Thermo Scientific DHX Series User manual

DHX Heat Exchanger User’s Guide
DOC0050 • Revision A
May 2019

Contents
Warnings and safety information 1
How to use this guide 4
Chapter 1 DHX Heat Exchanger overview 5
1.1 General information 5
1.2 Main components 5
Chapter 2 Installing the DHX 7
2.1 Performing an incoming inspection 7
2.2 Installing the system 7
2.3 DHX plate system optional configurations 9
Chapter 3 Operating information 11
3.1 Loading the BPC 11
3.2 Operating the DHX 15
3.3 Removing the BPC 16
Chapter 4 System features and specifications 134
4.1 Hardware features 135
4.1.1 Design features for 50–250 L systems 135
4.1.2 Design features for 500 L systems 136
4.1.3 Design features for 1,000 L systems 137
4.1.4 Design features for 2,000 L systems 138
4.2 Hardware specifications 139
4.3 Electrical box design 151
Chapter 5 Maintenance and troubleshooting 153
5.1 Maintenance 154
5.1.1 Routine maintenance 154
5.1.2 Preventive maintenance 154
5.2 Troubleshooting and frequently asked questions 156
5.2.1 Hardware operation issues 156
5.2.2 Cell culture operation issues 158
5.2.3 Sparging issues 159
5.2.4 Probe and connector issues 160
5.2.5 BPC issues 161

Chapter 6 General ordering information 162
6.1 Ordering instructions 163
6.2 Ordering/support contact information 163
6.3 Technical support 164
Contents

Warnings, safety, and warranty
information
Congratulations! You have purchased high-quality Thermo Scientific™
equipment. We have included safety information in this guide, based
on our knowledge and experience. It is important, however, for you
to work with your Safety Management personnel to ensure that this
equipment is integrated into your safety practices. Please take some
time to perform your own job safety analysis in order to identify and
control each potential hazard.
WARNING: Read and understand this user’s guide before
using this equipment.
The Thermo Scientific™DHX Heat Exchanger is designed to be
operated under traditional pharmaceutical conditions. A general
understanding of bioprocessing systems and their operation is
important prior to using the system for the first time. Read and
understand the user’s guide before operating; failure to do so could
result in injury and potential loss of product.
WARNING: Do not exceed maximum operating pressure.
• The maximum jacket operating pressure should not exceed 5.2
bar (75 psi).
• The maximum BioProcess Container (BPC) operating pressure
should not exceed 2.75 bar (40 psi). The recommended standard
operating pressure is 2.06 bar (30 psi).
WARNING: Moving and tipping hazard.
Due to the weight of the Thermo Scientific™DHX Heat Exchanger, two
operators are required to move the unit. Use caution when moving
the equipment. Ensure that the pathway is clear and free of obstacles.
Avoid moving up or down slopes unless properly supervised by an
equipment-moving professional.
WARNING: Ensure that the temperature of the BPC never
reaches above 50ºC (122ºF).
Warnings, safety, and warranty information
DHX Heat Exchanger User's Guide |1Thermo Scientific

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.
Warnings, safety, and warranty information
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
DHX Heat Exchanger User's Guide |2Thermo Scientific

Warnings, safety, and warranty information
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.
Seismic guidance
The buyer of the equipment is responsible for ensuring that country-
specific codes and seismic values are assessed for suitability of
equipment installation and safety at the designated site. In addition,
it is the buyer’s responsibility to assess the building structure for
the designated equipment to ensure correct seismic anchoring and
tethering designs for both the equipment and facility. It is highly
recommended that the buyer consult with a local, licensed third party
architecture and engineering firm to provide the buyer with correct
engineering analysis and stamped documentation prior to equipment
installation at the facility. In addition, the buyer will be responsible for
rigging and anchoring of the equipment to a specified, fixed location.
Upon request, Thermo Fisher Scientific can assist with establishing
compliant seismic anchoring and tethering designs for purchased
equipment based on building and country codes, at an agreed
upon fee.
It is also noted that movable equipment (i.e. non-fixed or caster
mount) is exempt from seismic design requirements according to
ASCE 7-16, Chapter 13, section 1.4. Although these units are exempt
from the seismic design requirements of ASCE 7, it should be noted
that such equipment is susceptible to overturning during a seismic
event. Therefore, it is the responsibility of the buyer to address seismic
safety for movable equipment at the designated facility.
DHX Heat Exchanger User's Guide |3Thermo Scientific

How to use this guide
Scope of this publication
This user's guide contains information about the standard Thermo
Scientific™DHX™Heat Exchanger, including hardware, components,
product design verification methods, installation, operation and
specifications. It is intended for use by people who may or may
not have experience with Thermo Scientific systems, but who have
some knowledge of bioproduction processes and large-scale mixing
systems.
Rev. Date Section Change made Author
-- 09/2016 -- Initial release
A05/2019 -- Reformatted E. Hale
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.
How to use this guide
DHX Heat Exchanger User's Guide |4Thermo Scientific

DHX Heat Exchanger
overview
1.1 General information
The Thermo Scientific™DHX Heat Exchanger is a modular system
that employs a plate-and-frame concept, using a single-use bag
assembly, or BioProcess Container (BPC), as the sterile fluid path.
Each bag fits tightly between a dimpled, stainless steel plate assembly
(5 total) to transfer heat in a counter-current flow path. In a completely
isolated flow path, the process fluid flows through the bags counter-
currently to the heating/cooling fluid within the plates. Once the bags
are loaded into place, no further operator interaction is required. The
system provides efficient, sterile heat transfer that easily integrates into
any new or existing process.
1.2 Main components
Figure 1.1 illustrates the components of the Thermo Scientific DHX
Heat Exchanger.
DHX Heat Exchanger User's Guide |5Thermo Scientific
Chapter 1 | DHX Heat Exchanger overview 1

DHX Heat Exchanger User's Guide |6
Chapter 1 | DHX Heat Exchanger overview
Thermo Scientific
Figure 1.1. DHX Heat
Exchanger components.
Fanning lever
Clean room-grade
casters
Locking lever
Plate system
hinges (6 total)
Fixed insulation
(on each end plate)
High point
vent valves
Cart base
Flexible hoses
connect plate system
Tabs (hold BPC in place)
Single-use tubing
(connects BPC assemblies)
Wing nut (6 total)

Installing the DHX
2.1 Performing an incoming inspection
Use the following steps to inspect the DHX Heat Exchanger:
1. Carefully uncrate the DHX.
2. Thoroughly review the product for damage.
3. Check the product and components against the parts list (see
Chapter 5).
4. If the product is damaged, or if the shipment is not complete,
please contact your service representative immediately.
2
DHX Heat Exchanger User's Guide |7
Chapter 2 | Installing the DHX
Thermo Scientific
2.2 Installing the system
Use the following steps to initially install the DHX Heat Exchanger:
1. Unlock all four (4) casters and transport the DHX to the desired
location.
2. Ensure the DHX is on a level surface and lock the casters in place.
3. Refer to Figure 2.1 for the recommended installation setup for the
DHX system.