cytiva FineLINE 35 User manual

FineLINE 35 oligo column
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1Introduction ........................................................................................................ 3
1.1 Important user information ....................................................................................................................... 4
1.2 About this manual ......................................................................................................................................... 6
1.3 Abbreviations .................................................................................................................................................. 7
2 Safety instructions ............................................................................................. 8
2.1 Safety precautions ........................................................................................................................................ 9
2.2 Labels and symbols ....................................................................................................................................... 14
3 System description ............................................................................................ 15
4 Installation .......................................................................................................... 18
5 Operation ............................................................................................................ 19
5.1 Safety precautions ........................................................................................................................................ 20
5.2 Packing the column ....................................................................................................................................... 22
5.3 Lekage test ....................................................................................................................................................... 24
5.4 Recommended operating conditions .................................................................................................... 25
5.5 Unpacking the column ................................................................................................................................. 26
5.6 Scaling up .......................................................................................................................................................... 27
6 Maintenance ....................................................................................................... 28
6.1 Safety Precautions ........................................................................................................................................ 29
6.2 User maintenance schedule ...................................................................................................................... 30
6.3 Cleaning ............................................................................................................................................................ 31
6.4 Storage .............................................................................................................................................................. 32
6.5 Disassembly and assembly ........................................................................................................................ 33
6.6 Component maintenance .......................................................................................................................... 36
7 Troubleshooting ................................................................................................. 39
8 Reference information ....................................................................................... 40
8.1 Specifications .................................................................................................................................................. 41
8.2 Chemical resistance ..................................................................................................................................... 42
8.3 Service and training ...................................................................................................................................... 43
8.4 Recycling information .................................................................................................................................. 44
8.5 Regulatory information ............................................................................................................................... 45
8.5.1 Contact information .................................................................................................................................... 46
8.5.2 European Union and European Economic Area .............................................................................. 47
8.6 Ordering information ................................................................................................................................... 48
8.7 Health and Safety Declaration Form ...................................................................................................... 52
Table of Contents
2 FineLINE 35 oligo Operating Instructions 28964957 AB

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 4
1.2 About this manual 6
1.3 Abbreviations 7
1 Introduction
FineLINE 35 oligo Operating Instructions 28964957 AB 3

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 the product
FineLINE™ 35 oligo column is intended for process development of oligonucleotide
synthesis.
FineLINE 35 oligo column shall not be used in any clinical procedures, or for diagnostic
purposes. .
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 and understand the Safety Instructions chapter in the Operating
Instructions.
•FineLINE 35 oligo column must be installed in accordance with the site require-
ments and instructions in the Operating Instructions.
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.
Typographical conventions
Software items are identified in the text by bold italic text.
1 Introduction
1.1 Important user information
4 FineLINE 35 oligo Operating Instructions 28964957 AB

Hardware items are identified in the text by bold text.
In electronic format, references in italics are clickable hyperlinks.
1 Introduction
1.1 Important user information
FineLINE 35 oligo Operating Instructions 28964957 AB 5

1.2 About this manual
Purpose of this manual
The Operating Instructions manual provides information needed to install, operate and
maintain the product in a safe way.
Scope of this manual
This Operating Instructions manual is valid for and cover the FineLINE 35 oligo column.
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.
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
6 FineLINE 35 oligo Operating Instructions 28964957 AB

1.3 Abbreviations
Introduction
This section explains abbreviations that are used in these Operating Instructions.
Abbreviations
Abbreviation Definition Translation
CIP cleaning-in-place cleaning-in-place
EPDM ethylene propylene diene monomer ethylene propylene diene monomer
ETFE ethylene-tetrafluoroethylene ethylene-tetrafluoroethylene
FFPM/FFKM/
Tecnoflon™ PFR91
perfluorinated elastomer perfluorinated elastomer
HETP height equivalent to a theoretical
plate
height equivalent to a theoretical
plate
HIC hydrophobic interaction chromatog-
raphy
hydrophobic interaction chromatog-
raphy
PEEK Polyetheretherketone Polyetheretherketone
PFR Perfluor rubber Perfluor rubber
POM Acetal plastic Acetal plastic
PTFE polytetrafluoroethene polytetrafluoroethene
RPC reversed phase chromatography reversed phase chromatography
SIP sanitation-in-place sanitation-in-place
THF Tetrahydrofurane Tetrahydrofurane
TC hygienic tubing connection hygienic tubing connection
1 Introduction
1.3 Abbreviations
FineLINE 35 oligo Operating Instructions 28964957 AB 7

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.
In this chapter
Section See page
2.1 Safety precautions 9
2.2 Labels and symbols 14
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
8 FineLINE 35 oligo Operating Instructions 28964957 AB

2.1 Safety precautions
Introduction
The safety precautions in this section are grouped into the following categories:
•General precautions, on page 9
•Flammable liquids and explosive environment, on page 10
•Personal protection, on page 11
•Operation, on page 11
•Maintenance, on page 13
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
The following general precautions must be considered at all times. There are also
context related precautions, which are written in their respective chapters.
WARNING
Only properly trained personnel may operate and maintain the
product.
2 Safety instructions
2.1 Safety precautions
FineLINE 35 oligo Operating Instructions 28964957 AB 9

WARNING
Do not operate the product in any other way than described in the
user documentation.
WARNING
Accessories. Use only accessories supplied or recommended by
Cytiva.
WARNING
Max. column pressure. The working pressure of the column
should never exceed 20 bar, otherwise there is a risk of personal
injury and damage to the column. Always use appropriate pressure
alarms, pressure vents or rupture discs, and safety equipment.
CAUTION
Make sure that any accessories used fulfill the specification
requirements (e.g., tubing withstands operating pressure and has
adequate chemical resistance).
WARNING
There should NEVER be air or gas under pressure in the column.
Flammable liquids and explosive
environment
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.
2 Safety instructions
2.1 Safety precautions
10 FineLINE 35 oligo Operating Instructions 28964957 AB

WARNING
Some of the chemicals used with the product 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.
Personal protection
WARNING
Hazardous substances. When using hazardous substances, 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 product.
WARNING
For personal safety during the transportation, installation, opera-
tion, maintenance and service of columns, use protective glasses
and other personal protective equipment appropriate for the
current application at all times. The following personal protective
equipment should always be available:
•Protective glasses
•Working gloves to protect against sharp edges
•Protective footwear, preferably with steel toe-cap
•Disposable gloves
Always use clean disposable gloves when manually handling parts.
Operation
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.
2 Safety instructions
2.1 Safety precautions
FineLINE 35 oligo Operating Instructions 28964957 AB 11

WARNING
Thoroughly check the glass column tube to make sure that it is not
cracked or has been severely scratched. Pay extra attention to the
end parts of the column tube. The pressure specifications are only
valid if the glass tube is undamaged.
WARNING
Max. column pressure. The working pressure of the column
should never exceed 20 bar, otherwise there is a risk of personal
injury and damage to the column. Always use appropriate pressure
alarms, pressure vents or rupture discs, and safety equipment.
WARNING
Observe extreme caution when in the vicinity of the column, espe-
cially if hydraulics are connected to the column. The force gener-
ated by the movement of the column could crush hands and limbs.
CAUTION
Make sure that any accessories used fulfill the specification
requirements (e.g., tubing withstands operating pressure and has
adequate chemical resistance).
CAUTION
Removing the top plate and adapter often causes spillages and
splashing. Remove any spillage on the floor immediately to mini-
mize the risk for slipping accidents.
CAUTION
Make sure that the pressure relief valve is correctly adjusted and
that connecting tubing has an unrestricted flow path.
CAUTION
After assembly, make sure that the column is tight and not leaking.
2 Safety instructions
2.1 Safety precautions
12 FineLINE 35 oligo Operating Instructions 28964957 AB

NOTICE
No other solvents than those specified in the Operating Instruc-
tions should be used as they could possibly damage the system.
NOTICE
The column material is not compatible with tetrahydrofurane, THF.
Maintenance
WARNING
Pressure may remain in the column and tubing for an extended
period after shutdown. Make sure the system is depressurized
before opening or disconnecting.
WARNING
Accessories. Use only accessories supplied or recommended by
Cytiva.
WARNING
Decontaminate before maintenance. To avoid personnel being
exposed to potentially hazardous substances, make sure that the
column is properly decontaminated and sanitized before mainte-
nance or service.
CAUTION
Make sure that any accessories used fulfill the specification
requirements (e.g., tubing withstands operating pressure and has
adequate chemical resistance).
CAUTION
After assembly, make sure that the column is tight and not leaking.
2 Safety instructions
2.1 Safety precautions
FineLINE 35 oligo Operating Instructions 28964957 AB 13

2.2 Labels and symbols
Introduction
This section describes the product nameplate (label) and other safety and regulatory
labels attached to the product.
Product labels
The labels on the product identify the equipment and show regulatory compliance
information.
The symbols and information on the labels are explained in the following table.
Symbol / text Description
Code no Ordering number for FineLINE 35 oligo column
Design pressure The design pressure, which must never be exceeded
Warning! Read the user documentation before using the
system. Do not open any covers or replace parts unless
specifically stated in the user documentation.
The system complies with applicable European directives.
Catalog number
or Product no
System serial number
Mfg Year Manufacturing year
2 Safety instructions
2.2 Labels and symbols
14 FineLINE 35 oligo Operating Instructions 28964957 AB

3 System description
About this chapter
This chapter gives an overview of FineLINE 35 oligo column, and a brief description of
its function.
Illustration of the column
1
2
3
4
5
6
7
8
9
10
11
Part Description
1 Column top connection
2 Adapter shaft
3 Mechanical locking unit
4 Bayonet adapter lid lock
5 Column top lid
6 Connecting rod
7 Column tube
8 Adapter filter unit
9 Bottom filter unit
10 Bottom lid with bottom connection
11 Hydraulic chamber connection
3 System description
FineLINE 35 oligo Operating Instructions 28964957 AB 15

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™.
The column is easy to operate.
Design
The FineLINE 35 oligo column design incorporates a number of features.
The FineLINE 35 oligo column 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.
Materials
All column parts are manufactured from high quality materials and meet the require-
ments 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, FFKM, Tecnoflon PFR91 and 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 8.6 Ordering information,
on page 48.
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.
3 System description
16 FineLINE 35 oligo Operating Instructions 28964957 AB

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.
3 System description
FineLINE 35 oligo Operating Instructions 28964957 AB 17

4 Installation
About this chapter
This chapter provides required information to enable users and service personnel to
unpack, install, move and transport the FineLINE 35 oligo column system.
Introduction
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 28946841 1
User manual 28964957 1
Hex key 4 mm 59037900 1
Hex key 2.5 mm 59444200 1
Union 5/16” female/M6 Male 18112776 3
Stop plug M6 56116377 1
Stop plug 5/16” 56118581 1
Wrench 18111088 1
Wrench (M6) 19748101 1
Valve SRV-1 19214501 1
4 Installation
18 FineLINE 35 oligo Operating Instructions 28964957 AB

5 Operation
About this chapter
This chapter gives instructions on how to operate FineLINE 35 oligo column in safe
way.
In this chapter
Section See page
5.1 Safety precautions 20
5.2 Packing the column 22
5.3 Lekage test 24
5.4 Recommended operating conditions 25
5.5 Unpacking the column 26
5.6 Scaling up 27
5 Operation
FineLINE 35 oligo Operating Instructions 28964957 AB 19

5.1 Safety 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
Thoroughly check the glass column tube to make sure that it is not
cracked or has been severely scratched. Pay extra attention to the
end parts of the column tube. The pressure specifications are only
valid if the glass tube is undamaged.
WARNING
Max. column pressure. The working pressure of the column
should never exceed 20 bar, otherwise there is a risk of personal
injury and damage to the column. Always use appropriate pressure
alarms, pressure vents or rupture discs, and safety equipment.
WARNING
Observe extreme caution when in the vicinity of the column, espe-
cially if hydraulics are connected to the column. The force gener-
ated by the movement of the column could crush hands and limbs.
CAUTION
Make sure that any accessories used fulfill the specification
requirements (e.g., tubing withstands operating pressure and has
adequate chemical resistance).
5 Operation
5.1 Safety precautions
20 FineLINE 35 oligo Operating Instructions 28964957 AB