Allegro™ 2D Standard Systems product photo Primary L

Allegro™ 2D Standard Systems

The Allegro 2D systems are state-of-the art single-use systems designed and built by Pall Life Sciences in order to speed up the current biopharmaceutical production process. These best-in-class systems are available in standard configurations in order to facilitate faster qualification following customer evaluation. In addition, Pall Life Sciences also provides the supporting hardware for these systems in the form of trays used stand alone, or in conjunction with the bioprocess workstation, which are essential best-fit solutions for mobility, storage and handling.

Pall Life Sciences tests and delivers customized Allegro single-use system solutions to our customers to meet specific application requirements. These systems are employed throughout the Active Pharmaceutical Ingredient (API) production process to hold and process product as well as to manage and supply peripheral fluids around unit operations, such as cell culture media, buffer, sampling operations, and cleaning solutions.The systems are supplied as a single standard part number as a fully integrated and validated solution.

Stringent quality control procedures are followed throughout manufacturing and supply process including component selection and qualification, system validation, and manufacturing. Where appropriate, these systems can be used immediately for holding various process solutions during processing. All standard systems are gamma irradiated.

Typical activities these systems can be used for include:
  • Long term stability studies/shelf life
  • Compatibility studies
  • Adsorption studies
  • Freezing studies
  • Holding process intermediates when no filtration is required
  • Leachable studies

The Allegro 2D systems are available with AdvantaPureu platinum-cured silicone or AdvantaFlexu tubing depending on the application requirements.

Quality Standards

The Allegro 2D systems and associated hardware are manufactured under a Quality Management System certified to ISO 9001. The Allegro 2D biocontainers are 100% leak tested during manufacturing. Allegro 2D 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 tests in vivo for Class VI - 50 °C Plastic
  • USP <87> Biological reactivity tests in vitro (cytotoxicity)
  • ISO 10993 (biological compatibility)
  • USP <661>, EP Section 3.1.5 and JP section 61 part 1 (physicochemical tests for plastics)
  • USP <85> and EP Section 2.6.14 (endotoxins)
  • USP <788> (particulates)
  • European directive 85/572/EEC for food contact plastic materials.

The assembled systems undergo stringent qualification and validation as part of the manufacturing process. Additionally, all assembled systems are inspected for quality. A summary of available 2D configurations for the standard systems and detailed design information are shown in Table 1 and Table 2.

Figure 1

Standard Allegro 2D 10 L system on an Allegro tray system LGRTPE20L



Need Help?
Ask a Question
* Required

Order Products

Allegro™ 2D biocontainer, 5 L, AdvantaFlex tubing, box of 10 product photo

Allegro™ 2D biocontainer, 5 L, AdvantaFlex tubing, box of 10

Product ID: 650-202Q
Unit of Measure
10/EA
Min Order Qty
10
Allegro™ 2D biocontainer, 20 L, AdvantaFlex tubing, box of 10 product photo

Allegro™ 2D biocontainer, 20 L, AdvantaFlex tubing, box of 10

Product ID: 650-202U
Unit of Measure
10/EA
Min Order Qty
10
Allegro™ 2D biocontainer, 50 L, AdvantaFlex tubing, box of 10 product photo

Allegro™ 2D biocontainer, 50 L, AdvantaFlex tubing, box of 10

Product ID: 650-202W
Unit of Measure
10/EA
Min Order Qty
10
Allegro™ 2D biocontainer, 100 mL, AdvantaPure tubing, box of 20 product photo

Allegro™ 2D biocontainer, 100 mL, AdvantaPure tubing, box of 20

Product ID: 650-202D
Unit of Measure
20/EA
Min Order Qty
20
Allegro™ 2D biocontainer, 10 L, AdvantaPure tubing, box of 10 product photo

Allegro™ 2D biocontainer, 10 L, AdvantaPure tubing, box of 10

Product ID: 650-202R
Unit of Measure
10/EA
Min Order Qty
10
Allegro™ 2D biocontainer, 50 mL, AdvantaFlex tubing, box of 20 product photo

Allegro™ 2D biocontainer, 50 mL, AdvantaFlex tubing, box of 20

Product ID: 650-202C
Unit of Measure
20/EA
Min Order Qty
20
Allegro™ 2D biocontainer, 50 mL, AdvantaPure tubing, box of 20 product photo

Allegro™ 2D biocontainer, 50 mL, AdvantaPure tubing, box of 20

Product ID: 650-202B
Unit of Measure
20/EA
Min Order Qty
20
Allegro™ 2D biocontainer, 500 mL, AdvantaFlex tubing, box of 20 product photo

Allegro™ 2D biocontainer, 500 mL, AdvantaFlex tubing, box of 20

Product ID: 650-202J
Unit of Measure
20/EA
Min Order Qty
20
Allegro™ 2D biocontainer, 1 L, AdvantaPure tubing, box of 20 product photo

Allegro™ 2D biocontainer, 1 L, AdvantaPure tubing, box of 20

Product ID: 650-202K
Unit of Measure
20/EA
Min Order Qty
20
Allegro™ 2D biocontainer, 20 L, AdvantaPure tubing, box of 10 product photo

Allegro™ 2D biocontainer, 20 L, AdvantaPure tubing, box of 10

Product ID: 650-202T
Unit of Measure
10/EA
Min Order Qty
10
Allegro™ 2D biocontainer, 2 L, AdvantaPure tubing, box of 20 product photo

Allegro™ 2D biocontainer, 2 L, AdvantaPure tubing, box of 20

Product ID: 650-202M
Unit of Measure
20/EA
Min Order Qty
20
Allegro™ 2D biocontainer, 250 mL, AdvantaFlex tubing, box of 20 product photo

Allegro™ 2D biocontainer, 250 mL, AdvantaFlex tubing, box of 20

Product ID: 650-202G
Unit of Measure
20/EA
Min Order Qty
20

Documents

Datasheets

Download: English

Description

The Allegro 2D systems are state-of-the art single-use systems designed and built by Pall Life Sciences in order to speed up the current biopharmaceutical production process. These best-in-class systems are available in standard configurations in order to facilitate faster qualification following customer evaluation. In addition, Pall Life Sciences also provides the supporting hardware for these systems in the form of trays used stand alone, or in conjunction with the bioprocess workstation, which are essential best-fit solutions for mobility, storage and handling.

Pall Life Sciences tests and delivers customized Allegro single-use system solutions to our customers to meet specific application requirements. These systems are employed throughout the Active Pharmaceutical Ingredient (API) production process to hold and process product as well as to manage and supply peripheral fluids around unit operations, such as cell culture media, buffer, sampling operations, and cleaning solutions.The systems are supplied as a single standard part number as a fully integrated and validated solution.

Stringent quality control procedures are followed throughout manufacturing and supply process including component selection and qualification, system validation, and manufacturing. Where appropriate, these systems can be used immediately for holding various process solutions during processing. All standard systems are gamma irradiated.

Typical activities these systems can be used for include:
  • Long term stability studies/shelf life
  • Compatibility studies
  • Adsorption studies
  • Freezing studies
  • Holding process intermediates when no filtration is required
  • Leachable studies

The Allegro 2D systems are available with AdvantaPureu platinum-cured silicone or AdvantaFlexu tubing depending on the application requirements.

Quality Standards

The Allegro 2D systems and associated hardware are manufactured under a Quality Management System certified to ISO 9001. The Allegro 2D biocontainers are 100% leak tested during manufacturing. Allegro 2D 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 tests in vivo for Class VI - 50 °C Plastic
  • USP <87> Biological reactivity tests in vitro (cytotoxicity)
  • ISO 10993 (biological compatibility)
  • USP <661>, EP Section 3.1.5 and JP section 61 part 1 (physicochemical tests for plastics)
  • USP <85> and EP Section 2.6.14 (endotoxins)
  • USP <788> (particulates)
  • European directive 85/572/EEC for food contact plastic materials.

The assembled systems undergo stringent qualification and validation as part of the manufacturing process. Additionally, all assembled systems are inspected for quality. A summary of available 2D configurations for the standard systems and detailed design information are shown in Table 1 and Table 2.

Figure 1

Standard Allegro 2D 10 L system on an Allegro tray system LGRTPE20L

Specifications

See product datasheet.

Applications

  • Cell cuture media preparation and storage
  • Buffer preparation and storage
  • Product harvesting
  • Chromatography fraction collection
  • Intermediate product storage
  • Bulk product storage prior to filling
  • Sampling

Type

Bioprocess Bags

Use

Fluid Control

Ordering Information

Table 1

Standard Allegro 2D systems - ordering information

 
Part Number Volume Tubing Box Quantity Figure Number
650-202B 50 mL AdvantaPure platinum-cured silicone 20 Figure 2
650-202C 50 mL AdvantaFlex biopharmaceutical grade TPE 20
650-202D 100 mL AdvantaPure platinum-cured silicone 20
650-202E 100 mL AdvantaFlex biopharmaceutical grade TPE 20
650-202F 250 mL AdvantaPure platinum-cured silicone 20
650-202G 250 mL AdvantaFlex biopharmaceutical grade TPE 20
650-202H 500 mL AdvantaPure platinum-cured silicone 20
650-202J 500 mL AdvantaFlex biopharmaceutical grade TPE 20
650-202K 1 L AdvantaPure platinum-cured silicone 20
650-202L 1 L AdvantaFlex biopharmaceutical grade TPE 20
650-202M 2 L AdvantaPure platinum-cured silicone 20
650-202N 2 L AdvantaFlex biopharmaceutical grade TPE 20
650-202P 5 L AdvantaPure platinum-cured silicone 10 Figure 3
650-202Q 5 L AdvantaFlex biopharmaceutical grade TPE 10
650-202R 10 L AdvantaPure platinum-cured silicone 10
650-202S 10 L AdvantaFlex biopharmaceutical grade TPE 10
650-202T 20 L AdvantaPure platinum-cured silicone 10
650-202U 20 L AdvantaFlex biopharmaceutical grade TPE 10
650-202V 50 L AdvantaPure platinum-cured silicone 10
650-202W 50 L AdvantaFlex biopharmaceutical grade TPE 10
 

Table 2

Standard Allegro 2D systems - assembly details

 
Part Number Volume Description System Details Figure Number
650-202B 50 mL Standard system
50 mL Allegro 2D
biocontainer
Line 1: 10 cm AdvantaPure internal diameter (ID) 1/4 in. outer diameter (OD) 7/16 in. with
needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaPure ID 1/4 in. OD 7/16 in. with pinch clamp, male MPC connector
closed with MPC cap
Line 3: Sealed-off port
Figure 2
650-202C 50 mL Standard system
50 mL Allegro 2D
biocontainer
Line 1: 10 cm AdvantaFlex ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaFlex ID 1/4 in. OD 7/16 in. with pinch clamp, male MPC connector closed with MPC cap
Line 3: Sealed-off port
650-202D 100 mL Standard system
100 mL Allegro 2D
biocontainer
Line 1: 10 cm AdvantaPure ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaPure ID 1/4 in. OD 7/16 in. with pinch clamp, male MPC connector closed with MPC cap
Line 3: Sealed-off port
650-202E 100 mL Standard system
100 mL Allegro 2D
biocontainer
Line 1: 10 cm AdvantaFlex ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaFlex ID 1/4 in. OD 7/16 in. with pinch clamp, male MPC connector closed with MPC cap
Line 3: Sealed-off port
650-202F 250 mL Standard system
250 mL Allegro 2D
biocontainer
Line 1: 10 cm AdvantaPure ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaPure ID 1/4 in. OD 7/16 in. with pinch clamp, male MPC connector closed with MPC cap
Line 3: Sealed-off port
650-202G 250 mL Standard system
250 mL Allegro 2D
biocontainer
Line 1: 10 cm AdvantaFlex ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaFlex ID 1/4 in. OD 7/16 in. with pinch clamp, male MPC connector closed with MPC cap
Line 3: Sealed-off port
650-202H 500 mL Standard system
500 mL Allegro 2D
biocontainer
Line 1: 10 cm AdvantaPure ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaPure ID 1/4 in. OD 7/16 in. with pinch clamp, male MPC connector closed with MPC cap
Line 3: Sealed-off port
650-202J 500 mL Standard system
500 mL Allegro 2D
biocontainer
Line 1: 10 cm AdvantaFlex ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaFlex ID 1/4 in. OD 7/16 in. with pinch clamp, male MPC connector closed with MPC cap
Line 3: Sealed-off port
650-202K 1 L Standard system
1 L Allegro 2D
biocontainer
Line 1: 10 cm AdvantaPure ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaPure ID 1/4 in. OD 7/16 in. with pinch clamp, male MPC connector closed with MPC cap
Line 3: Sealed-off port
650-202L 1 L Standard system
1 L Allegro 2D
biocontainer
Line 1: 10 cm AdvantaFlex ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaFlex ID 1/4 in. OD 7/16 in. with pinch clamp, male MPC connector closed with MPC cap
Line 3: Sealed-off port
650-202M 2 L Standard system
2 L Allegro 2D
biocontainer
Line 1: 10 cm AdvantaPure ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaPure ID 1/4 in. OD 7/16 in. with pinch clamp, male MPC connector closed with MPC cap
Line 3: Sealed-off port
650-202N 2 L Standard system
2 L Allegro 2D
biocontainer
Line 1: 10 cm AdvantaFlex ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaFlex ID 1/4 in. OD 7/16 in. with pinch clamp, male MPC connector closed with MPC cap
Line 3: Sealed-off port
650-202P 5 L Standard system
5 L Allegro 2D
biocontainer
Line 1: 10 cm AdvantaPure ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaPure ID 3/8 in. OD 5/8 in. with pinch clamp, female MPC connector closed with MPC plug
Line 3: 20 cm AdvantaPure ID 3/8 in. OD 5/8 in. with pinch clamp, male MPC connector closed with MPC cap
Line 4: Sealed-off port
Figure 3
650-202Q 5 L Standard system
5 L Allegro 2D
biocontainer
Line 1: 10 cm AdvantaFlex ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaFlex ID 3/8 in. OD 5/8 in. with pinch clamp, female MPC connector closed with MPC plug
Line 3: 20 cm AdvantaFlex ID 3/8 in. OD 5/8 in. with pinch clamp, male MPC connector closed with MPC cap
Line 4: Sealed-off port
650-202R 10 L Standard system
10 L Allegro 2D
biocontainer
Line 1: 10 cm AdvantaPure ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaPure ID 3/8 in. OD 5/8 in. with pinch clamp, female MPC connector closed with MPC plug
Line 3: 20 cm AdvantaPure ID 3/8 in. OD 5/8 in. with pinch clamp, male MPC connector closed with MPC cap
Line 4: Sealed-off port
650-202S 10 L Standard system
10 L Allegro 2D
biocontainer
Line 1: 10 cm AdvantaFlex ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaFlex ID 3/8 in. OD 5/8 in. with pinch clamp, female MPC connector closed with MPC plug
Line 3: 20 cm AdvantaFlex ID 3/8 in. OD 5/8 in. with pinch clamp, male MPC connector closed with MPC cap
Line 4: Sealed-off port
650-202T 20 L Standard system
20 L Allegro 2D
biocontainer
Line 1: 10 cm AdvantaPure ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaPure ID 3/8 in. OD 5/8 in. with pinch clamp, female MPC connector closed with MPC plug
Line 3: 20 cm AdvantaPure ID 3/8 in. OD 5/8 in. with pinch clamp, male MPC connector closed with MPC cap
Line 4: Sealed-off port
650-202U 20 L Standard system
20 L Allegro 2D
biocontainer
Line 1: 10 cm AdvantaFlex ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaFlex ID 3/8 in. OD 5/8 in. with pinch clamp, female MPC connector closed with MPC plug
Line 3: 20 cm AdvantaFlex ID 3/8 in. OD 5/8 in. with pinch clamp, male MPC connector closed with MPC cap
Line 4: Sealed-off port
650-202V 50 L Standard system
50 L Allegro 2D
biocontainer
Line 1: 10 cm AdvantaPure ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaPure ID 3/8 in. OD 5/8 in. with pinch clamp, female MPC connector closed with MPC plug
Line 3: 20 cm AdvantaPure ID 3/8 in. OD 5/8 in. with pinch clamp, male MPC connector closed with MPC cap
Line 4: Sealed-off port
650-202W 50 L Standard system
50 L Allegro 2D
biocontainer
Line 1: 10 cm AdvantaFlex ID 1/4 in. OD 7/16 in. with needle-free luer sampling valve and pinch clamp
Line 2: 20 cm AdvantaFlex ID 3/8 in. OD 5/8 in. with pinch clamp, female MPC connector closed with MPC plug
Line 3: 20 cm AdvantaFlex ID 3/8 in. OD 5/8 in. with pinch clamp, male MPC connector closed with MPC cap
Line 4: Sealed-off port
 




Packaging

650-****
Each unit placed is double bagged and heat sealed
Supplied in box quantities, gamma irradiated

Documentation

The documentation supplied with these systems is as follows:

  • System certificate
  • Irradiation certificate

Ordering Information

To order these standard Allegro systems, please contact your local Pall representative and quote the desired part number (from Table 1). Box quantities are as defined in Table 1.

Product Summary

Application mixing requires media and buffer preparation while maintaining homogeneity during hold steps. Allegro™ 2D Biocontainer with Powder Port makes this possible. Using single-use technology this mixing system adds safety and reduces time. The Biocontainer system makes production more efficient while maintaining top quality sanitary conditions throughout the entire biopharmaceutical development process.