GE FineLINE 35 oligo User manual

GE Healthcare
Operating Instructions
Original instructions
FineLINE™ 35 oligo column

FineLINE 35 oligo column Operating Instructions 28-9649-57 AA 3
Table of Contents
Table of Contents
1 Introduction .............................................................................. 5
1.1 Important user information ................................................................................. 6
1.2 Regulatory information .........................................................................................7
1.3 Column description ................................................................................................. 9
2 Safety instructions................................................................. 11
2.1 Safety precautions ............................................................................................... 11
2.2 Labels .......................................................................................................................... 15
2.3 Recycling procedures .......................................................................................... 15
3 Installation .............................................................................. 17
4 Operation ................................................................................ 19
4.1 Packing the column ............................................................................................. 20
4.2 Unpacking the column ....................................................................................... 22
4.3 Recommended operating conditions .......................................................... 23
4.4 Scaling up ................................................................................................................. 24
5 Maintenance ........................................................................... 25
5.1 User maintenance schedule ............................................................................ 26
5.2 Cleaning ..................................................................................................................... 26
5.3 Storage ....................................................................................................................... 26
5.4 Disassembly and assembly .............................................................................. 27
5.5 Component maintenance ................................................................................. 30
6 Troubleshooting ..................................................................... 33
7 Reference information .......................................................... 35
7.1 Specifications .......................................................................................................... 35
7.2 Chemical resistance ............................................................................................. 36
7.3 Service and training ............................................................................................ 37
7.4 Ordering information ........................................................................................... 38
7.5 Material abbreviations ........................................................................................ 40
Appendix A Health and Safety Declaration/Liability Form .. 41

Table of Contents
4FineLINE 35 oligo column Operating Instructions 28-9649-57 AA

FineLINE 35 oligo column Operating Instructions 28-9649-57 AA 5
Introduction 1
1 Introduction
Purpose of the Operating
Instructions
This Operating Instructions describes the specifications and characteristics of FineLINE
35 oligo column. It also describes procedures for packing, operation, maintenance and
troubleshooting in a safe way.
Prerequisites
In order to operate FineLINE 35 oligo column safely and according to the intended
purpose the following prerequisites must be met:
• You should be acquainted with the use of general laboratory equipment and with
handling of biological materials.
• You must read Chapter 2 Safety instructions‚ on page 11 of these Operating
Instructions.
• The system should be installed according to the instructions in Chapter 3 of these
Operating Instructions.
In this chapter
This chapter contains important user information and a general description of FineLINE
35 oligo column and its intended use.

1 Introduction
1.1 Important user information
6FineLINE 35 oligo column Operating Instructions 28-9649-57 AA
1.1 Important user information
Read this before using FineLINE
35 oligo column
All users must read the Safety Instructions in Chapter 2of these Operating Instructions
before installing, using or maintaining the column.
Do not operate FineLINE 35 oligo column in any other way than described in the user
documentation. 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
FineLINE 35 oligo column is intended for method development at pilot scale or small
scale production of oligonucleotides.
FineLINE 35 oligo column must not be used for any other purpose.
Safety notices
These Operating Instructions contain WARNINGS, CAUTIONS and NOTICES concerning
the use of the product, with meanings as defined 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.

FineLINE 35 oligo column Operating Instructions 28-9649-57 AA 7
Introduction 1
Regulatory information 1.2
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 procedures.
Typographical conventions
Software texts and commands are identified by bold italic text. A colon is used to
separate menu levels (e.g. File:Open refers to the Open option in the File menu).
1.2 Regulatory information
This section lists the directives and standards that are fulfilled by FineLINE 35 oligo
column.
Manufacturing information
CE Conformity
International standards
Requirement Content
Name and address of manufacturer GE Healthcare Bio-Sciences AB,
Björkgatan 30, SE 751 84 Uppsala
Sweden
Place and date of declaration Uppsala, Sweden, May 2009
Identity of person authorized to sign DoC See EC Declaration of Conformity
Directive Title
2006/42/EC Machinery Directive (MD)
Standard Description Notes
EN-ISO
12100-1, 12100-2
Safety of machinery – Basic concepts,
general principles and design
Harmonized with
2006/42/EC
EN-ISO
14121-1, 14121-2
Safety of machinery – Principles of
risk assessment
Harmonized with
2006/42/EC

1 Introduction
1.2 Regulatory information
8FineLINE 35 oligo column Operating Instructions 28-9649-57 AA
CE marking
The CE marking and the corresponding Declaration of Conformity is valid for the
instrument when it is:
• used as a stand-alone unit, or
• connected to other CE-marked instruments, or
• connected to other products recommended or described in the user
documentation, and
• used in the same state as it was delivered from GE Healthcare, except for
alterations described in the user documentation or explicitly authorized by GE
Healthcare.
Regulatory compliance of
connected equipment
Any equipment connected to FineLINE 35 oligo column should meet the safety
requirements of relevant harmonized standards. Within the European Union, connected
equipment must be CE-marked.

FineLINE 35 oligo column Operating Instructions 28-9649-57 AA 9
Introduction 1
Column description 1.3
1.3 Column description
Usage
FineLINE 35 oligo column is intended for method development at pilot scale or small
scale production of oligonucleotides.
It is designed for maximum scalability and coupling efficiency using Primer Support™
200. The column is easy to operate.
Design
The FineLINE 35 oligo column design incorporates a number of features.
The FineLINE 35 oligo column has a simple design. It comprises a number of complete
units, including a hydraulically or manually adjustable adapter and special nets in the
end-piece and adapter, which are easily assembled together.
The column tube is held in place between the top end-piece and bottom end-piece by
three support rods.
The top endpiece houses the hydraulically adjustable adapter. The adapter contains a
filter unit with a stainless steel (316L) filter.
The adapter is held in place by a mechanical locking unit on the adapter piston. The
adapter lid is secured to the top end-piece with a bayonet fitting. O-rings seal the lid
against the adapter rod and top end-piece. The adapter is sealed against the column
with two O-rings.
The bottom end-piece contains the bottom filter unit and stainless steel (316L) filter and
an O-ring seals the unit against the column tube.
Part Description
1 Column top connection
2 Adapter shaft
3 Mechanical locking unit
4 Bayonet adapter lid lock
5 Column top lid
6Connectingrod
7 Column tube
8 Adapter filter unit
9 Bottom filter unit
10 Bottom lid with bottom
connection
11 Hydraulic chamber connection
1
2
11
6
5
7
8
10
3
4
9

1 Introduction
1.3 Column description
10 FineLINE 35 oligo column Operating Instructions 28-9649-57 AA
Materials
All column parts are manufactured from high quality materials and meet the
requirements of industrial environments. The wetted parts are manufactured from
materials having high chemical resistance.
The materials used in the construction of the FineLINE 35 oligo column have been
carefully selected to be compatible with reagents commonly used in oligonucleotide
synthesis.
Materials of manufacture of FineLINE 35 oligo column include borosilicate glass, PEEK™,
polypropylene, stainless steel, Simriz. PFR91 and Teflon™ (PTFE).
In the current FineLINE 35 oligo column the top end-piece and adapter lid are made of
PEEK. Previous versions have these parts made of POM. PEEK is necessary only if ACN is
to be used in the hydraulic chamber. If ACN is to be used in old versions of the column,
PEEK-parts can be ordered and exchanged, Section 7.4 Ordering information‚ on
page 38.
PEEK parts are labelled P to be distinguished from POM parts.
The column material is not compatible with tetrahydrofurane, THF.
Connections
Located on the top end-piece is the hydraulic inlet, complete with a check valve, and
hydraulic outlet.
The inlet and outlet of the column are located at the bottom of the column, in the
bottom lid, and in the column top.
The inlet and outlets have 5/16” fitting and the hydraulic chamber has M6 fitting.

FineLINE 35 oligo column Operating Instructions 28-9649-57 AA 11
Safety instructions 2
Safety precautions 2.1
2 Safety instructions
This chapter describes safety precautions, safety labels and recycling of the FineLINE
35 oligo column.
2.1 Safety precautions
Introduction
The safety precautions in this section are grouped into the following categories:
•Explosiveenvironment
• Flammable liquids
• Personal protection
• Installation
•Systemoperation
•Maintenance

2 Safety instructions
2.1 Safety precautions
12 FineLINE 35 oligo column Operating Instructions 28-9649-57 AA
Explosive environment
Flammable liquids
Personal protection
Installation
WARNING
FineLINE 35 oligo column is not intended for usage in explosive
environment.
WARNING
Explosive or flammable liquids. If potentially flammable or explosive
liquids are used, consult local authorities regarding local rules and
regulations before use.
WARNING
Explosion hazard. To avoid building up an explosive atmosphere when
using flammable liquids, make sure that the room ventilation is
sufficient to remove any potentially explosive fumes.
WARNING
Fire Hazard. Before starting the system, make sure that there is no
leakage if potentially flammable or explosive liquids are used.
WARNING
Hazardous substances. When using hazardous chemical and
biological agents, take all suitable protective measures, such as
wearing protective glasses and gloves resistant to the substances used.
Follow local and/or national regulations for safe operation and
maintenance of the system.
WARNING
To ensure that the pressure specifications of the tubing are fulfilled, use
ONLY Tubing supplied by GE Healthcare (in accordance with the tables
showing length and sizes). Use of improper tubing can result in damage
to the instrument, the synthesis, and/or the user.
CAUTION
After assembly, ensure that the column is tight and not leaking

FineLINE 35 oligo column Operating Instructions 28-9649-57 AA 13
Safety instructions 2
Safety precautions 2.1
System operation
CAUTION
Ensure that the pressure relief valve is correctly adjusted. Otherwise,
the weakest seal in the system will leak when its limit is exceeded.
CAUTION
Incorrectly fitted tubing may 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. PEEK tubing should be tightened a further 1/4
turn using the supplied spanner or wrench. Do not tighten Teflon tubing
further as this will damage the end of the tubing.
CAUTION
Do not use in a dusty atmosphere or close to spraying water.
WARNING
Operators should have experience of working with pressure vessels.
WARNING
The design pressure must not be exceeded.
See Section 7.1 Specifications‚ on page 35 for pressure limit.
WARNING
No other solvents than those specified in the Operating Instructions
should be used as they could possibly damage the system.
WARNING
Emergency Stop. When the column is fed by an external pump or
system, the Emergency Stop for that system shall be used in case of an
emergency. Refer to the Operating Instructions for the used pump or
system before using the column.
CAUTION
To avoid precipitation keep all reagents at or above 18° C.

2 Safety instructions
2.1 Safety precautions
14 FineLINE 35 oligo column Operating Instructions 28-9649-57 AA
Maintenance
CAUTION
Use only components and spare parts delivered or authorized by GE
Healthcare. This equipment is classified with material specifications
which must be preserved.
CAUTION
Remove spillage immediately.
CAUTION
Make sure that the column has been cleaned and contains no residual
harmful substances before maintenance.

FineLINE 35 oligo column Operating Instructions 28-9649-57 AA 15
Safety instructions 2
Labels 2.2
2.2 Labels
This section describes safety labels and labels concerning hazardous substances that
are attached to the FineLINE 35 oligo column.
Labels on the instrument
Identification label
FineLINE 35 oligo column has two labels. Both labels show the following information:
•Productname.
• Manufacturing country.
•Articlenumber
In addition, the labels contain the following information
2.3 Recycling procedures
When taking FineLINE 35 oligo column out of service, the following must be followed:
• The equipment shall be emptied, decontaminated, cleaned and sterilized.
• All local regulations shall be followed with regard to scrapping of the equipment.
• The different materials must be separated and recycled according to national and
local environmental regulations.
• Design pressure, must never be exceeded.
• Warning triangle - indicates that the
Operating Instructions must be read before
use.
• CE-symbol - shows that the product
conforms with regulations as described in
Section CE marking‚ on page 8.
• Manufacturers name and address.
•Serial number.
• Machine readable identification bar code.
28946841 FineLINE™ 35 oligo Column
Made in Sweden GE Healthcare Bio-Sciences AB
751 84 Uppsala Sweden
Design pressure:
Code no: 28946844
20 bar
28946841
FineLINE™ 35 oligo Column
Serial no: 1234567
Made in Sweden
Catalog no: 2009Mfg Year:

2 Safety instructions
2.3 Recycling procedures
16 FineLINE 35 oligo column Operating Instructions 28-9649-57 AA

FineLINE 35 oligo column Operating Instructions 28-9649-57 AA 17
Installation 3
3 Installation
The FineLINE 35 oligo column is delivered assembled, with the adapter fitted in the
column.
Packing list
Item Article no. Qty
FineLINE 35 oligo column 28-9461-41 1
User manual 28-9649-57 1
Allen key 4 mm 19-0379-01 1
Allen key 2.5 mm 19-4442-01 1
Union 5/16” female/M6 Male 18-1127-76 3
Stop plug M6 56-1163-77 1
Stop plug 5/16” 56-1185-81 1
Wrench 18-1110-88 1
Wrench (M6) 19-7481-01 1
Valve SRV-1 19-2145-01 1

3 Installation
18 FineLINE 35 oligo column Operating Instructions 28-9649-57 AA

FineLINE 35 oligo column Operating Instructions 28-9649-57 AA 19
Operation 4
4Operation
WARNING
Hazardous substances. When using hazardous chemical and
biological agents, take all suitable protective measures, such as
wearing protective glasses and gloves resistant to the substances used.
Follow local and/or national regulations for safe operation and
maintenance of the system.
WARNING
The design pressure must not be exceeded.
See Section 7.1 Specifications‚ on page 35 for pressure limit.
WARNING
Emergency Stop. When the column is fed by an external pump or
system, the Emergency Stop for that system shall be used in case of an
emergency. Refer to the Operating Instructions for the used pump or
system regarding Emergency Stop before using the column.
CAUTION
Incorrectly fitted tubing may 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. PEEK tubing should be tightened a further 1/4
turn using the supplied spanner or wrench. Do not tighten Teflon tubing
further as this will damage the end of the tubing.
NOTICE
No other solvents than those specified in the Operating Instructions
should be used as they could possible damage the system.
NOTICE
The column material is not compatible with tetrahydrofurane, THF.

4 Operation
4.1 Packing the column
20 FineLINE 35 oligo column Operating Instructions 28-9649-57 AA
4.1 Packing the column
For optimum performance from FineLINE 35 oligo column and Primer Support, the
packing and unpacking procedures outlined below are recommended.
Please read the complete chapter before using the column!
FineLINE 35 oligo column is intended for use with ÄKTA™ oligopilot™ 100 and the
instructions in this section assumes that this is the case.
Table 4-1. Items required for packing
Note: Primer Support 200 should be packed as a slurry.
Item Quantity
FineLINE 35 oligo column 1
Operating Instructions 1
Allen key 4 mm 1
Union 5/16" female/M6 male 2
Tubing Connectors OD 1/8” tubing 12
Ferrules for OD 1/8” tubing 12
Stop plug 5/16” 1
Tubing ID 1.6 mm OD 1/8”, 30 cm 2
Tubing ID 1.6 mm OD 1/8”, 40 cm 3
100 or 250 ml bottle for support slurry 1
Funnel 1
Beaker 500 ml 1