cytiva FineLINE Pilot 35 column User manual

FineLINE Pilot 35 column
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1Introduction ........................................................................................................ 3
1.1 Important user information ....................................................................................................................... 4
1.2 About this manual ......................................................................................................................................... 5
1.3 Abbreviations .................................................................................................................................................. 6
2 Safety instructions ............................................................................................. 7
2.1 Safety precautions ........................................................................................................................................ 8
2.2 Labels and symbols ....................................................................................................................................... 13
3 System description ............................................................................................ 14
4 Installation .......................................................................................................... 17
5 Operation ............................................................................................................ 19
5.1 Safety precautions ........................................................................................................................................ 20
5.2 Systems and pumps ...................................................................................................................................... 22
5.3 Packing the column ....................................................................................................................................... 23
5.4 Evaluating the packing ................................................................................................................................ 28
5.5 Recommended operating conditions .................................................................................................... 31
5.6 Unpacking the column ................................................................................................................................. 32
5.7 Scaling up .......................................................................................................................................................... 33
6 Maintenance ....................................................................................................... 34
6.1 Safety Precautions ........................................................................................................................................ 35
6.2 General information ..................................................................................................................................... 36
6.3 User maintenance schedule ...................................................................................................................... 37
6.4 Cleaning ............................................................................................................................................................ 38
6.5 Assembly and disassembly ........................................................................................................................ 40
6.6 Component maintenance .......................................................................................................................... 43
6.7 Storage .............................................................................................................................................................. 46
7 Troubleshooting ................................................................................................. 47
7.1 General problems .......................................................................................................................................... 48
7.2 Column packing related problems .......................................................................................................... 50
8 Reference information ....................................................................................... 52
8.1 Specifications .................................................................................................................................................. 53
8.2 Chemical resistance ..................................................................................................................................... 54
8.3 Service and training ...................................................................................................................................... 56
8.4 Recycling information .................................................................................................................................. 57
8.5 Regulatory information ............................................................................................................................... 58
8.5.1 Contact information .................................................................................................................................... 59
8.5.2 European Union and European Economic Area .............................................................................. 60
8.6 Ordering information ................................................................................................................................... 61
8.7 Health and Safety Declaration Form ...................................................................................................... 66
Table of Contents
2 FineLINE Pilot 35 column Operating Instructions 28964850 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 5
1.3 Abbreviations 6
1 Introduction
FineLINE Pilot 35 column Operating Instructions 28964850 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
FineLINE™ Pilot 35 column is intended for separation of biomolecules such as proteins,
peptides and oligonucleotides, at pilot scale, primarily with SOURCE™ resin.
FineLINE Pilot 35 column must be used in accordance with the instructions given in
these Operating Instructions.
FineLINE Pilot 35 column shall not be used in any procedures, or for diagnostic
purposes.
Prerequisites
In order to operate FineLINE Pilot 35 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 Pilot 35 column must be installed in accordance with the site require-
ments and instructions in the Operating Instructions.
Notes
Note: A Note is used to indicate information that is important for trouble-free and
optimal use of the product.
1 Introduction
1.1 Important user information
4 FineLINE Pilot 35 column Operating Instructions 28964850 AB

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 Instruction manual is valid for and covers the FineLINE Pilot 35 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
FineLINE Pilot 35 column Operating Instructions 28964850 AB 5

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
PP polypropylene polypropylene
PTFE polytetrafluoroethene polytetrafluoroethene
RPC reversed phase chromatography reversed phase chromatography
SIP sanitation-in-place sanitation-in-place
TC hygienic tubing connection hygienic tubing connection
1 Introduction
1.3 Abbreviations
6 FineLINE Pilot 35 column Operating Instructions 28964850 AB

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 8
2.2 Labels and symbols 13
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
FineLINE Pilot 35 column Operating Instructions 28964850 AB 7

2.1 Safety precautions
Introduction
Before installing, operating and maintaining the column, you must be aware of the
hazards described in the user documentation. Follow the instructions provided to
avoid personal injury or damage to the equipment.
The safety precautions in this section are grouped into the following categories:
•Flammable liquids and explosive environment
•Personal protection
•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.
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.
2 Safety instructions
2.1 Safety precautions
8 FineLINE Pilot 35 column Operating Instructions 28964850 AB

WARNING
Only properly trained personnel may operate and maintain the
product.
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.
2 Safety instructions
2.1 Safety precautions
FineLINE Pilot 35 column Operating Instructions 28964850 AB 9

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.
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.
2 Safety instructions
2.1 Safety precautions
10 FineLINE Pilot 35 column Operating Instructions 28964850 AB

Operation
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.
2 Safety instructions
2.1 Safety precautions
FineLINE Pilot 35 column Operating Instructions 28964850 AB 11

CAUTION
Do not remove the support rods between the two end-pieces. They
must be tightened with a torque key to 1.4 Nm for safe operation.
CAUTION
After assembly, make sure that the column is tight and not leaking.
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
12 FineLINE Pilot 35 column Operating Instructions 28964850 AB

2.2 Labels and symbols
Introduction
This section describes the product nameplate (label) and other safety and regulatory
labels attached to the product.
Product label
The label on the product identifies the equipment and shows regulatory compliance
information.
The symbols and information on the product label are explained in the following table.
Symbol / text Description
Code no Ordering number for FineLINE Pilot 35 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 direc-
tives.
Catalog number or
Product no
System serial number
Mfg Year Manufacturing year
2 Safety instructions
2.2 Labels and symbols
FineLINE Pilot 35 column Operating Instructions 28964850 AB 13

3 System description
About this chapter
This chapter gives an overview of FineLINE Pilot 35 column, and a brief description of its
function.
Illustration of the column
5
6
7
9
10
3
4
2
1
8
3 System description
14 FineLINE Pilot 35 column Operating Instructions 28964850 AB

Part Description
1 Hydraulic chamber connection (2 pcs, one not shown)
2 Adapter knob with column top connection (not shown)
3 Adapter lid with O-ring seals
4 Adapter tube
5 Top end piece
6 Tie rod nut (3 pcs)
7 Tie rod (3 pcs)
8 Column tube
9 Bottom end piece with bottom filter unit 2 μm and column bottom
connection (not shown)
10 Adapter filter unit 2 μm with O-ring seals
Design overview
FineLINE Pilot 35 column is intended for method development at pilot scale, primarily
with SOURCE resin. They are designed for use in applications where standards of
hygiene are very high, such as in the production of biopharmaceuticals and are easy to
operate.
FineLINE Pilot 35 column has a simple design. They comprise a number of complete
units 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 bottom end-piece houses the bottom filter unit and 2 μm filter. An O-ring seals the
unit against the column tube. The top end-piece houses the hydraulically adjustable
adapter and two hydraulic connections.
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.
All tubing connections have M6 fittings.
Hydraulically adjustable adapter
The adapter is adjusted by hydraulic pressure. The hydraulic chamber, the space
between the adapter filter unit and the adapter lid, is filled with hydraulic liquid (20%
ethanol is recommended).
By pumping hydraulic liquid into the chamber, the pressure increases and the adapter
starts to move. To maintain hydraulic pressure on the adapter when in use, stop plugs
are placed on the hydraulic connections.
Materials
The materials used in the construction of FineLINE Pilot 35 column has been carefully
selected to be compatible with agents commonly used in chromatography, sanitiza-
tion and cleaning such as sodium hydroxide and ethanol.
3 System description
FineLINE Pilot 35 column Operating Instructions 28964850 AB 15

Materials include borosilicate glass, PEEK, polypropylene, EPDM and PTFE.
All column parts are manufactured from high quality materials and meet the require-
ments of industrial environments. The parts that come into contact with the sample
and eluent, the wetted parts, are manufactured from materials having very high chem-
ical resistance.
Refer to Section 8.2 Chemical resistance, on page 54 for information on material
resistance to different chemicals.
Components
In general, the components of the columns may be considered to contain “wet” parts,
which come in contact with process liquids, and “dry” parts, which do not.
A special O-ring kit is recommended when eluents for RPC resin are used (see Accesso-
ries, on page 64 for details).
3 System description
16 FineLINE Pilot 35 column Operating Instructions 28964850 AB

4 Installation
About this chapter
This chapter provides required information to enable users and service personnel to
unpack, install, move and transport the FineLINE Pilot 35 column system.
NOTICE
When working with sealings, the nets or surfaces in contact with
these components:
- Never use sharp tools.
- Do not scratch any such components or surfaces.
Unpacking the delivery box
The columns are delivered assembled, with the adapter fitted in the column.
Unpack the equipment carefully and check the contents of the container against the
packing list supplied with the column. Also check the equipment for signs of damage
that may have occurred during transportation.
Report any damage immediately to your local Cytiva representative and to the trans-
port company concerned. We recommend you keep the packaging material.
The columns are delivered assembled, with the adapter fitted in the column.
Pre-flanged inlet and outlet tubing of 1.2 mm i.d. is supplied with the column delivery.
To avoid bending the outlet tubing, it should be tucked into one of the slots on the
bottom end-piece.
Note: Before delivery, the columns are pressure tested using 20% (v/v) EtOH.
Some residual drops may remain in the column.
Illustrations of items supplied with
FineLINE Pilot 35 column
The image below shows items supplied with the FineLINE Pilot 35 column.
Note: The manual is not shown in the image.
4 Installation
FineLINE Pilot 35 column Operating Instructions 28964850 AB 17

Items on packing list
The table below describes the packing list for the FineLINE Pilot 35 column.
Item Article no. Qty
FineLINE Pilot 35 column 18110202 1
Tubing, D-flanged L 420 mm 18110220 2
i.d. 1.2 mm L 750 mm 18454601 3
Domed nut M6 18245001 4
Stop plug M6 18110221 4
Wrench 19748101 1
Hex key 2.5 59444200 1
Wrench 18111088 1
Operating instruction 28964850 1
4 Installation
18 FineLINE Pilot 35 column Operating Instructions 28964850 AB

5 Operation
About this chapter
This chapter gives instructions on how to operate FineLINE Pilot 35 column in safe way.
In this chapter
Section See page
5.1 Safety precautions 20
5.2 Systems and pumps 22
5.3 Packing the column 23
5.4 Evaluating the packing 28
5.5 Recommended operating conditions 31
5.6 Unpacking the column 32
5.7 Scaling up 33
5 Operation
FineLINE Pilot 35 column Operating Instructions 28964850 AB 19

5.1 Safety precautions
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.
5 Operation
5.1 Safety precautions
20 FineLINE Pilot 35 column Operating Instructions 28964850 AB