ThermoFisher Scientific thermo scientific imPULSE S.U.M. User manual

imPULSE S.U.M. with
Touchscreen Console User’s
Guide
DOC0099 • Revision A
October 2020

Thermo Scientific
Contents
Warnings, safety, and warranty information 1
How to use this guide 7
Chapter 1 Introduction to the imPULSE S.U.M. with
Touchscreen Console 9
1.1 Overview 10
1.2 Motor drive assembly 11
1.3 Pressure control device 11
1.4 Load cells 12
1.5 Powder port 12
1.6 BPC hoist system 12
1.7 imPULSE BPCs 12
1.8 Touchscreen Console characteristics 13
1.8.1 Touchscreen Console hardware components 13
1.8.2 Touchscreen Console features 14
Chapter 2 Hardware installation 15
2.1 Site preparation 16
2.1.1 Electrical connections 16
2.1.2 Hardware preparation 16
2.1.3 Recommended tools and resources 16
2.2 Installation instructions 17
2.2.1 Moving the imPULSE S.U.M. 17
2.2.2 Initial setup steps 21
2.2.3 Setting up the imPULSE S.U.M. with Touchscreen
Console hardware 22
Chapter 3 Touchscreen Console setup 30
3.1 Configuring the Touchscreen Console Home screen 31
3.1.1 Introduction to the Touchscreen Console 31
3.1.2 Adding modules to the Home screen 32
3.1.3 Creating and using an Administrator profile 35
3.2 Module overview 37
3.3 Required external components for modules 39

Thermo Scientific
Contents
3.4 Configuring modules 40
3.4.1 Alarms and interlocks 40
3.4.2 Configuring the Agitation module 41
3.4.3 Configuring the Mass module 45
3.4.4 Configuring the Timer module 50
3.4.5 Configuring the PCD module 50
3.4.6 Configuring the BPC Pressure module 55
3.4.7 Configuring the Pumps module 59
3.4.8 Configuring the Fill module 62
3.4.9 Configuring the Harvest module 66
3.4.10 Configuring the Temperature module 70
3.4.11 Configuring the pH module 76
3.4.12 Configuring the Conductivity module 82
3.4.13 Configuring the Liquid Pressure module 87
3.4.14 Configuring the Auxiliary Output module 92
3.4.15 Configuring the Auxiliary Input module 94
Chapter 4 Calibration procedures 99
4.1 Calibrating pumps 100
4.2 Calibrating pH 101
4.3 Calibrating conductivity 102
4.4 Calibrating agitation speed 104
4.5 Calibrating mass 104
4.6 Calibrating PCD pressure 105
4.7 Calibrating BPC air pressure 105
4.8 Calibrating liquid pressure 106
4.9 Calibrating temperature 106
Chapter 5 BPC loading instructions 107
5.1 General handling guidelines 108
5.1.1 BPC preparation and setup 108
5.1.2 BPC handling instructions 108
5.1.3 Working volume 108
5.1.4 Liquid transfer 108
5.1.5 Dispensing 108
5.2 BPC loading 109
5.2.1 Preparing to load 109

Thermo Scientific
Contents
5.2.2 Loading the BPC 111
5.3 Probe preparation and insertion 117
5.3.1 Making CPC AseptiQuik connections 117
5.3.2 Making CPC AseptiQuik connections 118
5.3.3 Probe insertion 121
5.3.4 Inserting temperature sensors 123
Chapter 6 Operating information 124
6.1 General hardware operating information 125
6.1.1 Heating performance 125
6.1.2 Protective earth grounding 125
6.1.3 Circuit protection 125
6.1.4 Scales and weighing systems 126
6.1.5 Using the E-Stop 127
6.2 Checkpoints prior to liquid fill 127
6.3 Filling the imPULSE S.U.M. 127
6.4 Controlling agitation 129
6.5 Using the timer 130
6.6 Monitoring and controlling functions 130
6.6.1 Mixing 130
6.6.2 Adjusting pH and conductivity 130
6.6.3 Adjusting temperature 131
6.6.4 Monitoring the BPC headspace pressure 132
6.6.5 Monitoring alarms 132
6.6.6 Monitoring other functions 133
6.6.7 Sampling 134
6.7 Harvesting 135
6.7.1 Using the Harvest module 135
6.7.2 Harvesting manually 136
6.8 Shutdown and disposal 137
6.8.1 Shutting down the imPULSE S.U.M. 137
6.8.2 Decommissioning the Touchscreen Console 137
6.8.3 Disposal information 138
Chapter 7 Maintenance and troubleshooting 139
7.1 Routine maintenance guidelines 140

Thermo Scientific
Contents
7.2 Touchscreen Console software maintenance 140
7.3 Preventive maintenance guidelines 141
7.4 imPULSE S.U.M. troubleshooting 141
7.5 Touchscreen Console troubleshooting 142
Chapter 8 Specifications and parts information 144
8.1 Hardware features 145
8.2 Hardware specifications 145
8.3 Touchscreen Console specifications 162
8.4 BPC specifications 163
8.5 Parts and accessories ordering information 165
8.6 Configurable options 169
Chapter 9 General ordering information 174
9.1 Ordering instructions 175
9.2 Ordering and support contact information 175
9.3 Technical support 175
Appendices Appendix A—Recommended torque values for head
cap screws 177

Thermo Scientific imPULSE S.U.M. with Touchscreen Console User’s Guide | 1
Warnings, safety, and warranty
information
Congratulations! You have purchased high-quality Thermo Scientific™
equipment. We have included safety information in this guide, based
on our knowledge and experience. It is important, however, for you
to work with your safety management personnel to ensure that this
equipment is integrated into your safety practices. Please take some
time to perform your own job safety analysis in order to identify and
control each potential hazard.
WARNING: Read and understand this user’s guide before using
this equipment.
The Thermo Scientific™imPULSE™Single-Use Mixer (S.U.M.) is
designed to be operated under traditional pharmaceutical conditions.
A general understanding of mixing systems and their operation
is important prior to using the system for the first time. Read and
understand the user’s guide before operating; failure to do so could
result in injury or potential loss of product.
WARNING: Refer to this guide if you encounter the warning
symbol (see left) displayed on the unit.
The user’s guide will assist in determining the nature of the hazard, and
any necessary precautions for avoiding exposure.
WARNING: Hazardous voltage inside.
The imPULSE S.U.M. and Touchscreen Console both have electrical
components. There is a risk of electrical shock and injury. Disconnect
power before opening electrical components. Service should be
performed by certified personnel only. Thermo Fisher Scientific
recommends using standard lockout procedures when working on
electrical components. The main breaker on the Touchscreen Console
may be locked out.
WARNING: Tipping hazard. The vessel should only be moved by
pushing using the provided handles or at the mid-point of the
vessel.
If pulled or moved too quickly, the vessel can tip, potentially leading
to damage to equipment or injury to personnel. To reduce the risk
of tipping, the vessel should only be moved slowly over smooth, flat
surfaces by at least two qualified personnel. During movement, any
locking feet should be retracted, and casters should be in the unlocked
position. The vessel should not be moved by pulling of any kind.
Warnings, safety, and warranty information

Thermo Scientific imPULSE S.U.M. with Touchscreen Console User’s Guide | 2
WARNING: Static electricity may build up in BPCs.
• BioProcess Containers (BPCs) may act as insulators for
electrostatic charge. If electrostatic charge is transferred to a BPC,
the charge may be stored in the BPC and/or the product inside.
This phenomena varies by product and use; therefore, it is the sole
responsibility of the end user to ensure a hazard assessment is
conducted and the risk of electrostatic shock is eliminated.
• Where applicable, a product contact stainless steel coupler may be
grounded to the frame to dissipate electrostatic build up from the
material within a BPC. It is good practice to dissipate electrostatic
buildup by grounding all BPCs prior to coming in contact with them.
When working with BPCs, the use of nonconductive materials, such
as nonconductive gloves, is recommended.
WARNING: Entanglement hazard.
Rotating and moving parts can cause injury. Keep hands away from
moving parts during operation.
• Do not operate this equipment unless the supplied guarding is in
place and properly functioning.
• It is the responsibility of the end user to assess this equipment
and ensure that equipment and safeguards are in good working
condition, and that all operators are trained and aware of
entanglement hazards and associated protective devices, such as
hazard signs and guarding.
WARNING: Use caution when filling the BPC.
Ensure that the door handle is fully engaged, and that the door handle
latch-pin is installed before filling the BPC. The static head pressure on
the door can create a large opening force.
WARNING: Use ladders and elevated platforms with caution.
A few operations, such as loading a BPC into a large imPULSE S.U.M.,
may require the use of a ladder or platform. Before use, ensure the
ladder has been inspected and weight-rated for its user. When using a
ladder or platform, be sure it is stable, maintain three points of contact,
and make sure the steps are clean.
WARNING: Follow lockout/tagout procedures.
To prevent injury, when servicing equipment, use your company’s
lockout/tagout procedures to isolate electrical, mechanical, pneumatic,
hydraulic, chemical, thermal, gravitational, or any other potential energy
and protect workers from the release of hazardous energy.
Warnings, safety, and warranty information

Thermo Scientific imPULSE S.U.M. with Touchscreen Console User’s Guide | 3
WARNING: Use caution with hazardous chemicals or materials.
Personnel servicing equipment need to know the hazards of any
chemicals or materials that may be present on or in the equipment.
Use general hazard communication techniques such as a Safety Data
Sheet (SDS), labels, and pictograms to communicate any hazards.
WARNING: Potential confined space.
Operators may enter larger imPULSE S.U.M. systems. Evaluate this
equipment against your confined space standards and procedures.
WARNING: High noise level.
Sound levels can exceed 70 dB—Use proper PPE.
WARNING: Burst hazard—air under pressure.
The imPULSE BPC chamber is under slight pressure under normal
operating conditions. Normal passive venting prevents any excess of
pressure building up within the chamber. Chamber pressure and inlet
line pressure should be monitored for proper settings.
• Contents under pressure
• Do not exceed 0.5 psi (0.03 bar) BPC pressure
• Do not exceed 5 psi (0.34 bar) inlet pressure
• Assure vent filter is correctly positioned and working properly
WARNING: Hot surface—do not touch.
The heating jacket is designed to heat the inner vessel wall. Normal
operating conditions generate heat and could create hot surfaces.
• Hot surface inside
• Contact with surfaces may cause burns
• Do not touch while in operation
WARNING: Pinch hazard.
• Use caution when opening or closing the pinch valves.
• The optional BPC hoist on the imPULSE S.U.M. can be raised and
lowered. Caution should be used to avoid pinching an operator
or causing damage to the equipment or the BPC. The maximum
weight limit of the bag hoist it 50 kg.
• The imPULSE linear drive carriage can settle, creating a potential
pinch hazard. Use the safety settling block when the safety guard is
removed and the carriage is in the “Up” position.
WARNING: The Thermo Scientific imPULSE Single-Use Mixer
may not be installed in a potentially explosive atmosphere as
set forth in the applicable EU ATEX Directive.
It is the responsibility of the end user to review and understand the
potential dangers listed in the ATEX 2014/34/EU guidelines.
Warnings, safety, and warranty information

Thermo Scientific imPULSE S.U.M. with Touchscreen Console User’s Guide | 4
Protective earth grounding
Protective earth grounding must be verified prior to plugging the
S.U.M. into any electrical outlet. Ensure the receptacle is properly earth
grounded.
Environmental conditions
• Operating: 17 to 27°C; 20 to 80% relative humidity, non-condensing
• Storage: –25 to 65°C
• Installation category II (over voltage) in accordance with IEC 664
• Altitude limit: 2,000 meters
• Pollution degree II
Electrical connections
Power should be supplied by a properly-sized non-GFCI circuit.
Ground faults occur when current is leaking somewhere, in effect,
electricity is escaping to the ground. Electrocution can occur when
the human body serves as the path for the leakage to the
ground. A Ground Fault Circuit Interrupter (GFCI) senses the current
flowing to the ground and switches off the power (trips the GFCI) in a
fraction of a second at currents well below those that are considered
dangerous. Due to the sensitivity of GFCIs to electrical leakage (a few
mA), it is recommended that the imPULSE Single-Use Mixer NOT be
plugged into a GFCI outlet.
Vessel jacket information
The imPULSE hardware unit with vessel jacket has been designed
to be operated with water/glycol as the heat transfer medium, with
temperatures not exceeding 50°C (122°F) under less than 150 psig (1
MPa) operating pressure. For the utmost safety it is recommended that
the S.U.M. be operated at 75 psig or less.
Note: While the vessel jacket may be operated at 50°C, the imPULSE
BPC is limited to 40°C maximum. As a result, the jacket may only be
operated at 50°C until the BPC temperature reaches 40°C, after which
it must be lowered. The internal pressure of the imPULSE BPC should
not exceed 0.5 psi.
Note: The vessel jacket is not required to be registered, inspected, and
stamped with the Code U symbol per section U-1(c)2(f) of the ASME
Boiler and Pressure Vessel Code and/or European Pressure Equipment
Directive (PED) 97/23/EC. Upon request, a Declaration of Conformity,
PED Sound Engineering Practices can be made available.
Warnings, safety, and warranty information

Thermo Scientific imPULSE S.U.M. with Touchscreen Console User’s Guide | 5
Warranty information
Any warranties, if applicable, covering this equipment exclude: (a)
normal wear and tear; (b) accident, disaster or event of force majeure;
(c) your misuse, fault or negligence; (d) use of the equipment in a
manner for which it was not designed; (e) causes external to the
equipment such as, but not limited to, external puncturing, power
failure or electrical power surges; (f) improper storage and handling of
the equipment; (g) use of the equipment in combination with equipment
or software that we did not supply; (h) equipment sold to you as ‘used’
products; (i) contact with improperly used or unapproved chemicals
or samples; (j) installation, removal, use, maintenance, storage, or
handling in an improper, inadequate, or unapproved manner, such as,
but not limited to, failure to follow the documentation or instructions in
the deliverables or related to the equipment, operation outside of stated
environmental or other operational specifications, or operation with
unapproved software, materials or other products; (k) not operating
the equipment according to our operation and maintenance guide;
(l) installation of software or interfacing or use of the equipment in
combination with software or products we have not approved; (m) the
performance, efficacy or compatibility of specified components; and
(n) the performance of custom equipment or products or specified
components or achievement of any results from the equipment,
specified components or services within ranges desired by you
even if those ranges are communicated to us and are described in
specifications, a quote, or a statement of work.
ADDITIONALLY, ANY INSTALLATION, MAINTENANCE, REPAIR,
SERVICE, RELOCATION OR ALTERATION TO OR OF, OR
OTHER TAMPERING WITH, THE EQUIPMENT PERFORMED BY
ANY PERSON OR ENTITY OTHER THAN US WITHOUT OUR
PRIOR WRITTEN APPROVAL, OR ANY USE OF REPLACEMENT
PARTS WE HAVE NOT SUPPLIED, WILL IMMEDIATELY VOID
AND CANCEL ALL WARRANTIES WITH RESPECT TO THE
AFFECTED EQUIPMENT. IF THE EQUIPMENT IS TO BE USED
IN THE UNITED STATES, WE MAY VOID YOUR WARRANTY IF
YOU SHIP THE EQUIPMENT OUTSIDE OF THE UNITED STATES.
WE DO NOT WARRANTY OR GUARANTEE THAT THE USE OF
THE EQUIPMENT WILL MEET ANY PARTICULAR REGULATORY
REQUIREMENTS, AND WE DO NOT INTEND FOR THE
EQUIPMENT DOCUMENTATION TO BE USED IN SUPPORT OF
YOUR REGULATORY APPROVALS.
Warnings, safety, and warranty information

Thermo Scientific imPULSE S.U.M. with Touchscreen Console User’s Guide | 6
Use restrictions
You must use this equipment in accordance with our documentation
and if applicable, with our other associated instructions, including
without limitation, a “research use only” product label or “limited use”
label license. This equipment is intended for research use or further
manufacturing in bioprocessing applications and not for diagnostic
use or direct administration into humans or animals, we do not submit
the equipment for regulatory review by any governmental body or
other organization, and we do not validate the equipment for clinical or
diagnostic use, for safety and effectiveness, or for any other specific
use or application.
Seismic guidance
The buyer of the equipment is responsible for ensuring that country-
specific codes and seismic values are assessed for suitability of
equipment installation and safety at the designated site. In addition,
it is the buyer’s responsibility to assess the building structure for
the designated equipment to ensure correct seismic anchoring and
tethering designs for both the equipment and facility. It is highly
recommended that the buyer consult with a local, licensed third party
architecture and engineering firm to provide the buyer with correct
engineering analysis and stamped documentation prior to equipment
installation at the facility. In addition, the buyer will be responsible for
rigging and anchoring of the equipment to a specified, fixed location.
Upon request, Thermo Fisher Scientific can assist with establishing
compliant seismic anchoring and tethering designs for purchased
equipment based on building and country codes, at an agreed upon
fee.
Warnings, safety, and warranty information

Thermo Scientific imPULSE S.U.M. with Touchscreen Console User’s Guide | 7
How to use this guide
Scope of this publication
This document covers information about installation, operation,
specifications, and maintenance of Thermo Scientific™imPULSE™
Single-Use Mixers (S.U.M.s) with Touchscreen Console.
Document change information
A summary of the changes that have been made to this document are
listed below.
Revision Date Section Change Author
Rev. A 10/2020 -- Initial release C. Jones
How to use this guide
Publication name Doc. number
Thermo Scientific BioProcess Container Unpacking and
Inspection Guide DOC0021
imPULSE S.U.M. Unpacking Guide DOC0074
Questions about this publication
If you have any questions or concerns about the content of this
publication, please contact technicaldocumentation@thermofisher.
com and your Thermo Fisher Scientific sales team.
Related publications
Other publications related to the imPULSE mixer are listed below.

Thermo Scientific imPULSE S.U.M. with Touchscreen Console User’s Guide | 8
How to use this guide
Abbreviations/acronyms
See the following list for definitions of abbreviations and acronyms
used in this publication.
BPC BioProcess Container
E-Box Electrical control panel
E-Stop Emergency stop button
GFCI Ground fault circuit interrupter
HMI Human-machine interface
PCD Pressure control device
RTD Resistance temperature detector
S.U.M. Single-Use Mixer
TCU Temperature control unit
VFD Variable frequency drive

Thermo Scientific imPULSE S.U.M. with Touchscreen Console User’s Guide | 9
Chapter 1 | Introduction to the imPULSE S.U.M. with Touchscreen Console
Introduction to the
imPULSE S.U.M. with
Touchscreen Console
Chapter contents
1.1 O v e r v i e w
1.2 Motor drive assembly
1.3 Pressure control device
1.4 Load cells
1.5 Powder port
1.6 BPC hoist system
1.7 imPULSE BPCs
1.8 Touchscreen Console characteristics
1

Thermo Scientific imPULSE S.U.M. with Touchscreen Console User’s Guide | 10
Chapter 1 | Introduction to the imPULSE S.U.M. with Touchscreen Console
1.1 Overview
The imPULSE Single-Use Mixer (S.U.M.) with Touchscreen Console
is designed for consistent mixing and scale-up, from 30 L up to
5,000 L. Its innovative disc technology and flexible design produce
superior mixing, while configurable high-end controls and monitors fit
user-specific process requirements.
Some of the key features of the imPULSE mixer include:
• Hexagonal stainless steel vessel with an open top, sloped
bottom, and openings for the BioProcess Container (BPC) and
tubing outlets.
• Integrated rolling diaphragm that provides pumping action to
the mixing disc, but will not abrade surfaces or produce particulate.
• Touchscreen Console, for monitoring and controlling multiple
sensors and functions.
Additional customizable options are available, depending on size,
including a BPC hoist. For all available options for specific imPULSE
sizes, see your Thermo Scientific sales representative.
Figure 1.1 shows the features of a 500 L imPULSE S.U.M. See sections
1.2–1.5 for more information about imPULSE features.

Thermo Scientific imPULSE S.U.M. with Touchscreen Console User’s Guide | 11
Chapter 1 | Introduction to the imPULSE S.U.M. with Touchscreen Console
1.2 Motor drive assembly
The motor drive is vessel-mounted, and features:
• Control from the Touchscreen Console Agitation module
• Stainless steel shafts with linear ball bearings
• A quick-connecting agitator with clamp block
• A guard with hardwired interlock to stop the motor if it is removed
1.3 Pressure control device
The imPULSE pressure control device (PCD) is an optional feature that
allows users to inflate the BPC during installation (prior to operation).
The PCD also maintains the integrity of the BPC while operating and
draining.
Figure 1.1. Features of a 500 L imPULSE S.U.M. with Touchscreen Console.
Touchscreen
Console
Motor drive assembly
Load cells
BPC hoist
(optional)
PCD Inflate/vent
system (optional)
Door for BPC
loading
Probe insertion
cutout
Car assembly
AC motor module
Jacket pressure lines
Fixed powder port or
Adjustable powder port
(optional; not shown)

Thermo Scientific imPULSE S.U.M. with Touchscreen Console User’s Guide | 12
Chapter 1 | Introduction to the imPULSE S.U.M. with Touchscreen Console
1.4 Load cells
Load cells or weight scales track operating volume and weight
measurements, allowing you control over the liquid volume to rated
working volume during the process run.
A load cell kit is available for all S.U.M. units, and can be installed at
the factory. The load cell kit comes with either three or four load cells
(for 2,000–5,000 L and 30–1,000 L, respectively), summing block, and
wiring.
1.5 Powder port
The powder port system is available as an option for powder-to-liquid
applications. It comes as either a fixed port holder or an adjustable
port holder. Each system type holds the container of powder above the
mixer and attaches it to the BPC with a clamp. The adjustable powder
port provides versitility allowing you to position it as you would like on
the S.U.M.
1.6 BPC hoist system
The BPC hoist system is optional on 500 L or larger vessels and is
standard on 5,000 L vessels. It uses an electric winch to provide
assistance in lifting powder bags to the top of the BPC. The system
can also be used to aid in lifting the BPC during installation, and it has
a maximum capacity of 50 kg (110 lb).
1.7 imPULSE BPCs
Standard BPCs designed for imPULSE S.U.M.s include the following
features:
• Two bottom-process tube ports, for inlet and outlet/recirculation.
• Three top-process tube ports, for process filling, inflation/venting,
and pressure sensing.
• Four side probe ports with CPC™AseptiQuik™G connections.
• One agitator drive port.
• One powder feed port with a 7.62 or 10.16 cm (3 or 4 in.) tri-clamp
connection.

Thermo Scientific imPULSE S.U.M. with Touchscreen Console User’s Guide | 13
Chapter 1 | Introduction to the imPULSE S.U.M. with Touchscreen Console
Mixing disc
(top-centered)
Mixing disc
(bottom-centered)
Fluid direction
during mixing
Figure 1.2. Typical imPULSE S.U.M. BPC.
1.8 Touchscreen Console characteristics
1. 8.1 Touchscreen Console hardware components
Figure 1.3 on the following page shows the components of the
Touchscreen Console hardware.
Note: Custom BPCs may be configured differently.
Side probe ports
(AseptiQuik G connector)
Inflate/vent line
Pressure sensing line
Outlet recirculation lines
Inlet line
Powder port
Standard tube sets for liquid addition, recirculation, inflation, and vent
control are also available for imPULSE BPCs. These tube sets can be
customized to best suit your individual processes. Consult your Thermo
Scientific sales representative for more information.
Figure 1.2 shows typical mixing characteristics of an imPULSE SUM
BPC.

Thermo Scientific imPULSE S.U.M. with Touchscreen Console User’s Guide | 14
Chapter 1 | Introduction to the imPULSE S.U.M. with Touchscreen Console
1.8.2 Touchscreen Console features
The Touchscreen Console enables users to monitor and control system
functions. A customizable Home screen allows users to add only the
functionality needed for their operations. For more detailed information,
see Chapter 3—Touchscreen Console Setup.
Touchscreen
Emergency stop
(E-Stop) button
Reset
button
Stainless steel
body
Figure 1.3. Front and back views of the Touchscreen Console.
Motor Control port
(AC motor module
COM)
Pump/auxiliary
output ports (4)
Various
communication
ports (24)
Pneumatic ports
(4)
Auxiliary output
power ports (4)
Auxiliary breaker
switch
USB port
Speaker
Digital
communication
ports (6)
Main breaker
switch
Main
switch
Power
cord
connection

Thermo Scientific imPULSE S.U.M. with Touchscreen Console User’s Guide | 15
Hardware installation
Chapter contents
2.1 Site preparation
2.2 Installation instructions
2
Chapter 2 | Hardware installation