pall,颇尔,Allegro一次性搅拌器,LGRMXTTE200L230B, LGRMXTTE200L120B, LGRMXTTE500L230B, LGRMXTTE500L120B, LGRMXTTE1000L230B, LGRMXTTE1000L120B

产品名称:
Allegro一次性搅拌器
产品型号:
LGRMXTTE200L230B, LGRMXTTE200L120B, LGRMXTTE500L230B, LGRMXTTE500L120B, LGRMXTTE1000L230B, LGRMXTTE1000L120B
产品描述:

产品介绍

pall,颇尔,Allegro一次性搅拌器,LGRMXTTE200L230B, LGRMXTTE200L120B, LGRMXTTE500L230B, LGRMXTTE500L120B, LGRMXTTE1000L230B, LGRMXTTE1000L120B
pall,颇尔,Allegro一次性搅拌器

Allegro一次性搅拌器

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).
 

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
 


 
 
 
The Allegro mixers are designed to provide exceptional mixing performance for a wide range of applications from upstream through the downstream process to formulation and filling.With jacketed and standard totes that can integrate on-line sensor technologies and load cells, potential applications include:
  • Upstream media preparation for cell culture
  • Downstream pH adjustment, virus inactivation and buffer preparation
  • Final formulation mixing
In addition to the mixers, 颇尔 also offers a wide range of complimentary technologies within the Allegro single-use platform (such as filters incorporating state-of-the-art membranes and sterile connection and disconnection devices) providing fully validated, integrated processing solutions from upstream to final formulation and filling.The Allegro mixers can be combined with the 颇尔 MVP system to fully automate mixing and filtration processes, including fluid transfer to and from the mixers.The high performance mixer lends itself 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.

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 (12 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)
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).

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).

 
The following irradiated system exists as off-the-shelf 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 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
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
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
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
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:    
 

 


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