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