WAVE BIOREACTOR™

CELLBAG™

HOT LIPS TUBE SEALER™

WAVE MIXER™

STERILE TUBE FUSER

c2

Innovate, never imitateGE Healthcare Wave Products Group is a research-based company that develops and manufactures innovative

process equipment for the pharmaceutical and biotechnology industries. Since 1999 our focus has been on

developing disposable bioprocess equipment for operations traditionally requiring stainless-steel tanks and

piping. Key products, such as the Wave Bioreactor, Wave Mixer and Sterile Tube Fuser, feature disposable

contact materials that eliminate cleaning and validation, thereby reducing costs in operations ranging from cell

culture, media preparation, buffer dissolution and thawing process intermediates to patient-specific cell therapy

in hospitals. These unique, patented devices can be installed and commissioned rapidly, drastically reducing the

time-to-market for biological products. Our equipment is in use in hundreds of companies worldwide, both for

R&D and commercial applications.

OUR PHILOSOPHY

CONTENTS

2 TESTIMONIALS

4 WAVE BIOREACTOR

12 WAVE MIXER

18 TUBE FUSER & TUBE SEALER

22 DISPOSABLE BIOPROCESSING

24 TRAINING & SERVICE

28 RESEARCH INITIATIVE & HISTORY

INNOVATEA LONG LIST OF FIRSTSFirst scalable disposable bioreactor l First

disposable bioreactor for large-scale virus

production l First disposable large-scale

bioreactor suitable for cGMP production of a

commercial therapeutic l First disposable bioreactor

for large-scale attachment culture l First disposable

bioreactor with internal perfusion filters l First

disposable bioreactor for cell and gene therapy l

First disposable bioreactor for large-scale plant

culture l First disposable bioreactor for microbial

culture l Extensive culture protocols and

technical support for many different cell lines and

applications l First flexible oxygen and pH sensors

for bioreactors l First oxygen gas generators

for cell culture bags l First automated perfusion

controllers l First user-customized disposable

bioreactors l First ultra-low cost disposable

bioreactors for vaccine production l First

calibratable and reusable optical oxygen sensors l

First mixing systems for flat bags to 500 liters l

First thawing systems for bags without a water

bath l First validatable aseptic tube welders l

First automated aseptic tube sealers l First tube

welders for large-bore fluid-filled tubing l First

research initiative for disposable bioreactors

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“The Wave Bioreactor has a lower requirement for facility utilities and can be retrofitted into our existing facilities.”

P. CLARKE, VP PRODUCTION AND TECHNICAL PROCESSES

Introgen Therapeutics, 2006

“I am amazed at how easy this reactor is to use...”

P. PIERGIOVANNI, PROFESSOR OF CHEMICAL ENGINEERING

Lafayette College, 2006

“We are very pleased to be able to work with WAVE as we proceed to expand the production of our pandemic and seasonal flu vaccine candidates. The process is reliable and can be readily scaled up.”

R. SINGHVI, PRESIDENT AND CEO

Novavax, 2005

2

“A disposable bioreactor offers advantages in the areas of cleaning, sterilization, validation, set-up and turn-around time between runs...we have demonstrated that systems run with a 25L, 100L or 500L working volume are comparable for cell growth, protein production, glucose consumption and lactate production.”

L. PIERCE & P. SHABRAM

PacificGMP/Ventana Biosciences, 2004

“One reason for...rapid maturity is that it cultures trillions of drug-producing cells in disposable plastic bags instead of using costly stainless steel vats...”

V. CICCARONE, ASSOCIATE DIRECTOR, GENE EXPRESSION

Macrogenics, 2005

REALIZE

3

The Ideal Device for Cell CultureWave Bioreactor is the ideal device for cell culture. Culture medium and cells contact only a presterile, disposable

chamber called a Cellbag that is placed on a special rocking platform. The rocking motion of this platform induces

waves in the culture fluid. These waves provide mixing and oxygen transfer, resulting in a perfect environment for

cell growth that can easily support over 10 x 106 cells/ml. The bioreactor requires no cleaning or sterilization,

providing the ultimate ease in operation and protection against cross-contamination.

CELL CULTURE

WAVE BIOREACTOR™

4

Cell culturemedia

WaveRockingmotion Wave

Wave action sweeps up cells and prevents settling

GROWCELLS

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6

Features Applications

LitersSYSTEM 20/50

1-25

LiterSYSTEM 2/10

0.1-5 LitersSYSTEM 200

10-100

SINGLE USENo cleaning, cross-contamination, or validation. Cells contact only disposable sterile biocompatible plastics. All materials conform to USP Class VI and ISO 10993.

CLOSED SYSTEMCellbag bioreactors, including all fittings and filters, aredelivered sterile and ready for use. Suitable for cGMPcommercial production. No biosafety cabinet is requiredfor inoculation or sampling.

VERSATILEMultiple instrument configurations specifically designed for suspension, microcarrier, batch, fed-batch or perfusion culture.

SCALABLESpinners, roller bottles, and similar systems are not scalable due to inherently limited mass transfer surface area. The Wave Bioreactor has no such limits. Operation up to 580 liters working volume has been demonstrated.

MONOCLONAL ANTIBODIESThe Wave Bioreactor has been used extensively for monoclonal antibody production. Culture can be started at low volume and then fresh media added whenever thecell count is sufficiently high. This enables inoculum scaleup without transfers.

Batches ranging from 100ml to 580 liters have been runwith cell densities over 10x106 cells/ml and productivityand product quality comparable to stirred tank bioreactors.Dissolved oxygen concentrations are not limiting andremain above 50% saturation.

ANCHORAGE DEPENDENT CELLS Agitation in the Wave Bioreactor is powerful enough to mix and aerate the culture, yet it is gentle enough to cultivate anchorage dependent cells on various microcarriers. The wave motion prevents settling and provides oxygenation without bubbles.

CELL CULTURE

WAVE BIOREACTOR

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VIRUS PRODUCTIONThe Wave Bioreactor provides a closed system that is idealfor virus production. In a gene therapy application, human293 cells have been grown in suspension and then infectedwith recombinant adenovirus. Cells grew to 4x106/ml andvirus production was 100,000 virus particles/cell.

The Wave Bioreactor produces viruses under complete containment without the need for a biosafety cabinet.

cGMP PRODUCTIONWave Bioreactors are in use in cGMP applications producinginoculum for large conventional bioreactors, and also forclinical and commercial production of human therapeutics.

Reduced cleaning and validation requirements make thisan ideal system for cGMP applications.

CUSTOM USES The Wave Bioreactor has many other uses, such as keeping in-process inoculum pools agitated and aerated prior to use; bead-to-bead transfer; thawing, and media mixing. Custom Cellbags can be provided for the Wave Bioreactor for any working volume between 100ml and 500 liters.

INSECT CELL/BACULOVIRUS The high oxygen supply capability of the Wave Bioreactormakes it ideal for insect cell culture. Cell densities over9x106 cells/ml are routinely achieved.

Baculovirus yields are higher than with conventional bioreactors. The Wave Bioreactor system is extremely easyto operate and inoculum scale-up and infection can bedone inside the bioreactor, reducing the need for transfers.

LitersSYSTEM 500/1000

100-500

PROVEN FOR: Insect Cell/BaculovirusPlant CultureCHOHELANS0Microbial

cGMP ProductionMicrocarriersPerfusion CultureMonoclonal AntibodiesYeast

T-CellsHEK293/AdenovirusPrimary Cell LinesProtein ExpressionVaccines

WAVEPOD INTEGRATED CONTROLLERThe new WAVEPOD instrument module integrates allinstrumentation associated with the Wave Bioreactor:dissolved oxygen, pH, and CO2/O2 gas mixing controls.

Developed in response to customer demand, this unit combinesthese four key instruments, previously available as separatecontrollers, into a single, compact device. The WAVEPODconnects via a digital link to a Wave Bioreactor BASE, and itslarge color touchscreen allows easy access to all parameters,including data from the bioreactor. By integrating all thecontrols associated with a bioreactor it is possible to developcomplex control schemes such as dissolved oxygen control byautomatically varying rocker speed or oxygen concentrationsupplied to the Cellbag. The WAVEPOD and Wave Bioreactorform a control cluster that can be accessed remotely over thebuilt-in Ethernet interface for remote data acquisition andsupervisory control. The WAVEPOD is designed for use withWave Bioreactor System2/10EH and System20/50EHT.

Multiple POD configurations are available to meet individualcell culture needs, for insect cell, mammalian cell, perfusionor cell therapy applications. PODs are available with left- orright-facing probe connections for ease of use.

WAVE BIOREACTOR INSTRUMENT MODULES*CO2MIX Infrared CO2 sensor and aeration system providesa continuous supply of CO2 conditioned air to the Cellbag.

O2MIX Oxygen-air mixing controller provides continuoussupply of O2 enriched gas to the Cellbag for insect cell, virus,and high cell density applications. O2MIX can also be usedto maintain low-oxygen environment for near-anaerobicapplications.

DOOPT Unique optical dissolved oxygen monitor withminiature fiber-optic microprobes allow real-time measurementof dissolved oxygen. DOOPT is the only optical DO detectorresistant to photobleaching and ambient light, and capableof high accuracy measurement.

pH Enables continuous pH measurement and control usingCO2 or acid/base addition. Electrochemical probe is singleuse, and available pre-installed in Cellbags.

LOADCELL Module enables on-line measurement of weightand can be used for automated fill/harvest, and perfusionoperations whereprecise volumecontrol is critical.

*Instrument Modules are available in WAVEPOD or as standalone units for System2/10 &System20/50. Fully integrated modules are available for System200 & System500/1000.

Accessories

CELL CULTURE WAVE BIOREACTOR

WAVEPOD™

CONTROL MODULES

CO2 Gas MixingO2 Gas MixingOptical Dissolved OxygenpH Control

Touchscreen access to all parameters

FEATURES

Multiple configurations ofsensor/control modules:

pH, DOOPT, CO2 and O2pH, DOOPT and CO2DOOPT and O2DOOPT, CO and O2pH and CO2

Compact design

Allows for development ofcomplex control schemes

Ethernet port for dataacquisition

Autoswitching 110/220 VACoperation

pH and DO probes

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CUSTOM ENGINEERING

Custom systems can beengineered for specialapplications. For example,the CABINET20/50 shownhere can accommodatethree SYSTEM20/50units and all associatedinstrumentation in aspace-saving roll-arounddesign.

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WORKING VOLUMERANGE

INTEGRAL FEATURES

OPTIONS

WEIGHT

DIMENSIONS

UTILITIES

BASE 2/10EH

0.1 L – 5 L

Speed/Angle controlTemperature controlAeration

CO2MIXO2MIXDOPHPERFUSION CTRL

BASE 2/10EH

9 lbs (4.2 kg)

19 x 13.1 x 8 in(489 x 330 x 200 mm)

110/220 VAC

BASE 20/50EHT

0.1 L – 25 L

Speed/Angle controlTemperature control Aeration

WAVEPODCO2MIXO2MIXDOPHLOADCELLDUAL AIR/TEMP

BASE 20/50EHTa

34 lbs (15.5 kg)

22.6 x 18.3 x 7.1 in (573 x 465 x 179 mm)w/ KIT20:28 x 22.6 x 10 in (711 x 575 x 254 mm) w/ KIT50:30.5 x 27.6 x 10 in (775 x 700 x 254 mm)

100/240 VAC6/3 A 50/60Hz

Pneumatic BASE20/50Pavailable upon request.Requires 30-90 psig.

BASE 200EH

5 L – 100 L

Speed/Angle controlTemperature controlAeration

CO2MIXO2MIXDOPHLOADCELLDUAL AIR/TEMP

BASE 200EHb

780 lbs (350 kg)

73 x 43 x 44 in(185 x 110 x 112 cm)Unit can be tilted fortransportation

200-240 VAC50/60Hz 15A3-PhasePhase-Phase ±5%NEMA L2130 Plug

BASE 500/1000EH

50 L – 500 L

Speed/Angle controlTemperature controlAerationLoadcell

CO2MIXO2MIXDOPH

BASE 500/1000EHb,c

w/ KIT500:2000 lbs (925 kg) w/ KIT1000:2250 lbs (1020 kg)

79 x 49 x 63 in (201 x 124 x 160 cm)w/ KIT500:89 x 49 x 63 in (226 x 124 x 160 cm) w/ KIT1000:89 x 91 x 63 in (226 x 231 x 160 cm)

200–240 VAC 50/60 Hz, 30A3-PhasePhase-Phase ±5%NEMA L2130 Plug

Specifications

NOTES:

a – BASE20/50 requires selection of KIT20 or KIT50. KIT20 accommodates Cellbag2L, 10L, & 20L. KIT50 accommodates Cellbag22L & 50L.

b – Unit provided with casters.

c – BASE500/1000 requires selection of KIT500 or KIT1000. KIT500 accommodates Cellbag500L. KIT1000 accommodates Cellbag1000L.

Features

*

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Cellbag bioreactor chambers are intended for single-use,and are suitable for cGMP production of human therapeutics.Cellbag components are similar to those used for biologicalstorage bags and meet USP Class VI specifications forplastics. Validation data and Cellbag DMF are available to demonstrate biocompatibility, however the user isadvised to validate suitability for specific applications.

FILM Cellbags are manufactured from multi-layer laminatedclear plastic films designed to provide high mechanicalstrength and bioinert fluid contact. Typically, the fluid contact layer is a medical grade low density polyethylene.The second or outer layer provides mechanical strengthand a gas-impermeable barrier. This non-contact layer is typically made of low density polyethylene, EVA or Nylon/EVOH copolymers. Other films for specialty applications are available.

STERILITY AND ENDOTOXINSterilized by gamma radiation at 25-40 kGy. Individual radiation indicators are affixed to each Cellbag. Lot radiation information provided. Each lot is tested for bacterial endotoxin. Lot release requires endotoxin below 0.125 EU/ml.

CUSTOMIZATIONCellbags can be readily customized for user-specified connectors, tube sets, and special components.

MECHANICAL STRENGTHFilm seal strength >67 N/cm. Each chamber is tested for leaks by pressure-hold test prior to sterilization.

CONNECTORS (TYPICAL)Air inlet 0.2 micron gas filter

Air outlet 0.2 micron gas filter with check valve

Sampling Needleless self-sealing syringe portNo laminar hood required

Fill/Harvest C-Flex™ tubing suitable for sterile fusing terminated with luer or MPC coupling

Multiuse Luer port with cap

Oxywell2TM Silicone sheath for DO probe

Many optional fittings such as pH probes, dip tubes, screw cap ports, temperature ports, perfusion filters, and special tubing ports are available.

BIOCOMPATIBILITY Testing is performed on irradiated film (50 kGy):

USP XXII plastic class VI and ISO 10993:

ISO 10993-5 Hemolysis study in vivo, extraction method

ISO 10993-5 Cytotoxicity study using ISO elution method

ISO 10993-6 Muscle implantation study in rabbit

ISO 10993-10 Acute intracutaneous reactivity study in rabbit

ISO 10993-11 Acute systemic toxicity in mouse

TEMPERATURE & PRESSURE RATINGCellbags may be used from 0°C to 50°C. Maximum operating pressure is 1.5 psig (0.1 bar).

Bioreactor Bags

CELL CULTURE CELLBAGS™

Outlet air filter

Inoculation/Harvestlines

Inlet air filter

Oxywell2

Needlelesssampling port

Spare luer port/optional pH probeCellbag rod

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Make Your Own Waves!

Add a filter, quick connect fitting or 10 feet of tubing – you decide! Disposable bioreactors can be easily customizedto suit your specific cell culture process needs for research,development or commercial manufacturing operations. Ourproduct specialists will work with you to create your ideal cell culture bag for use with the Wave Bioreactor™ System.

The Wave Approach to MixingThe Wave Mixer provides efficient mixing in a sealed bag by an innovative method. Instead of using a pump or

impeller to induce circulation flow, it uses waves generated by rocking motion. Wave motion moves large volumes

of fluid and disperses solids. The rocking motion is very efficient at generating waves because it essentially uses

gravity to accelerate the wave. The Wave Mixer eliminates the need for a mixing tank and conventional mixer.

This also eliminates equipment cleaning, sterilization and validation.

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FLUID

WAVE MIXER ™

MIXFLUIDS

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WAVE MIXING THEORYThe Wave Mixer makes it possible to mix materials contained in bags in a completely sterile manner. This special rocking platform induces a wave motion in the liquid without an impeller or other invasive mixer.The Wave Mixer has been optimized for extremely efficient mixing and dispersion. Ten liters of liquid can be mixed to homogeneity in less than 7 seconds.

The M*Bag™ allows ingredients to be mixed and dissolved using the Wave Mixer. The unique M*Bag is made of a multi-layer laminated clear plastic designed to provide high mechanical strength. A large screw capport allows powders or other solids to be easily pouredinto the bag. Probes to measure pH and conductivity can be inserted. A large outlet port allows the M*Bag to be drained completely.

The S*Bag™ is a presterilized holding bag with an attached presterile 0.1 micron liquid filter. After mixing, the outlet of the M*Bag is connected to the inlet of this filter. A peristaltic pump can be used to pump fromthe M*Bag into the S*Bag. This allows the rapid and safeproduction of sterile solutions. The filled S*Bag may thenbe used to dispense sterile media/solution when needed.

SCALABLE TECHNOLOGYStandard systems are available for 20 liter and 50 literbags. These can be used to mix volumes from 1 to 35 litersof liquid. Larger systems up to 500 liters liquid volume areavailable. The Wave Mixer principle has also been used forthe mixing of materials in custom-shaped rigid containers.

Features

Applications

MIXER20/50P or MIXER20/50E• In-process blending

• In-process pooling

• Blending for sampling

• Mixing prior to fill

• Reconstitution and dissolution

• In-process reactions

MIXER20/50EH• Thawing of frozen materials

• Warming blood and other biological fluids

• Maintaining temperature duringpooling operations

MIX Let the Wave Mixer rock the M*Bag to mix and dissolve the ingredients

2 3M*Bag

1

INSTALL A NEW M*BAG ADD INGREDIENTS Simply pour in the ingredients through the large screw cap port

PUMP FILTER

S*Bag

FILTER STERILIZE INTO S*BAG Connect the M*Bag to the sterilizing filter and pump into the presterile S*Bag

4

Up to15LitersMIXER20/50EH + MIXKIT20

5

FLUID WAVE MIXER™

Up to 40LitersMIXER20/50EH + MIXKIT50

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WORKING VOLUMERANGE

INTEGRAL FEATURES

OPTIONS

WEIGHT

DIMENSIONS

UTILITIES

MIXER20/50EMIXER20/50EH

1 L – 35 L

Speed/Angle controlTemperature control (EH)

pHLOADCELL

MIXER20/50Ea

MIXER20/50EHa

40 lbs (18 kg)

19.75 x 15 x 6.75 in(502 x 381 x 172 mm)w/ MIXKIT20:19.75 x 25.75 x 10 in (502 x 654 x 254 mm) w/ MIXKIT50:29 x 25 x 12 in (740 x 635 x 300 mm)

110/220 VAC, 10A

*Pneumatic MIXER20/50Pavailable upon request. Requires 30-90 psig.

MIXER500/1000EMIXER500/1000EH

50 L – 500 L

Speed/Angle controlTemperature control (EH)Loadcell

pH

MIXER500/1000Eb,c

MIXER500/1000EHb,c

w/MIXKIT500:2000 lbs (925 kg) w/MIXKIT1000:2250 lbs (1020 kg)

79 x 49 x 63 in (201 x 124 x 160 cm)w/ MIXKIT500:89 x 49 x 63 in(226 x 124 x 160 cm)w/ MIXKIT1000:89 x 91 x 63 in (226 x 231 x 160 cm )

208 - 240 VAC, 30A3-Phase

LOADCELL CONTROLLERAdds the capability to continuously weigh materials in themixing bag. This enables dispensing precise volumes whilerocking. Includes a 60kg capacity loadcell platform with 4 beam-type loadcells and controller. Installs in minutes. For use with MIXER20/50 models.

Features

Specifications

NOTES:

a – MIXER 20/50 requires selection of MIXKIT20 or MIXKIT50. MIXKIT20 accommodates M*BAG20L. MIXKIT50 accommodates M*BAG50L.

b - MIXER 500/1000 requires selection of MIXKIT500 or MIXKIT1000. MIXKIT500 accommodates M*BAG500L. MIXKIT1000 accommodates M*BAG1000L.

c – Unit provided with casters

Accessories

Safe and Rapid Fluid TransferThe Sterile Tube Fuser is a fully automated device for welding together thermoplastic tubing in a sterile operation

without the need for a laminar flow cabinet. The machine is useful for connecting tubing between sterile

containers, bioreactor bags, and process equipment. The unit can connect large diameter (up to 7/8 inch OD)

tubing for the rapid and safe transfer of large volumes. Major uses are bioprocessing, aseptic pharmaceutical

applications and final fill operations. Also now available in model to allow joining of fluid-filled tubes.

STERILE TUBE FUSERJOINED TUBING

16

Portable Heat-SealerThe Hot Lips Tube Sealer is a portable machine that can heat-seal thermoplastic tubing from 0.25 to 1.25 inch OD.

The seal forms a tamperproof and leakproof closure for securing tubes from bags, bottles, and other vessels. The

Hot Lips Tube Sealer is pre-programmed for many brands of tubing, and is fully automated for validatable operation.

The Sterile Tube Fuser and Hot Lips Tube Sealer devices are the key to secure fluid transfer in processes requiring

multiple connection and disconnection cycles.

HOT LIPS TUBE SEALER

SEALED TUBING

JOINTUBING

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™

18

STERILE TUBE FUSER

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Large diameter tubing greatly increases the maximum flowrate that can be achievedmaking transfers of large volumes muchquicker. This graph shows the typicalflowrates possible with a peristaltic pumpusing tubing from 1/4" to 7/8" OD.

MA

X F

LOW

LIT

ER

S/M

IN

TU B I NG OD (mm)

*DR

Y W

ELD

S O

NLY

• Sterile media transfer

• Vaccine manufacture

• Filling and formulation

• Bioreactors feed and harvest

• Pharmaceutical processfluid transfer

• High containment operations

• In-process pooling

• Transferring buffers

Applications

Insert a new blade and the tubing to be connected into the fuser and start the program1

The hot blade cuts the tubing and the cut ends are heldagainst the hot (>200°C) blade2

The machine slides the cut tubing into alignment alongthe hot blade ensuring sterile operation3

The blade moves out and the tubing ends are fusedtogether to form a welded connection4

Features How It WorksSTF-IRc STF-IRcWW

TUBING OD RANGE 0.25 – 0.875 in 0.25 – 0.625 in(6.4 – 22.2 mm) (6.4 – 15.5 mm)

TUBING CONDITION Dry thermoplastic Fluid-filled thermoplastic

FUSING CYCLE 2 – 3 minutes 2 – 3 minutes

OPTIONS Thermal Printer Thermal PrinterTUBE1-IR (0.625 in/15.5 mm) TUBE1-IR/WW (0.625 in/15.5 mm)TUBE2-IR (0.75 in/19.1 mm) TUBE3-IR/WW (0.4375 in/11.2 mm)TUBE3-IR (0.4375 in/11.2 mm) TUBE4-IR/WW (0.25 in/6.4 mm)TUBE4-IR (0.25 in/6.4 mm) TUBE7-IR/WW (0.50 in/12.5 mm)TUBE5-IR (0.3125 in/8 mm)TUBE6-IR (0.375 in/9.6 mm)TUBE7-IR (0.50 in/12.5 mm)TUBE8-IR (0.875 in/22.2 mm)

STF-IRc STF-IRcWWWEIGHT 35 lbs (16 kg) 35 lbs (16 kg)

DIMENSIONS 15.5 x 14 x 10.4 in 15.5 x 14 x 10.4 in(395 x 355 x 265 mm) (395 x 355 x 265 mm)

UTILITIES 110/220 VAC, 1A 110/220 VAC, 1A

Specifications

STF-IRcWW shown

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HOT LIPS TUBE SEALER

Applications

• Sealing tubing attached to bags

• Tamperproof sealing

• Sampling

• Shipping/storage

• Sealing transfer/sampling lines

1-1/4" 1/4"

TUBING OD

Specifications

WEIGHT 18 lbs (8 kg)

DIMENSIONS 14 x 6.5 x 8 in(356 x 165 x 203 mm)

UTILITIES 110/220 VAC, 1A

The tubing to be sealed is placed in the jaws. Push button to closejaws to a preset distance based on type and size1

Jaws heat to melt tubing2

Jaws push together to form the seal3

Fans cool the seal. Jaws open once seal is cool. The entire operationis performed by a sophisticated motion control system capable of0.01 mm positioning accuracy

4

Features

TUBING OD RANGE 0.25 – 1.25 in(6.4 – 31.8 mm)

TUBING CONDITION Dry or fluid-filled thermoplastic

FUSING CYCLE Approx. 2 minutes

How It Works

“The Pipeless Plant” is a reality!The biopharma industry has embraced the use of single-use systems in pilot plant operations as well as in commercial

production of approved therapeutics over the last decade. Disposables can be easily integrated as individual process

steps in existing stainless-steel operations, or as an entire production platform. Disposable bioreactors, mixers, tube

welders & sealers, allow users to configure facilities using disposables exclusively.

From scalable, customizable bioreactors & mixers, to integrated, single-use sensors, to tube welders & sealers,

WAVE provides an integrated solution for rapid, efficient & reliable bioprocessing.

DISPOSABLE BIOPROCESSING

MEDIA & BUFFER PREP

STERILE FLUID TRANSFERTUBE WELDING & SEALING

INOCULUM PROPAGATION

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INTEGRATELARGE SCALE CELL CULTURE OPERATIONS

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STERILE FLUID TRANSFERTUBE WELDING & SEALING

WAVE understands the need for prompt, reliable service in today’s research & development labs, pilot plants

& cGMP production environments. Our service engineers are factory-trained and have the experience to install

your instruments and maintain them in peak condition. We offer a range of support services to match your

needs, including Preventive Maintenance, On-Site and/or Mail-In Service Agreements, Operational &

Maintenance Training and Time and Material Services.

INSTALLATION &

TRAINING

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MAINTENANCE &

SERVICE

Preventive Maintenance is critical to instrument uptime and your success. Varying laboratory environments, daily

usage and multiple users can all affect instrument performance. WAVE recommends an annual PM to ensure your

instruments are running at optimal performance, and to identify and fix problems before they result in process

downtime. Unlike some preventive maintenance plans, WAVE offers Preventive Maintenance including full calibration

of all relevant instrument components and any necessary software upgrades. WAVE Instrument Service offers a

range of support services, tailored to your service needs.

SUPPORT

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INSTALLATIONInstallation by factory-trained service engineers is offered on our larger Wave Bioreactors such as the System200 and System500/1000. Installation includes pre-installationinspection, set-up and a full system check utilizing theinstrument’s “Startup Checklist.” Installation is also availablefor the smaller System20/50 for complex installations, multiple unit purchases, or purchases requiring high-levelbioreactor control strategies.

WAVE offers both FAT (Factory Acceptance Test) and SAT(Site Acceptance Test) services for the Wave Bioreactorto assist our customers with installation, validation activi-ties & regulatory compliance. Please contact your SalesRepresentative or our Service Department for furtherdetails on FAT and SAT services.

TRAININGWAVE offers instrument operation and maintenance trainingprograms tailored for your organization’s needs. Operational& Maintenance Training programs are available at yourlocation, or at our facilities in Somerset, New Jersey.We also offer an in-depth, hands-on cell culture coursethrough PacificGMP in San Diego, CA. This Wave DisposableBioProcessing Training Program is a two and a half dayprogram focused on creating expert-level Wave Bioreactorusers. The course is centered on implementing disposableprocesses, scale-up, perfusion and ease of fluid transfers.Visit our website for additional information & currentcourse dates. Please contact your local Sales Specialist or our Service Department for further information aboutany of our Training Programs.

SUPPORT

Installation & Training

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SERVICE AGREEMENTSWAVE Instrument Service offers a range of support services,tailored to your service needs.

Service Agreements offer:• Peace of mind• Total control over maintenance costs• Assistance in meeting regulatory requirements• Priority service response

Platinum Service Agreement (PSA): Full instrument coverageof electrical and mechanical assemblies, should emergencyservice be required, for the duration of the agreement.Includes one annual Preventive Maintenance visit. Includesall covered replacement parts, labor, and travel. PlatinumService customers also enjoy priority response.

Gold Service Agreement (GSA): Full instrument coverage of electrical and mechanical assemblies, should emergencyservice be required, for the duration of the agreement.Includes all covered replacement parts, labor, and travel.Gold Service customers also enjoy priority response.

Field Preventive Maintenance (FPM): Annually scheduledfield service following a customized maintenance procedure,including calibration. Includes PM parts, labor and travel.

Silver Service Agreement (SSA): Full instrument coverageof electrical and mechanical assemblies, should emergencyservice be required, for the duration of the agreement.Includes one annual PM. Instruments to be serviced onlyat WAVE Headquarters, Somerset, New Jersey, USA, orWave Europe Pvt Ltd offices, Cork, Ireland. Includes allcovered replacement parts and labor. Customer to bearcost of shipping to WAVE, WAVE will bear return shippingcosts.

Mail-In Preventive Maintenance: Scheduled service at customer-requested time interval following a customizedmaintenance procedure, including calibration. Includes PM parts and labor. PM will be performed only at WAVEHeadquarters, Somerset, New Jersey, USA, or Wave EuropePvt Ltd offices, Cork, Ireland. Customer pays for shippingto WAVE; WAVE will bear return shipping costs.

TIME AND MATERIAL SERVICEAt WAVE we offer the same quality service for those customerswho wish to maintain their instruments on a time andmaterial basis. Call us with the model name and serialnumber of your instrument and we will be glad to processyour service request.

Choose the plan that works for your laboratory and your business needs:

Field Plans Mail-In Plans

Coverage Platinum Gold Field PM Silver Mail-In PM

Preventive Maintenance ✔ Optional ✔ — ✔

Emergency Repair ✔ ✔ — ✔ —

Replacement Parts ✔ ✔ ✔ ✔ —

Calibration ✔ Optional ✔ Optional ✔

Labor & Travel ✔ ✔ ✔ — —

Labor & Return Shipping — — — ✔ ✔

Maintenance & Service

The Wave Research Initiative (WRI) is the first program of this type in the bioreactor industry. It reflects the commitment of

WAVE to listen to scientists, engineers, and users in order to develop and improve products like the Wave Bioreactor that make

cell culture easier and more reliable. A whole new generation of drugs will evolve from our increased knowledge and skills in

understanding the genetic basis for disease. To manufacture these drugs in commercial quantities will require a huge increase

in cell culture capability. Disposable cell culture will play a dominant role in providing cost-effective therapies.

Register online at www.wavebiotech.com

DISPOSABLE TECHNOLOGY

RESEARCH INITIATIVE

INSPIRE.

W A V E B I O T E C H

RESEARCH I N I T I A T I V E

WRI

The nation’s first hands-on disposablebioprocessing training program. Featuring the latest WAVE equipment,we are now offering practical instructionand hands-on production experience inthe set-up, the transition to and the useof disposable bioprocessing systems.

Register online at www.wavebiotech.com

Learning Center

26

Wave Biotech was founded by Dr. Vijay Singh, a recognized authority on large-scale cell culture and fluid mixing. Dr. Singh is the author

of many technical papers and the holder of several US patents. He has been involved with the design and operation of bioreactors

since 1980. The concept of wave-induced agitation for fluid mixing and oxygenation in inflated plastic bags was pioneered by him

in 1995 as a replacement for expensive and labor-intensive stirred tank bioreactors. This concept was developed into what is now

known as the Wave Bioreactor, hundreds of which have been sold since introduction in 1996. Technical innovations include the

development of bags with internal filters patented for perfusion and the scale up to culture volumes over 500 liters. Spinoffs of the

technology include Wave Mixers which provide non-invasive sterile mixing, heating for thawing applications, and a host of instru-

mentation suitable for introduction into disposable bags. In April, 2007, WAVE was acquired by GE Healthcare. The combination of

GE Healthcare and Wave Biotech will allow for future expansion into new applications and creation of a broad offering of added

value tools and services for the biopharmaceutical marketplace.

WAVE BIOTECH

OUR HISTORYY

Vijay Singh, Ph.D

“A whole new generation of

drugs will evolve from our

increased knowledge and skills

in understanding the genetic

basis for disease. Disposable

cell culture will play a

dominant role in providing

cost-effective therapies.”

27

cGMP PRODUCTION

NS0

INSECT CELL/BACULOVIRUS

PERFUSION CULTURE PLANT CELLSHEK293/ADENOVIRUS

CELL THERAPY

HELA

INOCULUM PROPAGATION

MONOCLONAL ANTIBODIES

PROTEIN EXPRESSIONCHO

PLANT CULTUREVACCINES

MICROCARRIERS

Wave Bioreactor, Cellbag, Wave Mixer and Hot Lips Tube Sealer are registered trademarks of GE Healthcare Bioscience BioProcess Corp.

GE Healthcare Bioscience BioProcess Corp.300 Franklin Square DriveSomerset, NJ 08873 USA

Toll free (877) WAVE·USATel (732) 302 3100Fax (732) 302 3101info@wavebiotech.com

Wave Europe Pvt. Ltd.Unit 10, Matthew Hill Commercial ParkForge Hill, Kinsale RoadCork, Ireland

Tel +353 21 497 7014Fax +353 21 497 7590

info@wave-europe.com

www .wavebiotech.com www.gelifesciences.com/wave

28-9282-57 AA

Wave Biotech, LLC and Wave Europe Pvt. Ltd. are now part of GE Healthcare Life Sciences.