Wave Bioreactor

Catalog 2006

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. Inflated plastic bag forms a disposable cultivation chamber

wave

Rocking Motion

Cell culture media

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.

Culture Volume
50ml to 250ml 50ml to 500ml 100ml to 1000ml 500ml to 5 liters 1 liter to 10 liters 1 liter to 10 liters 5 liters to 25 liters 5 liters to 50 liters 10 liters to 100 liters 50 liters to 250 liters 100 liters to 500 liters

Cellbag Part #
CELLBAG500mL CELLBAG1L CELLBAG 2L CELLBAG 10L CELLBAG 20L CELLBAG 22L CELLBAG 50L CELLBAG 100L CELLBAG 200L CELLBAG 500L CELLBAG 1000L

Fits Wave Bioreactor

SYSTEM2/10 SYSTEM2/10 SYSTEM2/10; SYSTEM20/50+KIT20 SYSTEM2/10; SYSTEM20/50+KIT20 SYSTEM20/50+KIT20 SYSTEM20/50+KIT50 SYSTEM20/50+KIT50 SYSTEM200 SYSTEM200 SYSTEM500/1000+KIT500EH SYSTEM500/1000+KIT1000EH

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.wave-europe.com. If you should need assistance selecting the appropriate options and accessories for your application, please consult with one of our Sales Engineers.

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SYSTEM2/10
SYSTEM2/10EH is a small, moderately priced Wave Bioreactor for use only with Cellbag500mL, 1L, 2L or 10L (working volume range of 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.

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 (User programmable). For use on benchtop or incubator (with heater disabled). Part No. BASE2/10EH

Holder2EH

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

Standalone instrumentation for CO2, O2, pH and DO for the SYSTEM20/50 product line can also be used with SYSTEM2/10EH.

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SYSTEM 20/50
SYSTEM20/50 is very versatile and designed for R&D and production use. It is a modular system consisting of a BASE unit with various integral options that can be either electrically powered (BASE20/50EHT), 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, 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 and stainless steel Cellbag holder. EH Kits also include a heater pad and temperature sensor. KITs can easily be interchanged in minutes providing flexibility for a wide range of culture volumes using a single BASE unit.

System20/50 BASE
Pneumatic rocker base Typically used inside an incubator or hot room. Requires compressed air 0.2 scfm at 30-90 psig (dry and filtered). Select KIT20P for up to 10 liter culture or KIT50P for up to 25 liter culture volume. Electric rocker base Also available with Loadcell module installed (-L). Part Nos. BASE20/50EHT BASE20/50EHT-L Part No. BASE20/50P

For benchtop use. Not for use inside an incubator. All EHT models include integral aeration control and touchpanel.

Requires KIT20EHT for up to 10 liter culture or KIT50EHT for up to 25 liter culture volume. Data port + analog/digital outputs. 110-220 VAC.

Electric rocker base Dual-sided air/dual temperature model. Also available with Loadcell module installed (-L). Select KIT20EHTD or KIT50EHTD for dualside temperature and aeration control model.

Part Nos.

BASE20/50EHTD BASE20/50EHTD-L

Electric rocker base EHT-CO2 includes CO2MIX20 for mammalian cell culture. Also available with Loadcell module installed (-L).

Part Nos.

BASE20/50EHT-CO2 BASE20/50EHT-CO2-L

BASE20/50EHTD shown with two Cellbag22L (dual option)

Electric rocker base EHT-O2 includes interface O2MIX20 for insect cell culture. Also available with Loadcell module installed (-L).

Part Nos.

BASE20/50EHT-O2 BASE20/50EHT-O2-L

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

System20/50 HOLDER KITS

Kit for BASE20/50P, includes mounting plate + HOLDER20 KIT20P accommodates 1x20L, 2x10L, 2x2L, 2x1L or 1x500mL size Cellbags. Kit for BASE20/50P, includes mounting plate + HOLDER50
HOLDER20

Part No. KIT20P Part No. KIT50P Part Nos. KIT20EHT KIT20EHTD Part Nos. KIT50EHT KIT50EHTD

KIT50P accommodates 1x50L or 2x22L Cellbags. Kit for BASE20/50 units, includes mounting plate + HOLDER20T + HEATERPAD20 + SRTDX temperature probe. KIT20EHT or KIT20EHTD accommodates 1x20L, 2x10L, 2x2L, 2x1L or 1x500mL size Cellbags. Kit for BASE20/50 units, includes mounting plate + HOLDER50T + HEATERPAD50 + SRTDX temperature probe(s). KIT50EHT or KIT50EHTD accommodates 1x50L or 2x22L Cellbags.

HEATERPAD20

For benchtop operation, covering the Cellbag with a LID is recommended. This prevents accidental damage to the bag. 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 ACCESSORIES
Protective lid for use with KIT20 series. Consists of rigid, clear PVC or white PVC (opaque W version for light-sensitive applications). Part Nos. LID20 LID20W

LID20W shown

Protective lid for use with KIT50 series. Consists of rigid, clear PVC cover or white PVC (opaque W version for light-sensitive applications).

Part Nos. LID50 LID50W Part No. FLTHTR2

Electric exhaust filter heater Prevents condensation in the exhaust filter. 5VDC 4W operation. LED indicator. Fits onto any Cellbag. Transmitter for BASE20/50P remote monitoring 4-20mA loop-powered rocking speed transmitter

Part No. SPDTX

SYSTEM20/50 has an extensive line of instrumentation. Choose from weight controllers for perfusion culture, dissolved oxygen amplifiers and pH controllers. Available in integrated WavePOD configuations or stand alone options.

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System20/50 INSTRUMENTATION WavePOD - Integrated controller & instruments for Wave Bioreactor 20/50EHT models Configurations: 1113 pH, DOOPT, CO2 and O2 1111 pH, DOOPT and CO2 0112 DOOPT and O2 0113 DOOPT, CO2 and O2 1011 pH and CO2
Available in right-side probe connections (-R) or left-side probe connections (-L ).

Part No. POD-R1113 POD-R1111 POD-R0112 POD-R0113 POD-R1011 POD-L1113 POD-L1111 POD-L0112 POD-L0113 POD-L1011 Part No. DOOPT20

Dissolved oxygen monitor fiber optic

High accuracy PMT optical detector with phase shift measurement. Range 0 to 250% saturation with autozero. Standard single-bay enclosure. Reusable DOOPT-PROBE purchased separately. Zero oxygen calibration solution also available.

pH controller
Includes acid/base pump controller (DB9 connector for user or Wave Biotech PUMP20. Mounted in single-bay enclosure. pHPROBE may be supplied presterilized in Cellbag or for user insertion. NOTE: Order PWR-RELAY if using acid/base pumps other than PUMP20

Part No. pH20

System20/50 compact multiunit enclosure

Stainless steel construction with 3 slide-out shelves and removable door and sides with tubing feed-through ports. Mounted on casters for mobility. Available with optional UPS. 110/220VAC, 15amp internal power distribution strip. Dimensions: 102cm x 79cm x 208cm (40W x 31D x 82H). Weight: 272kg (600lbs) empty.

Part No. CABINET20/50

Peristaltic Feed/Harvest Pump

Handles any suitable tubing up to 0.25 in. OD Digital speed control; remote start/stop function Available in right or left versions for acid/base or feed/harvest. Compact fits under tray of BASE20/50 For standalone use or with BASE20/50EHT series

PUMP20-R PUMP20-L

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Aeration/inflation pump are available as standalone options. Choose from the AIRPUMP, CO2MIX or O2MIX. The simple AIRPUMP 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 Mass flow technology with overpressure alarm 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 with NDIR sensor Mass flow technology or rotameter control (-R) 110/220 VAC operation MODBUS data port

Part No. CO2MIX20 CO2MIX20-R

O2/air mixture controller with aeration pump Range 0 to 50% O2 Mass flow technology or rotameter control (-R) 110/220 VAC operation MODBUS data port

Part No. O2MIX20 O2MIX20-R

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

Part No. RACK20

Oxygen generator Produces 4 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

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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.

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.
(Dual Control requires second set of gas mixers and instrumentation if desired)

Part No. BASE200EH Options: DUAL AIR 200 DUAL TEMP 200

Base dimensions: 1852mm x 1096mm x 1120mm (73 x 43 x 44). 200-240 VAC, 50/60Hz, 15 Amp, 3-phase operation. Supplied with two FLTHTR2. Plug-in modules increase the versatility of SYSTEM200EH:

System200EH OPTIONS
CO2/air mix plug-in controller Range 0-15 % CO2. Part No. CO2MIX200

Dissolved oxygen monitor fiber optic High accuracy PMT optical detector with phase shift measurement and temperature compensation.
Range 0 to 250% saturation with autozero. Reusable DOOPT-PROBE purchased separately.

Part No. DOOPT200

Weight/perfusion controller Includes remote pump START/STOP relay. O2/air mix plug-in controller Range 0-50 % O2. pH controller Includes ACID/BASE pump relays. pHPROBE can be supplied presterilized in Cellbag. ANALOG200 - Analog output card, 0-5V outputs, 8 variables available System200. Dual control configuration requires (2) cards.

Part No. LOADCELL200 Part No. O2MIX200 Part No. pH200

Part No. ANALOG200

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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.

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. Base dimensions: 2010mm x 1240mm x 1600mm (79 x 40 x 63). 200-240 VAC, 50/60Hz, 30 Amp, 3phase operation. * Select KIT500EH or KIT1000EH Part No. BASE500/1000EH

Select the appropriate size kit for use on the 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 only.

Part No. KIT1000EH

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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 monitor fiber optic High accuracy PMT optical detector with phase shift measurement.
Range 0 to 250% saturation with autozero. Reusable DOOPT-PROBE purchased separately.

Part No. DOOPT500

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

Part No. O2MIX500

pH controller Includes ACID/BASE pump relays. ANALOG500 - Analog output card, 0-5V outputs, 8 variables available System500/1000. Dual control configuration requires (2) cards.

Part No. pH500 Part No. ANALOG500

Document packages available for System20/50, System200 and System500/1000 bioreactors. Service Agreements available at discounted rate if selected at time of equipment purchase.
Platinum Service Agreement (PSA): Full instrument coverage of electrical and mechanical assemblies, should emergency service be required, for the duration of the agreement. Includes one annual Preventive Maintenance visit. Includes all covered replacement parts, labor, and travel. Platinum Service Customers also enjoy priority response. Gold Service Agreement (GSA): Full instrument coverage of electrical and mechanical assemblies, should emergency service be required, for the duration of the agreement. Includes all covered replacement parts, labor, and travel. Gold Service Customers also enjoy priority response. Silver Service Agreement (SSA): Full instrument coverage of electrical and mechanical assemblies, should emergency service be required, for the duration of the agreement. Includes one annual PM. Instruments to be serviced only at Wave Europe Pvt. Ltd., Cork, Ireland. Includes all covered replacement parts and labor. Customer to bear cost of shipping to Wave Europe, Wave Europe will bear return shipping costs. Field Preventive Maintenance (FPM): Annually scheduled service following a customized maintenance procedure, including calibration. Includes PM parts, labor and travel. Mail-In Preventive Maintenance: Scheduled service at customer-requested time interval following a customized maintenance procedure, including calibration. Includes PM parts and labor. PM will be performed only at Wave Europe Pvt. Ltd., Cork, Ireland.

Contact your Wave Europe Sales Specialist for details.

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FAX +353 21 497 7590 www.wave-europe.com

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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. PCDAQ/A extends runtime license to additional unlimited number of Wave Bioreactors on one PC. Requires PCDAQ/S.
PC data acquistion with graphing and spreadsheet data logging

Part No. PCDAQ/S

Part No. PCDAQ/A Part No. PCDAQ/M Part No. PCDAQ/DEV Part No. PCDAQ SPRVSR

PCDAQ/M extends PCDAQ runtime license to allow 1 server+ 4 clients to access data on user network. Requires PCDAQ/S. PCDAQ/DEV developer version (unlimited IO) that allows the user to generate new runtime configurations, custom screens, control strategies and database design. Requires PCDAQ/S. 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. Supervisory control not required for SYS200 or SYS1000 due to functions programmed into the integrated PLC ETHERNET485 MODBUS 485 to Ethernet converter option

Part No.
ETHERNET485

WBDELTAV - Hardware interface to connect the Wave Bioreactor systems to DeltaV (marketed by Emerson Electric) allowing industrial data acquisition and control for 21CFR11 compliance with regard to record keeping and access.

Part No. WBDELTAV

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

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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 Usable for 4-6 weeks after insertion into Cellbag. For use with DO20, DO200 or DO500. Part No. DOPROBE

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. DOOPTPROBE

Thermocouple type temperature compensation probe for use with DO20, DO200 or DO500. Reusable. 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. RTD probe, insertion type temperature probe For use with all Wave Bioreactor systems.
Requires Cellbags supplied with Tempwell

Part No. TCPROBE Part No. PHPROBE

DOOPT-PROBE

RTD-PROBE

Part No. RTDPROBE Part No. RTD-CAL Part No. SRTDH-200

RTD-Calibration NIST traceable RTDPROBE calibration with certificate. SRTD probe Surface temperature probe for use with BASE200EH Wave Bioreactor.

SRTDX Surface RTD temperature probe for used with BASE2/10EH and all BASE20/50 Wave Bioreactors.

Part No. SRTDX

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Cellbag bioreactor
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. See chart on next page for additional features. Specification sheets for Cellbags are available on our website, www.wavebiotech.com.

Complete Cellbag customization services are available. Contact your Wave Europe Sales Specialist for details.

Key: /B = Basic /FC = FibraCel microcarriers /pH = pH probe installed /S = Screwcap

/O = Oxywell2 /P = Perfusion filter installed

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Cellbag Features
Product Description Min vol. (L) 0.05 Max vol. (L) 0.25 Perfusion filter Screw cap pH 1/4" C-Flex 7/16 C-Flex 5/8 C-Flex Silicone Dip-tube Spare luer port

CELLBAG500mL

Provided with aeration filters and needleless sampling port. For incubator or warm room use only. 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9

CELLBAG1L CB2L/B CELLBAG2L/FC CELLBAG2L/O CELLBAG2L/P CELLBAG2L/S CB10L/B CELLBAG10L/FC (FibraCel) CELLBAG10L/O CELLBAG10L/P CELLBAG10L/pH CELLBAG10L/S CB20L/B CELLBAG20L/FC (FibraCel) CELLBAG20L/O CELLBAG20L/P CELLBAG20L/pH CELLBAG20L/S CELLBAG22L/O CELLBAG22L/pH CB50L/B CELLBAG50L/FC (FibraCel) CELLBAG50L/O CELLBAG50L/P CELLBAG50L/pH CELLBAG50L/P-pH CELLBAG100L/O CELLBAG100L/pH CELLBAG200L/O CELLBAG200L/pH CELLBAG500L/pH CELLBAG1000L/pH

0.05 0.1 0.1 0.1 0.1 0.1 0.5 0.5 0.5 0.5 0.5 0.5 1 1 1 1 1 1 1 1 5 5 5 5 5 5 5 5 10 10 50 100

0.5 1 1 1 1 1 5 5 5 5 5 5 10 10 10 10 10 10 10 10 25 25 25 25 25 25 50 50 100 100 250 500

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