products and capabilities

products and capabilities Single-use technology

Thermo Scientific Single-Use Systems

Table of contents

1

Introduction

Introduction to Thermo Scientific BioProcess Containers. ............................................................................................................. 2

BioProcess Container Manufacturing Process ............................................................................................................................. 5

BioProcess Container Manufacuring Sites .................................................................................................................................. 6

Quality Control and Assurance ............................................................................................................................................... 7–9

Products and Services

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

cell culture

lifetechnologies.com 2

Introduction

u Introduction to Thermo Scientific BioProcess Containers

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.

Introduction

3

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.

Support operation Applications BPC solution

Media/buffer preparation Powder delivery

Hydration in open top vessel

Hydration in closed/sterile system

Powdertainer™ BPC systems

Tank liners with outer support containers

Mixtainer™ BPC, Single-Use Mixer (S.U.M.)

Filtration Sterilization of media and buffers Custom BPC assembly or manifold including a filter option

Bulk storage Sterile storage of media, buffers and intermediates

Standard BPCs from 50 mL–2,000 L with outer support containers

Custom BPCs to cover additional options

Waste collection Non-aseptic collection of waste liquid from downstream processing

Tank liners for non-aseptic applications

Sampling Removal of sample volumes from bioreactors, mixers and storage containers for analysis

Standard BPCs from 50 mL–50 L

Custom manifolds

Custom tubing sets

Shipping Bulk sterile liquids, buffers, process liquids and intermediates between facilities

Bulk solutions or suspensions requiring mixing after shipping

Top and bottom drain BPCs up to 1,000 L with validated shipping configurations

Mixtainer BPC

4 lifetechnologies.com

Introduction

Unit operation Application BPC solution

Bioreactor Cell culture in stirred-tank system Single-Use Bioreactor (S.U.B.)

Fermentor Fermentation in stirred-tank system Single-Use Fermentor (S.U.F.)

Harvest Collection and storage of harvest from a bioreactor or fermentor

Standard top and bottom drain BPCs from 50 L–1,500 L with outer support containers

Custom BPCs to cover transfer assemblies

Additional options

Separation Feeding and receiving liquid from the separation system

Standard top and bottom drain BPCs from 50 L–1,500 L with outer support containers

Custom BPCs to cover transfer assemblies

Additional options

Purification Feeding buffers to the purification system

Fraction collection and storage

Standard bottom drain BPCs from 50 L–1,500 L with outer support containers. Standard BPCs from 50 mL–50 L

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

Transfer assemblies to transfer liquid from reservoir to filling system. Custom BPCs to cover additional options

u Introduction to Thermo Scientific BioProcess Containers

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.

Introduction

5

Key features

• All chambers and BPCs are produced in state-of-the-art cGMP facilities

• 33,000 square feet of Class 10,000/ISO Class 7 production area

• Manufacturing roadmap to match manufacturing capacity to market demand

• Multiple facilities with common processes for manufacturing redundancy

• Manufacturing sites in USA and Europe

• Capabilities to produce chambers from 50 mL to 10,000 L

• Automated lines for producing BPC chambers

• Strong engineering support to design and maintain products and processes

BPC manufacturing process

Chamber manufacture—The main component of a Thermo Scientific™ BPC chamber is plastic film produced by Thermo Scientific, or external suppliers in some cases. The other main components are ports that enable tubing to be attached to the chamber. There are a number of different port designs depending on the type of chamber.

The two main types of basic BPC chamber are:

Two-dimensional (2D)—This design is used for small, simple BPCs and is produced from twosheets 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 designsalso 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.


Introduction

u Thermo Scientific BPC manufacturing sites

Assembly Center, Logan, Utah

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.

BioCenter, Logan, Utah

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.

Our BioCenter includes:

Chamber manufacture—5 automated production lines manufacture the majority of our 2D and 3D BPC chambers. The BioCenter’s manufacturing equipment provides great versatility in batch size; film capability–CX3-9, CX 5-14, and Aegis5-14 Films; chamber size–from 50 mL to 3,000 L and larger; and chamber complexity–from simple tank liners, pillow-style 2D chambers and square-tube style 3D chambers to our most complex S.U.B., S.U.F. and S.U.M.

Final assembly—Although primarily a chamber manufacturing facility, our BioCenter serves as a back-up finished goods BPC assembly facility for BPC assemblies, tubing assemblies, and manifolded assemblies.

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:

Chamber manufacturing—We manufacture both Aegis and CX Film-based BPC chambers.

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.

Introduction

7

u Quality control and assurance

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.

Component type Inspection

Film Contamination Gels or carbons Width and gusset dimensions Film thickness Tensile strength and elongation–to ASTM D882 Chemical–using FT-IR analysis to ensure consistency and reliability

Ports, fittings and tubing Appearance and visual inspection Dimensions

Chambers Appearance Seam and port seal strength Dimensions Leak and burst testing

Test Details

100% visual inspection on a light table Correctness Completeness Particulate debris Defects and damage Correct packaging

Hydro-burst test Performed according to a statisical process control plan. The container is steadily inflated until there is a breach of integrity.

Final BPC product inspection

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.

Lot release Certificate of Analysis

Bill of materials Certificate of Irradiation Production quality inspections Production integrity testing Labels Deviations Certificate of analysis

Product name Part number Lot number Expiration date Irradiation dose Confirmation USP and EP testing of film

Component incoming inspection

Lot record and Certificate of Analysis


Introduction

u Quality control and assurance

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.

Endotoxin and particulate

Process validations and monitoring have been established for endotoxin and particulate for the manufacture of BPC systems. Particulate samples from the fluid path of a worst-case BPC assembly are tested according to USP 788: Light Obscuration Particle Count Test, and endotoxin testing is performed to USP 85 in conjunction with bioburden testing.

EMA/410/01 rev. 3 compliance

Due to heightened concerns over animal-origin components, we have taken a leadership role to compile vendor certificates of origin on each standard component.

These certifications not only provide information as to whether a given component is of animal origin, but also certify whether the component comes in contact with animal-derived materials in synthesis, purification, or other manufacture. Supplier statements also contain information on the species, tissue, and country of origin of any animal-derived substance along with supplier information on purification or manufacturing steps that would help reduce risk of adventitious animal-origin agents.

A Component Information Summary (CIS) is available on demand for each BPC product. This lists the NAO status and EMA/410 compliance of each product contact standard component.

Introduction

9

BPC validation documentation

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

BPC system hardware documentation

The hardware systems of the S.U.B., S.U.F. and S.U.M. are supplied with an Equipment Turnover Package (ETP) in electronic format with key supporting information including: top level hardware drawings, component/instrument manuals, utility requirements, recommended maintenance, torque wrench operating instructions, warranty statement, detailed electrical panel drawings and electrical schematics.

A Premium ETP is also available on request for an additional fee and includes: Factory Acceptance Test (FAT) Checklist, Site Acceptance Test (SAT) Protocol, and Weld and Passivation Certificates.

10

u Thermo Scientific CX5-14 Film

Schematic cross-section

lifetechnologies.com

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.

Property Test protocol Average values

Physical data

Tensile strength ASTM D882 2302 psi 15.9 MPa

Elongation ASTM D882 526%

Yield strength ASTM D882 1479 psi 10.2 MPa

2% secant modulus ASTM D882 43 ksi 296 MPa

Toughness ASTM D882 267 lbf-in 3.0 kN-cm

Puncture resistance Internal 160 lbf-in 1.8 kN-cm

Seam strength* ASTM D882 31 lbf-in 54 N/cm

O2 transmission rate ASTM D3985

0% RH outside, 100% RH inside, 23ºC

0.035 cc/100 in2/day 0.547 cc/m

2/day

CO2 transmission rate Mocon

0% RH outside, 100% RH inside, 23ºC

0.157 cc/100 in2/day 2.43 cc/m

2/day

Moisture vapor transmission rate

ASTM F1249 0% RH outside, 100% RH inside, 23ºC

0.020 g/100 in2/day 0.313 g/m

2/day

Haze ASTM D1003 (outside dry/inside wet)

59%

Glass transition temperature

ASTM E1640 -29ºF -34ºC

Film gauge 0.014 in 356 µm

Film contact material Polyethylene

Temperature range† -112 to 140ºF -80 to 60ºC

Sterilizable 5.0 Mrad 50 kGy

Biocompatibility data (post-gamma irradiation, >50 kGy)

USP Class VI USP <88> Pass

Cytotoxicity USP <87> Pass

Bacterial endotoxin USP <85> 0.005 EU/mL

Heavy metals USP <661> <1 ppm

Buffering capacity USP <661> <1 mL

Non-volatile residue USP <661> <1 mg

Residue on ignition USP <661> <1 mg

Hemolysis ISO 10993-4 Nonhemolytic

Appearance EP <3.2.2.1> Pass

Acidity and alkalinity EP <3.2.2.1> Pass

Absorbance EP <3.2.2.1> Pass

Reducing substances EP <3.2.2.1> Pass

Transparency EP <3.2.2.1> Pass

0.8

0.9

1.0

0.9

10.4

Polyester

Tie

EVOH

Tie

PE

Dimensions in mil

Schematic 3D view

Leachables and extractables testing

Extensive testing has been performed on the CX range of films using standard solutions. Information is available upon request.

All tests run post-gamma irradiation unless otherwise noted.*Data generated pre-gamma irradiation.†Sub-zero conditions require proper support and handling.


11

u Thermo Scientific CX3-9 Film

Schematic cross-section

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.


Physical data

Tensile strength ASTM D882 4300 psi 30 MPa

Elongation ASTM D882 1100%

Yield strength ASTM D882 900 psi 6 MPa


Toughness ASTM D882 435 lbf-in 4.9 kN-cm

Puncture resistance Internal 85 lbf-in 0.94 kN-cm

Seam strength ASTM D882 13 lbf-in 23 N/cm


ASTM F12490% RH outside,100% RH inside, 23ºC

0.06 g/100 in2/day 0.9 g/m2/day

Film gauge 0.009 in 229 µm

Film contact material Polyethylene

Temperature range* -112 to 140ºF -80 to 60ºC

Sterilizable 5.0 Mrad 50 kGy

Biocompatibility data (post-gamma irradiation, >50 kGy)

USP Class VI USP <88> Pass

Cytotoxicity USP <87> Pass

Bacterial endotoxin USP <85> <0.005 EU/mL

Heavy metals USP <661> <1 ppm

Buffering capacity USP <661> <1 mL

Non-volatile residue USP <661> <1 mg

Residue on ignition USP <661> <1 mg

Hemolysis ISO 10993-4 Pass

Appearance EP <3.2.2.1> Pass

Acidity and alkalinity EP <3.2.2.1> Pass

Absorbance EP <3.2.2.1> 0.0055 units

Reducing substances EP <3.2.2.1> <0.1 mL

Transparency EP <3.2.2.1> Pass

0.8

0.9

7.3

Polyester

Tie

PE

Schematic 3D view *Sub-zero conditions require proper support and handling.

Dimensions in mil

cell culture

12

u Thermo Scientific Aegis5-14 Film


Physical dataTensile strength ASTM D882 2276 psi 15.7 MPa

Elongation ASTM D882 507%Yield strength ASTM D882 1494 psi 10.3 MPa


Toughness ASTM D882 252 in-lb 2.85 kN-cm

Puncture resistance Internal 173 in-lb 1.95 kN-cm

Seam strength* ASTM D882 30lbf/in 53 N/cm

O2 transmission rate ASTM D39850% RH outside,100% RH inside, 23ºC

0.032 cc/100 in2/day 0.491 cc/m2/day

CO2 transmission rate Mocon0% RH outside,100% RH inside, 23ºC

0.177 cc/100 in2/day 2.737 cc/m2/day


ASTM F12490% RH outside,100% RH inside, 23ºC

0.022 g/100 in2/day 0.34 g/m2/day

Haze ASTM D1003 (outside dry/inside wet)

54%

Glass transition temperature ASTM E1640 -29ºF -34ºC

Film gauge 14 mil 356 µm

Film contact material PolyethyleneTemperature range† -112 to 140ºF -80 to 60ºC

Sterilizable 5.0 Mrad/50 kGyBiocompatibility data (post gamma irradiation, >50 kGy)USP class VI USP <88> PassCytotoxicity USP <87> PassBacterial endotoxin USP <85> 0.005 EU/mLHeavy metals USP <661> <1ppmBuffering capacity USP <661> <1mLNon-volatile residue USP <661> <1mgResidue on ignition USP <661> <1mgHemolysis ISO 10993-4 NonhemolyticAppearance EP <3.2.2.1> PassAcidity and alkalinity EP <3.2.2.1> PassAbsorbance EP <3.2.2.1> PassReducing substances EP <3.2.2.1> PassTransparency EP <3.2.2.1> Pass

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.

10.4

0.9

1.00.90.8Polyester

Tie

EVOH

Tie

Dimensions in mil

PE

Schematic Cross-Section

All tests run post-gamma irradiation unless otherwise noted.*Data generated pre-gamma irradiation.†Sub-zero conditions require proper support and handling.



Schematic 3D View

Leachables and extractables testing

Extensive testing has been performed on Aegis Film using standard solutions. Information is available upon request.

13

Tubing selection guide

u Thermo Scientific tubing selection guide

Although it is not practical to include the complete range of commercially available tubing in the Thermo Scientific™ Standard Component Library, a list of sizes for the key types used in the biopharmaceutical industry are represented.

Key factors in selection of tubing for inclusion in a BPC systems are:

• Pumping characteristics—Peristaltic pumping is the most common method so the flow rate and pump life of tubing in this system are important. More information is provided on Data Sheet 016.

• Clarity—Most but not all of the tubing types are clear. The ability to see tubing contents is normally important.

• Method of connection—Most connection systems involve attaching the tubing to a hose barb in a standard size. Tubing welders and sealers require specific types of tubing.

• Supporting data—Regulatory compliance, ADCF status and extractables studies are often required. A database of information on all standard tubing is available. More details are provided in Data Sheet 016.

• Economics—Different tubing types, bore sizes and wall thicknesses can vary widely in cost. In general, the larger the bore size and wall thickness, the more expensive the tubing.

• Sterilization method—It is standard for tubing used on BPCs to be suitable for irradiation.

Thermo Scientific tubing for BPC systems available

Type Description Use when:

C-Flex™ This is a common choice of tubing for use in standard and custom BPC systems due to its overall suitability. Three formulations are included: clear, opaque and ADCF. Its main advantages over silicone are increased chemical resistance and thermoplastic characteristics.

General purpose liquid handling is required. Also with tubing welding and sealing equipment.

Platinum-cured silicone A common choice of silicone based on multi-sourcing is recommended to maximize range of sizes, availability and cost. Silicone tubing in a range of sizes from suppliers such asCole-Parmer™, Saint-Gobain™ and Watson-Marlow™ is also available.

General purpose liquid handling is required.

PVC Medical grade PVC tubing is included in the Standard Component Library for historical reasons and was widely used before other alternatives like C-Flex became available.

Heat/radio frequency sealing or very high clarity are required.

PharMed™ This tubing has a longer pump life than C-Flex or silicone. Due 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.

Long pump life is required.

PharmaPure™ This is supplied by Saint-Gobain™ as an alternative to PharMed™ tubing with ultra-low particulate spallation.

Long pump life is required.

cell cultureTubing selection guide


Inner diameter x outer diameter sizes available

Pump size*

Default silicone

Clear C-Flex

Opaque C-Flex

ADCF C-Flex

PVC PharMed PharmaPure

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 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 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

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.

*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.

Product description

Weld and seal capability

Animal-derived components

Extractable profile

Gas perme-ation

Autoclave tolerance

Peristaltic pump life

Binding Clarity Sterilization method

C-Flex 374 ADCF

Yes No Good Very low Fair Good Low Clear Gamma Irr.

C-Flex clear formulation 082

Yes No Good Very low Fair Good Low Clear Gamma Irr.

C-Flex opaque formulation 072

Yes No Good Very low Fair Very good Low Opaque Gamma Irr.

Silicone, Tygon 3350

No No Excellent Moderate Excellent Fair Low Clear Autoclave or Gamma Irr.

Silicone, SPT-50

No No Very good Moderate Excellent Fair Low Clear Autoclave or Gamma Irr.

PharMed BPT Yes Yes Good Very low Good Excellent Low Opaque Autoclave or Gamma Irr.

cell culture

15

Connection selection guide

u Thermo Scientific connection system selection guide

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.

Luer connectors

Type Material Hose barb sizes available

luer lock Kynar™ 3.18 mm (1/8 in), 6.35 mm (¼ in)

luer lock Polypropylene 3.18 mm (1/8 in), 6.35 mm (¼ in)

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.


MPC series Polycarbonate 9.53 mm (3/8 in), 12.67 mm (½ in)

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. 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.


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 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)

Male luer lock connector

Female luer lock connector

Male (insert) Female (body)

Mini tri-clamp

SterilEnz fitting

Tri-clamp

16

Connection selection guide



SmartSite Acrylic/polyurethane/silicone N/A

Clave Information not available N/A


Unitized mini TC Silicone 9.52 mm (3/8 in), 12.7 mm (½ in)

Unitized TC Silicone 9.52 mm (3/8 in), 12.7 mm (½ in), 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 (TC and mini TC)

Polyetherimide/silicone

6.35 mm (¼ in), 12.7 mm (½ in)


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)

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)


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)

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.

Method of connection: Automatic instrument cuts and joins two tubes aseptically to form a connection.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.

Method of connection: Same as Tri-clamp where the mating flange will be part of a SIP supply assembly.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.

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.

Sample Ports

Steam in Place

Tubing welder

Aseptic connection devices (ACD)

Pall Kleenpak connection

Tubing in welder jaws

CPC Steam-thru connection

SmartSite connection

Female (body)

CPC AseptiQuik connection (X)

CPC AseptiQuik connection (S)

cell culture

17

u Thermo Scientific filter selection guide

Filter selection guide

Filtration is an important step in bioprocessing and a variety of filters are available through the Thermo Scientific Standard Component Library to meet your needs. Our open architecture approach to components enables us to provide customers a broad choice of both filters and manufacturers, including opportunities for dual sourcing.

Some major characteristics relevant to filter selection:

• 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.

Supplier Type Material Final filter pore sizes (µm)

DominickHunter™

PROPOR™ SG, DOMICAP™ capsule PES 0.1, 0.2

PROPOR™ SG, MURUS capsule PES 0.1, 0.2

Meissner™

SteriLUX™, UltraCap™ capsule PVDF 0.1, 0.2

SteriLUX, capsule PVDF 0.2

STyLUX™, UltraCap capsule PES 0.1, 0.2

STyLux, capsule PES 0.1, 0.2

Pall

Fluorodyne™ II DJL, Kleenpak capsule PVDF 0.1

Fluorodyne II DFL, Kleenpak capsule PVDF 0.2

Supor EKV, Kleenpak capsule PES 0.2

Millipore

Millipak™ filter unit PVDF 0.1, 0.2

Opticap™ XL capsule PVDF 0.1, 0.2

Opticap XL capsule PES 0.1, 0.2

Sartorius™ Sartopore™ 2 capsule PES 0.1, 0.2

18

Building a custom fluid transfer system? We are your ultimate customer partner for single-use fluid transfer assemblies.

• A complete end-to-end solution provider A single point of contact for design, manufacturing and service

• Your trusted guide for bioprocess applications Components from our superior Standard Components Library

• Delivering the benefits of single-use technology, customized Systems that integrate within your existing processes

Our fluid transfer assemblies are delivered sterile and ready-to-use for your bioprocess operations:

• Media and buffer transfer • Product sampling • Bioreactor feed transfer • Harvest collection

Contact your Thermo Scientific representative for more information.

u Thermo Scientific fluid transfer assemblies

• Filtration and purification process connection • Bulk product and final fill • Dispensing and aliquoting


Fluid transfer assemblies

• HyPerforma S.U.B. (Pg. 52)

• HyPerforma S.U.F. (Pg. 57)

• HyPerforma S.U.M. (Pg. 43)

• Harvestainer Microcarrier Separation BPC and System (Pg. 26)

Associated products

• 2D BPC Systems (Pg. 19)


• Tank Liners (Pg. 28)

19

2D BPC systems

Key features

• 2D Labtainer BPC systems are 2 panel, pillow-style BPCs

• Chambers are constructed from either CX5-14 Film or our premium Aegis5-14 Film

• Labtainer BPC systems have 2–3 edge ports along one end with a handle on the opposing end

• 2-port Labtainer BPCs are available in sizes from 50 mL to 2,000 mL

• 3-port Labtainer BPCs are available in sizes from 2 L to 50 L

• Line sets can be customized for easy integration with existing process operations and equipment

• Labtainers can be customized into multi-container manifold configurations

• Labtainers can be added as sample container adjuncts to 2D or 3D BPCs

Applications

• Harvest from bioreactors or fermentors

• Feed into bioreactors or fermentors

• Sample collection from bioreactors or fermentors

• Buffer preparation and storage

• Culture media preparation and storage

• Process liquid preparation and storage

• Chromatography feed and fraction collection

• Harvest, storage and transport of bulk drug product and bulk drug precursors

• Waste collection

Supporting information

• Aegis5-14 Film Fact Sheet

• CX5-14 Film Fact Sheet

Associated products




• HyPerforma S.U.M.(Pg. 43)

u 2D Labtainer BPC systems

20

2D BPC systems


Cat. No. Size Dimensions (L x W)

Aegis5-14 Film: SH30961.11 50

mL11.7 cm x 13.7 cm (4.6 in x 5.4 in) CX5-14 Film:

SH30658.11

Aegis5-14 Film: SH30961.12 100

mL14.7 cm x 14.2 cm (5.8 in x 5.6 in)

CX5-14 Film: SH30658.12

Aegis5-14 Film: SH30961.13 250

mL19.1 cm x 15 cm (7.5 in x 5.9 in)

CX5-14 Film: SH30658.13

Aegis5-14 Film: SH30961.14 500

mL26.4 cm x 17.3 cm (10.4 in x 6.8 in)

CX5-14 Film: SH30658.14

Aegis5-14 Film: SH30961.15

1 L 29.7 cm x 20.1 cm (11.7 in x 7.9 in)

CX5-14 Film: SH30658.15


2 L 34.8 cm x 24.4 cm (13.7 in x 9.6 in)

CX5-14 Film: SH30658.16

No. per case: 10 (all above)


Aegis5-14 Film: SH31048.11 50

mL11.7 cm x 13.7 cm (4.6 in x 5.4 in) CX5-14 Film:

SH30662.11

Aegis5-14 Film: SH31048.12 100

mL14.7 cm x 14.2 cm (5.8 in x 5.6 in)

CX5-14 Film: SH30662.12

Aegis5-14 Film: SH31048.13 250

mL19.1 cm x 15 cm (7.5 in x 5.9 in)

CX5-14 Film: SH30662.13

Aegis5-14 Film: SH31048.14 500

mL26.4 cm x 17.3 cm (10.4 in x 6.8 in)

CX5-14 Film: SH30662.14


1 L 29.7 cm x 20.1 cm (11.7 in x 7.9 in)

CX5-14 Film: SH30662.15


2 L 34.8 cm x 24.4 cm (13.7 in x 9.6 in)

CX5-14 Film: SH30662.16


Line 1

Female luer lock connection, polypropylene No tubing

Line 2

Male luer lock connection, polypropylene No tubing


Aegis5-14 Film: SH31050.11 50

mL

11.7 cm x 13.7 cm (4.6 in x 5.4 in)

CX5-14 Film: SH30657.11

Aegis5-14 Film: SH31050.12 100

mL 14.7 cm x 14.2 cm (5.8 in x 5.6 in)

CX5-14 Film: SH30657.12

Aegis5-14 Film: SH31050.13 250

mL19.1 cm x 15 cm (7.5 in x 5.9 in)

CX5-14 Film: SH30657.13

Aegis5-14 Film: SH31050.14 500

mL26.4 cm x 17.3 cm (10.4 in x 6.8 in)

CX5-14 Film: SH30657.14


1 L 29.7 cm x 20.1 cm (11.7 in x 7.9 in)

CX5-14 Film: SH30657.15


2 L 34.8 cm x 24.4 cm (13.7 in x 9.6 in)

CX5-14 Film: SH30657.16



2 portspack of 10

Line 1 Female luer lock connection, polypropylene Tubing: C-Flex length: 30 cm (12 in) ID x OD: 3.2 mm x 6.4 mm (1/8 in x ¼ in)

Line 2 Male luer lock connection, polypropylene Tubing: C-Flex length: 30 cm (12 in) ID x OD: 3.2 mm x 6.4 mm (1/8 in x ¼ in)

2D BPCs, pillow design, edge ports


Line 2

MPC insert, polycarbonate No tubing

2 portspack of 10

2 portspack of 10

2D BPC systems

21


Aegis5-14 Film: SH31050.11 50

mL

11.7 cm x 13.7 cm (4.6 in x 5.4 in)

CX5-14 Film: SH30657.11

Aegis5-14 Film: SH31050.12 100

mL 14.7 cm x 14.2 cm (5.8 in x 5.6 in)

CX5-14 Film: SH30657.12

Aegis5-14 Film: SH31050.13 250

mL19.1 cm x 15 cm (7.5 in x 5.9 in)

CX5-14 Film: SH30657.13

Aegis5-14 Film: SH31050.14 500

mL26.4 cm x 17.3 cm (10.4 in x 6.8 in)

CX5-14 Film: SH30657.14


1 L 29.7 cm x 20.1 cm (11.7 in x 7.9 in)

CX5-14 Film: SH30657.15


2 L 34.8 cm x 24.4 cm (13.7 in x 9.6 in)

CX5-14 Film: SH30657.16


Line 1 MPC insert, polycarbonate Tubing: C-Flex length: 30 cm (12 in) ID x OD: 9.5 mm x 12.7 mm (3/8 in x ½ in)

Line 2 MPC insert, polycarbonate Tubing: C-Flex length: 30 cm (12 in) ID x OD: 9.5 mm x 12.7 mm (3/8 in x ½ in)

Line 3 Plugged No tubing

Line 1 MPC insert, polycarbonate Tubing: C-Flex length: 61 cm (24 in) ID x OD: 9.5 mm x 15.9 mm (3/8 in x 5/8 in)

Line 2 MPC body, polycarbonate Tubing: C-Flex length: 61 cm (24 in) ID x OD: 9.5 mm x 15.9 mm (3/8 in x 5/8 in)

Line 3 Female luer lock connection, polypropylene Tubing: C-Flex length: 61 cm (24 in) ID x OD: 3.2 mm x 6.4 mm (1/8 in x 1/4 in)



2 L 29.5 cm x 31 cm (11.6 in x 12.2 in)

CX5-14 Film: SH30713.05


5 L 37.6 cm x 33.3 cm (14.8 in x 13.1 in)

CX5-14 Film: SH30713.01


10 L 62.2 cm x 30 cm (24.5 in x 11.8 in)CX5-14 Film:

SH30713.02


20 L 65.5 cm x 43.2 cm (25.8 in x 17 in)CX5-14 Film:

SH30713.03


50 L 82.6 cm x 58.4 cm (32.5 in x 23 in)

CX5-14 Film: SH30713.04



2 L 29.5 cm x 31 cm (11.6 in x 12.2 in)

CX5-14 Film: SH30712.05


5 L 37.6 cm x 33.3 cm (14.8 in x 13.1 in)

CX5-14 Film: SH30712.01


10 L 62.2 cm x 30 cm (24.5 in x 11.8 in)

CX5-14 Film: SH30712.02


20 L 65.5 cm x 43.2 cm (25.8 in x 17 in)

CX5-14 Film: SH30712.03



SH30712.04



2 L 29.5 cm x 31 cm (11.6 in x 12.2 in)

CX5-14 Film: SH30714.05


5 L 37.6 cm x 33.3 cm (14.8 in x 13.1 in)

CX5-14 Film: SH30714.01


10 L 62.2 cm x 30 cm (24.5 in x 11.8 in)

CX5-14 Film: SH30714.02



SH30714.03



SH30714.04


BPCs, edge ports

3 portssingle pack

Line 1 Male luer lock connection, polypropylene Tubing: C-Flex length: 30 cm (12 in) ID x OD: 6.4 mm x 9.5 mm (¼ in x 3/8 in)

Line 2 Female luer lock connection, polypropylene Tubing: C-Flex length: 30 cm (12 in) ID x OD: 6.4 mm x 9.5 mm (¼ in x 3/8 in)


3 portssingle pack

3 portssingle pack

cell culture2D BPC systems




2 L 29.5 cm x 31 cm (11.6 in x 12.2 in)

CX5-14 Film: SH30709.05


5 L 37.6 cm x 33.3 cm (14.8 in x 13.1 in)CX5-14 Film:

SH30709.01


10 L 62.2 cm x 30 cm (24.5 in x 11.8 in)

CX5-14 Film: SH30709.02



SH30709.03



SH30709.04

Cat. No. Size Outer container Cat. No.

CX5-14 Film: SH30667.01 50 L SV50076.02

CX5-14 Film: SH30667.02 100 L SV50076.03

CX5-14 Film: SH30667.03 200 L SV50076.04

Aegis5-14 Film equivalents for this product

are available as custom configurations.


BPCs, edge ports

3 portssingle pack

Line 1 MPC insert, polycarbonate No tubing

Line 2 MPC insert, polycarbonate No tubing

Line 3 Injection port No tubing

2D pillow design with panel ports

3 portssingle pack

Line 1 MCP insert, polycarbonate Tubing: C-Flex length: 61 cm (24 in) ID x OD: 9.5 mm x 15.9 mm (3/8 in x 5/8 in)

Line 2 MPC body, polycarbonate Tubing: C-Flex length: 61 cm (24 in) ID x OD: 9.5 mm x 15.9 mm (3/8 in x 5/8 in)


cell culture

23

cell culture3D BPC systems

u 3D BPC systems

3D square tube design with top dispense

Line 1 MPC insert, polycarbonate Tubing: C-Flex length: 45.7 cm (18 in) ID x OD: 9.5 mm x 15.9 mm (3/8 in x 5/8 in)

Line 2 MPC body, polycarbonate Tubing: C-Flex length: 45.7 cm (18 in) ID x OD: 9.5 mm x 15.9 mm (3/8 in x 5/8 in)

Line 1 MPX insert, polycarbonate Tubing: length: 121.9 cm (48 in) ID x OD: 12.7 mm x 19.1 mm (½ in x ¾ in), with dip tube length dependant on size

Line 2 Male luer lock conection, polypropylene Tubing: length: 121.9 cm (48 in) ID x OD: 6.4 mm x 9.5 mm (¼ in x 3/8 in)

Line 3 Female luer lock connection, polypropylene Tubing: length: 121.9 cm (48 in) ID x OD: 6.4 mm x 9.5 mm (¼ in x 3/8 in)

Line 4 MPX body, polycarbonate Tubing: length: 121.9 cm (48 in) ID x OD: 12.7 mm x 19.1 mm (½ in x ¾ in) dip tube length: 30.5 cm (12 in)



50 L dip tube: 38 cm (15 in)

SV50076.02CX5-14 Film: SH30649.01


Aegis5-14 Film: SH30964.02 100 L

dip tube: 71 cm (28 in)

SV50076.03CX5-14 Film: SH30649.02


Aegis5-14 Film: SH30964.03 200 L


SV50076.04CX5-14 Film: SH30649.03





SV50076.02CX5-14 Film: SH30651.01




SV50076.03CX5-14 Film: SH30651.02




SV50076.04CX5-14 Film: SH30651.03



Aegis5-14 Film: 50 L dip tube: 38 cm (15 in)

SV50076.02

CX5-14 Film: SH30653.01



SV50076.03CX5-14 Film: SH30653.02



SV50076.04

CX5-14 Film: SH30653.03


4 ports

Line 1 MPC insert, polycarbonate Tubing: C-Flex length: 121.9 cm (48 in) ID x OD: 9.5 mm x 15.9 mm (3/8 in x 5/8 in) with dip tube length dependant on size

Line 2 Male luer lock connection, polypropylene Tubing: C-Flex length: 121.9 cm (48 in) ID x OD: 6.4 mm x 9.5 mm (¼ in x 3/8 in )

Line 3 Female luer lock connection, polypropylene Tubing: C-Flex length: 121.9 cm (48 in) ID x OD: 6.4 mm x 9.5 mm (¼ in x 3/8 in)

Line 4 MPC body, polycarbonate Tubing: C-Flex length: 121.9 cm (48 in) ID x OD: 9.5 mm x 15.9 mm (3/8 in x 5/8 in) dip tube length: 30.5 cm (12 in)

4 ports2 ports

24

3D BPC systems


u 3D BPC systems

3D square tube design with bottom port dispense

For use with conical, bottom drain drums

Line 1 MPX body, polycarbonate Tubing: C-Flex length: 45.7 cm (18 in) ID x OD: 12.7 mm x 19.1 mm (½ in x ¾ in)


Line 3 MPX insert, polycarbonate Tubing: C-Flex length: 121.9 cm (48 in) ID x OD: 12.7 mm x 19.1 mm (½ in x ¾ in), bottom port

Line 1 19.1 mm (¾ in) tri-clamp, polyethylene Tubing: length: 45.7 cm (18 in) ID x OD: 12.7 mm x 19.1 mm (½ in x ¾ in)

Line 2 19.1mm (¾ in) tri-clamp, polyethylene Tubing: length: 45.7 cm (18 in) ID x OD: 12.7 mm x 19.1 mm (½ in x ¾ in)

Line 3 19.1mm (¾ in) tri-clamp, polyethylene Tubing: C-Flex, length: 121.9 cm (48 in) ID x OD: 12.7 mm x 19.1 mm (½ in x ¾ in)

Line 1 MPC insert, polycarbonate Tubing: C-Flex, length: 121.9 cm (48 in) dip tube ID x OD: 9.5 mm x 15.9 mm (3/8 in x 5/8 in) dip tube length: 30.5 cm (12 in)

Line 2 Male luer lock connection, polypropylene Tubing: C-Flex length: 121.9 cm (48 in) ID x OD: 6.4 mm x 9.5 mm (¼ in x 3/8 in)


Line 4 Plugged (no tubing)

Line 5 MPC body, polycarbonate Tubing: length: 121.9 cm (48 in) ID x OD: 9.5 mm x 15.9 mm (3/8 in x 5/8 in) bottom port, silicone




SV50076.02

CX5-14 Film: SH30650.01

SV50517.04

Aegis5-14 Film: SH30967.02 100 L


SV50076.03

CX5-14 Film: SH30650.02

SV50517.05

Aegis5-14 Film: SH30967.03 200 L


SV50076.04

CX5-14 Film: SH30650.03 SV50517.06



Aegis5-14 Film: SH30969.01 50 L


SV50517.04CX5-14 Film: SH30652.01

Aegis5-14 Film: SH30969.02 100 L


SV50517.05CX5-14 Film: SH30652.02


Aegis5-14 Film: SH30969.03 200 L


SV50517.06CX5-14 Film: SH30652.03





SV50076.02

CX5-14 Film: SH30672.01 SV50517.04


Aegis5-14 Film: SH30968.02 100 L


SV50076.03

CX5-14 Film: SH30672.02 SV50517.05


Aegis5-14 Film: SH30968.03 200 L


SV50076.04

CX5-14 Film: SH30672.03 SV50517.06


3 ports 3 ports 5 ports

Associated products






cell culture

25

BPCs for large volume containers


Aegis5-14 Film: SH30969.01 50 L


SV50517.04CX5-14 Film: SH30652.01

Aegis5-14 Film: SH30969.02 100 L


SV50517.05CX5-14 Film: SH30652.02


Aegis5-14 Film: SH30969.03 200 L


SV50517.06CX5-14 Film: SH30652.03


u BPCs for large volume stainless steel outer container systems

BPCs with bottom drain dispense

4/5 ports single pack

Line 1 MPC insert, polycarbonate Tubing: C-Flex, length: 121.9 cm (48 in) ID x OD: 9.5 mm x 15.9 mm (3/8 in x 5/8 in), dip tube length: 30.5 cm (12 in)

Line 2 Male luer lock, polypropylene Tubing: C-Flex, length: 121.9 cm (48 in) ID x OD: 6.4 mm x 9.5 mm (¼ in x 3/8 in)

Line 3 Female luer lock, polypropylene Tubing: C-Flex length: 121.9 cm (48 in) ID x OD: 6.4 mm x 9.5 mm (¼ in x 3/8 in)

Line 4 Plugged No tubing

Line 5 MPC body, polycarbonate Tubing: C-Flex length: 121.9 cm (48 in) ID x OD: 9.5 mm x 15.9 mm (3/8 in x 5/8 in) bottom port, silicone

3 ports single pack

Line 1 MPX insert, polycarbonate Tubing: C-Flex length: 51 cm (20 in) ID x OD: 12.7 mm x 19.1 mm (½ in x ¾ in)

Line 2 MPX insert, polycarbonate Tubing: C-Flex length: 51 cm (20 in) ID x OD: 12.7 mm x 19.1 mm (½ in x ¾ in)

Line 3 MPX insert, polycarbonate Tubing: C-Flex length: 51 cm (20 in) ID x OD: 12.7 mm x 19.1 mm (½ in x ¾ in), bottom port



500 L SV50160.02CX5-14 Film: SH30652.04


1000 L SV50160.03CX5-14 Film: SH30652.05


1500 L SV50160.04CX5-14 Film: SH30652.06



Aegis5-14 film: SH31047.01

100 L SV50160.01

CX5-14 Film: SH30717.01


200 L SV50160.01

CX5-14 Film: SH30717.02



500 L SV50160.02

CX5-14 Film: SH30717.03



Harvestainer BPC systems

For bioproduction processes using anchorage-dependent cells grown on microcarriers, the Thermo Scientific™ Harvestainer™ Microcarrier Separation BPC enables the simple and effective separation of microcarriers from the cell culture supernatant harvest in a single-step, single-use, completely closed system. The Harvestainer BPC features a dual chamber system comprising a 200 L BPC that contains a 25 L pillow style BPC within. This inner BPC, the Thermo Scientific™ Microbarrier Labtainer™ BPC, maximizes product recovery and microcarrier retention, with the beads remaining in this BPC while the supernatant collects inside the outer 200 L BPC.

Key features

• Simple, efficient, single-use microcarrier/harvest separation

• Self-contained closed system helps reduce cross-contamination risk

• One of the most economical options available

• Dual interior Microcarrier Labtainer option and Harvestainer BPC manifolding capability enable a spectrum of expansion, making the system scalable from process development to full cGMP commercial production

• Enables consistent pass-through rate from start to finish without decrease or impedance to flow

• Minimal loss in viability or yield post separation

• Minimal set-up and clean-up time

• Full product containment and single-use for easy disposal

• Helps eliminate need for investment in costly equipment


• Thermo Scientific Harvestainer BPC brochure

• Validation Guide for Thermo Scientific Harvestainer BPC

• Microcarrier bead separation and cell harvest using Thermo Scientific Harvestainer Application Note

• Thermo Scientific Harvestainer BPC animation clip

• Thermo Scientific Harvestainer BPC video

Cat. No. Description Volume Inner BPCSH30936.01 Harvestainer BPC w/ single inner BPC 200 L 1 x 25 L

No. per Case 5

SH30936.02 Harvestainer BPC w/ dual inner BPC 200 L 1 x 25 L

No. per Case 4

SV50517.29 Polyethylene drum, bottom drain with lid, latches and cap plug

SV50029.03 Drum dolly, 243/8 inches x 71/8 inches (D x H)

Associated products


u Thermo Scientific Harvestainer microcarrier separation BPC and system

Harvestainer BPC systems

27

Vent

Transfer Portfrom Bioreactor

Bottom Drain Port

MicrobarrierLabtainer BPC

MicrobarrierBeads

Outer BPC

Well characterized and customizable

The Harvestainer BPC is composed of well-characterized materials commonly used in single-use BPCs. Like all Thermo Scientific BPCs, the Harvestainer BPC is scalable and can be customized to readily integrate with existing equipment. It is designed to maximize product recovery and is built to the same quality standards found in all Thermo Scientific single-use products.

Adherent cells are cultured in a bioreactor using microcarrier beads

Harvestainer BPC and microcarriers are ready for disposal

Connect the Harvestainer BPC to the bioreactor via the transfer port

Drain bioreactor contents directly into the Harvestainer BPC

Microcarrier beads are trapped in the Microbarrier Labtainer BPC,

supernatant passes into the outer BPC

Supernatant is ready for the next processing stage

Flexibility and scalability

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.


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

Supporting information• CX3-9 Film Fact Sheet


• BPC Handling Data Sheet 047

• Drums Data Sheet 045

• Tank Liners Data Sheet 008

Liners, top drainFor use with cylinderical tanks


SH30647.01 50 L SV50076.02

No. per case: 30

SH30647.02 100 L SV50076.03

No. per case: 26

SH30647.03 200 L SV50076.04

No. per case: 15

CX3-9 Film: CX3-9 Film:


SH30647.04 50 L SV30111

No. per case: 34

SH30647.05 100 L SV30112

No. per case: 25

SH30647.06 300 L SV30114

No. per case: 12

SH30647.07 500 L SV30116

No. per case: 8

Liners, bottom drain

Line 1 MPX insert, polycarbonate Tubing: C-Flex length: 182.9 cm (72 in) ID x OD: 12.7 mm x 19.1 mm (½ in x ¾ in)

Liners, top drainFor use with Thermo Scientific drums




SV50076.02

CX3-9 Film: SH30646.01 SV50517.04

Aegis5-14 Film: SH30988.02 100 L


SV50076.03

CX3-9 Film: SH30646.02 SV50517.05


Aegis5-14 Film: SH30988.03 200 L


SV50076.04

CX3-9 Film: SH30646.03 SV50517.06


1 port

cell culture

Connection Selection Guide

29

Plastic tanks, drums and accessories




SV50076.02

CX3-9 Film: SH30646.01 SV50517.04

Aegis5-14 Film: SH30988.02 100 L


SV50076.03

CX3-9 Film: SH30646.02 SV50517.05


Aegis5-14 Film: SH30988.03 200 L


SV50076.04

CX3-9 Film: SH30646.03 SV50517.06


Thermo Scientific plastic tanks, drums and accessories

Cat. No. Size Dimensions (D x H)

SV30133 19 L 27.9 cm x 38.1 cm (11 in x 15 in)

SV30111 57 L 33 cm x 68.6 cm (13 in x 27 in)

SV30112 113 L 45.7 cm x 76.2 cm (18 in x 30 in)

SV30113 208 L 55.9 cm x 91.4 cm (22 in x 36 in)

SV30114 303 L 61 cm x 121.9 cm (24 in x 48 in)

SV30115 378 L 71.1 cm x 111.8 cm (28 in x 44 in)

SV30116 568 L 78.7 cm x 124.5 cm (31 in x 49 in)


SV50076.02 50 L 45 cm x 53 cm (175/8 in x 20¾ in)

SV50076.03 100 L 45 cm x 79 cm (175/8 in x 31¼ in)

SV50076.04 200 L 45.7 cm x 76.2 cm (18 in x 30 in)

Flat-bottom LLDPE drumtop dispense, with clamps

Conical LLDPE drum, 1 port, size: 10.2 cm (4 in) with clamps, use support plate

Cylindrical, flat-bottom LLDPE tank with lidtop dispense

Outer containers


SV50517.08 50 L 60 cm x 58 cm (23½ in x 23 in)

SV50517.09 100 L 60 cm x 76 cm (23½ in x 29¾ in)

SV50517.10 200 L 60 cm x 114 cm (23½ in x 44¾ in)

30

Plastic tanks, drums and accessories


Cat. No. Size

SV50102.02 50, 100, 200 L


SV50029.03 50, 100, 200, 300 L 62 cm x 18 cm (243/8 in x 71/8 in)


SV50517.04 50 L 60 cm x 58 cm (23½ in x 23 in)

SV50517.05 100 L 60 cm x 76 cm (23½ in x 29¾ in)

SV50517.06 200 L 60 cm x 114 cm (23½ in x 44¾ in)

Thermo Scientific plastic tanks, drums and accessories

Conical LLDPE drum, 1 port, size: 4.5 cm (1.75 in)with clamps

Plastic drum dolly

Support plate round plastic disk needed when using conical LLDPE drum with 4 inch port

cell cultureLarge volume rigid plastic support containers

31

We have selected and qualified rigid plastic vessels, known as ALLpaQ™ bins, to support our BPC products in helping meet your large volume liquid storage, handling, and shipping needs.

Key features

• Reusable—Robust design and sturdy construction permits multiple uses

• Convenient—Collapsible walls fold down for easy storage when bins are not in use

• Stackable—Enable extra storage both empty and full

• Bottom drain—True bottom drain options available

• Shippable—Units qualified for shipping with correct dunnage and pack-outs

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



Cat. No. Size Outer dimensions (W x D x H) Dispensing Material

SV50139.10 250 L 809 mm x 609 mm x 965 mm (31.8 in x 23.9 in x 38 in) Top and bottom dispense polypropylene

SV50139.12 500 L 1,200 mm x 800 mm x 1,040 mm (47.2 in x 31.5 in x 41 in) Top and bottom dispense ABS/HDPE

SV50139.11 600 L 1,155 mm x 1,155 mm x 980 mm (45.5 in x 45.5 in x 38.6 in) Top and bottom dispense polypropylene

SV50139.06 1000 L 1,155 mm x 1,155 mm x 1,294 mm (45.5 in x 45.5 in x 50.9 in) Top and bottom dispense polypropylene

Note: Other sizes and options available on a non-standard basis. For volumes under 500 liters, qualified plastic drums and tanks are recommended.

AllPaq rigid plastic support bins

ALLpaQ 316 stainless steel carts

Cart Cat. No. Size Support bin Cat. No.

SV50139.13 500 L SV50139.12

SV50139.16 1,000 L SV50139.02

SV50139.16 1,000 L

600 L

SV50139.06

SV50139.11

u Large volume rigid plastic support containers and accessories


Large volume stainless steel support containers

u Large volume stainless steel outer container systems

Key features

• Thermo Scientific™ HyPerforma™ Smartainer™ Systems have chambers constructed of Thermo Scientific Aegis5-14 Film and CX5-14 Film with dimensions optimized for Smartainer systems

• Smartainer systems are simple, durable and economic containers constructed in 304 stainless steel

• They are intended for in-house handling applications in critical areas

• Smartainer systems are non-jacketed outer container systems available in unit volumes of 200, 500, 1,000, 1,500 and 2,000 L

• It is a modular system with optional accessories for mobility and BPC handling

• Jacketed versions available in all sizes on a custom basis, for applications where heating or cooling are required

• Smartainer systems are designed to allow both top and bottom discharge from BPCs

• Standard BPC configurations are available in unit volumes of 100, 200, 500, 1,000 and 1,500 L

Applications

• Sterile media and buffer storage and transport within facility

• Feeding sterile media into bioreactors and buffers into purification systems

• Receiving and storage of harvest from bioreactors

• Not intended for shipping applications

Thermo Scientific HyPerforma Smartainer and jacketed Smartainer system components

u

x

uSmartainer/jacketed SmartainerStainless steel specially designed container to support the BPC

vBPC hoist (optional)Assists in handling and loading the BPC into theSmartainer and jacketed Smartainer systems

wTray assembly (optional)Conveniently holds dispense pumps, tube welders, and other items

xCart (optional)Assists in moving the Smartainer and jacketed Smartainer system short distances over smoothand level surfaces

w

Associated products


• Temperature Control Units (Pg. 63)

v

33

Stainless steel outer containers

Large volume stainless steel support containers

u Large volume stainless steel outer container systems and accessories

Thermo Scientific HyPerforma Smartainer systems

Cat. No. Size Overall Dimensions (W x D x H) Internal Dimensions (W x D x H)

SV50160.01 200 L 79.4 cm x 59.7 cm x 79.1 cm (31¼ in x 23½ in x 311/8 in) 73 cm x 53.3 cm x 58.4 cm (28¾ in x 21 in x 23 in)

SV50160.02 500 L 120.7 cm x 78.7 cm x 97.2 cm (47½ in x 31 in x 38¼ in) 114.3 cm x 73.7 cm x 74.5 cm (45 in x 29 in x 291/3 in)

SV50160.03 1,000 L 120.7 cm x 97.8 cm x 135 cm (47½ in x 38½ in x 531/8 in) 114.3 cm x 91.4 cm x 114.8 cm (45 in x 36 in x 451/5 in)

SV50160.04 1,500 L 120.7 cm x 97.8 cm x 175.3 cm (47½ in x 38½ in x 69 in) 114.3 cm x 91.4 cm x 152.4 cm (45 in x 36 in x 60 in)

SV50160.05 2,000 L* 120.7 cm x 97.8 cm x 223.5 cm (47½ in x 38½ in x 88 in) 114.3 cm x 91.4 cm x 200.7 cm (45 in x 36 in x 79 in)

*No standard BPC configurations are available. Custom options available. Note: Larger container system sizes available upon request.

Accessories

Stainless steel hoist (optional)

Cat. No. Size

SV50161.21 1,000 L

SV50161.22 1,500 L

SV50161.23 2,000 L

Tray (optional)

Cat. No. Size

SV50161.11 200 L

SV50161.12 500 L

SV50161.13 1,000/1,500 L

Custom options

• 316 stainless steel

• Load cells

• Lid

• Casters mounted directly on bin

• Filter bracket

• Pump shelf

• Tubing management

Cart (optional)

Cat. No. Size

SV50161.01 200 L

SV50161.02 500 L

SV50161.03 1,000/1,500 L

Note: Hoist recommended for all units 1000 L and greater


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

u Thermo Scientific mixtainer mixing systems

Mixtainer mixing systems

35

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

Mixtainer BPC Conical drum Magnetic stirring plate

Stainless steel support Dolly

Line 1 9.5 mm (3/8 in) Quick Connectinsert with 16.5 cm (6.5 in) dip tube tube length: 91 cm (36 in)

Line 2 6.3 mm (1/4 in) male luer locktube length: 91 cm (36 in)

Line 3 6.3 mm (1/4 in) female luer locktube length: 91 cm (36 in)

Line 4 9.53 mm (3/8 in) Quick Connectbody tube length: 91 cm (36 in)

Cat. No. Size

SH30687.04 50 L

SH30687.05 100 L

SH30687.06 200 L

Cat. No. Size

SV50517.11 50 L

SV50517.12 100 L

SV50517.13 200 L

Powder addition port: 38.1 mm (11/2 in) tri-clamp port

Cat. No. Area Description

SV30097.01 EU 230 V, 50/60 Hz, 0.5 amp

SV30097.02 US 115 V, 50/60 Hz, 1 amp

Cat. No. Area Description

SV30097.03 EU Stainless steel support

SV30097.04 US Stainless steel support

Cat. No. Size

SV50109.01 Universal

4 ports, top dispense, powder/liquid mixing

Top dispense, with clamps IKAMAGTM motor and support required

Dimensions (D x H)

62 cm x 18 cm (243/8 in x 71/8 in)


Mixtainer mixing systems Thermo Scientific HyPerforma DS 300 Single-Use Mixer

u Thermo Scientific mixtainer mixing systems

Dip tubes Specific lengths 6.36–12.7 mm (1/4–1/2 in) ID

Tubing typeC-Flex (clear or white)SiliconePVC

Tubing size Specific lengths of 3.18–19.05 mm (1/4–1/2 in) ID

Connectors

Luer ID: 3.18–6.35 mm (1/8–1/4 in) CPC ID: 6.35–19.05 mm (1/4–3/4 in) SIP tri-clamp ID: 6.35–19.05 mm (1/4–3/4 in) Mini tri-clamp ID: 6.35–19.05 mm (1/4–3/4 in)Hose barb

OthersInjection port ID: 6.35–9.53 mm (1/4–3/8 in)Filling bell ID: 6.35 mm (1/4 in)Filter capsule: Millipore, Pall, Sartorius, Domnick Hunter

Outer packagingSupplied “flat-packed”

Two polyethylene outer layers

Label

DescriptionProduct code

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

System options Material Supplier information

Thermo Scientific™ Powdertainer™ II powder feed bag: connect a Powder-tainer II to the Mixtainer using a concentric reducer 7.6 cm (3 in) tri-clamp to 3.8 cm (11/2 in) tri-clamp. Ordering information for the reducer is shown.

304 stainless steel Saint Patricks of Texas: ordering info—concentric reducer (3 x 1.5 in)www.stpats.com/sanitaryfittings.htm • phone: (512) 989-9727

304 stainless steel RT Process: part number 31-14MP-3X1.5-304www.rtprocess.com • phone: (801) 561-8877

316 stainless steel RT Process: part number 31-14MP-3X1.5-316www.rtprocess.com • phone: (801) 561-8877

Polypropylene Saint-Gobain (Sani-Tech):part number TAD300-150www.plastics.saint-gobain.com • phone: (800) 543-8823

Kynar material (PVDF) Saint-Gobain (Sani-Tech):part number KAD300-150www.plastics.saint-gobain.com • phone: (800) 543-8823

Custom BPC options Description

BPC presentation Description

Mixtainer systems information

37

Thermo Scientific HyPerforma DS 300 Single-Use Mixer

Key features

• The Thermo Scientific™ HyPerforma™ DS 300 Single-Use Mixer (S.U.M.) is a modular

mixing system consisting of a mixing station that mates to plastic drums containing

single-use BPCs or tank liners, offering the user a cost-effective, docking station–style

mixing platform with multiple mixing volume options

• The docking station consists of a stainless steel base with locking casters, an adjustable

handle, a tethered hand-held control device, an electronic vertical lift mechanism with

integrated height indicator, motor mount and motor, three sizes of drive shafts, two

adjustment tools—a spanner and a torque wrench. An adjustable-angle motor head and

drum positioned are available as add-on options

• Top-drain support containers are available in 50, 100, 200 and 300 L sizes; with

bottom-drain drums available in 50, 100 and 200 L sizes

• Top-drain tank liners are available in four sizes from 50 to 300 L

• Tank liners with bottom access ports are available in three sizes from 50 to 200 L

• Closed-top 3D BPCs, with both top and bottom drain access ports, are available in sizes 50,

100 and 200 L

• Optional dollies are available for all drum sizes

u HyPerforma DS 300 Single-Use Mixer


Thermo Scientific HyPerforma DS 300 Single-Use Mixer 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

14. Dolly

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

HyPerforma DS 300 S.U.M. system

Figure 1: S.U.M. DS 300 complete system diagram–front view.

Figure 2: S.U.M. DS 300 complete system diagram–back view.

39


Cat. No. Description

SUMDS0300.9000 DS300 unit standard

SUMDS0300.9001 DS300 unit with drum positioner

SUMDS0300.9002 DS300 unit with adjustable motor head

SUMDS0300.9003 DS300 unit with drum positioner and adjustable motor head

Cat. No. Description Dimensions Bottom drain Volume range

SH30959.01 50 L plastic drum with conical insert 60 x 58 cm (23.5 x 23 in) 10.2 cm (4 in) 10–50 L

SH30959.02 100 L plastic drum with conical insert 60 x 76 cm (23.5 x 29.75 in) 10.2 cm (4 in) 20–100 L

SH30959.03 200 L plastic drum 60 x 114 cm (23.5 x 44.75 in) 10.2 cm (4 in) 40–200 L

SH30959.04 300 L plastic drum 61 x 122 cm (24 x 48 in) N/A 60–300 L

SV50102.02 optional support plate for bottom drain 12.7cm (5 in) diameter split N/A 50–200 L

Cat. No. Description Material Quantity

SH30958.01 dolly for 50–200 L plastic drum polyethylene 1

SH30958.02 dolly for 50–200 L plastic drum polyethylene 2

SH30958.03 dolly for 300 L plastic drum stainless steel 1

Impeller material USP class VI, HDPE

Impeller to BPC system/tank liner location 5:1 off center

Number of impeller blades 3

Closed-top BPC system qualified LDPE

Open-top BPC tank liner qualified LDPE

Cat. No. Size Description

CX3-9 Film: SH30646.01 50 L

open-top, bottom drain, irradiatedCX3-9 Film: SH30646.02 100 L

CX3-9 Film: SH30646.03 200 L

CX3-9 Film: SH30647.06 300 L open-top, top drain, irradiated

DS 300 S.U.M. options

DS 300 S.U.M. drum options

DS 300 S.U.M. dolly options

DS 300 S.U.M. tank liner specifications

DS 300 S.U.M. irradiated BPC tank liner options

u HyPerforma DS 300 S.U.M.

HyPerforma DS 300 S.U.M. information


Thermo Scientific HyPerforma DS 300 Single-Use Mixer Thermo Scientific HyPerforma DS 300 Single-Use Mixer

Cat. No. Size Description

CX3-9 Film: SH30399.01 50 L

open-top, bottom drain, non-irradiatedCX3-9 Film: SH30399.02 100 L

CX3-9 Film: SH30399.03 200 L

Cat. No. Drum size Sleeve length Description

SH30749.11 50 L 35.3 cm (13.9 in) impeller, sleeve and connector for 66 cm (26 in) drive shaft

SH30749.12 100 L 53.1 cm (20.9 in) impeller, sleeve and connector for 83.8 cm (33 in) drive shaft

SH30749.13 200 L 77 cm (30.3 in) impeller, sleeve and connector for 108 cm (42.5 in) drive shaft

SH30749.08 300 L 96 cm (37.8 in) impeller, sleeve and connector for 129.5 cm (51 in) drive shaft

Part number Size Description

SV50177.77 50–300 L stainless steel bearing hub

Part number Size Description

Aegis5-14 Film: SH30946.01 50 L

closed-top, bottom drain, irradiated

Aegis5-14 Film: SH30946.02 100 L

Aegis5-14 Film: SH30946.03 200 L

DS 300 S.U.M. non-irradiated BPC tank liner options

DS 300 S.U.M. impeller sleeve options

DS 300 S.U.M. reusable hub options

DS 300 S.U.M. irradiated BPC system options

cell culture

41


Description Tubing set (Inner diameter x outer diameter x length)

End treatment

Bottom drain line 1.27 x 1.91 x 340.6 cm (1/2 in x 3/4 in x 11.17 ft)polycarbonate Quick Connect 12.7 mm (1/2 in) insert (MPX) and cap

Addition line 1 0.95 x 1.59 x 61 cm (3/8 in x 5/8 in x 2.0 ft)polycarbonate Quick Connect 9.5 mm (3/8 in) body (MPC) and plug

Addition line 2 1.91 x 2.54 x 121.9 cm (3/4 in x 1 in x 4.0 ft)38.1 mm (11/2 in) Tri-clamp with 19.1 mm (3/4 in) hose barb, with gasket SterilEnz II/H

Vent filter 0.64 x 1.27 x 10.1 cm (1/4 in x 1/2 in x 0.33 ft) hydrophobic vent with Emflon II, HB

Recirculation/sample line

1.27 x 1.91 x 91 cm (1/2 in x 3/4 in x 3 ft )1.27 x 1.91 x 30.5 cm (1/2 in x 3/4 in x 1 ft)1.27 x 1.91 x 61 cm (1/2 in x 3/4 in x 2 ft)

polycarbonate Quick Connect 12.7 mm (1/2 in) body (MPX) and plug

polycarbonate Quick Connect 12.7 mm (1/2 in) insert (MPX) and cap

Power 108–240 VAC, 50–60 Hz

Input amperage 15 amp

Operating temperature range ambient to 40°C

Motor speed 30 to 350 RPM

Foot print (L x W) 86.4 x 76.2 cm (34 x 30 in)

Height (lowest to tallest point)

122.4–162.3 cm (48.2–63.9 in)

Weight 180 kg (398 lb)

Control box built to IP65 standards

Flow type radial/axial

Hardware material 304 stainless steel

HyPerforma DS 300 S.U.M. information

DS 300 S.U.M. BPC system specifications

DS 300 S.U.M. general specifications

u HyPerforma DS 300 S.U.M.



Drum size Turndown ratio

Minimumworking liquid volume

Minimum hold up

Maximum liquid fill

Left to right offset*

Front to back position* Lift height*

Motor angle (fixed or adjustable motor head models)

Motor RPM

50 L 5:1 10 L 100 mL 50 L 02.5 cm (1 in) 0.48cm (3/16 in) 10° 350

100 L 5:1 20 L 100 mL 100 L 05.1 cm (2 in) 2.2cm (7/8 in) 10° 350

200 L 5:1 40 L 100 mL 200 L 05.4 cm (21/8 in)

30.64 cm (12 1/16 in)

10° 350

300 L 4:1† 79 L 500 mL 300 L1.3 cm

(½ in) left6.4 cm (2½ in)

39.98 cm (15.74 in)

10° 350

*All measurements listed in the above table are ± 0.16 cm (1/16 in) †For the 300 L drum, a 5:1 turndown ratio can be achieved using the adjustable angle motor head

Drum size Turndown ratio

Minimum working liquid volume

Minimum hold up

Maximum liquid fill

Left to right offset*

Front to back position* Lift height*

Motor angle (adjustable motor head models only)

Motor RPM†

50 L 5.4:1 9.2 L 100 mL 50 L2.5 cm

(1 in) left1.3 cm (½ in)

0 5° 180

100 L 10:1 9.8 L 100 mL 100 L2.5 cm


0 5° 205

100 L 6:1 16.7 L 100 mL 100 L2.5 cm


2.2 cm (7/8 in)

5° 140

200 L 10:1 20 L 100 mL 200 L1.9 cm

(¾ in) left3.2 cm (1¼ in)

28.1 cm (11 1/16 in)

5° 150

200 L 8.8:1 22.5 L 100 mL 200 L1.9 cm

(¾ in) left3.2 cm (1¼ in)

28.3 cm (11 1/8 in)

5° 140

300 L 5:1 61 L 500 mL 300 LN/A due to flat

bottomN/A

38.71 cm (15.24 in)

5° 164

300 L 5:1 65 L 500 mL 300 LN/A due to flat

bottomN/A

38.71 cm (15.24 in)

5° 124

*All measurements listed in the above table are ± 0.16 cm (1/16 in) †All values listed are ± 5 RPM

Typical open-top mixing with standard impeller sizes

Minimum open-top mixing for adjustable motor head S.U.M.s with standard impeller sizes

cell culture

43

u HyPerforma Single-Use Mixer

HyPerforma Single-Use Mixer

The Thermo Scientific™ HyPerforma™ S.U.M. has been designed using a proven engineered mixer platform design for upstream and downsteam mixing applications. The HyPerforma S.U.M. offers a more ergonomic and efficient user experience. The complete line of HyPerforma S.U.M.s includes 50, 100, 250, 500, 1,000, and 2,000 L sizes that helps ensure consistent scalability while providing a number of application usages from powder media and buffer hydration to advanced downstream havest and intermediate pooling steps.

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

• Powder media hydration

• Liquid media concentrate dilution

• Harvest hold tank

• Viral inactivation

• Downstream intermediate pooling

• Final product hold and additive suspension

Applications Associated products




• Powdertainer BPC System (Pg. 50)

• Services and Support (Pg. 69)

44


HyPerforma S.U.M. specifications

Specifications 50 L 100 L 200 L 500 L 1,000 L 2,000 L

Maximum liquid working volume 50 L 100 L 200 L 500 L 1,000 L 2,000 L

Minimum liquid working volume 10 L 20 L 40 L 100 L 200 L 400 L

Fluid geometry at working volume (height/diameter) ratio 1.5:1 1.5:1 1.5:1 1.5:1 1.1:1 1:1

Overall reactor geometry (height/diameter) ratio

1.9:1 1.5:1 1.95:1 1.7:1 1.2:1 1.2:1

Impeller (quantity x blade count) 1 X 3 1 X 3 1 X 3 1 X 3 1 X 3 1 X 3

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 (including cable management tree and electrical box)

94.2 x 84.3 x 198.6 cm (37.1 x 33.2 x 78.2 in)

94.8 x 87.3 x 175.3 cm (31.8 x 36.1 x 60.35 in)

94.8 x 87.3 x 175.3 cm (37.3 x 34.4 x 69 in)

122.5 x 130.2 x 251.1 cm (48.23 x 51.25 x 98.9 in)

148.3 x 155.8 x 201 cm (58.4 x 61.33 x 79.10 in)

172.2 x 159.6 x 224.8 cm (67.8 in 62.83 x 88.52 in)

Standard hardware part numbers

Cat. No. Description Size SUM0050.9001 Non-jacketed, DC motor, without load cell 50 L SUM0050.9002 Jacketed, DC motor, without load cell 50 LSUM0050.9003 Non-jacketed, 120VAC, AC motor, without load cell 50 L SUM0050.9004 Jacketed, 120VAC, AC motor, without load cell 50 L SUM0050.9005 Non-jacketed, 240VAC, AC motor, without load cell 50 LSUM0050.9006 Jacketed, 240VAC, AC motor, without load cell 50 L SUM0100.9001 Non-jacketed, DC motor, without load cell 100 LSUM0100.9002 Jacketed, DC motor, without load cell 100 LSUM0100.9003 Non-jacketed, 120VAC, AC motor, without load cell 100 LSUM0100.9004 Jacketed, 120VAC, AC motor, without load cell 100 LSUM0100.9005 Non-jacketed, 240VAC, AC motor, without load cell 100 LSUM0100.9006 Jacketed, 240VAC, AC motor, without load cell 100 LSUM0250.9001 Non-jacketed, DC motor, without load cell 200 LSUM0250.9002 Jacketed, DC motor, without load cell 200 LSUM0250.9003 Non-jacketed, 120VAC, AC motor, without load cell 200 LSUM0250.9004 Jacketed, 120VAC, AC motor, without load cell 200 LSUM0250.9005 Non-jacketed, 240VAC, AC motor, without load cell 200 LSUM0250.9006 Jacketed, 240VAC, AC motor, without load cell 200 LSUM0500.9001 Non-jacketed, DC motor 500 L SUM0500.9002 Water-jacketed, DC motor 500 LSUM0500.9003 Non-jacketed, 120VAC, AC motor 500 LSUM0500.9004 Water-jacketed, 120VAC, AC motor 500 LSUM0500.9005 Non-jacketed, 240VAC, AC motor 500 LSUM0500.9006 Water-jacketed, 240VAC, AC motor 500 L

Cat. No. Description Size SUM1000.9001 Non-jacketed, DC motor 1,000 LSUM1000.9002 Water-jacketed, DC motor 1,000 LSUM1000.9003 Non-jacketed, 120VAC, AC motor 1,000 LSUM1000.9004 Water-jacketed, 120VAC, AC motor 1,000 LSUM1000.9005 Non-jacketed, 240VAC, AC motor 1,000 LSUM1000.9006 Water-jacketed, 240VAC, AC motor 1,000 LSUM2000.9003 Non-jacketed, 120VAC, AC motor 2,000 L SUM2000.9004 Water-jacketed, 120VAC, AC motor 2,000 L SUM2000.9005 Non-jacketed, 240VAC, AC motor 2,000 L SUM2000.9006 Water-jacketed, 240VAC, AC motor 2,000 L


Note: Non-jacketed models do not provide heat transfer.

cell culture

45

u HyPerforma S.U.M. docking station option

HyPerforma S.U.M. docking station specifications

Item Docking station frame

Width 81.3 cm (34 in)Depth 113.8 cm (44.8 in)Height 61.9 cm (61.9 in)Weight 231 kg (509 lb)Electrical power supply requirement (voltage, phase, amp)

120 or 240 VAC, single, 15 amp, non-GFCI circuit

Top stair height 46.2 cm (18.2 in)

Programmable VFD, remote panel interface Standard

Mixer motor drive (voltage, phase, amp) 208 VAC, three, 15 ampMotor power rating 0.5 hp (372.8 W)Motor torque rating 80 lbf-in (9.04 Nm)Gear reduction 5:1

HyPerforma S.U.M. docking station

The S.U.M. is based on the same concept as the Thermo Scientific S.U.B. with a single-use BPC with an integrated impeller and a hardware system providing support, mobility, mixing motor and controller. In con-trast to the other options in the S.U.M. product family the docking station system has the mixing motor mounted on a separate docking station rather than on the tank itself. This allows the mixing motor to link with a range of separate tanks. Easy-to-use motor height and angle adjustment combined with a secure mechanism to locate and lock the docking sta-tion and tank in place helps make the changeover of tanks simple and rapid.

Key features

The stainless steel tank options include:

• Maximum volumes of 200, 500 and 1,000 L

• Mixer vessel is offered with a non-jacketed (no heat transfer) or water jacket for integration with external temperature control unit

• Three load cells weighing systems to 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

46


HyPerforma S.U.M. docking tank specifications

Item 200 L 500 L 1,000 L Rated liquid working volume 200 L 500 L 1,000 LMinimum liquid working volume 40 L 100 L 200 LBPC chamber diameter 50.8 cm (20 in) 75.6 cm (29.75 in) 105.4 cm (41.5 in)BPC chamber shoulder height 123.4 cm (48.6 in) 146 cm (57.5 in) 157.2 cm (61.9 in)Liquid height at rated working volume 99 cm (39 in) 111.8 cm (44 in) 115.6 cm (45.5 in)Overall geometry (height/diameter ratio) 1.95:1 1.5:1 1.1:1Fluid geometry at working volume (height/diameter) ratio 2.2:1 1.7:1 1.2:1Impeller (quantity x blade count) 1 x 3 1 x 3 1 x 3Impeller diameter 20 cm (7.88 in) 20 cm (7.88 in) 20 cm (7.88 in)Hold-up volume (typical) <50 mL <100 mL <300 mLSkid width 64.8 cm (25.5 in) 77 cm (30.4 in) 126 cm (49.6 in)Skid depth 73.7 cm (29 in) 95 cm (37.4 in) 125.2 cm (49.3 in)Skid height 147.8 cm (58.2 in) 165.3 cm (65.1 in) 161 cm (63.4 in)Dry skid weight (mass) non-heated tank 201 kg (443 lb) 352 kg (776 lb) 399 kg (880 lb)Dry skid weight (mass) jacketed tank 211 kg (465 lb) 364 kg (802 lb) 414 kg (913 lb)Wet skid weight—rated working volume (mass)non-heated tank

401 kg (884 lb) 852 kg (1,878 lb) 1,399 kg (3,084 lb)

Wet skid weight—rated working volume (mass)jacketed tank

411 kg (906 lb) 864 kg (1,905 lb) 1,414 kg (3,117 lb)

Minimum ceiling height recommended 305 cm (10 ft) 335 cm (11 ft) 335 cm (11 ft)

Minimum required floor scale platform dimensions58.4 x 55.8 cm

(23 x 22 in)68.6 x 60.9 cm

(27 x 24 in)96.5 x 96.5 in

(38 x 38 in)

Cat. No. Description

SUM0000.XXXX - ("X" is defined at time of quote) Single-Use Mixer (S.U.M.) docking station system (120 VAC)SUM0000.XXXX - ("X" is defined at time of quote) Single-Use Mixer (S.U.M.) docking station system (240 VAC) SUM0200.XXXX - ("X" is defined at time of quote) Single-Use Mixer (S.U.M.) docking station tank, non-jacketed, feetSUM0200.XXXX - ("X" is defined at time of quote) Single-Use Mixer (S.U.M.) docking station tank, non-jacketed, castersSUM0200.XXXX - ("X" is defined at time of quote) Single-Use Mixer (S.U.M.) docking station tank, jacketed, feetSUM0200.XXXX - ("X" is defined at time of quote) Single-Use Mixer (S.U.M.) docking station tank, jacketed, castersSUM0500.XXXX - ("X" is defined at time of quote) Single-Use Mixer (S.U.M.) docking station tank, non-jacketed, feetSUM0500.XXXX - ("X" is defined at time of quote) Single-Use Mixer (S.U.M.) docking station tank, non-jacketed, castersSUM0500.XXXX - ("X" is defined at time of quote) Single-Use Mixer (S.U.M.) docking station tank, jacketed, feetSUM0500.XXXX - ("X" is defined at time of quote) Single-Use Mixer (S.U.M.) docking station tank, jacketed, castersSUM1000.XXXX - ("X" is defined at time of quote) Single-Use Mixer (S.U.M.) docking station tank, non-jacketed, feetSUM1000.XXXX - ("X" is defined at time of quote) Single-Use Mixer (S.U.M.) docking station tank, non-jacketed, castersSUM1000.XXXX - ("X" is defined at time of quote) Single-Use Mixer (S.U.M.) docking station tank, jacketed, feetSUM1000.XXXX - ("X" is defined at time of quote) Single-Use Mixer (S.U.M.) docking station tank, jacketed, casters

HyPerforma S.U.M. docking station ordering information


47

Hyperforma S.U.M. standard BPCs

DescriptionProbe ports

Film type Size Cat. No.

Standard powder-liquid BPC 0 CX5-14 50 L SH30768.01Standard powder-liquid BPC 0 Aegis5-14 50 L SH30973.01Standard liquid-liquid BPC 0 CX5-14 50 L SH30767.01Standard liquid-liquid BPC 0 Aegis5-14 50 L SH30983.01Standard powder-liquid BPC 3 CX5-14 50 L SH31055.02Standard powder-liquid BPC 3 Aegis5-14 50 L SH31051.02Standard liquid-liquid BPC 3 CX5-14 50 L SH31055.04Standard liquid-liquid BPC 3 Aegis5-14 50 L SH31051.01Standard powder-liquid BPC 0 CX5-14 100 L SH31046.01Standard powder-liquid BPC 0 Aegis5-14 100 L SH31052.01Standard liquid-liquid BPC 0 CX5-14 100 L SH31046.03Standard liquid-liquid BPC 0 Aegis5-14 100 L SH31052.03Standard powder-liquid BPC 3 CX5-14 100 L SH31046.02Standard powder-liquid BPC 3 Aegis5-14 100 L SH31052.02Standard liquid-liquid BPC 3 CX5-14 100 L SH31046.04Standard liquid-liquid BPC 3 Aegis5-14 100 L SH31052.04Standard powder-liquid BPC 0 CX5-14 200 L SH30750.01

Standard powder-liquid BPC 0 Aegis5-14 200 L SH30973.02Standard liquid-liquid BPC 0 CX5-14 200 L SH30753.01Standard liquid-liquid BPC 0 Aegis5-14 200 L SH30983.02Standard powder-liquid BPC 3 CX5-14 200 L SH31054.02Standard powder-liquid BPC 3 Aegis5-14 200 L SH31053.02Standard liquid-liquid BPC 3 CX5-14 200 L SH31054.04Standard liquid-liquid BPC 3 Aegis5-14 200 L SH31053.04Standard powder-liquid BPC 0 CX5-14 500 L SH30751.01Standard powder-liquid BPC 0 Aegis5-14 500 L SH30973.03Standard liquid-liquid BPC 0 CX5-14 500 L SH30754.01Standard liquid-liquid BPC 0 Aegis5-14 500 L SH30983.03Standard powder-liquid BPC 3 CX5-14 500 L SH30751.02Standard powder-liquid BPC 3 Aegis5-14 500 L SH30974.03Standard liquid-liquid BPC 3 CX5-14 500 L SH30754.02Standard liquid-liquid BPC 3 Aegis5-14 500 L SH30982.03Standard powder-liquid BPC 0 CX5-14 1,000 L SH30752.02Standard powder-liquid BPC 0 Aegis5-14 1,000 L SH30973.04Standard liquid-liquid BPC 0 CX5-14 1,000 L SH30755.01Standard liquid-liquid BPC 0 Aegis5-14 1,000 L SH30983.04Standard powder-liquid BPC 3 CX5-14 1,000 L SH30752.02Standard powder-liquid BPC 3 Aegis5-14 1,000 L SH30974.03Standard liquid-liquid BPC 3 CX5-14 1,000 L SH30755.02Standard liquid-liquid BPC 3 Aegis5-14 1,000 L SH30982.04Standard powder-liquid BPC 0 CX5-14 2,000 L SH30770.01Standard powder-liquid BPC 0 Aegis5-14 2,000 L SH30973.05Standard liquid-liquid BPC 0 CX5-14 2,000 L SH30769.01Standard liquid-liquid BPC 0 Aegis5-14 2,000 L SH30983.05Standard powder-liquid BPC 3 CX5-14 2,000 L SH30770.02Standard powder-liquid BPC 3 Aegis5-14 2,000 L SH30974.05Standard liquid-liquid BPC 3 CX5-14 2,000 L SH30769.02Standard liquid-liquid BPC 3 Aegis5-14 2,000 L SH30982.05

DescriptionProbe ports

Film type

Size Cat. No.

Standard, open-top liner 0 CX3-9 50 L SH30762.04Standard, open-top liner 0 CX3-9 100 L SH30762.06Standard, open-top liner 0 CX3-9 200 L SH30762.01Standard, open-top liner 0 CX3-9 500 L SH30762.02Standard, open-top liner 0 CX3-9 1,000 L SH30762.03Standard, open-top liner 0 CX3-9 2,000 L SH30762.05

Description Size Cat. No. Impeller sleeve for open-top mixing 50 L SH30749.06Impeller sleeve for open-top mixing 100 L SH30749.14Impeller sleeve for open-top mixing 200 L SH30749.08Impeller sleeve for open-top mixing 500 L SH30749.10 Impeller sleeve for open-top mixing 1,000 L SH30749.10Impeller sleeve for open-top mixing 2,000 L SH30772.01


48


HyPerforma S.U.M. accessories

Description 50 L 100 L 200 L 500 L 1,000 L 2,000 L

Cable management tree SV50992.01 SV50992.02 SV50992.02 SV50992.03 SV50992.03 SV50992.03Load cell with summation box, without display

SV50988.01 SV50988.02 SV50988.02 SV50988.03 SV50177D.04 SV50177.173

Autoclave tray SV50177.01 SV50177.01 SV50177.01 SV50177.01 SV50177.01 SV50177.01Bioreactor probe assembly (non-sterile for use in autoclave)

SH30720.01 SH30720.01 SH30720.01 SH30720.01 SH30720.01 SH30720.01

Heavy-duty tubing clamp (each) SV20664.01 SV20664.01 SV20664.01 SV20664.01 SV20664.01 SV20664.01Heavy-duty tubing clamps (10 per pack)

SV20664.03 SV20664.03 SV20664.03 SV20664.03 SV20664.03 SV20664.03

Sterile sampling manifold with luer lock (each)

SH30845.01 SH30845.01 SH30845.01 SH30845.01 SH30845.01 SH30845.01

Sterile sampling manifold with luer lock (10 per pack)

SH30845.02 SH30845.02 SH30845.02 SH30845.02 SH30845.02 SH30845.02

Temperature/sample port SV20750.01 SV20750.01 SV20750.01 SV20750.01 SV20750.01 SV20750.01Reusable hub assembly with Tri-clamp

N/A N/A N/A N/A N/A SV50177.78

Reusable hub assembly with quick connect

SV50177.77 SV50177.77 SV50177.77 SV50177.77 SV50177.77 N/A


cell culture

49

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.

EX: SUM0500.AAA0000 S.U.M. 0500 A A A A 0 0 0 0 0

Single-Use Mixer

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

C = non-jacketed (316 SST) tank and cart are 316 SST

D = jacketed (316 SST) tank and cart are 316 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)

A = DC motor/no electrical enclosure

B = AC motor/no electrical enclosure

C = AC motor/120VAC electrical enclosure - R/H configuration (standard)

D = AC motor/240VAC electrical enclosure - R/H configuration (standard)

E = AC motor/120VAC electrical enclosure - L/H configuration (standard)

F = AC motor/240VAC electrical enclosure - L/H configuration (standard)

3. Drive shaft

A = 1 piece drive shaft (SST)

B = 2 piece drive shaft (SST)

4. RTD

0 = no RTD

A = single RTD, PT100, 60 inch Bulgin connector (standard)

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

D = duel RTD, PT100, 120 inch DB9 x 60 inch bulgin connectors

E = duel RTD, PT100, 120 inch Bulgin x 120 inch LEMO connectors

F = single RTD, PT100, 120 inch Bulgin connector

G = duel RTD, PT100, 120 inch DB9 x 120 Bulgin connectors

H = single RTD, PT100, 60 inch LEMO connector

5. Load cells and display

0 = no load cells

A = load cells, no display

B = load cells, wall mount display, analog output communication

C = load cells, wall mount display, Allen-Bradley communication

D = load cells, wall mount display, device net communication

E = load cells, wall mount display, Modbus communication

F = load cells, wall mount display, Profibus communication

6. Powder arm assembly

0 = no powder arm assembly

A = powder arm assembly

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)

0 = no cable management tree

A = cable management tree (L/H configuration)

B = cable management tree (R/H configuration)

8. Communication cable

0 = no communication cable

A = communication cable

9. Monitoring device

0 = no monitoring device

A = pH monitoring device, single channel with display

B = pH monitoring device, duel channel with display

C = pH conductivity monitoring device with display


50

Powdertainer BPC systems


Powder Handling BPCs


Key features

• Specifically designed for powder containment and discharge applications

• Employ a closed system for dust containment and to help minimize cross-contamination

risk

• Three-inch Tri-clamp port designed for secure connection to, and easy integration with

existing formulation vessels

• Suspensor handle for support during discharge

• Neck clamp to retain powder prior to discharge

• Two models including one with a wash-down line to remove residual powder enabling maximal recovery

• Three sizes for process flexibility: 1 kg, 5 kg and 25 kg

• Constructed from Thermo Scientific CX3-9 and Aegis5-14 Films

• Stainless steel filling stand to facilitate powder discharge process

Applications

• Storage and delivery of Thermo Scientific powder culture media and buffers

• Storage and dispensing of pre-weighed chemicals or other process powders


• CX3-9 Film Fact Sheet


• Powdertainer Data Sheet

Handle For support

during emptying

Clamp To retain powder prior

to emptying

Tube with CPC connector For washdown to remove any

powder residue

3-inch tri-clamp connection For secure connection to

formulation vessel

Associated products

• HyPerforma S.U.M. (Pg.43)

u Powder Handling BPCs


Powdertainer BPC systems


51

Wash down line

N/A

Powder port 7.6 cm (3 in) tri-clamp with integrated seal

Powdertainer II


CX5-14 Film: SH30864.01 1 kg

42.7 cm x 31.8 cm (16.8 in x 12.5 in)

No. per case: 45

CX5-14 Film: SH30864.01 5 kg

56.1 cm x 36.3 cm (22.1 in x 14.3 in)

No. per case: 20

CX5-14 Film: SH30864.01

25 kg

83.3 cm x 59.2 cm (32.8 in x 23.3 in)

No. per case: 20


CX5-14 Film: SH30737.01 1 kg

42.7 cm x 31.8 cm (16.8 in x 12.5 in)

No. per case: 20

CX5-14 Film: SH30737.02 5 kg

56.1 cm x 36.3 cm (22.1 in x 14.3 in)

No. per case: 15

CX5-14 Film: SH30737.03

25 kg

83.3 cm x 59.2 cm (32.8 in x 23.3 in)

No. per case: 20

Filling stand

Cat. No. Dimensions (L x W x H)

SV50143.01 (stainless steel, with casters)

91.4 cm x 91.4 cm x 134.6 cm (36 in x 36 in x 53 in)

SV50143.02 (stainless steel,

w/o casters)

91.4 cm x 91.4 cm x 114.3 cm (36 in x 36 in x 45 in)

2 ports

Wash down line

MPX body, polycarbonate 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 with integrated seal

2 ports

cell culture

52

u HyPerforma Single-Use Bioreactors

HyPerforma Single-Use Bioreactors


New HyPerforma™ S.U.B. and BPC are designed using traditional stainless steel bioreactor principles to ensure optimal cell culture performance. The complete line of HyPerforma S.U.B.s includes 50, 100, 250, 500, 1,000 and 2,000 L sizes that ensures consistent scalability from pilot-scale studies, preclinical to commercial production.

• The S.U.B. is a fully functional bioreactor 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

• 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

• S.U.B. BPCs offered in CX5-14 and Aegis5-14 Films

Key features


53

Applications

• Batch, fed batch and perfusion cultures

• Suspension and microcarrier cultures

• Poven for various celli lines like CHO, Sp2/0 hybridoma, NS0, PER.C6, HEK293, Vero, MDCK, etc.

HyPerforma S.U.B. specifications


Liquid working volume 50 L 100 L 250 L 500 L 1,000 L 2,000 L

Minimum liquid working volume

25 L 50 L 125 L 250 L 500 L 1,000 L

Total reactor volume(not a working volume)

65.5 L 120 L 316 L 660 L 1,320 L 2,575 L

Fluid geometry at working volume (height/diameter) ratio

1.5 1.5 1.5 1.5 1.5 1.5

Overall reactor geometry (height/diameter) ratio

1.9 1.9 1.9 1.9 1.9 1.9

Impeller (quantity x blade count)

1 x 3 1 x 3 1 x 3 1 x 3 1 x 3 1 x 3

Mixing rate range 30–200 RPM 30–200 RPM 30–150 RPM 30–150 RPM 20–110 RPM 20–75 RPM

Tank overall (including cable management tree) width x length x height

94.2 x 84.3 x 198.6 cm

(37.1 x 33.2 x 78.2 in)

98.5 x 91.2 x 201.5 cm

(38.8 x 35.9 x 79.3 in)

112.8 x 102.2 x 215.5 cm (44.4 x 40.25 x

84.4 in)

125.2 x 124.4 x 251.1 cm

(49.3 x 47.8 x 98.9 in)

143.8 x 139.2 x 284 cm

(56.6 x 54.8 x 111.8 in)

179.7 x 171.4 x 355.5 cm

(70.5 x 67.5 x 140 in)

Resistive tank weight dry/wet (at full working volume)

140.4 kg (309.5 lb)190.4 kg(419.8 lb)

196.40 kg (433 lb)

296.20 kg (653 lb)

234.3 kg (516.5 lb) 484.3 kg

(1,067.7 lb)

328.04 kg (724 lb) 828.26

(1,826 lb)

589.67 kg (1,300 lb)1,589 kg (3,505 lb)

N/A

Jacketed tank weight dry/wet (at full working volume)

141.2 kg (311.3 lb)191.2 kg (421.5 lb)

219.09 kg (483 lb)

318.88 kg (703 lb)

248.9 kg (548.7 lb) 498.9 kg

(1,099.9 lb)

362.42 kg (799 lb)

862.28 kg (1,901lb)

657.71 kg (1450 lb)

1,637.5 kg (3,610 lb)

816.47 kg (1,800 lb)2,812 kg (6,200 lb)

Associated products




• Bioreactor Control Solutions (Pg. 65)

• Harvestainer Microcarrier Separation BPC and Systems (Pg. 26)


54

Size Cat. No. (open pipe & porous frit sparger)

Cat. No. (drilled hole & 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 & porous frit sparger)

Cat. No. (drilled hole & 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

u HyPerforma Single-Use Bioreactors



HyPerforma S.U.B. BioProcess Containers in CX5-14 Film

HyPerforma S.U.B. BioProcess Containers in Aegis5-14 Film

cell culture

55

HyPerforma S.U.B. accessories



Cable management tree SV50992.01 SV50992.02 SV50992.02 SV50992.03 SV50992.04 N/A

Load cell with summation box, without display

SV50988.01 SV50988.02 SV50988.02 SV50988.03 N/A N/A

Autoclave tray SV50177.01 SV50177.01 SV50177.01 SV50177.01 SV50177.01 SV50177.01

Bioreactor probe assembly (non-sterile for use in autoclave)

SH30720.01 SH30720.01 SH30720.01 SH30720.01 SH30720.01 SH30720.01

Sparger line support SV50177B.19 SV50177B.19 SV50177B.19 SV50177B.14 SV50177B.14 SV50177.65

Heavy-duty tubing clamps (single pack)

SV20664.01 SV20664.01 SV20664.01 SV20664.01 SV20664.01 SV20664.01

Heavy-duty tubing clamps (10 per pack)

SV20664.03 SV20664.03 SV20664.03 SV20664.03 SV20664.03 SV20664.03

Sterile sampling manifold with luer lock (single pack)

SH30845.01 SH30845.01 SH30845.01 SH30845.01 SH30845.01 SH30845.01

Sterile sampling manifold with luer lock (10 per pack)

SH30845.02 SH30845.02 SH30845.02 SH30845.02 SH30845.02 SH30845.02

S.U.B. temperature/sample port

SV20750.01 SV20750.01 SV20750.01 SV20750.01 SV20750.01 SV20750.01

Complete condenser system (120 V) including cart, chill plate and mounting post with filter brackets, TCU, and pump


Complete condenser system (240 V) including cart, chill plate and mounting post with filter brackets, TCU, and pump


Mobile stairs N/A N/A N/A N/A N/A SV50935.01



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.

EX: SUB0500.AAA0000 S.U.B. 0500 A A A A 0 0

Single-Use Bioreactor

Vessel Size 0050 = 50 L 0100 = 100 L 0250 = 250 L 0500 = 500 L 1000 = 1,000 L 2000 = 2,000 L

Heater type/material

A = resistive (304 SST) (standard) tank and cart are 304 SST

B = jacketed (304 SST) (standard) tank and cart are 304 SST

C = resistive (316 SST) tank and cart are 316 SST

D = jacketed (316 SST) tank and cart are 316 SST

Motor/electrical type

A = DC motor/no electrical enclosure

B = AC motor/no electrical enclosure

C = AC motor/120VAC electrical enclosure - R/H configuration (standard) (resistive heater) (50–250 L only)

D = AC motor/240VAC electrical enclosure - R/H configuration (standard) (resistive heater)

E = AC motor/120VAC electrical enclosure - L/H configuration (resistive heater) (50–250 L only)

F = AC motor/240VAC electrical enclosure - L/H configuration (resistive heater)

G = AC motor/120VAC electrical enclosure - R/H configuration (standard) (jacketed heater) (50–250 L only)

H = AC motor/240VAC electrical enclosure - R/H configuration (standard) (jacketed heater)

J = AC motor/120VAC electrical enclosure - L/H configuration (jacketed heater) (50–250 L only)

K = AC motor/240VAC electrical enclosure - L/H configuration (jacketed heater)

Drive shaft

A = standard 1 piece drive shaft (aluminum) (50 L only)

B = standard 1 piece drive shaft or segmented pieces (100 L only)

C = standard 1 piece drive shaft (aluminum) (250 L only)

D = 1 piece drive shaft (SST) (250 L only)

E = 2 piece drive shaft (SST) (250 L only)

F = standard 2 piece drive shaft (SST) (500 L only)

G = 3 piece segmented drive shaft (1,000 L only)

H = 4 piece segmented drive shaft (1,000 L only)

J = 4 piece segmented drive shaft (carbon fiber)

RTD

A = single RTD, 60 inch Bulgin connector

B = duel RTD, PT100, 3 wire each, 120 inch DB9 connector on one lead and exposed wires on the other lead

C = duel RTD, PT100, 120 inch 2x Bulgin connectors

D = duel RTD element, PT100, 3 wire each, 120 inch, DB9 and quick connect

E = duel RTD, PT100, 120 inch Bulgin and LEMO connectors

F = single RTD, 120 inch Bulgin connector

Load cells and display

0 = no load cells

A = load cells, no display (50-500 L)

B = load cells, wall mount display, analog output communication (50–500 L, 2000 L)

C = load cells, wall mount display, Allen-Bradley communication (50–500 L, 2000 L)

D = load cells, wall mount display, device net communication (50–500 L, 2000 L)

E = load cells, wall mount display, Modbus communication (50–500 L, 2000 L)

F = load cells, wall mount display, Profibus communication (50–500 L, 2000 L)

G = load cells, panel mount display, analog output communication (1,000 L)

H = load cells, panel mount display, Allen-Bradley communication (1,000 L)

J = load cells, panel mount display, device net communication (1,000 L)

K = load cells, panel mount display, Modbus communication (1,000 L)

L = load cells, panel mount display, Profibus communication (1,000 L)

Cable management tree




HyPerforma S.U.B. MTO configuration table

cell culture

57

u HyPerforma Single-Use Fermentor

HyPerforma Single-Use Fermentors

The Thermo Scientific™ HyPerforma™ S.U.F. is designed to provide you with enhanced functionality, ease of use, and efficiency. The complete HyPerforma S.U.F. system consists of a fermentor tank and Thermo Scientific™ HyPerforma™ S.U.F. BPC, which is available in 30 L and 300 L sizes with a 5:1 turndown ratio. The HyPerforma S.U.F. maintains traditional stirred-tank fermentation design principles, including specific height-to-diameter ratios (3:1), top-driven impeller location that deliver optimum cell viability, and performance and scalability from process development through production.

• 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

• Unique proprietary mixing system enables conventional overhead mixing while maintaining sterility and integrity of the S.U.F. BPC


• Simplified bag loading with a front access door • Tank includes baffles that enhance mixing

• Side and bottom jacket for effective heat transfer

• 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

• State-of-the-art foam sensor that helps prevent exhaust filter failure

Key features

Associated products




• Bioreactor Control Solutions (Pg. 65)


58



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

• Exhaust condenser unit

• Choice of exhaust filters from Meissner or ZenPure™

• Option to use electrochemical or single-use sensors for pH, DO and pressure monitoring

• S.U.F. BPCs offered in CX5-14 and Aegis 5-14 Films

• Proven for various microbial cultures of Pichia and Bacillus

• Batch and fed-batch cultures

Applications

cell culture

59


Specifications 30 L 300 L

Liquid working volume 30 L 300 L

Minimum liquid working volume 6 L 60 L

Total reactor volume(not a working volume)

43 L 435 L

Fluid geometry at working volume (height/diameter) ratio

~2:1 ~2:1

Overall reactor geometry(height/diameter) ratio

3:1 3:1

Impeller (quantity x blade count) 3 x 6 3 x 6

Mixing rate range 55–600 RPM 35–375 RPM

Tank overall (including cable management tree)width x length x height

121.8 x 103.2 x 218.5 cm(48 x 40.7 x 86 in)

160.8 x 136.7 x 281 cm(63.3 x 53.8 x 110.6 in)

Jacketed tank weight dry/wet (at full working volume)

238 kg (524 lb)268 kg (590 lb)

555 kg (1,223 lb)855 kg (1,883 lb)


HyPerforma S.U.F. specifications


Description 30 L 300 L

MT single-use pH & DO, foam sensor, Meissner inlet and 1 x 5 inch exhaust filters, condenser SH31010.01









Traditional ports, foam sensor, Meissner inlet and 1 x 5 inch exhaust filters, condenser SH31036.01




Traditional ports, foam sensor, ZenPure inlet and 1 x 3 inch exhaust filters, condenser SH31034.01



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

HyPerforma S.U.F. BioProcess Containers, CX5-14 Film

HyPerforma S.U.F.



HyPerforma S.U.F. BioProcess Containers, Aegis5-14 Film


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™ connector

SV50191.41 SV50191.41

NEMA-rated 240 VAM vent filter heater with a thermocouple–includes preset temperature of 55°C and a Turck connector

SV50191.42 SV50191.42

NEMA-rated 120 VAM vent filter heater with a thermocouple–includes preset temperature of 55°C and a Turck connector and a standard IEC C14 plug

SV50191.35 SV50191.35

NEMA-rated 240 VAC vent filter heater with a thermocouple–includes preset temperature of 55°C and a Turck connector and a standard IEC C14 plug

SV50191.36 SV50191.36

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/plug

SV50177.309 SV50177.309

Mettler-Toledo IND331 display, harsh mount style with Profibus interface, 120 VAC US line chord/plug SV50177.310 SV50177.310


61

HyPerforma S.U.F. accessories


lifetechnologies.com 62

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.

EX: SUF0500.AAA0000 S.U.F. 0300 - - - - - - - - - - - -

Single-Use Fermentor

Vessel size

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)

A = AC motor/no electrical enclosure

B = AC motor/120VAC electrical enclosure - L/H configuration (standard)

C = AC motor/120VAC electrical enclosure - R/H configuration

D = AC motor/240VAC electrical enclosure - L/H configuration (standard for 300 L)

E = AC motor/240VAC electrical enclosure - R/H configuration

Drive shaft

A = standard 1 piece or segmented drive shaft (vessel specific size)

RTD

0 = no RTD

A = single RTD (standard)

Load cells and display

0 = no load cells

A = load cells, no display

B = load cells, wall mount display, analog output communication

C = load cells, wall mount display, Allen-Bradley communication

D = load cells, wall mount display, device net communication

E = load cells, wall mount display, Modbus communication

F = load cells, wall mount display, Profibus communication

Cable management treeL/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)




Condenser/vent filter heater bracket

A = 3 position vent filter heater bracket with exhaust clamp (default option included in base price)

B = condenser with 3 position vent filter heater bracket (includes TCU and TCU hoses)

Other options

0 = no other options included

Other options


Pinch clamp options


B = pinch clamp for 30 L without condenser

C = pinch clamp for 30 L with condenser

Other options


Other options


HyPerforma S.U.F. MTO configuration table

sub-catagory

63

u Thermo Scientific ThermoFlex recirculating chiller

* Capacity at 20ºC.†Positive displacement and magnetically-coupled centrifugal pump options are available.

ThermoFlex 2,500 chiller ThermoFlex 5,000 chiller ThermoFlex 10,000 chiller ThermoFlex 24,000 chiller

Cooling capacity, 60 Hz* 2,500 W 5,000 W 10,000 W 24,000 W

Cooling capacity, 50 Hz* 2,200 W 4,400 W 8,500 W 21,000 W

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

Temperature stability ±0.1ºC ±0.1ºC ±0.1ºC ±0.1ºC

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

Flow control with flow readout 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

Temperature control units

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

• Air- and water-cooled condenser

• Auto-refill

• Flow control with flow readout

ThermoFlex™ chiller specifications

Associated products




• Large Volume Stainless Steel Outer Containers (Pg. 32)


64

TCU hose kit TCU ball valve

Cat. No. Description Cat. No. Description Cat. No. Description

SV50239.27 ThermoFlex 2,500 temperature control unit (TCU), 2.5 kW cooling 2.8 W heating, –5–50°C, air-cooled, 200–230 VAC 50/60 Hz, no power cord

SV50239.31 TCU hose kit 3/4 inch ID, 10 ft, 1 1/2 inch tri-clamp

SV50239.34 TCU ball valve kit right angle, 1/2 inch NPT, ball valve

SV50239.05 ThermoFlex 2,500 TCU, 2.5 kW cooling 2.8 W heating, –5–50°C, liquid-cooled, 200–230 VAC 50/60 Hz, no power cord



SV50239.28 ThermoFlex 5,000 TCU, 5 kW cooling 2.8 W heating, –5–50°C, air-cooled, 200–230 VAC 50/60 Hz, no power cord



SV50239.06 ThermoFlex 5,000 TCU, 5 kW cooling 2.8 W heating, –5–50°C, liquid-cooled, 200–230 VAC 50/60 Hz, no power cord



SV50239.29 ThermoFlex 10,000 TCU, 10 kW cooling 6.1 W heating, –5–50°C, air-cooled, 400/460 VAC 50/60 Hz, no power cord

SV50239.37 TCU hose kit 1 inch ID, 10 ft, 1 1/2 inch tri-clamp

SV50239.41 TCU ball valve kit right angle, 1 inch NPT, ball valve

SV50239.07 ThermoFlex 10,000 TCU, 10 kW cooling 6.1 W heating, –5–50°C, liquid-cooled, 400/460 VAC 50/60 Hz, no power cord

SV50239.37 TCU hose kit 1 inch ID, 10 ft, 1 1/2 inch tri-clamp


SV50239.08 ThermoFlex 24,000 TCU, 24 kW cooling 22.5 W heating, –5–50°C, liquid-cooled, 400/460 VAC 50/60 Hz, no power cord

SV50239.37 TCU hose kit 1 inch ID, 10 ft, 1 1/2 inch tr-iclamp


Cool from 37˚C to 5˚C Heat from 5˚C to 37˚C

Temperature control unit

Single-use bioreactor

Volume Inlet psi Outlet psi RPM Minutes Hours Minutes Hours

ThermoFlex 2,500 50 L 50 L 6.6 5.4 185 109 1.8 66 1.1

ThermoFlex 2,500 50 L 25 L 6.6 5.4 147 82 1.4 50 0.8

ThermoFlex 2,500 100 L 100 L 6.4 5.7 155 205 3.4 115 1.9

ThermoFlex 2,500 100 L 50 L 6.4 5.7 123 128 2.1 70 1.2

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 10,000 500 L 250 L 34.7 20.3 82 149 2.5 92 1.5

ThermoFlex 24,000 1,000 L 1,000 L 31.6 21.3 87 181 3.0 109 1.8

ThermoFlex 24,000 1,000 L 500 L 31.6 21.3 69 123 2.1 79 1.3

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

*Heating and cooling times based on full- and half-tank volumes.

ThermoFlex Chiller heating and cooling calculation*

ThermoFlex chiller specifications

Temperature control units


cell culture

65

u Thermo Scientific bioreactor control solutions

Bioreactor control solutions

The Thermo Scientific from Applikon™ Bioreactor Control is available in both the ez-Control (embedded) and Allen Bradley or Siemens (PLC) platforms. The embedded system offers total bioreactor control at your fingertips. This system is designed to accurately control pH, temperature, dissolved oxygen (DO) and agitation. It can be used with a single- or dual-bioreactor setup. The PLC system is a scalable control that provides more advanced options than the embedded version. This also can be operated in the single- or dual-bioreactor setup. This unit is designed to effectively control processes from laboratory scale to pilot plant and production scale.

Key features

Embedded platform system

• Adaptive PID Control

• OPC Compliance

• User-definable control loop configuration

• Multiple user level

• Small footprint, flexibility and accurate control

PLC platform system

• Off-the-shelf, standard PLC solution

• Local bioreactor control and display

• System documentation that facilitates validation

• Supports compliance to 21 CFR part 11

• Helps save time and money during scale-up process

Associated products



66


Applikon bioreactor control summary details


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

Communication interfaces

1x Ethernet port (computer communication)

2x USB auxiliary

1x USB main

Control type PID control with selectable auto-tuning adaptive control

Actuators

Up to 3 speed pumps; fixed-speed for embedded-based, variable-speed for PLC-based

Up to 4 mass flow controllers

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

cell culture

67

u Thermo Scientific Bioreactor Control Solutions


The Thermo Scientific from Finesse™ Bioreactor Control utilizes the TruBio™ DV platform. This controller is a cart-mounted, self-contained unit that offers modularity and allows the ability to add functional-ity as your bioprocess evolves. This controller is designed to control Thermo Scientific bioreactors and can be operated singly or networked. This unit is ideal for easy, reliable and repeatable process development and cell culture optimization.

Key features

G3Lite™ with TruBio DV platform

• Supports compliance to 21 CFR part 11

• Remote access notification

• Offers small footprint, flexibility and accurate control

• Ability to be networked

• Helps save time and money during scale-up process

Associated products



68


Control and settings

pH control

Dissolved oxygen control

Weight control

Auxiliary input control

Agitator speed control

Gas flow control

Pump control

Foam control

Level control

Basic operations

Process signal conditioning

Vessel settings

Key parameter display on configuration page

Online parameter update

Total (liquid and gas) pages

Analyzer data entry pages

User access configuration

Electronic signature

Backup and restore procedure

Features to assist with 21 CFR part 11 compliance

Miscellaneous

Interlock configuration

pH/DO sensor redundancy

Dual

Triple

Finesse Bioreactor control summary details


Alarm management

Alarm configuration

Alarm priorities

Alarm type

Remote access notification

Recipe management

ISA 88 batch control (optional)

Recipe editor (optional)

Process data storage

Continuous historian

Audit trail

Calibration

pH sensor (one-point, two-point, slope/offset)

DO sensors (one-point, two-point)

Temperature sensors (one-point, two-point)

Pressure sensors (one-point, two-point)

Pump

Agitator speed (one-point, two-point)

Vessel weight (zero, tare)

Auxiliary input

cellsculture

69

u Thermo Scientific BioProduction services and support

Services and support

Bioproduction services involve both field- and office-based teams. The office-based team is located in Logan, Utah, and includes technical support, BioProduction Xpress (BPX), quality and services management teams. On a global scale, there are field application specialists (FAS) who are trained on hardware installation, servicing and also offer other post-sales support such as, training, consulting and process optimization assistance.

BioProduction services and support key services:

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

• Phone support for sales, service, technical questions, troubleshooting • Interfaces with quality, product management and R&D teams

Associated products




• Large Volume Stainless Steel Outer Containers (Pg. 32)


cell culture

u Cell line development products

Cell line development


The Gibco™ Freedom™ CHO-S™ Kit, co-developed with ProBioGen AG, is an easy-to-use, beginning-to-end product, for cloning and expression of recombinant proteins in Chinese Hamster Ovary (CHO)-derived suspension culture. The Freedom CHO-S Kit includes components for transfection, expression, clone creation and stable cell line selection, all in a conveniently packaged kit. The Freedom CHO-S Kit also enables high titers, and offers simplified commercial licensing options.

• 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

The Gibco™ Freedom™ DG44 Kit is an easy-to-use, beginning-to-end product, for cloning and expression of recombinant proteins in dihydrofolate reductase deficient (DHFR-) CHO cells. The Freedom DG44 Kit includes components for transfection, expression, clone creation, and stable cell line selection, all in a conveniently packaged kit. The Freedom DG44 Kit also enables a proven host cell line with simplified commercial licensing options.

• 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

Key features

Description Cat. No. Unit Size

Freedom CHO-S Kit A13696-01 1 kit

Freedom DG44 Kit A13737-01 1 kit

Need access to Gibco Freedom kit support? If additional support is needed beyond the manual, you can contact your account manager to receive a Process Science Fellow consultation. Don’t be surprised if one of our support scientists checks in with you to be sure your experience with the kit is as successful as possible. For further assistance, please email our support team with your questions and contact information at [email protected].

Key features

cell culturesub-catagory

71

u Cell culture media

Cell culture media

Description Cat. No. Unit Size

Freedom CHO-S Kit A13696-01 1 kit

Freedom DG44 Kit A13737-01 1 kit

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.

When to Use CD OptiCHO Medium?

Consider CD OptiCHO Medium when:

• 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

Cat. No. Unit size

A11222-01 100 L

A11222-03 10 kg

A11222-04 1 L

A11222-05 10 L

CD OptiCHO AGT Medium

1X CD OptiCHO Liquid Medium

Cat. No. Unit size

12681-001 1,000 mL

12681-029 6 x 1,000 mL


Cell culture media


Gibco™ CD CHO Medium and Gibco™ CD CHO AGT™ (Advanced Granulation Technology) Medium is protein-free, chemically-defined medium optimized for the growth of CHO cells and expression of recombinant proteins in suspension culture. CD CHO Medium and CD CHO AGT Medium contain no proteins or peptide components of animal, plant, or synthetic origin, as well as no undefined lysates or hydrolysates. The AGT dry media format is designed to provide increased consistency and productivity across all stages of production from development to commercial manufacturing.

When to Use CD CHO Medium?

Consider CD CHO Medium when:

• Your GS CHO cells are recommended to be grown in CD CHO Medium • Your cells have been successfully cultured in CD CHO Medium in the past and your process is nearing a regulatory filing (DMF available)

Cat. No. Unit size

10743-001 10 L

10743-002 20 L

10743-011 500 mL

10743-029 1,000 mL

1X CD CHO Medium

CD CHO AGT Medium

Cat. No. Unit size

12490-001 100 L

12490-017 1 L

12490-025 10 L

cell culture

73


Cell culture media

Cat. No. Unit size

10743-001 10 L

10743-002 20 L

10743-011 500 mL

10743-029 1,000 mL

Cat. No. Unit size

12490-001 100 L

12490-017 1 L

12490-025 10 L

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.

When to Use Dynamis AGT Medium?

Consider Dynamis AGT Medium when:

• 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

Cat. No. Unit Size

A2617501 10 L

A2617502 100 L

A2617503 10 kg

A2617504 1 L

Dynamis AGT Medium

74

u Cell culture feeds


Cell culture feeds

Gibco™ EfficientFeed™ + Supplements are dry-format single-part supplements for fed-batch addition to the culture of multiple cell lines to assist with process development and maximization of bioreactor utilization. These products are an animal origin–free, chemically-defined formulation that contains no proteins, hydrolysates, or components of incompletely defined composition.

EfficientFeed™ A+, B+, and C+ AGT™ Supplements Compared to original CHO CD EfficientFeed™ A AGT™ Nutrient Supplement, EfficientFeed™ A+ AGT™ Supplement has the ability to super-concentrate the supplement from 66.4 g/L (1X) to 199.2 g/L (3X) for reduction of product dilution or increased titers with additional feeding, when appropriate. Compared to original CHO CD EfficientFeed™ B AGT™ Nutrient Supplement, EfficientFeed™ B+ AGT™ Supplement has the ability to super-concentrate the supplement from 52.7 g/L (1X) to 158.1g/L (3X) for reduction of product dilution or increased titers with additional feeding, when appropriate. This product is designed to work with CHO cell lines expressing endog-enous glutamine synthetase (GS) as a single feed without the need for additional GS supplements. Compared to the original CD EfficientFeed™ C+ AGT™ Nutrient Supplement, EfficientFeed™ C+ AGT™ Supplement has the ability to super-concentrate the supplement from 81.2 g/L (1X) to 162.4 g/L (2X) for reduction of product dilution or increased titers with additional feeding, when appropriate.

Which EfficientFeed + Supplement to choose?

Consider EfficientFeed A+ AGT Supplement when:

• You have used CHO CD EfficientFeed A AGT Nutrient Supplement in the past and wish to explore simpler reconstitution and super-concentration benefits of new technology for delivery of key components • You are currently using CD OptiCHO as your base cell growth medium

Consider EfficientFeed B+ AGT Supplement when:

• 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

Consider EfficientFeed™ C+ AGT™ Supplement when:

• You have used CD EfficientFeed™ C AGT Nutrient Supplement in the past and wish to explore simpler reconstitution and super-concentration benefits of new technology for delivery of key components • You want higher productivity in GS CHO, CHO-K1 and CHO-S derived cell lines • You are currently using CD FortiCHO™ Medium as your base cell growth medium • You are using a base medium with greater than 6 g/L glucose or a hydrolysate at day 0

EfficientFeed A+ AGT Supplement

Cat. No. Unit Size

A25023-01 100 L

A25023-04 1 L

A25023-05 10 L

Cat. No. Unit Size

A25030-01 100 L

A25030-04 1 L

A25030-05 10 L

Cat. No. Unit Size

A25031-01 100 L

A25031-04 1 L

A25031-05 10 L

EfficientFeed B+ AGT Supplement

EfficientFeed C+ AGT Supplement

cell culture

75

FunctionMAX TiterEnhancer

Gibco™ FunctionMAX™ TiterEnhancer uses a new technology to combine key nutrients in a highly concentrated (150 g/L), pH-neutral, chemically-defined, AOF (animal origin–free) functional additive that is designed to reinforce existing feeds and amplify the productivity of standard high cell density fed-batch platforms. FunctionMAX TiterEnhancer is available in both this liquid format and an AGT dry format and is stable for over 1 year.

When to use FunctionMAX TiterEnhancer?

Consider FunctionMAX TiterEnhancer when:

• 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

• Up to double prior fed-batch titers

• Highly concentrated ingredients

• Easy to use pH-neutral format

• Specialized delivery of ingredients found in base media—nothing exotic

• Use that is economical

Cat. No. Unit Size

A15010-01 100 mL

A15010-02 500 mL

FunctionMAX TiterEnhancer (liquid format)

FunctionMAX TiterEnhancer, AGT (powder format)

Cat. No. Unit Size

A15009-01 10 L

A15009-02 100 L

u FunctionMAX TiterEnhancer

76

u POROS and CaptureSelect purification products

Description Cat. No.

POROS™ XQ Strong Anion Exchange Resin 1,000 mL 4467818


POROS™ HQ 50 µm 1 L 1-2559-07

POROS™ HQ 50 µm 5 L 1-2559-09

POROS™ HQ 50 µm 10 L 1-2559-08

POROS™ PI 50 µm 1 L 1-2459-07

POROS™ PI 50 µm 5 L 1-2459-09

POROS™ PI 50 µm 10 L 1-2459-08

POROS™ D 50 µm 1 L 1-3659-07

POROS™ D 50 µm 5 L 1-3659-09

POROS™ D 50 µm 10 L 1-3659-08

POROS anion exchange resins


POROS and CaptureSelect purification products

We offer a broad portfolio of purification products supporting biopharmaceutical development. These range from uniquechromatography resins used for primary capture and high-performance polishing, to a robust analytical toolset for characterization and detection of biological compounds. For large scale biomanufacturing we offer a variety of products for affinity chromatography, ion exchange, reversed-phase, and HIC applications designed to meet today’s biomolecule purification challenges. Applied Biosystems™ POROS™ bulk chromatog-raphy resins are used throughout the industry offering high-performance, high-throughput process-scale bioseparations. Life Technologies™ CaptureSelect™ affinity products are available for process-scale or analytical bioseparations for a wide variety of biotherapeutic compounds including antibodies and antibody fragments, recombinant and plasma proteins, and viral particles. Our custom ligand and resin discovery programs generate customized CaptureSelect™ affinity ligands that can be immobilized onto high-throughput POROS™ resins for your unique separation needs.

Key features of POROS anion exchange resins

Compared to other commercially available anion exchange resins, POROS anion exchange resins (POROS™ HQ 50, POROS™ PI 50 and POROS™ D 50 resins) are designed to have unique surface chemistries that drive different selectivity, which can impact protein binding and separation. The 50 μm average particle size enables enhanced resolution capability and the unique pore structure helps bring benefits to small and large recombinant protein purification. POROS™ XQ resin is a next-generation, high-capacity, high-resolution, salt-tolerant, strong anion exchange resin that enables >140 mg/mL dynamic binding capacity in the presence of up to 6.6 mS/cm NaCl, while helping deliver exceptional separation performance. A major improvement to the performance of traditional anion exchangers, POROS XQ resin sets the standard for strong anion exchange chromatography in bind-elute and flow-through modes of operation.

For more information, visit www.lifetechnologies.com/poros and www.lifetechnologies.com/captureselect




POROS™ HQ 50 µm 1 L 1-2559-07

POROS™ HQ 50 µm 5 L 1-2559-09

POROS™ HQ 50 µm 10 L 1-2559-08

POROS™ PI 50 µm 1 L 1-2459-07

POROS™ PI 50 µm 5 L 1-2459-09

POROS™ PI 50 µm 10 L 1-2459-08

POROS™ D 50 µm 1 L 1-3659-07

POROS™ D 50 µm 5 L 1-3659-09

POROS™ D 50 µm 10 L 1-3659-08



POROS™ HS 50 µm 1 L 1-3359-07

POROS™ HS 50 µm 5 L 1-3359-09

POROS™ HS 50 µm 10 L 1-3359-08

POROS™ XS Cation Exchange Resin 25 mL 4404339



POROS™ XS Cation Exchange Resin 1,000 mL 4404336




POROS™ MabCapture™ A Resin 1 L 4374735



CaptureSelect™ IgG-CH1 Affinity Matrix 5 mL 194320005



77

Key features of POROSTM cation exchange resins

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.

Key features of POROS and CaptureSelect affinity resins

POROS™ MabCapture™ Protein A chromatography resin enables high dynamic binding performance at low flow rates, while maintaining superior binding capacity at high linear velocities. CaptureSelect affinity ligand technology enables the purification of antibodies, antibody fragments and proteins with proven affinity solutions. These products enable increased purity and yield and are designed to simplify research workflows and reduce time and cost in biopharmaceutical drug development.

POROS cation exchange resins


POROS and CaptureSelect affinity resins

78

u POROS and CaptureSelect purification products


POROS™ A 20 µm Column, 10 x 100 mm, 7.9 mL (PEEK) 1-5022-46

POROS™ A 20 µm Column, 2.1 x 30 mm, 0.1 mL (PEEK) 2-1001-00



POROS™ A 20 µm Column, 2.1 x 30 mm, 0.1 mL (Stainless Steel) 1-5024-12

POROS™ CaptureSelect™ IgG Fc Affinity Column 2.1 x 30 mm 4469148

POROS™ CaptureSelect™ IgG Fc Affinity Column 4.6 × 50 mm 4469153


POROS™ CaptureSelect™ IgG Fc Affinity Column 10 × 100 mm 4469171

POROS analytical chromatography columns



Key features of POROSTM analytical chromatography columns

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.



POROS™ A 20 µm Column, 10 x 100 mm, 7.9 mL (PEEK) 1-5022-46




POROS™ A 20 µm Column, 2.1 x 30 mm, 0.1 mL (Stainless Steel) 1-5024-12

POROS™ CaptureSelect™ IgG Fc Affinity Column 2.1 x 30 mm 4469148



POROS™ CaptureSelect™ IgG Fc Affinity Column 10 × 100 mm 4469171

Applied Biosystems analytics

79

u Applied Biosystems analytics


resDNASEQ™ Quantitative CHO DNA Kit 4402085

resDNASEQ™ Quantitative CHO DNA Kit with PrepSEQ™ Residual DNA Sample Preparation Kit

4413713

resDNASEQ™ Human Residual DNA Quantitation Kit A26366

resDNASEQ™ Human Residual DNA Quantitation Kit with PrepSEQ™ Residual DNA Sample Preparation Kit

A27335

resDNASEQ™ Quantitative E. coli DNA Kit 4458435

resDNASEQ™ Quantitative E. coli DNA Kit with PrepSEQ™ Residual DNA Sample Preparation Kit

4460366

ResDNASEQ residual DNA quantitation kits

Applied Biosystems™ SEQ analytical testing products are rapid molecular methods for pharmaceutical manufacturing to help ensure the quality and safety of your pharmaceutical products, especially when accuracy and time-to-results are critical. These methods help detect impurities and identify contaminants by using molecular techniques such as DNA sequencing, PCR and real-time PCR, and are widely used for pharmaceutical analytics worldwide.

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.

Key features of host cell residual DNA quantitation

The removal of host cell impurities is a critical step in the purification of biopharmaceutical products. A major challenge is the accurate and sensitive quantitation of host cell DNA impurities in both the purification process and in drug substance samples.

With resDNASEQ™ Residual DNA Quantitation Systems:

• 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

For more information, visit www.lifetechnologies.com/pharmaanalytics

80

u Applied Biosystems analytics


ProteinSEQ™ CHO Host Cell Protein Quantification Kit A27601

ProteinSEQ Protein Quantitation Kit


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

MicroSEQ ID systems



Key features of host cell protein quantitation

The ProteinSEQ™ Protein Quantitation System is a breakthrough immuno-PCR–based method designed for sensitive and robust protein quantitation with 4 logs of dynamic range, providing greater confidence and quality of data throughout the quantitation process.

• 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

Key features of microbial identification

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.



ProteinSEQ™ CHO Host Cell Protein Quantification Kit A27601


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

81


MycoSEQ™ Mycoplasma Detection Kit, with Discriminatory Positive Control 4460623

MycoSEQ™ Mycoplasma Detection Kit, with Discriminatory Positive Control & sample preparation

4460626

MycoSEQ™ Mycoplasma detection kits



Key features of Mycoplasma Detection

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.

• Rapid time-to-results typically in less than 5 hours

• Detection of more than 90 Mycoplasma species

• Demonstrated sensitivity to detect less than 10 copies/reaction

• Offers proven specificity

• PrepSEQ sample preparation enables high efficiency DNA recovery

• Proprietary discriminatory positive/extraction control


82

u Applied Biosystems™ analytics

ViralSEQ detection kits


ViralSEQ™ Vesivirus Detection Kit 4448398C

ViralSEQ™ Mouse Minute Virus (MMV) Detection System 4444415



Key features of adventitious virus testing

MMV and Vesivirus contamination is a potential threat to mammalian cell culture manufacturing processes. Multiple cell culture manufacturing facilities have been negatively impacted over the past 20 years following contamination with these viruses. The ViralSEQ™ Detection System is an integrated DNA purification and real-time PCR-based test designed for rapid, sensitive detection of MMV and Vesivirus from a wide range of sample types.

• 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



ViralSEQ™ Vesivirus Detection Kit 4448398C

ViralSEQ™ Mouse Minute Virus (MMV) Detection System 4444415

83



PrepSEQ™ 1-2-3 Nucleic Acid Extraction Kit 4452222

PrepSEQ™ Express Nucleic Acid Extraction Kit 4466351

AutoMate™ Express Nucleic Acid Extraction System 4467754

MagMAX™ Express-96 Deep-Well Magnetic Particle Processor 4456933

Sample prep and automation

Software Description Cat. No.

AccuSEQ 2.0 Real-Time PCR Detection Software 4443420


Key features of AccuSEQTM Real-Time PCR Detection Software

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.

• Automated presence/absence calls for Mycoplasma detection

• Enables accurate quantitation of host cell line residual DNA

• Single software platform for current and future SEQ Real-Time PCR assays

• Helps enable 21 CFR Part 11 compliance

Key features in sample prep and automation

PrepSEQ™ chemistry is a time-saving, cost-effective universal sample preparation method used in multiple applications, including residual host cell DNA quantitation, mycoplasma detection, and viral detection. It offers high quality performance for quantitative recovery, high reproducibility, and consistent performance across a broad range of complex matrices.

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.

• AutoMate Express™ Nucleic Acid Extraction System—Ideal for in-process testing of contaminant and impurities, this closed system offers out-of-the-box automation with prefilled PrepSEQ™ Express cartridges to minimize the risk of cross-contamination

• MagMAX™ Express-96 Magnetic Particle Processor—High-throughput 96-well format

For more information, go to www.lifetechnologies.com/pharmaanalytics

Find out more at lifetechnologies.com/sut

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