cytiva AKTA ready User manual

ÄKTA ready
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1Introduction ........................................................................................................ 4
1.1 Important user information ....................................................................................................................... 5
1.2 About this manual ......................................................................................................................................... 7
1.3 Associated documentation ....................................................................................................................... 9
1.4 Abbreviations .................................................................................................................................................. 10
2 Safety instructions ............................................................................................. 11
2.1 Safety precautions ........................................................................................................................................ 12
2.2 Labels ................................................................................................................................................................. 16
2.3 Emergency procedures ............................................................................................................................... 18
3 System description ............................................................................................ 21
3.1 Overview ............................................................................................................................................................ 22
3.2 System illustrations ...................................................................................................................................... 23
3.3 System components ..................................................................................................................................... 28
3.3.1 Skid and electrical cabinet ....................................................................................................................... 29
3.3.2 Pumps ............................................................................................................................................................... 30
3.3.3 Valves ................................................................................................................................................................ 31
3.3.4 System transmitters and sensors ......................................................................................................... 33
3.4 Flowchart .......................................................................................................................................................... 34
3.5 Flow kits ............................................................................................................................................................. 36
3.5.1 Flow kit overview ........................................................................................................................................... 37
3.5.2 Flow kit sensors ............................................................................................................................................. 43
3.6 UNICORN control system ........................................................................................................................... 45
4 Installation .......................................................................................................... 47
4.1 Safety precautions ........................................................................................................................................ 48
4.2 Site requirements .......................................................................................................................................... 51
4.3 Included in the delivery ................................................................................................................................ 52
4.4 Unpacking ......................................................................................................................................................... 53
4.4.1 Unpack ÄKTA ready ................................................................................................................................... 54
4.4.2 Unpack the flow kit ....................................................................................................................................... 55
4.5 Transport .......................................................................................................................................................... 56
4.6 Connections ..................................................................................................................................................... 59
4.6.1 Connect power .............................................................................................................................................. 60
4.6.2 Connect compressed air ........................................................................................................................... 61
4.6.3 Connect computer ....................................................................................................................................... 62
4.6.4 Connect equipment to CUSTOMER I/O connector ...................................................................... 63
4.7 Finish installation ........................................................................................................................................... 66
5 Operation ............................................................................................................ 68
5.1 Safety precautions ........................................................................................................................................ 69
5.2 Start the system and log on to UNICORN ............................................................................................ 73
5.3 Install flow kit ................................................................................................................................................... 75
5.3.1 Safety precautions ....................................................................................................................................... 76
5.3.2 Prepare for flow kit installation ............................................................................................................... 77
5.3.3 Create flow kit installation method ....................................................................................................... 80
5.3.4 Install the flow kit for isocratic run ........................................................................................................ 82
Table of Contents
2 ÄKTA ready Operating Instructions 28960345 AE

5.3.5 Install the flow kit for gradient run ........................................................................................................ 100
5.4 Perform a component test ......................................................................................................................... 105
5.4.1 Run a component test ................................................................................................................................ 106
5.4.2 The test report ............................................................................................................................................... 110
5.5 Connect a column .......................................................................................................................................... 111
5.5.1 Install a column ............................................................................................................................................. 112
5.5.2 Run a column efficiency test (optional) ............................................................................................... 120
5.5.3 Rinse a column (optional) .......................................................................................................................... 123
5.6 Set ÄKTA ready specific parameters in Method Editor ................................................................ 124
5.6.1 Set UV stray light calibration ................................................................................................................... 125
5.6.2 Set flow meter fine tuning ......................................................................................................................... 127
5.6.3 Set totalizers ................................................................................................................................................... 128
5.6.4 Set PressureFlowControl ..................................................................................................................... 130
5.7 Run a method .................................................................................................................................................. 133
5.7.1 Prepare before a run ................................................................................................................................... 134
5.7.2 Run a method ................................................................................................................................................. 140
5.8 Controlled shutdown .................................................................................................................................... 143
6 Maintenance ....................................................................................................... 146
6.1 Safety precautions ........................................................................................................................................ 147
6.2 Maintenance schedule ................................................................................................................................ 149
6.3 Maintenance procedures ........................................................................................................................... 150
6.4 Calibration ........................................................................................................................................................ 154
6.4.1 Calibrate sensors .......................................................................................................................................... 155
6.4.2 Calibrate the gradient pump ................................................................................................................... 164
6.5 Cleaning ............................................................................................................................................................ 170
6.6 Storage .............................................................................................................................................................. 172
7 Troubleshooting ................................................................................................. 173
7.1 Troubleshooting the system ..................................................................................................................... 174
7.2 Troubleshooting a failed component test ........................................................................................... 181
8 Reference information ....................................................................................... 183
8.1 Specifications .................................................................................................................................................. 184
8.2 Chemical resistance ..................................................................................................................................... 185
8.3 Environmental requirements .................................................................................................................... 187
8.4 PID control ........................................................................................................................................................ 188
8.5 Recycling information .................................................................................................................................. 190
8.6 Regulatory information ............................................................................................................................... 192
8.6.1 Contact information .................................................................................................................................... 193
8.6.2 European Union and European Economic Area .............................................................................. 194
8.6.3 Eurasian Economic Union
Евразийский экономический союз .................................................................................................. 195
8.6.4 Regulations for North America ............................................................................................................... 197
8.6.5 Regulatory statements .............................................................................................................................. 198
8.6.6 Declaration of Hazardous Substances (DoHS) ................................................................................ 199
8.7 Flow kit ordering information .................................................................................................................... 201
8.8 More information ........................................................................................................................................... 202
8.9 Health and Safety Declaration Form ...................................................................................................... 203
Index ........................................................................................................................... 205
Table of Contents
ÄKTA ready Operating Instructions 28960345 AE 3

1 Introduction
About this chapter
This chapter contains information about this manual and associated user documenta-
tion, important user information, and intended use of the product.
In this chapter
Section See page
1.1 Important user information 5
1.2 About this manual 7
1.3 Associated documentation 9
1.4 Abbreviations 10
1 Introduction
4 ÄKTA ready Operating Instructions 28960345 AE

1.1 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 the product
ÄKTA ready is intended to be operated as an isocratic or gradient, low pressure, auto-
mated liquid chromatography system using corresponding isocratic or gradient flow
kit and ReadyToProcess columns.
ÄKTA ready is controlled by UNICORN software.
The system is based on proven liquid chromatography techniques, such as ion
exchange, affinity chromatography, and hydrophobic interaction.
ÄKTA ready is biocompatible and hygienic, and meets all GLP and cGMP demands for
drug development and manufacturing.
ÄKTA ready is not approved for use in a potentially explosive atmosphere or for
handling flammable liquids.
Flow kits and columns are not included in the system and are ordered separately. See
the Cytiva website for ordering information and lists of available flow kits.
Prerequisites
In order to operate the system in the way it is intended, the following prerequisites
must be fulfilled:
•The user must be acquainted with the use of general bioprocessing equipment and
with handling of biological materials.
•The user must read and understand the Safety Instructions chapter in the Oper-
ating Instructions.
•The user must have a working knowledge of UNICORN software. A user account
must have been created according to the UNICORN Administration and Technical
Manual (29191899).
•The user must have a working knowledge of Microsoft ® Windows ®.
1 Introduction
1.1 Important user information
ÄKTA ready Operating Instructions 28960345 AE 5

•The system must be installed in accordance with the site requirements and instruc-
tions in the Operating Instructions.
1 Introduction
1.1 Important user information
6 ÄKTA ready Operating Instructions 28960345 AE

1.2 About this manual
Purpose of this manual
The ÄKTA™ ready Operating Instructions manual provides you with the information
needed to install, operate and maintain the product in a safe way.
Scope of this manual
This Operating Instructions manual is valid for the ÄKTA ready and
ÄKTA ready gradient systems. Both systems are also referred to as "the products" in
this manual. This manual also describes the isocratic and gradient flow kits used with
the ÄKTA ready and ÄKTA ready gradient systems, respectively.
The illustration below shows ÄKTA ready gradient system (A) and ÄKTA ready system
(B). Both systems are shown with the flow kit, the connected ReadyToProcess™
column, and the column trolley.
A
B
The systems are operated using UNICORN™ version 7.0.2.
Detailed information about columns, chromatography resins and buffer tanks is not
included in this manual.
Typographical conventions
Software items are identified in the text by bold italic text.
1 Introduction
1.2 About this manual
ÄKTA ready Operating Instructions 28960345 AE 7

Hardware items are identified in the text by bold text.
In electronic format, references in italics are clickable hyperlinks.
Text that the user must either type exactly as shown in the manual, or that the software
displays as a response, is shown by a monospaced typeface.
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 About this manual
8 ÄKTA ready Operating Instructions 28960345 AE

1.3 Associated documentation
Related literature
This list describes related literature that can be downloaded or ordered from Cytiva.
Contact your Cytiva representative for more details.
Document name Description Product code
ReadyToProcess columns User Manual User Manual 28925644
ReadyToProcess columns Data file 28915987
Keep your ÄKTA ready operating in peak condition Preventive Mainte-
nance PM Fact Sheet
28998083
Process chromatography: A guide to optimization,
scale-up and validation
Handbook 18112156
Efficiency test of ReadyToProcess columns Application note 28919821
Ready-to-use fluid management solutions for chroma-
tography systems
Application note 28995879
Purification of a monoclonal antibody using ReadyTo-
Process columns
Application note 28919856
Downstream scale-up purification of influenza virus
using ReadyToProcess equipment
Application note 29043549
Connected polishing and concentration under one
automation method
Application note KA985271017AN
1 Introduction
1.3 Associated documentation
ÄKTA ready Operating Instructions 28960345 AE 9

1.4 Abbreviations
Introduction
This section explains abbreviations that are used in the user documentation for
ÄKTA ready.
Abbreviations
Abbreviation Definition (English) Translation (local language)
cGMP Current Good Manufacturing Prac-
tices
Current Good Manufacturing Prac-
tices
CIP Cleaning-in-place Cleaning-in-place
GLP Good laboratory practice Good laboratory practice
HV Manually actuated valve (hand valve) Manually actuated valve (hand valve)
I/O Input/Output Input/Output
PID Proportional integral derivative Proportional integral derivative
rpm Revolutions per minute Revolutions per minute
TC Hygienic tubing connection Hygienic tubing connection
UPS Uninterruptible power supply Uninterruptible power supply
XV Pneumatically actuated valve (auto-
matic valve)
Pneumatically actuated valve (auto-
matic valve)
1 Introduction
1.4 Abbreviations
10 ÄKTA ready Operating Instructions 28960345 AE

2 Safety instructions
About this chapter
This chapter describes safety precautions, labels and symbols that are attached to the
system. In addition, the chapter describes emergency and recovery 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.
In this chapter
Section See page
2.1 Safety precautions 12
2.2 Labels 16
2.3 Emergency procedures 18
2 Safety instructions
ÄKTA ready Operating Instructions 28960345 AE 11

2.1 Safety precautions
Introduction
ÄKTA ready is powered by mains voltage and handles materials that can be hazardous.
Before installing, operating or maintaining the system, you must be aware of the
hazards described in this manual.
The general precautions presented in this chapter must be considered at all times. The
context related precautions are located in their respective chapters.
Definitions
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.
General precautions
WARNING
Do not operate the product in any other way than described in the
user documentation.
2 Safety instructions
2.1 Safety precautions
12 ÄKTA ready Operating Instructions 28960345 AE

WARNING
Risk assessment. Perform a risk assessment for any risks due to
the process or process environment. Evaluate the effects the use of
the product and the operational processes may have on the classi-
fication of the hazardous area. Implement the risk reduction meas-
ures needed, including use of personal protective equipment.
WARNING
The customer must make sure that all installation, maintenance,
operation and inspection is carried out by qualified personnel who
are adequately trained, understand and adhere to local regulations
and the operating instructions, and have a thorough knowledge of
the product and the entire process.
WARNING
Electrical shock hazard. All installation, service and maintenance
of components inside the electronics cabinet must be done by
service personnel authorized by Cytiva. Do not open any covers or
replace parts unless specifically stated in the Operating Instruc-
tions.
WARNING
Protective earth. The product must always be connected to
protective earth when energized.
WARNING
Hazardous voltage. Only personnel authorized by Cytiva may
open the cabinet doors. Hazardous voltage inside the cabinet can
cause human injury or death.
WARNING
The electrical cabinet doors may only be opened when the product
is taken out of operation and subject to LOCK OUT / TAG OUT
(LOTO) (lockout-tagout).
2 Safety instructions
2.1 Safety precautions
ÄKTA ready Operating Instructions 28960345 AE 13

WARNING
Do not use ÄKTA ready if it is not working properly, or if it has
suffered any damage, for example:
•damage to the power cord or its plug
•damage caused by dropping the system
•damage caused by splashing liquid onto it
WARNING
Emergency stop. Pressing the EMERGENCY STOP does not
automatically depressurize the flow path.
WARNING
Emergency stop. Pressing the EMERGENCY STOP does not shut
off mains power to the cabinet.
WARNING
Do not use any accessories not supplied or recommended by
Cytiva.
Personal protection
WARNING
Always use appropriate Personal Protective Equipment (PPE)
during operation and maintenance of this product.
WARNING
Hazardous substances and biological agents. When using
hazardous chemical and biological agents, take all suitable protec-
tive measures, such as wearing protective clothing, glasses and
gloves resistant to the substances used. Follow local and/or
national regulations for safe operation and maintenance of this
product.
2 Safety instructions
2.1 Safety precautions
14 ÄKTA ready Operating Instructions 28960345 AE

WARNING
Personal Protective Equipment (PPE). Whenever packing,
unpacking, transporting or moving the product, wear:
•Protective footwear, preferably with steel toe-cap.
•Working gloves, protecting against sharp edges.
•Protective glasses.
WARNING
Corrosive substance. NaOH is corrosive and therefore dangerous
to health. When using hazardous chemicals, avoid spillage and
wear protective glasses and other suitable Personal Protective
Equipment (PPE).
Flammable liquids and explosive
environment
WARNING
Flammable liquids. This product is not approved for handling
flammable 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.
WARNING
Some of the chemicals used with ÄKTA ready columns may be
flammable under certain conditions. Make sure to use chemicals
only under conditions where they are not flammable. Refer to local
and/or national classifications of flammable liquids.
2 Safety instructions
2.1 Safety precautions
ÄKTA ready Operating Instructions 28960345 AE 15

2.2 Labels
Introduction
This section describes the system label and other safety or regulatory labels that are
attached to the product.
System label
The following symbols and text may be present on the system label.
Symbol/text Description
Code Number The number that identifies the system as
ÄKTA ready.
System Number The unique system installation number.
Manufacturing Year/
Month
Manufacturing year and month.
Supply Voltage Voltage alternatives for ÄKTA ready.
Configured For Voltage the system is currently configured for.
Frequency Supply voltage frequency.
Max Power Consumption Maximum effect of the system.
Pneumatic Supply Pneumatic supply pressure requirement.
Protection Class Protection class. Ingress protection according to IEC
60529.
This symbol indicates that the waste of electrical and
electronic equipment must not be disposed of as
unsorted municipal waste and must be collected
separately. Contact an authorized representative of
the manufacturer for information concerning the
decommissioning of equipment.
Warning! Read the user documentation before
using the system. Do not open any covers or replace
parts unless specifically stated in the user documen-
tation.
Safety labels
The table below describes the various safety labels that can be found on the system.
2 Safety instructions
2.2 Labels
16 ÄKTA ready Operating Instructions 28960345 AE

Symbol/Text Description
Warning! Read the user documentation before using
ÄKTA ready. Do not open any covers or replace parts
unless specifically stated in the user documentation.
Warning! Hazardous voltage. Disconnect power
before servicing. Authorized personnel only.
Warning! Pinch hazard. Never put your fingers or
any objects other than the intended tubing in the
pinch valve openings. Make sure that clothing or other
equipment does not get caught in the pinch valves.
Warning! Rotating rollers/cogwheels. Never touch
the pump or pump lid while the pump is running.
2 Safety instructions
2.2 Labels
ÄKTA ready Operating Instructions 28960345 AE 17

2.3 Emergency procedures
Introduction
This section describes how to shut down the ÄKTA ready system in an emergency
situation, and the procedure for restarting the system.
The section also describes the result in the event of power failure.
Safety precautions
WARNING
Emergency stop. Pressing the EMERGENCY STOP does not shut
off mains power to the cabinet.
WARNING
System pressurized during power failure. The system may
remain pressurized during a power failure, or when the EMER-
GENCY STOP button is pushed. Do not open a line or the vessel to
avoid releasing a hazardous liquid and causing an injury.
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.
Emergency shutdown
In an emergency situation, follow the steps below to stop the run.
2 Safety instructions
2.3 Emergency procedures
18 ÄKTA ready Operating Instructions 28960345 AE

Step Action
1Push the EMERGENCY STOP button on the front of the system cabinet.
Result:
The pump motor stops immediately. The system is set in Pause mode.
2Turn the MAINS POWER switch to the O position to completely turn off
power to the system.
3Release the pressure from all lines and the vessel if you need to open the
connections: press and hold the AIR VENT button to open the air trap valve.
Power failure
The following table describes the consequences of power failure to parts of the system.
Power failure Result
ÄKTA ready cabinet •The pump stops immediately.
•The valves change to their default position.
•The connection to the control software is lost
and UNICORN shows the Connection lost
message.
•The data is temporarily stored in the control unit
CU960.
After the power is restored, the run goes to the End
state. The temporarily stored data is automatically
copied to UNICORN.
2 Safety instructions
2.3 Emergency procedures
ÄKTA ready Operating Instructions 28960345 AE 19

Power failure Result
Computer •The computer and UNICORN shut down.
•The connection between UNICORN and
ÄKTA ready is lost.
•The run continues, and data is temporarily
stored in the control unit CU960.
After the power and the connection are restored,
the temporary data from the control unit CU960 is
automatically copied to UNICORN. The run
continues and can be accessed again through
UNICORN.
Compressed air system •The inlet and outlet valves close.
•All other valves open.
•The pressure is released through the air trap.
Note:
The purification product may be damaged.
Connection to a UPS can enable the system to continue to operate for a limited time. A
UPS is not included with the system. Contact your local Cytiva representative for more
information about the options for your specific system.
Restart after emergency shutdown or
power failure
To restart the system, follow the steps below:
Step Action
1Make sure that the condition that caused the power failure or emergency
stop is corrected.
2Reset the EMERGENCY STOP button by turning it clockwise.
3Click Continue in UNICORN.
2 Safety instructions
2.3 Emergency procedures
20 ÄKTA ready Operating Instructions 28960345 AE