Allegro™ 3D Standard Systems product photo Primary L

Allegro™ 3D Standard Systems

Faster Implementation of Validated Single-Use Systems

The Allegro 3D 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 totes and trolleys, which are essential best-fit solutions for transport, 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 bulk product as well as to manage and supply peripheral fluids around unit operations, such as cell culture media, buffer and cleaning solutions.

The systems are supplied as a single part number as a fully integrated and validated solution. Stringent quality control procedures are followed throughout the manufacturing and supply process including component selection and qualification, system validation, and manufacturing. Where appropriate, these systems can be used immediately for holding various 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
  • Holding process intermediates
  • Bulk product hold

The Allegro 3D systems are available with AdvantaPure platinum-cured silicone or AdvantaFlex tubing depending on the application requirements.

♦ AdvantaPure and AdvantaFlex are trademarks of NewAge Industries Inc.

Quality Standards

The Allegro 3D systems and associated hardware are manufactured under a Quality Management System certified to ISO 9001. The Allegro biocontainers are 100% leak tested during manufacturing 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 tests in vivo for Class VI - 50°C Plastics
  • 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 configurations for the standard systems and system details are shown in Table 1 and Table 2.



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Description

Faster Implementation of Validated Single-Use Systems

The Allegro 3D 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 totes and trolleys, which are essential best-fit solutions for transport, 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 bulk product as well as to manage and supply peripheral fluids around unit operations, such as cell culture media, buffer and cleaning solutions.

The systems are supplied as a single part number as a fully integrated and validated solution. Stringent quality control procedures are followed throughout the manufacturing and supply process including component selection and qualification, system validation, and manufacturing. Where appropriate, these systems can be used immediately for holding various 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
  • Holding process intermediates
  • Bulk product hold

The Allegro 3D systems are available with AdvantaPure platinum-cured silicone or AdvantaFlex tubing depending on the application requirements.

♦ AdvantaPure and AdvantaFlex are trademarks of NewAge Industries Inc.

Quality Standards

The Allegro 3D systems and associated hardware are manufactured under a Quality Management System certified to ISO 9001. The Allegro biocontainers are 100% leak tested during manufacturing 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 tests in vivo for Class VI - 50°C Plastics
  • 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 configurations for the standard systems and system details are shown in Table 1 and Table 2.

Applications
Allegro 3D Systems Applications
  • Cell culture media preparation and storage
  • Buffer preparation and storage
  • Product and cell harvesting
  • Intermediate product storage
  • Bulk product storage prior to filling
Specifications

Allegro 3D Biocontainers

Typical Film Data:

 
Characteristics Methods Typical Values
Thickness    325 µm
Haze  ASTM D-1033  5 %
Water Vapor Transmission Rate  ASTM F-1249  0.4 g/m².day
Oxygen Permeability  ASTM D-3985 (23 °C, 0 % RH)  0.1 cm³/m².day.bar
Carbon Dioxide Permeability  Mocon Permatran C-IV (23 °C, 0 % RH)  0.2 cm³/m².day.bar
 

 

Materials of Construction
 

 

Film:  Inner layer

Ultra Low Density Polyethylene
Gas barrier layer  EVOH
Outer layer Ultra Low Density Polyethylene 
 Ports  Polyethylene
 

 

Operating Parameters

 
 Temperature  4 °C to 40 °C
 

Sterilization Method

 
 Gamma irradiation  Max dose: 50 KGy
 

Allegro 3D Biocontainer Nominal Dimensions*

 

Biocontainer
Volume

Length (L) Maximum Width (W) Maximum Height (H) Inlet Port Outlet Port

Sample Port

50 L 440 mm
(17.3 in.)
420 mm
(16.5 in.)
300 mm
(11.8 in.)
⅜, ½, ¾ and 1 in. ⅜, ½, ¾ and 1 in. 2 x ¼ in.
100 L

 725 mm
(28.5 in.)

525 mm
(20.7 in.)

290 mm
(11.4 in.)

⅜, ½, ¾ and 1 in.

 ⅜, ½, ¾ and 1 in.

¼ in.
200 L

 725 mm
(28.5 in.)

525 mm
(20.7 in.)

570 mm
(22.4 in.)

⅜, ½, ¾ and 1 in.

⅜, ½, ¾ and 1 in.

¼ in.
500 L

1056 mm
(41.6 in.)

725 mm
(28.5 in.)

660 mm
(26.0 in.)

⅜, ½, ¾ and 1 in.

⅜, ½, ¾ and 1 in.

¼ in.
1000 L 1290 mm
(50.8 in.)
980 mm
(38.6 in.)
830 mm
(32.7 in.)
⅜, ½, ¾ and 1 in. ⅜, ½, ¾ and 1 in. ¼ in.
1500 L 1465 mm
(57.7 in.)
1110 mm
(43.7 in.)
960 mm
(37.8 in.)
⅜, ½, ¾ and 1 in. ⅜, ½, ¾ and 1 in. ¼ in.
2000 L 1100 mm
(43.3 in.)
910 mm
(35.8 in.)
2040 mm
(80.3 in.)
1.5 in. 1.5 in. ¼ in.
3000 L 1100 mm
(43.3 in.)
910 mm
(35.8 in.)
2940 mm
(115.7 in.)
1.5 in. 1.5 in. ¼ in.
 
*Retrofit biocontainer systems also available, please contact allegro@pall.com for further details.

Allegro 3D Biocontainers: Nominal Dimensions

For details of the full specification for the Allegro biocontainers included in the single-use systems, please download this datasheet

Ordering Information

Table 1

 
Part Number Volume Tubing Box Quantity Figure Number
6500-0374B 50 L AdvantaPure platinum-cured silicone 3 Figure 2
6500-0374C 50 L AdvantaFlex biopharmaceutical grade TPE 3
6500-0374D 100 L AdvantaPure platinum-cured silicone 3 Figure 3
6500-0373Z 100 L AdvantaFlex biopharmaceutical grade TPE 3
6500-0374E 200 L AdvantaPure platinum-cured silicone 3
6500-0374F 200 L AdvantaFlex biopharmaceutical grade TPE 3
6500-0374G 500 L AdvantaPure platinum-cured silicone 3
6500-0374H 500 L AdvantaFlex biopharmaceutical grade TPE 3
6500-0374J 1000 L AdvantaPure platinum-cured silicone 1 Figure 4
6500-0374K 1500 L AdvantaPure platinum-cured silicone 1
650-203U 2000 L AdvantaPure platinum-cured silicone 1 Figure 5
650-203V 3000 L AdvantaPure platinum-cured silicone 1
 

Table 2

Standard Allegro 3D systems - assembly details

 
Part Number Volume (L) Description Tube Type System Details Figure Number
6500-0374B 50 Standard system 50 L Allegro 3D biocontainer with silicone tubing Silicone Drain line: 50 cm tube ID ⅜ in. with male MPC connector and clamp
Inlet 1: 50 cm tube ID ⅜ in. with male MPC connector and clamp
Inlet 2: 50 cm tube ID ⅜ in. with female MPC connector and clamp
Sample line: 10 cm tube ID ¼ in. with needle-free luer sampling
Figure 2
6500-0374C Standard system 50 L Allegro 3D
biocontainer with TPE tubing
TPE
6500-0374D 100 Standard system 100 L Allegro 3D biocontainer with silicone tubing Silicon Drain line: 50 cm tube ID ½ in. with male MPX connector and clamp
Inlet 1: 50 cm tube ID ½ in. with male MPX connector and clamp
Inlet 2: 50 cm tube ID ½ in. with female MPX connector and clamp
Sample line: 10 cm tube ID ¼ in. with needle-free luer sampling
Figure 3
6500-0373Z Standard system 100 L Allegro 3D biocontainer with TPE tubing TPE
6500-0374E 200 Standard system 200 L Allegro 3D biocontainer with silicone tubing Silicone Drain line: 50 cm tube ID ½ in. with male MPX connector and clamp
Inlet 1: 50 cm tube ID ½ in. with male MPX connector and clamp
Inlet 2: 50 cm tube ID ½ in. with female MPX connector and clamp
Sample line: 10 cm tube ID ¼ in. with needle-free luer sampling
6500-0374F Standard system 200 L Allegro 3D biocontainer with TPE tubing TPE
6500-0374G 500 Standard system 500 L Allegro 3D biocontainer with silicone tubing Silicone Drain line: 150 cm tube ID ½ in. with male MPX connector and clamp
Inlet 1: 150 cm tube ID ½ in. with male MPX connector and clamp
Inlet 2: 150 cm tube ID ½ in. with female MPX connector and clamp
Sample line: 10 cm tube ID ¼ in. with needle-free luer sampling
6500-0374H Standard system 500 L Allegro 3D biocontainer with TPE tubing TPE
6500-0374J 1000 Standard system 1000 L Allegro 3D biocontainer with silicone tubing Silicone Drain line: 150 cm tube ID ¾ in. with 1½ in. sanitary connector and clamp
Inlet 1: 150 cm tube ID ¾ in. with 1½ in. sanitary connector and clamp
Inlet 2: 150 cm tube ID ¾ in. with 1½ in. sanitary connector and clamp
Sample line: 10 cm tube ID ¼ in. with needle-free luer sampling
Figure 4
6500-0374K 1500 Standard system 1500 L Allegro 3D biocontainer with silicone tubing Silicone
650-203U 2000 Standard system 2000 L Allegro 3D biocontainer with silicone tubing Silicone Drain line: 150 cm tube ID ¾ in. with 1½ in. sanitary connector and clamp
Inlet 1: 150 cm tube ID ¾ in. with 1½ in. sanitary connector and clamp
Sample line: 10 cm tube ID ¼ in. with needle-free luer sampling
Figure 5
650-203V 3000 Standard system 3000 L Allegro 3D biocontainer with silicone tubing Silicone
 


Packaging

650-****

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

6500-***

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.

Application
Biocontainers
Segment
Single-Use Solutions