High performance, easy-to-use mixers for manual to fully automated solution preparation
Mixing is a critical operation within biopharmaceutical processes for many applications, ranging from buffer and media preparation, in-process unit operations such as low pH viral inactivation, to final formulation.The Allegro single-use mixers are 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 principles and criteria for robust mixer design to deliver the ultimate in mixing performance.
The Allegro mixers are available in 50 L, 200 L, 500 L and 1000 L sizes, in both standard and jacketed stainless steel tote formats, and can incorporate sensors (e.g. pH, conductivity and temperature) for on-line monitoring and control.Sensor signals can be handled locally on the mixer, or alternatively, can be fed directly to an existing Distributed Control System (DCS) or to an Automated 颇尔 MVP single-use system.With the added capability of load cell integration, the Allegro mixers from 颇尔 can be fully integrated to the Allegro MVP automated single-use systems, 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 mixers are available in 50 L, 200 L, 500 L and 1000 L sizes, in both standard and jacketed stainless steel tote formats, and can incorporate sensors (e.g. pH, conductivity and temperature) for on-line monitoring and control.Sensor signals can be handled locally on the mixer, or alternatively, can be fed directly to an existing Distributed Control System (DCS) or to an Automated 颇尔 MVP single-use system.With the added capability of load cell integration, the Allegro mixers from 颇尔 can be fully integrated to the Allegro MVP automated single-use systems, providing complete automated process monitoring and control solutions for all applications that require mixing (e.g pH adjustment for buffers and virus inactivation).
Product Features and Benefits
| 特点 | 优势 |
| 4 pitch blade impeller | Efficient, low shear general purpose mixing over a wide range of applications and shear sensitive soluitons |
| 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 |
| 特点 | 优势 |
| Design principles based on existing Allegro 3D tote format for ease-of-use | Very easy and quick to install and remove the single-use systems pre and post-use |
| 特点 | 优势 |
| Inflation of the mixer bag | Provides mixing envelope for consistent performance from 50 - 1000 L and the ability to have a gas blanket in operation and mix a range of volumes |
| Mixer Size | 200 L | 500 L | 1000 L |
 |
 |
 |
|
| Minimum Volume (L)* | 50 | 100 | 155 |
| Maximum Volume (L) | 200 | 500 | 1000 |
* minimum volume also covers on-line sensors
| 特点 | 优势 |
| Jacketed Totes | Temperature control in appropriate applications |
| 特点 | 优势 |
| Sensor integration | Allows in-process monitoring and control through integration with automated Allegro MVP systems |
| 特点 | 优势 |
| Uses existing Allegro film with high clarity and ultra-low extractables | Material/validation consistency across all Allegro biocontainer based systems |
| 特点 | 优势 |
| Optional baffles available | To assist in reducing air entrapment at high rotation speed for sensitive molecules |
- Upstream media preparation for cell culture
- Downstream pH adjustment, virus inactivation and buffer preparation
- Final formulation mixing
Application Summary
| Type of Mixing | 解决方案 | 200 L | 500 L (150 rpm) | 1000 L (150rpm) |
| Solid – Liquid | Allura Red Dye (.05 g/L) | 5 seconds (75 rpm) | 2 min | 5 min |
| DMEM Media (5.36 g/L) | < 7 min (150 rpm) | 6 min | 11 min | |
| PBS Buffer (9.6 g/L) | < 5 min (150 rpm) | 4 min | 7 min | |
| NaCl (1 M) (58.44 g/L) | < 1 min (150 rpm) | 7 min | 12 min | |
| Liquid – Liquid | NaCl (200 g/L - 10 g/L) | < 1 min | 4 min | 6 min |
Technical Specifications
| Standard Mixer | Jacketed Mixer | |
| Mixer Tote Part Number |
LGRMXTTE200L230B LGRMXTTE200L120B |
LGRMXTTE200L230B LGRMXTTE200L120B |
| Mixing volume – Max (L) | 200 | 200 |
| Voltage (Vac) |
230 120 |
|
| Current (A) |
5.1 9.2 |
|
| Frequency (Hz) |
50 60 |
|
| Motor power (kW) | 0.37 | |
| Impeller range (rpm) | 50 - 150 | |
| Mixing volume - Covering impeller (L) | 40 | 40 |
| Mixing volume - Covering sensors/sample port (L) | 46 | 46 |
| Gas supply (barg/psig) | 4 - 6 / 60 - 90 | |
| Gas connections |
SUPPLY & CABINET VENT:10 mm Pneumatic tubing outside diameter BAG VENT:12 mm Pneumatic tubing outside diameter |
|
| Weight - empty (kg) | 120 | 195 |
| Weight - full (kg) | 340 | 421 |
| Footprint* (L x W) (mm) | 785 x 615 | 785 x 615 |
| Height (mm) | 1401 | 1401 |
| 材料成分 | Standard Mixer | Jacketed Mixer |
| Mixer Tote Part Number |
LGRMXTTE200L230B LGRMXTTE200L120B |
LGRMXTTE200L230B LGRMXTTE200L120B |
| Mixer tote | 304 SS | |
| Mixer biocontainer (original) |
Biocontainer film; outlet port; inlet manifold & top hat:Low Density Polyethylene (LDPE); Impeller:Polysulfone (PS); Flush outlet port valve (1⁄2 in.):Polysulfone (PS); Shaft:Stainless Steel SS; O-rings:Silicone; Mechanical seals:Low Density Polyethylene (LDPE) |
|
| Mixer biocontainer (sensor biocontainer) |
Biocontainer film; inlet ports; top hat; hose barb outlet port:Low Density Polyethylene (LDPE); Impeller:Polysulfone (PS); Shaft:Stainless Steel SS; O-ring:Silicone; Mechanical seals:Low Density Polyethylene (LDPE) |
|
*Leg centre distances
| Standard Mixer | Jacketed Mixer | |
| Mixer Tote Part Number |
LGRMXTTE500L230B LGRMXTTE500L120B |
LGRMXJTTE500L230B LGRMXJTTE500L120B |
| Mixing volume – Max (L) | 500 | 500 |
| Voltage (Vac) |
230 120 |
|
| Current (A) |
5.1 9.2 |
|
| Frequency (Hz) |
50 60 |
|
| Motor power (kW) | 0.37 | |
| Impeller range (rpm) | 50 - 150 | |
| Mixing volume - Covering impeller (L) | 80 | 80 |
| Mixing volume - Covering sensors/sample port (L) | 100 | 100 |
| Gas supply (barg/psig) | 4 - 6 / 60 - 90 | |
| Gas connections |
SUPPLY & CABINET VENT:10 mm Pneumatic tubing outside diameter BAG VENT:12 mm Pneumatic tubing outside diameter |
|
| Weight - empty (kg) | 180 | 313 |
| Weight - full (kg) | 730 | 878 |
| Footprint* (L x W) (mm) | 1170 x 815 | 1170 x 815 |
| Height (mm) | 1470 | 1470 |
| 材料成分 | ||
| Mixer tote | 304 SS | |
| Mixer biocontainer (sensor biocontainer) |
Biocontainer film; inlet ports; top hat; hose barb outlet port:Low Density Polyethylene (LDPE); Impeller:Polysulfone (PS); Shaft:Stainless Steel SS; O-ring:Silicone; Mechanical seals:Low Density Polyethylene (LDPE) |
|
*Leg centre distances
| Standard Mixer | Jacketed Mixer | |
| Mixer Tote Part Number |
LGRMXTTE1000L230B LGRMXTTE1000L120B |
LGRMXJTTE1000L230B LGRMXJTTE1000L120B |
| Mixing volume – Max (L) | 1000 | 1000 |
| Voltage (Vac) |
230 120 |
|
| Current (A) |
5.1 9.2 |
|
| Frequency (Hz) |
50 60 |
|
| Motor power (kW) | 0.37 | |
| Impeller range (rpm) | 50 - 150 | |
| Mixing volume - Covering impeller (L) | 125 | 125 |
| Mixing volume - Covering sensors/sample port (L) | 155 | 155 |
| Gas supply (barg/psig) | 4 - 6 / 60 - 90 | |
| Gas connections |
SUPPLY & CABINET VENT:10 mm Pneumatic tubing outside diameter BAG VENT:12 mm Pneumatic tubing outside diameter |
|
| Weight - empty (kg) | 220 | 434 |
| Weight - full (kg) | 1320 | 1549 |
| Footprint* (L x W) (mm) | 1360 x 1084 | 1360 x 1084 |
| Height (mm) | 1482 | 1482 |
| 材料成分 | ||
| Mixer tote | 304 SS | |
| Mixer biocontainer (sensor biocontainer) |
Biocontainer film; inlet ports; top hat; hose barb outlet port:Low Density Polyethylene (LDPE); Impeller:Polysulfone (PS); Shaft:Stainless Steel SS; O-ring:Silicone; Mechanical seals:Low Density Polyethylene (LDPE) |
|
*Leg centre distances
Heat Exchange Area Estimation for Jacketed Mixer Totes:
| Mixer Capacity (L) | Assumed Minimum Working Volume (L) | Area Available for Heat Exchange @ Min. Working Volume (m2) | Calculated Maximum Working Volume (L) | Area Available for Heat Exchange @ Max. Working Volume (m2) |
| 200 | 46 | 0.49 | 200 | 1.0 |
| 500 | 100 | 0.93 | 500 | 1.8 |
| 1000 | 155 | 1.37 | 1000 | 2.9 |
Single-Use Mixer Design
The Allegro single-use mixer design is based on proven engineering principles used to develop efficient and appropriate mixing in a wide range of biopharmaceutical applications.Aspects of power input, impeller geometry and position, flow characteristics, flow pattern, pumping and shear were all considered as part of the design process.
pH target of 8.40 to an accuracy of ± 0.06 pH units achieved after
36.5 doses in <12 minutes.
High Performance Mixing
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 summarizes the applications tested and the mixing performance achieved.Allegro single-use mixers have been tested to demonstrate capability to mix a wide variety of liquid-liquid, solid-liquid, and high viscosity solutions.For further details on mixing performance, please refer to the Application note, document reference:USD2744.
Quality Standards and Validation
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)
Product Validation
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 mixer.A summary of key validation tests are summarized 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 (Maximum 50 kGy)
- Leak tests
- Drainage/product recovery
- Tubing connection robustness
The mixer totes are manufactured under a Quality Management System Certified to ISO 9001 and ISO 14001 and is in conformity with the requirements of the European Directive 2004/108/EC (Electromagnetic Compatibility) and European Directive 2006/95/EC (Low Voltage Safety).
Single-use mixer systems can also be designed according to specific application requirements.For a customized design, please contact your 颇尔 representative with your specific application details.
Mixer System Design Number 609-40C 200 L
| Port ID | Basic irradiated design for fluid and powder addition |
| A | ¼ in.Thermo-elastomer tubing, welded end |
| B |
½ in.Thermo-elastomer tubing, welded end |
| C | ½ in.Thermo-elastomer tubing (0.2 m), female MPX and plug |
| D | ½ in.Thermo-elastomer tubing (0.2 m), female MPX and plug |
| E | 3 in.Blanked sanitary powder port |
Mixer System Design Number 609-80L 200 L
| Port ID | Basic design allows for acid/base adjustment and sampling for off-line analytics/QC (using customers own sensors) |
| A | ¼ in.Platinum cured silicone, plugged |
| B | ½ in.Platinum cured silicone, plugged |
| C | ¾ in.Platinum cured silicone with sanitary fittings |
| D | ¼ in.Platinum cured silicone with swabable Luer fittings |
| E | Closed |
| F | Closed |
| G | Closed |
| H | ¾ in.Platinum cured silicone with sanitary fittings |
| I | ¼ in.Platinum cured silicone with MPC male connector and cap |
| J | ¼ in.Platinum cured silicone with MPC male connector and cap |
| 钾 | 3 in.Powder port with gasket, blank and clamp |
Mixer System Design Number 609-80M 200 L
| Port ID | Design allows for 1 non-sterile sensor attachment (pH or Conductivity).Sampling for off-line analytics/QC and acid and base adjustment. |
| A | ¼ in.Platinum cured silicone, plugged |
| B | ½ in.Platinum cured silicone, plugged |
| C | ¾ in.Platinum cured silicone with sanitary fittings |
| D | ¼ in.Platinum cured silicone with swabable Luer fittings |
| E | ¾ in.Platinum cured silicone with sensor screw fitting |
| F | Closed |
| G | Closed |
| H | ¾ in.Platinum cured silicone with sanitary fittings |
| I | ¼ in.Platinum cured silicone with MPC male connector and cap |
| J | ¼ in.Platinum cured silicone with MPC male connector and cap |
| 钾 | 3 in.Powder port with gasket, blank and clamp |
Single-use mixer systems can also be designed according to specific application requirements.Appropriate filters (sterilizing grade/ bioburden/mycoplasma reduction) and Kleenpak sterile connectors for sterile fluid addition can be incorporated into system designs.For a customized design, please contact your 颇尔 representative with your specific application details.
Mixer System Design Number 609-80R – 500 L; 609-80Q – 1000 L
| Port ID | Basic Design:Sample line; Acid/Base addition lines; Main fluid in/out with sanitary ports |
| A | ¼ in.Platinum Cured Silicone, Plugged |
| B | ½ in.Platinum Cured Silicone, Plugged |
| C | 1 in.Platinum Cured Silicone + Sanitary fittings |
| D | ¼ in.Platinum Cured Silicone + Swabable Luer Fittings |
| E | ¾ in.Closed |
| F | ¾ in.Closed |
| G | ½ in.Closed |
| H | 1 in.Platinum Cured Silicone + Sanitary fittings |
| I | ¼ in.Platinum Cured Silicone + MPC Male Connector and Cap |
| J | ¼ in.Platinum Cured Silicone + MPC Male Connector and Cap |
| 钾 | 3 in.Powder Port with Gasket, Blank and Clamp |
Mixer System Design Number 609-80P – 500 L, 609-80Y 1000 L
| Port ID | Design allows for 2 non-sterile sensor attachment (pH and/or Conductivity).Sampling for off-line analytics/QC and acid and base adjustment |
| A | ¼ in.Platinum Cured Silicone, Plugged |
| B | ½ in.Platinum Cured Silicone, Plugged |
| C | 1 in.Platinum Cured Silicone + Sanitary fittings |
| D | ¼ in.Platinum Cured Silicone + Swabable Luer Fittings |
| E | ¾ in.Platinum Cured Silicone + Sensor Port/Plug (non-aseptic) |
| F | ¾ in.Platinum Cured Silicone + Sensor Port/Plug (non-aseptic) |
| G | ½ in.Closed |
| H | 1 in.Platinum Cured Silicone + Sanitary fittings |
| I | ¼ in.Platinum Cured Silicone + MPC Male Connector and Cap |
| J | ¼ in.Platinum Cured Silicone + MPC Male Connector and Cap |
| 钾 | 3 in.Powder Port with Gasket, Blank and Clamp |
To assist in identifying the options please use the following table to identify your specific requirements.Refer to notes for available combinations:
| Specify required options: | 注： | ||
| 1 | Size of mixers required (available:200/500/1000 L) | ||
| 2 | Standard or Jacketed totes: | ||
| 3 | Required voltage (available 120 or 230 V) | ||
| 4 | Standard reusable sensor options (Available:pH, Conductivity, Temperature): | Sensors can be connected to local displays on the mixers, or to off skid automated systems or DCS | |
| 5 | Weighing platform(s) | ||
| 6 | Powder bag support trolley | ||
| 7 | FAT (at 颇尔) | ||
| 8 | SAT (at Site) | ||
| 9 | Application summary: | ||
