ThermoFisher Scientific HyPerforma S.U.F. User manual

HyPerforma Single-Use Fermentor
(S.U.F.) User’s Guide
DOC0031 • Revision D
December 2018

Contents
Warnings, safety, and warranty information 1
How to use this guide 6
Chapter 1 Single-Use Fermentor (S.U.F.) overview 9
1.1 Introduction 10
1.2 Hardware characteristics 13
1.2.1 System features 13
1.2.2 Agitation 13
1.2.3 Control system 13
1.2.4 Exhaust management system 13
1.2.5 Exhaust vent filter heater 13
1.2.6 Temperature 14
1.2.7 Heating performance 14
1.2.8 External control 14
1.2.9 Load cells 14
1.3 End user and third-party supplied components 15
1.3.1 pH and dissolved oxygen (DO) probes 15
1.3.2 Single-use probes 15
1.3.3 Controllers 16
1.4 BioProcess Container characteristics 17
1.4.1 Single-Use Fermentor BPC features 17
1.4.2 Operating pressure 17
1.4.3 Working volume 17
1.4.4 Draining and harvest 18
1.4.5 Aeration 18
1.4.6 Aseptic connections 18
1.4.7 Sampling 18
1.4.8 BPC features 19
1.5 Additional system components 21
1.5.1 Probe integration 21
1.5.2 Accessories 21
Chapter 2 Installation and setup 23
2.1 Initial installation preparation 24
2.1.1 Hardware shipment and setup 24

2.1.2 Hardware uncrating 24
2.2 Site preparation 24
2.2.1 Electrical connections for units with an electrical
control box 24
2.2.2 Outer support container preparation 25
2.2.3 Electrical preparation for systems with electrical
control boxes 25
2.2.4 Load cell preparation 26
2.3 Installation 27
2.3.1 Exhaust filter bracket setup 29
2.3.2 Condenser unit setup (when present) 29
2.3.3 TCU/chiller connection to condenser unit
(when present) 30
2.3.4 Exhaust filter pinch clamp setup (when present) 32
2.3.5 Optional cable management system setup 33
2.3.6 Air line preparation 34
2.3.7 Drilled hole sparger line(s) 34
Chapter 3 Operating information 35
3.1 General system operating information 36
3.1.1 BPC preparation and loading 36
3.1.2 BPC handling instructions 36
3.1.3 BPC operating information 36
3.1.4 Hardware operating information 39
3.2 BPC and drive shaft loading for 30 L units 42
3.2.1 Initial installation steps for 30 L units 42
3.2.2 Drive shaft insertion for 30 L units 50
3.2.3 Final installation steps for 30 L units 53
3.3 BPC and drive shaft loading for 300 L units 55
3.3.1 Initial installation steps for 300 L units 55
3.3.2 Drive shaft insertion for 300 L units 63
3.3.3 Final installation steps for 300 L units 68
3.4 Exhaust system 71
3.4.1 Exhaust system functional overview 71
3.4.2 When to use the condenser 72
3.4.3 Condensers and reserve vent filters 73
3.4.4 Exhaust system setup 73
Contents

3.4.5 Exhaust system setup 74
3.5 Probe assembly 78
3.5.1 Preparation and sterilization 78
3.5.2 Making CPC AseptiQuik connections 79
3.5.3 Probe insertion 82
3.5.4 Probe calibration 84
3.5.5 Kleenpak connection instructions 84
3.6 Microbial cell culture operating instructions 94
3.6.1 Operating conditions for cell culture applications 94
3.6.2 Manual operation of drilled hole spargers 95
3.6.3 Checkpoints prior to media fill 96
3.6.4 Media fill 96
3.6.5 Agitation for units with electrical control boxes 97
3.6.6 Temperature control 98
3.6.7 pH probe calibration 99
3.6.8 DO probe calibration 99
3.6.9 Checkpoints prior to inoculation 99
3.6.10 Cell inoculation 99
3.6.11 In-process checkpoints 100
3.6.12 Dispense and harvest 100
3.6.13 S.U.F. shutdown and post-use BPC disposal 101
3.6.14 Preparation for the next run 102
3.7 BPC sampling 103
3.7.1 Aseptic sampling 103
3.7.2 Sampling with sterile manifold 104
3.8 Verification procedures 106
3.8.1 Mixer speed verification 106
3.8.2 Temperature controller verification 106
3.8.3 Pressure monitor verification (when present) 106
3.8.4 Load cell verification (when present) 106
Chapter 4 Specifications and parts information 107
4.1 Hardware features and dimensions 108
4.1.1 30 L S.U.F. design features 108
4.1.2 300 L S.U.F. design features 109
4.1.3 30 L S.U.F. dimensions and ordering information 110
Contents

4.1.4 300 L S.U.F. dimensions and ordering information 111
4.2 30 L and 300 L S.U.F. hardware specifications 112
4.3 Configurable hardware options 114
4.4 BPC features and specifications 115
4.4.1 Standard 30 L S.U.F. BPC 115
4.4.2 Standard 300 L S.U.F. BPC 117
4.5 BPC options and packaging information 119
4.6 Accessories and options specifications 120
4.6.1 Load cells 120
4.6.2 Cable management system 123
4.6.3 Vent filter heaters 124
4.6.4 Exhaust system 125
4.6.5 Miscellaneous items 128
Chapter 5 Maintenance and troubleshooting 131
5.1 Maintenance 132
5.1.1 Routine maintenance 132
5.1.2 Preventive maintenance schedule 132
5.2 Troubleshooting and frequently asked questions 134
5.2.1 Hardware operation issues 134
5.2.2 Cell culture operation issues 136
5.2.3 Probe and connector issues 139
5.2.4 BPC and sparging issues 140
Chapter 6 General ordering information 141
6.1 Ordering instructions 142
6.2 Ordering/support contact information 142
6.3 Technical support 143
Appendices Appendix A—Installation of female electrical receptacle for
units with AC motors and electrical boxes 144
Appendix B—Mettler Toledo IND331 Display load cell
calibration instructions 147
Appendix C—Pre-fermentation run checklist 149
Contents

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
operating this equipment.
The Thermo Scientific™HyPerforma™Single-Use Fermentor (S.U.F.)
is designed to be operated under traditional microbial cell culture
conditions. A general understanding of Fermentor systems and their
operation is important prior to using the system for the first time. Read
and understand user’s guide before operating; failure to do so could
result in injury. Proper procedures for the disposal of Single-Use
BioProcess Containers (BPCs) should be followed, depending
on the culture in use. See the appropriate section of this guide.
WARNING: Hazardous voltage inside.
Electrical components are required for the proper function of the S.U.F.
The mixer motor, motor controller, and control panel all have electrical
components. There is a risk of electrical shock and injury.
Disconnect power before opening electrical components.
Service by trained personnel only. Thermo Fisher Scientific
recommends using standard lockout procedures when working
on electrical components. The main breaker on the electrical
control panel may be locked out.
WARNING: Static electricity may build up in BPCs.
• 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
build up 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.
HyPerforma Single-Use Fermentor User’s Guide |1Thermo Scientific
Warnings, safety, and warranty information

WARNING: Rotating parts—entanglement hazard.
Rotating and moving parts can cause injury. Keep hands away from
moving parts.
• 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 ladders and elevated platforms with caution.
A few operations, such as mounting the motor to the 300 L S.U.F.
during setup, 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.
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 Safety Data Sheets,
labels and pictograms to communicate any hazards.
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: The Thermo Scientific HyPerforma S.U.F. may not
be installed in a potentially explosive atmosphere as set forth in
the applicable EU ATEX Directive.
Warnings, safety, and warranty information
HyPerforma Single-Use Fermentor User’s Guide |2Thermo Scientific

WARNING: Burst hazard.
The S.U.F. 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.
• Do not exceed 0.03 bar (0.5 psi) pressure within the BPC
• Do not exceed 0.34 bar (5 psi) pressure in the section of BPC
tubing between the inlet filter and the BPC
• Make sure the vent filter is properly positioned and working properly
• Maintain a minimum gas flow of 0.1 vvm or 0.01 psi in the BPC
while the impeller is spinning
Protective earth grounding
Protective earth grounding must be verified prior to plugging the
S.U.F. 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
Water jacket vessel information
S.U.F. hardware unit with water jacket has been designed to be
operated with water as the heat transfer medium with temperatures not
exceeding 50°C (122°F) under 150 psig (1 MPa) operating pressure. For
the utmost safety it is recommended that the water jacketed S.U.F. be
operated at 75 psig or less.
Note: The S.U.F. BPC operating limits for temperature are 5 to 40°C.
The internal pressure should not exceed .003 bar (0.5 psi). The water
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
HyPerforma Single-Use Fermentor User’s Guide |3Thermo Scientific

Electrical connections
Power should be supplied by a non-GFCI 15 amp 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 S.U.F. not be plugged into a GFCI outlet.
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) manufacture in
accordance with requirements you gave us; (l) installation of software
or interfacing or use of the equipment in combination with software
or products we have not approved; (m) use of the deliverables
or any documentation to support regulatory approvals; (n) the
performance, efficacy or compatibility of specified components; and
(o) 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
Warnings, safety, and warranty information
HyPerforma Single-Use Fermentor User’s Guide |4Thermo Scientific

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.
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.
It is also noted that movable equipment (i.e. non-fixed or caster mount)
is exempt from seismic design requirements according to ASCE
7-16, Chapter 13, section 1.4. Although these units are exempt from
the seismic design requirements of ASCE 7, it should be noted that
such equipment is susceptible to overturning during a seismic event.
Therefore, it is the responsibility of the buyer to address seismic safety
for movable equipment at the designated facility.
HyPerforma Single-Use Fermentor User’s Guide |5Thermo Scientific
Warnings, safety, and warranty information

How to use this guide
Scope of this publication
This user’s guide contains information about the standard Thermo
Scientific S.U.F. systems, including hardware, components, product
design verification methods, installation, operation and specifications.
It is intended for use by people who may or may not have experience
with Thermo Scientific systems, but who have some knowledge of
bioproduction processes and large-scale mixing systems.
Document change information
Rev. Date Section Change made Author
A.0 07/2014 -- Initial release S. Jelus
A11/2016 -- Reformatted E. Hale
A11/2016 3.1.4, 4.2 Updated maximum temperature setpoint J. Brown/E. Hale
A11/2016 3.5.2 Added CPC AseptiQuik connection instructions E. Hale
A11/2016 3.5.5 Removed references to sterility E. Hale
A11/2016 4.2 Updated nominal tip speed E. Hale
A11/2016 Appendix D Added Appendix D (Pre-fermentation run checklist) J. Brown/E. Hale
B04/2017 4.2 Added Minimum Ceiling Height Requirement to 30 and
300 L specifications E. Hale
B04/2017 4.2 Replaced “+/- 0.75% of full scale” with “+/- 5 rpm” in
Motor Speed specification field E. Hale
B04/2017 4.4.1 Corrected part number for standard 30 L BPC with two 5
in. exhaust filters E. Hale
B05/2017 Warnings and
Safety Added potentially explosive atmosphere (ATEX) warning E. Hale
B05/2017 2.3, 4.1, 4.6 Updated 30 L S.U.F. drawings to show the current motor
mount E. Hale
C09/2017
Warnings, safety,
and warranty
information
Added warranty and usage information E. Hale
C09/2017 -- Changed values from “psi (bar)” to “bar (psi)” E. Hale
C09/2017 -- Updated various aspects of formatting E. Hale
C09/2017 How to use this
guide Added “Abbreviations/acronyms” section E. Hale
C09/2017 4.2 Added “Noise level” to specifications table E. Hale
C11/2017 Chapter 4 Removed hardware, BPC part numbers E. Hale
C01/2018 -- Updated warning symbols E. Hale
D11/2018
Warnings, safety,
and warranty
information
Added seismic guidance E. Hale
HyPerforma Single-Use Fermentor User’s Guide |6Thermo Scientific
How to use this guide

Rev. Date Section Change made Author
D11/2018 How to use this
guide
Changed “Input into Thermo Scientific publications” to
“Questions about this publication” E. Hale
D11/2018 Various Removed references to metal probe clips E. Hale
D11/2018 2.2.3 Updated Figure 2.1, showing the interior of S.U.F.
E-Boxes, and removed Figure 2.2 E. Hale
D11/2018 3.6.5, 4.6.1 Updated Figures 3.104 and 4.12 E. Hale
D11/2018 Appendices Removed Appendix B (AC-Tech calibration) E. Hale
D11/2018
Warnings, safety,
and warranty
information
Added emphasis to “Electrical connections” section E. Hale
D12/2018 3.1.3, 3.6.5 Edited sentence (3.1.3) and reworded step #2 (3.6.5) E. Hale
D12/2018 4.2 Added tolerance (± 5 rpm) to “Motor speed” in
specifications E. Hale
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 documents
Please contact your local sales representative for information about the
related publications listed below.
Document Document number
Thermo Scientific HyPerforma S.U.F. Validation Guide DOC0032
Thermo Scientific HyPerforma S.U.F. Data Sheets (for
various sizes) --
Thermo Scientific HyPerforma S.U.F. Packing and Unpacking
Instructions MAN0010798
HyPerforma Single-Use Fermentor User’s Guide |7Thermo Scientific
How to use this guide

Abbreviations/acronyms
Refer to the list below for definitions of the abbrieviations and acronyms
used in this publication.
BPC BioProcess Container
DO Dissolved oxygen
ETP Equipment Turnover Package
GFCI Ground fault circuit interrupter
ID Inner diameter
IEC International Electrical Code
OD Outer diameter
PED Pressure Equipment Directive
PID Proportional integral derivative
P/V Power input to volume
rpm Revolutions per minute
RTD Resistance temperature detector
slpm Standard liters per minute
STR Stirred tank reactor
S.U.F. Single-Use Fermentor
TCU Temperature control unit
VFD Variable frequency drive
How to use this guide
HyPerforma Single-Use Fermentor User’s Guide |8Thermo Scientific

Single-Use Fermentor
(S.U.F.) overview
Chapter contents
1.1 Introduction
1.2 Hardware characteristics
1.3 End user and third-party supplied components
1.4 BioProcess Container characteristics
1.5 Additional system components
1
HyPerforma Single-Use Fermentor User’s Guide |9Thermo Scientific
Chapter 1 |S.U.F. overview

1.1 Introduction
The Thermo Scientific Single-Use Fermentor (S.U.F.) has been designed
to be a single-use alternative to conventional stirred tank aerobic
fermentors currently utilized in microbial cell culture applications.
Based on years of accepted stirred tank reactor (STR) design, the
S.U.F. emulates STR scalability and operating parameters, yet it
has the unique advantage of being a single-use device. Ease of
setup with respect to system operation and integration into existing
facilities makes the S.U.F. an attractive alternative to its stainless steel
counterpart. Critical design parameters such as height to diameter
ratios, mixer design and location, and typical control system interfaces
are consistent with traditional fermentation platforms. S.U.F. BPCs
are supplied sterilized by irradiation and therefore do not require any
facility hook-ups for sterilization or cleaning. A key element in the
single-use design is the plastic (polyethylene) impeller with a bearing/
seal assembly linking to an external mixer drive. Quick setup and
changeover allows for faster turnover in microbial cell culture runs over
traditional reusable systems.
S.U.F. systems consist of the following primary components:
• Outer support container with standard water jacket heating
system
• S.U.F. BioProcess Container (BPC)
• Electrical control panel (E-Box) for agitation
• Direct drive agitation mixing assembly with an AC motor, drive
shaft, and impeller
Chapter 1 |S.U.F. overview
HyPerforma Single-Use Fermentor User’s Guide |10Thermo Scientific

The stainless steel outer support container is engineered and
fabricated to fully support each S.U.F. BioProcess Container (BPC)
and allow easy access for operation. The outer support container is
mounted to a portable cart base and includes the mixing drive, water
jacket for heating and cooling, and optional controllers for mixing. The
drive shaft is detachable and reusable and is inserted into the BPC
through the motor assembly and into the bearing port. Load cells are
offered as an option.
Figure 1.1. 300 L S.U.F. with electrical
control panel, condenser, cable
management system, and bottle
management system
Chapter 1 |S.U.F. overview
HyPerforma Single-Use Fermentor User’s Guide |11Thermo Scientific

The BPC includes the impeller assembly, sparger, vent filter inlet/outlet
ports, probe integration ports, and filling, dispensing, and sampling
ports. The materials are fully qualified for biological product contact
per USP Class VI plastics. Each assembly is manufactured under
cGMP and is supported by qualification and validation information. No
reuse cleaning or sterilization validations are required as the BPC is
provided gamma irradiated. Innovative, proprietary technology allows
for the integration of the mixing shaft, pH and dissolved oxygen (DO)
probes, and the resistance temperature detector (RTD). The probe and
temperature interfaces are comparable to traditional systems with the
design allowing for simple, aseptic connections. Integrated spargers are
built into the S.U.F. BPC through universal ports.
The Thermo Scientific S.U.F. utilizes an open architecture design for the
control system, allowing for integration with customer systems or with
third-party controllers for feed pumps, mass flow controls, and HMI
(human-machine interface) screens. Controls for agitation are integrated
into the S.U.F., with temperature, pH/DO probes and controls being
supplied by the user or a third-party integrator. Water jacketed systems
require a temperature control unit (TCU) selected and supplied by the
end user or by Thermo Scientific.
This user’s guide covers the setup, operation, maintenance, and
troubleshooting of 30 and 300 liter S.U.F. systems.
Chapter 1 |S.U.F. overview
HyPerforma Single-Use Fermentor User’s Guide |12Thermo Scientific

1.2 Hardware characteristics
1.2.1 System features
The S.U.F. is designed for system mobility and easy integration while
utilizing a straightforward operator interface. Hardware drawings and
specification tables specific to volume can be found in Chapter 4 of this
guide. The following topics include general descriptions of the hardware
components of the S.U.F.
1.2.2 Agitation
If your system uses a Thermo Scientific electrical control panel (E-Box),
the stirring speed is adjusted by using the keypad interface on the
control panel. The agitation control interface utilizes a digital display
to indicate stirring speed in units of revolution per minute (rpm). Power
is supplied to the motor by a two-position power switch. The up and
down arrows on the agitation keypad adjust the stirring speed. Your
system may also be integrated and managed by a third-party controller.
1.2.3 Control system
The S.U.F. is designed to integrate with existing control systems in
their many configurations. The S.U.F. control system supplied with the
Thermo Scientific E-Box enclosure manages the agitation process
and monitors the pressure inside the BPC. Parameters of pH and DO,
gas management, feed addition, and base addition control must be
managed by an external controller supplied by the end user or a third-
party integrator.
1.2.4 Exhaust management system
A condenser system is recommended and is available as optional
hardware. It cools exhaust gases and re-circulates the condensate into
the fermentor.
1.2.5 Exhaust vent filter heater
An optional exhaust vent filter heater is available for increased longevity
of the exhaust filter on the S.U.F. BPC. Heating the filter sufficiently
to eliminate the formation of condensation is an effective means of
reducing the risk of fouling of the filter membrane. The heater is factory
preset to operate between 40–55°C, +/- 3 degrees. Temperature
settings above 60°C are not recommended.
Chapter 1 |S.U.F. overview
HyPerforma Single-Use Fermentor User’s Guide |13Thermo Scientific

1.2.6 Temperature
The S.U.F. can be operated within the temperature range from 5°C to
55°C. The process temperature is measured by means of a supplied
RTD (pt-100) that is inserted into the thermowell of the S.U.F. BPC.
Water jacketed system temperature control is maintained through the
TCU or a third-party controller.
1.2.7 Heating performance
Heating times for S.U.F. systems vary based on operating liquid volume
and temperature, ambient or heating fluid temperature, sparge rate, and
mixing rate. Users should adjust process liquid staging and seeding
strategies to the unique aspects of the S.U.F. Process controllers
are designed to provide optimum heat transfer and to minimize heat
up times, while maintaining the material integrity of the polymer film
construction of the S.U.F. BPC. Refer to section 3.7 for expected
heating times.
1.2.8 External control
Users can choose to bypass the mixing speed control and display
pressure systems provided with the S.U.F. and utilize existing
controllers. Refer to section 3.6 for more details.
1.2.9 Load cells
Load cells, used to determine the weight of the contents of a S.U.F., are
optional. Load cell kits can be installed at the factory or can be added
later by a certified service technician. The load cell kit comes with three
load cells, summing block, wiring and display with a choice of several
data interfaces.
Load cells arrive uncalibrated. It is recommended that the load cell
manufacturer or a qualified technician calibrate these systems on site.
Chapter 1 |S.U.F. overview
HyPerforma Single-Use Fermentor User’s Guide |14Thermo Scientific

1.3 End user and third-party supplied
components
1.3.1 pH and DO probes
The following table shows the length and diameter requirements for
traditional sensors (probes) that can be integrated into the S.U.F. These
requirements are based on the necessary insertion depth of the probe
when used with the probe ports. Note: The presence of a properly
positioned O-ring on the probe is critical for use with the S.U.F.
Table 1.1. Manufacturers and models of compatible pH/DO probes.
Probe lengths (from O-ring to tip) must not exceed 235 mm (9.25
in.)
O-ring to probe tip
Print/lit. Actual
Probe Part number Diameter Thread
type Length Length
AppliSens DO Z010023525 12 mm (0.47 in.) 13.5 PG 235 mm
(9.25 in.)
235 mm
(9.25 in.)
AppliSens pH Z001023551 12 mm (0.47 in.) 13.5 PG 235 mm
(9.25 in.)
235 mm
(9.25 in.)
Mettler Toledo DO InPRO 6800/12/220,
PN 52200966 12 mm (0.47 in.) 13.5 PG 215 mm (8.46 in.)
215 mm
(8.46 in.)
Mettler Toledo pH
405-DPAS-SC-
K8S/225, PN
104054481IG
12 mm (0.47 in.) 13.5 PG 195 mm
( 7.67 in.)
219 mm
(8.62 in.)
Broadley-James DO D140-B220-PT-D9 12 mm (0.47 in.) 13.5 PG 215 mm
(8.46 in.)
214 mm
(8.42 in.)
Broadley-James pH F-635-B225-DH 12 mm (0.47 in.) 13.5 PG 225 mm
(8.85 in.)
219 mm
(8.62 in.)
Finesse DO DOS-OFF-VP-225 12 mm (0.47 in.) 13.5 PG 225 mm
(8.85 in.)
220 mm
(8.66 in.)
Finesse pH PHS-EFP-K8-225 12 mm (0.47 in.) 13.5 PG 225 mm
(8.85 in.)
220 mm
(8.66 in.)
NOTE: Consult probe manufacturer’s website for appropriate probe cable connection and part number.
1.3.2 Single-use probes
Mettler Toledo single-use pH and DO sensors are supported, and
BPCs may be ordered with single-use sensors as fully integrated
components.
Chapter 1 |S.U.F. overview
HyPerforma Single-Use Fermentor User’s Guide |15Thermo Scientific