GE BioProcess LPLC User manual

GE Healthcare
Life Sciences
BioProcess™ LPLC and
BioProcess™ MPLC Columns
Operating Instructions
Original instructions

Table of Contents
51 Introduction ..........................................................................................................
61.1 About this manual ................................................................................................................................
71.2 Important user information .............................................................................................................
101.3 Regulatory information ......................................................................................................................
131.4 Associated documentation ..............................................................................................................
142 Safety instructions ...............................................................................................
152.1 Safety precautions ...............................................................................................................................
262.2 Labels .........................................................................................................................................................
292.3 Emergency procedures ......................................................................................................................
302.4 Recycling information .........................................................................................................................
313 Column description .............................................................................................
364 Installation ............................................................................................................
384.1 Site requirements ..................................................................................................................................
404.2 Transport ..................................................................................................................................................
424.3 Unpacking BioProcess LPLC and MPLC columns ...................................................................
444.4 Setup ...........................................................................................................................................................
454.4.1 Assembly of BioProcess LPLC and MPLC columns ...............................................................
474.4.2 Connecting a compressed air supply ........................................................................................
484.4.3 Process connections .........................................................................................................................
495 Operation ..............................................................................................................
505.1 Overview of the operation of BioProcess LPLC and MPLC columns .............................
525.2 Priming the column .............................................................................................................................
555.3 Slurry preparation and column filling ..........................................................................................
575.4 Column packing ....................................................................................................................................
605.5 Connecting a packed column .........................................................................................................
635.6 Unpacking BioProcess LPLC and MPLC columns ...................................................................
686 Maintenance .........................................................................................................
716.1 Disassembling the column ...............................................................................................................
746.2 Changing O-rings and seals ............................................................................................................
866.3 Assembling the column .....................................................................................................................
896.4 Cleaning and storage .........................................................................................................................
917 Troubleshooting ...................................................................................................
948 Reference information ........................................................................................
99Index .......................................................................................................................
LPLC and MPLC Columns Operating Instructions 28-9638-66 AC 3
Table of Contents

1 Introduction
About this chapter
This chapter contains important user information, descriptions of safety notices, regula-
tory information, intended use of BioProcess LPLC and MPLC columns, and lists of asso-
ciated documentation.
In this chapter
This chapter includes the following sections:
See pageSection
61.1 About this manual
71.2 Important user information
101.3 Regulatory information
131.4 Associated documentation
LPLC and MPLC Columns Operating Instructions 28-9638-66 AC 5
1 Introduction

1.1 About this manual
Purpose of this document
The Operating Instructions provide you with the instructions needed to install, operate
and maintain BioProcess LPLC and MPLC columns in a safe way.
Scope of this document
This manual is valid for all variants of standard BioProcess LPLC and MPLC columns.
General CE-classification information is provided. Specific configuration information for
your column can be found in the product-specific documentation package and on the
column label.
Detailed information regarding process systems, media and buffer tanks is not covered.
Typographical conventions
Software items are identified in the text by bold italic text. A colon separates menu levels,
thus File:Open refers to the Open command in the File menu.
Hardware items are identified in the text by bold text (e.g., Power switch).
6 LPLC and MPLC Columns Operating Instructions 28-9638-66 AC
1 Introduction
1.1 About this manual

1.2 Important user information
Read this before operating
BioProcess LPLC or MPLC
columns
All users must read the entire Operating Instructions before installing, operating or
maintaining the instrument. Always keep the Operating Instructions at hand when op-
erating BioProcess LPLC or MPLC columns.
Do not operate BioProcess LPLC or MPLC columns 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 of BioProcess LPLC
and MPLC columns
BioProcess LPLC and MPLC columns are Low Pressure Liquid Chromatography or Medium
Pressure Liquid Chromatography columns, respectively, designed for scale up chromato-
graphic separations in a sanitary environment.
BioProcess LPLC and MPLC columns are intended to operate at specified pressures
(gauge pressure of 0 to 10 bar g for LPLC columns and up to between 20 to 30 bar de-
pending on the specific MPLC column (please refer to the Equipment Data Sheet (EDS)
in the column documentation provided for individual column specifications). Consequently,
local authorities may consider BioProcess LPLC and MPLC columns to be pressure vessels.
Users of BioProcess LPLC and MPLC columns are responsible for making sure that the
columns are installed and handled in accordance with local regulations.
BioProcess LPLC and MPLC columns are only suitable for operation in a potentially
explosive atmosphere if they have been specifically certified for this purpose.
WARNING
Do not operate BioProcess LPLC or MPLC columns in any other way
than described in the BioProcess LPLC and MPLC column instruction
manual.
LPLC and MPLC Columns Operating Instructions 28-9638-66 AC 7
1 Introduction
1.2 Important user information

Prerequisites
In order to operate BioProcess LPLC and MPLC columns safely and according to the
intended purpose the following prerequisites must be met:
•You should be acquainted with the use of bioprocessing equipment and with the
handling of biological materials.
•You must read and understand the Safety chapter of this BioProcess LPLC and MPLC
column instruction manual.
•The column must be installed according to the instructions in the Installation chapter
of this BioProcess LPLC and MPLC column instruction manual.
Safety notices
This user documentation contains WARNINGS, CAUTIONS and NOTICES concerning the
safe use of the product. See definitions below.
EX
WARNING
EXPLOSION HAZARD! The triangle "EX" warning symbol highlights
instructions that must be followed to avoid death or serious injury
when working in a potentially explosive environment. It is important
not to proceed until all stated conditions are met and clearly under-
stood.
Warnings
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.
Cautions
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.
8 LPLC and MPLC Columns Operating Instructions 28-9638-66 AC
1 Introduction
1.2 Important user information

Notices
NOTICE
NOTICE indicates instructions that must be followed to avoid
damage to the product or other equipment.
LPLC and MPLC Columns Operating Instructions 28-9638-66 AC 9
1 Introduction
1.2 Important user information

1.3 Regulatory information
Introduction
This section lists the directives and standards that are fulfilled by BioProcess LPLC and
MPLC columns.
Manufacturing information
The table below summarizes the required manufacturing information. For further infor-
mation, see the EC Declaration Of Conformity document.
ContentRequirement
GE Healthcare Bio-Sciences AB,Name and address of manufacturer
Björkgatan 30, SE 751 84,
Uppsala, Sweden
Inspecta Sweden AB, NB 0409Name and ID of notified body for Euro-
pean market (97/23/EC)
See EC Declaration of ConformityPlace and date of declaration
See EC Declaration of ConformityIdentity of person authorized to sign DoC
International standards
The standard requirements fulfilled by this product are summarized in the table below.
NotesDescriptionStandard
Harmonized with
2006/42/EC
Safety of machinery. General princi-
ples for design. Risk assessment and
risk reduction.
EN ISO 12100
May be supplemented
or replaced by EN
13445-3
Pressure vessel and tubing stan-
dards
ASME-BPVC VIII
div. 1
May be supplemented
or replaced by ASME-
BPVC VIII div. 1
Unfired pressure vessels - Part 3:
Design
EN 13445-3
10 LPLC and MPLC Columns Operating Instructions 28-9638-66 AC
1 Introduction
1.3 Regulatory information

NotesDescriptionStandard
Harmonized with
94/9/EC
Explosive atmospheres - Explosion
prevention and protection - Part 1:
Basic concepts and methodology
EN 1127-1:2011
Harmonized with
94/9/EC
Non-electrical equipment for use in
potentially explosive atmospheres -
Part 1: Basic method and require-
ments
EN 13463-1:2009
CE Conformity
This product complies with the European directives listed in the table, by fulfilling the
corresponding harmonized standards.
TitleDirective
Machinery Directive (MD)2006/42/EC
Pressure Equipment Directive (PED)1 1997/23/EC
ATEX Directive2 1994/9/EC
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.
1Not applicable to all columns. See the EC Declaration of Conformity document.
2Not applicable to all columns. See the EC Declaration Of Conformity document and/or the
column identification label.
LPLC and MPLC Columns Operating Instructions 28-9638-66 AC 11
1 Introduction
1.3 Regulatory information

Regulatory compliance of
connected equipment
Any equipment connected to BioProcess LPLC or MPLC columns should meet the safety
requirements of EN 61010-1/IEC 61010-1, or relevant harmonized standards. Within EU,
connected equipment must be CE marked.
12 LPLC and MPLC Columns Operating Instructions 28-9638-66 AC
1 Introduction
1.3 Regulatory information

1.4 Associated documentation
Introduction
This section describes the documentation associated with BioProcess LPLC and MPLC
columns.
Column specific documentation
In addition to this Operating Instructions manual, the document package supplied with
BioProcess LPLC and MPLC columns also includes documentation binders containing
detailed specifications and traceability documents.
The most important documents in the document package with regard to the technical
aspects of BioProcess LPLC and MPLC columns are:
Purpose/ContentsAbbreviationDocument
Schematic overview of the entire process
flow, all components and instruments
and the control system.
P&IDPiping and Instrument
Diagram
Technical data for the column.EDSEquipment Data Sheet
Physical layout. Provides all dimensional
data.
ADAssembly Drawing
Detailed specifications for process
related components.
EQLEquipment List
EC declaration of conformity.DoCDeclaration of
Conformity1
List of spare parts available from GE
Healthcare.
SPLSpare Part List
1Applicable to columns supplied to customers within the European Community
Component documentation
Documentation for components produced both by GE Healthcare and by a third-party
are, if existent, also included in the document package.
LPLC and MPLC Columns Operating Instructions 28-9638-66 AC 13
1 Introduction
1.4 Associated documentation

2 Safety instructions
About this chapter
This chapter describes safety precautions and emergency shutdown procedures. Label
information is also explained and information regarding the decomissioning of columns
is provided.
Important
WARNING
Before installing, operating or maintaining
BioProcess LPLC or MPLC columns, all users must read and
understand the entire contents of this chapter to become aware
of the hazards involved.
Failure to do this may cause human injury or death, or damage to
the equipment.
In this chapter
This chapter contains the following sections:
See pageSection
152.1 Safety precautions
262.2 Labels
292.3 Emergency procedures
302.4 Recycling information
14 LPLC and MPLC Columns Operating Instructions 28-9638-66 AC
2 Safety instructions

2.1 Safety precautions
Introduction
The safety precautions in this section are grouped into the following categories:
•General precautions
•Flammable liquids and explosive environment
•Personal protection
•Installing and moving
•Operation
•Maintenance
General precautions
WARNING
Always follow these General Precautions to avoid injury when using
BioProcess LPLC or MPLC columns.
WARNING
Do not operate BioProcess LPLC or MPLC columns in any other way
than described in the BioProcess LPLC and MPLC column instruction
manual.
WARNING
The customer must ensure that all installation, maintenance,
operation and inspection is carried out by qualified personnel who
are adequately trained, understand and adhere to local regulations
and the operating instructions, and have a thorough knowledge
of the BioProcess column and the entire process.
LPLC and MPLC Columns Operating Instructions 28-9638-66 AC 15
2 Safety instructions
2.1 Safety precautions

WARNING
Do not use any accessories not supplied or recommended by GE
Healthcare.
WARNING
Do not use a BioProcess LPLC or MPLC column if it is not working
properly, nor if it has suffered any damage, for example:
•damage caused by dropping the equipment
•damage caused by splashing liquid onto it
WARNING
Perform a risk assessment for any risks due to the process or pro-
cess environment. Evaluate the effects the use of the BioProcess
column and processes have on the classification 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 protection equipment.
WARNING
High pressure. The emergency shutdown might result in high
pressures in the column and connected equipment flow path.
NOTICE
Whenever BioProcess LPLC or MPLC columns are used, always
keep the Operating Instructions on hand.
16 LPLC and MPLC Columns Operating Instructions 28-9638-66 AC
2 Safety instructions
2.1 Safety precautions

Flammable liquids and explosive
environment
EX
WARNING
EXPLOSION HAZARD! BioProcess LPLC and MPLC columns may
only be operated or maintained in a potentially explosive atmo-
sphere when specifically classified and certified for this purpose.
EX
WARNING
EXPLOSION HAZARD! If potentially explosive liquids will be used
with BioProcess LPLC or MPLC columns consult local authorities
regarding local rules and regulations before installing or operating.
EX
WARNING
EXPLOSION HAZARD! EX classification of
BioProcess LPLC and MPLC columns is valid only when it is used
according to the EX related safety instructions in this and the sub-
sequent chapters. The information is suggested best working
practice, but shall not take precedence over individual responsibil-
ities or local regulations.
LPLC and MPLC Columns Operating Instructions 28-9638-66 AC 17
2 Safety instructions
2.1 Safety precautions

EX
WARNING
EXPLOSION HAZARD Risk assessment! Perform a risk assessment
for any risks due to the process or process environment. Evaluate
the effects the use of the BioProcess column and processes have
on the classification 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 protection equipment.
To be considered when performing the risk assessment:
•All personnel involved in operating, maintaining and servicing
the column must have proper knowledge of ATEX and ATEX
columns.
•Risk of liquid leakage in case of failure or breakage of the col-
umn. Prepare procedures for handling leakages and testing
after corrective actions.
•Risk of air entering the flow path during filling and emptying
the column which might create an explosive atmosphere when
being mixed with vaporized solvent. Make sure that the liquid
flow path always is filled with 20% ethanol between runs.
•Risk of smaller leakages during maintenance. Make sure there
are no active ignition sources in the area during maintenance.
EX
WARNING
When using flammable liquids with BioProcess LPLC or MPLC
columns, follow these precautions to avoid any risk of fire or explo-
sion.
EX
WARNING
EXPLOSION HAZARD! When a BioProcess LPLC or MPLC column is
used in a potentially explosive atmosphere, EX-rated tools,
equipment and clothing MUST be used.
18 LPLC and MPLC Columns Operating Instructions 28-9638-66 AC
2 Safety instructions
2.1 Safety precautions

EX
WARNING
EXPLOSION HAZARD! To avoid building up an explosive atmosphere
when using flammable liquids, make sure that the room ventilation
meets the requirements specified in BioProcess LPLC or MPLC
columns Installation Guide.
EX
WARNING
EXPLOSION HAZARD! When a BioProcess LPLC or MPLC column is
operated or maintained in a potentially explosive atmosphere, it
MUST be properly grounded to avoid static discharge.
EX
WARNING
EXPLOSION HAZARD!
Avoid discharge from static electricity when working in potentially
explosive atmospheres by:
•Always using suitable clothing.
•Making sure that the entire system including the frame, piping
and column are connected to the plant grounding network.
•Use only non-sparking tools rated for EX-work.
EX
WARNING
EXPLOSION HAZARD!
Only tools and equipment for use in potentially explosive atmo-
spheres should be used for operation and maintenance.
EX
WARNING
Do not clean polymerics parts with a dry cloth or similar.
LPLC and MPLC Columns Operating Instructions 28-9638-66 AC 19
2 Safety instructions
2.1 Safety precautions

EX
WARNING
EXPLOSION HAZARD! Always use non-flammable liquids, for
example 20% ethanol, to pack the column, to flush solvents out of
the column, and to fill an empty column before filling it with sol-
vents. Otherwise, air might enter the flow path and create an
explosive atmosphere when being mixed with vaporized solvent.
The user is responsible for preparing procedures to make sure that
only nonflammable liquids, for example 20% ethanol, are used for
flushing the column or for filling an empty column before filling it
with solvents.
EX
WARNING
EXPLOSION HAZARD! When preparing organic solvent based
buffers in an empty container, always first fill the container with
inert gas. Work quickly with open containers. Otherwise, oxygen
and organic solvents might mix and create a potentially explosive
atmosphere.
EX
WARNING
Before maintenance, or if the column is to be moved to a non EX-
rated area, make sure that any flammable solvents have been
flushed out from the column.
Personal protection
WARNING
Always use appropriate personal protective equipment during
operation and maintenance of BioProcess LPLC or MPLC columns.
20 LPLC and MPLC Columns Operating Instructions 28-9638-66 AC
2 Safety instructions
2.1 Safety precautions