cytiva Chromaflow 50 User manual

Chromaflow Packing Station
50, 100, 200, and 400
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1Introduction ........................................................................................................ 4
1.1 About this manual ......................................................................................................................................... 5
1.2 Important user information ....................................................................................................................... 6
1.3 Associated documentation ....................................................................................................................... 8
2 Safety instructions ............................................................................................. 9
2.1 Safety precautions ........................................................................................................................................ 10
2.2 Labels ................................................................................................................................................................. 16
2.3 Emergency procedures ............................................................................................................................... 18
3 System description ............................................................................................ 22
3.1 Chromaflow Packing Station main components .............................................................................. 23
3.2 Control panels ................................................................................................................................................. 27
3.3 Flowchart .......................................................................................................................................................... 33
4 Installation .......................................................................................................... 36
4.1 Site requirements .......................................................................................................................................... 38
4.2 Transport in crate .......................................................................................................................................... 39
4.3 Unpack from the crate ................................................................................................................................. 40
4.4 Transport when unpacked .......................................................................................................................... 45
4.5 Setup ................................................................................................................................................................... 46
4.5.1 Set up your Chromaflow Packing Station ......................................................................................... 47
4.5.2 Connect compressed air supply ............................................................................................................. 48
4.5.3 Guidelines for connections ....................................................................................................................... 49
4.5.4 Grounding connection ................................................................................................................................ 50
4.5.5 Connect a column ........................................................................................................................................ 51
5 Operation ............................................................................................................ 56
5.1 Prepare your Chromaflow Packing Station ........................................................................................ 58
5.1.1 Final actions before operating ................................................................................................................ 59
5.1.2 Priming .............................................................................................................................................................. 60
5.2 Pack a column ................................................................................................................................................. 61
5.3 Unpack a column ............................................................................................................................................ 62
5.4 Disconnection after use .............................................................................................................................. 63
6 Maintenance ....................................................................................................... 64
6.1 User maintenance schedule ...................................................................................................................... 66
6.2 Cleaning ............................................................................................................................................................ 68
6.2.1 Cleaning a Chromaflow Packing Station without a connected column ............................... 70
6.2.2 Cleaning a Chromaflow Packing Station and a connected column ....................................... 75
6.3 Storage .............................................................................................................................................................. 76
7 Troubleshooting ................................................................................................. 78
8 Reference information ....................................................................................... 80
8.1 Specifications .................................................................................................................................................. 81
8.2 Chemical resistance ..................................................................................................................................... 85
Table of Contents
2 Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD

8.3 Noise level ......................................................................................................................................................... 86
8.4 Recycling information .................................................................................................................................. 87
8.5 Regulatory information ............................................................................................................................... 88
8.5.1 Contact information .................................................................................................................................... 89
8.5.2 European Union and European Economic Area .............................................................................. 90
8.5.3 Other regulations and standards .......................................................................................................... 91
8.6 Health and Safety Declaration Form ...................................................................................................... 92
8.7 Further information ...................................................................................................................................... 94
Index ........................................................................................................................... 95
Table of Contents
Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD 3

1 Introduction
About this chapter
This chapter contains important user information, descriptions of safety notices, regu-
latory information, intended use of Chromaflow™ Packing Station, and a list of associ-
ated documentation.
In this chapter
Section See page
1.1 About this manual 5
1.2 Important user information 6
1.3 Associated documentation 8
1 Introduction
4 Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD

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
The Operating Instructions cover all sizes of Chromaflow Packing Station.
For detailed information about each individual Chromaflow Packing Station refer to
the relevant information in the documentation package provided with each product.
Contact your local Cytiva representative for more information, if needed.
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.
1 Introduction
1.1 About this manual
Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD 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 operate the product in any other way than described in the user documenta-
tion. 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
Chromaflow Packing Station is intended to be used for packing and unpacking
Chromaflow columns with chromatography resin slurry.
Chromaflow Packing Station shall not be used in any clinical procedures, or for diag-
nostic purposes.
Chromaflow Packing Station is not suitable for operation in a potentially explosive
atmosphere or for handling liquids under conditions at which they could be flammable.
Prerequisites
In order to operate your Chromaflow Packing Station safely and according to the
intended purpose, the following prerequisites must be met:
•You should be acquainted with the use of general bioprocessing equipment and
with the handling of biological materials.
•You must read and understand the Safety chapter of these Operating Instructions.
•The system must be installed according to the instructions in Chapter 4 Installation,
on page 36.
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 Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD

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
Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD 7

1.3 Associated documentation
Introduction
This section describes the documentation associated with your Chromaflow Packing
Station.
Product specific documentation
In addition to the Operating Instructions manual, the documentation package supplied
with each Chromaflow Packing Station also includes detailed specifications and trace-
ability documents.
The most important documents in the documentation package with regard to tech-
nical aspects of each Chromaflow Packing Station are:
Document Abbrevia-
tion
Contents
Piping and Instrumenta-
tion Diagram
P&ID Schematic overview of the entire
process flow, including all components
and instruments.
General Specification GS Technical data for the system.
Assembly Drawing AD Physical layout. Provides all dimen-
sional data.
Bill of Material BoM Detailed parts list.
Material Conformity MC Details of compliance for materials.
Third-party component
documentation
Documentation for components produced by a third-party is included where appli-
cable.
1 Introduction
1.3 Associated documentation
8 Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD

2 Safety instructions
About this chapter
This chapter describes safety precautions and emergency shutdown procedures for
your Chromaflow Packing Station. The labels on the instrument and information
regarding recycling are also described.
In this chapter
Section See page
2.1 Safety precautions 10
2.2 Labels 16
2.3 Emergency procedures 18
2 Safety instructions
Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD 9

2.1 Safety precautions
Introduction
The safety precautions in this section are grouped in the following categories:
•General precautions, on page 10
•Flammable liquids and explosive environment, on page 11
•Personal protection, on page 11
•Installing and moving, on page 12
•System operation, on page 13
•Maintenance, on page 14
General precautions
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
Use only approved parts. Only spare parts and accessories that
are approved or supplied by Cytiva may be used for maintaining or
servicing the product.
2 Safety instructions
2.1 Safety precautions
10 Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD

Flammable liquids and explosive
environment
WARNING
Flammable liquids. This product is not approved for handling
liquids under flammable conditions. Make sure to use liquids only
under conditions where they are not flammable. Refer to local
and/or national classifications of flammable liquids.
WARNING
Non-flammable conditions. 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 flam-
mable. Refer to local and national classifications of flammable
liquids.
Personal protection
WARNING
Hazardous substances and biological agents. When using
hazardous chemical and biological agents, take all suitable protec-
tive measures, such as wearing protective clothing, glasses and
gloves resistant to the substances used. Follow local and/or
national regulations for safe operation and maintenance of this
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
Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD 11

CAUTION
Use ear protection whenever working close to the system in opera-
tion.
Installing and moving
WARNING
Heavy object. Because of the significant weight of Chromaflow
Packing Station, care must be taken not to cause squeezing or
crushing injuries during movement.
WARNING
Only personnel with appropriate training may move and unpack
the delivery crates. All movement and unpacking must be
performed in adherence with local regulations.
Even if the instructions in the user documentation and instruction
manuals are followed, it is the customers' responsibility to guar-
antee the safety of the personnel working with the product.
CAUTION
Lock wheels. The wheels of Chromaflow Packing Station should
be locked during normal use. The wheels should only be unlocked
when moving the instrument.
CAUTION
The product may be partly filled with denatured alcohol (18%
C2H5OH (ethanol), 2% C3H7OH (isopropanol) and 80% H2O (water))
at delivery.
The denatured alcohol mixture can be hazardous to humans
if consumed.
Flush out the denatured alcohol before assembling, testing or inte-
grating the product into the intended process context.
2 Safety instructions
2.1 Safety precautions
12 Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD

CAUTION
Do not turn on the air supply before all connections have been
made and checked.
NOTICE
The system is not fitted with lifting eye bolts or other equipment for
lifting with telphers or similar equipment. The system should only
be lifted using the lower part of the frame.
CAUTION
The product is designed for indoor use only.
System operation
WARNING
High pressure. The flow rate may under no circumstances exceed
the specified column maximum flow rate. High flows might affect
the packed resin, causing the pressure to exceed the specified
column maximum pressure.
WARNING
Operating limits. Never exceed the operating limits stated in this
document and on the product label.
WARNING
Power failure of connected systems. During a power failure of a
connected system, or if the EMERGENCY STOP button is pressed
on connected equipment, the equipment may remain pressurized.
Opening a line or vessel at this point could result in the release of
potentially hazardous process or cleaning fluid, and cause bodily
harm.
When recovering from a power failure or emergency shutdown of a
connected system, make sure all lines and vessels are depressur-
ized before opening.
2 Safety instructions
2.1 Safety precautions
Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD 13

WARNING
Use columns that withstand expected pressures. Always use
appropriate pressure alarms, pressure vents or rupture discs, and
safety equipment. If not, the columns might rupture, resulting in
injury.
CAUTION
Reduce the pump setting prior to using the START/RESET button,
to avoid an immediate high pressure increase in the system when it
is reactivated. A sudden pressure increase may cause rupture of
piping connections and consequent leakage.
CAUTION
Reduce the pump speed prior to turning the AIR SUPPLY switch to
OFF, to avoid an immediate high pressure increase in the system
when it is reactivated. A sudden pressure increase may cause
rupture of piping connections and consequent leakage.
CAUTION
Always turn off the compressed air supply before disconnecting
Chromaflow Packing Station from the column.
Maintenance
WARNING
LOCK OUT / TAG OUT (LOTO)! Before any maintenance or
decommissioning work is performed on the system, make sure
that:
•the system is empty and depressurized.
•the system is disconnected from process feed, electrical power
and pneumatic supply.
•the system is prevented from accidentally becoming re-ener-
gized during maintenance.
•the system is clearly tagged as taken out of operation.
•all process wetted areas are clean and decontaminated.
2 Safety instructions
2.1 Safety precautions
14 Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD

WARNING
Do not perform any type of service while Chromaflow Packing
Station is connected to an air supply.
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.
WARNING
Do not use chemicals at temperatures above the specified limits.
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
For continued protection against injury risks due to fluid jets or
burst pipes, 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
Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD 15

2.2 Labels
Introduction
This section describes the labels and symbols on your Chromaflow Packing Station.
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.
System label description
The system label information is explained in the table below.
Label text Description
The instrument complies with applicable Euro-
pean directives.
Code no. Code number identifying the product size and type
Serial no. Serial number of the individual product
Year of manufacture Manufacturing year
Operating temperature
TS:
Allowed fluid temperature range
Supply air pressure Compressed air supply pressure requirements
Air consumption Volume of air supply per minute required for oper-
ation
Max. outlet pressure Maximum outlet pressure
Pump capacity Volume able to be pumped, in liters per minute
Safety labels
The table below shows the safety labels that may be found on your Chromaflow
Packing Station.
2 Safety instructions
2.2 Labels
16 Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD

Symbol/text Description
Warning! Read the user documentation before using the
system. Do not open any covers or replace parts unless
specifically stated in the user documentation.
EMERGENCY STOP label, yellow with black text. (EMER-
GENCY STOP button is red).
See Section 2.3 Emergency procedures, on page 18 for
further information regarding the emergency stop.
WARNING. The pump housing is under spring pressure.
CAUTION! Pressure control valve shall be set to 6 bar g
for instrument air supply.
Ear protection must be worn whenever working close to a
Chromaflow Packing Station in operation.
Grounding point. Make sure to ground the system
according to the instructions in Grounding point, on page
50.
2 Safety instructions
2.2 Labels
Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD 17

2.3 Emergency procedures
Introduction
This section describes how to perform an emergency shutdown and the procedure for
restarting Chromaflow Packing Station following an emergency shutdown.
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.
2 Safety instructions
2.3 Emergency procedures
18 Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD

Emergency shutdown
Step Action
1Press the EMERGENCY STOP button on the lower control panel of the
Chromaflow Packing Station.
2Call medical help or apply first aid if the emergency situation has caused
injury.
3Depressurize the lines and vessels that are under pressure. This is done by
opening valves and disconnecting hoses carefully.
4Diagnose and remedy the root cause of the problem.
5Contact Cytiva if the problem cannot be solved.
Restart after emergency shutdown
Follow the instruction below to restart a Chromaflow Packing Station after emergency
shutdown.
2 Safety instructions
2.3 Emergency procedures
Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD 19

Step Action
1Make sure that the condition that caused the emergency stop is corrected.
2Reset the EMERGENCY STOP button by turning it clockwise.
2 Safety instructions
2.3 Emergency procedures
20 Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD