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Flexel® LevMixer® Bag Bag 50L

Shear sensitive proteins can degrade during mixing conditions. This can affect product quality and generate aggregates that in turn yield premature fouling of sterilizing filters.

By combining low shear mixing attributes and high torque, Flexel^® for LevMixer^® is ideal for the homogenization, viral inactivation and formulation of sensitive drug substances and drug products. The levitated impeller eliminates shear effects that can impact your product quality and avoid the generation of aggregates and particles that can reduce your filtration performance.

For Buffer & Media applications, we recommend you to use the Powerful Flexel^® for Magnetic.

To ensure security of supply, the following pre-designed standard products can be delivered with Liveo™ Pharma 50 silicone tubing or Tuflux^® SIL from our partner Raumedic. Traceability of the tubing supplier will be documented in each batch record and provided with the products as an appendix of the certificate of release. As a reminder the final use of the product shall be covered by the end user process qualification. To discover more about our multi-sourcing policy, check the assurance of quality supply page.

Item no.: FXB111567

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Overview

Using Flexel^® for LevMixer^® Pre-designed Solution in your process steps provide you with the best quality, change control, business continuity and delivery performances. You will also benefit from:

Low Shear Mixer to ensure product quality
Intelligent Mixer with a unique in-line monitoring and control to provide consistent quality and process efficiency while meeting PAT and cGMP requirements
Intuitive handling to enable quick start-up and simplified operations of your mixing bags in its Palletank^®
Large scale mixing offering with similar mixing technology for all your process and cGMP production scales

Documents

Application Note

Scalable Buffer Preparation With Single-Use Lev Mixer Technology

en 972.9 kB

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Glycine Buffer Make-up With Flexel® for Magnetic Mixer¹ and Modeling of Low pH Viral Inactivation With Flexel® for Lev Mixer²

en 1.1 MB

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Mixing Performance Study Of the Flexel® for Lev Mixer

en 816.2 kB

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Rapid and Scalable Media Preparation With Powdered Media and Single-Use Lev Mixer Technology

en 1.1 MB

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Brochure

Flexel® Pre-Designed Solutions for Mixing

en 5.0 MB

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Specifications

Aseptic Connector Device - Del

No

Accessories Information

pH Sensor

No

Applications

Application Area

Mixing
Process Step

Drug Product Formulation

Connections (Physical)

Additional Lines

1 bottom line: MPX male + sealing cap + ½″ ID Silicone (Multi-sourced: Liveo™ Pharma 50 or Raumedic Tuflux® SIL) 1 m (40″) + ½″ ID Clear C-Flex® 0.5 m (20″)
Drain Valve

No
Inlet Line

½" Tri-Clamp 1½" sanitary flange + ½" ID Silicone (Multi-sourced: Liveo™ Pharma 50 or Raumedic Tuflux® SIL) 1 m (40") + ½" ID Clear C-Flex® 0.5 m (20")
Outlet Line

½" Tri-Clamp 1½" sanitary flange + ½" ID Silicone (Multi-sourced: Liveo™ Pharma 50 or Raumedic Tuflux® SIL) 1 m (40") + ½" ID Clear C-Flex® 0.5 m (20")
Sampling Lines

Clave needleless sampling port + ¼" ID Silicone (Multi-sourced: Liveo™ Pharma 50 or Raumedic Tuflux® SIL) 0.15 m (6") + ⅛" ID Clear C-Flex®0.5 m (20")
Top Port

Opened 8" with gasket, cap and union

Features

Number of Ports

4 pc.

General Specifications

Filter

No

Materials of Construction

Film Material

Film S40: Polyethylene (PE)
Product Contact Layer Material

Polyethylene (PE)

Product Information

Brand

Flexel®
Mixing Technology

LevMixer®
Pack Size

2

Sterility

Delivery Condition

Sterile

Volumes

Volume

50 L

Accessories & Consumables

Mixing Palletank® and Drive Units

Superconducting Drive Machine with Universal Latch, US / EU plug, 110 - 230 VAC

Item no.

LT-DBTL300

The LevMixer^® drive unit combines low shear mixing attributes and high torque. It is ideal for the homogenization, viral inactivation and formulation of sensitive drug substances and drug products.

The Magnetic Mixer drive unit provides powerful mixing to achieve fast powder dissolution of Buffer and Media.