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
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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
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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