cytiva UniFlux10 User manual

UniFlux10
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1Introduction ........................................................................................................ 5
1.1 About this manual ......................................................................................................................................... 6
1.2 Important user information ....................................................................................................................... 7
1.3 Associated documentation ....................................................................................................................... 9
1.4 Abbreviations .................................................................................................................................................. 10
2 Safety instructions ............................................................................................. 11
2.1 Safety precautions ........................................................................................................................................ 12
2.2 Labels ................................................................................................................................................................. 22
2.3 Emergency procedures ............................................................................................................................... 25
3 System description ............................................................................................ 28
3.1 Configurations ................................................................................................................................................ 29
3.2 Illustrations ...................................................................................................................................................... 30
3.3 Standard components ................................................................................................................................. 35
3.3.1 Structural components .............................................................................................................................. 36
3.3.2 Control system components ................................................................................................................... 38
3.3.3 Connections and drains ............................................................................................................................. 39
3.3.4 Feed pump and feed line ........................................................................................................................... 41
3.3.5 Retentate line ................................................................................................................................................. 42
3.3.6 Permeate line ................................................................................................................................................. 43
3.3.7 Air integrity test device .............................................................................................................................. 45
3.3.8 Feed tank ......................................................................................................................................................... 46
3.4 Optional components .................................................................................................................................. 47
3.4.1 Peristaltic pumps .......................................................................................................................................... 48
3.4.2 Multiple inlets ................................................................................................................................................. 49
3.4.3 UV monitor ...................................................................................................................................................... 50
3.4.4 pH sensor ......................................................................................................................................................... 51
3.4.5 Conductivity sensor ..................................................................................................................................... 52
3.4.6 Feed tank mixer ............................................................................................................................................ 53
3.5 Filter cassette configuration ..................................................................................................................... 54
3.5.1 Filter cassette components ..................................................................................................................... 55
3.5.2 Cassette holder ............................................................................................................................................. 56
3.5.3 Filter cassettes .............................................................................................................................................. 58
3.6 Hollow fiber (HF) configuration ................................................................................................................. 59
3.6.1 UniFlux 10 HF configuration .................................................................................................................... 60
3.6.2 HF cartridges .................................................................................................................................................. 61
3.7 Meters and sensors ....................................................................................................................................... 63
3.7.1 Pressure ............................................................................................................................................................ 64
3.7.2 Flow .................................................................................................................................................................... 65
3.7.3 pH, conductivity and UV ............................................................................................................................. 66
3.7.4 Temperature .................................................................................................................................................. 67
3.7.5 Tank mass balance ...................................................................................................................................... 68
3.7.6 More information .......................................................................................................................................... 69
3.8 Flowchart .......................................................................................................................................................... 70
3.9 UNICORN control system ........................................................................................................................... 74
Table of Contents
2 UniFlux 10 Operating Instructions 28993587 AF

4 Installation .......................................................................................................... 78
4.1 Site requirements .......................................................................................................................................... 79
4.2 Transport .......................................................................................................................................................... 81
4.3 Unpacking ......................................................................................................................................................... 82
4.4 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 ............................................................................................................. 88
4.4.5 Filter setup, feed pump and CFF filter protection ........................................................................... 90
4.5 Power supply .................................................................................................................................................... 91
5 Operation ............................................................................................................ 95
5.1 Prepare the system ....................................................................................................................................... 97
5.1.1 Sample handling ........................................................................................................................................... 98
5.1.2 Start the system and software ................................................................................................................ 101
5.1.3 Install hollow fiber cartridges .................................................................................................................. 103
5.1.4 Install filter cassettes .................................................................................................................................. 104
5.1.5 Testing ............................................................................................................................................................... 105
5.2 Calibrations ...................................................................................................................................................... 108
5.2.1 Preparing mass measuring ...................................................................................................................... 109
5.2.2 Establishing and entering holdup volume ......................................................................................... 110
5.2.3 Meter range and calibration .................................................................................................................... 111
5.3 Perform a run ................................................................................................................................................... 112
5.4 Procedures after usage ............................................................................................................................... 114
6 Maintenance ....................................................................................................... 115
6.1 User maintenance schedule ...................................................................................................................... 117
6.2 Cleaning ............................................................................................................................................................ 119
6.2.1 Important considerations for cleaning ................................................................................................ 121
6.2.2 Cleaning-in-place (CIP) .............................................................................................................................. 123
6.3 Storage .............................................................................................................................................................. 124
6.4 Disassembly and assembly ........................................................................................................................ 127
6.5 pH calibration .................................................................................................................................................. 129
6.6 Repair and calibration .................................................................................................................................. 131
6.7 Change filter type .......................................................................................................................................... 133
7 Troubleshooting ................................................................................................. 138
8 Reference information ....................................................................................... 145
8.1 Specifications .................................................................................................................................................. 146
8.2 Signals ................................................................................................................................................................ 150
8.3 Battery limits ................................................................................................................................................... 151
8.4 Chemical resistance ..................................................................................................................................... 153
8.5 Recycling information .................................................................................................................................. 155
8.6 Regulatory information ............................................................................................................................... 156
8.6.1 Contact information .................................................................................................................................... 157
8.6.2 European Union and European Economic Area .............................................................................. 158
8.6.3 Eurasian Economic Union
Евразийский экономический союз .................................................................................................. 159
Table of Contents
UniFlux 10 Operating Instructions 28993587 AF 3

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
8.7 Further information ...................................................................................................................................... 166
8.8 Health and Safety Declaration Form ...................................................................................................... 167
Appendix A: Create a method with UNICORN 5 ...................................................... 169
A.1 The Method Editor ..................................................................................................................................... 170
A.1.1 Introduction to the Method Editor .................................................................................................... 171
A.1.2 Method Editor layout .............................................................................................................................. 173
A.1.3 Other Method Editor features ............................................................................................................ 175
A.2 An example of using the Method Editor ............................................................................................ 176
A.2.1 Introduction .................................................................................................................................................... 177
A.2.2 Create the method ....................................................................................................................................... 179
A.2.3 Block 1: Initial conditions ........................................................................................................................... 182
A.2.4 Block 2: Product transfer ........................................................................................................................... 185
A.2.5 Block 3: Fed-batch concentration ......................................................................................................... 191
A.2.6 Saving the method ....................................................................................................................................... 201
Appendix B: Create a method with UNICORN 6 and above .................................... 202
B.1 The Method Editor ..................................................................................................................................... 203
B.1.1 Introduction to the Method Editor .................................................................................................... 204
B.1.2 Method Editor layout ............................................................................................................................... 206
B.1.3 Other Method Editor features ............................................................................................................. 208
B.2 An example of using the Method Editor ............................................................................................ 209
B.2.1 Introduction .................................................................................................................................................... 210
B.2.2 Create the method ....................................................................................................................................... 212
B.2.3 Phase 1: Method Settings ......................................................................................................................... 214
B.2.4 Phase 2: Product Transfer ......................................................................................................................... 218
B.2.5 Phase 3: Fed Batch Concentration ........................................................................................................ 224
B.2.6 Saving the method ....................................................................................................................................... 235
Appendix C: Evaluation for UNICORN 5 ................................................................... 236
Appendix D: PID control and feedback tuning ........................................................ 239
D.1 Introduction ..................................................................................................................................................... 240
D.2 Using PID control ........................................................................................................................................... 242
D.3 More information ........................................................................................................................................... 243
Index ........................................................................................................................... 245
Table of Contents
4 UniFlux 10 Operating Instructions 28993587 AF

1 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
1.1 About this manual 6
1.2 Important user information 7
1.3 Associated documentation 9
1.4 Abbreviations 10
1 Introduction
UniFlux 10 Operating Instructions 28993587 AF 5

1.1 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). Classification information for your system is described on the system label.
Typographical conventions
Software items are identified in the text by bold italic text.
Hardware items are identified in the text by bold text.
In electronic format, references in italics are clickable hyperlinks.
1 Introduction
1.1 About this manual
6 UniFlux 10 Operating Instructions 28993587 AF

1.2 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. If you do, you may be exposed to hazards that can lead to personal injury and you
may cause damage to the equipment.
Intended use of UniFlux 10 system
UniFlux 10 system is intended for pilot to production scale biological separations.
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.
UniFlux 10 system shall not be used in any clinical procedures, or for diagnostic
purposes.
UniFlux 10 system shall not be used for operation in a potentially explosive atmosphere
or for handling flammable liquids.
WARNING
Do not operate the product in any other way than described in the
user documentation.
1 Introduction
1.2 Important user information
UniFlux 10 Operating Instructions 28993587 AF 7

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.
•You must have read and understood the Safety chapter of these Operating Instruc-
tions.
•The system must be installed according to the instructions in Chapter 4 Installation,
on page 78.
•You must have a working knowledge of the UNICORN™ software. Refer to the
UNICORN manuals for instructions on the software structure and the work flow.
Safety notices
This user documentation contains safety notices (WARNING, CAUTION, and NOTICE)
concerning the safe use of the product. See definitions below.
WARNING
WARNING indicates a hazardous situation which, if not avoided,
could result in death or serious injury. It is important not to proceed
until all stated conditions are met and clearly understood.
CAUTION
CAUTION indicates a hazardous situation which, if not avoided,
could result in minor or moderate injury. It is important not to
proceed until all stated conditions are met and clearly understood.
NOTICE
NOTICE indicates instructions that must be followed to avoid
damage to the product or other equipment.
Notes and tips
Note: A note is used to indicate information that is important for trouble-free and
optimal use of the product.
Tip: A tip contains useful information that can improve or optimize your proce-
dures.
1 Introduction
1.2 Important user information
8 UniFlux 10 Operating Instructions 28993587 AF

1.3 Associated documentation
System-specific documentation
In addition to the Operating Instructions, the documentation package supplied with
the UniFlux 10 system also includes product documentation binders containing
detailed specifications and traceability documents. The most important documents in
the document package with regard to technical aspects of the UniFlux 10 system are:
Document Abbrevia-
tion
Purpose/Contents
Piping and Instrumen-
tation Diagram
P&ID Schematic overview of the entire
process flow, all components and
instruments and the control system.
General Specification GS Technical data for the system.
Assembly Drawing AD Physical layout. Provides all dimen-
sional data.
Bill of Material BOM Detailed specifications for process
related components.
Declaration of
Conformity
DoC EU declaration of conformity.
Spare Part List SPL List of spare parts available from Cytiva.
Software documentation
Together with each system, the following software documentation is supplied
providing additional information that applies to UniFlux 10 system, independent of the
specific configuration:
Document Purpose/Contents
UNICORN™ manual package •The manuals contain detailed instructions on
how to administer UNICORN, work with
methods, perform runs and evaluate results.
•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.
1 Introduction
1.3 Associated documentation
UniFlux 10 Operating Instructions 28993587 AF 9

1.4 Abbreviations
Introduction
This section explains abbreviations that appear in the user documentation for UniFlux
10.
Abbreviations
Abbrevia-
tion
Definition (English) Translation
EPDM Ethylene Propylene Diene
Monomer
Ethylene Propylene Diene
Monomer
HEPA High Efficiency Particulate Air High Efficiency Particulate Air
PID Proportional Integral Deriva-
tive
A PID controller calculates an
error value as the difference
between a measured process
variable (PV) and a desired
setpoint (SP). The PID
controller attempts to mini-
mize the error by adjusting the
process control inputs (CV).
Proportional Integral Deriva-
tive
A PID controller calculates an
error value as the difference
between a measured process
variable (PV) and a desired
setpoint (SP). The PID
controller attempts to mini-
mize the error by adjusting the
process control inputs (CV).
PLC Programmable logic controller Programmable logic controller
PV Process variable, measured Process variable, measured
SP Setpoint
The target value that an auto-
matic control system, for
example PID controller, will
attempt to reach by adjusting
the process control inputs.
Setpoint
The target value that an auto-
matic control system, for
example PID controller, will
attempt to reach by adjusting
the process control inputs.
TC-clamp Hygienic tubing connection
clamp
Hygienic tubing connection
clamp
UPS Uninterruptible power supply Uninterruptible power supply
1 Introduction
1.4 Abbreviations
10 UniFlux 10 Operating Instructions 28993587 AF