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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.
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 |
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 |
525 mm |
290 mm |
⅜, ½, ¾ and 1 in. |
⅜, ½, ¾ and 1 in. |
¼ in. |
| 200 L |
725 mm |
525 mm |
570 mm |
⅜, ½, ¾ and 1 in. |
⅜, ½, ¾ and 1 in. |
¼ in. |
| 500 L |
1056 mm |
725 mm |
660 mm |
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. |
For details of the full specification for the Allegro biocontainers included in the single-use systems, please download this datasheet
Applications
- Cell culture media preparation and storage
- Buffer preparation and storage
- Product and cell harvesting
- Intermediate product storage
- Bulk product storage prior to filling
Type
Use
Related Documents
Regulatory/Quality Documentation
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.
Product Summary
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