or control ......................................................................................
2739.7 Pumps ........................................................................................................................................................
2749.8 Temperature control ...........................................................................................................................
2759.9 Temperature monitoring ...................................................................................................................
2769.10 Weight monitoring ...............................................................................................................................
27810 Reference information ........................................................................................
27910.1 System specifications .........................................................................................................................
28110.2 SP, CV and PV units and ranges .....................................................................................................
28210.3 Pump characteristics ..........................................................................................................................
28310.4 TCU ..............................................................................................................................................................
28410.4.1 TCU requirements ..........................................................................................................................
28510.4.2 Temperature control optimization ..........................................................................................
28610.4.3 TCU coolant specifications .........................................................................................................
28710.5 Temperature probe calibration ......................................................................................................
29110.6 Ordering information ..........................................................................................................................
29210.7 Health and Safety Declaration Forms .........................................................................................
294Appendix A Information about Appendix ............................................................
295Appendix B Add and remove users in local control software .........................
301Appendix C Download audit and data logs ........................................................
306Index .......................................................................................................................
4 Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH
Table of Contents

1 Introduction
About this chapter
This chapter contains important user information and regulatory information about
Xcellerex XDUO 2500 Mixer.
In this chapter
See pageSection
61.1 About this manual
71.2 Important user information
91.3 Regulatory information
151.4 Abbreviations
Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH 5
1 Introduction

1.1 About this manual
Purpose of this manual
The Operating Instructions provide operator, supervisor and administrator with the in-
structions needed to install, operate and maintain XDUO 2500 Mixer in a safe way.
Scope of this manual
This manual is valid for all variants of standard XDUO 2500 Mixer. Your system is either
CE-classified or UL-classified. The system configuration for your system is described in
the General Specification and on the system label.
Typographical conventions
Software items are identified in the text by bold italic text. A colon separates menu levels,
thus File:Open refers to the Open command in the File menu.
Hardware items are identified in the text by bold text (for example, Power).
6 Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH
1 Introduction
1.1 About this manual

1.2 Important user information
Introduction
This section contains important information regarding XDUO 2500 Mixer and this man-
ual.
Read this before operating the
product
All users must read the entire Operating Instructions before installing, operating or
maintaining the product.
Always keep the Operating Instructions at hand when operating the product.
Do not operate the product in any other way than described in the user documentation.
If you do, you may be exposed to hazards that can lead to personal injury and you may
cause damage to the equipment.
Intended use of XDUO 2500 Mixer
XDUO 2500 Mixer is a plug-and-play single-use mixing system for production of biophar-
maceuticals, vaccines, and other biologics. XDUO 2500 Mixer is configurable to meet a
broad range of mixing requirements.
XDUO 2500 Mixer is not a medical device and shall not be used in any clinical procedures,
or for diagnostic purposes.
Prerequisites
In order to operate XDUO 2500 Mixer in a safe way and according to its intended use,
the following prerequisites must be fulfilled:
•You should be acquainted with the use of general biomanufacturing equipment and
with handling of biological materials.
•You must read and understand the Safety instructions chapter in this manual.
•The system must be installed by a GE representative.
Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH 7
1 Introduction
1.2 Important user information

•A working knowledge of how to use Wonderware™ software is required, if the instru-
ment is operated using FlexFactory™ control system.
•Supervisors and administrators must be familiar with basic operations in Microsoft®
Windows®operating system.
Safety notices
This user documentation contains safety notices (WARNING, CAUTION, and NOTICE)
concerning the safe use of the product. See definitions below.
WARNING
WARNING indicates a hazardous situation which, if not avoided,
could result in death or serious injury. It is important not to proceed
until all stated conditions are met and clearly understood.
CAUTION
CAUTION indicates a hazardous situation which, if not avoided,
could result in minor or moderate injury. It is important not to pro-
ceed until all stated conditions are met and clearly understood.
NOTICE
NOTICE indicates instructions that must be followed to avoid
damage to the product or other equipment.
Notes and tips
A note is used to indicate information that is important for trouble-free and
optimal use of the product.
Note:
A tip contains useful information that can improve or optimize your procedures.
Tip:
8 Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH
1 Introduction
1.2 Important user information

1.3 Regulatory information
Introduction
This section lists the directives and standards that apply to XDUO 2500 Mixer.
Manufacturing information
The table below summarizes the required manufacturing information.
ContentRequirement
GE Healthcare Bio-Sciences AB,Name and address of manufacturer
Björkgatan 30, SE 751 84 Uppsala
Sweden
In this section
See pageSection
101.3.1 EU directives
111.3.2 Eurasian Customs Union
121.3.3 Regulations for USA and Canada
131.3.4 Korean regulatory information
141.3.5 Other regulations and standards
Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH 9
1 Introduction
1.3 Regulatory information

1.3.1 EU directives
Conformity with EU Directives
This product fulfills the European Directives listed below. See the EU Declaration of
Conformity for the directives and regulations that apply for the CE marking.
If not included with the product, a copy of the EU Declaration of Conformity is available
on request.
TitleDirective
Machinery Directive (MD)2006/42/EC
Electromagnetic Compatibility (EMC) Directive2014/30/EU
CE marking
The CE marking and the corresponding EU Declaration of Conformity is valid for the in-
strument when it is:
•used according to the Operating Instructions or user manuals, and
•used in the same state as it was delivered from GE, except for alterations described
in the Operating Instructions or user manuals.
10 Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH
1 Introduction
1.3 Regulatory information
1.3.1 EU directives

1.3.2 Eurasian Customs Union
Introduction
This section contains additional regulatory information to comply with the Eurasian
Customs Union technical regulations.
Manufacturing information
The table below summarizes the required manufacturing information. For further infor-
mation, see the EU Declaration of Conformity (DoC) document.
ContentRequirement
GE Healthcare Bio-Sciences AB,Name and address of manufacturer
Björkgatan 30, SE 751 84 Uppsala
Sweden
Telephone: + 46 771 400 600
GE Healthcare LLCImporter and/or company for obtain-
ing information about importer GE Healthcare Life Sciences
Presnenskaya nab., 10C, 12th floor
RU-123 317 Moscow, Russian Federation
Telephone 1: + 7 495 411 9714
Fax nr: + 7 495 739 6932
Email: [email protected]
Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH 11
1 Introduction
1.3 Regulatory information
1.3.2 Eurasian Customs Union

1.3.3 Regulations for USA and Canada
UL508A conformity
The UL Listed label appears only on products that are UL 508A compliant. If UL 508A
compliance applies, the UL Listed mark will be found inside the electrical cabinet.
FCC compliance
This device complies with part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause undesired
operation.
The user is cautioned that any changes or modifications not expressly approved
by GE could void the user’s authority to operate the equipment.
Note:
This equipment has been tested and found to comply with the limits for a Class A digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide rea-
sonable protection against harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses, and can radiate radio frequen-
cy energy and, if not installed and used in accordance with the instruction manual, may
cause harmful interference to radio communications. Operation of this equipment in a
residential area is likely to cause harmful interference in which case the user will be re-
quired to correct the interference at his own expense.
12 Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH
1 Introduction
1.3 Regulatory information
1.3.3 Regulations for USA and Canada

1.3.4 Korean regulatory information
NOTICE
Class A equipment (equipment for business use).
This equipment has been evaluated for its suitability for use in a
business environment.
When used in a residential environment, there is a concern of radio
interference.
주의사항
A급 기기 (업무용 방송통신 기자재)
이 기기는 업무용환경에서 사용할 목적으로 적합성평가를 받은
기기
로서 가정용 환경에서 사용하는 경우 전파간섭의 우려가 있습니
다.
Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH 13
1 Introduction
1.3 Regulatory information
1.3.4 Korean regulatory information

1.3.5 Other regulations and standards
Introduction
This section describes the standards that apply to XDUO 2500 Mixer.
Environmental conformity
This product conforms to the following environmental requirements.
TitleRequirement
Waste Electrical and Electronic Equipment (WEEE) Directive2012/19/EU
Management Methods for the Restriction of the Use of Haz-
ardous Substances in Electrical and Electronic Products.
China RoHS
Standards, machinery and
electrical equipment
Standard requirements fulfilled by this product are summarized in the table below.
DescriptionStandard
Safety of machinery. General principles for design. Risk
assessment and risk reduction.
EN ISO 12100
Safety of Machinery - Electrical equipment of machines.
Part 1: General requirements.
EN 60204-1
Electrical Equipment for Measurement, Control, and
Laboratory Use.
EN 61326-1
(Emission according to CISPR 11, Group 1, class A)
14 Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH
1 Introduction
1.3 Regulatory information
1.3.5 Other regulations and standards

1.4 Abbreviations
The following terms and abbreviations are used in the user documentation for XDUO
2500 Mixer :
DefinitionTerm/Abbreviation
aseptic connection deviceACD
controlled variableCV
The output from the PID controller, or a manually set value
that controls the process variable.
controlled variable high limitCVHL
controlled variable low limitCVLL
deadbandDB
The deadband is a defined range of process variable, where
the PID controller does not change the corresponding
controlled variable.
human-machine interfaceHMI
Input/Output CabinetI/O Cabinet
Open Platform CommunicationsOPC
proportional integral derivativePID
A PID controller tries to minimize the difference between
a measured PV and a defined SP. The PID controller calcu-
lates the control signal that controls the process toward
the SP.
programmable logic controllerPLC
process variablePV
The actual measured value of the parameter.
revolutions per minuterpm
resistance temperature detectorRTD
Secure Digital cardSD card
setpointSP
The process target value defined by a user or the system,
that the PID controller tries to reach by adjusting the pro-
cess control outputs.
Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH 15
1 Introduction
1.4 Abbreviations

DefinitionTerm/Abbreviation
setpoint high limitSPHL
setpoint low limitSPLL
hygienic tubing connectionTC
temperature control unitTCU
uninterruptible power supplyUPS
16 Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH
1 Introduction
1.4 Abbreviations

2 Safety instructions
About this chapter
This chapter describes safety precautions and emergency shutdown procedures for
XDUO 2500 Mixer. The labels on the system, information regarding recycling and security
levels are also described.
In this chapter
See pageSection
182.1 Safety precautions
272.2 Labels
312.3 Emergency procedures
402.4 Interlocks
412.5 Security levels
422.6 Recycling information
442.7 Declaration of Hazardous Substances (DoHS)
Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH 17
2 Safety instructions

2.1 Safety precautions
Introduction
The safety precautions in this section are grouped in following categories:
•General precautions, on page 18
•Personal protection, on page 19
•Installation, on page 21
•Flammable liquids and explosive environment, on page 22
•Power supply, on page 23
•System operation, on page 23
•Maintenance, on page 25
General precautions
WARNING
Awareness of all hazards. Before installing, operating or maintain-
ing XDUO 2500 Mixer, all users must read and understand the entire
contents of this chapter to become aware of the hazards involved.
Failure to do this may cause human injury or death, or damage to
the equipment.
WARNING
Operate as described. Do not operate XDUO 2500 Mixer in any
other way than described in the instrument user documentation.
WARNING
Qualification. The customer must make sure that all installation,
maintenance, operation, and inspection is carried out by qualified
personnel who are adequately trained, understand and adhere to
local regulations and the operating instructions, and have a thor-
ough knowledge of XDUO 2500 Mixer and the entire process.
18 Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH
2 Safety instructions
2.1 Safety precautions

WARNING
Damaged system. Do not use the product if it is not working
properly, or if it has suffered any damage, for example:
•damage to the power cord or its plug
•damage caused by dropping the equipment.
WARNING
High voltage. Only personnel authorized by GE may open the I/O
Cabinet doors. There is high voltage inside the lower part of the
cabinet that can cause human injury or death.
CAUTION
Use caution. Use caution close to moving parts, stored energy,
pressurization, and electrical sources.
CAUTION
Moving parts. Do not place objects or fingers into valves, rotating
pumps, fans or other moving parts. This can result in damage to
the equipment and/or cause personal injury.
Personal protection
WARNING
Slipping hazard. Remove any spillage on the floor immediately to
minimize the risk for slipping accidents.
Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH 19
2 Safety instructions
2.1 Safety precautions

WARNING
Hazardous substances. When using hazardous chemical and bio-
logical agents, take all suitable protective measures, such as
wearing protective glasses and gloves resistant to the substances
used. Follow local and national regulations for safe operation and
maintenance of the system.
WARNING
Spread of biological agents. The operator must take all necessary
actions to avoid spreading hazardous biological agents. The facility
must comply with the national code of practice for biosafety.
WARNING
Personal protective equipment. For personal safety during the
transportation, installation, operation and maintenance of the
system, always use protective glasses and other personal protective
equipment appropriate for the current application. The following
personal protective equipment should always be available:
•Protective glasses
•Working gloves to protect against sharp edges
•Protective footwear, preferably with steel toe-cap
•Disposable gloves
Always use clean disposable gloves when manually handling parts.
WARNING
Personal Protective Equipment (PPE). Whenever packing, unpack-
ing, transporting or moving the system, wear protective footwear,
preferably with steel toe cap.
20 Xcellerex XDUO 2500 Mixer Operating Instructions 29146667 AH
2 Safety instructions
2.1 Safety precautions