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Summary of Contents for Pall Allegro 50 L
- Page 1 Instructions For Use USD2915a Allegro™ 50 L Single-Use Mixer...
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Page 2: Table Of Contents
Contents 1. Introduction ..............................2 2. Warning ..............................2 3. Receipt of Equipment ..........................2 3.1 Allegro Mixer Hardware ..........................2 3.2 Single-Use Systems..........................2 4. Pictures and Schematics...........................3 4.1 Mixer Tote Pictures ..........................3 4.2 UCI Pictures............................4 4.3 Single-Use Pictures..........................5 5. System Operation ............................6 5.1 Connections to the User Control Interface (UCI)..................6 5.2 Connections to the Allegro Jacketed 50 L Mixer..................7 5.3 Preparing the Weigh Platform Trolley for Use ..................9 6. -
Page 3: Introduction
The following instructions are provided for installation of the Pall 50 L Allegro single-use mixer systems in 50 L plastic and jacketed Allegro mixer hardware. The Allegro 50 L mixer can be used for a wide range of applications required in the production of drug products, such as media and buffer preparation as well as final formulation preparations. -
Page 4: Pictures And Schematics
Interface (UCI) Sensor Support Bracket Motor and Gear Box Lockable Castors Figure 2 Standard Allegro 50 L mixer jacketed tote (as an alternative to the plastic tote) Hot/Cold Hot/Cold Hot/Cold 4 Sided Jacket (Left, Fluid Inlet Fluid Low Right, Rear and Bottom) -
Page 5: Uci Pictures
Direction Controls (Variable Speed Drive, Interlock LEDs VSD) Mixer Operation Inflation and Vent Ready LED Control Electrical 125 mm Connections Conductivity for Power Probe and Interlocks Electrical Power Isolation Switch Cabinet Vent and Indicator Light 225 mm pH Probe www.pall.com/biopharm... -
Page 6: Single-Use Pictures
Single-Use Pictures Figure 4 Allegro single-use mixer biocontainer ports NOTE: All materials of construction are polyethylene unless otherwise stated. PSU = Polysulfone ½ in. Fluid Inlet Port 3 in. Powder Addition Port ½ in. Gas Exhaust Port ¼ in. Fluid Inlet Ports ¼... -
Page 7: System Operation
Power Connection for Weighing Platform PORT 1 & PORT 2 Used for connecting appropriate sensor cables at manufacture (depending on mixer configuration). PORT 3 & PORT 4 Used for connecting appropriate retransmitting cables at manufacture (depending on mixer configuration). www.pall.com/biopharm... -
Page 8: Connections To The Allegro Jacketed 50 L Mixer
Used for supplying power to the weighing platform version of the Allegro 50 L Mixer. MOTOR COMMS Used to link the Allegro 50 L mixer to the Pall Allegro MVP automated system to enable control of the mixer remotely from the Allegro MVP system (either manually or as part of a defined automated phase programed in the Allegro MVP system Phase Step Configurator). - Page 9 / or by regulating the flow rate of heat transfer fluid into the jacket. Allegro 50 L jacketed mixer tote pressure drop <0.7 bar at 2 cubic meters/hr. Achieve the desired temperature in the jacket through the thermal circuit (usually the temperature of the product in the biocontainer).
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Page 10: Preparing The Weigh Platform Trolley For Use
Preparing the Weigh Platform Trolley for Use Weigh platform quick start guide: This information is intended to allow the user to quickly start using the weigh platform to measure the weight of the bag contents. For more advanced operation please refer to the full instruction manual included with the mixer. - Page 11 ‘B/G’ instead of ‘Net’ to indicate gross measurement. NOTE: In order to zero the display using the zero or tare button the display must be stable and not fluctuating. For information on calibration please contact Pall for further guidance. www.pall.com/biopharm...
- Page 12 If the weigh platform will not zero, check the wheel locks are on and the system is stable. In certain instances you may need to ‘Set Zero’ by following the steps indicated below:...
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Page 13: Installing Single-Use System (Sus)
Inspect system for damage. Do not use if damaged. Allegro single-use mixer systems are typically double bagged. Remove system carefully from packaging. 1. Check packaging is undamaged prior to opening. 2. Open the box and discard the protective packaging according to local regulations. www.pall.com/biopharm... - Page 14 3. Use the easy-tear to open up side of the SUS outer bag. 4. Pull the top face of the outer bag to tear down the sides to reveal the inner packaging bag. Remove outer bag. 5. Use the easy-tear to open up side of the SUS inner bag.
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Page 15: Installing The System
Power must be ON to control bag pressure during operation 3. Open the door to the Allegro 50 L mixer tote. 4. Push the white section at the top of the single-use system up through the hole in the lid of the plastic or jacketed tote www.pall.com/biopharm... - Page 16 5. Make sure the label of the single- use mixer system is parallel with the front of the tote 6. Check the ‘1 BAG’ light is illuminated 7. Connect the inflation and exhaust lines from the single-use system to the hose barbs on the User Control Interface (UCI) WARNING! Inflation and exhaust lines MUST be...
- Page 17 (see next picture). Drive coupling port Outlet tubing port Outlet tubing port 10. As the system approaches full inflation. STOP inflation by turning the BAG INFLATION switch to the ‘OFF’ position to allow operator to conduct steps 11 & 12. www.pall.com/biopharm...
- Page 18 11. Align the probe manifold on the single- use mixer system to the metal plate at the front of the mixer tote and attach the probe manifold clip. When the shaft coupling is correctly located, the ‘2 SHAFT’ light is illuminated on the UCI. If the light is not on, refer to troubleshooting.
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Page 19: Connecting Sensors
(typically 0.5 Nm). If the port leaks, tighten further. Contact Pall for recommended sensors. 4. Connect the sensor cable to the sensor to allow display of the values (either locally on the mixer via the optional sensor transmitter, or via a remote system such as the Allegro MVP automated system). -
Page 20: Aseptic Port Sensor Attachment (Connecting To A Female Kleenpak Sterile Connector)
Kleenpak sterile connector peel strip. 2. If required autoclave this assembly prior to use utilizing an appropriate support mechanism to avoid damage during autoclave. Contact Pall for details of support manifold. Connecting the bellows assembly (including sensor) to the single-use mixer 1. -
Page 21: Fluid Addition
UCI during filling, reduce the fluid filling rate. The fill rate for the 50 L mixer should not exceed 10 L/min Approximate fill volume can be observed using the volume indicator on the inside of the tote (viewed through the door during filling) www.pall.com/biopharm... -
Page 22: Running The Allegro Mixer
Accurate fill volume (by weight measurement) can be determined using the weigh platform version of the 50 L mixer. Here the mixer trolley is equipped with built in load cells. Running the Allegro Mixer The mixer speed percentage (%) and direction of rotation are controlled by the panel on the UCI. Figure 8 Setting the mixer rotation speed in % To set the % speed... -
Page 23: Adding Powder
Do not attempt to place hand through the 3 in. powder addition port at any point during operation. Risk of personal injury. 5. Reconnect 3 in. powder port cap, secure with clamp and switch inflation to 'ON' to re-inflate the mixer biocontainer. www.pall.com/biopharm... -
Page 24: Draining
Draining Draining can be performed in a number of ways according to the specific application requirements. Table 1 below gives drainage approaches according to application requirements. Before draining the mixer, follow the below instructions: 1. Connect the outlet port to the desired downstream equipment or receptacle according to the specific fitting on the single-use system (e.g. -
Page 25: Single-Use System Removal
Check the cable connection to the micro switch. Replace with spare item or call Pall for warranty/servicing. At the end of Inflation process, System is not powered up Check system is connected correctly to power supply and the the ‘2 SHAFT’... -
Page 26: Specifications
Specifications 50 L 50 L 50 L Std and 50 L Jkt and Standard Unit Jacketed Unit Weigh Plat Weigh Plat 230 Vac PN LGRMXTTE50L230A LGRMXJTTE50L230A LGRMXWTTE50L230A LGRMXWJTTE50L230A 120 Vac PN LGRMXTTE50L120A LGRMXJTTE50L120A LGRMXWTTE50L120A LGRMXWJTTE50L120A Weight (empty) (kg) Weight (full – 50 kg liquid 186.5 195.5 in jacket version (kg)) -
Page 27: General Maintenance
General Maintenance It is recommended that the Allegro 50 L single-use mixer is serviced on an annual basis. Pall Advanced Separation Systems (PASS) Servicing Group can provide this as a service. Please contact your Pall representative for further details. The following checks should be carried out on a regular basis: •... -
Page 28: Weee Declaration
Pall liability under any warranty is limited solely to replacing, or issuing credit for the Allegro systems and hardware that may become defective during the Warranty Period. -
Page 29: Appendix 1: Pneumatic Diagram For Gas Vent Operation
Use this position to control the inflation of the mixer bag during normal operation Switch in OFF position: Use this position when adding powder to the mixer via the powder port or when removing the bag from the system following use. www.pall.com/biopharm... -
Page 30: Appendix 2: Wiring Diagrams
Appendix 2: Wiring Diagrams Appendix 3: General Assembly Drawings... - Page 31 www.pall.com/biopharm...
- Page 33 www.pall.com/biopharm...
- Page 35 www.pall.com/biopharm...
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Page 36: Appendix 4: Ph Electrode Care
Appendix 4: pH Electrode Care Electrode Calibration Since glass pH electrodes measure H+ concentration relative to their reference half-cells, they must be calibrated periodically to ensure accurate, repeatable measurements. Our wide selection of commercial pH calibration buffers include solutions standardized against NIST-certified pH references for calibrating meters with resolution up to 0.001 pH. - Page 37 Korea, Malaysia, New Zealand, Norway, Philippines, Poland, Russia, Singapore, South Africa, biopharm@pall.com e-mail Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam. Distributors in all major industrial areas of the world. To locate the Pall office or distributor nearest you, visit European Headquarters www.pall.com/contact.
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