설명
Integrated into Allegro 2D Single-Use
Systems for Mixing Applications
2D single-use systems have been widely implemented throughout biopharmaceutical processes in many fluid management applications. The main drivers for this are improving operational flexibility, eliminating cleaning and cleaning validation, improving safety, and ultimately reducing 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, 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 system included on biocontainer | Allows for a 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 |
Typical System (with Options for Connections) for a Recirculation Set-Up
- 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♦
- Showing typical connectors used
- 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
- Showing options for sampling
♦BarbLock is a trademark of BarbLock Corporation
응용분야
Typical Mixing Applications(Via Recirculation Approach
- Media preparation
- Buffer preparation
- Homogeneity during hold steps
규격사양
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
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
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.성능
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
- 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
종류
Powder Handling Bags
사용
Powder Handling
관련 문서
Regulatory/Quality Documentation
주문정보
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.
적용분야
Biocontainers
영역
Single-Use Solutions
