cytiva OligoPilot 400 User manual

OligoPilot 400
Operating Instructions
Original instructions
Translation disc included
cytiva.com

Table of Contents
1 Introduction ........................................................................................................ 4
1.1 Important user information ....................................................................................................................... 5
1.2 About this manual ......................................................................................................................................... 7
1.3 Associated documentation ....................................................................................................................... 8
2 Safety instructions ............................................................................................. 10
2.1 Safety precautions ........................................................................................................................................ 11
2.2 Labels ................................................................................................................................................................. 23
2.3 Emergency procedures ............................................................................................................................... 27
3 System description ............................................................................................ 32
3.1 Overview ............................................................................................................................................................ 33
3.2 Illustrations of OligoPilot 400 .................................................................................................................. 34
3.3 System components ..................................................................................................................................... 42
3.3.1 Cabinet purging system ............................................................................................................................ 43
3.3.2 System pumps ............................................................................................................................................... 45
3.3.3 Meters and sensors ..................................................................................................................................... 48
3.3.4 Valves ................................................................................................................................................................ 52
3.3.5 Tubing ................................................................................................................................................................ 53
3.3.6 Cooler ................................................................................................................................................................ 54
3.3.7 Power and communication connections ............................................................................................ 55
3.3.8 Inert gas delivery system ......................................................................................................................... 58
3.4 Containers for reagents and solvents .................................................................................................... 60
3.5 Columns ............................................................................................................................................................ 61
3.6 Flowchart .......................................................................................................................................................... 62
3.7 UNICORN control system .......................................................................................................................... 64
4 Installation .......................................................................................................... 65
4.1 Unpacking and transport ............................................................................................................................ 68
4.2 Setup ................................................................................................................................................................... 70
4.3 Installation procedure ................................................................................................................................. 73
5 Operation ............................................................................................................ 77
5.1 Prepare the system ....................................................................................................................................... 79
5.2 Column packing procedure ....................................................................................................................... 85
5.3 Perform a run ................................................................................................................................................... 90
5.4 Procedures after a run ................................................................................................................................. 92
5.4.1 Unpack the column ...................................................................................................................................... 93
5.4.2 Procedures after a run ................................................................................................................................ 96
6 Maintenance ....................................................................................................... 97
6.1 User maintenance schedule ...................................................................................................................... 101
6.2 Component maintenance .......................................................................................................................... 103
6.2.1 Pumps ............................................................................................................................................................... 104
6.2.2 Membrane valve block ............................................................................................................................... 113
6.2.3 PCV valve ......................................................................................................................................................... 117
6.3 Cleaning ............................................................................................................................................................ 118
Table of Contents
2 OligoPilot 400 Operating Instructions 28960368 AH

6.4 Storage .............................................................................................................................................................. 119
7 Troubleshooting ................................................................................................. 120
8 Reference information ...................................................................................... 126
8.1 Specifications .................................................................................................................................................. 127
8.2 Chemical resistance ..................................................................................................................................... 129
8.3 Recommended reagents ............................................................................................................................ 133
8.4 Recycling information .................................................................................................................................. 134
8.5 Regulatory information ............................................................................................................................... 135
8.5.1 Contact information .................................................................................................................................... 136
8.5.2 European Union and European Economic Area .............................................................................. 137
8.5.3 Eurasian Economic Union
Евразийский экономический союз .................................................................................................. 138
8.5.4 Regulations for North America ............................................................................................................... 140
8.5.5 Regulatory statements .............................................................................................................................. 141
8.5.6 Declaration of Hazardous Substances (DoHS) ................................................................................ 142
8.5.7 Notification - products containing mercury ...................................................................................... 144
8.5.8 Other regulations and standards .......................................................................................................... 145
8.6 Health and Safety Declaration Form ...................................................................................................... 147
Index ........................................................................................................................... 149
Table of Contents
OligoPilot 400 Operating Instructions 28960368 AH 3

1 Introduction
About this chapter
This chapter contains important user information, descriptions of safety notices,
intended use of OligoPilot™ 400, and lists of associated documentation.
In this chapter
Section See page
1.1 Important user information 5
1.2 About this manual 7
1.3 Associated documentation 8
1 Introduction
4 OligoPilot 400 Operating Instructions 28960368 AH

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 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 OligoPilot 400
OligoPilot 400 is intended for process development, small and pilot scale production of
DNA and RNA oligonucleotides.
OligoPilot 400 shall not be used in any clinical procedures, or for diagnostic purposes.
WARNING
Do not operate the product in any other way than described in the
user documentation.
Prerequisites
In order to operate OligoPilot 400 safely and according to the intended purpose, the
following prerequisites must be met:
•The user should be acquainted with the use of bioprocessing equipment and
handling of biological materials.
•The user should have a general understanding of the basic concepts of automated
nucleotide synthesis, solvents and chemicals.
•The user must read and understand the Safety Instructions chapter in the Oper-
ating Instructions.
•OligoPilot 400 must be installed according to the instructions in Chapter 4 Installa-
tion, on page 65.
•A working knowledge of UNICORN™ software is required. Refer to the UNICORN
manual package.
1 Introduction
1.1 Important user information
OligoPilot 400 Operating Instructions 28960368 AH 5

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
1.1 Important user information
6 OligoPilot 400 Operating Instructions 28960368 AH

1.2 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
This Operating Instruction manual is valid for OligoPilot 400.
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
1.2 About this manual
OligoPilot 400 Operating Instructions 28960368 AH 7

1.3 Associated documentation
System documentation
In addition to the Operating Instructions, the documentation package supplied with
OligoPilot 400 also includes detailed specifications and traceability documents.
The following table provides examples of technical specification documents that can
be found in the documentation package delivered with the product.
Document Document
(transla-
tion into
local
language)
Abbrevi-
ation
Purpose/Contents
Piping and Instru-
mentation
Diagram
PID Schematic overview of the
process flow, components and
instruments and the control
system.
General Specifica-
tion
GS Technical data for the system.
Assembly Drawing AD Physical layout. Provides
dimensional data.
Bill of Material BOM Description of process-related
components, including wetted
materials and specifications.
Declaration of
Conformity
DoC EU Declaration of Conformity.
Spare Part List SPL List of spare parts available
from Cytiva.
Software Revision
Document Oligo-
Pilot 400 1
SRD Describes the Strategy revision
history and the included files
for Strategy OligoPilot
400_110, or later versions.
Software Configu-
ration Description
OligoPilot 4001
SCD Describes the content and
configuration of the strategy
Strategy OligoPilot 400_110, or
later versions.
1Included on Strategy CD
1 Introduction
1.3 Associated documentation
8 OligoPilot 400 Operating Instructions 28960368 AH

Software documentation
Together with each system, the following software documentation is supplied
providing additional information that applies to OligoPilot 400, 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 documentation package.
1 Introduction
1.3 Associated documentation
OligoPilot 400 Operating Instructions 28960368 AH 9

2 Safety instructions
About this chapter
This chapter describes safety precautions, labels and symbols that are attached to
OligoPilot 400. In addition, the chapter describes emergency and recovery procedures.
In this chapter
Section See page
2.1 Safety precautions 11
2.2 Labels 23
2.3 Emergency procedures 27
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.
2 Safety instructions
10 OligoPilot 400 Operating Instructions 28960368 AH

2.1 Safety precautions
Introduction
The safety precautions in this section are grouped in the following categories:
•General precautions, on page 11
•Flammable liquids and explosive environment, on page 13
•Personal protection, on page 14
•Installing and moving, on page 15
•Power supply, on page 17
•System operation, on page 18
•Maintenance, on page 20
General precautions
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. The process might cause the area to
increase or the zone classification to change. Implement the risk
reduction measures 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
Do not operate the product in any other way than described in the
user documentation.
2 Safety instructions
2.1 Safety precautions
OligoPilot 400 Operating Instructions 28960368 AH 11

WARNING
Only properly trained personnel may operate and maintain the
product.
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
WARNING
Emergency shutdown may result in high pressures remaining in
the system flow path.
WARNING
Before connecting a column, read the instructions for use of the
column. To avoid exposing the column to excessive pressure, make
sure that the pressure limit is set to the specified maximum pres-
sure for the column.
WARNING
Accessories. Use only accessories supplied or recommended by
Cytiva.
CAUTION
Waste tubes and containers must be secured and sealed to
prevent accidental spillage.
2 Safety instructions
2.1 Safety precautions
12 OligoPilot 400 Operating Instructions 28960368 AH

Flammable liquids and explosive
environment
WARNING
Explosion hazard: Avoid discharge from static electricity when
working in potentially explosive atmospheres by:
•Always using suitable clothing.
•Making sure that the entire system including the frame, piping
and column are connected to the plant grounding network.
•Using only non-sparking tools rated for explosive atmospheres.
•Always using antistatic cleaning cloths.
WARNING
Explosion hazard. The product uses potentially explosive liquids.
Consult local authorities regarding local rules and regulations
before installing or operating.
WARNING
Explosion hazard: After close down of the system, make sure that
the rear door is closed until the temperature of the components
has decreased and reached a level of the temperature class of the
system.
WARNING
Explosion hazard: Make sure that the power to the process
system is turned off when packing and connecting the column.
WARNING
Explosion hazard: Service or Maintenance of OligoPilot 400 must
be performed in a non-classified area.
2 Safety instructions
2.1 Safety precautions
OligoPilot 400 Operating Instructions 28960368 AH 13

WARNING
Explosion hazard: Avoid discharge from static electricity in
potentially explosive atmospheres. All fluids used in the system
must have a conductivity higher than 50 pS/cm. For example, 100%
toluene may not be used.
WARNING
Explosion hazard: Make sure that the local safety system at the
plant for shutting off the external media supply (acetonitrile, etc.) is
functioning.
WARNING
Explosion hazard: Only use inert gas when flushing solvents out
of the system, and before filling the system with solvents. Other-
wise, air might enter the flow path and create an explosive atmos-
phere when mixed with the vaporized solvent.
Personal protection
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
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 OligoPilot 400 Operating Instructions 28960368 AH

WARNING
OligoPilot 400 operates under high pressure. Wear protective
glasses and other required Personal Protective Equipment (PPE) at
all times.
WARNING
Always use appropriate Personal Protective Equipment (PPE)
during operation and maintenance of this product.
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.
WARNING
Heavy object. The crate ramp is not reinforced in the center. Do
not use a pallet lifter or forklift on the ramp
WARNING
System lifting. OligoPilot 400 shall only be lifted using the lower
part of the supporting frame. OligoPilot 400 is not equipped with
lifting eyebolts or telphers for hoist lift.
WARNING
Heavy object. When rolling the system down the ramp take great
care to avoid the wheels slipping off the edge of the ramp.
2 Safety instructions
2.1 Safety precautions
OligoPilot 400 Operating Instructions 28960368 AH 15

WARNING
Do not block access to the EMERGENCY STOP buttons. They must
always be easy to access.
WARNING
At least two persons are required for moving the system.
CAUTION
Make sure that all tubing, hoses and cables are placed so that the
risk of tripping accidents is minimized.
CAUTION
The product may be partly filled with denatured alcohol (18%
C2H5OH (ethanol), 2% C3H7OH (isopropanol) and 80% H2O (water))
at delivery.
The denatured alcohol mixture can be hazardous to humans
if consumed.
Flush out the denatured alcohol before assembling, testing or inte-
grating the product into the intended process context.
CAUTION
The product is designed for indoor use only.
CAUTION
Packing crates may have been exposed to pesticides, depending
on the regulations of the country of delivery. Recycle packing
crates according to local recommendations for pesticide-treated
wood.
2 Safety instructions
2.1 Safety precautions
16 OligoPilot 400 Operating Instructions 28960368 AH

Power supply
WARNING
OligoPilot 400 must always be connected to a grounded power
outlet.
WARNING
Before connecting the power cord make sure that the supply
voltage at the wall outlet corresponds to the marking on the equip-
ment.
WARNING
Disconnect power. Always disconnect power from the instru-
ment before replacing fuses.
WARNING
For continued protection from fire hazard, replace only with same
type and rating of fuse.
WARNING
Access to power switch and power cord. The power switch
must always be easy to access. The power cord must always be
easy to disconnect.
WARNING
Emergency stop. Pressing the EMERGENCY STOP button does
not shut off mains power to the instrument.
2 Safety instructions
2.1 Safety precautions
OligoPilot 400 Operating Instructions 28960368 AH 17

WARNING
Power failure. During a power failure, or if the EMERGENCY STOP
button is pressed, the system may remain pressurized. Opening a
line or vessel at this point could result in the release of potentially
hazardous process or cleaning fluid, and cause bodily harm. When
recovering from a power failure or emergency shutdown, make
sure all lines and vessels are depressurized before opening.
CAUTION
Do not use an external Uninterruptible Power Supply (UPS) outside
the range 100 to 240 V. For UL marked systems, do not use a UPS
supply exceeding 120 V.
CAUTION
Connection of an external UPS 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
Before starting to use the system, make sure that there are no
unintentional leakages in the system or in connections to it.
WARNING
Before beginning operation or maintenance a solvent-resistant
waste container must be connected to the system.
2 Safety instructions
2.1 Safety precautions
18 OligoPilot 400 Operating Instructions 28960368 AH

WARNING
Incorrectly fitted tubing might loosen, causing a jet of liquid to
spray out. This is especially dangerous if hazardous chemicals are
in use. Connect the tubing by first inserting the tubing fully, then
tightening the connector fingertight. Do not tighten ETFE
(ethylene-tetrafluoroethylene) tubing further as this will damage
the end of the tubing. If a leakage occurs, immediately switch off
the system before taking care of the leakage.
WARNING
Monitor UV-900 uses high intensity ultra-violet light. Do not
disconnect the optical fibres while the lamp is on.
WARNING
Never place solvent containers on top of the valve door. If this is
done, containers may fall down when the valve door is opened.
WARNING
Only use columns that withstand expected pressures. If not, the
column might rupture, resulting in injury.
WARNING
The flow rate may under no circumstances exceed the specified
maximum flow rate of the column. High flows might affect the
packed medium, causing the pressure to exceed the specified
maximum pressure of the column.
WARNING
Never block the waste outlet, for instance with stop plugs, since
this will create over-pressure and might result in injury.
CAUTION
Make sure that waste containers are dimensioned for maximum
possible volume when the instrument is left unattended.
2 Safety instructions
2.1 Safety precautions
OligoPilot 400 Operating Instructions 28960368 AH 19

CAUTION
Always make sure that the column media, columns and system
components are compatible with reagents and solvents at the
concentration, time, and temperatures used.
Maintenance
WARNING
Do not perform any type of maintenance work while the system is
powered electrically or when the piping system is pressurized. Note
that the piping system can be pressurized even when the system is
closed down.
WARNING
Decontaminate before maintenance. To avoid personnel being
exposed to potentially hazardous substances, make sure that the
OligoPilot 400 is properly decontaminated and sanitized before
maintenance or service.
WARNING
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
Always disconnect power from OligoPilot 400 before performing
any maintenance task.
WARNING
Hazardous chemicals during maintenance. When using
hazardous chemicals for system or column cleaning, wash the
system with acetonitrile and drain or dry the lines.
2 Safety instructions
2.1 Safety precautions
20 OligoPilot 400 Operating Instructions 28960368 AH