GE Xcellerex XDM Series User manual

Xcellerex™XDM 50-1000, XDUO
100-1000 mixers
Operating Instructions
Original instructions
Translation disc enclosed

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Table of Contents
71 Introduction ..........................................................................................................
81.1 About this manual ................................................................................................................................
91.2 Important user information .............................................................................................................
111.3 Regulatory information ......................................................................................................................
121.3.1 EU Directives ....................................................................................................................................
131.3.2 Eurasian Customs Union ............................................................................................................
141.3.3 Regulations for USA and Canada ...........................................................................................
151.3.4 Korean regulatory information ................................................................................................
161.3.5 Other regulations and standards ............................................................................................
171.4 Abbreviations ..........................................................................................................................................
182 Safety instructions ...............................................................................................
192.1 Safety precautions ...............................................................................................................................
282.2 Labels .........................................................................................................................................................
342.3 Emergency procedures ......................................................................................................................
352.3.1 Emergency procedures, Xcellerex XDM mixer ...................................................................
372.3.2 Emergency procedures, Xcellerex XDUO mixer ................................................................
422.3.3 Power or communication failure .............................................................................................
432.4 Xcellerex XDUO mixer interlocks ...................................................................................................
462.5 Security levels .........................................................................................................................................
472.6 Recycling information .........................................................................................................................
492.7 Declaration of Hazardous Substances (DoHS) ........................................................................
513 System description ..............................................................................................
523.1 System overview ...................................................................................................................................
533.2 Xcellerex XDM mixer system description ...................................................................................
543.2.1 System hardware ...........................................................................................................................
553.2.2 Illustration of Xcellerex XDM mixer ........................................................................................
583.3 Xcellerex XDUO mixer system description ................................................................................
593.3.1 System hardware ...........................................................................................................................
603.3.2 Illustration of Xcellerex XDUO mixer ......................................................................................
633.4 Mixer vessel components .................................................................................................................
643.4.1 Mixer vessel ......................................................................................................................................
663.4.2 Agitator ...............................................................................................................................................
683.4.3 Load cells ...........................................................................................................................................
703.4.4 Pumps .................................................................................................................................................
713.5 Safety hardware ....................................................................................................................................
723.6 Mixer automation and control ........................................................................................................
743.7 Temperature control unit ..................................................................................................................
753.8 Disposable components ....................................................................................................................
763.8.1 Disposable bag assembly ...........................................................................................................
823.8.2 Probe sheath assembly ...............................................................................................................
844 User interface .......................................................................................................
854.1 General description .............................................................................................................................
Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD 3
Table of Contents

904.2 Adjustment and control screens ...................................................................................................
934.3 Alarm screens .........................................................................................................................................
944.3.1 Alarm overview screen ................................................................................................................
954.3.2 Alarm configuration screens .....................................................................................................
984.4 Detail screens .........................................................................................................................................
994.4.1 Overview ............................................................................................................................................
1004.4.2 Agitator screen ................................................................................................................................
1024.4.3 Conductivity screen .......................................................................................................................
1034.4.4 pH screens ........................................................................................................................................
1074.4.5 Temperature screens ....................................................................................................................
1124.4.6 Weight screen ..................................................................................................................................
1134.5 Trend screens .........................................................................................................................................
1165 Installation ............................................................................................................
1175.1 Safety precautions ...............................................................................................................................
1195.2 Site requirements ..................................................................................................................................
1215.3 Installation of the mixer .....................................................................................................................
1225.4 Connect temperature control unit ................................................................................................
1296 Preparation ...........................................................................................................
1306.1 Safety precautions ...............................................................................................................................
1326.2 Stabilize the mixer vessel ..................................................................................................................
1336.2.1 Use jacking bolts ............................................................................................................................
1386.2.2 Lock and unlock casters ..............................................................................................................
1396.3 Prepare the disposable bag .............................................................................................................
1406.3.1 Unpack the disposable bag assembly ..................................................................................
1476.3.2 Install the disposable bag ..........................................................................................................
1576.4 Prepare and install the probes .......................................................................................................
1586.4.1 Calibrate the pH probe ................................................................................................................
1636.4.2 Prepare the conductivity probe ................................................................................................
1656.4.3 Autoclave probe sheath assembly .........................................................................................
1686.4.4 Insert probes into the disposable bag ..................................................................................
1826.5 Calibrate the monitors of Xcellerex XDM mixer ......................................................................
1836.6 Prepare the pumps ..............................................................................................................................
1877 Operation ..............................................................................................................
1887.1 Safety precautions ...............................................................................................................................
1907.2 Operate Xcellerex XDM mixer .........................................................................................................
1917.2.1 Start up the system .......................................................................................................................
1927.2.2 Operate the agitator motor .......................................................................................................
1967.2.3 Monitor temperature and weight ...........................................................................................
1977.2.4 Monitor pH and conductivity ....................................................................................................
1987.3 Operate Xcellerex XDUO mixer .......................................................................................................
1997.3.1 Start up the system .......................................................................................................................
2077.3.2 Operate the agitator motor .......................................................................................................
2117.3.3 Prepare the pump ..........................................................................................................................
2157.3.4 Control the pH .................................................................................................................................
2207.3.5 Control the temperature .............................................................................................................
2257.3.6 Manage mixer weight ..................................................................................................................
4 Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD
Table of Contents

2277.3.7 Set alarm limits ...............................................................................................................................
2297.4 Add liquid contents ..............................................................................................................................
2367.5 Add solid contents ................................................................................................................................
2407.6 Finish a batch run .................................................................................................................................
2417.6.1 Collect the product ........................................................................................................................
2427.6.2 Remove the disposable bag ......................................................................................................
2477.6.3 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 ...................................................................................................
27310 Reference information ........................................................................................
27410.1 System specifications .........................................................................................................................
27910.2 SP, CV and PV units and ranges .....................................................................................................
28010.3 Xcellerex XDM and XDUO mixers minimum working volumes ........................................
28110.4 Pump characteristics ..........................................................................................................................
28210.5 Disposable bag specifications ........................................................................................................
28310.6 Environmental requirements ...........................................................................................................
28410.7 Temperature control unit ..................................................................................................................
28510.7.1 TCU requirements ..........................................................................................................................
28710.7.2 Temperature control optimization ..........................................................................................
28810.7.3 TCU coolant specifications .........................................................................................................
28910.8 Temperature probe calibration ......................................................................................................
29410.9 Ordering information ..........................................................................................................................
29510.10 Health and Safety Declaration Forms .........................................................................................
297Appendix A Information about the appendices .................................................
298Appendix B Add and remove users ......................................................................
304Appendix C Download audit and data logs ........................................................
310Appendix D Privacy and security ..........................................................................
313Index .......................................................................................................................
Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD 5
Table of Contents

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1 Introduction
About this chapter
This chapter contains important user information and regulatory information about
Xcellerex XDM and XDUO mixers.
In this chapter
See pageSection
81.1 About this manual
91.2 Important user information
111.3 Regulatory information
171.4 Abbreviations
Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD 7
1 Introduction

1.1 About this manual
Purpose of this manual
The Operating Instructions provide you with the information needed to install, operate
and maintain the products in a safe way.
Scope of this manual
This manual is valid for the following sizes of stainless steel XDM mixer (50, 100, 200,
500, and 1000 L mixer) and XDUO mixer (100, 200, 500, and 1000 L mixer). The system
configuration for your system is described in the General Specification and on the system
label.
Examples of jacketed and non-jacketed mixer types are shown below:
•A: XDM mixer (200 L, jacketed)
•B: XDUO mixer (200 L, non-jacketed)
A B
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).
8 Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD
1 Introduction
1.1 About this manual

1.2 Important user information
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 the product
Xcellerex XDM and Xcellerex XDUO mixers are plug-and-play single-use mixing systems
used in commercial production of biopharmaceuticals, vaccines, and other biologics.
The XDM mixer is designed to operate as a stand-alone instrument. XDUO mixers can
be operated as a stand-alone instrument or as a FlexFactory™ component.
XDM and XDUO mixers are not medical devices and must not be used in any clinical
procedures, or for diagnostic purposes.
XDM and XDUO mixers are not intended for use in a potentially explosive atmosphere.
Prerequisites
In order to operate XDM and XDUO mixers in the way it is intended:
•The user must have a general understanding of the use of general biomanufacturing
equipment and local practices for biosafety and the handling of biological materials.
•The user must read and understand the Safety instructions chapter in this manual.
•Supervisors and administrators must be familiar with basic operations in Microsoft®
Windows®operating system.
•The product must be installed in accordance with the site requirements and instruc-
tions in the Operating Instructions.
Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD 9
1 Introduction
1.2 Important user information

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:
10 Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD
1 Introduction
1.2 Important user information

1.3 Regulatory information
Introduction
This section lists the regulations and standards that apply to XDM and XDUO mixers.
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
121.3.1 EU Directives
131.3.2 Eurasian Customs Union
141.3.3 Regulations for USA and Canada
151.3.4 Korean regulatory information
161.3.5 Other regulations and standards
Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD 11
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.
12 Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD
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.
Manufacturer and importer
information
The table below summarizes the manufacturer and importer information required by
the Eurasian Customs Union.
InformationRequirement
See Manufacturing informationName and address of manufacturer
Telephone: + 46 771 400 600Telephone number of manufacturer
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 XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD 13
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.
CAN ICES/NMB compliance
This product complies with the Canadian standard ICES-001/NMB-001 concerning
electromagnetic compatibility.
14 Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD
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 XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD 15
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 XDM and XDUO mixers.
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, applied to this
product
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.
IEC/EN 60204-1
UL 508A Industrial cabinetUL 508A
Electrical Equipment for Measurement, Control, and
Laboratory Use-EMC requirements-Part 1: General re-
quirements
IEC/EN 61326-1
Emission according to CISPR 11, Group 1, class A
Additional design considerations
For additional design considerations, such as ASME-BPE, GMP and cGMPs information,
refer to the product specific information in the documentation package, delivered with
each XDM mixer and XDUO mixer.
16 Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD
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:
DefinitionTerm/Abbreviation
aseptic connection deviceACD
controlled variableCV
The output from the PID controller, or a manually set value
that controls the process variable.
Input/Output CabinetI/O Cabinet
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 a process parameter.
revolutions per minuterpm
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.
hygienic tubing connectionTC
temperature control unitTCU
Product Documentation package (Turnover Package, ToP)ToP
uninterruptible power supplyUPS
variable frequency driveVFD
Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD 17
1 Introduction
1.4 Abbreviations

2 Safety instructions
About this chapter
This chapter describes safety precautions and emergency shutdown procedures for
XDM and XDUO mixers. The labels on the system, information regarding recycling and
security levels are also described.
All users must read this chapter before using XDM or XDUO mixers, and observe the
safety instructions at all times during use.
In this chapter
See pageSection
192.1 Safety precautions
282.2 Labels
342.3 Emergency procedures
432.4 Xcellerex XDUO mixer interlocks
462.5 Security levels
472.6 Recycling information
492.7 Declaration of Hazardous Substances (DoHS)
18 Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD
2 Safety instructions

2.1 Safety precautions
Introduction
The safety precautions in this section are grouped in following categories:
•General precautions, on page 19
•Personal protection, on page 20
•Installation, on page 22
•Flammable liquids and explosive environment, on page 23
•Power supply, on page 24
•System operation, on page 24
•Maintenance, on page 26
General precautions
WARNING
Awareness of all hazards. Before installing, operating or maintain-
ing the product, all users must read and understand the entire
contents of this chapter to become aware of the hazards involved.
WARNING
Operate as described. Do not operate the instrument 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 the instrument and the entire process.
Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD 19
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 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.
CAUTION
Dusty and damp atmosphere. Do not use the instrument in a dusty
atmosphere or close to spraying water.
Personal protection
WARNING
Slipping hazard. Remove any spillage on the floor immediately to
minimize the risk for slipping accidents.
20 Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD
2 Safety instructions
2.1 Safety precautions