cytiva ReadyToProcess 600 User manual

ReadyToProcess 600 columns
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1 Introduction ........................................................................................................ 3
1.1 About this manual ......................................................................................................................................... 4
1.2 Important user information ....................................................................................................................... 5
2 Safety instructions ............................................................................................. 7
2.1 Safety precautions ........................................................................................................................................ 8
2.2 Label .................................................................................................................................................................... 11
3 Column description ............................................................................................ 13
3.1 General description ...................................................................................................................................... 14
3.2 Chemical resistance ..................................................................................................................................... 16
4 Installation .......................................................................................................... 17
4.1 Unpacking ......................................................................................................................................................... 18
4.2 Start using the column ................................................................................................................................. 19
5 Operation ............................................................................................................ 20
5.1 Connect the column ..................................................................................................................................... 22
5.2 Disconnect the column prior to disposal .............................................................................................. 24
6 Reference information ....................................................................................... 25
Index ........................................................................................................................... 26
Table of Contents
2 ReadyToProcess 600 columns Operating Instructions 29340020 AB

1 Introduction
About this chapter
This chapter contains important user information, descriptions of safety notices and
intended use of the ReadyToProcess™ 600 columns.
In this chapter
Section See page
1.1 About this manual 4
1.2 Important user information 5
1 Introduction
ReadyToProcess 600 columns Operating Instructions 29340020 AB 3

1.1 About this manual
Purpose of this manual
The Operating Instructions provides you with information specific to ReadyToProcess
600 column operation.
For detailed information about the product, production, testing, sanitization, resin
properties, technical data, etc. consult the ReadyToProcess Column User Manual
(28925644).
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
4 ReadyToProcess 600 columns Operating Instructions 29340020 AB

1.2 Important user information
Read this before using
ReadyToProcess 600 columns
All users must read this entire manual to fully understand the safe use of
ReadyToProcess 600 columns.
Intended use of ReadyToProcess 600
columns
ReadyToProcess 600 columns are designed for purification of biomolecules and can be
suitable for production of material for clinical phases I, II and III studies. Depending on
the scale of operations, ReadyToProcess 600 can be suitable for full-scale manufac-
turing as well as preclinical studies.
ReadyToProcess 600 columns are recommended for upflow mode and primarily
intended for use together with ÄKTA™ ready XL chromatography systems. The
ReadyToProcess 600 columns can also be used with some ÄKTAprocess™ systems.
WARNING
Do not operate ReadyToProcess 600 columns in any other way
than described in the Operating instructions.
Safety notices
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.
1 Introduction
1.2 Important user information
ReadyToProcess 600 columns Operating Instructions 29340020 AB 5

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
6 ReadyToProcess 600 columns Operating Instructions 29340020 AB

2 Safety instructions
About this chapter
This chapter describes safety precautions and the column label and information.
In this chapter
Section See page
2.1 Safety precautions 8
2.2 Label 11
2 Safety instructions
ReadyToProcess 600 columns Operating Instructions 29340020 AB 7

2.1 Safety precautions
General precautions
The columns must be used in accordance with the safety instructions and technical
specifications given in this Operating Instruction to avoid personal injury or possible
damage to equipment.
This Operating Instruction does not guarantee user safety – it is the responsibility of
the user's employer to ensure safe operation and provide appropriate training.
Information given in this Operating Instruction is a suggested best working practice
and shall in no way take precedence over individual responsibilities or local regulations.
During the operation and during other work with a column, it is always each individual's
responsibility to consider:
•their own and others' personal safety.
•the safety of the equipment through correct use in accordance with the descrip-
tions and instructions given in this Operating Instruction.
Flammable liquids and explosive
environment
WARNING: EXPLOSION HAZARD
The columns are not approved for work in a potentially explosive
atmosphere.
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.
2 Safety instructions
2.1 Safety precautions
8 ReadyToProcess 600 columns Operating Instructions 29340020 AB

Installation and moving
WARNING
Wash the column before disconnecting it from a system after use
to ensure that no hazardous chemicals (for example halogen-
containing salt buffers) are left in the column prior to disposal.
CAUTION
Use appropriate transportation and lifting devices (e.g. carts,
telphers or pallet lifters). All lifting must be performed in accord-
ance with local regulations.
CAUTION
Take care not to cause squeezing or crushing injuries during move-
ment. At least two, but preferably three or more people are recom-
mended when moving ReadyToProcess 600 columns.
NOTICE
ReadyToProcess 600 columns have wheels for convenient
handling. Make sure to clean the columns according to local proce-
dures before moving them into production areas and follow the
recommendations for chemical resistance.
Column operation
WARNING
Make sure that there is no residual pressure in the column before
any tubing is disconnected.
2 Safety instructions
2.1 Safety precautions
ReadyToProcess 600 columns Operating Instructions 29340020 AB 9

WARNING
•Never exceed the rated operating pressure of the column.
•Install a pressure relief system (e.g. pressure relief valve or
rupture discs) according to local regulations.
•Always install the pressure relief system directly before the
column in the direction of flow.
•Make sure that the pressure relief valve or rupture disc has
adequate relieving capacity.
CAUTION
Wash/wipe off any NaOH residue from the surface of the column.
NOTICE
The column is designed to run in upflow mode. Therefore, the pres-
sure relief valve or rupture disc must be installed on the inlet tube.
If the column is run in downflow mode, the pressure relief valve or
rupture disc must be placed on the outlet tube.
2 Safety instructions
2.1 Safety precautions
10 ReadyToProcess 600 columns Operating Instructions 29340020 AB

2.2 Label
Column label
The column label contains the product name with information about the preservative
and if it is flammable. The items on the column label are described in the table below.
Label text Description
Article
number
Article number for the column.
Column size Column volume (L), (inner diameter (mm) / bed height (mm)).
Lot Lot number. Refers to a column produced at a specific time.
The lot number and ID number ensure that the ReadyToProcess
600 column is fully traceable to the production source.
Expiry Estimated expiry date. (YYYY-MM)
Id No. Identifies the individual column. The lot number and ID number
ensure that the ReadyToProcess 600 column is fully traceable to
the production source.
Manf. Manufacturing date. (YYYY-MM)
Bar code The bar code (GS1-128, a total of 30 digits) contains an application
identifier1 (90), the code number (digits 3 to 10), a second applica-
tion identifier (10), lot number (digits 13 to 20), a third application
identifier (21) and the ID number (digits 23 to 30).
Store at Recommended storage temperature when the column is not in
use.
Operating
Pressure
Shows the maximum operating pressure for the ReadyToProcess
600 column.
Note:
Different resins have different maximum operating pressure drops
to ensure the integrity of the packed bed.
Operating
Tempera-
ture
Shows the operating temperature interval for the ReadyToProcess
600 column.
For flammable resins, the word Warning and a "flammable" picto-
gram is on the label together with the text: Flammable liquid and
vapor. Keep away from heat/sparks/open flames/hot surfaces. No
smoking. Keep container tightly closed. Wear protective gloves.
Store in a well ventilated place. Keep cool.
2 Safety instructions
2.2 Label
ReadyToProcess 600 columns Operating Instructions 29340020 AB 11

Label text Description
The column complies with applicable European directives.
2 Safety instructions
2.2 Label
12 ReadyToProcess 600 columns Operating Instructions 29340020 AB

3 Column description
About this chapter
This chapter provides a description of the ReadyToProcess 600 columns and an illus-
tration of the exterior parts.
In this chapter
Section See page
3.1 General description 14
3.2 Chemical resistance 16
3 Column description
ReadyToProcess 600 columns Operating Instructions 29340020 AB 13

3.1 General description
ReadyToProcess 600 columns are supplied as complete, ready-to-use units that
connect directly to a chromatography system.
For detailed information about the product sizes, production, testing, sanitization,
resin properties, technical data, etc. consult the ReadyToProcess Column User Manual
(28925644).
Exterior parts
The image below shows the exterior parts of a ReadyToProcess 600 column.
1
2
3
4
5
6
7
8
9
10
Part Function
1 Column label
2 Column tube
3 Tie rod
3 Column description
3.1 General description
14 ReadyToProcess 600 columns Operating Instructions 29340020 AB

Part Function
4 Inlet (marked Bottom Inlet)
5 Outlet (marked Top Outlet)
6 Top lid
7 Protective rim
8 Handle
9 Bottom lid
10 Wheel
3 Column description
3.1 General description
ReadyToProcess 600 columns Operating Instructions 29340020 AB 15

3.2 Chemical resistance
Chemical resistance external
surfaces
The table below shows the chemical resistance of the external surfaces of 600 mm i.d.
ReadyToProcess 600 columns with exposure times up to 24 hours.
Chemical resistance of 600 mm i.d. columns Concentration
Ethanol120%
2-propanol230%
Acetone 2%
1Ethanol (maximum 20% w/w) is compatible with the acrylic tube material in ReadyToProcess
600 columns at < 30°C.
22-propanol (maximum 30% w/w) is compatible with the acrylic tube material in
ReadyToProcess 600 columns at < 30°C.
3 Column description
3.2 Chemical resistance
16 ReadyToProcess 600 columns Operating Instructions 29340020 AB

4 Installation
About this chapter
This chapter contains information about unpacking ReadyToProcess 600 columns and
removing the packaging, and warnings before use.
In this chapter
Section See page
4.1 Unpacking 18
4.2 Start using the column 19
4 Installation
ReadyToProcess 600 columns Operating Instructions 29340020 AB 17

4.1 Unpacking
Precautions
CAUTION
Use appropriate transportation and lifting devices (e.g. carts,
telphers or pallet lifters). All lifting must be performed in accord-
ance with local regulations.
CAUTION
Take care not to cause squeezing or crushing injuries during move-
ment. At least two, but preferably three or more people are recom-
mended when moving ReadyToProcess 600 columns.
Visual inspection
•Check that the equipment in the box is the same as the equipment listed on the
packing list.
•Examine the equipment for damage.
•If the equipment is damaged, make thorough record and contact Cytiva.
Handling the column upon arrival
ReadyToProcess 600 columns are delivered in a plastic bag inside a crate with sepa-
rate unpacking instructions. The columns have wheels for convenient handling.
NOTICE
Make sure to clean the columns according to local procedures
before moving them into production areas and follow the recom-
mendations for chemical resistance.
4 Installation
4.1 Unpacking
18 ReadyToProcess 600 columns Operating Instructions 29340020 AB

4.2 Start using the column
Precautions
WARNING
•Never exceed the rated operating pressure of the column.
•Install a pressure relief system (e.g. pressure relief valve or
rupture discs) according to local regulations.
•Always install the pressure relief system directly before the
column in the direction of flow.
•Make sure that the pressure relief valve or rupture disc has
adequate relieving capacity.
CAUTION
Do not exceed recommended maximum pressure drop over the
packed bed to avoid damage to the bed. The maximum pressure
drop varies with chromatography resin used.
NOTICE
Do not turn, twist or break the inlet TC-connection or the outlet TC-
connection. Handle the connections with care.
NOTICE
The column is designed to run in upflow mode. Therefore, the pres-
sure relief valve or rupture disc must be installed on the inlet tube.
If the column is run in downflow mode, the pressure relief valve or
rupture disc must be placed on the outlet tube.
4 Installation
4.2 Start using the column
ReadyToProcess 600 columns Operating Instructions 29340020 AB 19

5 Operation
About this chapter
This chapter provides the information required to operate ReadyToProcess 600
column in a safe way.
In this chapter
Section See page
5.1 Connect the column 22
5.2 Disconnect the column prior to disposal 24
Precautions
WARNING
•Never exceed the rated operating pressure of the column.
•Install a pressure relief system (e.g. pressure relief valve or
rupture discs) according to local regulations.
•Always install the pressure relief system directly before the
column in the direction of flow.
•Make sure that the pressure relief valve or rupture disc has
adequate relieving capacity.
WARNING
Make sure that there is no residual pressure in the column before
any tubing is disconnected.
CAUTION
Do not exceed recommended maximum pressure drop over the
packed bed to avoid damage to the bed. The maximum pressure
drop varies with chromatography resin used.
5 Operation
20 ReadyToProcess 600 columns Operating Instructions 29340020 AB