Professional Documents
Culture Documents
Products and Capabilities: Single-Use Technology
Products and Capabilities: Single-Use Technology
Products and Capabilities: Single-Use Technology
Single-Use Systems
Single-use technology
products and capabilities
Table of contents
Introduction
CX5-14 Film............................................................................................................................................................................ 10
CX3-9 Film.............................................................................................................................................................................. 11
Aegis5-14 Film........................................................................................................................................................................ 12
Tubing Selection Guide....................................................................................................................................................... 13–14
Connection Selection Guide............................................................................................................................................... .15–16
Filters...................................................................................................................................................................................... 17
Fluid Transfer Assemblies......................................................................................................................................................... 18
2D BioProcess Container Systems...................................................................................................................................... 19–22
3D BioProcess Container Systems...................................................................................................................................... 23–25
Harvestainer Microcarrier Separation BPC and System......................................................................................................... 26–27
Tank Liners............................................................................................................................................................................. 28
Plastic Tanks, Drums and Accessories................................................................................................................................. 29–30
Large Volume Rigid Plastic Support Containers.......................................................................................................................... 31
Large Volume Stainless Steel Outer Containers.................................................................................................................... 32–33
Mixtainer BioProcess Container System.............................................................................................................................. 34–36
HyPerforma Single-Use Mixer DS 300................................................................................................................................. 37–42
HyPerforma Single-Use Mixer............................................................................................................................................. 43–49
Powdertainer BioProcess Container Systems....................................................................................................................... 50–51
HyPerforma Single-Use Bioreactor....................................................................................................................................... 52–56
HyPerforma Single-Use Fermentor...................................................................................................................................... 57–62
Temperature Control Units.................................................................................................................................................. 63–64
Bioreactor Control Solutions............................................................................................................................................... 65–68
Services and Support ........................................................................................................................................................69
Cell Line Development.......................................................................................................................................................70
Cell Culture Media.............................................................................................................................................................71–73
Cell Culture Feeds.............................................................................................................................................................74
FunctionMAX TiterEnhancer Functional Additive...................................................................................................................75
Analytics and Purification...................................................................................................................................................76–83
1
Introduction
cell culture
For more than 20 years, Thermo Scientific has been pioneering single-use technology for
the biotech industry. We first launched single-use bioprocess containers (BPCs) in 1993
and launched our first single-use bioreactor (S.U.B.) in 2006; at a time when single-use
systems were regarded with some skepticism and doubt. Over the years, we helped drive
the advancement of single-use technologies by developing new single-use bioprocess
applications like the Thermo Scientific™ Harvestainer™ BPC for microcarrier bead
separation applications. In 2014, we were the first to launch a system specifically designed
for microbial fermentation–the Thermo Scientific™ HyPerforma™ Single-Use Fermentor
(S.U.F.).
Whether you are looking for an economical standard product solution or require a specific
custom-designed and -built system, we offer proven solutions at every scale. We offer a wealth of
experience, knowledge and solid quality processes behind every Thermo Scientific product, to help
you feel assured that your bioproduction process performs at its best.
As you browse the catalog, please keep in mind that you are looking at our standard product
catalog. We take pride in offering one of the largest standard component libraries in the industry,
which allows us to integrate connectors, tubing and sensors to design a BPC or an entire tubing
assembly to fit your specific needs.
Our experienced services organization is there to assist you with drawings, implementation, or
technical support to help ensure optimum production performance.
Our core technologies and expertise support consistent performing bioproduction and processes
that are optimized to help meet your needs. As part of the Thermo Scientific™ BioProduction
Portfolio, our Single-use systems have been tested and validated for easy integration with our
Gibco™ cell culture products.
Our products and services are specifically designed to enable proven performance through
innovative, efficient and highly effective upstream or downstream applications. From a single
source you can optimize production, improve process efficiency, add flexibility and fast track
product development and market introduction by selecting from our portfolio.
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Introduction
What is a BPC?
The heart of our single-use solutions is our BioProcess Container (BPC). BPCs are single-
use flexible container systems commonly used for critical liquid handling applications in the
biopharmaceutical industry. BPC systems are cost-effective alternatives to conventional stainless
steel systems. They employ a novel design approach and are highly-valued for their cost-
effectiveness and utility. BPC components are readily integrated into a variety of high-performance
systems for all steps in the production of biologics.
Filtration Sterilization of media and buffers Custom BPC assembly or manifold including a filter
option
Bulk storage Sterile storage of media, Standard BPCs from 50 mL–2,000 L with outer support
buffers and intermediates containers
Custom BPCs to cover
additional options
Waste collection Non-aseptic collection of waste liquid from downstream Tank liners for non-aseptic applications
processing
Sampling Removal of sample volumes from bioreactors, mixers and Standard BPCs from 50 mL–50 L
storage containers for analysis
Custom manifolds
Shipping Bulk sterile liquids, buffers, process liquids and Top and bottom drain BPCs up to 1,000 L with validated
intermediates between facilities shipping configurations
Bulk solutions or suspensions requiring mixing after shipping
Mixtainer BPC
3
Introduction
The following table lists typical unit operations and corresponding applicable BPC solutions. Since
there is often a complex system such as a bioreactor or purification skid at the center of each unit
operation, complete single-use solutions are not common today. This has been changing with the
introduction of products such as the S.U.B. and S.U.F. Our development program seeks to expand
the list of single-use unit operations over the next few years.
Harvest Collection and storage of harvest from a bioreactor Standard top and bottom drain BPCs from 50 L–1,500 L with outer
or fermentor support containers
Additional options
Separation Feeding and receiving liquid from the separation Standard top and bottom drain BPCs from 50 L–1,500 L with outer
system support containers
Additional options
Purification Feeding buffers to the Standard bottom drain BPCs from 50 L–1,500 L with outer support
purification system containers. Standard BPCs from 50 mL–50 L
Fraction collection and storage Custom BPCs to cover transfer assemblies, manifolds
Additional options
Filling Sterile bulk reservoir for filling systems Standard bottom drain BPCs from 50 L–1,500 L with outer support
containers
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Introduction
Key features
Two-dimensional (2D)—This design is used for small, simple BPCs and is produced from two
sheets of film that are heat sealed around the perimeter to form a flat, or pillow-shaped, chamber.
The ports are heat sealed into the end seal or onto one of the faces of the chamber. Some designs
also have a handle formed by the sealing process or by insertion of a plastic bar at one end.
Three-dimensional (3D)—This design is used for larger and more complicated BPCs. A square
tube is formed by heat sealing sheets of film together. Ports are usually larger, and a greater range
of size and complexity of chamber designs is possible.
All chambers are produced in a Class 10,000/ISO Class 7 clean room in one of our
manufacturing facilities. A combination of automated and manual systems to help maximize
reliability, efficiency and flexibility is employed for all Thermo Scientific products.
Final assembly—Additional components are attached to the BPC chamber to produce a complete
BPC. This is done to either a standard or custom specification in a Class 10,000/ISO Class 7 clean
room in one of our manufacturing facilities. Assembly is a manual process to attain the configuration
flexibility required. Thermo Scientific™ fluid transfer assemblies are also produced to complement
BPC systems. Final assembly is done in the same areas to the same level of quality.
Packaging—BPCs are packaged and sealed in two independent outer layers while still in the Class
10,000/ISO Class 7 area. They are then placed in cardboard cartons labeled with product and lot
identification.
Sterilization—BPCs are sterilized in their outer packaging by a gamma irradiation dose of
25–40 kGy by external local contractors in the US and Europe.
Final inspection—Each lot of BPCs is 100% visually inspected against product
specifications.
5
Introduction
This is our primary site for assembling BPCs, tubing sets and manifolds. In addition to
manufacturing, the Assembly Center site also houses quality control and assurance, materials
management, procurement, and production scheduling. This site’s 10,000 square feet of Class
10,000/ISO Class 7 clean room includes:
BPC final assembly—Standard BPCs based on both Thermo Scientific™ Aegis™ and CX Films
are assembled at our Assembly Center facility. Most custom BPC assemblies, tubing assemblies
and manifolds supplied to the Americas and Asia are assembled here.
Chamber manufacture—Our Assembly Center facility also has chamber production capabilities
for Aegis5-14, CX5-14, and CX3-9 Film-based BPC products, and in this way serves as the
primary back-up chamber production facility.
Our BioProcess Container Operations Center (BioCenter) is our primary BPC chamber
manufacturing facility. The BioCenter also houses our engineering laboratories, bioreactor
development center, quality control and assurance, project management, product management,
sales operations, finance, and human resources; as well as our applications, manufacturing,
and research and development engineering teams. The BioCenter has a total floor area of
61,000 square feet, with 14,000 square feet of Class 10,000/ISO Class 7 clean room area.
Cramlington, UK
Our European BPC operations site is situated in Northern England. The current facility received
major upgrades and expansions in 2004, and again in 2011. These upgrades significantly
expanded our overall capability to serve the increasing demand for BPCs, fluid Transfer assemblies
and manifolds. The upgrades also provide enhanced chamber manufacturing redundancy.
The BPC manufacturing area currently consists of a 7,900 square feet of Class 10,000/ISO
Class 7 clean room and support areas. This facility houses:
Final assembly—Both CX Film products and Aegis Film products can currently receive final
assembly at this site. Fluid transfer assemblies and manifolds are also assembled at this facility.
6 lifetechnologies.com
Introduction
To help ensure that BioProcess Container (BPC) Systems conform to the quality standards expected
in the bioprocess industry, they are subject to rigorous quality control in compliance with cGMP
(21 CFR Part 820) and ISO 9001:2000 from receipt of components to release of final product.
Our production control processes help ensure complete lot traceability for each batch.
The production control document becomes the stepwise manufacturing record that physically
accompanies the lot through the manufacturing process. At the end of the process, the production
record is reviewed by Quality Assurance for completeness and correctness prior to release of the lot
and issuance of the certificate of analysis.
7
Introduction
Validation
A BPC Validation Master Plan has been developed for all Thermo Scientific BPC products in
compliance with the concepts of cGMP for medical devices. Meaningful product validations are
designed to demonstrate compliance with release criteria and product claims. Process validation
evaluates manufacturing conditions as well as product cleanliness and consistency.
Process qualification is performed when a new product or change in a manufacturing process are
introduced. This consists of a production build and validation testing to verify that the product meets
the specification acceptance criteria.
Sterility assurance
Validation of the gamma irradiation Sterility Assurance Level (SAL) for the BPC products is
performed on a quarterly basis as per ANSI/AAMI/ISO 1137: 2006 parts 1, 2 and 3 guidelines.
It involves testing a “worst-case” BPC assembly. The current production irradiation dose of
25–40 kGy provides an SAL of 10-6. The dose audit performed follows the VDmax method outlined in
ANSI/AAMI/ISO 1137:2006.
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Introduction
Complex BPCs forming the single-use part of systems such as the Thermo Scientific™ S.U.B.,
S.U.F. and S.U.M. are supported by an “information package” covering important information
regarding their testing and design. The document is product-specific rather than lot-specific and is
supplied in electronic format. It is organized into two sections:
1. Materials guide—details of testing protocols and results obtained
2. Performance and functional testing—an overview of engineering design, testing
and test results of individual components as well as of the complete assembly
9
Film selection guide
Thermo Scientific™ CX5-14™ Film is a five-layer, 14 mil cast film produced in a cGMP facility.
The outer layer is a polyester elastomer coextruded with an ethyl vinyl alcohol (EVOH) barrier layer
and an ultra-low density polyethylene product contact layer.
CX5-14 Film is manufactured using no animal-derived components.
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Film selection guide
Thermo Scientific™ CX3-9 Film is a three-layer, 9 mil cast film produced in a cGMP
facility. The outer layer is a polyester elastomer coextruded with an ultra-low density
polyethylene product contact layer.
CX3-9 Film is manufactured using no animal-derived components.
11
Film selection
cell culture
guide
Thermo Scientific™ Aegis5-14™ Film is a five-layer, 14 mil cast film produced in a cGMP facility.
The outer layer is a polyester elastomer coextruded with an ethyl vinyl alcohol (EVOH) barrier layer
and an ultra-low density polyethylene product contact layer.
Aegis5-14 Film is manufactured using no animal derived components.
12 lifetechnologies.com
Tubing selection guide
Platinum-cured silicone A common choice of silicone based on multi-sourcing is General purpose liquid handling is required.
recommended to maximize range of sizes, availability and cost.
Silicone tubing in a range of sizes from suppliers such as
Cole-Parmer™, Saint-Gobain™ and Watson-Marlow™ is
also available.
PVC Medical grade PVC tubing is included in the Standard Heat/radio frequency sealing or very high
Component Library for historical reasons and was widely used clarity are required.
before other alternatives like C-Flex became available.
PharMed™ This tubing has a longer pump life than C-Flex or silicone. Due Long pump life is required.
to its cost and opacity it is normally used only in small sections
of tubing intended to be loaded into a peristaltic pump. The
remaining tube length on the BPC would be C-Flex or silicone.
13
Tubing selection
cell culture
guide
The tables below are intended to outline major features, types and sizes of tubing available. The tables
below also include references to Thermo Scientific™ Masterflex™ tubing size numbers. Standard BPC
systems are normally supplied with C-Flex or platinum-cured silicone tubing because of their suitable technical
and economic characteristics.
Product Weld Animal-derived Extractable Gas perme- Autoclave Peristaltic Binding Clarity Sterilization method
description and seal components profile ation tolerance pump life
capability
C-Flex 374 Yes No Good Very low Fair Good Low Clear Gamma Irr.
ADCF
C-Flex clear Yes No Good Very low Fair Good Low Clear Gamma Irr.
formulation
082
C-Flex opaque Yes No Good Very low Fair Very good Low Opaque Gamma Irr.
formulation
072
Silicone, Tygon No No Excellent Moderate Excellent Fair Low Clear Autoclave or Gamma Irr.
3350
Silicone, No No Very good Moderate Excellent Fair Low Clear Autoclave or Gamma Irr.
SPT-50
PharMed BPT Yes Yes Good Very low Good Excellent Low Opaque Autoclave or Gamma Irr.
Inner diameter x outer Pump Default Clear Opaque ADCF PVC PharMed PharmaPure
diameter sizes available size* silicone C-Flex C-Flex C-Flex
3.2 mm x 6.4 mm (1/8 in x ¼ in) 16 X X X X X X X
3.2 mm x 4.8 mm (1/16 in x 3/16 in) X
4.8 mm x 7.9 mm (3/16 in x 5/16 in) 25 X X X X X X X
4.8 mm x 9.5 mm (3/16 in x 3/8 in) 15 X X X X X X
6.4 mm x 9.5 mm (¼ in x 3/8 in) 17 X X X X X X
6.4 mm x 11.1 mm (¼ in x 7/16 in) 24 X X X X X X
6.4 mm x 12.7 mm (¼ in x ½ in) 26 X X X X X X X
7.9 mm x 11.1 mm (5/16 in x 7/16 in) 18 X X X X X X X
7.9 mm x 12.7 mm (5/16 in x ½ in) X X
9.5 mm x 12.7 mm (3/8 in x ½ in) X X X X X X
9.5 mm x 15.9 mm (3/8 in x 5/8 in) 73 X X X X X X X
9.5 mm x 14.3 mm (3/8 in x 9/16 in) X
12.7 mm x 15.9 mm (½ in x 5/8 in) X X
12.7 mm x 19 mm (½ in x ¾ in) 82 X X X X X X
12.7 mm x 17.5 mm (½ in x 11/16 in) 19 X X X X X X
12.7 mm x 22.2 mm (½ in x 7/8 in) X
15.9 mm x 22.2 mm (5/8 in x 7/8 in) X X X X
19 mm x 25.4 mm (¾ in x 1 in) 90 X X X X X X
19 mm x 28.6 mm (¾ in x 1 1/8 in) X X X
19 mm x 31.8 mm (¾ in x 1¼ in) X X X
22.2 mm x 28.6 mm (7/8 in x 1 1/8 in) X X X
22.2 mm x 31.8 mm (7/8 in x 1¼ in) X
25.4 mm x 31.8 mm (1 in x 1¼ in) X X X X
25.4 mm x 34.9 mm (1 in x 1 3/8 in) 92 X X
*Pump sizes listed are for Masterflex tubing pump systems. I.D./O.D. dimensions may vary from Masterflex brand tubing. Users should test product to determine suitability for use in their
application.
14 lifetechnologies.com
Connection selection
cell culture
guide
Luer connectors Method of connection: Push male and female together and twist to secure the connection.
Options: Luer connectors are available in different materials and barb sizes.
Advantages: Simple to use.
Limitations: Limited to ¼ inch barb sizes and not 100% secure.
Use when: Small volume aseptic connections are required and can be made in a Class 100
area.
Type Material Hose barb sizes available
luer lock Kynar™ 3.18 mm (1/8 in), 6.35 mm (¼ in)
Male luer lock Female luer lock luer lock Polypropylene 3.18 mm (1/8 in), 6.35 mm (¼ in)
connector connector
CPC quick connects Method of connection: Simply push male and female together until they click.
Options: Available in different materials and sizes. Includes HFC series with integral shut-off valve.
More information is available in Data Sheet 050.
Advantages: Quick, easy and secure to use.
Limitations: Requires Class 100 or better to make an aseptic connection.
Use when: Secure aseptic connections are required and can be made in a Class 100 area.
Type Material Hose barb sizes available
MPC series Polycarbonate 9.53 mm (3/8 in), 12.67 mm (½ in)
Male (insert) Female (body)
MPX series Polysulfone 12.7 mm (½ in)
MPU series Polysulfone 19 mm (¾ in)
HFC39 Polysulfone 6.35 mm (¼ in), 9.52 mm (3/8 in)
Tri-clamp Method of connection: Place flat flanges together with a gasket between them and secure using
a clamp.
Options: Available in 1½ inch and ¾ inch (also known as mini tri-clamps) tri-clamp (TC) flange
sizes in a range of different materials. SterilEnz™ fittings have the advantage that the tri-clamp
connection is protected by an integral bag. More information is available in Data Sheet 051.
Advantages: Largest barb size of all available connectors on BPCs. Very secure connection.
Limitations: Not suitable for making aseptic connections.
SterilEnz fitting Use when: A BPC has to be connected to a vessel or equipment with a tri-clamp port and sterility
is not required. Normally in downstream applications.
Type Material Hose barb sizes available
SterilEnz mini TC Polyethylene 12.7 mm (½ in)
SterilEnz TC Polyethylene 12.7 mm (½ in), 19 mm (¾ in)
Mini TC Polypropylene 3.18 mm (1/8 in), 6.35 mm (¼ in), 9.52 mm (3/8 in), 12.7 mm (½ in)
Mini tri-clamp
Mini TC Kynar 3.18 mm (1/8 in), 6.35 mm (¼ in), 9.52 mm (3/8 in), 12.7 mm (½ in)
TC Polypropylene 3.18 mm (1/8 in), 6.35 mm (¼ in), 9.52 mm (3/8 in), 12.7 mm (½ in), 25.4
mm (1 in)
TC Kynar 3.18 mm (1/8 in), 6.35 mm (¼ in), 9.52 mm (3/8 in), 12.7 mm (½ in), 25.4
mm (1 in)
Tri-clamp
15
Connection selection guide
Aseptic connection devices (ACD) Method of connection: Similar to Tri-clamp; connection faces vary by model.
Options: Pall™ Kleenpak™, ReadyMate™ Disposable Aseptic Connector (DAC) and CPC™
AseptiQuik™ connectors. More information is available in Data Sheet 053.
Advantages: Allow aseptic connections to be made anywhere without dependence on an
instrument.
Limitations: Not the most economical option.
Use when: Aseptic connections are required and a Class 100 area is not available.
Pall Kleenpak connection CPC AseptiQuik Type Material Hose barb sizes available
connection (X)
Pall Kleenpak Polycarbonate 6.35 mm (¼ in), 9.52 mm (in), 12.7 mm (½ in)
ReadyMate DAC Polycarbonate/Silicone 6.35 mm (¼ in), 9.52 mm (3/8 in), 12.7 mm (½ in), 19 mm
(¾ in)
CPC AseptiQuik Polycarbonate/Silicone 3.18 mm (1/8 in), 6.35 mm (¼ in), 12.7 mm (½ in), 9.5 mm
(3/8 in), 19 mm (¾ in)
CPC AseptiQuik Method of connection: Automatic instrument cuts and joins two tubes aseptically to form a
connection (S)
connection.
Tubing welder Options: Requires either C-Flex or PharMed tubing attached to the BPC. Since a terminal
connector is not required the normal end treatment is an end plug.
Advantages: Flexibility.
Limitations: Requires an instrument to make the connection.
Use when: Aseptic connections are required and a Class 100 area is not available.
Type Material Hose barb sizes available
End plug Polypropylene 3.18 mm (1/8 in), 6.35 mm (¼ in), 9.52 mm (3/8 in), 12.7 mm (½ in), 19 mm
(¾ in)
Tubing in welder jaws Female (body)
End plug Kynar 3.18 mm (1/8 in), 6.35 mm (¼ in), 9.52 mm (3/8 in), 12.7 mm (½ in)
Method of connection: Same as Tri-clamp where the mating flange will be part of a SIP supply
assembly.
Steam in Place Options: See Data Sheet 052 for available options.
Advantages: Validatable sterile connection is possible.
Limitations: Slow and requires clean steam.
Use when: A BPC sterile connection of a BPC to a stainless steel vessel with a tri-clamp port is
required.
Type Material Hose barb sizes available
Unitized mini TC Silicone 9.52 mm (3/8 in), 12.7 mm (½ in)
CPC Steam-thru Unitized TC Silicone 9.52 mm (3/8 in), 12.7 mm (½ in),
connection 19 mm (¾ in)
CPC Steam-Thru™ (TC and mini TC) Polysulfone 9.52 mm (3/8 in), 12.7 mm (½ in)
CPC Steam-Thru II Polysulfone 9.52 mm (3/8 in), 12.7 mm (½ in)
Millipore™ Lynx™ ST connectors Polyetherimide/ 6.35 mm (¼ in), 12.7 mm (½ in)
(TC and mini TC) silicone
Sample Ports Method of connection: Insert syringe into port to remove sample.
Options: Similar devices are available—SmartSite™ connector and Clave™ connector.
Advantages: No needle required.
Limitations: Flow rate.
Use When: Samples of 50 mL or less are required.
Type Material Hose barb sizes available
SmartSite Acrylic/polyurethane/silicone N/A
16 lifetechnologies.com
Filter selection
cell culture
guide
• Membrane material—The major types of filter material used in bioprocessing today are
polyethersulfone (PES) and polyvinylidene (PVDF)
• Membrane size—Required filter pore size will be influenced by the size of the materials
being filtered, as well as the level of filtration the process necessitates
• Affinity to water—The presence of aqueous solution impacts the type of filter that may
be most advantageous to your process
• Application—Sequence within your process where filtration takes place and the type of
material being filtered have implications for filter selection
A sample of the filters available through our comprehensive Standard Component Library include:
A variety of factors unique to your process may influence your choice of filter, in addition to those
considerations listed. Contact your Thermo Scientific product sales representative to assist with any
questions or for assistance with selecting the best filter for your process needs.
17
Fluid transfer assemblies
Associated products
• 2D BPC Systems (Pg. 19) • HyPerforma S.U.B. (Pg. 52) • Harvestainer Microcarrier Separation BPC and
• 3D BPC Systems (Pg. 23) • HyPerforma S.U.F. (Pg. 57) System (Pg. 26)
• Tank Liners (Pg. 28) • HyPerforma S.U.M. (Pg. 43)
18 lifetechnologies.com
2D BPC systems
Key features
Applications
Supporting information
Associated products
19
2D BPC systems
u 2D Labtainer BPC systems
Line 1 Female luer lock connection, Line 1 Female luer lock connection, Line 1 Female luer lock connection,
polypropylene Tubing: C-Flex polypropylene Tubing: C-Flex polypropylene
length: 30 cm (12 in) length: 30 cm (12 in) No tubing
ID x OD: 3.2 mm x 6.4 mm ID x OD: 3.2 mm x 6.4 mm
(1/8 in x ¼ in) (1/8 in x ¼ in)
Line 2 Male luer lock connection, Line 2 Male luer lock connection,
polypropylene Tubing: C-Flex Line 2 MPC insert, polycarbonate polypropylene
length: 30 cm (12 in) No tubing No tubing
ID x OD: 3.2 mm x 6.4 mm
(1/8 in x ¼ in)
Cat. No. Size Dimensions (L x W) Cat. No. Size Dimensions (L x W) Cat. No. Size Dimensions (L x W)
Aegis5-14 Film: Aegis5-14 Film: Aegis5-14 Film:
SH30961.11 SH31048.11 SH31050.11
50 11.7 cm x 13.7 cm 50 11.7 cm x 13.7 cm 50 11.7 cm x 13.7 cm
mL (4.6 in x 5.4 in) mL (4.6 in x 5.4 in) mL (4.6 in x 5.4 in)
CX5-14 Film: CX5-14 Film: CX5-14 Film:
SH30658.11 SH30662.11 SH30657.11
No. per case: 10 (all above) No. per case: 10 (all above) No. per case: 10 (all above)
20 lifetechnologies.com
2D BPC systems
Line 1 Male luer lock connection, Line 1 MPC insert, polycarbonate Line 1 MPC insert, polycarbonate
polypropylene Tubing: C-Flex Tubing: C-Flex Tubing: C-Flex
length: 30 cm (12 in) length: 61 cm (24 in) length: 30 cm (12 in)
ID x OD: 6.4 mm x 9.5 mm ID x OD: 9.5 mm x 15.9 mm ID x OD: 9.5 mm x 12.7 mm
(¼ in x 3/8 in) (3/8 in x 5/8 in) (3/8 in x ½ in)
Line 2 Female luer lock connection, Line 2 MPC body, polycarbonate Line 2 MPC insert, polycarbonate
polypropylene Tubing: C-Flex Tubing: C-Flex Tubing: C-Flex
length: 30 cm (12 in) length: 61 cm (24 in) length: 30 cm (12 in)
ID x OD: 6.4 mm x 9.5 mm ID x OD: 9.5 mm x 15.9 mm ID x OD: 9.5 mm x 12.7 mm
(¼ in x 3/8 in) (3/8 in x 5/8 in) (3/8 in x ½ in)
Line 3 Female luer lock connection, Line 3 Female luer lock connection, Line 3 Plugged
polypropylene polypropylene Tubing: C-Flex No tubing
Tubing: C-Flex length: 61 cm (24 in)
length: 30 cm (12 in) ID x OD: 3.2 mm x 6.4 mm
ID x OD: 3.2 mm x 6.4 mm (1/8 in x 1/4 in)
(1/8 in x ¼ in)
Cat. No. Size Dimensions (L x W) Cat. No. Size Dimensions (L x W) Cat. No. Size Dimensions (L x W)
Aegis5-14 Film: Aegis5-14 Film: Aegis5-14 Film:
SH31049.05 SH30963.05 SH30965.05
29.5 cm x 31 cm 29.5 cm x 31 cm 29.5 cm x 31 cm
2L 2L 2L
(11.6 in x 12.2 in) (11.6 in x 12.2 in) (11.6 in x 12.2 in)
CX5-14 Film: CX5-14 Film: CX5-14 Film:
SH30713.05 SH30712.05 SH30714.05
21
cellsystems
2D BPC culture
Aegis5-14 Film:
SH31005.04 Aegis5-14 Film equivalents for this product
82.6 cm x 58.4 cm
50 L
CX5-14 Film:
(32.5 in x 23 in) are available as custom configurations.
SH30709.04
22 lifetechnologies.com
3D BPC
cellsystems
culture
u 3D BPC systems
3D square tube design with top dispense
2 ports 4 ports 4 ports
Line 1 MPC insert, polycarbonate Line 1 MPC insert, polycarbonate Line 1 MPX insert, polycarbonate
Tubing: C-Flex Tubing: C-Flex Tubing: length: 121.9 cm (48 in)
length: 45.7 cm (18 in) length: 121.9 cm (48 in) ID x OD: 12.7 mm x 19.1 mm
ID x OD: 9.5 mm x 15.9 mm ID x OD: 9.5 mm x 15.9 mm (½ in x ¾ in), with dip tube length
(3/8 in x 5/8 in) (3/8 in x 5/8 in) with dip tube length dependant on size
dependant on size Line 2 Male luer lock conection,
Line 2 MPC body, polycarbonate
Line 2 Male luer lock connection, polypropylene Tubing: length:
Tubing: C-Flex
polypropylene Tubing: C-Flex 121.9 cm (48 in)
length: 45.7 cm (18 in)
length: 121.9 cm (48 in) ID x OD: 6.4 mm x 9.5 mm
ID x OD: 9.5 mm x 15.9 mm
ID x OD: 6.4 mm x 9.5 mm (¼ in x 3/8 in)
(3/8 in x 5/8 in)
(¼ in x 3/8 in ) Line 3 Female luer lock connection,
Cat. No. Size Outer container Line 3 Female luer lock connection, polypropylene Tubing: length:
Cat. No. polypropylene Tubing: C-Flex 121.9 cm (48 in)
length: 121.9 cm (48 in) ID x OD: 6.4 mm x 9.5 mm
Aegis5-14 Film:
SH30964.01
50 L ID x OD: 6.4 mm x 9.5 mm (¼ in x 3/8 in)
dip tube:
38 cm
SV50076.02 (¼ in x 3/8 in) Line 4 MPX body, polycarbonate
CX5-14 Film: Tubing: length: 121.9 cm (48 in)
SH30649.01
(15 in) Line 4 MPC body, polycarbonate
Tubing: C-Flex ID x OD: 12.7 mm x 19.1 mm
No. per case: 8 (all above) length: 121.9 cm (48 in) (½ in x ¾ in)
Aegis5-14 Film: ID x OD: 9.5 mm x 15.9 mm dip tube length: 30.5 cm (12 in)
SH30964.02 100 L (3/8 in x 5/8 in)
dip tube:
CX5-14 Film: 71 cm
SV50076.03 dip tube length: 30.5 cm (12 in) Cat. No. Size Outer container
SH30649.02 (28 in) Cat. No.
Cat. No. Size Outer container
No. per case: 10 (all above) Cat. No. Aegis5-14 Film: 50 L
dip tube:
Aegis5-14 Film: SV50076.02
Aegis5-14 Film: 50 L 38 cm
200 L SH30966.01 dip tube: CX5-14 Film: (15 in)
SH30964.03 SH30653.01
dip tube: SV50076.04 38 cm SV50076.02
CX5-14 Film:
CX5-14 Film: 81 cm SH30651.01 (15 in)
SH30649.03 (32 in) No. per case: 6 (all above)
No. per case: 5 (all above)
No. per case: 5 (all above) Aegis5-14 Film: 100 L
Aegis5-14 Film: 100 L
SH30966.02 dip tube: dip tube:
SV50076.03
71 cm SV50076.03 71 cm
CX5-14 Film:
CX5-14 Film: (28 in) SH30653.02 (28 in)
SH30651.02
No. per case: 6 (all above) No. per case: 4 (all above)
23
3D BPC systems
u 3D BPC systems
Line 1 MPX body, polycarbonate Line 1 19.1 mm (¾ in) tri-clamp, Line 1 MPC insert, polycarbonate
Tubing: C-Flex polyethylene Tubing: C-Flex, length:
length: 45.7 cm (18 in) Tubing: length: 45.7 cm (18 in) 121.9 cm (48 in) dip tube
ID x OD: 12.7 mm x 19.1 mm ID x OD: 12.7 mm x 19.1 mm ID x OD: 9.5 mm x 15.9 mm
(½ in x ¾ in) (½ in x ¾ in) (3/8 in x 5/8 in)
Line 2 Female luer lock connection, Line 2 19.1mm (¾ in) tri-clamp, dip tube length: 30.5 cm (12 in)
polypropylene Tubing: C-Flex polyethylene Line 2 Male luer lock connection,
length: 30.5 cm (12 in) Tubing: length: 45.7 cm (18 in) polypropylene Tubing: C-Flex
ID x OD: 6.4 mm x 9.5 mm ID x OD: 12.7 mm x 19.1 mm length: 121.9 cm (48 in)
(¼ in x 3/8 in) (½ in x ¾ in) ID x OD: 6.4 mm x 9.5 mm
Line 3 19.1mm (¾ in) tri-clamp, (¼ in x 3/8 in)
Line 3 MPX insert, polycarbonate
Tubing: C-Flex polyethylene Line 3 Female luer lock connection,
length: 121.9 cm (48 in) Tubing: C-Flex, polypropylene Tubing: C-Flex
ID x OD: 12.7 mm x 19.1 mm length: 121.9 cm (48 in) length: 121.9 cm (48 in)
(½ in x ¾ in), bottom port ID x OD: 12.7 mm x 19.1 mm ID x OD: 6.4 mm x 9.5 mm
(½ in x ¾ in) (¼ in x 3/8 in)
Cat. No. Size Outer container Line 4 Plugged (no tubing)
Cat. No. Cat. No. Size Outer container
Cat. No. Line 5 MPC body, polycarbonate
Aegis5-14 Film: 50 L SV50076.02 Tubing: length: 121.9 cm (48 in)
SH30967.01 Aegis5-14 Film: 50 L
dip tube: SH30968.01 SV50076.02 ID x OD: 9.5 mm x 15.9 mm
dip tube:
38 cm
38 cm
(3/8 in x 5/8 in)
(15 in)
CX5-14 Film:
SH30650.01
SV50517.04 CX5-14 Film: (15 in) SV50517.04 bottom port, silicone
SH30672.01
No. per case: 6 (all above) Cat. No. Size Outer container
Aegis5-14 Film: 100 L SV50076.03
SH30967.02 Cat. No.
dip tube:
Aegis5-14 Film:
71 cm SH30968.02 100 L SV50076.03 Aegis5-14 Film:
CX5-14 Film: dip tube: SH30969.01 50 L
(28 in) SV50517.05
SH30650.02 71 cm dip tube:
CX5-14 Film: SV50517.04
(28 in) 38 cm
SH30672.02 SV50517.05 CX5-14 Film:
SH30652.01 (15 in)
Aegis5-14 Film: 200 L SV50076.04
SH30967.03
dip tube: No. per case: 4 (all above) Aegis5-14 Film:
81 cm SH30969.02 100 L
CX5-14 Film: (32 in) SV50517.06 dip tube:
SH30650.03 Aegis5-14 Film: SV50076.04 SV50517.05
SH30968.03 200 L 71 cm
dip tube: CX5-14 Film:
SH30652.02 (28 in)
No. per case: 5 (all above) CX5-14 Film: 81 cm
SH30672.03 (32 in) SV50517.06 No. per case: 5 (all above)
No. per case: 5 (all above) Aegis5-14 Film:
SH30969.03 200 L
dip tube: SV50517.06
CX5-14 Film: 81 cm
SH30652.03 (32 in)
No. per case: 4 (all above)
24 lifetechnologies.com
BPCs for large volume cell
containers
culture
25
Harvestainer BPC systems
Key features
Supporting information
Associated
products
26 lifetechnologies.com
Harvestainer BPC systems
To help ensure added flexibility, the Harvestainer BPC comes in a 200 L size and is available with
single or dual Microbarrier Labtainer BPCs. Multiple Harvestainer BPCs can be linked together in
a manifold assembly, allowing for scale-up from process development to full-scale commercial
production.
Transfer Port
from Bioreactor
Vent
27
Tank liners
u Tank liners
Key features
• Thermo Scientific tank liners are designed for use with commercially available overhead
mixers (not supplied)
• Removes the need for tank cleaning and helps reduce cycle times
• Chamber constructed of CX3-9 Film (and Aegis5-14 Film for bottom-drain) with dimensions
optimized for Thermo Scientific™ standard drums and commonly used industry standard
cylindrical tanks
• Top entry for standard products for maximum recovery using industry standard connection
systems in unit volumes of 50, 100 and 200 L
• Supplied sterile to minimize bioburden
• Dolly available to provide mobility
Applications
• Hydration of powdered media and buffers
• Pooling of non-sterile solutions and fluids
28 lifetechnologies.com
Plastic tanks, drums and accessories
cell culture
Outer containers
29
Plastic tanks, drums and accessories
Support plate
round plastic disk needed when using conical LLDPE drum with 4 inch port
Cat. No. Size
SV50102.02 50, 100, 200 L
30 lifetechnologies.com
Large volume rigid plastic support cell
containers
culture
Key features
Applications
• Sterile media and buffer storage and transport within a facility
• Feeding sterile media into bioreactors and buffers into purification systems
• Receiving and storing of harvest from bioreactors
• Shipping sterile bioprocess liquids to another site when proper packing and dunnage
utilized
Associated products
31
Large volume stainless steel support containers
Key features
Applications
32 lifetechnologies.com
Large volume stainless steel support containers
Accessories
Stainless steel hoist (optional) Custom options
Cat. No. Size • 316 stainless steel
SV50161.21 1,000 L • Load cells
SV50161.22 1,500 L • Lid
SV50161.23 2,000 L
• Casters mounted directly on bin
Note: Hoist recommended for all units 1000 L and greater
• Filter bracket
• Pump shelf
• Tubing management
Tray (optional)
Cat. No. Size
SV50161.11 200 L
SV50161.12 500 L
SV50161.13 1,000/1,500 L
Cart (optional)
Cat. No. Size
SV50161.01 200 L
SV50161.02 500 L
SV50161.03 1,000/1,500 L
33
Mixtainer mixing systems
Key features
• The Thermo Scientific™ Mixtainer™ System is an integrated, single-use sterile unit for mixing of
cell culture media, and other process liquids such as buffers, reagents and bulk drug precursors
or products
• The Mixtainer system utilizes a sophisticated BPC constructed of CX5-14 Film with a plastic dish
welded into the base of the BPC
• The plastic dish contains a magnetic stir-bar that is held in the proper operating position using an
integrated locking ring
• Available in 50, 100 and 200 L unit volumes
• Standard BPCs available for liquid/liquid- and powder/liquid-mixing
• Supporting hardware optimized for mixing, storage, transport and discharge in a closed system to
help minimize the risk of cross-contamination
34 lifetechnologies.com
Mixtainer mixing systems
Line 1 9.5 mm (3/8 in) Quick Connect Cat. No. Size Cat. No. Area Description
insert with 16.5 cm
SV50517.11 50 L 230 V, 50/60 Hz,
(6.5 in) dip tube SV30097.01 EU
0.5 amp
tube length: 91 cm (36 in)
SV50517.12 100 L
Line 2 6.3 mm (1/4 in) male luer lock
SV30097.02 115 V, 50/60 Hz,
US
tube length: 91 cm (36 in) SV50517.13 200 L 1 amp
Line 3 6.3 mm (1/4 in) female luer lock
tube length: 91 cm (36 in)
35
Mixtainer mixing systems
Supplied “flat-packed”
Outer packaging
Two polyethylene outer layers
Description
Product code
Label
Lot number
Expiry date on outer packaging and shipping container
Sterilization Irradiation (25 to 38 kGy) inside outer packaging
Shipping container Durable cardboard carton
Documentation Certificate of Analysis provided
36 lifetechnologies.com
Thermo Scientific HyPerforma DS 300 Single-Use Mixer
Key features
37
Thermo Scientific HyPerforma DS 300 Single-Use Mixer
1. Motor assembly
2. Horizontal support arm
3. Height indicator and cable
management housing
4. Vertical lift
5. Handheld control device
6. Electrical box
7. Main disconnect switch
8. E-stop reset button
9. Drive shaft (stored)
10. Mounted drive shaft, sleeve
and impeller
11. Plastic drum
12. Liquid drain port
13. Conical insert
Figure 1: S.U.M. DS 300 complete system diagram–front view.
14. Dolly
38 lifetechnologies.com
Thermo Scientific HyPerforma DS 300 Single-Use Mixer
39
Thermo Scientific HyPerforma DS 300 Single-Use Mixer
CX3-9 Film:
SH30399.02 100 L open-top, bottom drain, non-irradiated
CX3-9 Film:
SH30399.03 200 L
40 lifetechnologies.com
Thermo Scientific HyPerforma DS 300 Single-Use
cell culture
Mixer
41
Thermo Scientific HyPerforma DS 300 Single-Use Mixer
†For the 300 L drum, a 5:1 turndown ratio can be achieved using the adjustable angle motor head
Minimum open-top mixing for adjustable motor head S.U.M.s with standard impeller sizes
Minimum
Motor angle
Turndown working Minimum Maximum Left to right Front to back Motor
Drum size Lift height* (adjustable motor
ratio liquid hold up liquid fill offset* position* RPM†
head models only)
volume
2.5 cm 1.3 cm
50 L 5.4:1 9.2 L 100 mL 50 L 0 5° 180
(1 in) left (1/2 in)
2.5 cm 1.3 cm
100 L 10:1 9.8 L 100 mL 100 L 0 5° 205
(1 in) left (1/2 in)
2.5 cm 1.3 cm 2.2 cm
100 L 6:1 16.7 L 100 mL 100 L 5° 140
(1 in) left (1/2 in) (7/8 in)
1.9 cm 3.2 cm 28.1 cm
200 L 10:1 20 L 100 mL 200 L 5° 150
(3/4 in) left (11/4 in) (11 1/16 in)
1.9 cm 3.2 cm 28.3 cm
200 L 8.8:1 22.5 L 100 mL 200 L 5° 140
(3/4 in) left (11/4 in) (11 1/8 in)
N/A due to flat 38.71 cm
300 L 5:1 61 L 500 mL 300 L N/A 5° 164
bottom (15.24 in)
N/A due to flat 38.71 cm
300 L 5:1 65 L 500 mL 300 L N/A 5° 124
bottom (15.24 in)
*All measurements listed in the above table are ± 0.16 cm (1/16 in)
†All values listed are ± 5 RPM
42 lifetechnologies.com
HyPerforma Single-Use
cell culture
Mixer
Key features
The Hyperforma S.U.M. is a fully functional single-use mixing vessel including single-use sterile
contact surfaces for mixing, venting and temperature sensing. Additional ports are included to allow
choice of aseptic connections for filling, emptying and sampling.
• Unique proprietary mixing system that provides conventional overhead mixing while
maintaining sterility and integrity of the S.U.B. BPC
• Minimized vessel footprint and reduced hold-up volumes
• Simplified bag loading with a vertical access door (available on 500 L, 1,000 L sizes and
on 2,000 L S.U.M.)
• Cable management system provides greater organization for electrical cables, tubing and
line sets while making the unit easier to clean.
• Dedicated adjustable tool holder keeps necessary tools available for convenience and ease
• Mixer vessel is offered with electrical non-jacketed (no heat transfer) or water jacket
(vessel side and bottom) for integration with external temperature control unit.
• Offered with choice of AC motor or DC motor with precise agitation control. Brushless DC
motor includes encoder feedback to help improve RPM accuracy and is GFCI-compatible.
(Electrical box not available with DC motors).
• Three load cells weighing systems enable accurate batch weight monitoring.
• Option to use probes for temperature, pH, conductivity and pressure monitoring.
• Electrical box with communication cable that provides output signals to customer plant
controller
• S.U.B. BPCs offered in CX5-14 and Aegis5-14 Films
43
HyPerforma Single-Use Mixer
Fluid geometry at working volume 1.5:1 1.5:1 1.5:1 1.5:1 1.1:1 1:1
(height/diameter) ratio
Impeller (quantity x blade count) 1X3 1X3 1X3 1X3 1X3 1X3
Mixing rate range 30–350 RPM 30–350 RPM 30–350 RPM 30–350 RPM 30–350 RPM 30–350 RPM
Tank overall W x L x H 94.2 x 84.3 x 94.8 x 87.3 x 94.8 x 87.3 x 122.5 x 130.2 148.3 x 155.8 172.2 x 159.6 x
(including cable management tree 198.6 cm (37.1 x 175.3 cm (31.8 x 175.3 cm (37.3 x x 251.1 cm (48.23 x 201 cm (58.4 x 224.8 cm (67.8 in
and electrical box) 33.2 x 78.2 in) 36.1 x 60.35 in) 34.4 x 69 in) x 51.25 x 98.9 in) 61.33 x 79.10 in) 62.83 x 88.52 in)
44 lifetechnologies.com
HyPerforma S.U.M. docking
cell culture
station
Key features
The stainless steel tank options include:
45
HyPerforma Single-Use Mixer
46 lifetechnologies.com
HyPerforma Single-Use Mixer
47
HyPerforma Single-Use Mixer
48 lifetechnologies.com
HyPerforma Single-Use
cell culture
Mixer
S.U.M MTO Configuration Table: This table describes the part number and configurable (make-to-order; MTO) options for the S.U.M. product line.
Vessel size
0500 = 500 L
1. Vessel type/material
A = non-jacketed (304 SST) (standard) tank and cart are 304 SST
B = jacketed (304 SST) (standard) tank and cart are 304 SST
2. Motor/electrical enclosure: L/H = electrical box mounted on left and cable management tree on right side of
tank. (See DWG) R/H= electrical box mounted on right and cable management Tree on left side of tank. (See
DWG)
3. Drive shaft
4. RTD
0 = no RTD
B = duel RTD, PT100, 120 inch DB9 connector x 120 inch open lead wires
C = duel RTD, PT100, 120 inch Bulgin x 120 inch Bulgin connectors
E = duel RTD, PT100, 120 inch Bulgin x 120 inch LEMO connectors
0 = no load cells
7. Cable management tree: L/H = cable management tree mounted on left and cable management tree on right
side of tank. (See DWG) R/H= cable management tree mounted on right and cable management Tree on left side
of tank. (See DWG)
8. Communication cable
0 = no communication cable
A = communication cable
9. Monitoring device
0 = no monitoring device
49
Powdertainer BPC systems
Key features
Applications
• Storage and delivery of Thermo Scientific powder culture media and buffers
• Storage and dispensing of pre-weighed chemicals or other process powders
Supporting information
Associated products
Handle
For support Tube with CPC connector
during emptying For washdown to remove any
powder residue
50 lifetechnologies.com
Powdertainer BPC systems
Powder
Handling BPCs
Wash down N/A Wash down MPX body, polycarbonate
line line Tubing: length:
20.3 cm (8 in)
ID x OD:12.7 mm x 19.1 mm
(½ in x ¾ in), silicone
Powder port 7.6 cm (3 in) tri-clamp Powder port 7.6 cm (3 in) tri-clamp
with integrated seal with integrated seal
Cat. No. Size Dimensions (L x W) Cat. No. Size Dimensions (L x W) Cat. No. Dimensions (L x W x H)
SV50143.01
CX5-14 Film: 42.7 cm x 31.8 cm CX5-14 Film: 42.7 cm x 31.8 cm 91.4 cm x 91.4 cm x 134.6 cm
1 kg 1 kg (stainless steel,
SH30864.01 (16.8 in x 12.5 in) SH30737.01 (16.8 in x 12.5 in) with casters) (36 in x 36 in x 53 in)
51
HyPerforma Single-Use Bioreactors
cell culture
Key features
• Unique proprietary mixing system that enables conventional overhead mixing while
maintaining sterility and integrity of the S.U.B. BPC
• Simplified bag loading with a vertical access door (available on 500 and 1,000 L sizes;
pneumatic hoist provided on 2,000 L S.U.B.)
• Universal filter bracket easily adjusts to various heights and positions on the vessel and
facilitates single or dual filters of either 6-inch and/or 10-inch filters.
• Cable management system offers greater organization for electrical cables, tubing and line
sets while making the unit easier to clean
• Dedicated adjustable tool holder keeps necessary tools available for convenience and ease
• Bioreactor vessel is offered with electrical heating blanket or water jacket (vessel side and
bottom) for integration with external temperature control unit.
• Offered with choice of AC motor or DC motor with precise agitation control. Brushless DC
motor includes encoder feedback for improved RPM accuracy and is GFCI-compatible
• Option to choose Bioreactor vessel as open architecture system and integrate with existing
or choice of controllers OR complete turnkey system with a choice of dedicated controls
from Finesse™ or Applikon™. These systems work on PC, Delta V™, Allen-Bradley or
Siemens™ software platforms
• Choice of sparging in combination of Drilled Hole Sparger (DHS) with Frit or Frit with open
pipe sparger to facilitate efficient mass transfer and CO2 stripping
• Option to use electrochemical or single-use sensors for pH, DO and Pressure monitoring
• Possibility to add condenser for 1,000 L and 2,000 L S.U.B.s depending on process need
52 lifetechnologies.com
HyPerforma Single-Use Bioreactors
• Batch, fed batch and perfusion cultures • 2D BPC Systems (Pg. 19)
• Harvestainer Microcarrier
Separation BPC and Systems (Pg. 26)
53
HyPerforma Single-Use Bioreactors
Size Cat. No. (open pipe & Cat. No. (drilled hole &
porous frit sparger) porous frit sparger)
50 L SH30774.01 SH30985.01
100 L SH30774.02 SH30985.02
250 L SH30774.03 SH30985.03
500 L SH30774.04 SH30985.04
1,000 L SH30774.05 SH30985.05
2,000 L SH30774.07* SH30985.07*
2,000 L SH30774.08† SH30985.08†
*With condenser †Without condenser
Size Cat. No. (open pipe & Cat. No. (drilled hole &
porous frit sparger) porous frit sparger)
50 L SH30972.01 SH30999.01
100 L SH30972.02 SH30999.02
250 L SH30972.03 SH30999.03
500 L SH30972.04 SH30999.04
1,000 L SH30972.05 SH30999.05
2,000 L SH30972.07* SH30999.07*
2,000 L SH30972.08** SH30999.08**
* With condenser †Without condenser
54 lifetechnologies.com
HyPerforma Single-Use Bioreactors
cell culture
S.U.B. temperature/sample
SV20750.01 SV20750.01 SV20750.01 SV20750.01 SV20750.01 SV20750.01
port
Complete condenser
system (120 V) including
cart, chill plate and N/A N/A N/A N/A N/A SV50232.01
mounting post with filter
brackets, TCU, and pump
Complete condenser
system (240 V) including
cart, chill plate and N/A N/A N/A N/A N/A SV50232.02
mounting post with filter
brackets, TCU, and pump
55
HyPerforma Single-Use Bioreactors
HyPerforma S.U.B. MTO configuration table
S.U.B. MTO Configuration Table: This table describes the part number and configurable (make-to-order; MTO) options for the S.U.B. product line.
56 lifetechnologies.com
HyPerforma Single-Use Fermentors
cell culture
Key features
• The S.U.F. is a fully functional fermentor vessel including single-use sterile contact surfaces
for mixing, venting, sparging and temperature sensing. Additional ports are included to allow
choice of aseptic connections for filling, emptying and sampling
• Cable management system offers greater organization for electrical cables, tubing and line
sets while making the unit easier to clean
• Dedicated adjustable tool holder keeps necessary tools
• BPC utilizes three Rushton-style impellers and sparger configuration with a proprietary
exhaust management system
Associated products
57
HyPerforma Single-Use Fermentors
Options
• Option to choose Bioreactor vessel as open architecture system and integrate with existing
or choice of controllers OR complete Turnkey system with a choice of dedicated controls
from Finesse or Applikon. These systems work on PC, Delta V, Allen-Bradley or
Siemens software platforms
• Option to use electrochemical or single-use sensors for pH, DO and pressure monitoring
Applications
58 lifetechnologies.com
HyPerforma Single-Use Fermentors
cell culture
Specifications 30 L 300 L
Liquid working volume 30 L 300 L
Minimum liquid working volume 6L 60 L
Total reactor volume
43 L 435 L
(not a working volume)
Fluid geometry at working volume
~2:1 ~2:1
(height/diameter) ratio
Overall reactor geometry 3:1 3:1
(height/diameter) ratio
Impeller (quantity x blade count) 3x6 3x6
Mixing rate range 55–600 RPM 35–375 RPM
Tank overall (including cable
121.8 x 103.2 x 218.5 cm 160.8 x 136.7 x 281 cm
management tree)
(48 x 40.7 x 86 in) (63.3 x 53.8 x 110.6 in)
width x length x height
Jacketed tank weight dry/wet 238 kg (524 lb) 555 kg (1,223 lb)
(at full working volume) 268 kg (590 lb) 855 kg (1,883 lb)
59
HyPerforma Single-Use Fermentors
Description 30 L 300 L
MT single-use pH & DO, foam sensor, Meissner inlet and 1 x 5 inch exhaust filters, condenser SH31019.01
MT single-use pH & DO, foam sensor, Meissner inlet and 2 x 5 inch exhaust filters, condenser SH31019.02
MT single-use pH & DO, foam sensor, Meissner inlet and 2 x 10 inch exhaust filters, condenser SH31017.02
MT single-use pH & DO, foam sensor, Meissner inlet and 4 x 10 inch exhaust filters, condenser SH31017.03
Traditional ports, foam sensor, Meissner inlet and 1 x 5 inch exhaust filters, condenser SH31036.01
Traditional ports, foam sensor, Meissner inlet and 2 x 5 inch exhaust filters, condenser SH31038.01
Traditional ports, foam sensor, Meissner inlet and 2 x 10 inch exhaust filters, condenser SH31030.05
Traditional ports, foam sensor, Meissner inlet and 4 x 10 inch exhaust filters, condenser SH31030.06
Traditional ports, foam sensor, ZenPure inlet and 1 x 3 inch exhaust filters, condenser SH31034.01
Traditional ports, foam sensor, ZenPure inlet and 1 x 5 inch exhaust filters, condenser SH31037.01
Traditional ports, foam sensor, ZenPure inlet and 2 x 5 inch exhaust filters, condenser SH31035.01
Traditional ports, ZenPure inlet and 1 x 5 exhaust filters SH31039.01
Traditional ports, foam sensor, ZenPure inlet and 1 x 10 exhaust filters, condenser SH31030.01
Traditional ports, foam sensor, ZenPure inlet and 2 x 10 exhaust filters, condenser SH31030.02
Traditional ports, ZenPure inlet and 1 x 10 inch exhaust filters SH31030.04
Traditional ports, ZenPure inlet and 2 x 10 inch exhaust filters SH31030.03
Description 30 L 300 L
MT single-use pH & DO, foam sensor, Meissner inlet and 1 x 5 inch exhaust filters, condenser SH31010.01
MT single-use pH & DO, foam sensor, Meissner inlet and 2 x 5 inch exhaust filters, condenser SH31010.02
MT single-use pH & DO, foam sensor, Meissner inlet and 2 x 10 inch exhaust filters, condenser SH31009.02
MT single-use pH & DO, foam sensor, Meissner inlet and 4 x 10 inch exhaust filters, condenser SH31009.03
60 lifetechnologies.com
HyPerforma Single-Use Fermentors
Description 30 L 300 L
Cable management system SV51006.01
Cable management system, left-hand configuration SV51006.02
Cable management system, right-hand configuration SV51006.03
Bottle management system SV50992.10 SV50992.10
Feed bag management hook SV51006.03 SV51006.03
Exhaust filter pinch clamp for 30 L system SV50177E.16
Exhaust filter pinch clamp for 300 L system SV50177E.15
Autoclave tray SV50177.01 SV50177.01
Bioreactor probe assembly (Non-sterile for use in autoclave) SH30720.01 SH30720.01
Heavy-duty tubing clamp (single pack) SV20664.01 SV20664.01
heavy-duty tubing clamp (10 per pack) SV20664.03 Sv20664.03
Sterile sampling manifold with luer lock (single pack) SH30845.01 SH30845.01
Sterile sampling manifold with luer lock (10 per pack) SH30845.02 SH30845.02
S.U.B. temperature/sample port SV20750.01 SV20750.01
Complete condenser system with 120 VAC for 30 L S.U.F unit (TCU for condenser is included) SV51009.02 N/A
Complete condenser system with 240 VAC for 30 L S.U.F unit (TCU for condenser is included) SV51009.03 N/A
Complete condenser system with 120 VAC for 300 L S.U.F unit (TCU for condenser is included) N/A SV51009.01
Thermo Scientific Masterflex™ pump (115 VAC/50 or 60 Hz, or 230 VAC/50 or 60 Hz) for 300 L system N/A SV50241.02
NEMA-rated 120 VAC vent filter heater with a thermocouple–includes preset temperature of 55°C and a Turck™ SV50191.41 SV50191.41
connector
NEMA-rated 240 VAM vent filter heater with a thermocouple–includes preset temperature of 55°C and a Turck SV50191.42 SV50191.42
connector
NEMA-rated 120 VAM vent filter heater with a thermocouple–includes preset temperature of 55°C and a Turck SV50191.35 SV50191.35
connector and a standard IEC C14 plug
NEMA-rated 240 VAC vent filter heater with a thermocouple–includes preset temperature of 55°C and a Turck SV50191.36 SV50191.36
connector and a standard IEC C14 plug
3x load cell with summing box without display SV50988.04 SV50988.03
Mettler-Toledo™ IND331 display, harsh mount style with analog interface (STD), 120 VAC US line cord/plug SV50177.306 SV50177.306
Mettler-Toledo IND331 display, harsh mount style with Allen-Bradley RIO interface, 120 VAC US line cord/plug SV50177.307 SV50177.307
Mettler-Toledo IND331 display, harsh mount style with device net interface, 120 VAC US line cord/plug SV50177.308 SV50177.308
Mettler-Toledo IND331 display, harsh mount style with ethernet/IP and Modbus TCP interface, 120 VAC line chord/ SV50177.309 SV50177.309
plug
Mettler-Toledo IND331 display, harsh mount style with Profibus interface, 120 VAC US line chord/plug SV50177.310 SV50177.310
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HyPerforma Single-Use Fermentors
S.U.F. MTO Configuration Table: This table describes the part number and configurable (make-to-order; MTO) options for the S.U.F. product line.
0030 = 30 L
Vessel type/material
A = jacketed (304 SST) (standard)
B = jacketed (316 SST) (standard)
Motor/electrical type
L/H = electrical box mounted on left and cable management tree on right side of tank. (See
DWG) R/H= electrical box mounted on right and cable management Tree on left side of tank.
(See DWG)
B = condenser with 3 position vent filter heater bracket (includes TCU and TCU hoses)
Other options
0 = no other options included
Other options
0 = no other options included
Pinch clamp options
0 = no other options included
B = pinch clamp for 30 L without condenser
C = pinch clamp for 30 L with condenser
Other options
0 = no other options included
Other options
0 = no other options included
62 lifetechnologies.com
Temperature control units
sub-catagory
The environmental conditions of single-use bioreactors, fermentors, and
media mixers need to be closely monitored and controlled in order to
provide optimal growth conditions. One of the most important conditions
is temperature, which must be accurately regulated to ensure reliability
and consistency of your processes.
Key features
• Auto-refill
Associated products
ThermoFlex™ chiller specifications ThermoFlex 2,500 chiller ThermoFlex 5,000 chiller ThermoFlex 10,000 chiller ThermoFlex 24,000 chiller
Heater capacity 2.8 kW at 230 V 2.8 kW at 230 V 6.1 kW at 460 V 22.5 kW at 460 V
Temperature range –5ºC to 50ºC –5ºC to 50ºC –5ºC to 50ºC –5ºC to 50ºC
Air-cooled condenser Y Y Y Y
Water-cooled condenser Y Y Y Y
Anti-drainback Y Y Y Y
Auto-refill Y Y Y Y
Pump performance, 60 Hz† 3.5 gpm at 60 PSID 10 gpm at 32 PSID 10 gpm at 32 PSID 20 gpm at 60 PSID
Pump performance, 50 Hz† 9.5 lpm at 1.4 bar 37.9 lpm at 1.4 bar 37.9 lpm at 1.4 bar 75.7 lpm at 1.4 bar
Communications Analog and digital Analog and digital Analog and digital Analog and digital
Power options Global voltage Global voltage 50/60 Hz, 3 phase 50/60 Hz, 3 phase
* Capacity at 20ºC.
†Positive displacement and magnetically-coupled centrifugal pump options are available.
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Temperature control units
SV50239.27 ThermoFlex 2,500 temperature control SV50239.31 TCU hose kit 3/4 inch ID, 10 ft, SV50239.34 TCU ball valve kit right angle,
unit (TCU), 2.5 kW cooling 2.8 W heating, 1 1/2 inch tri-clamp 1/2 inch NPT, ball valve
–5–50°C, air-cooled, 200–230 VAC
50/60 Hz, no power cord
SV50239.05 ThermoFlex 2,500 TCU, SV50239.31 TCU hose kit 3/4 inch ID, 10 ft, SV50239.34 TCU ball valve kit right angle,
2.5 kW cooling 2.8 W heating, –5–50°C, 1 1/2 inch tri-clamp 1/2 inch NPT, ball valve
liquid-cooled, 200–230 VAC 50/60 Hz,
no power cord
SV50239.28 ThermoFlex 5,000 TCU, SV50239.31 TCU hose kit 3/4 inch ID, 10 ft, SV50239.42 TCU ball valve kit right angle,
5 kW cooling 2.8 W heating, –5–50°C, 1 1/2 inch tri-clamp 3/4 inch NPT, ball valve
air-cooled, 200–230 VAC 50/60 Hz,
no power cord
SV50239.06 ThermoFlex 5,000 TCU, SV50239.31 TCU hose kit 3/4 inch ID, 10 ft, SV50239.42 TCU ball valve kit right angle,
5 kW cooling 2.8 W heating, –5–50°C, 1 1/2 inch tri-clamp 3/4 inch NPT, ball valve
liquid-cooled, 200–230 VAC 50/60 Hz,
no power cord
SV50239.29 ThermoFlex 10,000 TCU, SV50239.37 TCU hose kit 1 inch ID, 10 ft, SV50239.41 TCU ball valve kit right angle,
10 kW cooling 6.1 W heating, –5–50°C, 1 1/2 inch tri-clamp 1 inch NPT, ball valve
air-cooled, 400/460 VAC 50/60 Hz,
no power cord
SV50239.07 ThermoFlex 10,000 TCU, SV50239.37 TCU hose kit 1 inch ID, 10 ft, SV50239.41 TCU ball valve kit right angle,
10 kW cooling 6.1 W heating, –5–50°C, 1 1/2 inch tri-clamp 1 inch NPT, ball valve
liquid-cooled, 400/460 VAC 50/60 Hz,
no power cord
SV50239.08 ThermoFlex 24,000 TCU, SV50239.37 TCU hose kit 1 inch ID, 10 ft, SV50239.41 TCU ball valve kit right angle,
24 kW cooling 22.5 W heating, –5–50°C, 1 1/2 inch tr-iclamp 1 inch NPT, ball valve
liquid-cooled, 400/460 VAC 50/60 Hz,
no power cord
ThermoFlex Chiller heating and cooling calculation* Cool from 37˚C to 5˚C Heat from 5˚C to 37˚C
Temperature Single-use
Volume Inlet psi Outlet psi RPM Minutes Hours Minutes Hours
control unit bioreactor
ThermoFlex 2,500 100 L 100 L 6.4 5.7 155 205 3.4 115 1.9
ThermoFlex 5,000 250 L 250 L 32.6 22.8 124 229 3.8 188 3.1
ThermoFlex 5,000 250 L 125 L 32.6 22.8 98 150 2.5 123 2.1
ThermoFlex 10,000 500 L 500 L 34.7 20.3 104 221 3.7 156 2.6
ThermoFlex 24,000 1,000 L 1,000 L 31.6 21.3 87 181 3.0 109 1.8
ThermoFlex 24,000 2,000 L 2,000 L 24.1 20.2 73 275 4.6 165 2.8
ThermoFlex 24,000 2,000 L 1,000 L 24.1 20.2 58 208 3.5 136 2.3
64 lifetechnologies.com
Bioreactor controlcellsolutions
culture
Key features
Embedded platform system Associated products
65
Bioreactor control solutions
Summary Details
pH Operates with both traditional and single-use sensors
Temperature sensor Pt 100, 3 wire
Dissolved oxygen Operates with both traditional and single-use sensors
Foam/level Conductivity-based measurement
Analog in 8x available
Analog out 4x available
Digital in 8x available
Digital out 8x available
Biomass Capacitance or optical density (optional)
Display 12–15 in. color display with resistive touchscreen
1x Ethernet port (computer communication)
Communication interfaces 2x USB auxiliary
1x USB main
Control type PID control with selectable auto-tuning adaptive control
Up to 3 speed pumps; fixed-speed for embedded-based, variable-speed for PLC-based
Up to 4 mass flow controllers
Actuators
Heating and cooling via thermocirculator, heating blanket, cooling water valve
Water-cooled condenser connection
Additional features Emergency stop connection, central alarm output, color touch-screen operation
Power (EU/US) 230 VAC 50 Hz/115 VAC 60 Hz
Dimensions (H x W x L) 711 x 408 x 474 mm
Weight 30 kg
66 lifetechnologies.com
Bioreactor controlcellsolutions
culture
Key features
Associated products
67
Bioreactor control solutions
68 lifetechnologies.com
Services and
cellsculture
support
Field support
• Hardware installation–Factory acceptance test (FAT) and site acceptance test (SAT)
• Training–Single-Use Bioreactors, Single-Use Mixers, Single-Use Fermentors, bins and
BPCs
• Validation service–Installation Qualification (IQ), Operation Qualification (OQ), and
Performance Qualification (PQ)
• Warranty
• Service contracts
BioProduction Xpress
• R&D scientists and engineers specializing in S.U.B., S.U.M. and S.U.F. processes
• Scale-up studies
• Customer-specific application studies
• Quality testing
• Non-GMP quick response studies or tests
Technical support
Associated products
69
Cell line development
cell culture
Key features
• Flexible commercial licensing without the need for royalties
• Ability to achieve IgG titers over 3 g/L
• Complete workflow that can take your gene of interest from transfection to lead clone
typically in 5 months
• Convenient packaging, for simplified ordering and storage
Key features
• Flexible commercial licensing without the need for royalties
• Ability to achieve IgG titers over 3 g/L
• Complete workflow that can take your gene of interest from transfection to lead clone typically in
less than 6 months
• Convenient packaging, for simplified ordering and storage
70 lifetechnologies.com
Cell culture
cell culture
media
sub-catagory
Gibco™ CD OptiCHO™ Liquid Medium and Gibco™ CD OptiCHO
AGT™ Medium are specifically designed to offer high performance and yield with
recombinant CHO cells in a chemically defined fed-batch environment. The protein–free, animal
origin–free formulations are designed to provide consistency and reduces the need to screen for
adventitious agents. CD OptiCHO Medium builds on Gibco™ CD CHO Medium and its legacy of
consistent cell growth and titers, while offering up to 40% better titer and cell growth over select
competitors. Thanks to its low osmolality and advanced Gibco™ CHO CD EfficientFeed™ Liquid
Nutrient Supplement Kit feeding options, CD OptiCHO Medium is capable of gaining a 2- to 5-
fold increases in fed-batch productivity over batch culture.
• You are using a transfected CHO cell line other than CHO K1, GS CHO or CHO-S cell lines
• Optimization of feeding strategies will be part of your base medium–selection testing in an
effort to maximize productivity
• Your CHO cell line is “finicky;” i.e., hard to grow or adapt
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Cell culture media
1X CD CHO Medium
Cat. No. Unit size
10743-001 10 L
10743-002 20 L
10743-011 500 mL
10743-029 1,000 mL
72 lifetechnologies.com
Cell culture
cell culture
media
Gibco™ Dynamis™ AGT™ dry format medium is specifically designed to offer the high
batch and fed-batch culture performance and yield with recombinant CHO cells in a chemically-
defined environment. The chemically-defined, protein-free, animal origin component–free
formulation provides the power to achieve high titers, start process development faster, and
streamline or simplify transfer to manufacturing scale.
• The cell line you are using is a transfected CHO K1, GS CHO, or CHO-S cell line
• Maximum batch culture cell densities and protein titers are needed
• You have time to adapt cells into a new medium in an effort to maximize titers
• Cell health at harvest is a priority for downstream processing
73
Cell culture feeds
• You have used CHO CD EfficientFeed™ B AGT Nutrient Supplement in the past and wish to
explore simpler reconstitution and super-concentration benefits of a newer technology for
delivery of key components
• You are currently using CD CHO as your base cell growth medium
74 lifetechnologies.com
FunctionMAX TiterEnhancer
cell culture
u FunctionMAX TiterEnhancer
• You have a drop off in specific productivity late in a high density fed-batch culture;
FunctionMAX TiterEnhancer may be able to improve your titers
• You have an extremely low peak cell density fed-batch culture; you may want to consult with
PD-Direct™ Services for advice on cell adaptation and/or fed-batch optimization
• You have no drop off in specific productivity late in a high density fed-batch culture and
still need higher titers; you may want to consult with PD-Direct Services for advice on
fed-batch optimization
Key features
75
POROS and CaptureSelect purification products
76 lifetechnologies.com
POROS and CaptureSelect purification products
POROS™ XS and HS strong cation exchange resins are rigid, polymeric cation exchange
chromatography resins that can be used to separate biomolecules including monoclonal
antibodies, recombinant proteins, and peptides. The resin backbone consists of cross-
linked poly[styrene-divinylbenzene]. A polyhydroxyl surface coating enables low non-specific
binding, and surface functionalization with sulphopropyl yields a strong cation exchanger
ionizable over the complete pH range. Designed especially for the separation of target proteins from
process impurities, POROS™ HS resin is a high-performance resin for cation polish
chromatography. POROS™ XS resin is designed to deliver greater than approximate 100 mg/mL
dynamic binding capacity for monoclonal antibodies and recombinant proteins, without sacrificing
superior resolution.
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POROS and CaptureSelect purification products
POROS Protein A, G and CaptureSelect™ analytical columns are used throughout the industry to
monitor monoclonal antibody titer and yield from cell culture supernatant, and can be operated on
any standard high performance liquid chromatography (HPLC) or medium pressure chromatography
system. POROS™ analytical chromatography columns, available in 10 and 20 micron particle size,
enable rapid separation for biomolecules for both analytical and lab-scale preparative
applications. POROS™ Protein A analytical columns are widely used in the industry for
monitoring monoclonal antibody titer and yield from cell culture supernatant. The addition of
POROS™ CaptureSelect™ analytical columns expand the advantages of high-speed,
high-performance quantitation to IgM, Fab fragments and fusion proteins.
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Applied Biosystems analytics
Rapid molecular methods are also ideal for use in public health
laboratories, cosmetics and personal care products manufacturing, food
testing laboratories, and academic and research centers.
• Quantitate host cell residual DNA typically in under 5 hours with the resDNASEQ™
Residual DNA Quantitation Assays for human, CHO, E. coli, MDCK, Vero, NS0 and Pichia
pastoris cell lines
• Helps recover high levels of DNA from complex matrices with the PrepSEQ™ Residual
DNA Sample Preparation Kit
• Analyze results with AccuSEQ™ Real-Time PCR Detection Software
79
Applied Biosystems analytics
• PCR sensitivity—Quantitation to as low as 0.2 ng/mL generic host cell protein (HCP)
• Wide dynamic range—4 logs
• Designed for robustness—dilution linearity and efficiency in complex matrices
• Semi-automation—2-hour walk-away time
Harmful bacteria and fungi can contaminate raw materials, production facilities, and branded
products. The use of a phylogenetic approach for microbial detection based on the 16S rDNA gene
for bacteria or a specific genomic region of the large subunit for fungi can help prevent delayed
product releases, back orders and even recalls.
Identify thousands of bacterial and fungal species typically in under 5 hours with the MicroSEQ™
Microbial Identification System.
MicroSEQ ID systems
Description Cat. No.
MicroSEQ™ Rapid Microbial ID System II with 3500 Genetic Analyzer 4462993
MicroSEQ™ Rapid Microbial ID System II with 3500xL Genetic Analyzer 4462992
Fast MicroSEQ™ 500 16S rDNA PCR Kit 4370489
MicroSEQ™ D2 rDNA Fungal PCR Kit 4349153
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Applied Biosystems analytics
The MycoSEQ™ Mycoplasma Detection System integrates real-time PCR assays, instruments, and
software with optimized PrepSEQ™ sample preparation reagents– enabling results in hours, not
days. This enables you to test at multiple points in cell lines, cell banks, and harvest media, helping
to increase your productivity and reduce risk of downstream contamination.
81
Applied Biosystems analytics
• Proven TaqMan™ technology for highly sensitive detection down to 20 genome copies per
reaction (viral particles equivalent to 0.002 TCID50)
• Specific, no cross-reactivity with unrelated DNA
• Discriminatory positive/extraction DNA control to help minimize the possibility of false
positive test results from accidental cross-contamination with control DNA
• Use with PrepSEQ™ 1-2-3 Nucleic Acid Extraction Kit, designed for optimized, highly
efficient DNA recovery
• Rapid time-to-results, typically in less than 4 hours
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Applied Biosystems analytics
The AccuSEQ Real-Time PCR Detection Software is part of a system that performs analytical testing
for impurities and contaminants during the biopharmaceutical manufacturing process. Designed
to work with the 7500 Fast Real-Time PCR instrument, the software supports the SEQ family of
analytical detection and quantitation assays. The AccuSEQ Software offers a plug-in analysis
module for automated presence⁄ absence calls when using the MycoSEQ Mycoplasma Detection
System, while a custom module built into the main application can be used with the resDNASEQ
CHO residual DNA quantitation system.
Software
Description Cat. No.
AccuSEQ 2.0 Real-Time PCR Detection Software 4443420
Applied Biosystems™ MagMAX™ Express-96 and AutoMate Express™ systems offer labs a
boost in productivity by helping to reduce hands-on sample preparation time, increase throughput,
reduce costs, and improving the quality of sample extractions. Intuitive to operate and pre-loaded
with protocols, our automated sample preparation instruments help meet your throughput needs.
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Find out more at lifetechnologies.com/sut
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