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