cytiva Oligo Column User manual

Adjustable Oligo Column
Operating Instructions
cytiva.com

Table of Contents
1 Introduction ........................................................................................................ 5
1.1 Important user information ....................................................................................................................... 6
1.2 About this manual ......................................................................................................................................... 7
1.3 Abbreviations .................................................................................................................................................. 8
2 Safety instructions ............................................................................................. 9
2.1 Safety precautions ........................................................................................................................................ 10
2.2 Symbols and abbreviations ........................................................................................................................ 14
3 Product description ........................................................................................... 15
4 Unpacking and installation ................................................................................ 18
5 Operation ............................................................................................................ 19
5.1 Preparation ...................................................................................................................................................... 21
5.2 Pack the column ............................................................................................................................................. 22
5.3 Unpack and empty the column ................................................................................................................. 24
6 Maintenance ....................................................................................................... 25
6.1 Disassemble and assemble for cleaning and maintenance .......................................................... 26
6.2 Cleaning ............................................................................................................................................................ 27
6.3 Part replacement ........................................................................................................................................... 28
7 Troubleshooting ................................................................................................. 30
8 Reference information ....................................................................................... 31
8.1 Specification .................................................................................................................................................... 32
8.2 Chemical resistance ..................................................................................................................................... 33
8.3 Recycling information .................................................................................................................................. 35
8.4 Regulatory information ............................................................................................................................... 36
8.5 Ordering information ................................................................................................................................... 37
8.6 Health and Safety Declaration Form ...................................................................................................... 38
Index ........................................................................................................................... 40
Table of Contents
Adjustable Oligo Column Operating Instructions 28967444 AC 3

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1 Introduction
About this chapter
This chapter contains important user information, intended use of Adjustable Oligo
Column, and lists of abbreviations used in this documentation.
In this chapter
Section See page
1.1 Important user information 6
1.2 About this manual 7
1.3 Abbreviations 8
1 Introduction
Adjustable Oligo Column Operating Instructions 28967444 AC 5

1.1 Important user information
Read this before operating the
product
All users must read the entire Operating Instructions before installing,
operating 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
equipment.
Intended use of the product
Adjustable Oligo Column is intended for synthesis and method development of
oligonucleotides at pilot scale using Primer Support ™. The column is designed for
maximum scalability and coupling efficiency with a flexible column volume.
Adjustable Oligo Column is intended for use with ÄKTA™ OligoPilot™ plus 100.
Adjustable Oligo Column must not be used in any clinical procedures, or for diagnostic
purposes.
Prerequisites
In order to operate the product in the way it is intended:
•The user must have a general understanding of oligonucleotide synthesis.
•The user must read and understand the Safety Instructions chapter in this manual.
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.
1 Introduction
1.1 Important user information
6 Adjustable Oligo Column Operating Instructions 28967444 AC

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 manual describes how to use Adjustable Oligo Column. The illustration below
shows Adjustable Oligo Column.
1 Introduction
1.2 About this manual
Adjustable Oligo Column Operating Instructions 28967444 AC 7

1.3 Abbreviations
Introduction
This section explains abbreviations that appear in the user documentation for the
product.
Abbreviations
Abbreviation Meaning
CV Column volume
EPDM Ethylene propylene diene
monomer
ETFE Ethylene-tetrafluoroethylene
ID Internal diameter
OD Outer diameter
PEEK Polyetheretherketone
PTFE Polytetrafluoroethylene
THF Tetrahydrofurane
1 Introduction
1.3 Abbreviations
8 Adjustable Oligo Column Operating Instructions 28967444 AC

2 Safety instructions
About this chapter
This chapter describes safety precautions, as well as labels and symbols that are
attached to the equipment.
In this chapter
Section See page
2.1 Safety precautions 10
2.2 Symbols and abbreviations 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
Adjustable Oligo Column Operating Instructions 28967444 AC 9

2.1 Safety precautions
Introduction
Adjustable Oligo Column is used with materials that can be hazardous. Before
installing, operating or maintaining the product, you must be aware of the hazards
described in this manual.
Follow the instructions 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 into the following categories:
•General precautions
•Personal protection
•Installing and moving
•Operation
•Maintenance
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.
2 Safety instructions
2.1 Safety precautions
10 Adjustable Oligo Column Operating Instructions 28967444 AC

General precautions
WARNING
Do not operate the product in any other way than described in the
user documentation.
WARNING
Only properly trained personnel may operate and maintain the
product.
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
Do not use the product if it is not working properly, or if it has
suffered any damage, for example if damage is caused by dropping
the equipment.
Personal protection
WARNING
Hazardous substances and biological agents. When using
hazardous chemical and biological agents, take all suitable
protective 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.
Installing and moving
CAUTION
Do not use the product in a dusty atmosphere or close to spraying
water.
2 Safety instructions
2.1 Safety precautions
Adjustable Oligo Column Operating Instructions 28967444 AC 11

CAUTION
The product is designed for indoor use only.
Operation
WARNING
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 overtighten PTFE tubing as this will damage the end of the
tubing.
WARNING
Never use pressure limits above the column specification.
WARNING
Never exceed the operating limits stated in this document and on
the system nameplate. Operation of the product outside these
limits can damage equipment and cause personal injury or death.
CAUTION
No other solvents than those specified in this manual should be
used as they could possibly damage the column.
2 Safety instructions
2.1 Safety precautions
12 Adjustable Oligo Column Operating Instructions 28967444 AC

Maintenance
WARNING
LOCK OUT / TAG OUT (LOTO)! Before any maintenance or
decommissioning work is performed on the column, make sure
that:
•the column is empty and depressurized.
•the column is disconnected from process feed, electrical power
and pneumatic supply.
•the column is prevented from accidentally becoming re-
energized during maintenance.
•the column is clearly tagged as taken out of operation.
•all process wetted areas are clean and decontaminated.
WARNING
Decontaminate before maintenance. To avoid personnel being
exposed to potentially hazardous substances, make sure that the
column is properly decontaminated and sanitized before
maintenance or service.
WARNING
Hazardous chemicals during maintenance. When using
hazardous chemicals for system or column cleaning, wash the
system or columns with a neutral solution in the last phase or step.
2 Safety instructions
2.1 Safety precautions
Adjustable Oligo Column Operating Instructions 28967444 AC 13

2.2 Symbols and abbreviations
Introduction
This section describes the information on the system label and other safety or
regulatory labels that are attached to the product.
Column label
The column label nameplate identifies the product and shows regulatory compliance
information.
Description of symbols on the column
label
The following symbols may be present on the column label.
Label Meaning
Follow instructions for use in the Operating Instructions manual.
Warning! Read the user documentation before using the column.
Do not open any covers or replace parts unless specifically stated
in the user documentation.
Mfg. Year Year (YYYY) and month (MM) of manufacture
2 Safety instructions
2.2 Symbols and abbreviations
14 Adjustable Oligo Column Operating Instructions 28967444 AC

3 Product description
About this chapter
This chapter gives an overview of Adjustable Oligo Column.
Column design
The Adjustable Oligo Column has a simple design. It comprises a number of complete
units which are easily assembled together. The column tube is manufactured from
borosilicate glass. It is held in place between the top end-piece and bottom end-piece
by three support rods.
Note: If the support rods between the two end-pieces have been removed and
refitted, they must be tightened with a torque key to 1.45 to 1.55 Nm for safe
operation.
The bottom end-piece contains the bottom filter unit in which a titanium filter and an
O-ring seals the unit against the column tube. The top end-piece houses the adapter.
The adapter contains a filter unit with a titanium filter. The unit is sealed against the
column with two O-rings. The adapter is held in place in the column by a screw-thread.
3 Product description
Adjustable Oligo Column Operating Instructions 28967444 AC 15

Column illustration
13
4
5
6
7
8
6
9
10
11
2
Part Function
1 Securing ring adapter
2 Connection point to the column
3 Prefilter unit including O-ring
4 Tubing D-flange
5 O-ring, 64.5×3 mm diameter
3 Product description
16 Adjustable Oligo Column Operating Instructions 28967444 AC

Part Function
6 O-ring, 55×1.6 mm diameter
7 Glass column tube
8 Distribution unit
9 Securing ring
10 Connection point from the column
11 Tie rod and hex-nut
3 Product description
Adjustable Oligo Column Operating Instructions 28967444 AC 17

4 Unpacking and installation
About this chapter
This chapter describes how to unpack the column.
Note: The column is delivered assembled, with the adapter fitted in the column.
Unpacking
On delivery of the column, perform the following steps.
Step Action
1Open the box and carefully remove the column.
2Inspect the column for any damage.
3Report any damage to your local Cytiva representative immediately.
4 Unpacking and installation
18 Adjustable Oligo Column Operating Instructions 28967444 AC

5 Operation
About this chapter
This chapter gives instructions on how to operate the product in a safe way.
In this chapter
Section See page
5.1 Preparation 21
5.2 Pack the column 22
5.3 Unpack and empty the column 24
Precautions
WARNING
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 overtighten PTFE tubing as this will damage the end of the
tubing.
WARNING
Never use pressure limits above the column specification.
CAUTION
Do not use solvents other than those specified in this manual, as
this could result in damage to the column.
5 Operation
Adjustable Oligo Column Operating Instructions 28967444 AC 19

NOTICE
To avoid precipitation keep all reagents at or above 18°C.
5 Operation
20 Adjustable Oligo Column Operating Instructions 28967444 AC

5.1 Preparation
Selection of flow direction
Linear flow rates and the number of column volumes used during method
development are generally the same as those to be used during the intended full-scale
process.
The recommended flow direction for swellable supports, like Primer Support 5G, is
from top to bottom (downflow). The flow direction is chosen due to the headspace
needed in the first cycles of the synthesis run. For other types of support it might be
different.
The table below lists a few advantages with the respective flow direction.
Flow direction
Upflow Downflow
•Can help some supports to spread the
reagents more evenly. Reagents enter the
column through the bottom filter and exit
through the top adapter filter.
•Using flow direction from bottom to top
also simplifies changing a dirty adapter
filter, since the inlet filter most likely is
dirtier than the outlet filter.
•Reduces the length of the
tubing connecting the
column. This shortens the
cycle times and reduces the
risk of dilution of the synthesis
reagents entering the column.
Flow rate conversions
The following table shows the unit conversion of flow velocity in cm/hour into flow rate
mL/min for Adjustable Oligo Column.
cm/hour mL/min
60 28.26
150 70.65
300 141.3
400 188.4
5 Operation
5.1 Preparation
Adjustable Oligo Column Operating Instructions 28967444 AC 21