Allegro™ 2D Biocontainer - Powder Port product photo Primary L

Allegro™ 2D Biocontainer - Powder Port

Integrated into Allegro 2D Single-Use
Systems for Mixing Applications

Single-use systems have been widely implemented throughout biopharmaceutical processes in many fluid management applications. The main drivers for this are to improve operational flexibility, eliminate cleaning and cleaning validation, improve safety, and ultimately reduce costs by removing non-value added steps from the process and shortening drug development time. Single-use technologies and systems are now available for more advanced applications, such as tangential flow filtration for concentration and diafiltration and in-process mixing.

 
Features Benefits
Biocontainer uses the standard Allegro 2D and 3D biocontainer film Consistent materials across full range of Allegro biocontainers
Powder addition port included on biocontainer Allows for powder to be added into the biocontainer for recirculation mixing
Inert low density polyethylene (LDPE) fluid contact layer High clarity and flexibility
Compatible with a wide range of chemicals Very low level of extractables and leachables
No animal derived ingredients Appropriate materials for biopharmaceutical applications
Excellent gas barrier properties Stability of product during storage
 

Mixing is an essential operation for any biopharmaceutical process such as mAbs, therapeutic proteins or vaccines. Mixing is applied at multiple stages and for many applications within a process.

Typical applications include preparation of buffer and media solutions, control of important fluid parameters such as pH and conductivity around chromatography operations, and final formulation prior to filling.

Mixing systems can vary for a wide range of applications and volume sizes. Pall Life Sciences provides a 2-dimensional (2D) pillow-type Allegro biocontainer equipped with a screw cap powder port for single-use mixing system for small volume batches (10 – 50 L). The Allegro 2D biocontainer with powder port can be integrated into Pall Allegro single-use systems to provide mixing using a recirculation method, or for use on an appropriate rocking mechanism. A typical system configuration for recirculation mixing, showing various options for connections is shown below.

Typical System (with Options for Connections) for a Recirculation Set-Up


Typical System Configuration for Recirculation Mixing with Connection Options

  • 1 Recirculation Loop(with fluid inlet line)
    • Lengths (and connections) defined by application
  • 2 Outlet
    • Showing typical connectors used
      • Kleenpak™ sterile connector
      • Quick connect
    • Showing options for tubing/hose barb connection
      • Cable ties
      • BarbLock
  • 3 Allegro Biocontainer (with powder port)
    • Available in 20 L or 50 L
  • 4 Optional Sampling Line
    • Showing options for sampling
      • Swabable luer (needleless)
      • Septum

This typical set-up can be adapted as required to provide a customized solution depending on the specific mixing application requirements.

BarbLock is a trademark of BarbLock Corporation


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Description

Integrated into Allegro 2D Single-Use
Systems for Mixing Applications

Single-use systems have been widely implemented throughout biopharmaceutical processes in many fluid management applications. The main drivers for this are to improve operational flexibility, eliminate cleaning and cleaning validation, improve safety, and ultimately reduce costs by removing non-value added steps from the process and shortening drug development time. Single-use technologies and systems are now available for more advanced applications, such as tangential flow filtration for concentration and diafiltration and in-process mixing.

 
Features Benefits
Biocontainer uses the standard Allegro 2D and 3D biocontainer film Consistent materials across full range of Allegro biocontainers
Powder addition port included on biocontainer Allows for powder to be added into the biocontainer for recirculation mixing
Inert low density polyethylene (LDPE) fluid contact layer High clarity and flexibility
Compatible with a wide range of chemicals Very low level of extractables and leachables
No animal derived ingredients Appropriate materials for biopharmaceutical applications
Excellent gas barrier properties Stability of product during storage
 

Mixing is an essential operation for any biopharmaceutical process such as mAbs, therapeutic proteins or vaccines. Mixing is applied at multiple stages and for many applications within a process.

Typical applications include preparation of buffer and media solutions, control of important fluid parameters such as pH and conductivity around chromatography operations, and final formulation prior to filling.

Mixing systems can vary for a wide range of applications and volume sizes. Pall Life Sciences provides a 2-dimensional (2D) pillow-type Allegro biocontainer equipped with a screw cap powder port for single-use mixing system for small volume batches (10 – 50 L). The Allegro 2D biocontainer with powder port can be integrated into Pall Allegro single-use systems to provide mixing using a recirculation method, or for use on an appropriate rocking mechanism. A typical system configuration for recirculation mixing, showing various options for connections is shown below.

Typical System (with Options for Connections) for a Recirculation Set-Up


Typical System Configuration for Recirculation Mixing with Connection Options

  • 1 Recirculation Loop(with fluid inlet line)
    • Lengths (and connections) defined by application
  • 2 Outlet
    • Showing typical connectors used
      • Kleenpak™ sterile connector
      • Quick connect
    • Showing options for tubing/hose barb connection
      • Cable ties
      • BarbLock
  • 3 Allegro Biocontainer (with powder port)
    • Available in 20 L or 50 L
  • 4 Optional Sampling Line
    • Showing options for sampling
      • Swabable luer (needleless)
      • Septum

This typical set-up can be adapted as required to provide a customized solution depending on the specific mixing application requirements.

BarbLock is a trademark of BarbLock Corporation
Applications

Typical Mixing Applications(Via Recirculation Approach

  • Media preparation
  • Buffer preparation
  • Homogeneity during hold steps

For more detailed information on applications, please read the Allegro 2D Powder Port Biocontainer, Recirculation Mixing at 20 and 50 L Application Note.
Specifications

Materials of Construction

  • Inner Layer: LDPE
  • Oxygen Barrier Layer: EVOH (ethylene-vinyl alcohol copolymer)
  • Outer Layer: LDPE
  • Fluid Inlet /Outlet /Sample Ports: Polyethylene
  • Powder Port: Polyethylene (LDPE)

Operating Parameters

  • Temperature: 4 °C to 60 °C

Sterilization Method

  • Gamma Irradiation Maximum Dose: 50 KGy

Film Typical Data

 
Thickness   0.325 mm
Haze   5%
Water Vapor Transmission Rate ASTM F-1249 0.32 g / (m².day) at 23 °C
Oxygen Transmission Rate ASTM D-3985 <0.05 cm³ /  (m².day.bar) at 23 °C, 0% RH
Carbon Dioxide Transmission Rate Mocon Permatran C-IV <0.2 cm³ / (m².day.bar) at 23 °C, 0% RH
 

Hardware Specifications

 
Component Length Width Height Weight
Trolley Base Section 1092 mm
(43.0 in.)
821 mm
(32.3 in.)
628 mm
(214.7 in.)
30 Kg
Trolley Stacking Section 1092 mm
(43.0 in.)
821 mm
(32.3 in.)
550 mm
(21.6 in.)
13 Kg
10 and 20 L Tray 800 mm
(31.5 in.)
530 mm
(20.1 in.)
110 mm
(4.3 in.)
5.7 Kg
50 L Tray 1052 mm
(41.4 in.)
812 mm
(31.2 in.)
110 mm
(4.3 in.)
10.4 Kg
Adapter for 200 and 500 L Totes 826 mm
(32.5 in.)
541 mm
(21.3 in.)
183 mm
(7.2 in.)
3.6 Kg
 

Pump Flow Rate

  • Typical Pump Fow Rate During Recirculation Mixing: 13 L/min
Note: Pall can provide specifications of specific pumps to meet the above flow requirement

Allegro Biocontainer Nominal Dimensions

 
Biocontainer Volume Max Width Max Length (Without Ports)3 Inlet/ Outlet Ports Sampling Port Powder Addition Port
20 L 485 mm
(19.5 in.)
738 mm
(29.7 in.)
12. 7 mm
(0.5 in.)
6.3 mm
(0.25 in.)
38mm
(1.5 in.)
50 L 678 mm
(27.2 in.)
909 mm
(36.5 in.)
12.7 mm
(0.5 in.)
6.3 mm
(0.25 in.)
38mm
(1.5 in.)
 

Schematic Structure of Allegro Films


Schematic Structure of Allegro Films 

The powder port biocontainer has the same state-of-the-art low extractable/high transparency film structure as the standard Allegro biocontainers. The only additional material compared to the standard biocontainer range is the powder port (LDPE) to allow the addition of powders or fluids or access for sensors during operations.
Performance
Pall’s application group has conducted a number of performance tests for mixing using the Allegro 2D powder port biocontainer configured for recirculation. The full details of the application work can be found in the Pall Application note USD 2747: Allegro™ 2D Powder Port Biocontainer – Recirculation Mixing.

Mixing Performance

 
  Mixing Achieved in 1 hour?
Solution 20 L 50 L
1 M NaCl Yes Yes
0.75 mM NaOH Yes Yes
Phosphate buffered saline (Dulbecco’s formulation) Yes Yes
Tris buffer Yes Yes
Sodium citrate buffer Yes No
1 M Ammonium sulfate No No
13.4 g/L DMEM (Dulbecco’s modified eagle’s medium) Yes Yes
47.6 g/L Terrific broth Yes Yes
30 g/L Tryptic soy broth Yes No
 

Quality Standards

  • The Allegro trolleys, trays and biocontainers are manufactured under a Quality Management System certified to ISO 9001 and are suitable for use according to GMP
  • The Allegro biocontainers are 100% leak tested
  • Allegro biocontainers are manufactured in a controlled environment (Class 10,000, grade C)
  • The materials of construction of the Allegro biocontainers meet:
    • USP 88 Biological reactivity in vivo for Class VI Plastics - 50 °C
    • USP 87 (cytotoxicity)
    • ISO 10993 (biological compatibility)
    • USP 661 Physicochemical tests for plastics
    • European Pharmacopoeia (Section 3.1.5)
    • Japanese Pharmacopoeia (Section 61 Part 1)
    • European directive 85/572/EEC for food contact plastic materials

An extensive validation program has been conducted to include testing for:
  • Oxygen permeability
  • Carbon dioxide permeability
  • Water vapor transmission rate
  • Gamma stability and shelf life
  • Sterilization according to AAMI/ANSI/ISO 1137
  • Endotoxin and particulate testing
  • Extractables
Ordering Information
The Allegro 2D biocontainers with powder port are supplied as part of an integrated and validated Allegro single-use system. These systems include the powder port biocontainer integrated with other components (e.g. tubing, fittings, standard biocontainers, Kleenpak™ sterile connectors and disconnectors and filters) to comprise a fully operational system.

Please talk to your Pall representative regarding your requirements so we can provide a suitable system design for your application.
Application
Biocontainers