Thermo Scientific HyPerforma 5.1 S.U.B. Assembly Instructions

Single-Use Systems Hardware
Integrator’s Guide
DOC0039 • Revision A
July 2017

Thermo Scientific Single-Use Systems Integrator’s Guide | 3
Chapter 1 Single-use systems configuration
guidelines 9
1.1 Maximum agitation rates for bioreactors 9
1.2 S.U.B. agitation acceleration and
deceleration rates 14
1.3 Drive shaft longevity and maintenance 14
1.4 Pressure regulation 15
1.5 Motor cap safety sensor 15
Chapter 2 Electrical box overview 16
2.1 Introduction to single-use systems
hardware 16
2.2 Thermo Scientific e-box information 17
Chapter 3 Motor connection 19
3.1 Units without Thermo Scientific e-boxes 19
3.2 Units with the Thermo Scientific e-boxes 27
3.3 Motor general information 28
Chapter 4 Resistive heater connection 30
4.1 Units without the Thermo Scientific e-box 31
4.2 Units with the Thermo Scientific e-box 32
4.3 Resistive heater general information 34
Chapter 5 Load cell connection 36
5.1 Units without the Thermo Scientific e-box 37
5.2 Units with the Thermo Scientific e-box 38
5.3 Load cell communication information 39
Contents
How to use this guide 5
Safety, warnings and warranty information 6
Acronym definitions 8

Chapter 6 RTD connection 40
6.1 Units without the Thermo Scientific e-box 40
6.2 Units with the Thermo Scientific e-box 40
6.3 RTD connection general information 43
Chapter 7 Pressure sensor connection 44
7.1 Units without the Thermo Scientific e-box 44
7.2 Units with the Thermo Scientific e-box 45
Pressure sensors general information 48
Chapter 8 Vent filter heater connection 49
8.1 Units without the Thermo Scientific e-box 50
8.2 Units with the Thermo Scientific e-box 52
Chapter 9 Pinch clamp connection 53
9.1 Tubing style pinch clamp 53
9.2 Film manifold style pinch clamp 54
Chapter 10 TCU communication connection 56
10.1 Neslab TCUs 57
10.2 Lauda TCUs 59
10.3 TCU connections general information 61
Chapter 11 Dip switch functionality 62
11.1 Top DIN rail in the leftmost position 62
11.2 Bottom DIN rail In the leftmost position 63
Chapter 12 16-Pin communication cable 64
Thermo Scientific Single-Use Systems Integrator’s Guide | 4

How to use this guide
Scope of this publication
The purpose of this guide is to provide detailed information about
how to integrate standard Thermo Scientific single-use bioreactors,
mixers, and fermentors into third-party controllers. It describes
Thermo Scientific interlock and speed governor requirements,
the intended use of each electrical component, and specific wire/
pin out definitions. This guide may not cover unique, custom, or
customer-specific changes to the electrical enclosure or other
components of the system.
Document change information
Revision Date Section Change made Author
A06/2017 -- Initial release J. Lee/S. Jelus
Input into Thermo Scientific publications
Your satisfaction with the scope and content of this publication is
important to us. Please send any corrections or suggestions you
have for this guide (or for any other Thermo Scientific technical
publication) to [e-mail].
Related publications
Please contact Thermo Fisher for information about the related
publications listed below.
Publication Description
Thermo Scientific™HyPerforma™5.1 S.U.B.
User’s Guide
Safety, operating information, and
specifications
Thermo Scientific HyPerforma 2.1 S.U.B.
User’s Guide
Safety, operating information, and
specifications
Thermo Scientific HyPerforma S.U.M. User’s
Guide
Safety, operating information, and
specifications
Thermo Scientific HyPerforma S.U.F. User’s
Guide
Safety, operating information, and
specifications
Thermo Scientific Single-Use Systems Integrator’s Guide | 5
How to Use This Guide

Thermo Scientific Single-Use Systems Integrator’s Guide | 6
Safety, warnings and warranty
information
See the appropriate User’s Guide for detailed safety information. We have
based that safety information on our experience with these products.
However, you should work with your Safety Management personnel to
integrate this equipment into your safety practices. Please take some time to
perform your own job safety analysis in order to identify and control potential
hazards.
WARNING: Read and understand the User’s Guide, including
Warnings and Safety Information, before using this equipment.
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 RESPECT TO THE
AFFECTED EQUIPMENT. WE MAY ALSO VOID YOUR WARRANTY IF
YOU SHIP THE EQUIPMENT OUTSIDE OF THE UNITED STATES.
Warnings, Safety and Warranty Information

Use Restrictions
Thermo Scientific Single-Use Systems Integrator’s Guide | 7
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.

Acronym Definitions
Acronym definitions
Acronym Definition
AC Alternating Current
AWG American Wire Gauge
BPC BioProcess Container
DC Direct Current
DIP Dual Inline Package
E-Box Electrical Box
HMI Human-Machine Interface
Hz Hertz
I/O Input/Output
J-Box Junction Box
mA Milliamps
N/A Not Applicable
NC Normally Closed
NO Normally Open
PV Present Value
PID Proportional-Integral-Derivative temperature controller
PLC Programmable Logic Controller
RPM Rotations per Minute
RTD Resistive Temperature Detector
SP Set Point
SSR Solid State Relay
S.U.B. Single- Use Bioreactor
S.U.F. Single-Use Fermentor
S.U.M. Single- Use Mixer
S.U.S. Single- Use System
TCU Thermal Control Unit (used on water-jacketed vessels)
VAC Volts Alternating Current
VDC Volts Direct Current
VFD Variable Frequency Drive
Thermo Scientific Single-Use Systems Integrator’s Guide | 8

Thermo Scientific Single-Use Systems Integrator’s Guide | 9
Chapter 1 | S.U.S. Configuration Guidelines
Single-use systems
(S.U.S.) configuration
guidelines
1.1 Maximum agitation rates for
Single-use bioreactors
Using agitation speed governors and safety
interlocks
Agitation speed governors must be set up on Single-Use Bioreactor
(S.U.B.) controllers to limit the maximum mixing speed, according to
pre-defined liquid volumes. Safety interlocks, which stop agitation
when the volume in a S.U.B. drops below defined limits, and speed-
based governors prevent damage to the drive shaft in the bioreactor.
We recommend the use of speed governors and safety interlocks to
prevent the hazardous conditions listed below.
• Operating the motor at any speed while loading the drive shaft.
• Operating the agitator when volumes are less than 50% of a sys-
tem’s working volume for mixers, fermentors and 2.1 bioreactors, or
below 20% of a system’s working volume for 5.1 S.U.B. systems.
• Operating the agitator above the recommended speeds based on
qualified power input to volume (P/V) thresholds (see the next sec-
tion of this guide).
1

Thermo Scientific Single-Use Systems Integrator’s Guide | 10
These hazardous conditions must be avoided in order to ensure
reliability. Using safety interlocks and agitation speed governors
eliminates the chance of human error.
The amount of liquid in the vessel and the amount of power applied to
the impeller have an impact on the applied deflection on the drive shaft.
This, and other improper use of the system, might cause the drive shaft
to break, which could damage the BPC, compromise sterility, and result
in the loss of a cell culture batch.
Speed governors are required for 2,000 L bioreactor systems. For
more information about using P/V ratios for bioreactor systems, see
the next section of this chapter.
WARNING: Safety interlocks should be used to stop agitation when
the volume falls below the minimum (50% of the rated volume for
the 2.1 bioreactor system and 20% of the rated volume for the 5.1
system). These interlocks will prevent running the system outside of
recommended volumes, which could damage the hardware and the
BPC, and result in the loss of a cell culture batch.
Agitation rate calculations
Using power input to volume (P/V) ratios
Using power input to volume ratios for agitation speed
The power input to volume ratio (P/V) allows for scale-up or scale-
down of bioreactor platforms by equating mixing power between
differently-sized systems. P/V is the most broadly accepted method
for determining a practical scale-up approach for agitation speed in
stirred tank reactors used for animal cell culture. This relationship is
dependent on the density of the liquid in the system (ρ), the inherent
power number of the impeller (Np), the diameter of the impeller (Di),
the volume of liquid in the vessel (V), the speed of the drive shaft in
RPM (n), and the power input to the liquid (P).
This relationship can be rearranged to solve for mixing speed as a
function of the other variables.
For known values of P/V, impeller power number, density, and
impeller diameter, this equation can be simplified by consolidating all
other values into a single coefficient (A).
Chapter 1 | S.U.S. Configuration Guidelines

Thermo Scientific Single-Use Systems Integrator’s Guide | 11
Values for appropriate agitator drive shaft speed were calculated for
different sizes of S.U.B.s using 20-100% of the rated working volumes.
These values assume an impeller power number of 2.1, viscosity similar
to water, and a constant density of 993 kg/m3.
Values of 20 watts/meter3(W/m3) provide the nominal rating (the
suggested default parameter for CHO cultivation), and values of 40 W/
m3provide the maximum recommended parameter that has been
qualified for use in the system.
P/V agitation values for all S.U.B. sizes
Equation coefficient values for every size of S.U.B. for P/V values of 20
and 40 watts/meter3(W/m3) are provided in Table 1.1 below.
Table 1.1. Equation coefficient values (A) for different S.U.B.s.
n = A x V1/3 (for values of n in RPM)
50 L
S.U.B.
100 L
S.U.B.
250 L
S.U.B.
500 L
S.U.B.
1,000 L
S.U.B.
2,000 L
S.U.B.
P/V
20 W/m349.650 31.491 18.634 12.764 8.471 5.950*
40 W/m362.554 39.676 23.477 16.081 10.673 7.031**
* Coefficient value is used to determine operating speeds for drive shafts implemented for a 180-
day working duration at 20 W/m3.
** Consult Thermo Scientific engineers for the drive shaft working duration at 40 W/m3.
Agitation speeds for P/V values of 20 and 40 W/m3are provided in
Tables 1.2 and 1.3. Follow the agitation rates in tables 1.2 and 1.3 when
setting up interlocks and agitation speed governors. Note that load cell
values must also be used with interlocks to keep the system operating
within recommended P/V ranges.
Chapter 1 | S.U.S. Configuration Guidelines

Thermo Scientific Single-Use Systems Integrator’s Guide | 12
Table 1.2. Maximum agitation rates (in RPM) for S.U.B.s at a P/V
of 20 Wm3. With the exception of 2,000 L systems, the RPM values in this
table represent a 360-day duration of use.
50 L
S.U.B.
100 L
S.U.B.
250 L
S.U.B.
500 L
S.U.B.
1,000 L
S.U.B.
2,000 L
S.U.B.*
Fill %
2.1 and 5.1 Systems
100 183 146 117 101 86 75
95 180 144 115 100 83 74
90 177 141 113 98 82 72
85 173 138 111 96 80 71
80 170 136 109 94 79 70
75 166 133 107 92 77 68
70 162 130 104 90 75 67
65 158 127 102 88 73 65
60 154 123 99 85 71 63
55 150 120 96 83 69 61
50 145 116 93 80 68 60
5.1 Systems Only
45 140 112 90 78 65 57
40 135 108 86 75 62 55
35 129 103 83 71 60 53
30 122 98 79 68 57 50
25 115 92 74 64 53 47
20** 107 85 69 59 50 44
* Using these RPM values requires replacement of the drive shaft after 180 days of use.
** RPM values assume the system is operating at no less than 20% volume. In order to en-
sure proper volume measurements, end users are responsible for ensuring proper load cell
calibration prior to system use.
NOTE: Load cell values must be used with interlocks to keep the system operating
within recommended P/V ranges.
Chapter 1 | S.U.S. Configuration Guidelines

Thermo Scientific Single-Use Systems Integrator’s Guide | 13
Chapter 1 | Configuration Guidelines
Please Note: The impeller power number assumption of Np=2.1
is only an approximation, based on an academic exercise.
Recommended best practice for determination and comparison of
Np between bioreactors should be carried out by the end user and
should be based on conditions matching the specific application. End
users should also anticipate and accept some variability that may be
inherent in the analysis technique or modeling method chosen. If a
different or alternative Np value is determined by the end user, the
safety interlocks must be based solely on the maximum prescribed
RPM for a working volume as found in the reference tables in this
publication. Never rely strictly on an estimated magnitude of
P/V when setting the agitator speed interlock levels.
Table 1.3. Maximum agitation rates (in RPM) for S.U.B.s at a P/V
of 40 W/m3. Using the 2,000 L S.U.B. above 20Wm3 requires con-
sultation with Thermo Fisher Engineering.
50 L
S.U.B.
100 L
S.U.B.
250 L
S.U.B.
500 L
S.U.B.
1,000 L
S.U.B.
2,000 L
S.U.B.
Fill %
2.1 and 5.1 Systems
100 230 184 148 127 109 *
95 227 181 145 125 105 *
90 222 178 143 123 103 *
85 218 174 140 121 101 *
80 214 171 137 118 99 *
75 209 167 134 116 97 *
70 205 164 131 113 95 *
65 200 160 128 111 92 *
60 194 155 125 108 90 *
55 189 151 121 105 87 *
50 183 146 117 101 86 *
5.1 Systems Only
45 177 141 113 98 82 *
40 170 136 109 94 79 *
35 162 130 104 90 75 *
30 154 123 99 85 71 *
25 145 116 93 80 67 *
20** 135 107 86 75 64 *
* Consultation with Thermo Fisher Scientific engineers is required when operating 2,000 L
S.U.B.s at a P/V of 40 W/m3.
** RPM values assume the system is operating at no less than 20% volume. In order to
ensure proper volume measurements, end users are responsible for ensuring proper load
cell calibration prior to system use.
NOTE: Load cell values must be used with interlocks to keep the system operating
within recommended P/V ranges.

Chapter 1 | Configuration Guidelines
Thermo Scientific Single-Use System Interegrator’s Guide | 14
RPM Verification
The accuracy of the RPM should be verified, at 25%, 50%, 75%, and
100% or the RPM range, using one of the following.
• A hand-held tachometer
• An RPM proximity sensor
An RPM proximity sensor may be used to verify the RPM value on
a continuous basis. RPM proximity sensors are sold as add-on
accessories and may be purchased through Thermo Fisher Scientific.
1.2 S.U.B. agitation acceleration and
deceleration rates
To decrease the stress on the drive shaft, a minimum acceleration rate
of 5 seconds, beginning at 0 RPM and going to the setpoint, must
be applied to 50L to 1,000L S.U.B. systems. The same rate must be
applied when decelerating the agitation rate for 50L to 1,000L S.U.B.
systems. 2,000L S.U.B. systems have a longer drive shaft, which
experiences more stress-related fatigue. Minimum acceleration and
declaration rates required fomr 2,000L S.U.B. systems are from 0 RPM
to 75 RPM in 60 seconds and from 75 RPM to 0 RPM in 60 seconds.
Acceleration and deceleration rates for agitation rates above 76 RPM
must be calculated at 1.25 RPM per second.
1.3 Drive shaft longevity and
maintenance
Under normal operating conditions, drive shafts for 50 L- 1000L
bioreactors, mixers, and fermentors are expected to last 360 days.
However, the 2,000L S.U.B. drive shaft requires special care. See Table
1.2 and Table 1.3 for more specific information about 2,000L drive shaft
usage.
When testing 2,000L S.U.B systems, drive shafts used for system setup
and testing must be discarded. Customers are required to log their
drive shaft usage for warranty purposes. For this reason, a new
drive shaft should be employed by when customers start to use
the system.

Chapter | Configuration Guidelines
Thermo Scientific Single-use Systems Integrator’s Guide | 15
1.4 Pressure regulation
For safety, interlocks are recommended for pressure regulation inside
the BPC for all single-use systems. The gassing strategy should be
reduced as the pressure inside the BPC approaches 0.5 psi (0.03 bar).
Any time the pressure exceeds 0.5 psi (0.03 bar) in the BPC, the gas
flow should be stopped.
1.5 Motor cap safety sensor
An optional safety switch may be installed on the motor cap of all
single-use systems. This device uses a reed switch that is normally
closed when the cap is closed. When the cap is open, a safety
interlock should prevent the rotation of the drive shaft.

Chapter 2 | Electrical Box Overview
Thermo Scientific Single-Use System integrator’s Guide | 16
Electrical box overview
2.1 Introduction to single-use
systems hardware
A typical single-use system (S.U.S.) is shown in Figure 2.1. The major
sub-components are noted, although some sub-components vary
based on the type of unit— Single-Use Bioreactor (S.U.B.), Single-Use
Mixer (S.U.M.) or Single-Use Fermentor (S.U.F.).
2
Figure 2.1, View of a typical
S.U.S., in this case a 300L
Single-Use Fermentor.

Chapter 2 | Electrical Box Overview
These electrical boxes (e-boxes) share a common schematic based
upon their input voltage:
• 120 VAC – Thermo Scientific drawing number 24390
• 240 VAC – Thermo Scientific drawing number 17521
Schematic drawings are available upon request, and should be
referenced for all applications that use a Thermo Scientific e-box.
2.2 Thermo Scientific e-box
information
The Thermo Scientific e-box can be purchased with any S.U.S. It
may not be provided with fully integrated units, but it can be used
by third-party integrators who do not want to spec out components
to control motor RPM, pressure monitoring, weight monitoring,
temperature monitoring, and/or temperature control of resistive blanket
units. Integrators who want to build and specify their own electrical
components may order units without the Thermo Scientific e-box.
Figure 2.2, Figure 2.3, and Figure 2.4 show a typical resistive-style
e-box. Jacketed-style e-boxes are subsets of the e-boxes shown.
Thermo Scientific Single-Use Systems Integrator’s Guide | 17
Figure 2.2, E-box front view.
AGITATION CONTROLLER

Figure 2.3. E-box bottom view.
Thermo Scientific Single-Use Systems Integrator’s Guide | 18
Figure 2.4. E-box side view.
Chapter 2 | Electrical Box Overview

Chapter 3 | Motor Connection
Thermo Scientific Single-Use System integrator’s Guide | 19
Motor connection
This section provides information for third-party integrators on how to
connect standard AC- and DC-powered motors supplied on the S.U.S.
3.1 Units without Thermo Scientific
e-boxes
3.1.1 AC moto r
The AC motor comes with a 4-pin male receptacle on the J-box, as
shown in Figure 3.1.
3
Figure 3.1. Typical AC motor.
4-pin male receptacle

Chapter 3 | Motor Connection
Thermo Scientific Single-User Systems Integrator’s Guide | 20
Table 3.1. AC motor connection table.
Item Description
Thermo Scientific Electrical Box connector (male
receptacle) Part # C01620C00310012
Controller connector (female inline) Part # C01620D00311012
Controller connector (female receptacle) Part # C01620G00310012
Connector manufacturer Amphenol
Recommended AWG 16/4 – shielded
Wiring
Pin 1 U phase
Pin 2 V phase
Pin 3 W phase
GRD GRD
Figure 3.2. AC motor connector.
Table 3.1 shows the connection/pinout for the AC motor. The table
includes information for the mating female connector, if the integrator
wants to build a motor power cable. Figure 3.2 shows a close-up of
the connector on the motor.