cytiva AKTA pilot 600 User manual

ÄKTA pilot 600
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1Introduction ........................................................................................................ 4
1.1 About this manual ......................................................................................................................................... 5
1.2 Important user information ....................................................................................................................... 6
1.3 Associated documentation ....................................................................................................................... 8
2 Safety instructions ............................................................................................. 11
2.1 Safety precautions ........................................................................................................................................ 12
2.2 Labels ................................................................................................................................................................. 21
2.3 Emergency procedures ............................................................................................................................... 22
3 System description ............................................................................................ 24
3.1 Overview of the ÄKTA pilot 600 system ................................................................................................ 25
3.2 Description of the ÄKTA pilot 600 instrument ................................................................................... 26
3.3 Tubing and connectors ................................................................................................................................ 33
3.4 Available modules for ÄKTA pilot 600 ................................................................................................... 36
3.5 In-line filters ..................................................................................................................................................... 40
3.6 Accessories ...................................................................................................................................................... 42
3.7 Description of the flow path ....................................................................................................................... 46
3.8 UNICORN system control software ........................................................................................................ 48
3.8.1 UNICORN software overview .................................................................................................................. 49
3.8.2 The System Control module ..................................................................................................................... 50
4 Installation .......................................................................................................... 55
4.1 Site preparation .............................................................................................................................................. 56
4.1.1 Delivery, storage and unpacking ........................................................................................................... 57
4.1.2 Room requirements .................................................................................................................................... 59
4.1.3 Site environment .......................................................................................................................................... 62
4.1.4 Power requirements ................................................................................................................................... 64
4.1.5 Computer requirements ........................................................................................................................... 66
4.2 Installing the ÄKTA pilot 600 system ..................................................................................................... 67
4.2.1 Introduction .................................................................................................................................................... 69
4.2.2 Install the instrument and computer ................................................................................................... 70
4.2.3 Fit inlet and outlet tubing .......................................................................................................................... 72
4.2.4 Install the Air Trap ....................................................................................................................................... 79
4.2.5 Install the pump rinsing system ............................................................................................................. 82
4.2.6 Fit the pH electrode ..................................................................................................................................... 84
4.2.7 Install optional external air sensors ..................................................................................................... 88
4.2.8 Install the optional steel filter housing ................................................................................................ 90
4.2.9 Install the optional ULTA filter ................................................................................................................. 94
4.2.10 Install and uninstall optional modules ................................................................................................. 99
4.3 Connecting the system units .................................................................................................................... 106
4.4 Installing UNICORN software ................................................................................................................... 108
4.5 Connecting the ÄKTA pilot 600 instrument to UNICORN software .......................................... 109
4.6 Performance tests ......................................................................................................................................... 114
4.7 Delay volumes ................................................................................................................................................. 115
4.8 Moving the ÄKTA pilot 600 system ......................................................................................................... 117
5 Prepare the system for a run .............................................................................. 120
5.1 Start the instrument and software .......................................................................................................... 121
Table of Contents
2 ÄKTA pilot 600 Operating Instructions 29261688 AC

5.2 Prepare the flow path .................................................................................................................................. 122
5.3 Prepare the pH monitor (optional) .......................................................................................................... 124
5.4 Prime the flow path ....................................................................................................................................... 130
5.5 Fill the air trap and the filter (optional) ................................................................................................... 134
5.6 Connect the columns ................................................................................................................................... 139
6 Perform a run ....................................................................................................... 143
6.1 Before you start .............................................................................................................................................. 144
6.2 Manual operations ........................................................................................................................................ 146
6.3 Sample application ........................................................................................................................................ 147
6.4 Start a method run ........................................................................................................................................ 150
6.5 Monitor the run ............................................................................................................................................... 151
6.6 Procedures after the run ............................................................................................................................ 152
7 Maintenance ....................................................................................................... 154
7.1 Maintenance schedule ................................................................................................................................ 156
7.2 Cleaning procedures .................................................................................................................................... 158
7.2.1 Cleaning before planned service ........................................................................................................... 159
7.2.2 Clean the instrument surfaces ............................................................................................................... 160
7.2.3 Clean the flow path ...................................................................................................................................... 161
7.2.4 Clean and store the pH electrode .......................................................................................................... 163
7.3 Replacement procedures ........................................................................................................................... 165
7.3.1 Change the pump rinsing solution ........................................................................................................ 166
7.3.2 Replace pump rinse tubing ...................................................................................................................... 168
7.3.3 Replace flow path tubing and connectors ......................................................................................... 170
7.3.4 Replace valve membranes ....................................................................................................................... 171
7.3.5 Replace the main fuses .............................................................................................................................. 177
8 Troubleshooting ................................................................................................. 179
9 Reference information ....................................................................................... 182
9.1 System specifications .................................................................................................................................. 183
9.2 Tubing and connectors ................................................................................................................................ 184
9.3 Chemical resistance guide ......................................................................................................................... 185
9.3.1 General information .................................................................................................................................... 186
9.3.2 Chemical resistance specifications ...................................................................................................... 187
9.4 Recycling information .................................................................................................................................. 189
9.5 Regulatory information ............................................................................................................................... 190
9.5.1 Contact information .................................................................................................................................... 191
9.5.2 European Union and European Economic Area .............................................................................. 192
9.5.3 Eurasian Economic Union
Евразийский экономический союз .................................................................................................. 193
9.5.4 Regulations for North America ............................................................................................................... 195
9.5.5 Regulatory statements .............................................................................................................................. 196
9.5.6 Declaration of Hazardous Substances (DoHS) ................................................................................ 197
9.5.7 Other regulations and standards .......................................................................................................... 199
9.6 Health and Safety Declaration Form ...................................................................................................... 200
Index ........................................................................................................................... 202
Table of Contents
ÄKTA pilot 600 Operating Instructions 29261688 AC 3

1 Introduction
About this chapter
This chapter contains important user information, descriptions of safety notices,
intended use of the ÄKTA™ pilot 600 system, and lists of associated documentation.
In this chapter
Section See page
1.1 About this manual 5
1.2 Important user information 6
1.3 Associated documentation 8
1 Introduction
4 ÄKTA pilot 600 Operating Instructions 29261688 AC

1.1 About this manual
Purpose of this manual
The Operating Instruction manual provides information needed to install, operate and
maintain the product in a safe way.
Scope of this manual
The Operating Instructions cover the ÄKTA pilot 600 instrument, optional modules and
accessories. The ÄKTA pilot 600 instrument is controlled by a PC running UNICORN
system control software version 7.3 or higher. For detailed information about the
system control software, see the UNICORN user documentation. For information
about chromatography columns, see the respective user manuals or instructions.
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
ÄKTA pilot 600 Operating Instructions 29261688 AC 5

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 install, operate, or perform maintenance on the product in any other way than
described in the user documentation. If you do, you may be exposed or expose others
to hazards that can lead to personal injury and you may cause damage to the equip-
ment.
Intended use of the product
The ÄKTA pilot 600 system is a low-pressure automated liquid chromatography
system intended for the precision transportation of fluids to and from chromatography
columns of varying sizes.
The system is intended for process development, scale up and scale down of
processes, as well as sanitary production of material for pre-clinical and clinical phases
of applicable scale.
Process engineers, process operators and other trained laboratory personnel are the
intended users of the ÄKTA pilot 600 system.
The ÄKTA pilot 600 system shall not be used in any clinical procedures, or for diag-
nostic purposes.
The ÄKTA pilot 600 system shall not be used in a potentially explosive atmosphere or
for handling flammable liquids.
Prerequisites
In order to follow this manual and use the system in the manner it is intended:
•The user should have a general understanding of how the computer and Microsoft®
Windows® work.
•The user must understand the concepts of liquid chromatography.
•The user must have read and understood the Safety instructions chapter in this
manual.
•The ÄKTA pilot 600 system must have been installed according to the instructions
in Chapter 4 Installation, on page 55.
•A user account must have been created according to the UNICORN™ Administra-
tion and Technical Manual.
1 Introduction
1.2 Important user information
6 ÄKTA pilot 600 Operating Instructions 29261688 AC

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.
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
ÄKTA pilot 600 Operating Instructions 29261688 AC 7

1.3 Associated documentation
Introduction
This section describes the user documentation that is delivered with the product, and
how to find related literature that can be downloaded or ordered from Cytiva.
User documentation for ÄKTA pilot
600
The user documentation listed in the table below. Translations of the Operating
Instructions are provided on the User Documentation CD, together with the User
Manual, Product Documentation, and Unpacking Instructions. Printed copies of the
User Manual are available on request from Cytiva.
Documentation Main contents
ÄKTA pilot 600 Operating Instructions
(this document)
Instructions needed to prepare and
operate the ÄKTA pilot 600 system in a
correct and safe way.
System overview, site requirements,
and instructions for moving the system
within the same building.
Instructions for basic maintenance and
troubleshooting.
ÄKTA pilot 600 User Manual Additional information in order to get
the optimal performance from the
system.
Functional description of modules.
Instructions for maintenance and trou-
bleshooting activities.
ÄKTA pilot 600 Site Preparation Guide Information needed to prepare the site
for installation and use of the ÄKTA pilot
600 system.
ÄKTA pilot 600 Unpacking Instructions Instructions for handling the delivery
package and unpacking the ÄKTA pilot
600 system.
ÄKTA pilot 600S Product Documenta-
tion
Specifications and material conformity.
1 Introduction
1.3 Associated documentation
8 ÄKTA pilot 600 Operating Instructions 29261688 AC

Product Documentation binders
(Regulatory version only)
In addition to the user documentation, the documentation package supplied with
ÄKTA pilot 600R (Regulatory) systems also includes Product Documentation binders
containing detailed specifications and traceability documents, specific to each indi-
vidual system.
For more information about the ÄKTA pilot 600R instrument, see Standard and Regu-
latory versions of the instrument, on page 26.
The following table provides some examples of documents that can be found in the
Product Documentation package delivered with ÄKTA pilot 600R.
Document Abbrevia-
tion
Purpose/Contents
Piping and Instrumenta-
tion Diagram
P&ID Schematic overview of the process flow,
components and instruments and the
control system.
General Specification GS Technical data for the system.
Assembly Drawing AD Physical layout. Provides dimensional
data.
Bill of Material BOM Description of process-related compo-
nents, including wetted materials and
specifications.
Declaration of
Conformity
DoC Declaration of Conformity for EU and/or
other regions.
Spare Part List SPL List of spare parts available from Cytiva.
UNICORN documentation
The UNICORN documentation is listed in the following table. The documents are avail-
able in the UNICORN Online Help and Documentation section of the online help
(see Online help, on page 10).
Documentation Main contents
Getting started with
Evaluation (accessed
through the online help in
the UNICORN Evaluation
module)
•Video clips showing common workflows in the
Evaluation module.
•Overview of features of the Evaluation module.
UNICORN Method Manual 1•Overview and detailed descriptions of the
method creation features in UNICORN.
•Workflow descriptions for common operations.
1 Introduction
1.3 Associated documentation
ÄKTA pilot 600 Operating Instructions 29261688 AC 9

Documentation Main contents
UNICORN Administration
and Technical Manual 1•Overview and detailed description of network
setup and complete software installation.
•Administration of UNICORN and the UNICORN
database.
UNICORN Evaluation
Manual 1•Overview and detailed descriptions of the
Evaluation Classic module in UNICORN.
•Description of the evaluation algorithms used in
UNICORN.
UNICORN System Control
Manual 1•Overview and detailed description of the system
control features in UNICORN.
•Includes general operation, system settings and
instructions on how to perform a run.
UNICORN OPC User Manual Instructions for setting up and using the UNICORN
OPC server.
1Current UNICORN version is added to the title of the manual.
Online help
To access online help in any module in UNICORN software, use the Help menu or press
the F1 key on the keyboard. Help is displayed for the currently active pane or dialog
box.
User documentation and other
literature on the web
User documentation and other literature related to ÄKTA pilot 600 system may be
downloaded from the web. Follow the steps below to access the documentation.
Step Action
1Go to cytiva.com/aktapilot.
2Navigate to RELATED DOCUMENTS.
3Select the type of document and download the chosen literature.
1 Introduction
1.3 Associated documentation
10 ÄKTA pilot 600 Operating Instructions 29261688 AC

2 Safety instructions
About this chapter
This chapter describes safety precautions, labels and symbols that are attached to the
equipment. 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 21
2.3 Emergency procedures 22
2 Safety instructions
ÄKTA pilot 600 Operating Instructions 29261688 AC 11

2.1 Safety precautions
Introduction
ÄKTA pilot 600 is powered by mains voltage and handles materials that can be consid-
ered hazardous. Before installing, operating or maintaining the system, you must be
aware of the hazards described in this manual.
Follow the instructions provided to avoid injury to the operator or other
personnel, damage to samples or other substances handled by the equipment,
to the product, or to other equipment in the area.
The safety precautions in this section are grouped in the following categories:
•General precautions
•Personal protection
•Flammable liquids and explosive environment
•Installing and moving the product
•Power supply
•Operation
•Maintenance
•Decommissioning
General precautions
WARNING
Do not operate the product in any other way than described in the
ÄKTA pilot 600 user documentation.
WARNING
Only properly trained personnel may operate and maintain the
product.
WARNING
Accessories. Use only accessories supplied or recommended by
Cytiva.
2 Safety instructions
2.1 Safety precautions
12 ÄKTA pilot 600 Operating Instructions 29261688 AC

WARNING
Do not use the product 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 equipment
•damage caused by splashing liquid onto it
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.
WARNING
Spread of biological agents. The operator must take all neces-
sary actions to avoid spreading hazardous biological agents. The
facility must comply with the national code of practice for
biosafety.
WARNING
High pressure. The product operates under high pressure. Wear
protective glasses and other required Personal Protective Equip-
ment (PPE) at all times.
2 Safety instructions
2.1 Safety precautions
ÄKTA pilot 600 Operating Instructions 29261688 AC 13

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.
Installing and moving the product
WARNING
Heavy object. Use suitable lifting equipment when moving the
instrument. Four people are required to lift the system safely. All
lifting and moving must be performed in accordance with local
regulations.
WARNING
Access to power plug. Do not block access to the power outlet
and power plug. The power cord with plug must always be easy to
disconnect.
WARNING
When moving the instrument for maintenance or other purposes,
disconnect all cables from wall sockets and separate equipment so
that the cables do not pull on the instrument or equipment.
WARNING
Remove any column with associated tubing, bottles, and inlet,
outlet and waste tubing before moving the instrument.
2 Safety instructions
2.1 Safety precautions
14 ÄKTA pilot 600 Operating Instructions 29261688 AC

CAUTION
Tipping risk. Before moving the instrument on a trolley, secure the
instrument using straps with a minimum strength of 100 kg.
CAUTION
pH electrode. Handle the pH electrode with care. The glass tip
may break and cause injury.
CAUTION
The product is filled with 20% ethanol at delivery. The alcohol can
be hazardous to humans if consumed. Flush out the alcohol
before assembling, testing or integrating the product into the
intended process context.
CAUTION
Installing the computer. The computer must be installed and
used according to the instructions provided by the manufacturer of
the computer.
CAUTION
When installing additional modules, make sure that the modules
are correctly mounted and sealed against the front of the instru-
ment. Incorrect mounting can cause leakage of liquid in to the
instrument electronics.
CAUTION
If the product is installed on a trolley, keep the trolley wheels locked
at all times except when moving the product.
Power supply
WARNING
Power cord. Only use power cords with approved plugs delivered
or approved by Cytiva.
2 Safety instructions
2.1 Safety precautions
ÄKTA pilot 600 Operating Instructions 29261688 AC 15

WARNING
Protective ground. The product must always be connected to a
grounded power outlet.
WARNING
For continued protection from fire hazard, replace only with same
type and rating of fuse.
Operation
WARNING
Before use, check that the column is not damaged or otherwise
defective. Damaged or defective columns might leak or rupture.
WARNING
Before connecting a column, read the instructions for use of the
column.
WARNING
High pressure. The flow rate may under no circumstances exceed
the specified column maximum flow rate. High flows might affect
the packed resin, causing the pressure to exceed the specified
column maximum pressure.
WARNING
To avoid exposing system components to excessive pressure,
make sure that the system pressure limit is set at or below the
specified maximum pressure for the component with the lowest
pressure limit (including in-line filters, which often have lower pres-
sure tolerance than other system components).
WARNING
When ULTA filters are used, the system pressure alarm must be set
to a maximum of 5 bar in the UNICORN software System
Settings.
2 Safety instructions
2.1 Safety precautions
16 ÄKTA pilot 600 Operating Instructions 29261688 AC

WARNING
Overpressure. Never block the outlet tubing with, for instance,
stop plugs, since this will create overpressure and might result in
injury.
CAUTION
The flow path may remain pressurized while a run is paused. Do not
loosen any connections.
CAUTION
Do not place items such as buffer bottles on top of the instrument.
CAUTION
Avoid spillage and overflow. Make sure that the waste tubing is
inserted in an appropriate waste container and secured in place.
CAUTION
Make sure that the waste container is dimensioned for maximum
possible volume when the equipment is left unattended.
CAUTION
Secure all outlet tubing carefully so that it remains in the container
even when high flow rates cause vibrations in the tubing.
CAUTION
Do not use a Superloop without its protective jacket. The Superloop
may crack if exposed to overpressure.
2 Safety instructions
2.1 Safety precautions
ÄKTA pilot 600 Operating Instructions 29261688 AC 17

Maintenance
WARNING
Electrical shock hazard. All repairs should be done by service
personnel authorized by Cytiva. Do not open any covers or replace
parts unless specifically stated in the user documentation.
WARNING
Disconnect power. Always disconnect power from the instru-
ment before replacing any component on the instrument, unless
stated otherwise in the user documentation.
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
tubes or potentially explosive atmosphere, the user must test the
tubing system for leakage at maximum operating pressure.
Always perform a leakage test using distilled water after assembly
or maintenance.
WARNING
Hazardous chemicals during run. When using hazardous chemi-
cals, flush the entire system tubing with distilled water, before
service and maintenance.
WARNING
Hazardous chemicals. Always empty the system of liquids before
service.
2 Safety instructions
2.1 Safety precautions
18 ÄKTA pilot 600 Operating Instructions 29261688 AC

WARNING
Decontaminate before maintenance. To avoid exposing
personnel to potentially hazardous substances, clean and sanitize
the ÄKTA pilot 600 system before maintenance or service.
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).
WARNING
If a fuse requires repeated replacement, do not continue to use the
instrument. Contact an authorized service engineer.
WARNING
Avoid leakage. When replacing the filter cassette, make sure that
the cassette is correctly fitted.
CAUTION
Sharp tool. The tubing cutter is very sharp and can cause injuries if
it is not handled with care.
CAUTION
The system uses high intensity ultra-violet light that is harmful to
the eyes. Before changing or cleaning the UV detector, make sure
that the UV lamp is switched off or that the power is disconnected.
Decommissioning
WARNING
Decommissioning. Decontaminate the equipment before
decommissioning to make sure that hazardous residues are
removed.
2 Safety instructions
2.1 Safety precautions
ÄKTA pilot 600 Operating Instructions 29261688 AC 19

CAUTION
Always use appropriate personal protective equipment when
decommissioning the equipment.
2 Safety instructions
2.1 Safety precautions
20 ÄKTA pilot 600 Operating Instructions 29261688 AC