cytiva Sepax C-Pro User manual

Sepax™ C-Pro
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1Introduction ........................................................................................................ 4
1.1 Important user information ....................................................................................................................... 5
1.2 About this manual ......................................................................................................................................... 6
1.3 Associated documentation ....................................................................................................................... 7
2 Safety instructions ............................................................................................. 9
2.1 Safety precautions ........................................................................................................................................ 10
2.2 Labels and symbols ....................................................................................................................................... 12
2.3 Emergency procedures ............................................................................................................................... 15
3 System description ............................................................................................ 18
3.1 System overview ............................................................................................................................................ 19
3.2 Touchscreen user interface ....................................................................................................................... 23
3.2.1 User roles ......................................................................................................................................................... 24
3.2.2 GMAP 5.5 user interface ............................................................................................................................ 27
3.2.3 GMAP 6.0 user interface ............................................................................................................................ 38
3.3 Data privacy and security ........................................................................................................................... 48
3.4 Applications and kits .................................................................................................................................... 50
3.4.1 Applications .................................................................................................................................................... 51
3.4.2 Cell processing kits ...................................................................................................................................... 52
3.4.3 Application and kit combinations .......................................................................................................... 53
3.4.4 Pneumatic kit for manual purge ............................................................................................................ 54
3.5 Peripherals ....................................................................................................................................................... 55
4 Installation .......................................................................................................... 56
4.1 Safety precautions ........................................................................................................................................ 57
4.2 Site preparation .............................................................................................................................................. 58
4.2.1 Delivery, storage and unpacking ........................................................................................................... 59
4.2.2 Room requirements .................................................................................................................................... 64
4.2.3 Site environmental requirements ......................................................................................................... 67
4.2.4 Power requirements ................................................................................................................................... 68
4.3 Electrical connections ................................................................................................................................. 69
5 Operation GMAP 5.5 ........................................................................................... 73
5.1 Safety precautions ........................................................................................................................................ 74
5.2 Start-up and shutdown ................................................................................................................................ 75
5.3 Changing settings ......................................................................................................................................... 79
5.3.1 Traceability settings .................................................................................................................................... 80
5.3.2 Authentication settings ............................................................................................................................. 82
5.3.3 System settings ............................................................................................................................................. 84
5.4 Managing users .............................................................................................................................................. 86
5.5 Managing applications ................................................................................................................................ 90
5.6 Running a procedure .................................................................................................................................... 92
5.6.1 Overview ........................................................................................................................................................... 93
5.6.2 Select an application ................................................................................................................................... 94
5.6.3 Edit parameters ............................................................................................................................................ 95
5.6.4 Set up traceability IDs ................................................................................................................................. 99
5.7 Working with data files ................................................................................................................................ 101
Table of Contents
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 2

5.8 Working with system logs ........................................................................................................................... 103
6Operation GMAP 6.0 ........................................................................................... 106
6.1 Safety precautions ........................................................................................................................................ 107
6.2 Start-up and shutdown ................................................................................................................................ 108
6.3 Changing settings ......................................................................................................................................... 112
6.3.1 Traceability settings .................................................................................................................................... 113
6.3.2 Authentication settings ............................................................................................................................. 115
6.3.3 System settings ............................................................................................................................................. 117
6.4 Managing users .............................................................................................................................................. 118
6.5 Managing applications ................................................................................................................................ 122
6.6 Running a procedure .................................................................................................................................... 124
6.6.1 Overview ........................................................................................................................................................... 125
6.6.2 Select an application ................................................................................................................................... 126
6.6.3 Edit parameters ............................................................................................................................................ 127
6.6.4 Set up traceability IDs ................................................................................................................................. 131
6.7 Working with data files ................................................................................................................................ 134
6.8 Working with system logs ........................................................................................................................... 136
7 Maintenance ....................................................................................................... 139
7.1 Safety precautions ........................................................................................................................................ 140
7.2 Cleaning ............................................................................................................................................................ 141
7.3 Cleaning before planned maintenance/service ................................................................................. 143
8 Troubleshooting ................................................................................................. 144
8.1 Overview ............................................................................................................................................................ 145
8.2 Warning and error messages .................................................................................................................... 146
9 Reference information ....................................................................................... 157
9.1 Get Help ............................................................................................................................................................. 158
9.2 Specifications .................................................................................................................................................. 159
9.3 Recycling information .................................................................................................................................. 161
9.4 Regulatory information ............................................................................................................................... 162
9.4.1 Contact information .................................................................................................................................... 163
9.4.2 Regulatory support ...................................................................................................................................... 164
9.4.3 European Union and European Economic Area .............................................................................. 165
9.4.4 Great Britain ................................................................................................................................................... 166
9.4.5 Eurasian Economic Union (Евразийский экономический союз) .......................................... 167
9.4.6 North America ............................................................................................................................................... 169
9.4.7 Regulatory statements .............................................................................................................................. 170
9.4.8 Declaration of Hazardous Substances (DoHS) ................................................................................ 171
9.5 Health and Safety Declaration Form ...................................................................................................... 173
Table of Contents
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 3

1 Introduction
About this chapter
This chapter contains information about this manual and associated user documenta-
tion, important user information and intended use of the product.
In this chapter
Section See page
1.1 Important user information 5
1.2 About this manual 6
1.3 Associated documentation 7
1 Introduction
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 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.
Introduction to Sepax C-Pro
The Sepax™ C-Pro Cell Processing System consists of the Sepax C-Pro instrument,
Sepax C-Pro cell processing kits, and Sepax C-Pro software applications.
Intended use
The Sepax C-Pro Cell Processing System is an automated and functionally-closed tech-
nology developed for cell processing when manufacturing cell therapy products. It
combines exclusively with Sepax C-Pro software applications and cell processing kits
to process cellular products. The system allows for versatile combinations of multiple
processing steps, including and not limited to concentration, enrichment, magnetic
bead incubation, spinoculation, washing, dilution, and splitting.
The Sepax C-Pro is not intended for any therapeutic or diagnostic use in humans. Only
for use with compatible Sepax C-Pro software applications and cell processing kits.
Automation benefits
The Sepax C-Pro system enables automated cell processing, reducing the need for
manual handling. Accordingly, processing of cells can be performed in a time-efficient
and reliable manner. Furthermore, the functionally closed single-use kits allow the cell
processing to be carried out in a closed environment, which reduces the risk of envi-
ronmental contamination of the cellular product, improves reproducibility and facili-
tates compliance to Good Manufacturing Practices.
1 Introduction
1.1 Important user information
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 5

1.2 About this manual
Purpose of this manual
This manual provides information needed to install, operate and maintain the product
in a safe way.
Scope of this manual
The Sepax C-Pro Operating Instructions covers the Sepax C-Pro instrument only. For
how to use an application with the Sepax C-Pro instrument, see the separate Operator
Manual supplied with the application.
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.
Typographical conventions
Software items are identified in the text by bold italic text.
Hardware items are identified in the text by bold text.
Text that the user must either type exactly as shown in the manual, or that the software
displays as a response (not a regular part of the graphic user interface), is shown by a
monospaced typeface (for example, Recipe Information).
Tip: The text can include clickable hyperlinks to reference information.
1 Introduction
1.2 About this manual
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 6

1.3 Associated documentation
User documentation for Sepax C-Pro
The user documentation is listed in the table below.
Translations of the Operating Instructions are provided on the USB flash drive located
in the instrument box. Printed copies of the user documentation are available on
request from Cytiva.
Documentation Main Contents
Sepax C-Pro Operating Instructions
(29350570)
(this document)
Instructions needed to prepare and
operate the Sepax C-Pro instrument in a
correct and safe way.
System overview, site requirements,
and instructions for moving the system
within the same building.
Instructions for basic maintenance and
troubleshooting.
Sepax S-100, Sepax 2 RM, and Sepax C-
Pro GMAP 5.5 Privacy and Security
Manual (29494414)
Privacy and Security considerations of
the use of Sepax C-Pro instrument with
GMAP 5.5 .
Sepax S-100, Sepax 2 RM, and Sepax C-
Pro GMAP 6.0 Privacy and Security
Manual (29699386)
Privacy and Security considerations of
the use of Sepax C-Pro instrument with
GMAP 6.0 .
BeadWash C-Pro Operator Manual
(29297121)
Information needed to run the Bead-
Wash C-Pro application on the Sepax C-
Pro instrument.
CultureWash C-Pro Operator Manual
(29371953)
Information needed to run the Culture-
Wash C-Pro application on the Sepax C-
Pro instrument.
Dilution C-Pro Operator Manual
(29658287)
Information needed to run the Dilution
C-Pro application on the Sepax C-Pro
instrument.
NeatCell C-Pro Operator Manual
(29657667)
Information needed to run the NeatCell
C-Pro application on the Sepax C-Pro
instrument.
PeriCell C-Pro Operator Manual
(29657669)
Information needed to run the PeriCell
C-Pro application on the Sepax C-Pro
instrument.
PlateletFree-Pro Operator Manual
(29297124)
Information needed to run the Platelet-
Free-Pro application on the Sepax C-Pro
instrument.
1 Introduction
1.3 Associated documentation
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 7

Documentation Main Contents
SpinOculation C-Pro Operator Manual
(29367191)
Information needed to run the SpinOcu-
lation C-Pro application on the Sepax C-
Pro instrument.
1 Introduction
1.3 Associated documentation
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 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 12
2.3 Emergency procedures 15
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
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 9

2.1 Safety precautions
Introduction
Sepax C-Pro is powered by mains voltage and handles materials that can be hazardous.
Before installing, operating or maintaining the system, you must be aware of the
hazards described in this manual.
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.
General precautions
WARNING
Only properly trained users may operate the system.
WARNING
Contact your local representative if you are unsure about any
aspect of using the system.
2 Safety instructions
2.1 Safety precautions
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 10

WARNING
Only approved service personnel should maintain and repair the
system.
WARNING
Always use appropriate Personal Protective Equipment (PPE)
during operation and maintenance of this product.
WARNING
Do not use the instrument if it is not working properly, or if it has
suffered any damage, for example:
•damage to the power cord or its plug,
•damage caused by dropping the instrument,
•damage caused by splashing liquid onto the instrument.
WARNING
Do not operate the system in any other way than described in the
user documentation.
NOTICE
Avoid any shock or vibration to the instrument, as this may damage
the instrument.
NOTICE
Do not expose the instrument to equipment that contains magnets
or generates magnetic or electromagnetic fields. This includes
devices such as mobile phones
NOTICE
Only use chemicals proven not to be harmful to the system.
2 Safety instructions
2.1 Safety precautions
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 11

2.2 Labels and symbols
Introduction
This section describes the nameplate, labels, and other safety and regulatory informa-
tion attached to the product.
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.
Symbols on the system label
The following symbols and text may be present on the system label:
Label Meaning
Warning! Read the user documentation before using the system.
Do not open any covers or replace parts unless specifically stated
in the user documentation.
Product number.
Serial number.
Name and address of the manufacturer
Year (YYYY), month (MM) and day (DD) of manufacture.
Input Electrical rating: Voltage (VAC), Frequency (Hz) and Max. power
(VA).
IP 21 Degree of protection provided by the enclosure.
Fuse rating Fuse rating: number of fuses, type F (fast), trip current (A),
maximum voltage (V)
Symbols on the kit
The following symbols may be present on the kit:
2 Safety instructions
2.2 Labels and symbols
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 12

Label Meaning
Sterilized using Ethylene oxide.
Use-by-date.
Do not re-use.
Product number.
Batch number in alphanumeric format.
Do not use in case the package is damaged.
Non-pyrogenic.
Kit ID in barcode format that forms a unique traceability number.
2 Safety instructions
2.2 Labels and symbols
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 13

Label Meaning
Serial number.
2 Safety instructions
2.2 Labels and symbols
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 14

2.3 Emergency procedures
Introduction
This section describes how to shut down the Sepax C-Pro instrument or abort an on-
going procedure in an emergency situation, and how to restart the Sepax C-Pro instru-
ment.
The section also describes the result in the event of power failure.
Precautions
WARNING
Access to power switch and power cord with plug. Do not
block access to the power switch and power cord. The power switch
must always be easy to access. The power cord with plug must
always be easy to disconnect.
Emergency shutdown
WARNING
In an emergency situation, follow the emergency shutdown
procedure. Do not continue to use the system.
To shut down the instrument in an emergency situation, disconnect the power cord
from the grounded wall outlet.
Emergency stop during a procedure
If the Sepax C-Pro instrument and software is functioning, follow the steps below to
abort a procedure:
2 Safety instructions
2.3 Emergency procedures
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 15

Step Action
1Press the STOP button (or tap STOP on the touchscreen) to abort the proce-
dure.
Result:
All stopcocks move to the closed configuration.
2Follow the on-screen instructions. Tap OK to confirm.
3If the screen is not functional, press the power switch at the back of the
instrument to the OFF (O) position.
4Refer to the troubleshooting procedures in the application Operator Manual
to recover the cellular product.
Power failure
In the event of a power failure to the Sepax C-Pro instrument, the procedure is inter-
rupted immediately.
To prevent any leakage, close all clamps on the single-use kit.
The procedural data collected up to the time of the power failure is available in the
logfiles.
Restart after emergency shutdown or
power failure
When power is restored after a power failure or emergency shutdown, restart the
Sepax C-Pro instrument and the application software. For detailed instructions refer to
the following sections:
2 Safety instructions
2.3 Emergency procedures
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 16

•For GMAP 5.5 software version, see Section 5.2 Start-up and shutdown, on page 75.
•For GMAP 6.0 software version, see Section 6.2 Start-up and shutdown, on page 108.
Refer to the troubleshooting procedures in the application Operator Manual to recover
the cellular product.
Hardware start-up test
After validating an Error alarm, performing an emergency stop, or upon restarting the
instrument, the Sepax C-Pro instrument automatically performs a hardware start-up
test to verify the functionality of the hardware.
If the hardware start-up test is a success, the user interface on the Sepax C-Pro instru-
ment returns to the Home menu.
If the hardware start-up test is a failure, a warning message appears on the screen. The
following table describes the options for proceeding after a failed hardware start-up
test.
Option Action
Retry the hardware start-
up test. 1. Perform the corrective action listed in the on-
screen prompt.
2. Tap Retry.
Quit the hardware start-
up test. 1. Tap Shutdown.
2. Shut down the instrument and restart.
3. If the error persist, contact Cytiva.
2 Safety instructions
2.3 Emergency procedures
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 17

3 System description
About this chapter
This chapter gives an overview of the Sepax C-Pro system.
In this chapter
Section See page
3.1 System overview 19
3.2 Touchscreen user interface 23
3.3 Data privacy and security 48
3.4 Applications and kits 50
3.5 Peripherals 55
3 System description
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 18

3.1 System overview
Overview
Sepax C-Pro processes cellular product and directs it into dedicated kit bags, at the
end of the procedure.
The instrument core technology includes the following features:
•An electric centrifugation motor to concentrate, separate, and wash cellular
product via the separation chamber of the single-use kit.
•A pneumatic circuitry to drive the separation chamber piston in order to fill and
extract the content of the separation chamber.
•A pressure sensor and an optical sensor to monitor the procedure.
Additional features are:
•Rotary pins to align the position of the stopcocks on the single-use kit.
•Windows Operating System embedded and proprietary GMAP software.
•Four USB ports and two Ethernet ports to provide connectivity and traceability.
•User interface with touchscreen.
Main parts of the instrument
Part Description
1STOP button. Stops a procedure in case of an emergency.
3 System description
3.1 System overview
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 19

Part Description
2Touchscreen display. Pressure sensitive display allowing the user
to interact with the instrument.
3Stopcock holder and rotary pins. Align the position of the stop-
cocks attached to the kits.
4Optical sensor. Identifies separated component layers to auto-
matically manage the procedure.
5Separation chamber pit and moveable covers. The kit separation
chamber is installed here.
6Air filter. Prevents dust from entering the instrument.
7Handles. Two handles (one per side) with rubber grips for moving
the instrument.
8Bag hooks. Two hooks on each side for placing bags on the instru-
ment.
NOTICE
Do not exceed a total load of 2 kg per hook.
9Pressure sensor. Monitors the pressure within the tubing during a
procedure.
10 Drip chamber holder.
11 Bag pole.
12 Bag hooks. Two hooks for hanging, for example, the initial product
bag.
NOTICE
Do not exceed a total load of 2 kg.
3 System description
3.1 System overview
Sepax C-Pro Operating Instructions 29350570 AE OM-3074 20