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

• Cell culture media preparation and storage
• Buffer preparation and storage
• Product and cell harvesting
• Intermediate product storage
• Bulk product storage prior to filling

Allegro 3D Biocontainers

Typical Film Data:

Characteristics	Methods
Thickness
Haze	ASTM D-1033
Water Vapor Transmission Rate	ASTM F-1249
Oxygen Permeability	ASTM D-3985 (23 °C, 0 % RH)
Carbon Dioxide Permeability	Mocon Permatran C-IV (23 °C, 0 % RH)

 

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.