Thermo Scientific Thermo Scientific HyPerforma DS 300 User manual

Thermo Scientific HyPerforma
DS 300 Single-Use Mixer (S.U.M.)
User’s Guide
DOC0011 • Revision B
February 2018

Contents
Warnings, safety, and warranty information 1
How to use this guide 5
Chapter 1 DS 300 Single‑Use Mixer (S.U.M.) overview 7
1.1 Introduction to the DS 300 S.U.M. 8
1.2 Hardware characteristics 9
1.3 BPC characteristics 13
1.3.1 S.U.M. BPC features 13
1.3.2 Open-top mixing configurations 13
1.3.3 Closed-top mixing configurations 14
1.4 Operating characteristics 14
1.4.1 Operating pressure 14
1.4.2 Working volume 14
1.4.3 Dispensing 14
Chapter 2 Setup and operating information 15
2.1 Site preparation 16
2.1.1 Electrical connections 16
2.1.2 Protective earth grounding 16
2.2 Initial setup 16
2.3 Docking station preparation 21
2.4 BPC preparation and setup 23
2.4.1 BPC handling instructions 23
2.4.2 Working volume 24
2.4.3 Liquid transfer 24
2.4.4 Dispensing 24
2.5 BPC loading 24
2.5.1 Open-top liner loading 24
2.5.2 Closed-top BPC loading 27
2.6 Operating information 30
2.6.1 Powering on 30
2.6.2 Height adjustment 30
2.6.3 Motor angle adjustment 31
2.6.4 Reusable bearing hub insertion for open-top liners 31
2.6.5 Drive shaft insertion 32
2.6.6 Drive shaft rotation 35
2.6.7 Controlling agitation 35

Chapter 3 Maintenance and troubleshooting 36
3.1 Routine maintenance 37
3.2 Preventive maintenance 37
3.3 Troubleshooting 38
Chapter 4 Specifications and part numbers 40
4.1 Hardware features and specifications 41
4.1.1 Hardware features 41
4.1.2 Hardware specifications 42
4.2 BPC specifications 42
4.2.1 Closed-top BPC for 50 L, 100 L, and 200 L drums 43
4.2.2 Open-top liners for 50 L, 100 L, 200 L, and 300 L
drums 44
4.3 General mixing specifications 44
4.4 Part numbers for components, parts, and accessories 45
4.5 Part numbers for replacement and spare parts 48
Chapter 5 General ordering information 49
5.1 Ordering instructions 50
5.2 Ordering/support contact information 50
5.3 Technical support 51
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
operating the equipment.
The Thermo Scientific™HyPerforma™DS 300 Single-Use Mixer
(S.U.M.) 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.
WARNING: Hazardous voltage inside.
Disconnect power before opening. Service should be performed by
trained personnel only. Electrical components are designed into the
DS 300 S.U.M., and required for the unit to function properly. The
mixing motor, motor controller, electronic lift mechanism, and hand-
held control device all have electrical components. Modification,
replacement, by-passing, and/or adding any electrical component
without the written consent of Thermo Scientific voids any/all
warranties, ETL/CE certification(s) and liabilities.
WARNING: Static electricity may build up in BPCs.
• BioProcess Containers (BPCs) may act as insulators for
electrostatic charge. If electrostatic charge is transferred to a BPC,
the charge may be stored in the BPC and/or the product inside.
This phenomena varies by product and use; therefore, it is the
sole responsibility of the end user to ensure a hazard assessment
is conducted and the risk of electrostatic shock is eliminated.
• Where applicable, a product contact stainless steel coupler
may be grounded to the frame to dissipate electrostatic build up
from the material within a BPC. It is good practice to dissipate
electrostatic buildup by grounding all BPCs prior to coming
in contact with them. When working with BPCs, the use of
nonconductive materials, such as nonconductive gloves, is
recommended.
HyPerforma DS 300 Single‑Use Mixer User's Guide |1Thermo Scientific

WARNING: Rotating parts—entanglement hazard.
Rotating parts can cause severe injury. Keep hands away from
moving parts. The safety cap on drive shaft motor must never
be removed and must always be locked in place during use. If
the safety cap is broken, call Thermo Scientific service personnel to
replace it prior to use.
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: Use caution with hazardous chemicals or
materials.
Personnel servicing equipment need to know the hazards of any
chemicals or materials that may be present on or in the equipment.
Use general hazard communication techniques such as Safety Data
Sheets, labels, and pictograms to communicate any hazards.
WARNING: Burst hazard—air under pressure.
Under normal operating conditions, the closed-top mixing BPC
chamber is under slight pressure. Normal passive venting prevents
any excess of pressure building up within the chamber. Chamber
pressure and inlet line pressure should be monitored for proper
settings.
• Contents are under pressure
• Do not exceed 0.03 bar (0.5 psi) BPC pressure
• Do not exceed 0.34 bar (5 psi) inlet pressure
• Assure vent filter is properly positioned and working properly
WARNING: Pinch hazard.
Under normal operating conditions, the mixing head can be manually
raised and lowered. Caution should be used to avoid pinching or
crushing an operator or causing damage to equipment and/or the
BPC.
WARNING: The Thermo Scientific HyPerforma DS 300 Single-
Use Mixer may not be installed in a potentially explosive
atmosphere as set forth in the applicable EU ATEX Directive.
Thermo Scientific
Warnings, safety, and warranty information
HyPerforma DS 300 Single‑Use Mixer User's Guide |2

Protective earth grounding
Protective earth grounding for the DS 300 S.U.M. system and
controller is provided through the ground terminal of the plug
providing power. Source power to the controller must provide
grounding to this terminal in order to minimize the hazard of a possible
shock in the occurrence of a fault condition. The equipment should
NOT be operated without a proper protective earth ground.
Environmental conditions
• Operating: 17 to 27°C; 20 to 80% relative humidity, non-
condensing
• Storage: -25 to 65°C
• Installation category II (over voltage) in accordance with IEC 664
• Altitude Limit: 2,000 meters
Electrical connections
Power should be supplied by a non-GFCI 15 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 the S.U.B. NOT be plugged into a GFCI outlet.
Main power: 20 A 108–240 VAC or 208–250 VAC, 1 Phase, 50/60 Hz
circuit.
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
Warnings, safety, and warranty information
Thermo Scientific HyPerforma DS 300 Single‑Use Mixer User's Guide |3

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.
Warnings, safety, and warranty information
Thermo Scientific HyPerforma DS 300 Single‑Use Mixer User's Guide |4

How to use this guide
Scope of this publication
This user's guide contains information about the standard Thermo
Scientific™HyPerforma™DS 300 S.U.M. systems, 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.
Document change information
Rev. Date Section Change made Author
A03/2013 -- Initial release G. Brau
B02/2018 -- Updated formatting to current brand
standards E. Hale
B02/2018 Ch. 4 Removed hardware and BPC part
numbers E. Hale
Input into Thermo Scientific publications
The accuracy of the information in this publication and your
satisfaction with the scope and content of this publication are
important to us. Please send any corrections or suggestions you
have for this user's guide (or for any other Thermo Scientific technical
publication) to [e-mail].
Related publications
Please contact your local sales representative for information about
the related publications listed below.
Publication Description
Thermo Scientific HyPerforma DS 300 S.U.M.
Unpacking Guide (DOC0010)
Information about validation
procedures
Thermo Scientific HyPerforma DS 300 S.U.M.
Data Sheets
Product descriptions and
ordering information
Thermo Scientific
How to use this guide
HyPerforma DS 300 Single‑Use Mixer User's Guide |5

Abbreviations/acronyms
Refer to the list below for definitions of the abbrieviations and
acronyms used in this publication.
BPC BioProcess Container
E-Box Electrical control panel
E-Stop Emergency stop
ETP Equipment Turnover Package
GFCI Ground fault circuit interrupter
ID Inner diameter
IEC International Electrical Code
OD Outer diameter
S.U.M. Single-Use Mixer
Thermo Scientific
How to use this guide
HyPerforma DS 300 Single‑Use Mixer User's Guide |6

DS 300 Single-Use
Mixer (S.U.M.) overview
Chapter contents
1.1 Introduction to the DS 300 S.U.M.
1.2 Hardware characteristics
1.3 BPC characteristics
1.4 Operating characteristics
1
Thermo Scientific HyPerforma DS 300 Single‑Use Mixer User's Guide |7

Figure 1.1. HyPerforma DS 300
S.U.M. docking station and
drum (front view)
1.1 Introduction to the DS 300 S.U.M.
The Thermo Scientific™HyPerforma™DS 300 Single-Use Mixer
(S.U.M.) offers a single-use alternative for traditional stirred tank
mixing. It is designed using the same mixing principles as the
stainless steel Thermo Scientific S.U.M. Both systems use an impeller
linked to an overhead mixing motor, and a sealed bearing assembly
which allows the impeller to turn while maintaining the integrity of the
system. The HyPerforma DS 300 S.U.M. is intended for powder-to-
liquid and liquid-to-liquid mixing in either open-top or closed-top bags
with single-use contact surfaces.
The major components of the DS 300 S.U.M. system are shown in
Figures 1.1 and 1.2, and described in more detail in the sections that
follow.
1
23
4
5
6
7
8
9
10
11
12
14
13
1. Motor assembly
2. Vertical lift
3. Horizontal support arm
4. Drive shaft (stored)
5. Handheld control device
6. E-Stop reset button
7. Main disconnect switch
8. E-Box
9. Height indicator and cable
management housing
10. Dolly
11. Plastic drum
12. Liquid drain port
13. Mounted drive shaft, sleeve,
and impeller
14. Conical insert
Chapter 1 |DS 300 S.U.M. overview
Thermo Scientific HyPerforma DS 300 Single‑Use Mixer User's Guide |8

15. Adjustable handle (in stored position)
16. Reusable bearing hub (open top applications only)
17. Square torque wrench
18. Spanner wrench
19. Drum positioner (optional)
20. Locking rear casters
1.2 Hardware characteristics
Hardware docking station
The stainless steel DS 300 S.U.M. is designed for mobility and
easy integration with single-use containers, and utilizes a simple
operator interface for mixing. It is designed for easy maneuverability,
is lightweight, and has a small footprint. Control of the system is
managed through a tethered handheld device that manages the
agitation speed and manual height adjustment. The mast assembly
and E-Box house the electrical components and the main power
switch. The mixer is pre-assembled, and is comprised of the following
sub-assemblies and parts:
• Docking station base with locking casters in the rear
• Adjustable handle that can be locked in position or stored away
• Mast support structure that houses the main control unit
18
17
16
19
20
15
Figure 1.2. HyPerforma DS 300
S.U.M. docking station and
drum (back view)
Thermo Scientific
Chapter 1 |DS 300 S.U.M. overview
HyPerforma DS 300 Single‑Use Mixer User's Guide |9

• Handheld control device
• Vertical lift mechanism
• Height indicator and cable management housing
• Motor mount and motor
• Drive shafts (customer-specified)
• Tools (spanner wrench and torque wrench)
Available options include an adjustable motor mount mixing head
capable of angular adjustments from 0–30°, drum positioner, and
reusable bearing hub for use in open-top mixing.
Mixing drums and dollies
Lightweight, reusable plastic mixing drums (Figure 1.3) are available in
four sizes: 50 L, 100 L, 200 L, and 300 L. Plastic dollies for the drums
are available in two sizes, one for 50–200 L drums, and another for
300 L drums.
Figure 1.3. Reusable plastic
mixing drum
Single-use BioProcess Container
The single-use BioProcess Container (BPC) provides gamma
irradiated, ready-to-use single-use contact surfaces, including:
• Drive shaft sleeve
• Sealed bearing assembly (closed-top option only)
• Tubing for liquid transfer
Available options include:
• Open-top liner for media or buffer preparation
• Impeller sleeve with quick connect fitting (used with the reusable
bearing hub in open-top mixing applications)
Thermo Scientific
Chapter 1 |DS 300 S.U.M. overview
HyPerforma DS 300 Single‑Use Mixer User's Guide |10

• Closed-top BPCs designed for liquid-to-liquid applications and
critical sterile solutions
• Containers are available in 50 L, 100 L, 200 L, and 300 L sizes
Handheld agitation and height control device
The operation of the DS 300 is simple and user-friendly. The handheld
control device (Figure 1.4) gives the user freedom to move around the
mixer with all controls available. The handheld device includes a digital
rpm display, motor control knob, on/off power to the motor, vertical
lift up and down buttons, and emergency stop (E-Stop) button. The
height is visually indicated in inches on the height indicator bar and
labeled for each standard drum size.
Figure 1.4. Handheld control
device
Fixed motor head or optional adjustable motor head
On the standard model, the mixing motor head (Figure 1.5) is fixed
at a 10° angle. On adjustable motor head models, the angle of the
adjustable motor head may be changed. The adjustable motor head
option enables fixing the motor head at an angle in 5° increments
from 0 – 30°.
Figure 1.5. Motor head
Thermo Scientific
Chapter 1 |DS 300 S.U.M. overview
HyPerforma DS 300 Single‑Use Mixer User's Guide |11

Mixer control system
Electronic components inside the unit control motor power, motor fan,
vertical lift, main incoming power, Ethernet (in a future enhancement),
handheld device power, motor hall-effect sensors, and the main
disconnect switch. The control system (Figure 1.6) is located in the
mast support structure of the DS 300 S.U.M. mixer unit. Component
cables run from the mixer control system to the tethered handheld
control device.
Figure 1.6. Mixer control
system
Optional drum positioner
An optional drum positioner (Figure 1.7) is designed to be used with
the dolly that is supplied with the DS 300 S.U.M. The drum postitioner
may be utilized when the location of the drum, relative to the impeller
location in the drum, is critical.
Figure 1.7. Optional drum
positioner
Mixing motor assembly
The mixing motor assembly is a directly coupled drive assembly that
supplies power to the drive shaft and impeller to initiate the mixing
process. The mixing motor assembly is made up of the parts shown
in Figure 1.8.
Drum
positioner
Thermo Scientific
Chapter 1 |DS 300 S.U.M. overview
HyPerforma DS 300 Single‑Use Mixer User's Guide |12

1.3 BPC characteristics
1.3.1 S.U.M. BPC features
Two standard BPC configurations are available for the S.U.M.:
a closed-top configuration, and a linear with a separate impeller
sleeve for open-top mixing. The BPC (or open-top liner) contains the
mixing process. The BPC chamber is manufactured from CX 5-14
film and the open-top liner from CX 3-9 film. Both are co-extruded
film structures specifically designed for biopharmaceutical process
usage. All materials are qualified for a range of physical, mechanical,
biological, and chemical compatibility requirements. The BPC is
validated using gamma irradiated processes.
1.3.2 Open-top mixing configurations
The open-top mixing configuration (Figure 1.9) includes an open-top
liner that also utilizes a separate, single-use sleeve that covers the
drive shaft once it is inserted into the mixing assembly. A reusable
bearing hub is used for all open-top mixing applications. A quick
connect fitting is used to connect the drive shaft sleeve to the bearing
hub.
Figure 1.8. Mixing motor
assembly
Motor
Latch pin
for safety
cover
Cap
Safety
cover
Drive shaft
head
Drive
shaft
Figure 1.9. Open‑top liner
Thermo Scientific
Chapter 1 |DS 300 S.U.M. overview
HyPerforma DS 300 Single‑Use Mixer User's Guide |13

1.3.3 Closed-top mixing configurations
The closed-top mixing configuration (Figure 1.10) is a fully integrated
BPC with a bearing hub, drive shaft sleeve, bottom drain with sample
port, inoculation line, and vent filter.
Figure 1.10. Closed‑top
BPC
1.4 Operating characteristics
1.4.1 Operating pressure
The DS 300 closed-top BPC is not rated as a pressure vessel. Gas
pressure should not exceed 0.03 bar (0.5 psi) within the BPC. The
BPC should not be allowed to become tight during inflation. Excessive
pressure may result in BPC damage or personal injury.
1.4.2 Working volume
Each DS 300 drum is designed for a working volume range. The
minimum working volume and the rated working volume are listed in
the general mixing specifications provided in Chapter 4: Specifications
and part numbers. Actual working volumes should not exceed the
indicated rated working volumes. Working volumes less than the
stated minimums can result in damage to the BPC and hardware
malfunction.
1.4.3 Dispensing
The DS 300 drums in the 50, 100, and 200 L sizes are equipped
with a bottom drain line that allows for liquid harvest by means
of peristaltic pump. Connection of the bottom drain line can be
accomplished by use of the provided 1.27 cm (0.5 in.) quick connect
fitting. Manipulation of the BPC as the last few liters of liquid are
removed can minimize liquid hold-up. Liquid hold-up is 100 ml for 50,
100, and 200 L containers, and 500 ml for 300 L containers.
Thermo Scientific
Chapter 1 |DS 300 S.U.M. overview
HyPerforma DS 300 Single‑Use Mixer User's Guide |14

Setup and operating
information
Chapter contents
2.1 Site preparation
2.2 Initial setup
2.3 Docking station preparation
2.4 BPC preparation and setup
2.5 BPC loading
2.6 Operating information
HyPerforma DS 300 Single‑Use Mixer User's Guide |15
2
Thermo Scientific

2.1 Site preparation
2.1.1 Electrical connections
The DS 300 S.U.M. unit can be used on circuits equipped with
GFCI circuit protection. The unit is equipped with a plug connection
appropriate to specific countries.
2.1.2 Protective earth grounding
Protective earth grounding for the S.U.M. system and controller
is provided through the ground terminal of the plug providing the
power. Source power to the controller must provide protective earth
grounding to this terminal in order to minimize the hazard of a possible
shock in case of a fault condition.
2.2 Initial setup
The DS 300 S.U.M. will arrive with the following items:
• Docking station mixer unit
• Handheld control device
• Motor and mount
• Optional drum positioner
• Drive shafts (customer specified)
• Torque and spanner wrenches
• Equipment Turnover Package (ETP), the standard or detailed
documentation package (if ordered), located on the USB drive
provided with the equipment
DS 300 drums will arrive with the following items:
• Outer support container or drum
• Drum dolly
Hardware uncrating
The DS 300 S.U.M. will arrive crated. Follow the provided unpacking
instructions (DOC0010) in addition to the following instructions.
Note: When uncrating hardware, retain all packing materials for
possible future use.
Chapter 2 |Setup and operating information
Thermo Scientific HyPerforma DS 300 Single‑Use Mixer User's Guide |16

1. Remove the security screws from each of the four latches on
either side of the front of the crate (Figure 2.1).
Figure 2.1. Removing security
screws from crate latches
2. Swing the crate door down. The door will create a ramp for
moving items in and out (Figure 2.2).
Support
brace
Crate door and
ramp
Tools
Drive shafts
Figure 2.2. Open DS 300
S.U.M. crate
Thermo Scientific
Chapter 2 |Setup and operating information
HyPerforma DS 300 Single‑Use Mixer User's Guide |17