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.

Figure 2.1. DHX system
recommended setup.
DHX Heat Exchanger User's Guide |8
Chapter 2 | Installing the DHX
Thermo Scientific
Process outlet
Process inlet
*
I
TE PI
**
TE
TIC
TIT
HTF outlet
PI
HTF supply
(pump or TCU)
FE
PI STR
PSV
*High pressure interlock recommended
to shut down pumps or flow source.
**Temperature control loop
recommended for heating and high
temperature applications. May not be
required for cooling applications.
4. The DHX inlet and outlet connections are 1/2 inch compression
fittings, as standard. It is highly recommeded that a strainer be
used upstream for the DHX plate system if the heat transfer fluid
may contain debris. Any debris that collects within the DHX will
restrict the flow and affect performance.
5. Connect the heat transfer fluid inlet and outlet connections, as
shown in Figure 2.2.
Figure 2.2. DHX fluid inlet
and outlet connections.
HTF inlet
HTF outlet

DHX Heat Exchanger User's Guide |9
Chapter 2 | Installing the DHX
Thermo Scientific
6. The DHX plate system operates independently of the single-use
bag assembly, or BioProcess Container (BPC). The installation of a
BPC is not required during the initial priming of the plate system.
7. Ensure that all hoses are securely connected to each plate and
that the high point vent valves are closed.
8. Ensure that the plate system is closed, using the locking and
fanning levers.
9. Ensure that the six (6) DHX plate system hinges are secure. Ensure
that the bolts sit in the recessed section of the plate tab, and that
the six (6) wing nuts are firmly hand-tightened.
10. Open the heat transfer circuit to the DHX. Note: It is normal to
hear some "knocking" as the plate system initially pushes the air
through the plates.
11. Bleed off the air in each plate using the high point bleed valves
and a small container to collect any released heat transfer fluid.
The bleeding steps should be repeated until all the air is expelled
from the DHX plate system.
12. Once the DHX plate system is bled, it is ready for operation.
2.3 DHX plate system optional configurations
The DHX system is a modular and changeable system in which one to
three single-use bags can be used. All five (5) plates are not required
to be used at one time. If one to three bags are used, there are two
options in setting up the DHX plate system.
Option 1: Insulation foam between the unused plates
The heat transfer fluid may run through all five plates when using
an assembly consisting of one to three single-use bags. Flexible
insulation foam spacers are provided by Thermo Scientific. These
spacers must be inserted between every unused plate—after the
bags have been installed—to prevent damage or warping (Figure 2.3).

Insulation foam
spacers
Figure 2.3. DHX system
Configuation Option 1.
DHX Heat Exchanger User's Guide |10
Chapter 2 | Installing the DHX
Thermo Scientific
Option 2: Bypassing the unused plates
The DHX system's unused plates may be disconnected per Figure
2.4. Insulation foam spacers must be inserted between every unused
plate to prevent damage or warping. If option 2 is chosen, the
installation and bleeding instructions described in sections 2.1 and 2.2
must be followed accordingly for the plates in use. Note: Any unused
plates should be capped or sealed appropriately.
Figure 2.4. DHX system
Configuration Option 2.
Insulation foam
spacers
Disconnected
DHX plates

Chapter 3 | Operating information
Thermo Scientific
Operating information
3.1 Loading the BPC
Note: Ensure all four (4) casters are in the locked position (down)
before loading the BPC assembly into the DHX.
1. Isolate the heat transfer fluid circuit to stop the heat transfer circuit
from flowing through the DHX plate system. It is acceptable to
have the plates pressurized with heat transfer fluid during the BPC
loading process.
2. Remove the wing nuts and bolts from the six (6) DHX plate system
hinges in the order shown in Figure 3.1. Note: It is recommended
to keep a free hand under the wing nut during its removal to
prevent it from dropping to the floor.
3
Figure 3.1. Six (6) DHX
plate system hinges.
3
1
2
4
6
5
DHX Heat Exchanger User's Guide |11

1. Once the bolts are removed, the DHX will open slightly and relax
against the locking mechanism. Use the safety levers to fan out
the plates. This can be done by pulling the locking lever (located
towards the bottom of the unit, closest to the heat transfer fluid
ports) slightly to release the locking mechanism (Figure 3.2).
DHX Heat Exchanger User's Guide |12
Chapter 3 | Operating information
Thermo Scientific
Figure 3.2. Pulling the
locking lever.
Locking
lever
2. Using the upper fanning lever, move it towards the locking lever
with control to fan out the DHX plates (Figure 3.3). Remove the
insulation foam spacers, if applicable. The DHX is now in the open
position and the single-use BPC assembly can be placed.
Figure 3.3. Moving
fanning lever towards
the locking lever to
open position.
Fanning
lever
Fanning
lever
Locking
lever

3. There are tabs to secure each BPC to the corresponding plate on
the top and bottom of the single-use BPC (Figure 3.4). For ease
of installation, all tabs should be separated prior to placing the
BPCs between the plates. Insert each BPC used in the 1–4 single-
use BPC assembly within each corresponding plate. Ensure the
tubing cascades from one BPC to the next. [See section 2 to view
the two different configuration options if using less than all five (5)
plates.] Attach the bottom tabs of each BPC first.
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Chapter 3 | Operating information
Thermo Scientific
4. The process flow must always be set up so the process fluid
fills from the bottom of the BPC to the top to displace any air
throughout the single-use BPC assembly.
5. For the DHX BPC assemblies with drain ports, ensure that the
drain port is connected to the proper drain connection in the
process. Close the pinch clamps on each drain line before starting
the process fluid flow.
6. The process must be set up for counter-current flow where the
process fluid enters from the opposite side of the heat transfer
fluid in order to provide the most efficient heat transfer method.
The process fluid should cascade through each BPC in the series
in the opposite direction of the heat transfer fluid path (Figure 3.5).
Figure 3.4. Securing
the single-use BPCs.

7. Connect the inlet and outlet of the single-use BPC assembly to
the upstream and downstream process connections with the
DACs, tube welds, or connections specified for the user's custom
BPC assembly.
8. If the optional single-use BPC assembly with low-point drains are
used, the low-point drain connections are manifolded together.
9. The single-use flow path tubing left in its natural state could be
trapped between the braided heat transfer hoses when the DHX
unit is being closed. To prevent this, rest the single-use flow path
tubing across the top of the heat transfer hose assemblies (Figure
3.6).
DHX Heat Exchanger User's Guide |14
Chapter 3 | Operating information
Thermo Scientific
Heating/cooling
fluid
Process
fluid
Figure 3.5. DHX fluid
flow.
Figure 3.6. Flow path
tubing.
Incorrect Correct

10. Reinstall the hinge bolts one at a time in the order shown in Figure
3.7. Position all bolts before fully tightening them, and ensure that
each bolt is recessed in the plate tab appropriately. It is a good
practice to check the tightness of the side bolts after tightening
the top bolts and vice versa.
DHX Heat Exchanger User's Guide |15
Chapter 3 | Operating information
Thermo Scientific
Figure 3.7. Hinge bolt
installation (left) and
hinge detail (right).
21
3
5
4
6
3.2 Operating the DHX
1. Once the fluid connections are made, start the processing by
resuming the heat transfer fluid circuit. The flow of the heat
transfer fluid can be initiated up to 15 lpm. The bleed valves at the
top of each plate can be used to vent any trapped air (Figure 3.8).
A piece of tubing should be used to direct any fluid that may exit
the valves to a waste receptacle.
Figure 3.8. Bleed valve
locations.

2. Begin the process flow slowly, starting at 3 lpm (or less). The
BPCs fill from the bottom to top, displacing the air as the process
fluid cascades through the assembly.
3. Carefully monitor the BPC assembly during the priming step to
ensure that there are no leaks, the tubing is not pinched, and all
air is being displaced accordingly.
4. Once the single-use BPC assembly is primed, the desired flow
rate may be set and the process can run continuously. Any
time the flow is stopped while in operation, it is recommended
to slowly ramp-up the pump when the flow is resumed. This
recommendation is especially the case for high flow rate
applications in order to prevent pressure surges in the single-use
BPC assembly.
3.3 Removing the BPC
1. Once the process operation is complete, the single-use BPC
assembly should be depressurized and drained to the extent
possible prior to removal form the DHX plate system.
2. After the BPCs have been partially drained, and they are no longer
pressurized, remove the wing nuts and bolts from each of the six
(6) DHX plate system hinges.
3. Open the DHX plate system using the safety levers (see section
3.1, steps 1 through 3).
4. Release the bottom and top tabs on all the BPCs and remove the
single-use BPC assembly.
5. If gross recovery of the process fluid is desired, start with the BPC
at the process inlet, remove the BPC tabs from the corresponding
connection points on the plate, and gently lift and tilt the BPC
toward the drain lines. Once the first BPC is nearly drained, repeat
the process with the consecutive BPCs until the last BPC in the
assembly has been drained.
6. If the single-use BPC assembly with low-point drains was used,
any remaining process fluid may be recovered through the
process inlet by reversing the pump, or through the low-point
drain manifold outlet. To use the process inlet, the process outlet
and low-point drain manifold outlet tubing should be closed using
a clamp. Open the pinch clamps on each individual drain line
DHX Heat Exchanger User's Guide |16
Chapter 3 | Operating information
Thermo Scientific

before starting the process fluid flow. The process fluid can be
recovered by reversing the pump and routing the process fluid
to an appropriate collection ocntainer. Alternately, to use the low
point drain manifold outlet, the process inlet and outlet tubing of
the BPC assembly should be closed using a clamp and the low
point drain manifold outlet tubing can be routed to a pump so
the process fluid may be recovered. Open the clamps on each
individual drain line before starting the process fluid flow.
7. Discard the assembly in the appropriate waste stream as dictated
by the end user's requirements.
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Chapter 3 | Operating information
Thermo Scientific