ThermoFisher Scientific HyPerforma DynaDrive User manual

Single-Use Bioreactor
HyPerforma DynaDrive
Single-Use Bioreactor
Service Guide
Revision | A
December 2021
Service Guide | DOC0154

Contents
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 [e-mail] 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
loading
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.