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