cytiva BPG Columns User manual

BPG Columns
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1Introduction ........................................................................................................ 4
1.1 About this manual ......................................................................................................................................... 5
1.2 Important user information ....................................................................................................................... 6
2 Safety instructions ............................................................................................. 8
2.1 Safety precautions ........................................................................................................................................ 9
2.2 Symbols and abbreviations ........................................................................................................................ 15
2.3 Emergency procedures ............................................................................................................................... 17
3 Column descriptions .......................................................................................... 18
3.1 Overview ............................................................................................................................................................ 19
3.2 BPG 100, 140 and 200 columns ................................................................................................................ 22
3.3 BPG 300 column ............................................................................................................................................. 25
3.4 BPG 450 column ............................................................................................................................................. 28
3.5 Accessories ...................................................................................................................................................... 31
4 Installation .......................................................................................................... 33
4.1 Site requirements .......................................................................................................................................... 34
4.2 Transport .......................................................................................................................................................... 35
4.3 Unpacking ......................................................................................................................................................... 36
4.4 How to level the column .............................................................................................................................. 38
4.5 Grounding kit ................................................................................................................................................... 40
4.6 Setup ................................................................................................................................................................... 42
5 Operation ............................................................................................................ 45
5.1 Preparation ...................................................................................................................................................... 47
5.1.1 Column flow packing method ................................................................................................................. 49
5.1.2 Slurry preparation ........................................................................................................................................ 50
5.2 Column packing .............................................................................................................................................. 53
5.2.1 Preparing the column ................................................................................................................................. 54
5.2.2 Preparing the adapter ................................................................................................................................ 57
5.2.3 Packing the column - first step ............................................................................................................... 62
5.2.4 Packing the column - second step ........................................................................................................ 67
5.2.5 Storage and unpacking of packed columns ...................................................................................... 70
5.2.6 Pressure flow curve ..................................................................................................................................... 71
5.3 Performance evaluation of the column ................................................................................................. 72
6 Maintenance ....................................................................................................... 75
6.1 Service and preventive maintenance .................................................................................................... 77
6.2 Replacements of nets and O-rings .......................................................................................................... 79
6.2.1 Replacements in the adapter .................................................................................................................. 81
6.2.2 Replacements in the column ................................................................................................................... 87
6.3 Replacement sealing washer .................................................................................................................... 98
6.4 Fitting a packing extension tube ............................................................................................................. 99
6.5 Disassemble and assemble the adapter ............................................................................................... 101
6.6 Leakage test .................................................................................................................................................... 113
6.7 Cleaning ............................................................................................................................................................ 115
Table of Contents
2 BPG Columns Operating Instructions 29193223 AB

6.8 Storage .............................................................................................................................................................. 119
7Troubleshooting ................................................................................................ 121
8 Reference information ....................................................................................... 124
8.1 Specifications .................................................................................................................................................. 125
8.1.1 BPG 100 ............................................................................................................................................................ 127
8.1.2 BPG 140 ............................................................................................................................................................ 128
8.1.3 BPG 200 ............................................................................................................................................................ 129
8.1.4 BPG 300 ............................................................................................................................................................ 130
8.1.5 BPG 450 ............................................................................................................................................................ 131
8.2 Chemical resistance ..................................................................................................................................... 132
8.3 Abbreviations .................................................................................................................................................. 135
8.4 Recycling information .................................................................................................................................. 136
8.5 Regulatory information ............................................................................................................................... 137
8.5.1 Contact information .................................................................................................................................... 138
8.5.2 European Union and European Economic Area .............................................................................. 139
8.6 Health and Safety Declaration Form ...................................................................................................... 140
Index ........................................................................................................................... 142
Table of Contents
BPG Columns Operating Instructions 29193223 AB 3

1 Introduction
About this chapter
This chapter contains important user information, descriptions of safety notices, and
the intended use of BPG columns.
In this chapter
Section See page
1.1 About this manual 5
1.2 Important user information 6
1 Introduction
4 BPG Columns Operating Instructions 29193223 AB

1.1 About this manual
Purpose of this manual
The Operating Instructions provide you with the information needed to install, operate,
and maintain the product in a safe way.
Scope of this document
This document describes the basic components and principles of operation of BPG
columns. Specific configuration information can be found in the product documenta-
tion provided with each column and on the column label.
Detailed information regarding process systems, media and buffer tanks is not covered
in this document.
1 Introduction
1.1 About this manual
BPG Columns Operating Instructions 29193223 AB 5

1.2 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
BPG columns are intended for industrial applications that demand high standards of
hygiene. BPG columns can be used in conjunction with BioProcess™ Chromatography
media. The pressure specifications and low flow resistance make these columns suit-
able for use with BioProcess media in ion exchange, hydrophobic interaction, affinity
and gel filtration chromatography.
BPG columns are intended for production use only and should not be used for diag-
nostic purposes in any clinical or in vitro procedures.
Prerequisites
In order to operate the equipment in the way it is intended, the following prerequisites
must be fulfilled:
•You must have read and understood the safety instructions in the user documenta-
tion.
•You must have experience of working with pressure vessels.
•You must have knowledge of the entire system and process that the column is part
of.
•All operations should be performed by qualified personnel who are adequately
trained.
Definitions
This user documentation contains safety notices (WARNING, CAUTION, and NOTICE)
concerning the safe use of the product. See definitions below.
1 Introduction
1.2 Important user information
6 BPG Columns Operating Instructions 29193223 AB

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
1.2 Important user information
BPG Columns Operating Instructions 29193223 AB 7

2 Safety instructions
About this chapter
This chapter describes safety precautions and the label attached to the equipment. In
addition, the chapter describes emergency and recovery procedures.
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.
In this chapter
Section See page
2.1 Safety precautions 9
2.2 Symbols and abbreviations 15
2.3 Emergency procedures 17
2 Safety instructions
8 BPG Columns Operating Instructions 29193223 AB

2.1 Safety precautions
About this section
The safety precautions in this section are grouped in the following categories:
•General precautions, on page 9
•Flammable liquids and explosive environment, on page 10
•Personal protection, on page 11
•Installing and moving, on page 11
•Operation, on page 12
•Maintenance, on page 13
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
Do not use any accessories not supplied or recommended by
Cytiva.
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.
2 Safety instructions
2.1 Safety precautions
BPG Columns Operating Instructions 29193223 AB 9

Flammable liquids and explosive
environment
WARNING
EXPLOSION HAZARD! If cleaning the column in a potentially
explosive atmosphere, prevent static electric charges building up.
Do not rub excessively using a dry cloth and over large areas at a
time. Instead, clean the column using a damp cloth with slow
movements across small areas at a time.
WARNING
EXPLOSION HAZARD! Some of the chemicals used with BPG
columns may be flammable under certain conditions. Make sure to
use chemicals only under conditions where they are not flam-
mable. Refer to local and/or national classifications of flammable
liquids.
WARNING
EXPLOSION HAZARD! When the BPG column is operated or
maintained in a potentially explosive atmosphere, it MUST be
properly grounded to avoid static discharge.
WARNING
EXPLOSION HAZARD! When connecting the grounding cable,
make sure that there is no explosive atmosphere present. Static
electricity discharge could occur when connecting the grounding
cable.
2 Safety instructions
2.1 Safety precautions
10 BPG Columns Operating Instructions 29193223 AB

Personal protection
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.
WARNING
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
BPG columns.
Installing and moving
WARNING
Only personnel with appropriate training may move and unpack
the delivery crates. All moving and unpacking must be performed
according to local regulations.
Even if the safety instructions in the user documentation are
followed, it is the customers' responsibility to guarantee the safety
of the personnel working with BPG columns.
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.
2 Safety instructions
2.1 Safety precautions
BPG Columns Operating Instructions 29193223 AB 11

WARNING
Have a minimum of two people on hand, as well as the appropriate
lifting equipment for the application, such as a hoist, when moving
or lifting a heavier BPG column, i.e., BPG 300 or 450.
WARNING
Be careful not to unscrew the wheels too far. If they are unscrewed
totally the column may fall and cause injury or damage. Make sure
that the wheel support is fully engaged into the stand before start
leveling.
WARNING
Make sure that the wheel support is fully engaged into the stand
before start moving.
CAUTION
After moving the column to its resting position, lock the wheel
brakes and level the column. Place the column on an even floor
area.
CAUTION
Make sure that the safety equipment's (for example pressure relief
valve or rupture disc) connecting tubing has an unrestricted flow
path and connected to waste.
Operation
WARNING
The working pressure of the column should never exceed its design
pressure, otherwise there is a risk of personal injury and damage to
the column. Always use appropriate safety equipment, for example
pressure relief valve or rupture discs.
2 Safety instructions
2.1 Safety precautions
12 BPG Columns Operating Instructions 29193223 AB

WARNING
There should NEVER be air or gas under pressure in the column.
WARNING
Pay extra attention when fitting the adapter to the column as there
is a risk of crushing your hands.
CAUTION
Do not use chemicals with temperatures above the specified limits.
Maintenance
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
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
For continued protection against injury risks due to fluid jets, burst
pipes or explosive atmosphere, the piping system must be tested
for leakage at maximum pressure when the following situations
apply:
•After assembly or maintenance
•Before operation or Cleaning-In-Place (CIP)
2 Safety instructions
2.1 Safety precautions
BPG Columns Operating Instructions 29193223 AB 13

CAUTION
After assembly, check that the column is tight and not leaking.
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.
2 Safety instructions
2.1 Safety precautions
14 BPG Columns Operating Instructions 29193223 AB

2.2 Symbols and abbreviations
Introduction
This section describes the information on the system label and other safety or regula-
tory labels that are attached to the product.
System label
The system label is located on the back of the equipment. The system label identifies
the equipment and shows electrical data, regulatory compliance, and warning
symbols.
Description of symbols on the system
label
The following symbols and text may be present on the system label:
Label text Description
Code number Code number identifying the column as a BPG column
product.
Serial number Serial number.
Mfg date Year and month the instrument was produced (YYYY/
MM).
Tare mass Weight of the instrument when empty. (Tare mass is not
always presented on the label.)
Operating temp. TS Permitted operating temperature range.
Design pressure PS Pressure the instrument has been designed to tolerate.
PED fluid group / cat. Pressure Equipment Directive fluid group and category
classification.
Warning! Read the user documentation before using the
system.
The equipment complies with applicable European direc-
tives.
Applicable to BPG 200/950, 300/500, 300/750, 300/950,
450/500, 450/750 and 450/1000.
2 Safety instructions
2.2 Symbols and abbreviations
BPG Columns Operating Instructions 29193223 AB 15

Placement of system label
The system label is placed on the flange on the column.
2 Safety instructions
2.2 Symbols and abbreviations
16 BPG Columns Operating Instructions 29193223 AB

2.3 Emergency procedures
Precautions
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.
Emergency shutdown
The operation of BPG columns is controlled by the equipment that is connected to the
column. All operations are therefore stopped by stopping the operation of the
connected equipment.
If the column is connected to a system, the procedure for the emergency shutdown of
the system should be followed. This may involve pressing the EMERGENCY STOP
button to stop the operation of the equipment controlling the pumping system
connected to the column. Alternatively, the process system may require to be paused
or shutdown. Follow the manufacturer's instructions for the system.
Restart
To restart after an emergency shutdown:
Step Action
1Make sure that the condition that was the root cause of the emergency stop
has been corrected.
2If an EMERGENCY STOP button was used to shutdown the equipment
connected to the column, reset this before restart.
3Reduce pump settings prior to reactivation to avoid immediate high pres-
sure increases.
4Restart the equipment connected to the column.
2 Safety instructions
2.3 Emergency procedures
BPG Columns Operating Instructions 29193223 AB 17

3 Column descriptions
About this chapter
This chapter contains a general description of BPG columns and illustrations of the
BPG models.
In this chapter
Section See page
3.1 Overview 19
3.2 BPG 100, 140 and 200 columns 22
3.3 BPG 300 column 25
3.4 BPG 450 column 28
3.5 Accessories 31
3 Column descriptions
18 BPG Columns Operating Instructions 29193223 AB

3.1 Overview
Introduction
The BPG column can be used conjunction with a BioProcess system or as a stand-alone
unit connected to a pump. There are five sizes of the BPG columns.
The BPG columns are listed in the table below with the internal diameters, specific
design pressure and the various heights.
Characteristics BPG 100 BPG 140 BPG 200 BPG 300 BPG 450
Internal diameter
(mm)
100 140 200 296 446
Design pressure
(bar)
8 6 6 4 2.5
Column height
(mm)
500, 750 ,
950
500, 750 ,
950
500, 750 ,
950
500, 750 ,
950
500, 750 ,
1000
For detailed specifications of the BPG columns, refer to Column specifications, on page
125.
All BPG columns are equipped with wheels with brakes, except the BPG 100 column, for
which wheel with brakes are an option.
3 Column descriptions
3.1 Overview
BPG Columns Operating Instructions 29193223 AB 19

Column material
The materials used in the BPG columns are compatible with the solvents most
commonly used in chromatography separations of biomolecules, column mainte-
nance and cleaning processes. All polymeric materials in contact with the process
stream meet the requirements for USP class VI, described in USP <88> Biological Reac-
tivity Tests, In Vivo.
Adapter and rods
The adapter top plate and the adjuster nut are bolted to the column flange. The
adjuster nut is allowed to rotate on a bushing ring in the adapter top plate, altering the
height of the adapter plate in the column tube.
The adapter O-ring forms a seal between the adapter and the glass column when it is
compressed by the sealing unit. This is controlled by the seal adjuster knob.
The rods hold the flange and end-piece to the glass tube which is sealed by O-rings. The
O-rings effectively isolate the glass tube from direct contact with the stainless steel
components.
Nets
The column is delivered with 23 μm (PolyPropylene) nets. For media with an average
particle diameter <70 μm, change to 10 μm (Polyamide), or 12 μm (PEEK) in both
adapters and end-pieces. For big beads use 54 μm nets, see Recommended net sizes,
on page 48.
Connections
BPG columns can be connected to different types of tubing and systems. To protect
the packed bed it is advisable to have isolation valves on both the inlets and outlets of
the column.
3 Column descriptions
3.1 Overview
20 BPG Columns Operating Instructions 29193223 AB