ThermoFisher Scientific HyPerforma DynaDrive Bedienungsanleitung

Single-Use Bioreactor

HyPerforma DynaDrive

Single-Use Bioreactor

Service Guide

Revision | A

December 2021

Service Guide | DOC0154

Contents

Warnings, safety, and warranty information 1

How to use this guide 4

Chapter 1. DynaDrive S.U.B. overview 5

Chapter 2. Servicing and preventive maintenance 9

2.1. Servicing checklists 10

2.2. Maintenance 10

2.2.1. Routine maintenance 10

2.2.2. Preventive maintenance 10

Chapter 3. Replacing parts 11

3.1. Replacement parts and part numbers 12

3.2. Replacing the S.U.B. common-jacket drain valve and

wing nut tri-clamp 13

3.2.1. Required parts and tools 13

3.2.2. Preparation 13

3.2.3. Replacement procedures 14

3.3. Replacing the 50 and 500 L quick-release pin 15

3.3.1. Required parts and tools 15

3.3.2. Replacement procedures 16

3.4. Replacing the 50 and 500 L assembly bottom hub clamp 17

3.4.1. Required parts and tools 17

3.4.2. Preparation 17

3.4.3. Replacement procedures 17

3.5. Replacing the IPM motor, BPC lift mechanism, and

hub locking mechanism 18

3.5.1. Required parts and tools 18

3.5.2. Preparation 18

3.6. Replacing the 50 and 500 L load cells 26

3.6.1. Required parts and tools 26

3.6.2. Preparation 26

3.6.3. Replacement procedures 29

Thermo Scientific

Contents

3.7. Replacing the 3,000 and 5,000 L load cells 35

3.7.1. Required parts and tools 35

3.7.2. Preparation 35

3.7.3. Replacement procedures 37

3.8. Replacing the 3,000 and 5,000 L cables and coolant hoses 38

3.8.1. Required parts and tools 38

3.8.2. Preparation 38

3.8.3. Replacement procedures 38

3.9. Replacing the 3,000 and 5,000 L pulleys and pulley cables 38

3.9.1. Required parts and tools 38

3.9.2. Preparation 39

3.9.3. Replacement procedures for pulleys 39

3.9.4. Replacement procedures for pulley cables 42

3.10. Replacing the 3,000 and 5,000 L BPC lift cylinder 43

3.10.1. Required parts and tools 43

3.10.2. Preparation 43

3.10.3. Replacement procedures 43

3.11. Replacing the 3,000 and 5,000 L platform locking mechanism 43

3.11.1. Required parts and tools 43

3.11.2. Prep arati on 43

3.11.3. Replacement procedures 45

3.12. Replacing the 3,000 and 5,000 L assembly bottom hub clamp 46

3.12.1. Required parts and tools 46

3.12.2. Preparation 46

3.12.3. Replacement procedures 46

3.13. Replacing the 3,000 and 5,000 L condenser heater 47

3.13.1. Required parts and tools 47

3.13.2. Preparation 47

3.13.3. Replacement procedures 48

3.14. Additional replacement parts and part numbers 51

3.14.1. Installing cable management system 51

3.14.2. Installing foam probe holder 52

3.14.3. Installing BPC tab holders 52

Chapter 4. Recommended spare part inventory 54

Thermo Scientific

Contents

Chapter 5. Troubleshooting and frequently asked questions 58

5.1. Hardware operation issues 59

5.2. Cell culture operation issues 60

5.3. Sparging issues 61

5.4. Probe and connector issues 62

5.5. Other issues 62

Chapter 6. DynaDrive S.U.B. specifications 63

Chapter 7. Regional contact information 70

7.1. Ordering/support contact information 71

7.2. Technical support 71

Thermo Scientific

Warnings, safety, and warranty information

WARNING: Read and understand this guide before servicing

the equipment.

The Thermo Scientific™HyPerforma™DynaDrive Single-Use Bioreactor (S.U.B.) is

designed to be operated under traditional eukaryotic cell culture conditions. A general

understanding of bioreactor systems and their operation is important prior to using

the system for the first time. Read and understand this user’s guide before operating;

failure to do so could result in injury and potential loss of product. Only trained operators

should be allowed to operate the equipment.

WARNING: Hazardous voltage inside.

The agitation motor, motor controller, and electrical control panel (E-Box)

all 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.

Please note any electrical hazard labels on the equipment. Thermo Fisher Scientific

recommends using standard lockout procedures when working on electrical

components. The main switch on the E-Box may be locked out.

WARNING: Rotating parts—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: 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: 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

Warnings, safety, and warranty information

Thermo Scientific 1DynaDrive S.U.B. Service Guide

Warnings, safety, and warranty information

WARNING: Pinch hazard.

To avoid pinching and injuring an operator or causing damage to the equipment or the

BioProcess Container (BPC), use caution when opening and closing the door, securing

the BPC to the bottom port in the tank, or during operation of the DynaDrive S.U.B.

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.

WARNING: The Thermo Scientiﬁc HyPerforma DynaDrive S.U.B. 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.

Electrical connections

Power should be supplied by a non-GFCI 20 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 DynaDrive

S.U.B.s are NOT plugged into a GFCI outlet.

Power outlet accessibility

For safety, the power outlet used to power the unit must be accessible at all times. In

case of emergency, you must be able to immediately disconnect the main power supply

to all of the equipment. Allow adequate space between the wall and the equipment so

that power cords can be disconnected in case of emergency.

Thermo Scientific 2DynaDrive S.U.B. Service Guide

Warnings, safety, and warranty information

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. 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.

Thermo Scientific 3DynaDrive S.U.B. Service Guide

How to use this guide

Scope of this publication

The purpose of this service guide is to provide detailed information about how to service

and maintain Thermo Scientific™HyPerforma™DynaDrive S.U.B. systems. It is intended

for use by Thermo Fisher Scientific certified service personnel who may or may not have

experience with the DynaDrive S.U.B.

Document change information

A summary of the changes that have been made to this document are listed below.

How to use this guide

Revision Date Description Author

A12/2021 Initial release T. Golightly

Publication Document number

HyPerforma DynaDrive Single-Use Bioreactor User’s Guide DOC0090

HyPerforma DynaDrive S.U.B. Unpacking Guide DOC0149

50 L HyPerforma DynaDrive S.U.B. Quick Start Guide DOC0148

500 L HyPerforma DynaDrive S.U.B. Quick Start Guide DOC0171

3,000 and 5,000 L HyPerforma DynaDrive S.U.B. Unpacking and Setup Guide DOC0176

HyPerforma DynaDrive S.U.B. Validation Guide DOC0172

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

Please contact your local sales representative for information about the related

publications listed below.

Thermo Scientific 4DynaDrive S.U.B. Service Guide

Chapter 1 | DynaDrive S.U.B. overview 1

DynaDrive S.U.B.

overview

Thermo Scientific 5DynaDrive S.U.B. Service Guide

Chapter 1 | DynaDrive S.U.B. overview

Figures 1.1 and 1.2 illustrate the front and back views of the 50 L DynaDrive S.U.B. unit.

Bottom cutouts/

pins for BPC

attachment

Tri-clamp jacket

inlet/outlet

connections

Casters

Vessel

handle bars

E-Box

(optional)

Exhaust vent filter

holder

Agitator motor

Cart assembly

Tubing management

clip

Door for BPC

Double probe clips on

probe hanger bracket

BPC lift mechanism

Top BPC tab holders

Foam probe

holder

Figure 1.1. Front view of 50 L DynaDrive

S.U.B. (with optional E-Box).

Figure 1.2. Back view of 50 L DynaDrive S.U.B. (with

optional E-Box).

Thermo Scientific 6DynaDrive S.U.B. Service Guide

The Thermo Scientific HyPerforma DynaDrive Single-Use Bioreactor (S.U.B.) offers a

flexible new alternative to traditional stirred-tank mixing. The system uses a redesigned

impeller system: a drive train is connected to both an overhead mixing motor via a

sealed bearing assembly and the bottom of the tank, allowing improved mixing while

maintaining the integrity of the system. In addition, the DynaDrive S.U.B. facilitates

greater scalability by allowing users to begin mixing at only 10% volume in 50 L units,

~8% in 3,000 L units, and 5% in 500 and 5,000 L units.

Each DynaDrive S.U.B. system consists of the following main components:

• Stainless steel outer support container with a water jacket heating system.

The outer support container is made of 304 or 316 stainless steel, and holds and

supports the BioProcess Container (BPC). The square shape of the DynaDrive S.U.B.

allows an optimized footprint in contrast to traditional round reactors.

• BPC, which is supplied gamma irradiated for ready-to-use, single-use mixing. The

ﬂex drive train is located entirely inside of the BPC, and connects to the reactor at

the bottom of the tank in addition to the standard top hub, removing the need for

traditional drive shafts.

• Control system, provided by Thermo Scientiﬁc or a third party.

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