The Allegro™ 200 L Single-Use Mixer is a device designed for mixing solutions in biopharmaceutical applications. It consists of a mixer tote and a single-use biocontainer, providing a sterile and efficient mixing solution.
Function Description
The Allegro 200 L Single-Use Mixer is used for preparing and mixing solutions in a controlled environment. The system utilizes a single-use biocontainer within a reusable mixer tote, which minimizes cleaning and validation efforts between batches. The mixer operates by inflating the biocontainer and then using an impeller to mix the fluid. It supports both fluid addition and draining operations, with options for maintaining homogeneity during dispensing.
Important Technical Specifications
Mixer Tote (LGRMXTTE200L230 / LGRMXTTE200L120):
- Voltage: 230 Vac (for LGRMXTTE200L230) or 120 Vac (for LGRMXTTE200L120)
- Current: 5.1 A (for 230V) or 9.2 A (for 120V)
- Frequency: 50 Hz (for 230V) or 60 Hz (for 120V)
- Volume: 50 – 200 L
- Gas Supply: 4 – 6 barg
- Gas Connection: 10 mm Pneumatic tubing outside diameter
- Weight: 120 Kg (without fluid in system)
- Footprint: 1054 mm (W) x 748 mm (D)
- Height: 1378 mm
- Materials of Construction (Mixer Tote): 304 SS
Mixer Biocontainer:
- Materials of Construction:
- Biocontainer film; outlet flange; inlet manifold and top hat: Low Density Polyethylene (LDPE)
- Impeller: Polysulfone (PS)
- Outlet port: Polysulfone (PS)
- Shaft: Stainless Steel (SS)
- Outlet O-rings: Silicone
Motor:
UCI Details (LGRMXUCI200L230 / LGRMXUCI200L120):
Usage Features
Installation and Operation:
- Receipt of Equipment: Upon receipt, users should inspect the hardware for damage and ensure all components are present. The mixer hardware should be stored in an appropriate indoor location, clean rooms, and classified areas.
- System Installation: The system involves connecting the power cord to the User Control Interface (UCI) and ensuring proper gas supply connections. Safety interlocks (micro-switches) are crucial for operation, including those for the shaft, doors, and support arm.
- Biocontainer Installation: The single-use system is securely placed into the mixer tote, aligning the impeller shaft with the tube support and inlet port plate. The locating plate on the outlet port must be correctly positioned.
- Inflation and Exhaust Tubing: The biocontainer is inflated using the gas inlet, and exhaust tubing is connected to the UCI. The inflation process is monitored via a pressure gauge.
- Closing Doors: The mixer tote doors are closed and secured, ensuring the system locating plate remains under the closed doors. The handle is turned to the 'closed' position, and the 'DOOR' LED on the UCI should illuminate green.
- Locking Doors: The doors are locked using a key for security.
- Support Arm Activation: The support arm micro switch is depressed, and the 'SUPPORT' LED on the UCI should illuminate green, indicating proper engagement of the powder port.
- Baffles: The mixer tote can be installed with baffles to improve mixing efficiency and reduce air entrapment and vortex generation.
- Fluid Addition: Fluid is added to the single-use mixer system through the fluid inlet line. The pressure in the biocontainer should be monitored during filling, ensuring it does not exceed 20 mbar.
- Powder Addition: Powder can be added once the desired volume of fluid is achieved. The bag inflation control valve is switched to 'OFF' position, and the powder port is opened for adding solids.
- Operating the Mixer: The mixer speed (RPM) and direction of rotation (clockwise/downflow or counter-clockwise/up-flow) can be controlled via the UCI panel. The maximum continuous mixing life is 3 days (72 hours).
Drain/Removal Instructions:
- Draining: The outlet port is connected to downstream equipment, and the outlet port valve is opened to allow fluid to flow out. Draining can be performed with the mixer off (for stable solutions) or running (to maintain homogeneity).
- Gas Blanket: If a gas blanket is used during draining, it must be deactivated at the end of dispensing.
- Fluid Recovery: The tote design maximizes fluid recovery, with typical residual volumes less than 150 mL. Lifting the edges of the biocontainer can further improve recovery.
- Biocontainer Removal: After drainage, all inlets and outlets are closed and tubing removed. The tote doors are unlocked and opened. The impeller shaft is pulled out, and the biocontainer is fully removed for disposal according to local regulations.
Maintenance Features
General Maintenance Recommendations:
- Annual Servicing: It is recommended that the Allegro 200 L single-use mixer be serviced on an annual basis by Pall Advanced Separation Systems (PASS).
- Critical Spares: Certain critical spares should be kept in stock to prevent system downtime. These include:
- Support arm/seal housing microswitch (200 L mixer tote) (Part Number: DC201772C00)
- Door magnetic switch (200 L mixer tote) (Part Number: DC201773C00)
- UCI cabinet key (Part Number: DC201774B00)
- Tote/lock key (Part Number: DC201775B00)
- Tube support assembly (Part Number: KDC201340C00)
- Support arm (Part Number: DC200694C00)
- Motor and gearbox assembly (Part Number: DC201385C00)
- UCI (230 V) (Part Number: LGRMXUCI200L230)
- UCI (120 V) (Part Number: LGRMXUCI200L120)
- Optional Spares:
- Baffle kit (Part Number: LGRMXBK200L)
- Powder bag support frame (Part Number: LGRMXPBS200L)
Troubleshooting:
The manual provides a detailed troubleshooting guide for various issues, including:
- 'Shaft' LED not illuminated: Possible causes include the system not being powered up or a malfunction of the micro switch. Corrective actions involve checking power supply, cable connections, and replacing spare items.
- Misalignment of seal housing: Re-installing the single-use system with careful alignment of the shaft and seal housing.
- 'Door' LED not illuminated: Check power supply, ensure the door is closed, and the handle is in the 'closed' position.
- 'Support' LED not illuminated: Check power supply, cable connections, and ensure the powder port is fully located.
- Inflation process stopped: Check if the single-use mixer system is snagged.
WEEE Compliance:
The product contains electrical and electronic materials and should be disposed of separately from unsorted waste, in accordance with European Directive 2002/96/EC, to prevent adverse environmental and health effects. Users are advised to recycle the product when replacing it or when it has outlived its useful life.
Warranty:
Pall warrants that Allegro hardware and systems, when properly stored, installed, and operated according to specifications, will be free from defects in material and workmanship during their shelf life. Pall's liability is limited to replacing or crediting defective Allegro systems and hardware.