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 颇尔’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.
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.
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 颇尔 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 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.
特色及优点
特点 | 优势 | |
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) | |
验证
As part of our rigorous approach to product validation, 颇尔 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 颇尔.
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 | 应用 | 解决方案 | 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 | |
缓冲液制备 | 9.6 g/L PBS | ‹ 2 minutes | |
1 M Ammonium Sulfate | 4.5 minutes | ||
21 g/L Citrate Buffer | 2 minutes | ||
Dye Test | 0.05 g/L Allura Red Dye | 2.5 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 | |
230 Vac PN |
LGRMXTT E50L230A |
LGRMXJTT E50L230A |
LGRMXWTT E50L230A |
LGRMXJWTT E50L230A |
120 Vac PN |
LGRMXTT E50L120A |
LGRMXJTT E50L120A |
LGRMXWTT E50L120A |
LGRMXJWTT E50L120A |
Min/Max Volume (L) | 2 – 50 | |||
Current (A) | 5.1 (230 Vac) 9.2 (120 Vac) | |||
Frequency (Hz) | 50-60 | |||
Motor Power (kW) | 0.37 | |||
Impeller Speed (%) | 0 - 100 | |||
Gas Supply (barg/psi) | 2 – 6 / 30 - 90 | |||
Weight (empty) (kg) | 94 | 133 | 103 | 142 |
Weight (full) (kg) | 144 | 186.5 | 153 | 195.5 |
Footprint (L x W) (mm/in.) | 883 x 654 / 35 x 26 | 883 x 654 / 35 x 26 | 964 x 654 / 40 x 26 | 964 x 654 / 40 x 26 |
Height (mm/in.) | 30-46 | 30-46 | 30-46 | 30-46 |
IP Rating | 65/Nema 4 | 65/Nema 4 | 65/Nema 4 | 65/Nema 4 |
Weighing Platform Accuracy (g) | 不可用 | 20 | ||
材料成分 | ||||
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
Allegro 50 L Mixer showing installed system and support frame:
Standard Hardware Options
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 |
|
230 Vac |
LGRMXTT E50L230A |
LGRMXJTT E50L230A |
LGRMXWTT E50L230A |
LGRMXJWTT E50L230A |
120 Vac |
LGRMXTT E50L120A |
LGRMXJTT E50L120A |
LGRMXWTT E50L120A |
LGRMXJWTT E50L120A |
230 Vac with pH/Cond Transmitter |
LGRMXTT E50L01 |
LGRMXTT E50L05 |
LGRMXTT E50L09 |
LGRMXTT E50L13 |
120 Vac with pH/Cond Transmitter |
LGRMXTTE50L02 | LGRMXTTE50L06 | LGRMXTTE50L10 | LGRMXTTE50L14 |
230 Vac with Temperature Transmitter |
LGRMXTTE50L03 | LGRMXTTE50L07 | LGRMXTTE50L11 | LGRMXTTE50L15 |
120 Vac with Temperature Transmitter |
LGRMXTTE50L04 | LGRMXTTE50L08 | LGRMXTTE50L12 | LGRMXTTE50L16 |
125 mm Conductivity Sensor |
LGRMX125COND | |||
125 mm pH Sensor | LGRMX125PH | |||
225 mm pH Sensor | LGRMX225PH | |||
PT100 Temperature Sensor |
LGRMXTEMP | |||
Powder Bag/Tubing Support Frame |
LGRMX50LSF | |||
Funnel Support | LGRMX50LFS | |||
Tubing Support | LGRMX50LTBS | |||
FAT | LGRMXTTE50L-FAT | LGRMXJTTE50L-FAT | LGRMXWTTE50L-FAT | LGRMXJWTTE50L-FAT |
Standard Single-use Systems
The following systems exist as standard designs for different mixing applications.Further standard designs are available.Contact 颇尔 for full details.
Single-use mixer systems can also be designed according to specific application requirements.For a customized design, please contact your 颇尔 representative with specific application details.
A | Powder addition port | 3 in. |
B | Fluid addition port | ¼ in. |
C | Fluid addition port | ¼ in. |
D | Main fluid outlet | ½ in. |
E | Sensor port | ¾ in. |
F | Sensor port | ¾ in. |
G | Sensor port | ½ in. |
H | Sample port | ¼ in. |
I | Gas inflation port | ¼ in. |
J | Main fluid inlet | ½ in. |
钾 | Gas exhaust port | ½ in. |
颇尔 Part Number | 描述 | Schematic |
609-100Q | Quick connect fittings Flush outlet port Needleless luer sample port | |
609-100R | Quick connect fittings Flush outlet port Needleless luer sample port One threaded sensor port (for 125 mm sensors) | |
609-100S | Quick connect fittings Flush outlet port Needleless luer sample port Two threaded sensor ports (for 125 mm sensors) | |
颇尔 Part Number | 描述 | Schematic |
609-100T | Quick connect fittings Flush outlet port Needleless luer sample port One thermowell port (for PT100 sensor) | |
609-100U | Kleenpak™ sterile connectors Flush outlet port Needleless luer sample port Sterilizing grade vent filters | |
609-100V | Kleenpak sterile connectors Flush outlet port Needleless luer sample port Sterilizing grade vent filters One Kleenpak sensor port (for 225 mm pH sensor).Use with Bellows assembly (639-80N) | |
639-100W | Quick connect fittings Flush outlet port Needleless luer sample port NON IRRADIATED | |
639-80N | Bellows assembly for use with Kleenpak sensor port and 225 mm pH sensor NON-IRRADIATED | |