Allegro™ 2D Biocontainers

Pall Allegro biocontainers have been specifically designed for applications where biocontainers must be both reliable and flexible. Our biocontainers are made from top quality Low Density Polyethylene (LDPE) film which complies with the very high standards expected for biotechnology and pharmaceutical manufacturing. The Allegro 2D biocontainers also include unique design features which significantly improve the design and robustness of single-use systems, while enabling high product recovery.

Allegro 2D biocontainers are available in sizes from 50 mL up to 50 L. A sampling port is available for all options.

For 5 L biocontainers and larger, there is the option to use a ½ in. port for the inclusion of sensors, therefore allowing process monitoring.

Film Properties and Benefits

• Coextruded film, comprising inert polyethylene in the inner and outer layers and a gas barrier film interlayer
• Inert polyethylene fluid contact layer
• Excellent gas barrier properties
• High clarity and flexibility
• Compatible with a wide range of chemicals 
• Very low level of leachables
• No animal derived ingredients 

Benefits

• Superior film
• High oxygen barrier properties
• Superior design
• Shape enables efficient drainage of the product
• Choice of outlet and inlet connections from ¼ in.to ½ in. Option for ¼ in. port for all sizes
• Potential to insert probe through a ½ in. port
• Ports have been designed to allow tubing attachments with cable ties or barblock
• Improved labelling for optimum traceability
• Bag part number and batch number visible on the bag
• Possibility for the end user to input product batch information
  

Quality Standards

• Manufactured in a controlled environment (Class 10,000)
• Manufactured under a Quality Management System certified to ISO 9001

The materials of construction meet:

• Biological reactivity in vivo for Class VI – 50 °C Plastics
• ISO10993
• USP 87
• USP Physicochemical tests for plastics
• An extensive validation program has been conducted toinclude testing for:
  
  • Oxygen permeability
  • Carbon dioxide permeability
  • Water vapor transmission rate
  • Gamma stability
  • Sterility testing to AAMI
  • Leachables

Further Information

Further information is available at BioPharmaceutical Single Use System Components

• 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

Materials of Construction

Inner Layer	Low Density Polyethylene
Oxygen Barrier Layer	EVOH
Outer Layer	Low Density Polyethylene
Adapters	Polyethylene

Operating Parameters

Temperature	- 80 °C to 45 °C

Sterilization Method

Gamma Irradiation Maximum dose	50 KGy

Film – Typical Data

Characteristics	Method	Typical Value
Thickness		360 μm
Haze	ASTM D-1003	5 %
Water Vapor Transmission Rate	ASTM F-1249	0.4 g/m². day (23 °C)
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)

Nominal Dimensions

Biocontainer Volume	Maximum Width	Maximum Length (without ports)	Inlet/outlet Ports	Sample Port	Sensor Port
50 mL	148 mm	90 mm	¼ in.	¼ in.	No
500 mL	259 mm	140 mm	¼ in.	¼ in.	No
1 L	178 mm	327 mm	¼ in.	¼ in.	No
5 L	300 mm	550 mm	¼ in., 3/8in, ½ in.	¼ in.	½ in.
10 L	430 mm	652 mm	¼ in., 3/8in, ½ in.	¼ in.	½ in.
20 L	497 mm	773 mm	¼ in., 3/8in, ½ in.	¼ in.	½ in.
50 L	690 mm	945 mm	¼ in., 3/8in, ½ in.	¼ in.	½ in.

Allegro biocontainers will not be sold as a stand alone item, but rather integrated into Allegro single-use systems.

In order to choose the right biocontainer for your system, please use the chart provided in the specifiction section, and contact your local Pall representative for further assistance or email Allegro@pall.com