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SELECTION GUIDE

Finally, a machine able to mix materials in standard biological storage bags. The Wave Mixer is the first device that can mix materials in completely sealed bags, thereby assuring sterile operation. Rapid mixing is achieved using the wave motion pioneered in our Wave Bioreactor disposable cell culture bioreactors. Wave Mixer

applications include thawing, pooling, mixing, media and buffer preparation.

A sealed bioprocessing bag containing the materials to be mixed is placed in a tray that is in turn placed on a stainless-steel Wave Mixer. The machine rocks the tray back and forth at an optimized rate and at a preset angle. The induced wave motion results in large and rapid bulk movement of the liquid in the bag. Typically, complete homogeneity is achieved in less than one minute.

The Wave Mixer uses a rocking motion to induce waves.

Applications Reconstitution of powdered and concentrated media. Buffer preparation. In-process intermediate blending and homogenization. In-process pooling. Product mixing prior to sampling. Product homogenization prior to filling. Thawing frozen materials in bags and bottles.

Fluid

Wave Mixer

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The Wave Mixer is a disposable system that eliminates the need for a mixing tank and conventional mixer. There is no equipment cleaning, sterilization, validation, or cross-contamination. Media and process intermediates are stored in standard biological storage bags. Why not mix in the same bags? In order to select the correct system for your application, first establish the liquid volume capacity you require. This will determine the M*Bag size you need. Next, select a Wave Mixer System that is suitable for this M*Bag:

Next, select instrumentation and options. Available options include temperature, weight, and pH controllers. M*Bags can also be customized with different options such as specialized ports or additional tubing lengths. Extensive technical literature, detailed specifications and manuals are available online on our website: www.wave-europe.com. For assistance selecting the appropriate options and accessories for your application, please consult with one of our Sales Engineers.

Features

Portable - System20/50 can be used in hot or cold rooms. - System500/1000 mounted on casters.

Rugged stainless-steel construction. System20/50 utilizes standard 20 and 50 liter bags.

Customize M*Bags for specific needs or existing process.

Reliable and well-proven pneumatic or electric operation. Available with integral heater and temperature control for uniform and rapid thawing.

Working Volume M*Bag Part # Fits Wave Mixer

1 liter to 15 liters M*BAG20L MIXER20/50 + MIXKIT20

5 liters to 35 liters M*BAG50L MIXER20/50 + MIXKIT50

50 liters to 300 liters M*BAG500L MIXER500/1000 + MIXKIT500

100 liters to 600 liters M*BAG1000L MIXER500/1000 + MIXKIT1000

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Wave Agitation Theory

For many years, it was thought that mixing materials in a bag was impossible. The only useful ideas were to use a bag as a tank liner. This eliminated the need to clean a tank, but sterile operation was not possible due to the need for an invasive mixer. Other unsuccessful ideas included pump-around loops. A simple fluid mechanics calculation can quickly show that mixing using a pump-around loop is very inefficient, especially for dissolution or suspension of particles.

The Wave Mixer changes all this. Mixing can be done in a sealed bag with no invasive impeller. Waves are generated in the liquid by a precisely regulated rocking motion. The wave motion moves large volumes of liquid in the bag sweeping up particles and dispersing them. It is known that chaotic flow patterns are far more effective than uniform motion in mixing. The Wave Mixer forces a directional reversal every rock. This creates a very effective chaotic folding motion. Wave agitation provides a unique way to achieve non-invasive mixing. While apparently simple in concept, the generation of waves inside flexible containers is a complex phenomenon. Extensive experimental studies in bags from 1 to 500 liters were performed to develop a mathematical model of the process and relate key parameters such as bag geometry, fill volume, rocking speed, and tilt angle. Bag design and supports were developed to eliminate cracking and bag failure. The Wave Mixer is the result of this optimization and is designed to provide efficient, low-cost, and reliable operation. Safety is assured, as unstable operation due to out-of-phase resonance is avoided.

Experiments have been done in bags with volumes up to 500 liters. In all cases, rocking conditions were determined that achieved complete homogeneity within minutes. The only restriction of this technology is that there must be some free space in the bag for the waves to propagate. Typically, up to about 75% of the total bag volume can be filled with liquid. The free space can be air, inert gas, or simply partially empty. Experiments using conductivity measurements prove that the Wave Mixer can rapidly dissolve salts, and suspend solid particles.

Dye injection

10 liters in M*Bag20L. Shows complete mixing of the dye in 6.5 seconds

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MIXER20/50

MIXER20/50 is a very versatile, modular system consisting of a base unit that can be either electrically powered (MIXER20/50E or EH), or powered by compressed air (MIXER20/50P). The compressed air unit is especially suited for incubators and hot rooms since there is no heat generation from a motor.

Mixer20/50 BASE

MIXER20/50P shown with MIXKIT20

Pneumatic rocker base

Typically used inside an incubator, hot room or for applications not requiring temperature control.

Requires compressed air 0.2 scfm at 30-90 psig (dry and filtered). Use LC910 portable compressor for electric operation.

Requires MIXKIT20 for up to 15 liter volume or MIXKIT50 for up to 35 liter working volume.

Part No.

MIXER20/50P

Electric rocker base

For benchtop use. Ideal when compressed air is not available, and temperature control is not desired.

Requires MIXKIT20 for up to 15 liter volume or MIXKIT50 for up to 35 liter working volume.

Touchpanel user interface.

Part No.

MIXER20/50E

MIXER20/50E shown with MIXKIT20

MIXER20/50EH shown with MIXKIT20EH

Heated, Electric rocker base

Ideal for warming and thawing materials in bags. For benchtop use.

Integral temperature controller. Requires MIXKIT20EH for up to 15

liter volume or MIXKIT50EH for up to 35 liter working volume.

Touchpanel user interface.

Part No.

MIXER20/50EH

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After selecting the base, you must select MIXKIT20 or MIXKIT50 according to the capacity required. MIXKIT20 is designed to handle a single M*Bag20L (1 15 liter volume). MIXKIT50 fits a single M*Bag50L (5 35 liter culture) only. Each MIXKIT includes a mounting plate and fiberglass M*Bag MIXHOLDER. MIXKIT20EH and MIXKIT50EH units also include a heater pad and temperature sensor. KITs can easily be interchanged in minutes providing flexibility for a wide range of fluid volumes using a single rocker unit.

Note: MIXKITs can accommodate smaller 5L or 10L bags in addition to those listed above.

For benchtop operation, it may be desirable to cover the MIXHOLDER with a plastic lid. This option is currently available for the MIXKIT20. This prevents accidental damage to the bag and improves temperature control.

Mixer20/50 HOLDER KITS

Kit for MIXER20/50P or MIXER20/50E, includes mounting plate + MIXHOLDER20.

MIXKIT20 accommodates 1x20L M*Bag.

Part No.

MIXKIT20

MIXHOLDER50 shown

Kit for MIXER20/50P or MIXER20/50E, includes mounting plate + MIXHOLDER50.

MIXKIT50 accommodates 1x50L M*Bag.

Part No.

MIXKIT50

Kit for MIXER20/50EH, includes mounting plate +MIXHOLDER20 with integral heater and temperature sensor.

MIXKIT20EH accommodates 1x20L M*Bag.

Requires MIXHEATER20/50.

Part No.

MIXKIT20EH

MIXHOLDER20EH shown

Kit for MIXER20/50EH, includes mounting plate +MIXHOLDER50 with integral heater and temperature sensor.

MIXKIT50EH accommodates 1x50L M*Bag.

Requires MIXHEATER20/50.

Part No.

MIXKIT50EH

Mixer20/50 ACCESSORIES

Spare fiberglass tray for MIXER20/50 with MIXKIT20, accommodates 1x20L M*Bag.

Part No.

MIXHOLDER20

Spare fiberglass tray for MIXER20/50 with MIXKIT50, accommodates 1x50L M*Bag.

Part No.

MIXHOLDER50

Lid for MIXHOLDER20.

Part No.

MIXLID20

Transmitter for MIXER20/50P remote monitoring

4-20mA loop-powered rocking speed transmitter

Part No.

SPDTX

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MIXER20/50 has an extensive line of instrumentation. Choose from weight controllers for easy fill/draining options, optional temperature and pH controllers.

Mixer20/50 INSTRUMENTATION / MISC

Weight monitor/controller for MIXER20/50

Includes pump controller for automated fill/harvest. Mounted in single-bay enclosure or in optional RACK20.

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

Part No.

LOADCELL20M

Temperature controller

Temperature control retrofit option for MIXER20/50P. Mounted in single-bay enclosure or in optional RACK20.

Not included in MIXKIT20EH or MIXKIT50EH. Purchase separately.

Part No.

MIXHEATER20/50

pH controller

Includes acid/base pump controller. Mounted in single-bay enclosure or in optional RACK20. pHPROBE can be supplied presterile for user insertion.

Probe is compatible with female luer lock.

Part No.

pH20

19 Instrument rack

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

Part No.

RACK20

MIXER20 compact multiunit enclosure

Stainless steel construction supplied with 3 slide-out shelves for MIXER20s and removable door. Cannot accommodate MIXER50 KITs.

Mounted on casters for mobility. 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

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MIXER500/1000

MIXER500/1000 is designed for R&D and cGMP 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.

Mixer500/1000 BASE

Mixer500/1000 electric rocker base

Stainless steel construction with linear motor rocking system.

Integral loadcell with adjustable color touchpanel operator interface.

Aeration controller. Dimensions: 231cm x 226cm x 160cm

(91 x 89 x 63)

208-240 VAC, 30 ampere, 3 phase Select MIXER500/1000EH for

temperature control capability.

* Use 1xM*Bag500L or 1xM*Bag1000L

Part No.

MIXER 500/1000E

or

MIXER 500/1000EH

Mixer500/1000 HOLDER KITS

Kit for MIXER500/1000E, includes MIXHOLDER500.

MIXHOLDER500 accommodates 1x500L M*Bag.

Part No.

MIXKIT500

Shown with MIXKIT500

Kit for MIXER500/1000E, includes MIXHOLDER1000.

MIXHOLDER1000 accommodates 1x1000L M*Bag or 2x500L M*Bags.

Part No.

MIXKIT1000

Kit for MIXER500/1000EH, includes MIXHOLDER500 + heater and temperature sensor.

MIXHOLDER500 accommodates 1x500L M*Bag.

Part No.

MIXKIT500EH

Shown with MIXKIT1000

Kit for MIXER500/1000EH, includes MIXHOLDER1000 + heater and temperature sensor.

MIXHOLDER1000 accommodates 1x1000L M*Bag or 2x500L M*Bags.

Part No.

MIXKIT1000EH

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Plug-in modules increase the versatility of MIXER500/1000.

Specially developed probes are available for M*Bags. These are flexible and have a diameter less than 2.5mm for easy insertion into M*Bags.

System500/1000 OPTIONS

pH controller

Includes ACID/BASE pump relays. pHPROBE can be supplied

presterile in Cellbag.

Part No.

pH500

Probes

Electrochemical flexible microbore combination pH electrode

For use with pH20 or pH500 instrumentation. Reusable. Can be provided gamma-sterilized for user insertion.

Part No.

pHPROBE

Immersion type Pt100 temperature sensor

For immersion in Tempwell for in-bag temperature control. For use with M*Bag500 and M*Bag1000 only. Reusable. Can be recalibrated by user.

Part No.

RTDPROBE

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M*Bag mixing chambers

Designed for the production of therapeutics and satisfies all applicable cGMP requirements. Validation data available on request include biocompatibility tests on the M*Bag films and USP Class VI specifications for plastics. All M*Bags are provided with a screwcap port to allow for addition of powders & solids.

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

Biocompatibility 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

ENDOTOXIN : 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: M*Bags may be used from 0oC to 50oC. Max operating pressure is 0.1 bar.

All M*Bags have fill/harvest ports with CPC quick connect fittings standard. Contact Wave Europe Pvt.Ltd. for information on customization of mixing bags to meet your application requirements.

M*Bag Features (standard)

Part # Min vol. (L)

Max vol. (L)

Screwcap

1.25 ID 2.3 ID

1/4" C-Flex

3/8" C-Flex

5/8 C-Flex

pH/Sample port

Spare luer port

M*BAG20L 1 15

M*BAG50L 5 35

M*BAG500L 50 300

M*BAG1000L 100 600

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Wave Mixer Price List PART # DESCRIPTION

Retail Pricing ( )

BASE UNITS MIXER20/50P Pneumatic rocker base

MIXER20/50E Electric rocker base. Specify 110 or 220V operation on order.

MIXER20/50EH Heated, electric rocker base with temperature control capability. Specify 110 or 220V operation on order.

MIXER500/1000E Electric rocker unit for M*Bag500L or M*Bag1000L

MIXER500/1000EH Heated, electric rocker unit for M*Bag500L or M*Bag1000L with temperature control capability

COMPONENTS

MIXKIT20 Mounting plate and fiberglass MIXHOLDER20 for MIXER20/50P or MIXER20/50E

MIXKIT50 Mounting plate and fiberglass MIXHOLDER50 for MIXER20/50P or MIXER20/50E

MIXKIT20EH Mounting plate with integral heater, temperature sensor and fiberglass/stainless-steel MIXHOLDER20 for MIXER20/50EH

MIXKIT50EH Mounting plate with integral heater, temperature sensor and fiberglass/stainless-steel MIXHOLDER50 for MIXER20/50EH

MIXKIT500 Stainless steel MIXHOLDER500 for MIXER500/1000E

MIXKIT1000 Stainless steel MIXHOLDER1000 for MIXER500/1000E

MIXKIT500EH Heater pad and stainless steel MIXHOLDER500 for MIXER500/1000EH

MIXKIT1000EH Heater pad and stainless steel MIXHOLDER1000 for MIXER500/1000EH

ACCESSORIES

MIXHOLDER20 Spare fiberglass holder for M*BAG20

MIXHOLDER50 Spare fiberglass holder for M*BAG50

MIXLID20 Fiberglass cover for MIXKIT20

SPDTX Speed transmitter for MIXER20/50P

CABINET20/50 Stainless steel cabinet for (3) MIXER20/50 bases. Will not accommodate bases with MIXKIT50 installed.

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PART # DESCRIPTION Retail Pricing

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INSTRUMENTATION

LOADCELL20M Weight/perfusion controller for MIXER20/50. Includes 60Kg capacity loadcell plate.

MIXHEATER20/50 Temperature controller RETROFIT option for MIXER20/50P or MIXER20/50E. Requires MIXKIT20EH or MIXKIT50EH.

RACK20 Instrument cabinet 4 bays. Puchase modules individually.

pH20 pH controller (stand alone)

pH500 pH control module for MIXER500/1000

PROBES & CONSUMABLES

pHPROBE pH probe

RTDPROBE Pt100 stainless-steel temperature probe for use with M*Bag500L or 1000L only.

M*Bag Price List

Wave Europe Pvt. Ltd. Unit 10, Matthew Hill Commercial Park Forge Hill, Kinsale Road Cork, IRELAND email: info@wave-europe.com www.wave-europe.com

Applied Critical Fluids Industriestrae 53 68169 Mannheim

Deutschland Tel +49 (0) 621 / 3 09 80 93-0

Fax +49 (0) 621 / 3 09 80 93-99 http://www.acftec.de

Copyright 2005, Wave Europe Pvt. Ltd

QTY (ea) Retail Pricing ( )

M*BAG20L

M*BAG50L

M*BAG500L

M*BAG1000L

SPECIAL - Custom size, fittings, tubes or filters