cytiva Media Wand User manual

Media Wand™ and Media
Handling Unit
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1 Introduction ........................................................................................................ 4
1.1 Important user information ....................................................................................................................... 5
1.2 About this manual ......................................................................................................................................... 7
1.3 Abbreviations .................................................................................................................................................. 8
2 Safety instructions ............................................................................................. 9
2.1 Safety precautions ........................................................................................................................................ 10
2.2 Labels and symbols ....................................................................................................................................... 13
2.3 Emergency procedures ............................................................................................................................... 14
3 System description ............................................................................................ 16
3.1 Media Wand and Media Handling Unit .................................................................................................. 17
3.2 Control panel ................................................................................................................................................... 20
3.3 Media Wand .................................................................................................................................................... 22
4 Installation .......................................................................................................... 26
4.1 Safety precautions ........................................................................................................................................ 27
4.2 Site requirements .......................................................................................................................................... 28
4.3 Transport .......................................................................................................................................................... 29
4.4 Unpacking ......................................................................................................................................................... 30
4.5 Assembly ........................................................................................................................................................... 31
5 Operation ............................................................................................................ 33
5.1 Safety precautions ........................................................................................................................................ 34
5.2 Prime the Media Wand and Media Handling Unit ............................................................................. 35
5.3 Check the flow of the Media Handling Unit ......................................................................................... 38
5.4 Remove transport solution from a resin container ........................................................................... 40
5.5 Adjust resin concentration and prepare a slurry ............................................................................... 42
5.6 Use of Media Wand with Chromaflow Packing Station 100 .......................................................... 47
5.6.1 Connect a Media Wand to a Chromaflow Packing Station 100 ............................................... 48
5.6.2 Prime the Chromaflow Packing Station 100 and Media Wand ................................................ 50
5.6.3 Check the flow of the Chromaflow Packing Station 100 ............................................................. 52
5.6.4 Remove the transport solution from a resin container ................................................................. 54
5.6.5 Prepare the slurry for use .......................................................................................................................... 56
5.7 Procedures after a run ................................................................................................................................. 62
6 Maintenance ....................................................................................................... 63
6.1 Safety precautions ........................................................................................................................................ 64
6.2 Cleaning before planned service ............................................................................................................. 65
6.3 User maintenance schedule ...................................................................................................................... 66
6.4 Rinse the Media Wand and Media Handling Unit with water ........................................................ 67
6.5 Clean the Media Wand ................................................................................................................................ 69
6.6 Clean the Media Handling Unit ................................................................................................................ 70
6.7 Storage .............................................................................................................................................................. 73
Table of Contents
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7 Troubleshooting ................................................................................................. 74
8 Reference information ....................................................................................... 75
8.1 Media Wand specifications ........................................................................................................................ 76
8.2 Media Handling Unit specifications ........................................................................................................ 77
8.3 Chemical resistance ..................................................................................................................................... 78
8.4 Recycling information .................................................................................................................................. 80
8.5 Regulatory information ............................................................................................................................... 81
8.5.1 Contact information .................................................................................................................................... 82
8.5.2 European Union and European Economic Area .............................................................................. 83
8.5.3 Great Britain ................................................................................................................................................... 84
8.5.4 Other regulations and standards .......................................................................................................... 85
8.6 Ordering information ................................................................................................................................... 86
8.7 Health and Safety Declaration Form ...................................................................................................... 87
Index ........................................................................................................................... 89
Table of Contents
Media Wand and Media Handling Unit Operating Instructions 28963868 AD 3

1 Introduction
About this chapter
This chapter contains important user information, descriptions of safety notices and
intended use of the Media Wand™ and the Media Handling Unit.
In this chapter
Section See page
1.1 Important user information 5
1.2 About this manual 7
1.3 Abbreviations 8
1 Introduction
Media Wand and Media Handling Unit Operating Instructions 28963868 AD 4

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
The Media Wand and Media Handling Unit are intended for use in the preparation and
handling of bulk chromatography resin solutions for the separation of biomolecules
such as proteins, peptides and oligonucleotides in GMP-regulated environments.
Use of the Media Wand and Media Handling Unit facilitates the preparation of chroma-
tography resin solutions and the transfer of chromatography resin solutions to the
column or slurry tank. Media Wand can also be used together with Chromaflow™
Packing Station 100, see Section 5.6 Use of Media Wand with Chromaflow Packing
Station 100, on page 47.
The products are specifically developed for the simplification of the following proce-
dures:
•removal of transport solutions from resin containers.
•addition of buffer and preparation of resin slurry in a resin container.
•transfer of resin slurry to a process column or slurry tank.
The Media Handling Unit is not approved for use in a potentially explosive environment
or for other purposes than those described in this manual.
The Media Wand and Media Handling Unit are intended for production use only and
must not be used for diagnostic purposes in any clinical or in vitro procedures.
Prerequisites
In order to operate the products in a safe way and according to the intended purpose
the following prerequisites must be met:
•The user must be acquainted with the use of general process equipment and with
handling of biological materials.
1 Introduction
1.1 Important user information
Media Wand and Media Handling Unit Operating Instructions 28963868 AD 5

•The user must read Chapter 2 Safety instructions, on page 9 of these operating
instructions.
•The products must be installed according to the instructions in Chapter 4 Installa-
tion, on page 26 of these Operating Instructions.
•The user must be trained in handling chromatography resin in general.
1 Introduction
1.1 Important user information
Media Wand and Media Handling Unit Operating Instructions 28963868 AD 6

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
The Operating Instructions cover the Media Wand and Media Handling Unit.
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
Media Wand and Media Handling Unit Operating Instructions 28963868 AD 7

1.3 Abbreviations
Introduction
This section explains abbreviations that appear in the user documentation for Media
Wand and Media Handling Unit.
Abbreviation Definition Translation
CIP Cleaning In Place Cleaning In Place
i.d. inner diameter inner diameter
o.d. outer diameter outer diameter
PPE Personal Protective Equip-
ment
Personal Protective Equip-
ment
TC-clamp hygienic tubing connection hygienic tubing connection
WFI Water For Injection Water For Injection
1 Introduction
1.3 Abbreviations
Media Wand and Media Handling Unit Operating Instructions 28963868 AD 8

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 10
2.2 Labels and symbols 13
2.3 Emergency procedures 14
Important
WARNING
All users must read and understand the entire contents of
this general safety chapter, and the specific safety precau-
tions information in each subsequent chapter of this manual
to become aware of the hazards involved.
2 Safety instructions
Media Wand and Media Handling Unit Operating Instructions 28963868 AD 9

2.1 Safety precautions
Introduction
Before installing, operating or maintaining the instruments, you must be aware of the
hazards described in the user documentation.
Follow the instructions provided 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
•Flammable liquids
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
Media Wand and Media Handling Unit Operating Instructions 28963868 AD 10