High performance, easy-to-use mixers for manual
to fully automated solution preparation between 2 and 50 L

Mixing is a critical operation within many biopharmaceutical processes for applications ranging from buffer and media preparation, in-process unit operations such as low pH viral inactivation, to final formulation. The Allegro 50 L single-use mixer is part of Pall’s expanding range of Allegro products and services providing integrated process solutions throughout the drug production process. The Allegro mixers combine critical requirements for single-use technologies, such as extreme ease-of-use, with established engineering design principles and criteria for robust mixer design to deliver the ultimate in mixing performance. The 50 L mixer is a scale down version of the larger mixers in the Allegro range (200 L, 500 L and 1000 L) with the additional feature of an advanced impeller design to facilitate low volume mixing down to 2 L.

Sensor signals can be displayed locally on the mixer, or alternatively, can be connected to an automated Allegro MVP system. With the added capability of a Weighing Platform option, the Allegro mixer from Pall can be fully integrated to the Allegro MVP automated single-use system, providing complete automated process monitoring and control solutions for all applications that require mixing (e.g pH adjustment for buffers and virus inactivation).The standard model of the Allegro 50 L mixer incorporates a plastic tote. As with the other mixers in the range, the mixer is also available in a jacketed stainless steel tote format, and can incorporate sensors (e.g. pH, conductivity and temperature) for on-line monitoring and control.

The Allegro 50 L mixer is designed to provide exceptional mixing performance for a wide range of applications from upstream through downstream process to formulation and filling. Due to its efficient mixing and high turn-down ratio, this mixer is especially suited to small volume formulation applications where fast, reproducible results are required. Potential applications include:

• Upstream media preparation for cell culture
• Downstream pH adjustment, virus inactivation and buffer preparation
• Final formulation mixing

The entire range of Allegro mixers can be combined with the Allegro MVP system to fully automate mixing and filtration processes, including fluid transfer to and from the mixers. These high performance mixers lend themselves especially well to difficult mixing applications (mixing dense powders or high viscosities), applications requiring repeatable, fast mixing performance, or where biologicals sensitive to shear are being mixed.

Features and Benefits

Features	Benefits
Four pitch blade low volume impeller	Efficient low shear general purpose mixing over a wide range of applications. Capable of mixing down to 2 L.
Impeller rotation in clockwise or counter-clockwise direction	Flexibility to perform both up-flow and down-flow for floating (low density) and settling (high density) fluid or solids
Inflation of the mixer bag	Provides mixing envelope for consistent performance from 2 - 50 L and the ability to have a gas blanket in operation
Jacketed tote	Temperature control in appropriate applications
Plastic tote with see-through door	Excellent visibility of mixing process
Sensor integration	In-process monitoring and control with local display and/or integration with automated Allegro MVP systems
Weighing trolley option	Accurate control of fluid and powder additions during operation (can also link to the Allegro MVP system for automation)
Contoured floor (Plastic tote version)	Extremely high fluid recovery – 50 mL hold-up volume following draining (tested with water)

Validation

As part of our rigorous approach to product validation, Pall has conducted a wide range of tests in addition to the general performance tests to prove the robustness of the Allegro 50 L mixer. A summary of key validation tests is provided below:

• Biological safety (USP<87> and <88>)

• Physico-chemical tests (USP<661>)

• Particulate matter in Injections (USP <788>)

• USP<85> LAL endotoxin (compared to limit for WFI)

• Extractables testing (water and ethanol)

• Gamma resistance

• Leak tests

• Drainage/product recovery

• Tubing connection robustness

• Shelf life studies

Full details of product validation in the form of a comprehensive validation guide can be requested from Pall.

Quality Standards

The Allegro single-use mixer biocontainers are 100% leak tested at manufacture.

All Allegro biocontainers, including the mixer, are manufactured in a controlled environment (Class 10,000) certified to ISO 13485 and ISO9001.

The materials of construction of the Allegro mixer biocontainer meet:

• USP<88> Biological reactivity test In Vivo for Class VI - 50 °C Plastics

• USP<87> Biological Reactivity Tests In Vitro, Cytotoxicity

• ISO 10993 Biological Evaluation of Medical Devices

• USP<661> Physico-chemical testing for plastics

• European Pharmacopeia (section 3.1.5)

• Japanese Pharmacopeia (section 61 Part 1)

The Allegro mixer totes are manufactured under a Quality Management System Certified to ISO 9001 and ISO 14001 and are in conformity with the requirements of the European Directive 2004/108/EC (Electromagnetic Compatibility) and European Directive 2006/95/EC (Low Voltage Safety).

The Allegro mixers have been tested on a wide range of applications representing a broad range of biopharmaceutical operations where mixing is required. The Applications Summary Table lists the applications tested and the mixing performance achieved.

Mixing Type	Application	Solution	Time to Mix
Liquid – Liquid	Final Formulation & Filling	1 % (v/v) Acetone	‹1 minute
		200 g/L > 10 g/L NaCl	4.5 minutes
	Conductivity Adjustment	200 g/L > 10 g/L NaCl	‹ 1 minute
Solid – Liquid	Conductivity Adjustment	1 M NaCl	5.5 minutes
	Media Preparation	5.36 g/L DMEM	4 minutes
		47.6 g/L Terrific Broth	3 minutes
	Vaccine Formulation	1.4 g/L Aluminum Hydroxide	‹ 10 minutes
	Final Formulation & Filling	0.04 g/L Allura Red Dye in 250 cP Corn Syrup	3.5 minutes

Allegro 50 L Standard Mixer	Allegro 50 L Jacketed Mixer	Allegro 50 L Standard Mixer and Weigh Platform	Allegro 50 L Jacketed Mixer and Weigh Platform	Allegro 50 L Standard Mixer
230 Vac PN	LGRMXTT E50L230A	LGRMXJTT E50L230A	LGRMXWTT E50L230A	230 Vac PN
120 Vac PN	LGRMXTT E50L120A	LGRMXJTT E50L120A	LGRMXWTT E50L120A	120 Vac PN
Min/Max Volume (L)	2 – 50			Min/Max Volume (L)
Current (A)	5.1 (230 Vac) 9.2 (120 Vac)			Current (A)
Frequency (Hz)	50-60			Frequency (Hz)
Motor Power (kW)	0.37			Motor Power (kW)
Impeller Speed (%)	0 - 100			Impeller Speed (%)
Gas Supply (barg/psi)	2 – 6 / 30 - 90			Gas Supply (barg/psi)
Weight (empty) (kg)	94	133	103	Weight (empty) (kg)
Weight (full) (kg)	144	186.5	153	Weight (full) (kg)
Footprint (L x W) (mm/in.)	883 x 654 / 35 x 26	883 x 654 / 35 x 26	964 x 654 / 40 x 26	Footprint (L x W) (mm/in.)
Height (mm/in.)	1286 / 51	1286 / 51	1364 / 54	Height (mm/in.)
IP Rating	65/Nema 4	65/Nema 4	65/Nema 4	IP Rating
Weighing Platform Accuracy (g)	N/A	20		Weighing Platform Accuracy (g)
Materials of Construction
Tote	Plastic (acrylic)	304 Stainless Steel	Plastic (acrylic)	304 Stainless Steel
Frame	304 Stainless Steel
Wheels	Nylon/Stainless Steel

*Height does not include installed system height or the optional powder bag/tubing support frame