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Integrity PadReactor A New Culture in Cell Growth ATMI LifeSciences The Source of Bioprocess Efficiency

Integrity PadReactor - Teknol

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Page 1: Integrity PadReactor - Teknol

Integrity™ PadReactor™

A New Culture in Cell Growth

ATMI LifeSciencesThe Source of Bioprocess Efficiency™

Page 2: Integrity PadReactor - Teknol

Overview

The Integrity PadReactor system is a single-use bioreactor specifically designed to fulfill the needs of cell culturists. It is perfectly suited to laboratory environments, process develop-ment centers, clinical material supply and flexible GMP manufacturing.

The PadReactor offers an open architecture controller platform, which gives the end user the opportunity to choose a preferred controller or use an existing control system.

The bioreactor vessel, which offers comparable functionality to classical stirred tank bioreactors, is a single-use bag integrating an internal paddle mixing and sparger system. This innovative bag design allows a non-invasive connection to the system. The paddle is enclosed in a medical grade ULDPE sleeve, made from the same contact material as the bag itself, and is coupled on top of the vessel with the mechanical mixing head.

As with all ATMI LifeSciences’ single-use systems, the Integrity PadReactor utilizes disposable mixing bags made from Integrity TK8 bioprocess film. The product-contacting layer of TK8 film is blow-extruded in-house by ATMI under cleanroom conditions using medical-grade ultra low-density polyethylene resin. It is then laminated to create a gas bar-rier film of exceptional cleanliness, strength, and clarity that is animal derived component free (ADCF) and complies fully with USP Class VI requirements.

The Integrity PadReactor single-use bioreactor consists of the following:

Drive Unit – The flexible drive unit allows the system to cultivate cells in disposable bags. One drive unit can allow the user to mix in multiple disposable mixing bags of various sizes. Each system comes with the appropriate mixing stick for your container.

Mobile Retaining Tank – The purpose of the retaining tank is to support the mixing bag and provide mobility before and after operation. Various tank sizes and options are available.

Bioreactor Vessel – The reactor vessel uses an innovative bag design that allows a non-invasive connection to the mixer. Mixing is achieved when the integrated paddle/sparger inside the bag rotates within the bag.

Highlights & Benefits

reduced shear stress

oxygenation and kLa

adherent cells at very high densities

bag technology)

Open architecture allows connection to preferred or existing control systems.

Mixing is achieved when the integrated paddle/sparger inside the bag rotates within the bag.

F l e x i b l e , F a s t , E f f e c t i v e

Page 3: Integrity PadReactor - Teknol

E f f i c i e n t S o l u t i o n s

PadReactor Vessel & Container

Class VI compliant, fully ADCF (Animal Derived Component Free)

Line Description

1...4

5...8

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17

Multi port fitment - can be used for: nutrient addition, gas exhaust/foam trap, acid addition, media filling, inoculation...

Multi port fitment - can be used for: nutrient addition, gas exhaust/foam trap, acid addition, media filling, inoculation...

Disposable bioreactor bag (ATMI LifeSciences TK8 ADCF film)

Sampling port

Perfusion connection/extra sampling connection

Connection for pH, T or DO probe with aseptic Kleenpak connector

Sensing probe assembly to be connected to (12) by Kleenpak counterpart

Easy drain connector

Micro (20μm) or macro (2mm holes) rigid and in motion sparger device

ATMI paddle mixing stick surrounded by sleeve

Gas inlet through sparger device PadReactor front view diagram.

The single-use vessel is equipped with a paddle sleeve, which allows non-invasive connection to the mixing motor.

PadReactor side view diagram.

Page 4: Integrity PadReactor - Teknol

ATMI, 10851 Louisiana Avenue South, Bloomington , MN 55438 USA, 800.966.6698 or 952.942.0855 ATMI, Reugelstraat 2, 3320 Hoegaarden, Belgium, +32.16.76.80.70 www.atmi-lifesciences.com [email protected] © 2010 ATMI, Inc. All rights reserved. ATMI, the ATMI logo and PadReactor are trademarks or registered trademarks of Advanced Technology Materials, Inc. in the U.S., other countries, or both.

Data Sheet BD004E 1005rev1

ATMI LifeSciences The Source of Bioprocess Efficiency™

PadReactor Weight & Dimensions

Dimension Bag Holder 25L

Width DepthHeight without Drive UnitTotal PadReactor Height

With Drive Unit Positioned:

Jacket Liguid VolumeTotal Weight (Empty Bag)

439 mm559 mm680 mm1132 mm

13 L74 kg

439 mm559 mm700 mm1132 mm

17 L75 kg

Bag Holder 50L

Bag Holder 250L

Bag Holder 600L

Bag Holder 1200L

689 mm878 mm1425 mm1875 mm

44 L200 kg

853 mm1075 mm1435 mm1900 mm

105 L225 kg

1120 mm1265 mm1600 mm2100 mm

124 L300 kg

UtilitiesThe mixing system can be connected to the controller by analog cable.Analogue Connection Specification available on the controller:

1 Digital Input (24VDC) : bag looked

1 Digital Input (24VDC) : door looked 1 Digital Input (24VDC) : power ON status 1 Digital Output (24VDC) : ON/OFF Motor frequency inverter 1 Analogue Output (4-20mA) : Speed Set point 1 Analogue Input (0-10VDC) : Speed Returned Value Lenze model SM frequency inverter

The mixing system can be connected to 230VAC 50Hz Mono 5Amps or to 110VAC 60Hz Mono 20Amps.

PadReactor Drive Unit (to be positioned on top of the container). Adjustable to both 250L, 600L and 1200L container (with adaptor).

Thermostatic Cooling/Heating Bath Guidelines (TCU, Required) For 25 liter bag holder: Working temperature range: -45 °C / +200 °CHeater power: 3.5 kWCooling capacity at 20 °C: 0.80 kWPump pressure/suction max: 0.7/0.4 barPump flow maximum pressure / suction: 25/23 L/minMaximum bath volume: 8 LSize of bath (W x D x H): 150 x 150 x 200 mmOverall dimensions (W x D x H): 285 x 430 x 688 mm

For 250 liter and 600 liter bag holders: Working temperature range: -30 °C / +120 °CHeater power: 6 kWCooling capacity at 20 °C: 4.6 kWPump pressure max: 3.2 barPump flow maximum pressure: 40 L/minMaximum bath volume: 18 LOverall dimensions (W x D x H): 550 x 650 x 970 mm400V, 3/N/PE 5OHz

Indicative performance ratesfor 25 liter bag holder: Heating rate: 22°C: hour (20 to 37 °C in 45 min)Cooling rate: 4°C/hour

Indicative performance ratesfor 250 liter bag holder: Heating rate: 8°C /hour (20 to 37 °C in 2h)Cooling rate: 4°C/hour