Thermo Scientific HyPerforma 5.1 S.U.B. Instrucciones de montaje

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 TechnicalDocumentation@ThermoFisher.com.

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).

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

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