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Wave Bioreactor® Catalog 2005

SELECTION GUIDE

The Wave Bioreactor® is a disposable cell culture system. It consists of three major components – 1) a rocker platform, 2) a single-use cell culture Cellbag® and 3) an aeration/inflation pump. The rocker platform imparts the wave motion to the liquid inside the presterilized Cellbag and provides the necessary oxygen transfer and mixing for cell growth and productivity.

In order to select the correct system for your application you must first establish the culture volume you wish to cultivate. This will determine the Cellbag size you need. Next, you need to select a Wave Bioreactor System that is suitable for this Cellbag. There are four Wave Bioreactor Systems.

Next you need to select the instrumentation and options you need. These include weight controllers, dissolved oxygen amplifiers, pH control and data acquisition. Cellbags are also available with different options such as perfusion filters and specialized ports. Extensive technical literature, detailed specifications, cell culture protocols and manuals are available online on our website: www.wavebiotech.com. If you should need assistance selecting the appropriate options and accessories for your application, please consult with one of our Sales Engineers.

Culture Volume Cellbag Part # Fits Wave Bioreactor

100ml to 500ml CELLBAG.500mL SYSTEM2/10

100ml to 1000ml CELLBAG 2L SYSTEM2/10; SYSTEM20/50+KIT20

500ml to 5 liters CELLBAG 10L SYSTEM2/10; SYSTEM20/50+KIT20

1 liter to 10 liters CELLBAG 20L SYSTEM20/50+KIT20

1 liter to 10 liters CELLBAG 22L SYSTEM20/50+KIT50

5 liters to 25 liters CELLBAG 50L SYSTEM20/50+KIT50

5 liters to 50 liters CELLBAG 100L SYSTEM200

10 liters to 100 liters CELLBAG 200L SYSTEM200

50 liters to 250 liters CELLBAG 500L SYSTEM500/1000+KIT500EH

100 liters to 500 liters CELLBAG 1000L SYSTEM500/1000+KIT1000EH

Rocking Motion wave

Inflated plastic bag forms a disposable cultivation chamber

Cell culture media


SYSTEM2/10

SYSTEM2/10EH is a small, moderately priced Wave Bioreactor for use only with Cellbag2L or 10L (100ml to 5L culture). This compact unit is ideal for ideal for animal, insect, and plant cell culture with integral features such as aeration, heating and temperature control.

Standalone instrumentation for CO2, O2, pH and DO for the SYSTEM20/50 product line can also be used with SYSTEM2/10EH. All Cellbags have OXYWELL ports for insertion of our micropolarographic dissolved oxygen probes.

System2/10EH BASE

System2/10EH electric rocker base Includes Cellbag HOLDER. RS-485 communications port. LCD display and control interface. Integral airpump with mass flow meter. Temperature control with heater and sensor. Requires 110 or 220 VAC For use on benchtop or incubator (with heater disabled)

Part No. BASE2/10EH

System2/10 ACCESSORY

System2/10EH Perfusion controller for use with Cellbag2L/P only

Integral feed/harvest pumps Integral Loadcell for feed/harvest bags

Part No.

PERFCONT2E


SYSTEM 20/50

SYSTEM20/50 is a very versatile Wave Bioreactor designed for R&D and production use. It is a modular system consisting of a BASE unit that can be either electrically powered (BASE20/50EH), or powered by compressed air (BASE20/50P). The compressed air unit is especially suited for incubators and hot rooms since there is no heat generation from a motor. After selecting the BASE, you must select KIT20 or KIT50. KIT20 is designed to handle a single Cellbag20L (1 – 10 liter culture) or two Cellbag10L (0.5 – 5 liter culture). Two Cellbag2L can also be accommodated. KIT50 fits a single Cellbag50L (5 – 25 liter culture) or two Cellbag22L (1 – 10 liter culture). Each KIT includes a mounting plate, heater pad, temperature sensor, and stainless steel Cellbag holder. KITs can easily be interchanged in minutes providing flexibility for a wide range of culture volumes using a single BASE unit.

System20/50 BASE

shown with KIT20P

Pneumatic rocker base Typically used inside an incubator or hot room. Requires compressed air 0.2 scfm at 30-90 psig (dry and filtered). Use LC910 portable compressor for electric operation. Requires KIT20P for up to 10 liter culture or KIT50P for up to 25 liter culture volume.

Part No. BASE20/50P

shown with KIT20EH & AIRPUMP20

Electric rocker base For benchtop use. Not for use inside an incubator. Includes temperature controller. Data port + analog/digital outputs. 110-220 VAC. Requires KIT20EH for up to 10 liter culture or KIT50EH for up to 25 liter culture volume.

Part No. BASE20/50EH


Select one of the following Kits for use with the BASE20/50 units:

For benchtop operation, covering the Cellbag with a plastic lid is recommended. This prevents accidental damage to the bag and improves temperature control. A filter heater for the exhaust filter is strongly recommended otherwise water will condense in the filter and may lead to clogging and overpressure in the bag.

System20/50 HOLDER KITS

Kit for BASE20/50P, includes mounting plate + HOLDER20 KIT20P accommodates 1x20L, 2x10L, or 2x2L Cellbags

Part No. KIT20P

HOLDER20 Kit for BASE20/50P, includes mounting plate + HOLDER50 KIT50P accommodates 1x50L Cellbag only.

Part No. KIT50P

Kit for BASE20/50EH, includes mounting plate + HOLDER20 + HEATERPAD20 + SRTD temperature probe. KIT20EH accommodates 1x20L, 2x10L, or 2x2L Cellbags.

Part No. KIT20EH

HEATERPAD20

Kit for BASE20/50EH, includes mounting plate + HOLDER50 + HEATERPAD50 + SRTD temperature probe. KIT50EH accommodates 1x50L Cellbag only.

Part No. KIT50EH

System20/50EH ACCESSORIES

Protective lid for use with KIT20EH. Consists of clear PVC cover and stainless steel frame. FLEXCOVER20 replacement cover also available.

Part No. FLEXLID20

Opaque, protective lid for use with KIT20EH in light-sensitive applications. Consists of white PVC cover and stainless steel frame. FLEXCOVER20/W replacement cover also available.

Part No. FLEXLID20/W

Protective lid for use with KIT50EH. Consists of clear PVC cover and stainless steel frame. FLEXCOVER50 replacement cover also available.

Part No. FLEXLID50

FLEXLID20/W shown

Opaque, protective lid for use with KIT50EH in light-sensitive applications. Consists of white PVC cover and stainless steel frame. FLEXCOVER50/W replacement cover also available.

Part No. FLEXLID50/W

Electric exhaust filter heater Prevents condensation in the exhaust filter. 5VDC 4W operation. LED indicator. Fits onto any Cellbag.

Part No. FLTHTR2


Several accessories are also available for SYSTEM20/50P pneumatic rocker bases:

System20/50P ACCESSORIES

Low-noise portable oil-free compressor

For use with BASE20/50P units. Specify 110 or 220 VAC operation.

Part No. LC910

Transmitter for BASE20/50P remote monitoring

4-20mA loop-powered rocking speed transmitter.

Part No. SPDTX


All SYSTEM20/50 units require an aeration/inflation pump. Choose from the AIRPUMP, CO2MIX or O2MIX. The simple AIRPUMP20 pumps ambient air (or user-supplied gas) into the Cellbag bioreactor. This is ideal for incubator use where CO2 conditioned air is supplied by the incubator or for applications where CO2 control is not needed. The CO2MIX module combines a CO2 controller and air pump. It can mix CO2 with air to deliver any CO2 mixture from 0 to 15% CO2. The O2MIX module combines an oxygen controller and aeration pump, mixing oxygen and air or nitrogen to deliver any mixture from 0-50% O2. All three pumps have automatic overpressure limits to prevent overinflation.

System20/50 AERATION UNITS

Cellbag standalone aeration pump Overpressure alarm indicator. High accuracy mass flow technology Electrical power (110 or 220 VAC). Adjustable flow rate 0 to 0.5 liters per minute. Compact, rugged stainless steel/aluminum construction

Part No. AIRPUMP20

CO2/air mixture controller with aeration pump Range 0 to 15% CO2.

High accuracy mass flow technology 110/220 VAC operation. MODBUS data port. NDIR CO2 sensor. Standard double-bay enclosure or in optional RACK20.

Part No. CO2MIX20

O2/air mixture controller with aeration pump Range 0 to 50% O2.

High accuracy mass flow technology 110/220 VAC operation. MODBUS data port. O2 sensor. Standard double-bay enclosure or in optional RACK20.

Part No. O2MIX20

Oxygen generator

Produces 2 liters per minute of 92% O2 from ambient air. Use in conjunction with O2MIX20 or O2MIX200 instead of cylinder-supplied oxygen 110/220 VAC operation. Floor standing unit, stainless steel enclosure.

Part No. O2GEN


SYSTEM20/50 has an extensive line of instrumentation. Choose from weight controllers for perfusion culture, dissolved oxygen amplifiers and pH controllers.

System20/50 INSTRUMENTATION / MISC

Dissolved oxygen monitor with temperature compensation

Range 0 to 100% saturation with autozero.

Standard single-bay enclosure or in optional RACK20.

Reusable DOPROBE and TCPROBE purchased separately.

Part No. DO20

Dissolved oxygen monitor with temperature compensation – fiber optic PMT optical detector with phase shift measurement.

Range 0 to 250% saturation with autozero.

Standard single-bay enclosure or in optional RACK20.

Reusable DOOPT-PROBE purchased separately.

Zero oxygen calibration solution also available.

Part No. DOOPT20

Weight monitor/controller for BASE20/50 Includes pump controller for automated fill/perfusion.

Mounted in single-bay enclosure or in optional RACK20.

For retrofit option, please use part # LOADCELL-RETRO.

Part No. LOADCELL20

pH controller Includes acid/base pump controller.

Mounted in single-bay enclosure or in optional RACK20.

pHPROBE may be supplied presterilized in Cellbag or for user insertion.

Part No. pH20

19” Instrument rack Each rack has 4 bays for instrument modules, purchased separately.

Part No. RACK20

System20/50 compact multiunit enclosure Stainless steel construction with 3 slide-out shelves and removable door and sides with tubing feed-through ports.

Hinged rear door for maintenance access.

Mounted on casters for mobility.

110/220VAC, 15amp internal power distribution strip.

Dimensions: 102cm x 79cm x 208cm (40”W x 31”D x 82”H).

Weight: 272kg (600lbs) empty.

Part No. CABINET20/50


SYSTEM 200 SYSTEM200EH is designed for R&D and GMP production use. It is a self-contained system with integral heating, temperature control, aeration pump, and rocking controller. Provided with casters, it can be easily relocated.

Plug-in modules increase the versatility of SYSTEM200EH:

System200EH BASE

System200EH electric rocker base Stainless steel construction with fully gasketed chamber and linear motor rocking control system. Integral heaterpad with temperature controller. Adjustable color touchpanel operator interface. Aeration controller. Dual Cellbag controller systems available. Dimensions: 1930mm x 1016mm x 990mm (76” x 40” x 39”). 230 ±10% VAC, 20 ampere, 3 phase. Supplied with two FLTHTR2. * Use 1xCellbag200L or 2xCellbag100L

Part No. BASE200EH

System200EH OPTIONS

CO2/air mix plug-in controller Range 0-15 % CO2.

Part No. CO2MIX200

Dissolved oxygen amplifier/controller Range: 0-100% with autozero. Provides automatic speed control to maintain DO. Reusable DOPROBE and TCPROBE purchased separately.

Part No. DO200

Dissolved oxygen monitor with temperature compensation – fiber optic PMT optical detector with phase shift measurement. Range 0 to 250% saturation with autozero.


Part No. DOOPT200

Weight/perfusion controller Includes remote pump START/STOP relay.

Part No. LOADCELL200

O2/air mix plug-in controller Range 0-50 % O2.

Part No. O2MIX200

pH controller Includes ACID/BASE pump relays. pHPROBE can be supplied presterilized in Cellbag.

Part No. pH200


SYSTEM 500/1000

SYSTEM500/1000EH is designed for R&D, process development and GMP production use. It is a self-contained system with integral heating, loadcell, temperature control, aeration pump, and rocking controller. Supplied with casters, it can be easily relocated.

Select the appropriate size kit for use on the BASE500/1000EH:

System500/1000EH BASE

System500/1000EH electric rocker base Stainless steel construction with linear motor rocking system. Integral heaterpad with temperature controller. Integral loadcell with adjustable color touchpanel operator interface. Aeration controller. Dimensions: 2300mm x 2000mm x 1000mm (91” x 85” x 65”). 230 ±10 % VAC, 30 ampere, 3 phase. * Select KIT500EH or KIT1000EH

Part No. BASE500/1000EH

System500/1000 KITS

Shown with KIT500EH

Kit for BASE500/1000EH, includes HOLDER500 + HEATERPAD500. KIT500EH accommodates 1x500L Cellbag only.

Part No. KIT500EH

Shown with KIT1000EH

Kit for BASE500/1000EH, includes HOLDER1000 + HEATERPAD1000. KIT1000EH accommodates 1x1000L or 2x500L Cellbags.

Part No. KIT1000EH


Plug-in modules increase the versatility of SYSTEM500/1000:

System500/1000 OPTIONS

CO2/air mix plug-in controller Range 0-15 % CO2.

Part No. CO2MIX500

Dissolved oxygen amplifier/controller Range: 0-100% with autozero. Provides automatic speed control to maintain DO. Reusable DOPROBE and TCPROBE purchased separately.

Part No. DO500

Dissolved oxygen monitor with temperature compensation – fiber optic PMT optical detector with phase shift measurement. Range 0 to 250% saturation with autozero.


Part No. DOOPT500

O2/air mix plug-in controller Range 0-50 % O2.

Part No. O2MIX500

pH controller Includes ACID/BASE pump relays. pHPROBE can be supplied presterilized in Cellbag.

Part No. pH500


DATA ACQUISITION & CONTROL

Data acquisition hardware and software is available for data logging, supervisory control, and alarming. Based on the proven Lookout program from National Instruments, they are supplied with all cables and preprogrammed displays for immediate implementation.

DATA ACQUISITION for Wave Bioreactors

Single PC runtime license for data acquisition for up to 5 Wave Bioreactor systems. Includes prebuilt screens and graphing/spreadsheet generation. No programming required. Data acquisition and alarm software for Windows 2000/NT4.0/XP or later. System requirements: Pentium 4 with free serial port, at least 32 MB RAM and 45 Mb free disk space. Interface hardware, software and cables included.

Part No. PCDAQ/S

PCDAQ/A extends runtime license to additional 5 Wave Bioreactors on one PC. Requires PCDAQ/S.

Part No. PCDAQ/A

PCDAQ/M extends PCDAQ runtime license to allow 1 server+ 4 clients to access data on user network. Requires PCDAQ/S.

Part No. PCDAQ/M

PCDAQ/DEV developer version that allows the user to generate new runtime configurations, custom screens, control strategies and database design. Requires PCDAQ/S.

Part No. PCDAQ/DEV

PC data acquistion with graphing and spreadsheet

data logging

PCDAQ SPRVSR - Supervisory control license - Allows for pH control with CO2 gas supplied by CO2MIX20 and dissolved oxygen control with O2 gas supplied by O2MIX20. Requires purchase of pH20/CO2MIX20 and/or DO20/DOOPT20/O2MIX20 instruments, and relevant probes. Requires PCDAQ/S.

Part No. PCDAQ SPRVSR

ANALOG200 - Analog output card, 0-5V outputs, 8 variables available – System200.

Part No. ANALOG200

ANALOG500 - Analog output card, 0-5V outputs, 8 variables available – System500/1000.

Part No. ANALOG500

SUPERVISORY CONTROL for Wave Bioreactors

Tablet PC Supervisory control module - Allows for pH control with CO2 gas supplied by CO2MIX20 and dissolved oxygen control with O2 gas supplied by O2MIX20. Requires purchase of pH20/CO2MIX20 and/or DO20/DOOPT20/O2MIX20 instruments, and relevant probes. Includes PCDAQ/S and PCDAQ SPRVSR licenses.

Part No. WB SPRVSR


PROBES Specially developed probes are available for all Cellbags. These are flexible and have a diameter less than 2.5mm for easy insertion into Cellbags.

Disposable Probes

Polarographic flexible microbore dissolved oxygen electrode Low drift. Usable for 4-6 weeks after insertion into Cellbag. For use with DO20, DO200 or DO500.

Part No. DOPROBE

Fiber optic dissolved oxygen electrode Fast response time (t90< 10 seconds). Reusable. Operating life up to 1 year. For use with DOOPT20, DOOPT200, & DOOPT500.

Includes two (2) packages of calibration solution (ZERO OXYSOLN).

Part No. DOOPT-PROBE

Thermocouple type temperature compensation probe for use with DO20, DO200 or DO500.

Reusable.

Part No. TCPROBE

DOPROBE

DOOPT-PROBE

Electrochemical flexible microbore combination pH electrode For use with pH20, pH200 or pH500 instrumentation. Reusable. Can be provided gamma-sterilized for user insertion or pre-installed in Cellbag.

Part No. PHPROBE

RTD probe, insertion type temperature probe For use with BASE20/50EH, BASE200EH and BASE500/1000EH Wave Bioreactor. Requires Tempwell™ for use in Cellbags.

Part No. RTDPROBE

RTD-Calibration NIST traceable RTDPROBE calibration with certificate.

Part No. RTD-CAL

SRTD probe Surface temperature probe for use with BASE20/50EH Wave Bioreactor.

Part No. SRTDH-20


Part No. SRTDH-50

RTD-PROBE

SRTD probe Surface temperature probe for use with BASE200EH Wave Bioreactor.

Part No. SRTDH-200


Part No. SRTDH-1000


Cellbag® bioreactor chambers Designed for the production of therapeutics and satisfies all applicable GMP requirements. Validation data available on request includes biocompatibility tests on the Cellbag® films and USP Class VI specifications for plastics. FILM: Fluid contact layer is typically a medical grade low density polyethylene (LDPE). The outer layer provides mechanical strength and a gas impermeable barrier. This non-contact layer is a LDPE + EVA or Nylon/EVOH copolymer. BIO-COMPATIBILITY: testing is performed on irradiated film at 50 kGy. USP XXII plastic class VI test and ISO 10993: Acute Intracutaneous Reactivity Study in rabbit ISO 10993-10 Acute Systemic Toxicity in mouse ISO 10993-11 Muscle Implantation Study in rabbit ISO 10993-6 Cytotoxicity Study using ISO Elution Method ISO 10993-5 Hemolysis Study in Vitro, Extraction Method ISO 10993-5 STERILITY AND ENDOTOXIN : Cellbags® are irradiated by Gamma radiation at 25-40 kGy. Radiation indicators are affixed to each bag. Lot radiation certification is provided. Each lot is tested for endotoxin < 0.125 EU/ml. MECHANICAL STRENGTH: Film seal strength > 67 N/cm. Integrity test using pressure hold test. PRESSURE AND TEMPERATURE: Cellbags® may be used from 0 oC to 50 oC. Max operating pressure is 0.1 bar.

All Cellbags have air inlet and outlet filters, needleless sampling port, Oxywell2 dissolved oxygen probe insertion port and fill/harvest port.

Cellbag Features (standard)

Part # Min vol. (L)

Max vol. (L)

Perfusion filter

Screw cap

pH PROBE

1/4" C-Flex

7/16” C-Flex

5/8” C-Flex

Silicone Dip-tube

Spare luer port

CELLBAG.500mL 0.1 0.5 Provided with aeration filters and needleless sampling port only

CELLBAG2L/O 0.1 1

CELLBAG2L/S 0.1 1

CELLBAG2L/P 0.1 1

CELLBAG10L/O 0.5 5

CELLBAG10L/S 0.5 5

CELLBAG20L/O 1 10

CELLBAG20L/S 1 10

CELLBAG20L/P 1 10

CELLBAG22L/O 1 10

CELLBAG50L/O 5 25

CELLBAG50L/P 5 25

CELLBAG50L/pH 5 25

CELLBAG100L/O 10 50

CELLBAG100L/pH 10 50

CELLBAG200L/O 10 100





CATALOG EFFECTIVE March 1st, 2005. Supercedes all previous catalogs. Please contact your Sales Engineer for pricing.

The Wave Bioreactor® is designed exclusively for use with the Cellbag®. Use of any substitute bag product not approved or licensed by Wave Biotech LLC will not be supported, and will exclude the user from new product updates, features, technical support and assistance, and will void the warranty. Copyright© 2005, Wave Biotech, LLC

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