Page 1 UniFlux10 Operating Instructions Original instructions cytiva.com...
Page 2: Table Of Contents
Table of Contents Table of Contents Introduction ......................5 About this manual ............................6 Important user information ........................7 Associated documentation ........................9 Abbreviations ..............................10 Safety instructions ..................... 11 Safety precautions ............................12 Labels ................................. 22 Emergency procedures ..........................25 System description ....................
Page 3 Table of Contents Installation ......................78 Site requirements ............................79 Transport ................................81 Unpacking ................................. 82 UniFlux 10 Setup ............................84 4.4.1 Lock the wheels ............................. 85 4.4.2 Stand-alone computer ..........................86 4.4.3 Setup of control system and network ....................87 4.4.4 Connect compressed air supply ......................
Page 4 Table of Contents 8.6.4 Regulations for North America ....................... 161 8.6.5 Regulatory statements ..........................162 8.6.6 Declaration of Hazardous Substances (DoHS) ................163 8.6.7 Other regulations and standards ......................165 Further information ............................166 Health and Safety Declaration Form ...................... 167 Appendix A: Create a method with UNICORN 5 ............
Page 5: Introduction
1 Introduction Introduction About this chapter This chapter contains important user information, descriptions of safety notices, intended use of the UniFlux™ 10 system and a list of associated documentation. In this chapter Section See page About this manual Important user information Associated documentation Abbreviations UniFlux 10 Operating Instructions 28993587 AF...
Page 6: 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 product in a safe way. Scope of this manual This Operating Instructions covers all variants of UniFlux 10 system. The components included in the configuration are described in the General Specifica- tion (GS).
Page 7: 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, oper- ating 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 documenta- tion.
Page 8 1 Introduction 1.2 Important user information Prerequisites In order to operate UniFlux 10 system in a safe way, and according to the intended purpose, the following prerequisites must be met: • You should be acquainted with the use of bioprocessing equipment and with the handling of biological materials.
Page 9: Associated Documentation
• The Online help contains dialog descriptions for UNICORN. The Online help is accessed from the Help menu. Component documentation Documentation for components produced both by Cytiva and by a third-party are, if existent, also included in the product documentation package. UniFlux 10 Operating Instructions 28993587 AF...
Page 10: Abbreviations
1 Introduction 1.4 Abbreviations Abbreviations Introduction This section explains abbreviations that appear in the user documentation for UniFlux Abbreviations Translation Abbrevia- Definition (English) tion EPDM Ethylene Propylene Diene Ethylene Propylene Diene Monomer Monomer HEPA High Efficiency Particulate Air High Efficiency Particulate Air Proportional Integral Deriva- Proportional Integral Deriva- tive...
Page 11: Safety Instructions
2 Safety instructions Safety instructions About this chapter This chapter describes safety precautions, emergency shutdown procedures and labels information for UniFlux 10 In this chapter Section See page Safety precautions Labels Emergency procedures Important WARNING Before installing, operating or maintaining the product, all users must read and understand the entire contents of this chapter to become aware of the hazards involved.
Page 12: Safety Precautions
2 Safety instructions 2.1 Safety precautions Safety precautions Introduction The safety precautions in this section are grouped in the following categories: • General precautions on page 12 • Flammable liquids and explosive environment, on page 14 • Personal protection on page 14 •...
Page 13 2 Safety instructions 2.1 Safety precautions WARNING Protective earth. The product must always be connected to protective earth when energized. WARNING Do not use UniFlux 10 system if it is not working properly, or if it has suffered any damage, for example: •...
Page 14 2 Safety instructions 2.1 Safety precautions Flammable liquids and explosive environment WARNING Flammable liquids. This product is not approved to handle flam- mable liquids. WARNING Explosive environment. The product is not approved for work in a potentially explosive atmosphere. The product does not fulfill the requirements of the ATEX Directive.
Page 15 2 Safety instructions 2.1 Safety precautions Installing and moving WARNING The product must be installed and prepared by Cytiva personnel or a third party authorized by Cytiva. WARNING Move transport crates. Make sure that the lifting equipment has the capacity to safely lift the crate weight. Make sure that the crate is properly balanced so that it will not accidentally tip when moved.
Page 16 2 Safety instructions 2.1 Safety precautions WARNING Access to power switch and power cord with plug. Do not block access to the power switch and power cord. The power switch must always be easy to access. The power cord with plug must always be easy to disconnect.
Page 17 2 Safety instructions 2.1 Safety precautions CAUTION Make sure that correct air pressure is always maintained. Too high or too low air pressure may be hazardous and may cause erroneous results and leakage. CAUTION Before moving the UniFlux 10 system, make sure that: 1.
Page 18 CAUTION Connection of an external Uninterruptible Power Supply (UPS) (uninterrupted power supply) for system operation shall only be performed by authorized personnel to avoid mismatching or connection errors. Contact your local Cytiva representative for more information. System operation WARNING Safe distance. Always maintain a safe distance from UniFlux 10 system during drainage or other activities that may involve splashing.
Page 19 2 Safety instructions 2.1 Safety precautions WARNING During operation, all cabinet doors must be closed and locked. WARNING Before operation, all process connections and the piping system must be tested for leakage at maximum pressure for continued protection against injury risks due to fluid jets, burst pipes or potentially explosive atmosphere.
Page 20 2 Safety instructions 2.1 Safety precautions WARNING Emergency stop. Pressing the EMERGENCY STOP will not shut off mains power to the electrical cabinet. WARNING Alarm signals. All alarm signals must be set within the limits specified in the system documentation. Pressure and temperature control must be activated while the system is in use to prevent leakage or damage to the piping system.
Page 21 WARNING Use only approved parts. Only spare parts and accessories that are approved or supplied by Cytiva may be used for maintaining or servicing the product. WARNING For continued protection against injury risks due to fluid jets, burst pipes or potentially explosive atmosphere, the user must test the piping system for leakage at maximum operating pressure.
Page 22: Labels
2 Safety instructions 2.2 Labels Labels Introduction This section describes the various labels on the UniFlux 10 system and their meaning. System label The system label is located on the back of the equipment. The system label identifies the equipment and shows electrical data, regulatory compliance, and warning symbols.
Page 23 2 Safety instructions 2.2 Labels Safety labels The table below describes the various safety labels that may be found on UniFlux 10. Symbol/text Description Warning! Read the user documentation before using the system. Do not open any covers or replace parts unless specifically stated in the user documentation.
Page 24 IMPORTANT! Before service/maintenance or return to Cytiva, clean the equipment and accompany it with a decontamination statement, specifying substances with which it has been in contact during use and the method of cleaning.
Page 25: Emergency Procedures
2 Safety instructions 2.3 Emergency procedures Emergency procedures Introduction Under normal circumstances, the UniFlux 10 system should always be shut down as described in Section 5.4 Procedures after usage, on page 114. Shutting down the UniFlux 10 system by pressing the EMERGENCY STOP button should only be performed if an emergency situation prevents normal shutdown.
Page 26 2 Safety instructions 2.3 Emergency procedures Part Function EMERGENCY STOP button MAIN SWITCH, power Emergency shutdown Step Action Press the EMERGENCY STOP button (A). Result: • All motors and externally moving components stop immediately. • No data is lost. If required, also switch off the MAIN SWITCH (B), disconnect the power cord or switch off the fixed power supply circuit breaker.
Page 27 NOTICE If UniFlux 10 system fails to restart correctly following an emer- gency shutdown or power failure, contact Cytiva for further advice and assistance. Data recovery upon restart The UNICORN interface control unit, CU-960 (located inside the electrical cabinet), has capabilities to store real time data during short disconnection from the computer.
Page 28: System Description
3 System description System description About this chapter This chapter provides descriptions of UniFlux 10 system and an overview of all compo- nents, including the UNICORN control system. In this chapter Section See page Configurations Illustrations Standard components Optional components Filter cassette configuration Hollow fiber (HF) configuration Meters and sensors...
Page 29: Configurations
3 System description 3.1 Configurations Configurations Introduction The UniFlux 10 series is a product range of cross flow filtration (CFF) systems that utilizes UNICORN software for full automation with data logging capabilities over the entire cross flow process. The systems are configured to operate hollow fiber cartridges suited for microfiltration applications such as cell clarification/harvesting, or cassettes/hollow fibers for ultrafil- tration applications, such as protein concentration and diafiltration in downstream unit operations.
Page 30: Illustrations
3 System description 3.2 Illustrations Illustrations Introduction This section provides illustrations of the UniFlux 10 system. The main features and components are indicated. Front view Part Function Permeate line equipment mounting beam Tank and peristaltic pumps mounting beam Filter cassette, cassette configuration shown UniFlux 10 Operating Instructions 28993587 AF...
Page 31 3 System description 3.2 Illustrations Part Function EMERGENCY STOP button PAUSE button RUN/PAUSE indicator light POWER indicator light MAIN SWITCH, power ALARM indicator light CONTINUE button Caster without brake (2 pcs) Caster with brake (2 pcs) UniFlux 10 Operating Instructions 28993587 AF...
Page 32 3 System description 3.2 Illustrations Rear view Part Function Electrical cabinet door locks (2 pcs) Filter and fan for cabinet cooling External device connectors, refer to External connectors, on page 33 UniFlux 10 Operating Instructions 28993587 AF...
Page 33 3 System description 3.2 Illustrations External connectors The illustrations below show the external connectors on the UniFlux 10 system. Part Function M-241 Mixer motor control AIT-131 UV-connector EXTERNAL Connector for user process site signal communications SIGNALS PROFIBUS PROFIBUS™ connector AIR INLET System air inlet UNICORN UNICORN Ethernet connector...
Page 34 3 System description 3.2 Illustrations Connectors in front recess Part Function P-202 Transfer pump control P-203 Permeate pump control AIT-131 UV-signal Connectors on rear side UniFlux 10 Operating Instructions 28993587 AF...
Page 35: Standard Components
3 System description 3.3 Standard components Standard components About this section This section provides an overview of the standard components of UniFlux 10 system. In this section Section See page 3.3.1 Structural components 3.3.2 Control system components 3.3.3 Connections and drains 3.3.4 Feed pump and feed line 3.3.5...
Page 36: Structural Components
3 System description 3.3 Standard components 3.3.1 Structural components 3.3.1 Structural components Skid The rigid stainless steel structure supports and protects all process components and the electrical cabinet. The structure is designed for handling in a production environ- ment and is easy to move and keep clean. The structure occupies a small box-shaped space that makes it easy to fit into any loca- tion in the production facility.
Page 37 3 System description 3.3 Standard components 3.3.1 Structural components Electrical cabinet The electrical cabinet contains all electrical and pneumatic equipment. When the door is closed, the entire cabinet is ingress protected according to IP55. UniFlux 10 Operating Instructions 28993587 AF...
Page 38: Control System Components
3 System description 3.3 Standard components 3.3.2 Control system components 3.3.2 Control system components Introduction This section describes the components that allow automation of the UniFlux 10 system by the UNICORN control system. Control system The UniFlux 10 system is fully automated by means of the UNICORN control system. Once the required methods are created and approved, a non-expert user can safely operate the system.
Page 39: Connections And Drains
3 System description 3.3 Standard components 3.3.3 Connections and drains 3.3.3 Connections and drains Illustration Part Label on system Function FEED Feed inlet to system RETENTATE Retentate outlet PERMEATE Permeate outlet PERMEATE RECYCLE Permeate recycle to feed tank FEED DRAIN Feed drain point and product outlet Clean-In-Place agent outlet RETENTATE DRAIN...
Page 40 3 System description 3.3 Standard components 3.3.3 Connections and drains Description The basic configuration of the UniFlux 10 system is provided with the following process connections: • Feed inlet • Filter inlet, filter outlet and drain connections • Retentate outlet •...
Page 41: Feed Pump And Feed Line
3 System description 3.3 Standard components 3.3.4 Feed pump and feed line 3.3.4 Feed pump and feed line Illustration FEED OUT FEED IN PT-112 XV-001 FT-142 XV-061 PT-111 P-201 Description The main purposes of the feed line are to transfer product (or feed) from the recircula- tion tank, to the filter (FILTER) and to raise the pressure of the feed so that correct trans membrane pressure (TMP), filter pressure and feed flow is achieved.
Page 42: Retentate Line
3 System description 3.3 Standard components 3.3.5 Retentate line 3.3.5 Retentate line Illustration FA-231 XV-051 XV-052 PT-113 FILTER TANK PCV-341 XV-063 TE-161 Description Particles / molecules that are too large to pass through the filter pores are retained through the filter as retentate. Retentate is exhausted from the filter (FILTER) through the retentate connection and then guided to the retentate outlet.
Page 43: Permeate Line
3 System description 3.3 Standard components 3.3.6 Permeate line 3.3.6 Permeate line Illustration AE-121 XV-031 XV-032 TANK CE-101 FT-142 AE-131 FILTER XV-063 PT-114 Description Particles / molecules that are small enough to pass through the filter pores are collected as permeate. Permeate is exhausted from the filter through the permeate connection (FILTER) and guided to the permeate outlet through XV-031 or back to the recirculation tank (TANK) through XV-032.
Page 44 3 System description 3.3 Standard components 3.3.6 Permeate line TMP is controlled by means of the pressure control valve PCV-341 on the retentate line and the permeate pump P-203 if installed (option). Flow control Permeate flow can be controlled by the optional permeate pump, see Permeate control pump P-203, on page Recycling...
Page 45: Air Integrity Test Device
3 System description 3.3 Standard components 3.3.7 Air integrity test device 3.3.7 Air integrity test device Description UniFlux 10 is provided with an air integrity test device. The principle is to apply pressurized air or nitrogen to the filter feed inlet with the reten- tate outlet closed.
Page 46: Feed Tank
3 System description 3.3 Standard components 3.3.8 Feed tank 3.3.8 Feed tank Illustration Description The UniFlux 10 system is provided with a built-in feed tank with 5 or 10 liter volume. The feed tank is connected to the pump feed inlet, the retentate outlet and the permeate recycle outlet by means of flexible hoses routed so that mass measuring during processing is not affected.
Page 47: Optional Components
3 System description 3.4 Optional components Optional components About this section UniFlux 10 system can be ordered or upgraded with a range of optional components. This section briefly describes the optional components. In this section Section See page 3.4.1 Peristaltic pumps 3.4.2 Multiple inlets 3.4.3...
Page 48: Peristaltic Pumps
As material is separated out from the feed as permeate, the transfer pump can keep the feed tank level within set limits. If a feed tank is not provided by Cytiva, a signal from the customer plant installations can be used to control the transfer pump through UNICORN. Refer to the SW-docu- mentation provided with the system or contact your Cytiva representative for more information.
Page 49: Multiple Inlets
3 System description 3.4 Optional components 3.4.2 Multiple inlets 3.4.2 Multiple inlets Illustration Description The feed inlet (option) is an upgrade to a multiple inlets blocks with four valves. Typically, the inlets can be connected to product, buffer, water and CIP. UniFlux 10 Operating Instructions 28993587 AF...
Page 50: Uv Monitor
3 System description 3.4 Optional components 3.4.3 UV monitor 3.4.3 UV monitor Illustration Description The UV monitor (optional) is installed on the permeate line and is used to detect protein leakage through the filter. The UV light and detector operates at 280 nm. Since UV measuring employs optics, it must be understood that the optical system must be kept clean and undamaged to provide reliable readings.
Page 51: Ph Sensor
3 System description 3.4 Optional components 3.4.4 pH sensor 3.4.4 pH sensor Illustration Description The pH sensor AE-121 (option) is installed on the permeate line and is used to measure the pH of the permeate. UniFlux 10 Operating Instructions 28993587 AF...
Page 52: Conductivity Sensor
3 System description 3.4 Optional components 3.4.5 Conductivity sensor 3.4.5 Conductivity sensor Illustration Description The conductivity sensor CE-101 (option) is installed on the permeate line and is used to measure the conductivity of the permeate. UniFlux 10 Operating Instructions 28993587 AF...
Page 53: Feed Tank Mixer
3 System description 3.4 Optional components 3.4.6 Feed tank mixer 3.4.6 Feed tank mixer Illustration Description The mixer option allows the feed to be stirred during processing. The mixer motor is completely controlled by UNICORN. UniFlux 10 Operating Instructions 28993587 AF...
Page 54: Filter Cassette Configuration
3 System description 3.5 Filter cassette configuration Filter cassette configuration Overview When the UniFlux 10 system is operated with filter cassettes, the cassette holder and required components of the piping system must be installed. The retentate line must be located in the lower position. In this section Section See page...
Page 55: Filter Cassette Components
3 System description 3.5 Filter cassette configuration 3.5.1 Filter cassette components 3.5.1 Filter cassette components Illustration UniFlux 10 Operating Instructions 28993587 AF...
Page 56: Cassette Holder
3 System description 3.5 Filter cassette configuration 3.5.2 Cassette holder 3.5.2 Cassette holder Description The cassette holder provides a convenient way to install and use the filter cassettes for a filtering run. The cassette holder follows industry standard cassette dimensions and accepts other cassettes of standard layout.
Page 57 3 System description 3.5 Filter cassette configuration 3.5.2 Cassette holder Part Function Feed inlet Retentate outlet Movable back plate Filter retaining nut (2) Filter retaining threaded rod (2) 8, 9 Filter retaining spacers (4) Spillage plate drain outlet Spillage plate UniFlux 10 Operating Instructions 28993587 AF...
Page 58: Filter Cassettes
When more than one cassette is used for a filtering run, the holes of the cassettes align with each other to form common sealed channels. Available types of cassettes Refer to your Cytiva representative for information regarding different cassettes that can be used with the UniFlux 10 filtration system. UniFlux 10 Operating Instructions 28993587 AF...
Page 59: Hollow Fiber (Hf) Configuration
3 System description 3.6 Hollow fiber (HF) configuration Hollow fiber (HF) configuration Overview When a UniFlux 10 system is operated with hollow fiber cartridges, required compo- nents of the piping system must be installed. In this section Section See page 3.6.1 UniFlux 10 HF configuration 3.6.2...
Page 60: Uniflux 10 Hf Configuration
3 System description 3.6 Hollow fiber (HF) configuration 3.6.1 UniFlux 10 HF configuration 3.6.1 UniFlux 10 HF configuration Illustration Part Function Retentate hose Permeate hose Hollow fiber cartridge, size 5 or 6 is accepted. HF cartridge drain valve (XV-064) HF cartridge drain hose UniFlux 10 Operating Instructions 28993587 AF...
Page 61: Hf Cartridges
UniFlux 10 system is designed to accept Hollow fiber cartridges of different sizes. These cartridges are described in the Hollow fiber cartridges for membrane separations Operating Handbook, Cytiva article no 18116530. and in the Hollow fiber cartridges and systems for membrane separations Selection Handbook, Cytiva article no.
Page 62 3 System description 3.6 Hollow fiber (HF) configuration 3.6.2 HF cartridges HF cartridge draining Hollow fibre cartridges are provided with two connections to the permeate compart- ment, one in each end. When mounted vertically, which is the case for all UniFlux 10 systems, the bottom connection serves as drain for the permeate.
Page 63: Meters And Sensors
3 System description 3.7 Meters and sensors Meters and sensors About this section This section describes the meters and sensors that are available as basic configuration and optional components for UniFlux 10 system. In this section Section See page 3.7.1 Pressure 3.7.2 Flow...
Page 64: Pressure
3 System description 3.7 Meters and sensors 3.7.1 Pressure 3.7.1 Pressure Pressure sensors PT-113 PT-114 PT-112 PT-111 Description Four pressure sensors are provided. The pressure sensors PT-111 and PT-112 provide pressure data for the feed pump outlet and filter feed inlet pressure, PT-113 measures retentate pressure and PT-114 measures permeate pressure.
Page 65: Flow
3 System description 3.7 Meters and sensors 3.7.2 Flow 3.7.2 Flow Flow sensors FT-142 FT-141 Description FT-141 measures the feed flow and FT-142 measures the permeate flow. The retentate flow is calculated by UNICORN by subtracting the permeate flow from the feed flow.
Page 66: Ph, Conductivity And Uv
3 System description 3.7 Meters and sensors 3.7.3 pH, conductivity and UV 3.7.3 pH, conductivity and UV pH, Cond and UV AE-121 CE-101 AE-131 Description The optional pH sensor AE-121 measures permeate pH. Calibration prior to each filtration run is recommended. pH calibration is described in Section 6.5 pH calibration, on page 129.
Page 67: Temperature
3 System description 3.7 Meters and sensors 3.7.4 Temperature 3.7.4 Temperature Temperature TE-161 Description Temperature is measured in the retentate line with the sensor TE-161. UniFlux 10 Operating Instructions 28993587 AF...
Page 68: Tank Mass Balance
3 System description 3.7 Meters and sensors 3.7.5 Tank mass balance 3.7.5 Tank mass balance Illustration Description The UniFlux 10 system has a built-in feed tank that is provided with a balance for mass measuring. Prior to each filter run the balance should reset to zero to ensure reliable output. The balance should be calibrated each time the system is moved or its balance is disturbed.
Page 69: More Information
3 System description 3.7 Meters and sensors 3.7.6 More information 3.7.6 More information Sensor signals Sensor signals are described in detail in Section 8.2 Signals, on page 150. Location and tagging of sensors Location and tagging of each sensor is described in Section 3.8 Flowchart, on page UniFlux 10 Operating Instructions 28993587 AF...
Page 70: Flowchart
3 System description 3.8 Flowchart Flowchart UniFlux 10: Flow diagram CE/TE -101 AE-121 AE-131 FT-142 PT-114 PT-112 FT-141 PT-111 UniFlux 10 Operating Instructions 28993587 AF...
Page 71 3 System description 3.8 Flowchart Component description Tag / System Function Note More information AE-121 Permeate pH sensor Option Section 3.7.3 pH, conduc- tivity and UV, on page 66 AE-131 Permeate UV monitor Option Tank feed inlet Section 3.3.8 Feed tank, on page 46 B2, B3, B4 Quadruple inlets 1, 2 and 3...
Page 72 3 System description 3.8 Flowchart Tag / System Function Note More information Permeate pump outlet Part of permeate Permeate control pump pump option P-203, on page 48 Retentate drain Section 3.3.3 Connections and drains, on page 39 Feed drain / CIP outlet Section 3.3.3 Connections and drains, on page 39 Permeate drain...
Page 73 3 System description 3.8 Flowchart Tag / System Function Note More information TE-101 Permeate temperature Option. Included Section 3.7.4 Temperature, meter in cond CE-101. on page 67 WE-176 Tank load cell Section 3.3.8 Feed tank, on page 46 XV-001 Pump feed valve Section 3.3.4 Feed pump and feed line, on page 41 XV-031...
Page 74: Unicorn Control System
System operators are responsible for designing methods which conform to standard operating procedures and Good Manufacturing Practice procedures. UNICORN is technically compatible with all relevant sections of FDA 21 CFR Part 11. A part 11-system assessment checklist is available on request through the local Cytiva representative. Prerequisite knowledge A working knowledge of UNICORN is required to operate the UniFlux 10 system safely.
Page 75 3 System description 3.9 UNICORN control system Software modules The UNICORN control software consists of four modules: Module Function UNICORN File handling and administration tasks; for example, definition Manager/ of systems and managing user profiles. Administration (UNICORN version dependent) Method Editor Method creation and editing for preprogrammed control of UniFlux 10 system.
Page 76 3 System description 3.9 UNICORN control system Cabinet controls and indicators Note: The EMERGENCY STOP and MAIN SWITCH controls are not part of UNICORN and are described in Section 2.3 Emergency procedures, on page Label Type Color Function PAUSE Sets UNICORN in PAUSE mode Button (is equal to the PAUSE button in the UNICORN computer user...
Page 77 • The valves and other components on the system are set to their default positions. Note: If an alarm is displayed that is not explained in the Software documentation, please contact your local Cytiva representative. Alarm test The alarm buzzer can be tested from the control system using the buzzer test function Alarms →BuzzerTest.
Page 78: Installation
4 Installation Installation About this chapter This chapter provides required information to enable users and service personnel to unpack, install, move and transport UniFlux 10 system. In this chapter Section See page Site requirements Transport Unpacking UniFlux 10 Setup Power supply Precautions WARNING Before attempting to perform any of the procedures described in...
Page 79: Site Requirements
4 Installation 4.1 Site requirements Site requirements Space and floor load For space and floor requirement, see external dimensions and weights in Section 8.1 Specifications, on page 146. • Make sure that the floor can handle the UniFlux 10 system weight at fully loaded conditions.
Page 80 The term "battery limits" represents all interface points between the UniFlux 10 and the customer process plant. System battery limits require connections, not included in the Cytiva delivery. Section 3.8 Flowchart, on page 70 Section 8.3 Battery limits, on page 151 description of required connections.
Page 81: Transport
4 Installation 4.2 Transport Transport Introduction This section outlines important information that must be considered when trans- porting UniFlux 10 system. Transport in crate Use a pallet jack or forklift with a minimum capacity to match the empty weight of the system plus the transport crate.
Page 82: Unpacking
4 Installation 4.3 Unpacking Unpacking Precautions WARNING Heavy object. Because of the significant weight of the product, great care must be taken not to cause squeezing or crushing inju- ries during movement. At least two, but preferably three or more, people are recommended when moving the unit.
Page 83 • Check that all equipment is enclosed in the crate according to the packing list. • Check that the equipment for any apparent damage and document carefully if found. If any equipment is missing or damage is found, contact your Cytiva representative immediately. General unpacking instructions...
Page 84: Uniflux 10 Setup
4 Installation 4.4 UniFlux 10 Setup UniFlux 10 Setup Precautions CAUTION To prevent bacterial growth, the product may be partly filled with denatured alcohol (18% C OH (ethanol), 2% C OH (isopro- panol) and 80% H O (water)) at delivery. The denatured alcohol mixture can be hazardous to humans if consumed.
Page 85: Lock The Wheels
4 Installation 4.4 UniFlux 10 Setup 4.4.1 Lock the wheels 4.4.1 Lock the wheels After positioning the system at its designated location, lock the wheels as illustrated below. UniFlux 10 Operating Instructions 28993587 AF...
Page 86: Stand-Alone Computer
4 Installation 4.4 UniFlux 10 Setup 4.4.2 Stand-alone computer 4.4.2 Stand-alone computer Connect a stand-alone computer to the UniFlux 10 system Connect a stand-alone computer with UNICORN to UniFlux 10 by plugging in an Ethernet cable to the UNICORN ETHERNET connector illustrated below. Note: When installing a stand-alone computer ensure that it is installed with appropriate precautions for the intended environment that might expose...
Page 87: Setup Of Control System And Network
4 Installation 4.4 UniFlux 10 Setup 4.4.3 Setup of control system and network 4.4.3 Setup of control system and network Introduction This section describes the steps that need to be performed to set up the UNICORN control system and network connections. Install UNICORN Make sure that the UniFlux 10 control software UNICORN is installed on your computer.
Page 88: Connect Compressed Air Supply
4 Installation 4.4 UniFlux 10 Setup 4.4.4 Connect compressed air supply 4.4.4 Connect compressed air supply Introduction This section describes how to connect the compressed air supply. For requirements on air supply, see Section 4.1 Site requirements, on page Connect compressed air supply to UniFlux 10 10 Step Action...
Page 89 4 Installation 4.4 UniFlux 10 Setup 4.4.4 Connect compressed air supply Step Action Make sure that the supply pressure to the cabinet is between 5.5 and 7 bar g. The manometer is set to 6 bar g at the factory and shall not be changed. UniFlux 10 Operating Instructions 28993587 AF...
Page 90: Filter Setup, Feed Pump And Cff Filter Protection
4 Installation 4.4 UniFlux 10 Setup 4.4.5 Filter setup, feed pump and CFF filter protection 4.4.5 Filter setup, feed pump and CFF filter protection Filter setup If the system is configured for the intended filter type (HF or cassette), no need for further installations are required at arrival to the process site or between processing.
Page 91: Power Supply
UPS power supply Cytiva does not offer a UPS (Uninterrupted Power Supply) as an accessory. However, the system is prepared for UPS operation. For UPS operation, a UPS should be connected to the main power supply of UniFlux 10.
Page 92 If the cable needs to be replaced due to damage, the same type of cable or equivalent must be used. WARNING Only personnel authorized by Cytiva may perform service, installa- tion, and maintenance of components inside the cabinet. Main power supply wire colors and tags The power cord wires are color coded as shown in the table below.
Page 93 Ground fault breaker UniFlux 10 system is not equipped with a general Ground Fault Circuit Breaker and it is not an option that is available from Cytiva. However, if ground fault protection for the system is desired, check the following: •...
Page 94 4 Installation 4.5 Power supply More information Wiring diagrams for the system, voltage, power, fuse requirements and the tripping current for the fixed power supply ground fault protector can be found in the system documentation package. UniFlux 10 Operating Instructions 28993587 AF...
Page 95: Operation
5 Operation Operation About this chapter This chapter provides the information required to operate the UniFlux 10 system in a safe way. In this chapter Section See page Prepare the system Calibrations Perform a run Procedures after usage Precautions WARNING Before attempting to perform any of the procedures described in this chapter, you must read and understand all contents of the corresponding section(s) in the Safety instructions chapter as...
Page 96 Only use chemicals listed in the Chemical Resistance information. The wetted parts of the product may be damaged by chemicals not listed in the Chemical Resistance information. Contact your Cytiva representative before using chemicals that are not listed. for more information.
Page 97: Prepare The System
5 Operation 5.1 Prepare the system Prepare the system About this section This section describes the steps that should be performed to prepare UniFlux 10 system for a run. In this section Section See page 5.1.1 Sample handling 5.1.2 Start the system and software 5.1.3 Install hollow fiber cartridges 5.1.4...
Page 98: Sample Handling
NFF can be used when recovering the processed product from the system. Recommendations The table below describes the situations where the Cytiva range of ULTA™ NFF capsules can be used. UniFlux 10 Operating Instructions 28993587 AF...
Page 99 5 Operation 5.1 Prepare the system 5.1.1 Sample handling If... Then use the following NFF... Placement... If large particles Between the • ULTA Prime CG capsule are present in the sample container sample container and the system feed inlet If large particles Between the •...
Page 100 5 Operation 5.1 Prepare the system 5.1.1 Sample handling Part Function Container for recovered material, preferably a ReadyCircuit™ bag (part of the ReadyToProcess™ portfolio) or equal UniFlux 10 Operating Instructions 28993587 AF...
Page 101: Start The System And Software
5 Operation 5.1 Prepare the system 5.1.2 Start the system and software 5.1.2 Start the system and software Start UniFlux 10 Step Action Make sure that the air supply to the system is turned on. Turn on the UPS if used. Make sure that the electrical cabinet doors are closed and locked.
Page 102 5 Operation 5.1 Prepare the system 5.1.2 Start the system and software Step Action When UNICORN is connected to the system, the Run button in the status bar is enabled. The button initially has a green color indicating the system is ready to run.
Page 103: Install Hollow Fiber Cartridges
5 Operation 5.1 Prepare the system 5.1.3 Install hollow fiber cartridges 5.1.3 Install hollow fiber cartridges Follow the instruction below to install the HF cartridges. Step Action Make sure that the system is configured for using HF cartridges and of the intended size, see Section 6.7 Change filter type, on page 133 if required.
Page 104: Install Filter Cassettes
5 Operation 5.1 Prepare the system 5.1.4 Install filter cassettes 5.1.4 Install filter cassettes General preparation of the cassettes The table below describes general preparations before installing the cassettes. Step Action If the filter cassettes to be used are new, it is strongly recommended to perform an air integrity test to establish its characteristic air or nitrogen flow.
Page 105: Testing
5 Operation 5.1 Prepare the system 5.1.5 Testing 5.1.5 Testing Introduction Before using your UniFlux 10 system and cassette to process product, do the following: 1. Perform a leakage test. 2. Perform an air integrity test. Leakage test Note: For allowed deviations from reference values during leakage testing, refer to Section 8.2 Signals, on page 150 or Functional Test Records, in the documentation package.
Page 106 5 Operation 5.1 Prepare the system 5.1.5 Testing Step Action Open the Permeate valve XV-031 to Permeate. NOTICE Never let the test pressure exceed the maximum filter pressure as stated by the filter manufacturer. If the filter is subjected to pressures exceeding this value, unrecov- erable damage may occur.
Page 107 5 Operation 5.1 Prepare the system 5.1.5 Testing If... Then... The air/nitrogen flow is signifi- The filter is clogged and needs to be cleaned. cantly lower than the charac- teristic flow. The air/nitrogen flow is signifi- The are pores in the membranes or fibers that cantly higher than the charac- have become larger than the nominal pore size.
Page 108: Calibrations
5 Operation 5.2 Calibrations Calibrations About this section This section describes how to establish and enter hold-up volume, prepare mass meas- uring, control meter range and calibration. In this section Section See page 5.2.1 Preparing mass measuring 5.2.2 Establishing and entering holdup volume 5.2.3 Meter range and calibration UniFlux 10 Operating Instructions 28993587 AF...
Page 109: Preparing Mass Measuring
5 Operation 5.2 Calibrations 5.2.1 Preparing mass measuring 5.2.1 Preparing mass measuring Introduction Before the mass measuring system can be used to reliably measure and indicate the contents of the tank, make sure that all load cell locking screws are fully released. The measuring scale must then be set with regard to zero point and slurry density if the density differs significantly from 1.0.
Page 110: Establishing And Entering Holdup Volume
5 Operation 5.2 Calibrations 5.2.2 Establishing and entering holdup volume 5.2.2 Establishing and entering holdup volume Introduction The holdup volume is necessary for correct VolTank data. This is critical for the concentration factor and diafiltration factor calculations as these instructions latch onto the VolTank value.
Page 111: Meter Range And Calibration
5 Operation 5.2 Calibrations 5.2.3 Meter range and calibration 5.2.3 Meter range and calibration Conductivity range Make sure that the conductivity meter is set to the correct range. See Conductivity range, on page 131. Conductivity calibration If necessary, calibrate the conductivity meter. See Conductivity test, on page 132.
Page 112: Perform A Run
5 Operation 5.3 Perform a run Perform a run Precautions WARNING During operation, all cabinet doors must be closed and locked. NOTICE Excessive temperatures may damage the equipment. Do not run the system at higher temperatures than the specified maximum operation temperature as stated on the system label.
Page 113 5 Operation 5.3 Perform a run Step Action Select the method to start. Click OK. A Start Protocol is displayed, consisting of a number of dialog boxes. On the Variables page, it is possible to fine-tune the method before proceeding. Checking the Show details box will display more detailed information.
Page 114: Procedures After Usage
5 Operation 5.4 Procedures after usage Procedures after usage Clean the filters The filters can be cleaned in place if the method is set within the specific ranges for solutions, temperature and pressure. The filters should be cleaned as described in Clean the filters, on page 121.
Page 115: Maintenance
6 Maintenance Maintenance About this chapter This chapter provides required information to enable users and service personnel to clean, maintain, calibrate and store the UniFlux 10 system. In this chapter Section See page User maintenance schedule Cleaning Storage Disassembly and assembly pH calibration Repair and calibration Change filter type...
Page 116 6 Maintenance WARNING For continued protection against injury risks due to fluid jets, burst pipes or potentially explosive atmosphere, the user must test the piping system for leakage at maximum operating pressure. • Always perform a leakage test after assembly or maintenance. •...
Page 117: User Maintenance Schedule
The table below lists maintenance actions that are required monthly. Component Action Pump Check for oil leakage. (If the pump leaks, contact your local Cytiva representative). Connections and Check for leakage. Replace seals if needed. Perform a leakage seals test at maximum operating pressure.
Page 118 Action Complete system A preventive maintenance test procedure on all instruments, sensors, pumps and valves should be performed annually by trained and certified personnel. Contact your local Cytiva representative. Replace all gaskets, o-rings and valve diaphragms. Complete stain- Inspect stainless steel systems for rust. If needed, passivate...
Page 119: Cleaning
6 Maintenance 6.2 Cleaning Cleaning About this section This section describes procedures and recommendations for cleaning UniFlux 10 system. Procedures for cleaning both the exterior, and CIP (cleaning-in-place) proto- cols for cleaning the flow path are described. In this section Section See page 6.2.1...
Page 120 6 Maintenance 6.2 Cleaning NOTICE Replace the pH electrode with the pH-probe dummy before performing CIP with strong acids or alkali. NOTICE The filter may not be compatible with the CIP solutions. If so, remove the filter and store or dispose of it in accordance with the recommendations of the manufacturer.
Page 121: Important Considerations For Cleaning
The UV cell and conductivity cells are cleaned by flushing the cells with 1 M sodium hydroxide or 20% ethanol. Clean the filters • Cytiva Hollow fiber cartridges cleaning procedures are provided in the Hollow fiber cartridges for membrane separations Operating Handbook, Cytiva article no 18116530..
Page 122 6 Maintenance 6.2 Cleaning 6.2.1 Important considerations for cleaning • Filter units shall be cleaned according to the instructions from the respective manu- facturer. Clean external surfaces The UniFlux 10 system is designed to be operated in a clean environment and the external surfaces should not normally accumulate any substantial amount of dust or dirt.
Page 123: Cleaning-In-Place (Cip)
6 Maintenance 6.2 Cleaning 6.2.2 Cleaning-in-place (CIP) 6.2.2 Cleaning-in-place (CIP) CIP methods in UNICORN It is recommended that specific CIP protocols are developed to standardize the CIP procedure in a repeatable and reliable manner depending on the applied user applica- tion.
Page 124: Storage
If the system is dried, the valve bodies should be grounded before nitrogen or air flow is applied. Contact your Cytiva representative regarding purchase and installation of grounding kits. NOTICE Fit protective caps on all electrical and optical connectors when not in use.
Page 125 6 Maintenance 6.3 Storage Short-term storage The table below describes the procedure for short-term storage. This procedure is applicable for storage durations of up to one month. Step Action Perform cleaning as described in Section 6.2 Cleaning, on page 119. If the system is configured for filter cassettes, release the pressure of the hydraulic unit to approximately 50 bar.
Page 126 The reference below provides storage procedures for Hollow fiber filters. • Cassettes storage instructions are provided by the filter cassette manufacturer. • Cytiva Hollow fiber cartridges storage procedures are provided in the Hollow fiber cartridges for membrane separations Operating Handbook, Cytiva article no 18116530..
Page 127: Disassembly And Assembly
6.4 Disassembly and assembly Disassembly and assembly Introduction This section covers all disassembly and assembly procedures that the end user is allowed to perform without support from Cytiva. Precautions WARNING Only authorized personnel may open the electrical cabinet doors. There is hazardous voltage inside the electrical cabinet that can cause human injury or death.
Page 128 Other than described in this chapter, the UniFlux 10 is not designed to be disassembled or assembled by the user. If the need for further disassembly should arise, always contact your Cytiva represen- tative for advice before attempting any actions not described by this document.
Page 129: Ph Calibration
6 Maintenance 6.5 pH calibration pH calibration Required equipment • pH reference solution for low pH-measuring point, preferably pH 4.00. • pH reference solution for high pH-measuring point, preferably pH 7.00. • Clean cloth. • Clean water in spray bottle. Calibration procedure The table below describes how to calibrate the pH probe.
Page 130 6 Maintenance 6.5 pH calibration Step Action Remove the pH-probe from the holder and rinse it with distilled water. Remove the cup with the first buffer from the holder and replace it with the cup with the second buffer. Relocate the pH probe in the holder with the end submerged in the buffer. Enter the pH value for the buffer in the Reference value 2 field, wait for the value to stabilize, and click Read value 2.
Page 131: Repair And Calibration
Introduction This section describes component checks, repair and calibration of other components (beside the pH probe) that the user can perform without Cytiva support. Procedures can also be found in the respective product manuals found in the product documentation package.
Page 132 Components not covered by any of the above described procedures may not be cali- brated by the user. If any non user-calibratable components on the UniFlux 10 system appear to operate off specifications, contact your Cytiva representative for advice. UniFlux 10 Operating Instructions 28993587 AF...
Page 133: Change Filter Type
HF operation. NOTICE While system filter type reconfiguration can be performed by a properly skilled user technician, Cytiva recommends that a Cytiva service engineer is assigned for this work. Contact your Cytiva representative for more information on changing filter configurations if required.
Page 134 6 Maintenance 6.7 Change filter type Step Action Remove the following components: • The cassette holder. • All cassette holder fittings. The system should look like this when all components are removed: UniFlux 10 Operating Instructions 28993587 AF...
Page 135 6 Maintenance 6.7 Change filter type Step Action Install the HF-specific components as shown in the illustration: Install a decommisioned or dummy HF cartridge and test the system for operation and leakages. UniFlux 10 Operating Instructions 28993587 AF...
Page 136 6 Maintenance 6.7 Change filter type Change from HF cartridge to filter cassette Step Action Make sure that all components required for the cassette setup are available, refer to Illustration, on page Remove the following components: • The HF cartridge. •...
Page 137 6 Maintenance 6.7 Change filter type Step Action Install the cassette specific components as shown in the illustration: Install a dummy or decommisioned filter cassette and test the system for operation and leakages. UniFlux 10 Operating Instructions 28993587 AF...
Page 138: Troubleshooting
UniFlux 10 system. If the suggested actions in this guide do not solve the problem, or if the problem is not covered by this guide, contact your Cytiva representative for advice. Precautions...
Page 139 • Emergency button has been pressed. • No inlet or outlet valve open. Check method and valves. • Incorrect method. Check by entering Pump →ManFlow > 1%. • If none of the above, contact Cytiva service personnel. UniFlux 10 Operating Instructions 28993587 AF...
Page 140 7 Troubleshooting Compo- Possible cause Corrective action nent Little or no flow. • Check that connected inlet is actually used. • Inlet containers are placed too low rela- tive to the pump. Check inlet containers. • No liquid is supplied to the pump. Check inlet containers.
Page 141 7 Troubleshooting Pressure curve Error symptom Possible cause Corrective action Erratic flow, noisy Gas bubbles passing Check that there is sufficient baseline signal, irreg- through or trapped in supply of liquid. ular pressure trace. the pump. Check all connections for leaks.
Page 142 7 Troubleshooting Cross flow filtration Air integrity test, on page 105. Component Problem Possible Corrective action cause Filter prob- The flow is too high in the air Clogged filter. Clean the filter. lems integrity test. The flow is too low in the air integ- The pores in Change the filter.
Page 143 "P203 not healthy". faulty set up or 2. Run instruction: not working. P202_clear faults P203_clear faults. 3. Contact your local Cytiva representative. Little or no flow. Broken or 1. Check the pump hose. damaged 2. Contact your local hose. Cytiva representative.
Page 144 7 Troubleshooting pH curve Error symptom Possible cause Corrective action No response to pH The cable to the elec- Check the cable connection. changes. trode not properly connected. The electrode Replace the electrode. membrane might be cracked. Small or slow response The electrode Clean the electrode, refer to to pH changes.
Page 145: Reference Information
8 Reference information Reference information About this chapter This chapter provides reference information that may become useful when installing, operating, maintaining and troubleshooting UniFlux 10 system. It also contains ordering information. The UniFlux 10 system is a modular built instrument that can be configured in many different ways.
Page 146: Specifications
8 Reference information 8.1 Specifications Specifications Dimensions Note: • All dimensions are presented in cm where nothing else is noted. • Dimensions and weights are valid for standard systems. • Dimensions may vary for individual units by +/- 1 cm. •...
Page 147 8 Reference information 8.1 Specifications Weights Configuration Weight Complete configuration 300 kg Complete configuration including crate, acces- 440 kg sories and documentation kit Capacity Property Value Operating flow, feed pump / recircula- 1 L/min at 4 bar tion flowrate 10 l/min Feed transfer- and permeate control 20 ml/min pump option, flow at 2 bar outlet back-...
Page 148 8 Reference information 8.1 Specifications Parameter Value Relative Humidity Max 80% for temperatures up to 31°C, decreasing linearly to 50% relative humidity at 40°C. Ambient temperature Requirement regarding ambient temperature is specified in the General Specification included in the system documentation kit Ingress protection IP 55 Compressed air...
Page 149 8 Reference information 8.1 Specifications Sound levels Property Value Feed pump <80 dB Typical value under normal running conditions 59 dB Measured at the feed flow rate 5 l/min and feed pressure 2 bar Electric power Property Value Power supply System Type L-N-PE...
Page 150: Signals
8 Reference information 8.2 Signals Signals Signal Signal / Tag Measuring Set range Acceptance name unit range Feed Weight WIT-176 0 to 30 000 0 to 25 000 Pressure PT-111, bar g 0 to 6 0.1 to 6 PT-112 Flow FT-141 l/min 0 to 15...
Page 151: Battery Limits
8 Reference information 8.3 Battery limits Battery limits About battery limits Battery limits represent interface points between the UniFlux 10 system and the customer plant process equipment. Battery limits can be thought as the points where functional responsibility is handed over from the plant to the UniFlux 10 system or vice versa.
Page 152 8 Reference information 8.3 Battery limits Battery limit Size and connector type UPS power failure alarm input Terminal connection, normally Optional I/O interface 16-pole connector Unicorn Ethernet port on system 4-pole connector UniFlux 10 Operating Instructions 28993587 AF...
Page 153: Chemical Resistance
Introduction The table below gives allowed exposure concentrations and times for various chemi- cals that may be used in Cytiva BioProcess™ instruments in general. For information regarding hollow fiber chemical resistance, please refer to Hollow fiber cartridges for membrane separations Operating Handbook, Cytiva article no 18116530.
Page 154 8 Reference information 8.4 Chemical resistance Chemical Concentration Max. time / cycle Max. acc. Usage expos. Urea 5000 h Purification, Cleaning 1% to 6% STERIS™ 3 h at temp ≤ 60°C 3000 h CIP 100™, 0.5% solutions Henkel P3™-11, 0.2% Micro, 0.2% Terg-a-zyme™, 0.1% Tween™...
Page 155: Recycling Information
Recycling of hazardous substances UniFlux 10 system contains hazardous substances. Detailed information is available from your Cytiva representative. Disposal of electrical components Waste electrical and electronic equipment must not be disposed as unsorted munic- ipal waste and must be collected separately.
Page 156: Regulatory Information
8 Reference information 8.6 Regulatory information Regulatory information Introduction This section lists the regulations and standards that apply to the product. In this section Section See page 8.6.1 Contact information 8.6.2 European Union and European Economic Area 8.6.3 Eurasian Economic Union Евразийский...
Page 157: Contact Information
Manufacturing information The table below summarizes the required manufacturing information. Requirement Information Name and address of manufacturer Cytiva Sweden AB Björkgatan 30 SE 751 84 Uppsala Sweden Telephone number of manufacturer + 46 771 400 600 UniFlux 10 Operating Instructions 28993587 AF...
Page 158: European Union And European Economic Area
8 Reference information 8.6 Regulatory information 8.6.2 European Union and European Economic Area 8.6.2 European Union and European Economic Area Introduction This section describes regulatory information for the European Union and European Economic Area that applies to the equipment. Conformity with EU Directives See the EU Declaration of Conformity for the directives and regulations that apply for the CE marking.
Page 159: Eurasian Economic Union
Presnenskaya nab., 10, fl. 12, pr. III, room 6 Telephone: + 7 495 739 6931 Fax nr: + 7 495 739 6932 E-mail: rucis@cytiva.com Информация о производителе и импортере В следующей таблице приводится сводная информация о производителе и импортере, согласно требованиям Технических регламентов Таможенного союза...
Page 160 Пресненская наб., д. 10, эт. 12, пом. III, ком. 6 Телефон: + 7 495 739 6931 Факс: + 7 495 739 6932 Адрес электронной почты: rucis@cytiva.com Description of symbol on the system label Описание обозначения на этикетке системы This Eurasian compliance mark indicates that the product is...
Page 161: Regulations For North America
Note: The user is cautioned that any changes or modifications not expressly approved by Cytiva could void the user’s authority to operate the equip- ment. 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 162: Regulatory Statements
8 Reference information 8.6 Regulatory information 8.6.5 Regulatory statements 8.6.5 Regulatory statements Introduction This section shows regulatory statements that apply to regional requirements. EMC emission, CISPR 11: Group 1, Class A statement NOTICE This equipment is not intended for use in residential environments and may not provide adequate protection to radio reception in such environments.
Page 163: Declaration Of Hazardous Substances (Dohs)
8 Reference information 8.6 Regulatory information 8.6.6 Declaration of Hazardous Substances (DoHS) 8.6.6 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.
Page 164 8 Reference information 8.6 Regulatory information 8.6.6 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 Compo- Hazardous substance nent name 铅汞镉六价铬多溴联苯多溴二苯醚 (Pb) (Hg) (Cd)
Page 165: Other Regulations And Standards
8 Reference information 8.6 Regulatory information 8.6.7 Other regulations and standards 8.6.7 Other regulations and standards Introduction This section describes the standards that apply to the product. Additional design considerations For additional design considerations, such as ASME-BPE, GMP and cGMPs information refer to the product-specific specification information provided in the documentation package delivered with each equipment.
Page 166: Further Information
Spare parts and accessories Additional information regarding spare parts and acccessories can be found in the system documentation. Your local Cytiva representative will also be able to suggest recommended spare parts and accessories. Remaining aspects Regarding any of the below topics, please contact your local Cytiva representative for advice.
Page 167: Health And Safety Declaration Form
Service Ticket #: To make the mutual protection and safety of Cytiva 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, complete this checklist and present it to the Service Engineer upon arrival.
Page 168 To make sure the mutual protection and safety of Cytiva personnel, our customers, transportation personnel and our environment, all equipment must be clean and free of any hazardous contaminants before shipping to Cytiva. To avoid delays in the processing of your equipment, complete this checklist and include it with your return.
Page 169: Appendix A: Create A Method With Unicorn 5
A. Create a method with UNICORN 5 Appendix A Create a method with UNICORN 5 About this chapter This chapter describes how to create a method for UniFlux 10 system in the UNICORN Method Editor. In a basic example, the general structure of a method is shown, along with the different steps required to create it.
Page 170: The Method Editor
A. Create a method with UNICORN 5 A.1 The Method Editor The Method Editor In this section Section See page A.1.1 Introduction to the Method Editor A.1.2 Method Editor layout A.1.3 Other Method Editor features UniFlux 10 Operating Instructions 28993587 AF...
Page 171: Introduction To The Method Editor
A. Create a method with UNICORN 5 A.1 The Method Editor A.1.1 Introduction to the Method Editor A.1.1 Introduction to the Method Editor Description The Method Editor is used to build new methods in a step-by-step manner using blocks and instructions as building elements. The Method Editor can also be used to edit already existing methods.
Page 172 A. Create a method with UNICORN 5 A.1 The Method Editor A.1.1 Introduction to the Method Editor Open the Method Editor Open the Method Editor window from the UNICORN Manager module by selecting it in the task bar at the bottom of the screen. Step Action Click on the Customize Panes icon in the Method Editor toolbar.
Page 173: Method Editor Layout
A. Create a method with UNICORN 5 A.1 The Method Editor A.1.2 Method Editor layout A.1.2 Method Editor layout Text pane The Text pane contains an overview of the method in the form of an expandable list with all blocks and instructions in the method. Blocks are marked by blue square symbols.
Page 174 A. Create a method with UNICORN 5 A.1 The Method Editor A.1.2 Method Editor layout Note: Changing the Breakpoint of an instruction using Change will move not only the instruction, but also all subsequent instructions in the block. Using Replace moves only the selected instruction. Instructions placed at the same breakpoint will execute simultaneously, while blocks will execute in the order they occur in the Text pane.
Page 175: Other Method Editor Features
A. Create a method with UNICORN 5 A.1 The Method Editor A.1.3 Other Method Editor features A.1.3 Other Method Editor features Introduction The method created in the following chapter covers the most basic aspects of how a method is built. Follow this example to learn the basics of designing a filtration method. A few useful features demonstrated in this example are briefly described here.
Page 176: An Example Of Using The Method Editor
A. Create a method with UNICORN 5 A.2 An example of using the Method Editor An example of using the Method Editor In this section Section See page A.2.1 Introduction A.2.2 Create the method A.2.3 Block 1: Initial conditions A.2.4 Block 2: Product transfer A.2.5 Block 3: Fed-batch concentration A.2.6 Saving the method UniFlux 10 Operating Instructions 28993587 AF...
Page 177: Introduction
A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.1 Introduction A.2.1 Introduction About the example Create a method involves: 1. Creating and naming the method. 2. Adding the blocks and instructions to it. In this section, a basic example is used to illustrate the different steps required.
Page 178 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.1 Introduction Save your method at regular intervals while developing it by pressing the → Save in the menu. disk-icon or select File Preconditions In order to create a method, the following preconditions must be fulfilled: •...
Page 179: Create The Method
A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.2 Create the method A.2.2 Create the method This step creates the method and sets some initial conditions to it. Step Action Select File →New in the Method Editor menu. UniFlux 10 Operating Instructions 28993587 AF...
Page 180 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.2 Create the method Step Action In the New Method dialog shown: a. Select the desired system. b. Select Method Editor (pre-selected). c. Click OK. The new method will be displayed in the Text pane as the Main block with a single Base Time instruction.
Page 181 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.2 Create the method Step Action This instruction is required to avoid repeated display of the warning message "No flow in beginning of method". a. In the Text pane, select the Base Time instruction. b.
Page 182: Block 1: Initial Conditions
A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.3 Block 1: Initial conditions A.2.3 Block 1: Initial conditions Purpose The first block in the method will set the filter area and the pressure alarms. Block: Initial conditions Step Action...
Page 183 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.3 Block 1: Initial conditions Instruction: Membrane area Step Action In the Text pane, expand the Block INITIAL_CONDITIONS block by clicking the + to the left of the block. In the Block INITIAL_CONDITIONS instructions list, select the Base Time instruction.
Page 184 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.3 Block 1: Initial conditions Instructions: Filter pressure alarm Step Action In the Text pane, select the Base Time instruction of the Block INITIAL_CONDITIONS block. In the Instruction box, do the following settings: •...
Page 185: Block 2: Product Transfer
A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.4 Block 2: Product transfer A.2.4 Block 2: Product transfer Purpose and structure The second block in the method will fill the tank with the solution to be processed. This block will contain nested blocks.
Page 186 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.4 Block 2: Product transfer Instruction: Recirculation loop Step Action In the Text pane, select the Base Time instruction of the Block PRODUCT_TRANSFER_FLOWPATH block. In the Instruction box: •...
Page 187 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.4 Block 2: Product transfer Nested block: Delay to allow the valves to react Step Action In the Text pane, select the Base Time instruction of the Block PRODUCT_TRANSFER_FLOWPATH block In the Method Editor menu, select Block →New.
Page 188 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.4 Block 2: Product transfer Nested block: Start and stop the product transfer Step Action In the Text pane, select the Base Time instruction of the Block PRODUCT_TRANSFER block.
Page 189 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.4 Block 2: Product transfer Step Action In the Instruction box: • Set Breakpoint to 0.00 min. • In the Instructions group box, select Watch and WatchTankLevel. •...
Page 190 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.4 Block 2: Product transfer UniFlux 10 Operating Instructions 28993587 AF...
Page 191: Block 3: Fed-Batch Concentration
A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.5 Block 3: Fed-batch concentration A.2.5 Block 3: Fed-batch concentration Purpose and structure This block will start the concentration of the feed. Block: Fed-batch concentration Step Action In the Text pane, select the Base Time instruction of the Main node.
Page 192 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.5 Block 3: Fed-batch concentration Instructions: Recirculation loop Step Action In the Text pane, select the Base Time instruction of the Block FLOWPATH_CONCENTRATION block. In the Instruction box: •...
Page 193 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.5 Block 3: Fed-batch concentration Step Action In the Instruction box: • Set Breakpoint to 0.00 min. • In the Instructions group box, select Other and Block. In the Parameters field, select the Block DELAY_3_SEC block.
Page 194 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.5 Block 3: Fed-batch concentration Step Action In the Parameters field: • Check Maintain or set Setpoint for the tank level to a desired value. •...
Page 195 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.5 Block 3: Fed-batch concentration Instruction: Start concentration factor calculation Step Action In the Text pane, select the Base Time instruction of the Block PARAMETERS_CONCENTRATION block. In the Instruction box: •...
Page 196 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.5 Block 3: Fed-batch concentration Step Action In the Text pane, select the Base Time instruction of the Block FED_BATCH_CONCENTRATION block. In the Method Editor menu, select Block →New. In the New Block dialog: •...
Page 197 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.5 Block 3: Fed-batch concentration Step Action In the Parameters field: • Set BaseLine to for instance 0.1 bar. • Set MinPeak to 0.00 bar. Click Insert.
Page 198 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.5 Block 3: Fed-batch concentration Step Action In the Text pane, select the Base Time instruction of the Block FED_BATCH_CONCENTRATION block. In the Method Editor menu, select Block →New. In the New Block dialog: •...
Page 199 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.5 Block 3: Fed-batch concentration Step Action In the Parameters field: • Set Test to Greater_Than. • Set Value to an appropriate permeate volume. • Set Action to END_BLOCK. Click Insert.
Page 200 A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.5 Block 3: Fed-batch concentration If any step appears to be missing, misplaced or carries incorrect values, use the various editing methods available in the Method Editor to correct the errors. UniFlux 10 Operating Instructions 28993587 AF...
Page 201: Saving The Method
A. Create a method with UNICORN 5 A.2 An example of using the Method Editor A.2.6 Saving the method A.2.6 Saving the method To save the method, click the discette icon or select File →Save in the menu. UniFlux 10 Operating Instructions 28993587 AF...
Page 202: Appendix B: Create A Method With Unicorn 6 And Above
B. Create a method with UNICORN 6 and above Appendix B Create a method with UNICORN 6 and above About this chapter This chapter describes how to create a method for UniFlux 10 system in the UNICORN Method Editor. In a basic example, the general structure of a method is shown, along with the different steps required to create it.
Page 203: The Method Editor
B. Create a method with UNICORN 6 and above B.1 The Method Editor The Method Editor In this section Section See page B.1.1 Introduction to the Method Editor B.1.2 Method Editor layout B.1.3 Other Method Editor features UniFlux 10 Operating Instructions 28993587 AF...
Page 204: Introduction To The Method Editor
B. Create a method with UNICORN 6 and above B.1 The Method Editor B.1.1 Introduction to the Method Editor B.1.1 Introduction to the Method Editor Description The Method Editor is used to build new methods in a step-by-step manner using phases, blocks and instructions as building elements.
Page 205 B. Create a method with UNICORN 6 and above B.1 The Method Editor B.1.1 Introduction to the Method Editor Step Action When the User Defined phase has been added to the Method Outline, the phase name is enabled for editing. Type a name for the phase and press the Return keyboard key.
Page 206: Method Editor Layout
B. Create a method with UNICORN 6 and above B.1 The Method Editor B.1.2 Method Editor layout B.1.2 Method Editor layout Text Instructions tab Click the Method Editor window from UNICORN by selecting it in the task bar at the bottom of the screen.
Page 207 B. Create a method with UNICORN 6 and above B.1 The Method Editor B.1.2 Method Editor layout • Instructions: — Contains controls for selecting an instruction from a list. The instructions available are grouped according to function. • Parameters for — Contains parameter fields for the chosen instruction. The parameters will vary between the different instructions.
Page 208: Other Method Editor Features
B. Create a method with UNICORN 6 and above B.1 The Method Editor B.1.3 Other Method Editor features B.1.3 Other Method Editor features Introduction The method created in the following chapter covers the most basic aspects of how a method is built. Follow this example to learn the basics of designing a filtration method. A few useful features demonstrated in this example are briefly described here.
Page 209: An Example Of Using The Method Editor
B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor An example of using the Method Editor In this section Section See page B.2.1 Introduction B.2.2 Create the method B.2.3 Phase 1: Method Settings B.2.4 Phase 2: Product Transfer B.2.5 Phase 3: Fed Batch Concentration B.2.6 Saving the method...
Page 210: Introduction
B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.1 Introduction B.2.1 Introduction About the example Create a method involves the following steps: 1. Creating and naming the method. 2. Adding the blocks and instructions to it. In this section, a basic example is used to illustrate the different steps in the procedure.
Page 211 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.1 Introduction Tip: Save your method at regular intervals while developing it by pressing the → Save in the menu. disk-icon or select File Preconditions In order to create a method, the following preconditions must be fulfilled: •...
Page 212: Create The Method
B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.2 Create the method B.2.2 Create the method The following step creates the method and sets some initial conditions to it. Step Action Select File →New Method in the Method Editor menu.
Page 213 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.2 Create the method Step Action In the New Method dialog shown: a. Select the desired system. b. Click OK. The new method will be displayed in the Text Instructions tab. The new method starts with the Phase →Method Settings phase, for UniFlux 10 systems this contains a Base →SameAsMain instruction and an End_Block instruction.
Page 214: Phase 1: Method Settings
B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.3 Phase 1: Method Settings B.2.3 Phase 1: Method Settings Purpose The first phase in the method will set the filter area and the pressure alarms. Phase: Method Settings This instruction is required to avoid repeated display of the warning message "No flow in beginning of method".
Page 215 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.3 Phase 1: Method Settings Step Action In the Instruction Box, do the following settings: • Set Breakpoint to 0.00 min. • In the Instructions: list, select Other and Flow_Warning. •...
Page 216 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.3 Phase 1: Method Settings Instruction: Membrane area Step Action In the Text Instructions tab, select the Base →SameAsMain instruction of the Phase →Method Settings phase. In the Instruction Box, do the following settings: •...
Page 217 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.3 Phase 1: Method Settings Step Action In the Instruction Box, do the following settings: • Set Breakpoint to 0.00 min. • In the Instructions: list, select Alarms and DeltaP_Alarms. •...
Page 218: Phase 2: Product Transfer
B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.4 Phase 2: Product Transfer B.2.4 Phase 2: Product Transfer Purpose and structure The second phase in the method will fill the tank with the solution to be processed. This phase will contain nested blocks.
Page 219 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.4 Phase 2: Product Transfer Nested block: Product Transfer path Step Action In the Text Instructions tab, select the Base →SameAsMain instruction of the Phase →Product Transfer phase.
Page 220 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.4 Phase 2: Product Transfer Step Action In the Instruction Box: • Set Breakpoint to 0.00 min. • In the Instructions: list, select Permeate. Select Permeate, set to Closed, click Insert.
Page 221 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.4 Phase 2: Product Transfer Nested block: Delay to allow the valves to react Step Action In the Text Instructions tab, select the last instruction before the End_Block instruction of the Block →PROD_TRANSFER_FLOWPATH block.
Page 222 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.4 Phase 2: Product Transfer Instruction: Transfer feed pump Step Action In the Text Instructions tab, select the Base →SameAsMain instruction of the Block →PROD_TRANSFER_VOLUME block. In the Instruction Box: •...
Page 223 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.4 Phase 2: Product Transfer Progress review The Method Editor window should now look something like this. UniFlux 10 Operating Instructions 28993587 AF...
Page 224: Phase 3: Fed Batch Concentration
B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.5 Phase 3: Fed Batch Concentration B.2.5 Phase 3: Fed Batch Concentration Purpose and structure This phase will start the concentration of the feed. Creating a phase: Fed Batch Concentration Follow the instructions below to create a new phase.
Page 225 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.5 Phase 3: Fed Batch Concentration Step Action To include instructions for the Phase →Fed Batch Concentration phase, select the Text Instructions tab and text edit the method. Note: The Phase Properties tab will show a list of variables used in the phase.
Page 226 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.5 Phase 3: Fed Batch Concentration Step Action Set IntegrityTestValve to Closed, click Insert. Set Retentate_Control_Valve_PCV341 to 100%, click Insert. Set Retentate to Retentate, click Insert. Instructions: Permeate outlets Step Action...
Page 227 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.5 Phase 3: Fed Batch Concentration Nested block: Fed Batch Concentration parameters Step Action In the Text Instructions tab, select the Block →FLOWPATH_CONCEN- TRATION instruction of the Phase →Fed Batch Concentration phase.
Page 228 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.5 Phase 3: Fed Batch Concentration Step Action In the Instruction Box: • Set Breakpoint to 0.00 min. • In the Instructions: list, select Recirc and TransferFeedPump. In the Parameters for field: •...
Page 229 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.5 Phase 3: Fed Batch Concentration Nested block: Stable differential pressure (Delta P) This block ensures that a stable Delta P value is reached. Step Action In the Text Instructions tab, select the Block →PARAMETERS_CONCEN-...
Page 230 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.5 Phase 3: Fed Batch Concentration Step Action In the Instruction Box: • Set Breakpoint to 0.00 min. • In the Instructions: list, select Other and Block. •...
Page 231 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.5 Phase 3: Fed Batch Concentration Instruction: Setting Delta P watch Step Action In the Text Instructions tab, select the Base →SameAsMain instruction of the Block →STABLE_DELTA_P block.
Page 232 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.5 Phase 3: Fed Batch Concentration Step Action In the Instruction Box: • Set Breakpoint to 0.00 min. • In the Instructions: list, select Other and Block. •...
Page 233 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.5 Phase 3: Fed Batch Concentration Step Action In the Parameters for field: • Set Signal to FIT142VTot. • Set Test to Greater_Than. •...
Page 234 B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.5 Phase 3: Fed Batch Concentration If any step appears to be missing, misplaced or carries incorrect values, use the various editing methods available in the Method Editor to correct the errors. UniFlux 10 Operating Instructions 28993587 AF...
Page 235: Saving The Method
B. Create a method with UNICORN 6 and above B.2 An example of using the Method Editor B.2.6 Saving the method B.2.6 Saving the method To save the method, click the discette icon or select File →Save in the menu. UniFlux 10 Operating Instructions 28993587 AF...
Page 236: Appendix C: Evaluation For Unicorn 5
C. Evaluation for UNICORN 5 Appendix C Evaluation for UNICORN 5 Associated documentation This section is only valid for UNICORN 5. There is no corresponding evaluation function for UNICORN 6. The use of the Crossflow Evaluation module in UNICORN 5 is described in detail in the User Reference Manual - UNICORN 5.1 - Evaluation for Cross Flow Filtration.
Page 237 C. Evaluation for UNICORN 5 Main functions Function Usage Any vs any Generates a plot of any combination of process data collected during a run. The process data could be for example detector signals, flows, flux, and pressures. Process Creates a graphical analysis of process optimization run(s). For optimizatio example a process optimization to find an optimal flux as a func- tion of TMP.
Page 238 C. Evaluation for UNICORN 5 Step Action Repeat the procedure until all chromatograms have been selected as groups. The displayed dialog should now look something like this: Click Next to continue the evaluation. Normalized Water Flux Use this function to get normalized Water Flux values calculated. The results can be used to maintain long term analysis of the filter recovery.
Page 239: Appendix D: Pid Control And Feedback Tuning
D. PID control and feedback tuning Appendix D PID control and feedback tuning About this chapter This chapter provides information to enable users to set up a satisfactory control behaviour of the UniFlux 10 by being able to understand and use the PID control func- tions provided by UNICORN.
Page 240: Introduction
D. PID control and feedback tuning D.1 Introduction Introduction Illustration This illustration shows the behaviour of the P, I and D components of a typical PID process control regulator. • Process is the process to be controlled. • Time is elapsed time. •...
Page 241 D. PID control and feedback tuning D.1 Introduction Parameter Meaning Behaviour Usage Integrating Samples the error The I parameter eliminates the stationary over time and rein- error, but results in a slight instability forces the regulator leading to oscillations in the actual flow or output as long as the pressure.
Page 242: Using Pid Control
D. PID control and feedback tuning D.2 Using PID control Using PID control Usage in UNICORN for UniFlux 10 Whenever an automated process step requires the control of pressure (feed, retentate and permeate pressure), the UNICORN control software of UniFlux 10 employs PID- type controllers to control the pressure to its setpoint.
Page 243: More Information
D. PID control and feedback tuning D.3 More information More information Introduction This section describes tuning and adjustments and related troubleshooting. Tuning the PID parameters If tuning of the PID control is required, it is most likely that control settings for feed pump or permeate pump need to be adjusted.
Page 244 D. PID control and feedback tuning D.3 More information Troubleshooting If the Is too... Consequence parameter... Large The system will become unstable. Small The system will respond slow to errors and possibly be unable to eliminate errors completely. Large The system will oscillate after the error has been elimi- nated.
Page 245: Index
Index Index Conductivity probe, test, 131 Conductivity sensor option, 52 Abbreviations, 10 Conductivity sensors, 66 Accessories, 166 Connections, 39, 91 Alarms, 216, 217 power supply, 91 filter pressure, 216 Create a block, 205 TMP alarm, 217 Create a method, 212 Ambient environment, 79 Create a phase, 204 Automation, 38...
Page 246 Index Filter area setting, 214 Mass sensor, feed tank, 68 Filter area, setting in method, 182 Material compliance, 29 Filter cassette holder, 56 Media supply, 79 Filter cassette installation prepa- Membrane area, 216 rations, 104 Meter range and calibration, 111 Filter cassettes, 58 Method, 212, 218, 235 Filter integrity test, 45...
Page 247 Index Repair and calibration, 131 Restart after emergency, 27 Parameters, 207, 208 Retentate, 42 instruction box, 208 Rinsing, 123 method editor, 207 after CIP, 123 Parameters, method editor, 173 Peristaltic pump, 143 troubleshooting, 143 Safety labels, 23 Permeate, 43 Permeate outlets, 219 Safety notices, 8 Permeate pump option, 48 Safety precautions, 12...
Page 248 Index overview, 74 prerequisite, 74 software modules, 75 system networks, 74 Warnings, 77 work flow, 75 Unpacking, 82, 83 procedure, 83 tools required, 82 visual inspection, 83 User allowed actions, 127 UV monitor option, 50 UV sensors, 66 Variables, 208 instruction box, 208 Weights, 147 Wetted materials, 166...
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Page 250 Standard Software End-User License Agreement is available on request. All goods and services are sold subject to the terms and conditions of sale of the supplying company operating within the Cytiva business. A copy of those terms and conditions is available on request. Contact your local Cytiva representative for the most current information.

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