GE Xcellerex XDM Series Operating Instructions Manual
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GE Xcellerex XDM Series Operating Instructions Manual

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

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Summary of Contents for GE Xcellerex XDM Series

  • Page 1 Xcellerex ™ XDM 50-1000, XDUO 100-1000 mixers Operating Instructions Original instructions Translation disc enclosed...
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  • Page 3: Table Of Contents

    Table of Contents Table of Contents Introduction ......................About this manual ..........................Important user information ......................Regulatory information ........................1.3.1 EU Directives ............................ 1.3.2 Eurasian Customs Union ......................1.3.3 Regulations for USA and Canada ................... 1.3.4 Korean regulatory information ....................1.3.5 Other regulations and standards ....................
  • Page 4 Table of Contents Adjustment and control screens ....................Alarm screens ............................4.3.1 Alarm overview screen ........................ 4.3.2 Alarm configuration screens ..................... Detail screens ............................4.4.1 Overview ............................4.4.2 Agitator screen ..........................4.4.3 Conductivity screen ........................4.4.4 pH screens ............................4.4.5 Temperature screens ........................
  • Page 5 Table of Contents 7.3.7 Set alarm limits ..........................Add liquid contents ..........................Add solid contents ..........................Finish a batch run ..........................7.6.1 Collect the product ........................7.6.2 Remove the disposable bag ...................... 7.6.3 Shut down the system ......................... Maintenance ......................Safety precautions ..........................
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  • Page 7: Introduction

    1 Introduction Introduction About this chapter This chapter contains important user information and regulatory information about Xcellerex XDM and XDUO mixers. In this chapter Section See page 1.1 About this manual 1.2 Important user information 1.3 Regulatory information 1.4 Abbreviations Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 8: About This Manual

    1 Introduction 1.1 About this manual 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).

  • Page 9: Important User Information

    1 Introduction 1.2 Important user information 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.
  • Page 10 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.

  • Page 11: Regulatory Information

    This section lists the regulations and standards that apply to XDM and XDUO mixers. Manufacturing information The table below summarizes the required manufacturing information. Requirement Content Name and address of manufacturer GE Healthcare Bio-Sciences AB, Björkgatan 30, SE 751 84 Uppsala Sweden In this section Section See page 1.3.1 EU Directives...

  • Page 12: Eu Directives

    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. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 13: Eurasian Customs Union

    Telephone: + 46 771 400 600 Importer and/or company for obtain- GE Healthcare LLC 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: LSrus@ge.com...

  • Page 14: Regulations For Usa And Canada

    The user is cautioned that any changes or modifications not expressly approved by GE could void the user’s authority to operate the equipment. 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.

  • Page 15: Korean Regulatory Information

    1 Introduction 1.3 Regulatory information 1.3.4 Korean regulatory information 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.

  • Page 16: Other Regulations And Standards

    1 Introduction 1.3 Regulatory information 1.3.5 Other regulations and standards 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. Requirement Title 2012/19/EU Waste Electrical and Electronic Equipment (WEEE) Directive China RoHS...

  • Page 17: Abbreviations

    1 Introduction 1.4 Abbreviations Abbreviations The following terms and abbreviations are used in the user documentation: Term/Abbreviation Definition aseptic connection device controlled variable The output from the PID controller, or a manually set value that controls the process variable. I/O Cabinet Input/Output Cabinet proportional integral derivative A PID controller tries to minimize the difference between...

  • Page 18: Safety Instructions

    2 Safety instructions 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.

  • Page 19: Safety Precautions

    2 Safety instructions 2.1 Safety precautions 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 •...
  • Page 20 • 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.
  • Page 21 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.
  • Page 22 2 Safety instructions 2.1 Safety precautions WARNING Strong magnets. Magnets may interfere with functioning of pacemakers or implanted heart defibrillators and cause DEATH or SERIOUS INJURY. Magnets are located on the bottom of XDM and XDUO mixer, and in the impeller assembly of the disposable bags. •...
  • Page 23 2 Safety instructions 2.1 Safety precautions WARNING Keep jacking bolts. Do not remove jacking bolts from the installed system. CAUTION Heavy object. Because of the significant weight of the object, great care must be taken not to cause squeezing or crushing injuries during lifting.
  • Page 24 2 Safety instructions 2.1 Safety precautions WARNING Explosive environment. The products are not approved for work in a potentially explosive atmosphere. The products do not fulfill the requirements of the ATEX Directive. Power supply WARNING High voltage. It is essential for the safety of personnel working in or around electrically powered equipment to follow a company policy and procedure for Lock-Out / Tag-Out (LOTO).
  • Page 25 2 Safety instructions 2.1 Safety precautions CAUTION Heavy object. The container with solid ingredients is heavy. Use caution when filling the disposable bag from the top of the mixer, to avoid personal injury. CAUTION Liquid expands. Do not completely fill the disposable bag with cold liquid.
  • Page 26 Turn off equipment. Turn off the system and Lock-out / Tag-out (LOTO) the electrical equipment before doing maintenance. WARNING Spare parts. Only spare parts that are approved or supplied by GE may be used for maintaining or servicing the system. CAUTION Hot surface.
  • Page 27 2 Safety instructions 2.1 Safety precautions CAUTION Contamination hazard. Before performing any service work on the system, make sure that the system has been properly decon- taminated. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 28: Labels

    2 Safety instructions 2.2 Labels Labels Introduction This section describes the system label and other safety or regulatory labels that are attached to the product. Labels on the system A system label (1) with regulatory information is present on the system. Your system may also have an ASME label (2).
  • Page 29 10 kA Largest Motor: 0.3 Hp Protection Class: IP 45 Enclosure Type: Electrical Documentation: ICES 001/NMB 001 GE Healthcare Bio-Sciences AB 751 84 Uppsala MSIP-REM-2GE-0XXXX Made in Sweden The system label information is explained below. Label text Meaning Vessel Type: Jacketed or non-jacketed.
  • Page 30 2 Safety instructions 2.2 Labels Label text Meaning Enclosure Type: Electrical cabinet type. Electrical Documentation: Electrical schematic drawing number. The regulatory information is specific for each individual mixer. The following regulatory symbols may be found on the product. Label Meaning This symbol indicates that the waste of electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately.
  • Page 31 2 Safety instructions 2.2 Labels ASME label The label shown below is an example. Actual data printed on the label is specific for each individual system and may vary from system to system. N.B. # Certified by 4 Boulevard Charles de Gaulle - BP 12 42120 LE COTEAU Cedex - FRANCE Tél: (33) 04.77.67.39.55 - Fax: (33) 04.77.72.27.87 JACKET...
  • Page 32 2 Safety instructions 2.2 Labels Label text/symbol Meaning MDMT Minimum design metal temperature for the vessel. YEAR BUILT Year the equipment was produced. SERIAL # Identification number of the specific instrument (serial number). CRN # Canadian registration number for the vessel. FLUID Type of fluid the vessel is designed for.
  • Page 33 2 Safety instructions 2.2 Labels Safety labels The following table describes the various safety labels that are located on the parts of XDM and XDUO mixers. Safety label Description Warning! Do not use XDM or XDUO mixers before reading the Operating Instructions. Do not open any covers or replace parts unless specifically stated in the user documentation.

  • Page 34: Emergency Procedures

    2 Safety instructions 2.3 Emergency procedures Emergency procedures Introduction This section describes how to do an emergency shutdown of XDM and XDUO mixers, what happens as the result of power failure, and the procedure for restarting the mixers. In this section Section See page 2.3.1 Emergency procedures, Xcellerex XDM mixer...

  • Page 35: Emergency Procedures, Xcellerex Xdm Mixer

    2 Safety instructions 2.3 Emergency procedures 2.3.1 Emergency procedures, Xcellerex XDM mixer 2.3.1 Emergency procedures, Xcellerex XDM mixer Emergency shutdown of XDM mixer Action Result Switch off the mains power supply by turning the The agitator motor is immediately stopped. All power switch counterclockwise to the O OFF posi- power is removed from the mixer.
  • Page 36 2 Safety instructions 2.3 Emergency procedures 2.3.1 Emergency procedures, Xcellerex XDM mixer Step Action Connect the power cord to the mains power supply. Turn the system power switch to I ON position. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 37: Emergency Procedures, Xcellerex Xduo Mixer

    2 Safety instructions 2.3 Emergency procedures 2.3.2 Emergency procedures, Xcellerex XDUO mixer 2.3.2 Emergency procedures, Xcellerex XDUO mixer Emergency shutdown of XDUO mixer Action Result Press the EMERGENCY STOP button. The power is instantly removed from the • pumps and the pumps are placed in a safe state.
  • Page 38 2 Safety instructions 2.3 Emergency procedures 2.3.2 Emergency procedures, Xcellerex XDUO mixer Action Result If required: All power is removed from the I/O Cabinet. Turn the system power switch to O OFF posi- • tion. Disconnect the power cord from the mains •...
  • Page 39 2 Safety instructions 2.3 Emergency procedures 2.3.2 Emergency procedures, Xcellerex XDUO mixer Step Action Turn on the mains power supply by turning the system power switch to I ON position. Disengage the EMERGENCY STOP button by turning it clockwise. Result: The EMERGENCY STOP button pops out. Tap Login on the top toolbar of the home screen.
  • Page 40 2 Safety instructions 2.3 Emergency procedures 2.3.2 Emergency procedures, Xcellerex XDUO mixer Step Action Type your user name and password in the text boxes. Tap OK. Tap RESET on the local control software screen. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 41 2 Safety instructions 2.3 Emergency procedures 2.3.2 Emergency procedures, Xcellerex XDUO mixer The following happens after XDUO mixer has been restarted: System Result Stand-alone mixer E-STOP message is no longer shown on the local control software screen. XDUO mixer remains in a safe state with nothing running.

  • Page 42: Power Or Communication Failure

    2 Safety instructions 2.3 Emergency procedures 2.3.3 Power or communication failure 2.3.3 Power or communication failure Power failure XDM and XDUO mixers are not provided with UPS power backup. If the XDUO mixer is disconnected from power supply, then agitation, pH control, and temperature control stop.

  • Page 43: Xcellerex Xduo Mixer Interlocks

    2 Safety instructions 2.4 Xcellerex XDUO mixer interlocks Xcellerex XDUO mixer interlocks Description Condition Result The vessel weight is less than the Interlocks stop the agitator and the pumps • Min Weight interlock limit. (pH control). The vessel temperature control goes into •...
  • Page 44 2 Safety instructions 2.4 Xcellerex XDUO mixer interlocks Interlock limits The following table shows the interlock limits for different sizes of XDUO mixer. Interlock type Mixer vessel size Max Weight Min Weight 100 L 110 kg 28 kg 200 L 220 kg 44 kg 500 L...
  • Page 45 2 Safety instructions 2.4 Xcellerex XDUO mixer interlocks The interlock status is shown as follows: Interlock button Description The interlock is active. The interlock icon and name are shown in orange. The interlock is not active. The interlock icon and name are shown in gray.

  • Page 46: Security Levels

    2 Safety instructions 2.5 Security levels Security levels Overview XDUO mixer local control software has three security levels: • Operator • Supervisor • Administrator The following table shows the access levels for individual system functions in the local control software. System functions Security level Operator...

  • Page 47: Recycling Information

    Recycling of hazardous substances XDM and XDUO mixers contain hazardous substances. Detailed information is available from your GE representative. Disposal of electrical components Waste electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately.
  • Page 48 2 Safety instructions 2.6 Recycling information Instructions for disposal Follow the instructions below for disposal of mixer vessel and the I/O Cabinet: Step Action Decontaminate the mixer vessel and the I/O Cabinet following appropriate procedures dependent on what type of environment the unit was located in.

  • Page 49: Declaration Of Hazardous Substances (Dohs)

    2 Safety instructions 2.7 Declaration of Hazardous Substances (DoHS) Declaration of Hazardous Substances (DoHS) 根据SJ/T11364-2014《电子电气产品有害物质限制使用标识要求》特提供如下有关污染控制方面的 信息。 The following product pollution control information is provided according to SJ/T11364-2014 Marking for Restriction of Hazardous Substances caused by electrical and electronic products. 电子信息产品污染控制标志说明 Explanation of Pollution Control Label 该标志表明本产品含有超过中国标准GB/T 26572 《电子电气产品中限用物质的限...
  • Page 50 2 Safety instructions 2.7 Declaration of Hazardous Substances (DoHS) 有害物质的名称及含量 Name and Concentration of Hazardous Substances 产品中有害物质的名称及含量 Table of Hazardous Substances’ Name and Concentration 部件名称 有害物质 Component name Hazardous substance 铅 汞 镉 六价铬 多溴联苯 多溴二苯醚 (Pb) (Hg) (Cd) (Cr(VI)) (PBB) (PBDE) XDM mixer...

  • Page 51: System Description

    3 System description System description About this chapter This chapter contains descriptions of Xcellerex XDM and XDUO mixers. In this chapter Section See page 3.1 System overview 3.2 Xcellerex XDM mixer system description 3.3 Xcellerex XDUO mixer system description 3.4 Mixer vessel components 3.5 Safety hardware 3.6 Mixer automation and control 3.7 Temperature control unit...

  • Page 52: System Overview

    3 System description 3.1 System overview System overview Operating principle Xcellerex XDM and XDUO mixers are standalone systems for liquid-liquid and liquid-solid mixing operations for biopharmaceutical applications. The mixing process is designed to minimize the risk of cross-contamination. An aseptic single-use bag is installed in the vessel and the mixing process is done inside the disposable bag.

  • Page 53: Xcellerex Xdm Mixer System Description

    3 System description 3.2 Xcellerex XDM mixer system description Xcellerex XDM mixer system description Introduction This section gives a general overview of XDM mixer. In this section Section See page 3.2.1 System hardware 3.2.2 Illustration of Xcellerex XDM mixer Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 54: System Hardware

    3 System description 3.2 Xcellerex XDM mixer system description 3.2.1 System hardware 3.2.1 System hardware Description The XDM mixer is available in two variants: • Jacketed stainless steel mixer • Non-jacketed stainless steel mixer Both mixer variants are available in 50, 100, 200, 500, and 1000 L sizes. Functionality The XDM mixer functionality depends on the purchased options.

  • Page 55: Illustration Of Xcellerex Xdm Mixer

    3 System description 3.2 Xcellerex XDM mixer system description 3.2.2 Illustration of Xcellerex XDM mixer 3.2.2 Illustration of Xcellerex XDM mixer Introduction The following illustrations show a full configuration of a jacketed 200 L XDM mixer. The configuration of each mixer may vary according to the selected optional features. Front view Part Function...
  • Page 56 3 System description 3.2 Xcellerex XDM mixer system description 3.2.2 Illustration of Xcellerex XDM mixer Part Function Variable frequency drive display I/O Cabinet Opening for liquid addition lines Acrylic lid Push bar Test tube rack Probe window and probe support bar Rear view Part Function...
  • Page 57 3 System description 3.2 Xcellerex XDM mixer system description 3.2.2 Illustration of Xcellerex XDM mixer Part Function Coolant inlet (from TCU) Caster (4) Vessel jacket safety outlet (from burst disc) Agitator motor Load cell and jacking bolt (4) Ventilation hood (2) Power switch Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 58: Xcellerex Xduo Mixer System Description

    3 System description 3.3 Xcellerex XDUO mixer system description Xcellerex XDUO mixer system description Introduction This section gives a general overview of XDUO mixer. In this section Section See page 3.3.1 System hardware 3.3.2 Illustration of Xcellerex XDUO mixer Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 59: System Hardware

    3 System description 3.3 Xcellerex XDUO mixer system description 3.3.1 System hardware 3.3.1 System hardware Description The XDUO mixer is available in two variants: • Jacketed stainless steel mixer • Non-jacketed stainless steel mixer Both mixer variants are available in 100, 200, 500, and 1000 L sizes. Functionality The XDUO mixer functionality depends on the purchased options.

  • Page 60: Illustration Of Xcellerex Xduo Mixer

    3 System description 3.3 Xcellerex XDUO mixer system description 3.3.2 Illustration of Xcellerex XDUO mixer 3.3.2 Illustration of Xcellerex XDUO mixer Introduction The following illustrations show a full configuration of a jacketed 500 L XDUO mixer. The configuration of each mixer may vary according to the selected optional features. Front view Part Function...
  • Page 61 3 System description 3.3 Xcellerex XDUO mixer system description 3.3.2 Illustration of Xcellerex XDUO mixer Part Function USB connection port with protective cover pH/conductivity transmitter display Emergency stop button Local control software touchscreen Acrylic lids Opening for liquid addition lines Push bar Side access door Test tube rack...
  • Page 62 3 System description 3.3 Xcellerex XDUO mixer system description 3.3.2 Illustration of Xcellerex XDUO mixer Rear view Part Function Coolant outlet (to TCU) Mixer vessel Coolant inlet (from TCU) Caster (4) Vessel jacket safety outlet (from burst disc) Agitator motor Load cell and jacking bolt (4) Ventilation hood (2) Power switch...

  • Page 63: Mixer Vessel Components

    3 System description 3.4 Mixer vessel components Mixer vessel components Introduction This section provides an overview of the components of the mixer vessel. In this section Section See page 3.4.1 Mixer vessel 3.4.2 Agitator 3.4.3 Load cells 3.4.4 Pumps Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 64: Mixer Vessel

    3 System description 3.4 Mixer vessel components 3.4.1 Mixer vessel 3.4.1 Mixer vessel Description of mixer vessel The mixer vessel is a stainless steel rectangular container. The mixer is designed for high speed liquid-solid or liquid-liquid dissolution. For minimum working volumes, see Sec- tion 10.3 Xcellerex XDM and XDUO mixers minimum working volumes, on page 280.
  • Page 65 3 System description 3.4 Mixer vessel components 3.4.1 Mixer vessel Illustration of mixer lid The following illustration shows the mixer lids for 50 L to 500 L mixers (A) and 1000 L mixer (B). Part Function Opening for liquid addition lines Lid part Lid handle (4) Powder addition port...

  • Page 66: Agitator

    3 System description 3.4 Mixer vessel components 3.4.2 Agitator 3.4.2 Agitator Description The contents of the disposable bag are stirred by an impeller. The impeller assembly is a built-in feature of the disposable bag. The agitation is provided by a motor. The motor and the impeller assembly are magnetically coupled.
  • Page 67 3 System description 3.4 Mixer vessel components 3.4.2 Agitator The following illustration shows the agitator motor and drive head. Part Function Agitator drive head Agitator motor Agitation performance The agitator motor operates continuously between 10 to 200 rpm. A frequency inverter is used to change the motor speed.

  • Page 68: Load Cells

    3 System description 3.4 Mixer vessel components 3.4.3 Load cells 3.4.3 Load cells Description Load cells measure and record the weight of the mixer. Load cells are not a structural load bearing component. Load cells must be protected when the mixer is moved, for example during re-arrange- ment of a manufacturing line.
  • Page 69 3 System description 3.4 Mixer vessel components 3.4.3 Load cells Illustration of a load cell Part Description Function Securing nut Secures the engaged jacking bolt Top nut Fastens the vessel frame to the jacking bolt Bottom nut Lifts the vessel off the load cell Jacking bolt Takes the load off from the load cell Bolt locking nut...

  • Page 70: Pumps

    3 System description 3.4 Mixer vessel components 3.4.4 Pumps 3.4.4 Pumps Description The pumps introduce acids and bases into the disposable bag for adjustment of the pH of the bag contents. The pumps are located on the I/O Cabinet. Pumps are an optional component for the XDUO mixer. Pump models Two Watson-Marlow™...

  • Page 71: Safety Hardware

    This prevents catastrophic failure of the vessel jacket. Any leaking or dripping from the vessel jacket should immediately be reported to your GE representative to get support. Interlocks Each XDUO mixer contains interlock safety functionality that prevents mixer operation, if process variable values are within the defined interlock limits.

  • Page 72: Mixer Automation And Control

    3 System description 3.6 Mixer automation and control Mixer automation and control Introduction 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. The XDM mixer is monitored and controlled using the displays on the I/O Cabinet. The agitator is operated using the variable frequency drive display.
  • Page 73 3 System description 3.6 Mixer automation and control • Weight monitoring See Chapter 4 User interface, on page 84 for more information about the software. FlexFactory component Two control modes are available in this setup. The following table describes the features of these control modes.

  • Page 74: Temperature Control Unit

    3 System description 3.7 Temperature control unit Temperature control unit Description Temperature control is applicable for the jacketed mixers. The mixer vessel is surrounded by a vessel jacket where a temperature controlling fluid circulates. Temperature control is provided by a separate temperature control unit (TCU). The TCU keeps the circulating fluid at the designated temperature.

  • Page 75: Disposable Components

    3 System description 3.8 Disposable components Disposable components Introduction This section provides information about the disposable components that are needed for a mixing process. In this section Section See page 3.8.1 Disposable bag assembly 3.8.2 Probe sheath assembly Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 76: Disposable Bag Assembly

    3 System description 3.8 Disposable components 3.8.1 Disposable bag assembly 3.8.1 Disposable bag assembly Description The disposable bag assembly is a pre-sterilized single-use bag, designed for solid-liquid or liquid-liquid dissolution processes. The disposable bag assembly is available in three variants: •...
  • Page 77 3 System description 3.8 Disposable components 3.8.1 Disposable bag assembly Illustrations of the Plus Flex bag assembly The following illustration shows the top of the Plus Flex bag. The following illustration shows the underside of the Plus Flex bag. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 78 3 System description 3.8 Disposable components 3.8.1 Disposable bag assembly Part Function 3″ powder addition port, capped Liquid addition line i.d. ½″, with clamp, female MPX connector, plugged Sample line i.d. ⅛″, with clamp, Luer™ lock connector Temperature probe port Probe ports, female Kleenpak™...
  • Page 79 3 System description 3.8 Disposable components 3.8.1 Disposable bag assembly Illustrations of the Plus bag assembly The following illustration shows the top of the Plus bag. The following illustration shows the underside of the Plus bag. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 80 3 System description 3.8 Disposable components 3.8.1 Disposable bag assembly Part Function Liquid addition line i.d. ¾″, with clamp, plugged 3″ powder addition port, capped Liquid addition line i.d. ½″, with clamp, female MPX connector, plugged Liquid addition line i.d. ⅛″, Luer lock connector Probe ports, female Kleenpak™...
  • Page 81 3 System description 3.8 Disposable components 3.8.1 Disposable bag assembly The following illustration shows the underside of the Basic bag. Part Function Liquid addition line, with clamp, plugged Sample line, with clamp, Luer lock connector 3" powder addition port, capped Impeller baseplate with impeller assembly Drain line, with clamp, plugged Storage of the disposable bag...

  • Page 82: Probe Sheath Assembly

    3 System description 3.8 Disposable components 3.8.2 Probe sheath assembly 3.8.2 Probe sheath assembly Description The probe sheath is an accessory to the disposable bag. The probe sheath provides aseptic connection of a probe with the cell culture inside the disposable bag. The probe sheath with the inserted probe constitutes the probe sheath assembly, which is inserted into the disposable bag probe port.
  • Page 83 3 System description 3.8 Disposable components 3.8.2 Probe sheath assembly Illustration of the probe sheath The following illustration shows the probe sheath. Part Description Aseptic connection device (male end) Aseptic membrane Anti-actuation ring Bellows End plug Illustration of the probe sheath assembly The following illustration shows a probe sheath with the inserted probe.

  • Page 84: User Interface

    4 User interface User interface About this chapter The XDUO mixer is operated using local control software. This chapter provides an overview of the user interface for the local control software. The parts used in daily op- erations are described in Section 7.3 Operate Xcellerex XDUO mixer, on page 198. In this chapter Section See page...

  • Page 85: General Description

    4 User interface 4.1 General description General description User interface The user communicates with the PLC using the local control panel touchscreen on the I/O Cabinet. A home screen (start screen) gives a general overview of the software and is used as a gateway to other screens.
  • Page 86 4 User interface 4.1 General description Part Description Function Navigation toolbar Tapping a button opens the detail screen for the corresponding process variable. Tapping HOME takes the user back to the home screen. The icon is gray if no alarm is active. •...
  • Page 87 4 User interface 4.1 General description Part Description Function Displays the pH value of the disposable bag contents. The active control mode (Manual or Auto) is shown at the top of the display. See pH Detail screen, on page 103. Interlocks Shows Agitator, Min Weight and Max Weight inter- lock status:...
  • Page 88 4 User interface 4.1 General description Part Function Tag name Current value of the process variable and the measurement unit Selected sensor (black) Nonselected sensor (gray) If two sensors are installed on your system, both process variable values are shown on the display (these options are available for temperature and pH).
  • Page 89 4 User interface 4.1 General description Numerical entry box Tapping a text box for numeric entry opens a numeric keypad. The following illustration shows the numeric keypad. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 90: Adjustment And Control Screens

    4 User interface 4.2 Adjustment and control screens Adjustment and control screens XDUO Mixer System Info screen The XDUO Mixer System Info screen is opened by tapping INFO on the navigation toolbar. The following illustration shows the XDUO Mixer System Info screen. Part Display Function...
  • Page 91 FlexFactory connected systems). Customer Equip # Instrument number in customer equipment inventory. XLX Mixer # Instrument serial number. This button is visible only for administrators. This screen is for GE use only. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 92 4 User interface 4.2 Adjustment and control screens Time Management screen The Time Management screen is opened by tapping SET CLOCK on the XDUO Mixer System Info screen. The following illustration shows the Time Management screen. Part Description Text boxes for date and time information Button to set the date and time When the date and time are changed, it may take a few minutes until the new time is shown on the top toolbar.

  • Page 93: Alarm Screens

    4 User interface 4.3 Alarm screens Alarm screens Introduction This section provides information of the alarm overview screen and alarm configuration screens. In this section Section See page 4.3.1 Alarm overview screen 4.3.2 Alarm configuration screens Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 94: Alarm Overview Screen

    4 User interface 4.3 Alarm screens 4.3.1 Alarm overview screen 4.3.1 Alarm overview screen Description The alarm overview screen is opened by tapping ALARMS on the navigation toolbar. The alarm overview screen shows all currently active alarms. To remove an alarm from this list, the user must clear the alarm condition (for example drain the excess liquid from the mixer to clear the weight High High Alarm).

  • Page 95: Alarm Configuration Screens

    4 User interface 4.3 Alarm screens 4.3.2 Alarm configuration screens 4.3.2 Alarm configuration screens Description Alarm configuration screens are available for the following functionalities: • Agitator (Agitator Alarm Config) • Conductivity (Conductivity Alarm Config) • pH (pH Alarm Config) • Temperature (Temperature Alarm Config) •...
  • Page 96 4 User interface 4.3 Alarm screens 4.3.2 Alarm configuration screens Weight alarm limits The weight Critical Alarm limit is equal to the Max Weight interlock limit. The Critical Alarm limit depends on the size of the vessel. If the Max Weight interlock limit is reached, the pH regulation is deactivated.
  • Page 97 4 User interface 4.3 Alarm screens 4.3.2 Alarm configuration screens Illustration of alarm configuration screen The following illustration shows an example of an alarm configuration screen. The user can set all four alarm setpoints (SP) for each functionality. If duplicate probes are installed on the system (pH or temperature probes), the PLC uses data from the currently selected probe for the alarm.

  • Page 98: Detail Screens

    4 User interface 4.4 Detail screens Detail screens Introduction This section provides descriptions of the local control software detail screens for agitator, pH, conductivity, temperature, and weight. In this section Section See page 4.4.1 Overview 4.4.2 Agitator screen 4.4.3 Conductivity screen 4.4.4 pH screens 4.4.5 Temperature screens 4.4.6 Weight screen...

  • Page 99: Overview

    4 User interface 4.4 Detail screens 4.4.1 Overview 4.4.1 Overview Detail screens The detail screens are available for agitator, pH, conductivity, temperature, and weight. All detail screens have the following buttons: Button Description Tapping BACK takes the user back to the previous screen. Tapping ALARM CONFIG opens the alarm configuration screen for the parameter.

  • Page 100: Agitator Screen

    4 User interface 4.4 Detail screens 4.4.2 Agitator screen 4.4.2 Agitator screen Agitator Detail screen The Agitator Detail screen is opened by tapping AGITATION on the navigation toolbar. The following illustration shows an example of the Agitator Detail screen. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 101 4 User interface 4.4 Detail screens 4.4.2 Agitator screen Part Function Agitator motor speed setpoint (SP), text box for input. Process variable (PV) display. Agitator motor drive state indicator: Enabled or Disabled. Note: If the agitator motor drive is enabled, but the agitator state is shown as Stopped, the agitator motor drive is defective.

  • Page 102: Conductivity Screen

    4 User interface 4.4 Detail screens 4.4.3 Conductivity screen 4.4.3 Conductivity screen Conductivity Detail screen The Conductivity Detail screen is opened by tapping COND. on the navigation toolbar. The following illustration shows an example of the Conductivity Detail screen. The screen shows the process variable (PV) value for the conductivity probe. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 103: Ph Screens

    4 User interface 4.4 Detail screens 4.4.4 pH screens 4.4.4 pH screens pH Detail screen The pH Detail screen is opened by tapping pH on the navigation toolbar. The following illustration shows an example of the pH Detail screen. Part Display/Button Description PHC_125 pH SP...
  • Page 104 4 User interface 4.4 Detail screens 4.4.4 pH screens Part Display/Button Description PHC_125 Manual CV User-defined CV (controlled variable) value for pH PID controller output. Note: In Manual mode, this value is used as PHC_125 pH CV. AIT_121/AIT_122 Toggle button to select the pH probe. Auto/Manual Toggle button to select the control mode.
  • Page 105 4 User interface 4.4 Detail screens 4.4.4 pH screens pH PID Settings screen The pH PID Settings screen is opened by tapping PID SETTINGS on the pH Detail screen. The following illustration shows an example of the pH PID Settings screen. Part Button/Display Function...
  • Page 106 4 User interface 4.4 Detail screens 4.4.4 pH screens Part Button/Display Function Deadband User-defined deadband value. When the pH value (process variable, PV) is within the deadband range from SP, the pumps do not operate. Auto/Manual Toggle button to select the control mode. P-Term (proportional) User-defined PID tuning parameters.

  • Page 107: Temperature Screens

    4 User interface 4.4 Detail screens 4.4.5 Temperature screens 4.4.5 Temperature screens Temperature Detail screen The Temperature Detail screen is opened by tapping TEMP. on the navigation toolbar. The temperature probe contains two sensors. The data from both sensors is displayed on the Temperature Detail screen.
  • Page 108 4 User interface 4.4 Detail screens 4.4.5 Temperature screens Part Description Function TC_163 Manual CV User-defined CV (controlled variable) value for temperature PID controller output. Note: In Manual mode, this value is used as TC_163 Temperature CV. The value is shown in % of configured TCU remote setpoint temperature range.
  • Page 109 4 User interface 4.4 Detail screens 4.4.5 Temperature screens Temperature PID screen The Temperature PID screen is opened by tapping PID SETTINGS on the Temperature Detail screen. The following illustration shows an example of the Temperature PID screen. Part Description Function Temperature setpoint (SP), the designated temperature of the disposable bag contents.
  • Page 110 4 User interface 4.4 Detail screens 4.4.5 Temperature screens Part Description Function P-Term (proportional) User-defined PID tuning parameters. I-Term (integral) D-Term (derivative) CV HiLimit User-defined limits for temperature PID con- troller output (controlled variable, CV). The CV CV LoLimit limits (in %) specify the allowed temperature range for the TCU.
  • Page 111 4 User interface 4.4 Detail screens 4.4.5 Temperature screens Transmitter Offsets screen The Transmitter Offsets screen is opened by tapping OFFSETS on the Temperature Detail screen. The Transmitter Offsets screen is used for calibration of temperature probes. The temperature probe contains two sensors. The data from both sensors is displayed on the Transmitter Offsets screen.

  • Page 112: Weight Screen

    4 User interface 4.4 Detail screens 4.4.6 Weight screen 4.4.6 Weight screen Weight Detail screen The Weight Detail screen is opened by tapping WEIGHT on the navigation toolbar. The following illustration shows an example of the Weight Detail screen. The screen shows the process variable (PV) value for the mixer vessel weight. Tapping Tare lets the user to tare the mixer vessel weight.

  • Page 113: Trend Screens

    4 User interface 4.5 Trend screens Trend screens Description Trend screens are available for the following functionalities: • Agitator speed (Agitator Trend) • Conductivity (Conductivity Trend) • pH (pH Trend) • Temperature (Temperature Trend) • Weight (Weight Trend) All five Trend screens have similar layout. The pH Trend and Temperature Trend screens show the graphs for the setpoint (SP), the current process variable (PV), and the controlled variable (CV) in relevant measurement units.
  • Page 114 4 User interface 4.5 Trend screens Parameter ranges for trending The trending ranges for each measured parameter and the controlled variable are shown in the following table. Parameter Setpoint (SP) Controlled variable Process variable (CV) (PV) Agitator 10 to 200 rpm Not applicable 0 to 200 rpm Conductivity...
  • Page 115 4 User interface 4.5 Trend screens Part Description Process variable (PV) axis and measurement unit Graph area Controlled variable (CV) axis and measurement unit Legend Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 116: Installation

    5 Installation Installation About this chapter This chapter describes pre-installation tasks and site requirements for the installation of XDM and XDUO mixers. Instructions for connecting external equipment are also pro- vided. Components not covered in this manual must not be installed by the customer. For unpacking instructions, see separate Xcellerex XDM and XDUO mixers Unpacking Instructions manual.

  • Page 117: Safety Precautions

    5 Installation 5.1 Safety precautions Safety precautions WARNING Personal Protective Equipment (PPE). Whenever packing, unpack- ing, transporting or moving the system, wear protective footwear, preferably with steel toe cap. WARNING Electrical installation. All electrical installation must be performed by authorized personnel only. WARNING Strong magnets.
  • Page 118 5 Installation 5.1 Safety precautions WARNING High voltage. The system must always be connected to a grounded power outlet. WARNING High voltage. It is essential for the safety of personnel working in or around electrically powered equipment to follow a company policy and procedure for Lock-Out / Tag-Out (LOTO).

  • Page 119: Site Requirements

    5 Installation 5.2 Site requirements Site requirements Introduction This section describes the requirements for space and supplies in the building where XDM or XDUO mixers will be installed. Space and floor For space and floor requirements, see the dimensions and weights of XDM mixer or XDUO mixer in the General Specification (GS) in the Product Documentation package (ToP) for the instrument.
  • Page 120 5 Installation 5.2 Site requirements Electrical power Parameter Requirement Supply voltage, mixer 100-120 V AC, 50 or 60 Hz, 4.5 A 220-240 V AC, 50 or 60 Hz, 3.0 A Number of electrical outlets Two outlets for the following units: I/O Cabinet •...

  • Page 121: Installation Of The Mixer

    5 Installation 5.3 Installation of the mixer Installation of the mixer Moving when unpacked XDM and XDUO mixers can be rolled by hand on hard and level surfaces with wheel brakes released. NOTICE Always engage the jacking bolts before moving the instrument. This prevents damage to the load cells.

  • Page 122: Connect Temperature Control Unit

    5 Installation 5.4 Connect temperature control unit Connect temperature control unit Read this before operating the temperature control unit All users must read the TCU manufacturer's instructions before installing, operating or maintaining the TCU. Always keep the instructions at hand when operating the TCU. Do not operate the TCU in any other way than described in the user documentation.
  • Page 123 5 Installation 5.4 Connect temperature control unit Step Action Connect the communication cable to the HEC-246 TCU port on the underside of the I/O Cabinet. Note: The connectors and labels on your instrument may differ from the layout illus- trated below. Fill the vessel jacket CAUTION Slippery surface.
  • Page 124 5 Installation 5.4 Connect temperature control unit Follow the instructions below to fill the vessel jacket with the coolant. Step Action Make sure that the vent valve and the drain valve of the mixer vessel jacket are closed. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 125 5 Installation 5.4 Connect temperature control unit Step Action Connect the TCU outlet tubing to the coolant inlet (SUPPLY) of the mixer vessel. Connect the TCU inlet tubing to the coolant outlet (RETURN) of the mixer vessel. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 126 5 Installation 5.4 Connect temperature control unit Step Action If available, use quick connect devices for the connections between the tubing and the TCU. Lock the Snap-tite™ quick disconnect connector as follows: Pull back the locking ring. Push both parts of the connector together. Release the locking ring.
  • Page 127 5 Installation 5.4 Connect temperature control unit Step Action Wait 5 minutes and then release air slowly through the vent valve until the fluid flow starts, then close the valve. Result: The vessel jacket is purged. Stop the TCU, remove the reservoir cap, refill the reservoir with coolant, and then reinstall the cap.
  • Page 128 5 Installation 5.4 Connect temperature control unit Step Action Prepare an applicable container for collection of the drained coolant. See Section 10.1 System specifications, on page 274 for the information on the vessel jacket volume. Connect the drain valve (1) to the collection container as applicable. Open the drain valve (1).

  • Page 129: Preparation

    6 Preparation Preparation About this chapter This chapter provides required information to prepare XDM and XDUO mixers for opera- tion. In this chapter Section See page 6.1 Safety precautions 6.2 Stabilize the mixer vessel 6.3 Prepare the disposable bag 6.4 Prepare and install the probes 6.5 Calibrate the monitors of Xcellerex XDM mixer 6.6 Prepare the pumps Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 130: Safety Precautions

    6 Preparation 6.1 Safety precautions Safety precautions 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: •...
  • Page 131 6 Preparation 6.1 Safety precautions NOTICE Always engage the jacking bolts before moving the instrument. This prevents damage to the load cells. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 132: Stabilize The Mixer Vessel

    6 Preparation 6.2 Stabilize the mixer vessel Stabilize the mixer vessel Introduction This section provides information about how to make sure that XDM and XDUO mixers are in a stable position during preparation and operation. In this section Section See page 6.2.1 Use jacking bolts 6.2.2 Lock and unlock casters Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 133: Use Jacking Bolts

    6 Preparation 6.2 Stabilize the mixer vessel 6.2.1 Use jacking bolts 6.2.1 Use jacking bolts Engage jacking bolts NOTICE Securing the jacking bolts in a way other than described in this manual may damage the load cells. Follow the instructions below to engage the jacking bolts. Step Action Verify the following conditions:...
  • Page 134 6 Preparation 6.2 Stabilize the mixer vessel 6.2.1 Use jacking bolts Step Action Turn down the top nut (1) with your fingers to the support plate, and tighten it slightly with a wrench. Turn down the securing nut (2) with your fingers to the top nut, and tighten it slightly with a wrench.
  • Page 135 6 Preparation 6.2 Stabilize the mixer vessel 6.2.1 Use jacking bolts Disengage jacking bolts WARNING Keep jacking bolts. Do not remove jacking bolts from the installed system. Follow the instructions below to disengage the jacking bolts. Step Action Turn up the securing nut (1) on the bolt by a few turns using a wrench. Turn up the top nut (2) on the bolt by 1 to 2 turns using the wrench.
  • Page 136 6 Preparation 6.2 Stabilize the mixer vessel 6.2.1 Use jacking bolts Step Action Loosen the bottom nut using the wrench. Turn the nut all the way down (the distance between the support plate and the bottom nut must be at least 2 to 3 mm).
  • Page 137 6 Preparation 6.2 Stabilize the mixer vessel 6.2.1 Use jacking bolts Before operation Before operation, verify that the mixer is clear of obstructions. Depending on site require- ments, a functional check or load cell calibration might be required before operating the mixer.

  • Page 138: Lock And Unlock Casters

    6 Preparation 6.2 Stabilize the mixer vessel 6.2.2 Lock and unlock casters 6.2.2 Lock and unlock casters Lock the casters After moving the instrument to the designated location, lock the casters by pressing down the tab on each brake. Unlock the casters Before moving the instrument, unlock each caster by pushing hard the top tab towards the instrument frame.

  • Page 139: Prepare The Disposable Bag

    6 Preparation 6.3 Prepare the disposable bag Prepare the disposable bag Introduction This section describes how to unpack and install the disposable bag assembly. The in- structions are applicable for both XDM and XDUO mixers. In this section Section See page 6.3.1 Unpack the disposable bag assembly 6.3.2 Install the disposable bag Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 140: Unpack The Disposable Bag Assembly

    6 Preparation 6.3 Prepare the disposable bag 6.3.1 Unpack the disposable bag assembly 6.3.1 Unpack the disposable bag assembly Prepare for unpacking NOTICE Before opening the box, clear the inspection area of sharp objects. All personnel who handle the disposable bag assembly must re- move watches, rings, and any items with sharp edges or points that could damage the disposable bag.
  • Page 141 6 Preparation 6.3 Prepare the disposable bag 6.3.1 Unpack the disposable bag assembly Step Action Open the box and remove the packing materials. Take out the disposable bag assembly and place the bag on the inspection table. Carefully open the outer protective bag and take out the bag assembly. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 142 6 Preparation 6.3 Prepare the disposable bag 6.3.1 Unpack the disposable bag assembly Step Action Unfold the bag assembly. Remove the bubble wrap and protective materials that surround the bag assembly. NOTICE Do not remove the wrap from the tubing ports, tubing connectors, and filters.
  • Page 143 MFG DATE: MMMYYYY EXPIRES: MMMYYY STORAGE: 10 °C - 34 °C STERILE - FOR SINGLE USE 222222 REV: XX Product Certification can be found at: GE Healthcare Bio-Sciences Corp. www.gelifesciences.com/certificates 14 Walkup Drive Made in USA Westborough, MA 01581 Patents: www.pall.com/patents Note: The label above is an example.
  • Page 144 6 Preparation 6.3 Prepare the disposable bag 6.3.1 Unpack the disposable bag assembly Unwrap bag parts Continue the unpacking of the bag assembly as described below. Step Action If your disposable bag has probe ports, remove the bubble wrap from the probe ports.
  • Page 145 6 Preparation 6.3 Prepare the disposable bag 6.3.1 Unpack the disposable bag assembly Step Action Remove the bubble wrap from the liquid addition lines. NOTICE Do not remove zip ties that hold the lines together. Loose lines can be damaged during bag installation. Remove the bubble wrap from the drain line.
  • Page 146 6 Preparation 6.3 Prepare the disposable bag 6.3.1 Unpack the disposable bag assembly Step Action Immediately close all clamps after removing the wrap from each component. Lay the bag assembly flat on the table and inspect the disposable bag. Verify that the disposable bag has no tears, rips or cuts. Note: Light scratches and creases may be present on the bag due to handling.

  • Page 147: Install The Disposable Bag

    6 Preparation 6.3 Prepare the disposable bag 6.3.2 Install the disposable bag 6.3.2 Install the disposable bag Different mixer models Details in the following illustrations may differ from your system, depending on the configuration of your mixer. Start bag installation NOTICE Before starting the disposable bag installation, wipe clean and dry the vessel wall if necessary.
  • Page 148 6 Preparation 6.3 Prepare the disposable bag 6.3.2 Install the disposable bag Step Action Remove the side access door from 500 and 1000 L mixers. Follow the instruc- tions below: Hold the door handle tightly. Turn the door counterclockwise. Remove the door. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 149 6 Preparation 6.3 Prepare the disposable bag 6.3.2 Install the disposable bag Step Action From the top of the mixer vessel, locate the following: Agitator drive head: large opening at the bottom center (1). • Drain opening at the bottom corner of the vessel (2). •...
  • Page 150 6 Preparation 6.3 Prepare the disposable bag 6.3.2 Install the disposable bag Step Action Carefully move the disposable bag assembly to the vessel and lower the bag into the vessel. If you are installing a Plus or Plus Flex bag assembly, make sure that the probe connectors (1) face the probe port (2).
  • Page 151 6 Preparation 6.3 Prepare the disposable bag 6.3.2 Install the disposable bag Step Action Insert the drain line through the drain opening. Carefully pull the line through the opening. Tip: The drain line is more easily reached from the underside of the vessel. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 152 6 Preparation 6.3 Prepare the disposable bag 6.3.2 Install the disposable bag Step Action Set the impeller baseplate above the agitator drive head in the agitator opening. CAUTION Magnetic components. Use caution when handling magnetic components. There is a strong magnetic at- traction between the impeller and the motor drive coupling.
  • Page 153 6 Preparation 6.3 Prepare the disposable bag 6.3.2 Install the disposable bag Step Action Adjust the probe connectors of Plus or Plus Flex bag assembly by gently pulling the connectors through the probe window. Adjust impeller position If the impeller baseplate is not correctly installed, the agitator system is not properly magnetically coupled and does not function correctly.
  • Page 154 6 Preparation 6.3 Prepare the disposable bag 6.3.2 Install the disposable bag Step Action Position the impeller baseplate correctly, as shown below. CAUTION Magnetic components. Use caution when handling magnetic components. There is a strong magnetic at- traction between the impeller and the motor drive coupling.
  • Page 155 6 Preparation 6.3 Prepare the disposable bag 6.3.2 Install the disposable bag Step Action Pull all tubing away from the sides of the bag assembly and hang the tubing over the rim of the mixer vessel. Note: Correct position of tubing helps the adjustment of the disposable bag. Install the hopper, if applicable.
  • Page 156 6 Preparation 6.3 Prepare the disposable bag 6.3.2 Install the disposable bag Step Action B. Make sure that the O-ring stays in place on the powder addition port. C. Put the hopper onto the powder addition port and secure it with the TC-clamp.

  • Page 157: Prepare And Install The Probes

    6 Preparation 6.4 Prepare and install the probes Prepare and install the probes Introduction This section gives information on how to prepare and install the probes into the disposable bag. This section is relevant for the Plus and Plus Flex bag assembly. In this section Section See page...

  • Page 158: Calibrate The Ph Probe

    6 Preparation 6.4 Prepare and install the probes 6.4.1 Calibrate the pH probe 6.4.1 Calibrate the pH probe Materials Note: If the mixer is used in a GMP regulated environment, the pH probe is a GMP critical component. Before calibrating the pH probe, prepare the following: •...
  • Page 159 6 Preparation 6.4 Prepare and install the probes 6.4.1 Calibrate the pH probe Calibrate the pH probe Perform the autocalibration of the pH probe as follows: Step Action Locate the pH/DO transmitter display on the I/O Cabinet. Press MENU (1). Result: A menu is displayed on the transmitter screen.
  • Page 160 6 Preparation 6.4 Prepare and install the probes 6.4.1 Calibrate the pH probe Step Action 1 Select Calibrate and press ENTER (2). 2 Select Sensor 1 and press ENTER. 3 Select pH and press ENTER. 4 Select Buffer Cal and press ENTER. 5 Select Auto and press ENTER.
  • Page 161 6 Preparation 6.4 Prepare and install the probes 6.4.1 Calibrate the pH probe If the calibration fails, find the cause of the failure using the transmitter and sensor user manuals. Tip: If duplicate probes are used, label the calibrated probe as pH-1. Then repeat the steps described above to calibrate the second pH probe and label it as pH-2.
  • Page 162 6 Preparation 6.4 Prepare and install the probes 6.4.1 Calibrate the pH probe Step Action Press MENU (1). Result: A menu is displayed on the transmitter screen. Use the navigation keys to make selections in the menu: 1 Select Calibrate and press ENTER (2). 2 Select Sensor 1 and press ENTER.

  • Page 163: Prepare The Conductivity Probe

    6 Preparation 6.4 Prepare and install the probes 6.4.2 Prepare the conductivity probe 6.4.2 Prepare the conductivity probe Install the conductivity probe To install and calibrate a new conductivity probe or to replace a probe, follow the instruc- tions below. Step Action Take the probe out of the packaging.
  • Page 164 6 Preparation 6.4 Prepare and install the probes 6.4.2 Prepare the conductivity probe Step Action Use the navigation keys to make selections in the menu: Select Calibrate and press ENTER (2). Select Sensor 2 and press ENTER. Select Cell K. Use the navigation keys to enter the cell constant value that you found in the accompanying manual.

  • Page 165: Autoclave Probe Sheath Assembly

    6 Preparation 6.4 Prepare and install the probes 6.4.3 Autoclave probe sheath assembly 6.4.3 Autoclave probe sheath assembly Conditions The probe sheath assembly with inserted probe must be autoclaved. The recommended conditions for autoclaving are as follows: • Temperature > 121°C •...
  • Page 166 6 Preparation 6.4 Prepare and install the probes 6.4.3 Autoclave probe sheath assembly Step Action Insert the pipette into the probe sheath assembly through the threaded hole in the probe sheath assembly end plug. Inject the water into the probe sheath assembly. Note: The inserted water provides the steam inside the probe sheath assembly during autoclaving.
  • Page 167 Tip: Use a probe assembly holder (optional) to position the probe sheath assembly correctly during autoclaving. Contact your GE representative for more infor- mation. Start the autoclave. See Conditions, on page 165 for sterilization conditions. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 168: Insert Probes Into The Disposable Bag

    6 Preparation 6.4 Prepare and install the probes 6.4.4 Insert probes into the disposable bag 6.4.4 Insert probes into the disposable bag Prepare probe sheath assembly All types of analytical probes are installed using the same procedure. The probe sheath assembly should be autoclaved before installation. See Section 6.4.3 Autoclave probe sheath assembly, on page 165 for instructions.
  • Page 169 6 Preparation 6.4 Prepare and install the probes 6.4.4 Insert probes into the disposable bag Step Action Install two ratchet clamps over the section of tubing between the bag as- sembly probe port (welded into the disposable bag) and the female aseptic connection device (ACD) connector attached to the probe port of the dispos- able bag, at the location shown in the following illustration.
  • Page 170 6 Preparation 6.4 Prepare and install the probes 6.4.4 Insert probes into the disposable bag Step Action Install one ratchet clamp at the section of the probe sheath assembly be- tween the male ACD connector and the bellows section of the probe sheath assembly, as shown in the following illustration.
  • Page 171 6 Preparation 6.4 Prepare and install the probes 6.4.4 Insert probes into the disposable bag Step Action Verify that the impeller baseplate is magnetically connected to the agitator drive head. Verify that the probe Kleenpak connectors are aligned with the probe port. Remove the protective caps from both ACD connectors.
  • Page 172 6 Preparation 6.4 Prepare and install the probes 6.4.4 Insert probes into the disposable bag Step Action Press the two ACD connectors together until they snap to closed position. A double-click sound indicates that the connectors have been closed and the ACDs are fully engaged.
  • Page 173 6 Preparation 6.4 Prepare and install the probes 6.4.4 Insert probes into the disposable bag Step Action NOTICE If only one membrane strip is removed or if a mem- brane strip breaks and only part of it is removed, the connection should not be considered aseptic.
  • Page 174 6 Preparation 6.4 Prepare and install the probes 6.4.4 Insert probes into the disposable bag Step Action Push the thumb rest of the male connector down towards the base of the body of the connector until the thumb rest meets the body. Note: A ratchet sound is heard from the male ACD connector during this motion.
  • Page 175 6 Preparation 6.4 Prepare and install the probes 6.4.4 Insert probes into the disposable bag Step Action Perform a visual inspection of the mated connection to confirm that the sealing O-rings are in place and that they are not distorted. NOTICE If there is any indication that the connection might not be aseptic, immediately clamp off this probe sheath...
  • Page 176 6 Preparation 6.4 Prepare and install the probes 6.4.4 Insert probes into the disposable bag Step Action Hold the mated connectors with one hand and push the end plug of the probe sheath assembly inwards toward the disposable bag, compressing the bellows section of the probe sheath assembly.
  • Page 177 6 Preparation 6.4 Prepare and install the probes 6.4.4 Insert probes into the disposable bag Step Action Hold the probe sheath assembly in its fully compressed state in one hand and tighten the three ratchet clamps with a tool, until 7 clamp teeth are engaged.
  • Page 178 6 Preparation 6.4 Prepare and install the probes 6.4.4 Insert probes into the disposable bag Step Action The following illustration shows a compressed probe sheath assembly in place. Repeat steps 1 to 11 above to connect the next probe. Collect all loose probe cables and place the cables into the cable holders on the short side of the mixer vessel.
  • Page 179 6 Preparation 6.4 Prepare and install the probes 6.4.4 Insert probes into the disposable bag Completed probe sheath installation When the primary and secondary seals are in place and properly tightened, the probe sheath assembly stays in the compressed condition against the internal pressure in the disposable bag without the need of external fixtures.
  • Page 180 6 Preparation 6.4 Prepare and install the probes 6.4.4 Insert probes into the disposable bag Step Action Connect the temperature probe connector to the TT-161 cable that is at- tached to the underside of the I/O Cabinet. Note: The connectors and labels on your instrument may differ from the configura- tion shown below.
  • Page 181 6 Preparation 6.4 Prepare and install the probes 6.4.4 Insert probes into the disposable bag Step Action Attach the temperature probe cable to the probe support bar (for example with a zip tie) to prevent operators from accidentally removing the temper- ature probe from the thermowell.

  • Page 182: Calibrate The Monitors Of Xcellerex Xdm Mixer

    6 Preparation 6.5 Calibrate the monitors of Xcellerex XDM mixer Calibrate the monitors of Xcellerex XDM mixer Calibrate the monitors The displays on XDM mixer vessel allow monitoring of disposable bag temperature and vessel weight. To calibrate the monitors, see the instructions in the monitor manufacturer's documen- tation.

  • Page 183: Prepare The Pumps

    6 Preparation 6.6 Prepare the pumps Prepare the pumps Select addition lines The Plus Flex bag assembly has two liquid addition lines i.d. ¼″, with Luer lock connectors, designated for addition of acid and base solutions to the disposable bag. See Illustrations of the Plus Flex bag assembly, on page 77 for overview of the disposable bag.
  • Page 184 6 Preparation 6.6 Prepare the pumps Tubing in the pump The following illustration shows the direction of the liquid flow through the pump, when the pump is running in a clockwise direction. See the following section for tubing installation instructions. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 185 6 Preparation 6.6 Prepare the pumps Install tubing in pump model 313 To install the tubing in pump model 313 follow the instructions below. Step Action Open the pump head cover. Insert the tubing through the pump. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 186 6 Preparation 6.6 Prepare the pumps Step Action Close the pump head cover. If the tubing is moving in the pump head, tighten the adjustment wheel half a turn clockwise. CAUTION Do not overtighten. Do not overtighten the adjustment wheel on the pumps. The flow through the tubing may be cut off.

  • Page 187: Operation

    7 Operation Operation About this chapter The XDM mixer is operated using the variable frequency drive (VFD). The XDUO mixer is operated using local control software. This chapter gives instructions for the operation of both mixers. In this chapter Section See page 7.1 Safety precautions 7.2 Operate Xcellerex XDM mixer...

  • Page 188: Safety Precautions

    7 Operation 7.1 Safety precautions 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.
  • Page 189 7 Operation 7.1 Safety precautions CAUTION Pinch hazard. Do not operate the pumps without the covers in place. CAUTION Secure pump tubing. Make sure that the pump tubing is secure and in good condition before using the pump. Do not block or kink the tubing downstream of the pump.

  • Page 190: Operate Xcellerex Xdm Mixer

    7 Operation 7.2 Operate Xcellerex XDM mixer Operate Xcellerex XDM mixer Introduction This section describes how to operate XDM mixers. In this section Section See page 7.2.1 Start up the system 7.2.2 Operate the agitator motor 7.2.3 Monitor temperature and weight 7.2.4 Monitor pH and conductivity Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 191: Start Up The System

    7 Operation 7.2 Operate Xcellerex XDM mixer 7.2.1 Start up the system 7.2.1 Start up the system Start the system To start the XDM mixer, turn the system power switch to I ON position. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 192: Operate The Agitator Motor

    7 Operation 7.2 Operate Xcellerex XDM mixer 7.2.2 Operate the agitator motor 7.2.2 Operate the agitator motor Start and stop the agitator motor When the power to XDM mixer is turned on, the digital display shows the currently valid agitator speed (rpm) and the agitator direction. NOTICE Prior to starting the agitator, the disposable bag must be filled to at least the minimum working volume.
  • Page 193 7 Operation 7.2 Operate Xcellerex XDM mixer 7.2.2 Operate the agitator motor Change agitator speed and direction The speed and the direction can be changed before starting the agitator motor, and during the run. Follow the instructions below to adjust the agitator run conditions. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 194 7 Operation 7.2 Operate Xcellerex XDM mixer 7.2.2 Operate the agitator motor Step Action Adjust the agitator speed with the up and down arrow buttons. Result: The digital display shows the motor speed. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 195 7 Operation 7.2 Operate Xcellerex XDM mixer 7.2.2 Operate the agitator motor Step Action To change the agitation direction, press the direction button. Result: The agitator direction is shown in the upper left corner of the digital display. F (Forward) - the agitator rotates in clockwise direction. •...

  • Page 196: Monitor Temperature And Weight

    7 Operation 7.2 Operate Xcellerex XDM mixer 7.2.3 Monitor temperature and weight 7.2.3 Monitor temperature and weight Monitor temperature in the disposable bag The upper display shows the temperature in the disposable bag. When the power to the XDM mixer is turned on, the temperature monitoring starts automatically. Monitor weight of the disposable The lower display shows the mixer weight.

  • Page 197: Monitor Ph And Conductivity

    7 Operation 7.2 Operate Xcellerex XDM mixer 7.2.4 Monitor pH and conductivity 7.2.4 Monitor pH and conductivity Monitor the parameters The transmitter display shows the measured pH and conductivity (mS/cm) values. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 198: Operate Xcellerex Xduo Mixer

    7 Operation 7.3 Operate Xcellerex XDUO mixer Operate Xcellerex XDUO mixer Introduction This section describes how to operate XDUO mixers using the local control software. In this section Section See page 7.3.1 Start up the system 7.3.2 Operate the agitator motor 7.3.3 Prepare the pump 7.3.4 Control the pH 7.3.5 Control the temperature...

  • Page 199: Start Up The System

    7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.1 Start up the system 7.3.1 Start up the system Start the system Follow the instructions below to start XDUO mixer. Step Action Make sure that the EMERGENCY STOP button is disengaged. Turn the system power switch to I ON position. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 200 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.1 Start up the system Log in Follow the instructions below to log in to local control software. Step Action Tap Login on the top toolbar of the home screen. Result: The Login dialog box opens. Type your user name and password in the text boxes.
  • Page 201 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.1 Start up the system Step Action Tap RESET on on the top toolbar. Result: The local control of the mixer is enabled. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 202 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.1 Start up the system Log out On the top toolbar, tap the user name to log out of the local control software. Result: The user is logged out. The user name is replaced by Login. Connect to Xcellerex FlexFactory Follow the instructions below to connect the XDUO mixer to FlexFactory.
  • Page 203 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.1 Start up the system Step Action Tap INFO on the home screen. Result: XDUO Mixer System Info screen is shown. Tap Request FlexFactory Control. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 204 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.1 Start up the system Step Action Result: FlexFactory control of XDUO mixer is enabled. The Local Control message on the top toolbar is replaced by FlexFactory Control. Disconnect from Xcellerex FlexFactory Follow the instructions below to disconnect from FlexFactory. Step Action Tap INFO on the home screen.
  • Page 205 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.1 Start up the system Step Action Tap Release FlexFactory Control. Result: FlexFactory control of XDUO mixer is disabled. The FlexFactory Control message on the top toolbar is replaced by Local Control. Start and stop data logging Data logging saves the data to the memory card on the HMI.
  • Page 206 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.1 Start up the system Step Action Tap START LOGGING (1) on the XDUO Mixer System Info screen to log data locally. Result: Data logging starts. The START LOGGING button text changes to STOP LOGGING.

  • Page 207: Operate The Agitator Motor

    7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.2 Operate the agitator motor 7.3.2 Operate the agitator motor Start the agitator motor NOTICE Prior to starting the agitator, the disposable bag must be filled to at least the minimum working volume. This prevents bag damage. The minimum working volume depends on the mixer vessel size.
  • Page 208 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.2 Operate the agitator motor Step Action On the Agitator Detail screen, type an applicable agitator speed value into the SP text box (3). Tap START (4). Result: The agitator motor starts. Note: Operating the agitator in viscous solutions may cause the agitator blade to decouple.
  • Page 209 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.2 Operate the agitator motor Stop the agitator motor Follow the instructions below to stop the agitator motor. Step Action On the home screen, tap Agitation to open the Agitator Detail screen. On the Agitator Detail screen, tap STOP. Result: The agitator motor stops.
  • Page 210 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.2 Operate the agitator motor Step Action Change agitation direction The toggle button location shows if the agitator motor runs clockwise or counter- clockwise. See Agitation direction, on page 67 for more information on agitation direction. Follow the instructions below to change the agitation direction.

  • Page 211: Prepare The Pump

    7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.3 Prepare the pump 7.3.3 Prepare the pump Change pump direction See Tubing in the pump, on page 184 for more information about the liquid flow direction. Follow the instructions below to change the pump direction. Step Action On the home screen, tap pH to open the pH Detail screen.
  • Page 212 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.3 Prepare the pump Step Action On the Prime Pumps screen, change the pump direction for Pump 1 (Acid pump, 1), or for Pump 2 (Base pump, 2) by dragging the toggle button to CW or CCW.
  • Page 213 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.3 Prepare the pump Step Action Make sure the measured pH value shown on the home screen is a valid value. On the home screen, tap pH top open the pH Detail screen. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 214 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.3 Prepare the pump Step Action On the pH Detail screen, tap PUMPS SETUP. Result: The Prime Pumps screen opens. To prime the acid pump, press and hold Acid. • To prime the base pump, press and hold Base. •...

  • Page 215: Control The Ph

    7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.4 Control the pH 7.3.4 Control the pH pH PID control loop The pH PID control loop is a split range loop: the output of the pH control loop controls both the acid and base pump PID control loops. The acid and base PID control loops are nested loops inside the pH control loop.
  • Page 216 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.4 Control the pH Step Action If your system has two pH probes, select the probe: drag the toggle button to AIT121 or AIT122 to select the applicable pH probe. Type an applicable pH setpoint value into the PHC_125 pH SP text box. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 217 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.4 Control the pH Step Action Set the mixer in Auto mode: drag the toggle button to Auto. Result: The pH of the disposable bag contents is controlled by acid and base pumps to the given setpoint. Work in Manual mode In Manual mode, the manually defined CV (pHC_125 Manual CV) range 0% to 50% controls the CV of the acid pump (SC_201), and the CV range 50% to 100% controls the...
  • Page 218 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.4 Control the pH pHC_125 Manual CV (%) SC_201 Acid CV (%) SC_202 Base CV (%) To set the pH control to work in Manual mode follow the instructions below. Step Action On the home screen, tap pH to open the pH Detail screen. Set the mixer in Manual mode: drag the toggle button to Manual.
  • Page 219 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.4 Control the pH Step Action Type an applicable value (% of total pump speed range, as described above) into the PHC_125 Manual CV text box. Result: The instrument keeps the pump speed as specified, using a split range control loop.

  • Page 220: Control The Temperature

    7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.5 Control the temperature 7.3.5 Control the temperature Introduction The temperature of the disposable bag contents is controlled using the temperature control unit (TCU). The temperature control can be set to work in Auto or in Manual mode. •...
  • Page 221 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.5 Control the temperature Step Action On the home screen, make sure the temperature value measured by the active temperature sensor is a valid value. Tap TEMP. on the home screen to open the Temperature Detail screen. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 222 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.5 Control the temperature Step Action On the Temperature Detail screen, drag the toggle button to TE_161 or TE_162 to select the applicable temperature sensor (1). Type an applicable temperature setpoint value into the TC_163 Temperature SP text box (2).
  • Page 223 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.5 Control the temperature Work in Manual mode To set the temperature control to work in Manual mode follow the instructions below. Step Action On the home screen, make sure that no interlocks are active. The inactive interlocks are shown in gray.
  • Page 224 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.5 Control the temperature Step Action Set the mixer in Manual mode: drag the toggle button to Manual (1). Type an applicable value (% of total TCU remote setpoint range) into the TC_163 Manual CV text box (2). Result: The control of mixer vessel temperature is enabled.

  • Page 225: Manage Mixer Weight

    7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.6 Manage mixer weight 7.3.6 Manage mixer weight Tare mixer weight If the weight of the mixer is not displayed as 0 kg, you can tare the mixer weight. NOTICE The disposable bag must be empty during the tare procedure to prevent activation of the weight interlock.
  • Page 226 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.6 Manage mixer weight Step Action On the Weight Detail screen, tap Tare. Result: The Tare Confirmation screen opens. On the Tare Confirmation screen, tap Yes (1) to confirm. Result: The mixer vessel weight is tared. The Tare Confirmation screen stays open.

  • Page 227: Set Alarm Limits

    7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.7 Set alarm limits 7.3.7 Set alarm limits Alarm limits Alarm can be set for the following functionalities: • Agitator • Conductivity • • Temperature • Weight For more information on weight Critical Alarm, see Weight alarm limits, on page 96. Set alarm limits The alarms are set on an Alarm Config screen for each functionality.
  • Page 228 7 Operation 7.3 Operate Xcellerex XDUO mixer 7.3.7 Set alarm limits Step Action On the Detail screen, tap ALARM CONFIG. On the Alarm Config screen, type the applicable values into the setpoint text boxes (1). Result: The alarm limits are set. Tap BACK (2) to go back to the Detail screen.

  • Page 229: Add Liquid Contents

    7 Operation 7.4 Add liquid contents Add liquid contents Introduction This section describes how to add liquid material into the disposable bag. The information is applicable for both XDM and XDUO mixers. Liquid entry points Fluids are added through the addition lines. The illustration below shows the possible liquid entry points.
  • Page 230 7 Operation 7.4 Add liquid contents Prepare the mixer Before adding the liquids, make the following preparations: Step Action Verify that the liquid addition lines are not kinked and are free from obstruc- tions. Verify that the liquid addition lines do not prevent the adjustment of the disposable bag inside the mixer.
  • Page 231 7 Operation 7.4 Add liquid contents Add liquids into the disposable CAUTION Spread of hazardous and biological substances. Do not overfill the bag. An overfilled bag might burst. NOTICE Adjust the disposable bag position during the filling procedure. Folds in the disposable bag might interfere with the mixing process. Adjustment of the disposable bag also makes sure that the maxi- mum capacity of the bag is used.
  • Page 232 7 Operation 7.4 Add liquid contents Step Action Re-install the side access door to 500 and 1000 L mixers. Follow the instruc- tions below: Using the handle, lift the door and align it with the side access opening. Turn the door clockwise to attach it. Release the handle.
  • Page 233 7 Operation 7.4 Add liquid contents Step Action Make sure that the unused probe ports have been clamped, if you use a Plus or Plus Flex bag assembly without the probes. Make sure that the installed probes stay in place in the probe window during the filling.
  • Page 234 7 Operation 7.4 Add liquid contents Step Action Set one part of the lid on top of the vessel and set the rectangular lid opening towards the addition lines. Tip: The lid helps to protect the top of the bag and to hold the powder addition port in place.
  • Page 235 7 Operation 7.4 Add liquid contents Step Action The lid of the 1000 L mixer has two center openings. Make sure that the powder addition port is inserted into the opening as shown in the following illustration. Adjust the lines through the rectangular lid openings. If needed, clamp the fill lines and disconnect the liquid source.

  • Page 236: Add Solid Contents

    7 Operation 7.5 Add solid contents Add solid contents Introduction This section describes how to add solid material into the disposable bag. The information is applicable for both XDM and XDUO mixers. Consider before addition Before addition, consider the following aspects: •...
  • Page 237 7 Operation 7.5 Add solid contents Step Action Set one part of the lid on top of the vessel and set the rectangular lid opening towards the addition lines. For 50 to 500 L mixers: push the powder addition port of the bag into the center opening of the lid.
  • Page 238 7 Operation 7.5 Add solid contents Step Action The lid of the 1000 L mixer has two center openings. Make sure that the powder addition port is inserted into the opening as shown in the following illustration. Disconnect the TC-clamp from the powder addition port. Remove the protective cap from the powder addition port.
  • Page 239 7 Operation 7.5 Add solid contents Step Action Set the hopper onto the powder addition port and attach the hopper to the port with the TC-clamp. Verify that the agitator motor is running. See Start and stop the agitator motor, on page 192 or Start the agitator motor, on page 207 for instructions how to start the agitator motor.

  • Page 240: Finish A Batch Run

    7 Operation 7.6 Finish a batch run Finish a batch run Introduction This section describes how to finish a batch run. The information is applicable for both XDM and XDUO mixers. In this section Section See page 7.6.1 Collect the product 7.6.2 Remove the disposable bag 7.6.3 Shut down the system Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 241: Collect The Product

    7 Operation 7.6 Finish a batch run 7.6.1 Collect the product 7.6.1 Collect the product Drain the disposable bag contents Follow the instructions below to drain the contents of the disposable bag. Consider also your local requirements for product and waste handling. Step Action Insert the drain line into a suitable receptacle.

  • Page 242: Remove The Disposable Bag

    7 Operation 7.6 Finish a batch run 7.6.2 Remove the disposable bag 7.6.2 Remove the disposable bag Disconnect the disposable bag Follow the instructions below to disconnect the probes and lines from the disposable bag after finished mixing procedure. Step Action Make sure the disposable bag is empty.
  • Page 243 7 Operation 7.6 Finish a batch run 7.6.2 Remove the disposable bag Step Action Disconnect the probe cables as appropriate: pH probes • Conductivity probes • Remove the temperature probe from the disposable bag. Clean the probe according to facility procedures. Store the probe in a clean place according to manufacturer's instruction.
  • Page 244 7 Operation 7.6 Finish a batch run 7.6.2 Remove the disposable bag Step Action Clamp all probe connector ends. Disconnect all lines. Remove the disposable bag CAUTION Magnetic components. Use caution when handling magnetic components. There is a strong magnetic attraction between the impeller and the motor drive coupling.
  • Page 245 7 Operation 7.6 Finish a batch run 7.6.2 Remove the disposable bag Step Action Remove the side access door from 500 and 1000 L mixers. Follow the instruc- tions below: Hold the door handle tightly. Turn the door counterclockwise. Remove the door. Disconnect the agitator drive head by pulling off the impeller baseplate of the disposable bag from the magnetic drive head in the agitator opening.
  • Page 246 7 Operation 7.6 Finish a batch run 7.6.2 Remove the disposable bag Disposal of the bag Follow the instructions below to dispose of the used disposable bag assembly. Step Action If the site policy requires decontamination of the bag prior to disposal, rinse the walls of the empty bag with a bleach solution, then drain.

  • Page 247: Shut Down The System

    7 Operation 7.6 Finish a batch run 7.6.3 Shut down the system 7.6.3 Shut down the system Shut down the mixer To turn off the mixer do the following: Step Action Turn the system power switch to O OFF position. If required, disconnect the power cord.

  • Page 248: Maintenance

    8 Maintenance Maintenance About this chapter This chapter provides required information to enable users and service personnel to clean, maintain, calibrate and store XDM and XDUO mixers. In this chapter Section See page 8.1 Safety precautions 8.2 Maintenance schedules 8.3 Lock-Out / Tag-Out (LOTO): turn-off procedure 8.4 Lock-Out / Tag-Out (LOTO): turn-on procedure 8.5 Cleaning 8.6 Hardware maintenance...

  • Page 249: Safety Precautions

    8 Maintenance 8.1 Safety precautions Safety precautions WARNING Trained personnel. Maintenance of this product must be performed by properly trained personnel only. WARNING Turn off equipment. Turn off the system and Lock-out / Tag-out (LOTO) the electrical equipment before doing maintenance. CAUTION Contamination hazard.

  • Page 250: Maintenance Schedules

    It is the responsibility of the system owner to make sure that the required maintenance is performed. The user should inspect the system for signs of wear and damage and request a service visit if anything abnormal is found. Contact your GE representative to schedule mainte- nance and service. Cleaning before planned...
  • Page 251 8.2 Maintenance schedules User maintenance schedule The following table describes maintenance activities that must be scheduled by customer personnel. All maintenance that is not described in this manual must be performed by a GE service engineer. Frequency Activity Performed by...
  • Page 252 Calibration technician Section 10.8 Temperature as needed bration probe calibration, on page 289 Annually Calibration of weight GE service engineer or See the manufacturer's monitoring function (1 personnel trained by GE manual. weight calibration) As needed Conductivity transmitter Calibration technician...

  • Page 253: Lock-Out / Tag-Out (Loto): Turn-Off Procedure

    8 Maintenance 8.3 Lock-Out / Tag-Out (LOTO): turn-off procedure Lock-Out / Tag-Out (LOTO): turn-off procedure Introduction This section describes the recommended Lock-Out / Tag-Out (LOTO) turn-off procedure. This section is not intended to describe or supersede a comprehensive Lock-Out / Tag- Out (LOTO) policy that includes thorough procedures and frequent training.
  • Page 254 8 Maintenance 8.3 Lock-Out / Tag-Out (LOTO): turn-off procedure Step Action For a jacketed mixer: if your mixer is connected to a TCU, turn off the TCU following the manufacturer's instructions. For a jacketed mixer: empty the mixer vessel jacket as described in Empty the vessel jacket, on page 127.

  • Page 255: Lock-Out / Tag-Out (Loto): Turn-On Procedure

    8 Maintenance 8.4 Lock-Out / Tag-Out (LOTO): turn-on procedure Lock-Out / Tag-Out (LOTO): turn-on procedure Introduction This section describes the recommended Lock-Out / Tag-Out (LOTO) turn-on procedure. This section is not intended to describe or supersede a comprehensive Lock-Out / Tag- Out (LOTO) policy that includes thorough procedures and frequent training.
  • Page 256 8 Maintenance 8.4 Lock-Out / Tag-Out (LOTO): turn-on procedure Step Action Turn the system power switch to I ON position. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 257: Cleaning

    8 Maintenance 8.5 Cleaning Cleaning Safety precautions WARNING Squeezing or crushing injuries. Due to the significant weight of the system, great care must be taken not to cause squeezing or crushing injuries during movement. CAUTION Hot surface. Make sure that the instrument surface temperature is equal to room temperature before cleaning.
  • Page 258 8 Maintenance 8.5 Cleaning Instructions for cleaning NOTICE Make sure that the probe connector on the probe cable is protected from cleaning liquids. Step Action Set the protective covers on the connection ports: USB port • Ethernet ports • Use a non-abrasive cloth with mild detergent and water to clean the exterior of the mixer vessel and the I/O Cabinet.

  • Page 259: Hardware Maintenance

    If the burst disc has ruptured and the cause for the rupture is known, the burst disc must be replaced. Use only the replacement parts approved by GE. If the cause for the rupture is not known, contact your GE representative. Follow the instructions below to replace the burst disc.
  • Page 260 8 Maintenance 8.6 Hardware maintenance Step Action Loosen the screw (1). Remove the clamp (2). Tilt the pipe (3) outwards and remove the ruptured burst disc. Insert the new burst disc. See the manufacturer's documentation for more information. Attach the clamp. Close the clamp with the screw.
  • Page 261 8 Maintenance 8.6 Hardware maintenance Verify weight monitoring accuracy Follow the instructions below. Step Action On the local control software home screen, tap Weight. Result: The Weight Detail screen opens. Tare the mixer weight. See Tare mixer weight, on page 225 for instructions. Use water or weights to increase the mixer weight: Add a known quantity of water into the disposable bag installed inside •...
  • Page 262 Verify that the weight displayed in the WT_176 Weight PV text box corre- sponds to the added weight. Result: Mixer weight monitoring functionality is verified. Note: If the weight reading is not correct, contact your GE representative for assis- tance. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 263: Storage, Moving And Reinstallation

    8 Maintenance 8.7 Storage, moving and reinstallation Storage, moving and reinstallation Contact your GE representative for instructions on how to store, move and re-install the instrument. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 264: Troubleshooting

    If the suggested actions in this guide do not solve the problem, or if the problem is not covered by this guide, contact your GE representative for advice. Note: Depending on the selected configuration of the system, some components listed in this chapter may not be applicable for each mixer.
  • Page 265 9 Troubleshooting Agitation, Xcellerex XDUO mixer Problem Possible causes Corrective action The agitator does not start. Min Weight interlock is active. Check the weight of the dispos- able bag. See Section 2.4 Xcellerex XDUO mixer interlocks, on page 43 for more informa- tion.
  • Page 266 9 Troubleshooting Problem Possible causes Corrective action The agitator assembly does not The agitator is not properly Contact your GE representative fit properly in place. aligned. to schedule agitator alignment check and maintenance. The agitator drive head rubs against the agitator base plate support and a grinding sound is emitted.
  • Page 267 9 Troubleshooting pH control The information presented in this section is relevant for XDUO mixer only. Problem Possible causes Corrective action pH is not coming The deadband is set to 0. pH control must use a deadband. If no to equilibrium deadband is used, acid and base are even if the pumps alternately introduced.
  • Page 268 9 Troubleshooting pH/Conductivity monitoring Problem Possible causes Corrective action pH sensor changes are very The pH sensor needs cleaning. If available, switch the input to slow: two sensors change their the second pH channel. readings at different rates. Keep probes clean between us- es, and clean them with a solu- tion designed to maintain their properties.
  • Page 269 The information presented in this section is relevant for jacketed XDM and XDUO mixers. Troubleshooting for most common TCU models is described below. If your TCU model is not described, contact your GE representative for help with troubleshooting. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 270 9 Troubleshooting Problem Possible causes Corrective action Temperature control TCU is not powered. Switch on the power. unit (TCU) does not re- There is no connection between the Check if the connection between the ceive setpoint data: I/O Cabinet and the PolyScience™ I/O Cabinet and TCU is functioning the temperature is •...
  • Page 271 If the mixer was filled while the jacking bolt was engaged, the weight measurements of the batch are not accurate. The configuration on the load Contact your GE representative. cell transmitter is incorrect or corrupt. Load cells require calibration. Schedule the calibration of the load cells.
  • Page 272 If the mixer was filled while the jacking bolt was engaged, the weight measurements of the batch are not accurate. Weight transmitter configuration Contact your GE representative. incorrect or corrupt. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 273: 10 Reference Information

    10 Reference information 10 Reference information About this chapter This chapter lists the technical specifications of XDM and XDUO mixers. The chapter also includes a chemical resistance guide, ordering information, and Health and Safety Dec- laration form for service. In this chapter Section See page 10.1 System specifications...

  • Page 274: 10.1 System Specifications

    10 Reference information 10.1 System specifications 10.1 System specifications Xcellerex XDM mixers, jacketed Property System Value Supply voltage I/O Cabinet 100-120 V AC, 50 or 60 Hz, 4.5 A 220-240 V AC, 50 or 60 Hz, 3.0 A Temperature control unit See the manufacturer's documentation.
  • Page 275 10 Reference information 10.1 System specifications Property System Value Construction material Vessel Stainless steel Polycarbonate Casters Stainless steel / nylon / polyurethane Sound level XDM 50 to 1000 < 70 dB(A) Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 276 10 Reference information 10.1 System specifications Xcellerex XDM mixers, non-jacketed Property System Value Supply voltage I/O Cabinet 100-120 V AC, 50 or 60 Hz, 4.5 A 220-240 V AC, 50 or 60 Hz, 3.0 A Maximal power con- XDM 50 to 1000 720 VA sumption Dimensions...
  • Page 277 10 Reference information 10.1 System specifications Xcellerex XDUO mixers, jacketed Property System Value Supply voltage I/O Cabinet 100-120 V AC, 50 or 60 Hz, 4.5 A 220-240 V AC, 50 or 60 Hz, 3.0 A Temperature control unit See the manufacturer's documentation. Maximal power con- XDUO 100 to 1000 720 VA...
  • Page 278 10 Reference information 10.1 System specifications Xcellerex XDUO mixers, non-jacketed Property System Value Supply voltage I/O Cabinet 100-120 V AC, 50 or 60 Hz, 4.5 A 220-240 V AC, 50 or 60 Hz, 3.0 A Maximal power con- XDUO 100 to 1000 720 VA sumption Dimensions...

  • Page 279: 10.2 Sp, Cv And Pv Units And Ranges

    10 Reference information 10.2 SP, CV and PV units and ranges 10.2 SP, CV and PV units and ranges Ranges for SP, CV, and PV The following SP, CV, and PV units and ranges are set in the local control software for the XDUO mixers. Controller loop Setpoint Controlled variable...

  • Page 280: Xcellerex Xdm And Xduo Mixers Minimum Working Volumes

    10 Reference information 10.3 Xcellerex XDM and XDUO mixers minimum working volumes 10.3 Xcellerex XDM and XDUO mixers minimum working volumes Mixer vessel size Minimum working volume (L) 50 L 100 L 200 L 500 L 1000 L Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 281: 10.4 Pump Characteristics

    10 Reference information 10.4 Pump characteristics 10.4 Pump characteristics Pump types XDUO mixers optionally comprise two Watson-Marlow pumps model 313. Low speed High speed Tubing i.d. Maximal speed Maximal flow rate Maximal speed Maximal flow rate 3.2 mm 100 rpm 0.1 L/min 350 rpm 0.35 L/min...

  • Page 282: 10.5 Disposable Bag Specifications

    10 Reference information 10.5 Disposable bag specifications 10.5 Disposable bag specifications Storage of the disposable bag assembly The recommended storage temperature for the disposable bag assembly is between 10°C and 34°C. Information about the storage temperature is shown on the bag label. Operating temperature The disposable bag assembly is rated for temperatures between -5°C and 65°C.

  • Page 283: 10.6 Environmental Requirements

    10 Reference information 10.6 Environmental requirements 10.6 Environmental requirements Environmental specifications The installation site must comply with the following specifications: Parameter Specification Allowed location Indoor use only Ambient temperature, operation 5°C to 30°C Max. relative humidity, operation 20% to 85% RH, non-condensing Ambient temperature, transportation -20°C to 60°C Ambient temperature, storage...

  • Page 284: 10.7 Temperature Control Unit

    10 Reference information 10.7 Temperature control unit 10.7 Temperature control unit Introduction This section provides information about the requirements and specifications for TCU. In this section Section See page 10.7.1 TCU requirements 10.7.2 Temperature control optimization 10.7.3 TCU coolant specifications Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 285: Tcu Requirements

    10 Reference information 10.7 Temperature control unit 10.7.1 TCU requirements 10.7.1 TCU requirements TCU requirements - 50 L, 100 L, 200 L mixer Property Parameter Value General requirements Cooling capacity 5 kW Heating capacity 5 kW Process requirements Fluid outlet pressure 2.8 bar (40 psi g) Fluid outlet flow 40 L/min...
  • Page 286 10 Reference information 10.7 Temperature control unit 10.7.1 TCU requirements Property Parameter Value Remote control interface Setpoint 4 to 20 mA (for XDUO mixers only) On/Off emergency stop Required Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 287: Temperature Control Optimization

    (TC_163) in the local control software. The default PID parameters for the temperature control are designated for the TCU models recommended by GE. The default PID parameters provide a stable mixer vessel temperature across the full weight range.

  • Page 288: Tcu Coolant Specifications

    10 Reference information 10.7 Temperature control unit 10.7.3 TCU coolant specifications 10.7.3 TCU coolant specifications TCU water quality specifications Tap water can be used to prepare the coolant, when the coolant temperature (mixer jacket temperature) is designated to be between 6°C and 65°C (the temperature of the disposable bag contents is between 10°C and 60°C ).

  • Page 289: 10.8 Temperature Probe Calibration

    10 Reference information 10.8 Temperature probe calibration 10.8 Temperature probe calibration Introduction NOTICE Do not use electronic simulation of resistance to calibrate the temperature probe. NOTICE Do not calibrate the temperature probe while the vessel is being controlled to a temperature setpoint. Note: If the instrument is used in a GMP compatible environment, the temperature probe is a GMP critical component.
  • Page 290 10 Reference information 10.8 Temperature probe calibration Calibration Calibrate the temperature probe as follows: Step Action Set the circulating bath temperature to the batch operating temperature (the middle calibration point). Note: The batch operating temperature is the crucial temperature of the process. Verify that the temperature probe is correctly connected to the I/O Cabinet.
  • Page 291 10 Reference information 10.8 Temperature probe calibration Step Action Set the circulating bath temperature to one of the calibration end point temperatures; or use another bath if available. Repeat steps 3 to 5 above. Set the circulating bath temperature to the other calibration end point temperature;...
  • Page 292 10 Reference information 10.8 Temperature probe calibration Step Action Tap TEMP. on the home screen to open the Temperature Detail screen. On the Temperature Detail screen, tap OFFSETS. Result: The Transmitter Offsets screen opens. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 293 If the calibration of the new temperature probe does not bring the system into tolerance, contact your GE representative for service. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 294: 10.9 Ordering Information

    10 Reference information 10.9 Ordering information 10.9 Ordering information Visit gelifesciences.com Please refer to our website or contact a GE representative for more information about the following questions: • System recommendations • Literature • Service • Training • Ordering information Contact information Contact information can be found on the back page of this document.

  • Page 295: 10. 1 0 Health And Safety Declaration Forms

    Service Ticket #: To make the mutual protection and safety of GE service personnel and our customers, all equipment and work areas must be clean and free of any hazardous contaminants before a Service Engineer starts a repair. To avoid delays in the servicing of your equipment, please complete this checklist and present it to the Service Engineer upon arrival.
  • Page 296 To make sure the mutual protection and safety of GE personnel, our customers, transportation personnel and our environment, all equipment must be clean and free of any hazardous contaminants before shipping to GE. To avoid delays in the processing of your equipment, please complete this checklist and include it with your return.

  • Page 297: Appendix A Information About The Appendices

    A Information about the appendices Appendix A Information about the appendices Description The Appendices provide general information about local control software for XDUO mixer, and important cyber security information. Following this information section, the following appendices are found in this manual: •...

  • Page 298: Appendix B Add And Remove Users

    B Add and remove users Appendix B Add and remove users Introduction This appendix describes user management functions for XDUO mixer local control soft- ware. The user management is done on the User Administration screen. The User Ad- ministration screen is available by tapping USER ADMIN on the XDUO Mixer System Info screen.
  • Page 299 B Add and remove users Step Action Tap INFO on the home screen to open the XDUO Mixer System Info screen. Tap USER ADMIN on the XDUO Mixer System Info screen to open the User Administration screen. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 300 B Add and remove users Step Action Find Administrator in the User column and tap the password in the Pass- word column to open a dialog box. Type the new password in the text box and tap Return. Result: The password dialog box re-opens. Close the dialog box by tapping the close button Result: The new administrator password is saved and hidden.
  • Page 301 B Add and remove users Add a user account Follow the instructions below to add a user account. Step Action Tap a blank row in the User column (1) to open a dialog box. Type the new user name in the text box and tap Return. Tap the new user row in the Password column (2) to open a dialog box.
  • Page 302 B Add and remove users Change user account properties To change a user name, password, group, or logoff time follow the instructions below. Step Action On the User Administration screen, find the user on the list. Tap the applicable text box to change the user account properties: user name (1), password (2), or logoff time (4).
  • Page 303 Tap the user row in the User column (1). Delete the user name and tap Return. Result: The user account is deleted. NOTICE Do not delete the HMIAdmin account. This account is used by GE service personnel. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...

  • Page 304: Appendix C Download Audit And Data Logs

    C Download audit and data logs Appendix C Download audit and data logs Introduction This appendix provides information on about how to download audit and data logs from the local control panel to an external computer. The logs are stored as .csv files on the SD card on the local control panel. The logs can be exported to an external computer using Ethernet or USB.
  • Page 305 C Download audit and data logs Used if XDUO mixer has both pH (PH1) and conductivity (Cond) monitoring. Download the logs using Ethernet The standard IP address of the HMI is 172.20.42.152. Follow the instructions below to download the audit or data logs to an external computer. Step Action Connect a computer to the Ethernet connection port on the underside of...
  • Page 306 C Download audit and data logs Step Action Click File Browser in the left pane. Click Storage Card SD in the File Browser pane. Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD...
  • Page 307 C Download audit and data logs Step Action Find the file you want to copy: The audit trail file is located in the StorageCardSD folder. • The data log file is located in the Logs subfolder. • Copy the file as follows: Right-click the file name, and then click Save As on the shortcut menu.
  • Page 308 C Download audit and data logs Step Action Log in to the local control software using the administrator account pass- word. See Manage the Administrator account, on page 298 for more informa- tion about administrator account. Tap INFO on the home screen to open the XDUO Mixer System Info screen. Tap CONTROL PANEL on the XDUO Mixer System Info screen to open the Windows CE Control Panel.
  • Page 309 C Download audit and data logs Step Action Find the file you want to copy and select the file. The audit trail file is located in the StorageCardSD folder. • The data log file is located in the Logs subfolder. •...

  • Page 310: Appendix D Privacy And Security

    GE recommends to implement cyber secure operation as part of an overall "defence in depth" information assurance strategy that is used throughout an Information Technol- ogy environment.
  • Page 311 Network connections When network connections are required, GE strongly recommends that the system is operated using a secure network that is protected from unauthorized access. The cus- tomer should use an effective arrangement for isolating and protecting the network, for example implementing firewall protection, demilitarized zones (DMZs), virtual Local Area Networks (VLANs) and network enclaves.
  • Page 312 Appendix. Cyber security vulnerability GE works closely with the third party software suppliers to monitor and evaluate cyber security vulnerabilities applicable to this product. This work includes vulnerabilities in the application software, third party components, and the underlying operating system.

  • Page 313: Index

    Index Index [[ProductName4]] Alarm disposal, 48 Critical Alarm, 96 set limits, 227 Alarm configuration screen, 95 illustration, 97 Abbreviations Alarm overview screen, 94 parameters, 304 Ambient environment, 119 terms, 17 Aseptic connection device ACD, 82 (ACD), 82 ACD connector, 167, 171 connector, 167, 171 Audit logs liquids, 229...
  • Page 314 Index pH probe, 158 Data logs schedule, 252 download, 304 temperature probe, 289 Data storage Casters cyber security, 312 lock, 138 Deadband, 267 unlock, 138 Delete user account, 302 Dimensions, 274, 276–278 conformity, 12 Disconnect marking, 12 FlexFactory, 204 Change lines, 242 password, 302 probe, 242...
  • Page 315 Index XDUO mixer, 37 high weight, 43 EMERGENCY STOP local control software, 44 button location, 37 Max Weight, 43 location, 71 Min Weight, 43 Environmental conditions, 119 status, 44 Environmental require- ments, 283 E-STOP, 41 Jacket E-Stop Active, 41 emptying, 127 E-STOP condition filling, 124 clear, 38...
  • Page 316 Index turn-on procedure, 255 measuring units, 279 PID control loop, 215 troubleshooting, 267–268 pH control Maintenance Auto mode, 215 hardware, 250, 259 Manual mode, 217 schedule, 251 split range loop, 215 Manual mode, 88 pH Detail screen, 103 Manufacturing information, 11 pH PID Settings screen, 105 Maximal power consump- pH probe...
  • Page 317 Index compressed, 178 calibration, 252 holder, 167 maintenance, 251 illustration, 83 Screens insert probe, 166 Agitator Detail, 100 Product alarm configuration, 95 collect, 241 alarm overview, 94 Product return or servicing, 296 Conductivity Detail, 102 Programmable logic con- home screen, 85 troller, 72 pH Detail, 103 Pumps...
  • Page 318 Index System power switch, 38 agitation, XDM mixer, 264 burst disc, 266 conductivity, 268 load cells, 271 Tare local control panel, 266 weight, XDM mixer , 196 pH, 267–268 Tare weight, 225 pumps, 269 TCU, 74 TCU, 270 connect, 122 temperature control, 270 connection, 74 temperature monitor-...
  • Page 319 Index monitoring, XDM mixer , 196 restart, 35 set alarm limits, 96 start, 191 tare, 225 start agitator, 192 tare, XDM mixer , 196 stop agitator, 192 Weight Detail screen, 112 tare weight, 196 Weight monitoring temperature, 196 accuracy, 261 XDUO mixer calibration, 252 agitator direction, 210...
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  • Page 322 All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them. A copy of these terms and conditions is available on request. Contact your local GE Healthcare repre- sentative for the most current information.

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