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6.

Installing Single-Use System (SUS)

6.1

Removing the System from the Packaging

WARNING!

Do not use a knife or scissors to open the system packaging. These can damage the single-use
system. Inspect system for damage. Do not use if damaged.
Allegro single-use mixer systems are typically double bagged. Remove system carefully from
packaging.

www.pall.com/biopharm

12

1. Check packaging is undamaged

prior to opening.

2. Open the box and discard the protective

packaging according to local regulations.

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Содержание Allegro 50 L

Страница 1: ...USD2915a Instructions For Use Allegro 50 L Single Use Mixer ...

Страница 2: ...m the Packaging 12 6 2 Installing the System 14 6 3 Connecting Sensors 18 6 3 1 Non Aseptic Port Sensor Attachment 18 6 3 2 Aseptic Port Sensor Attachment Connecting to a Female Kleenpak Sterile Connector 19 7 Fluid Addition 20 8 Running the Allegro Mixer 21 9 Adding Powder 22 10 Draining 23 11 Single Use System Removal 24 12 Troubleshooting 24 13 Specifications 25 14 General Maintenance 26 15 WEE...

Страница 3: ...he exterior of the biocontainers may in circumstances where significant stress repetitive bending and twisting is applied during use cause damage to the molded LDPE inlet and outlet ports The flexible LDPE film of the Allegro 3D biocontainers is not affected This mixer must only be used by persons who have been trained and authorized to do so 3 Receipt of Equipment 3 1 Allegro Mixer Hardware Take ...

Страница 4: ... systems used in the Allegro mixer range are designed for single use only 4 Pictures and Schematics 4 1 Mixer Tote Pictures Figure 1 Standard Allegro 50 L mixer with plastic tote Figure 2 Standard Allegro 50 L mixer jacketed tote as an alternative to the plastic tote Acrylic Perspex Tote Powder Bag tubing Support Frame optional Plastic Tote Door Sensor Support Bracket Motor and Gear Box 4 Sided Ja...

Страница 5: ... Cabinet Vent 225 mm pH Probe Electrical Power Isolation Switch and Indicator Light in Hose Barb Gas Exhaust Port Blanking Plate Used for Optional Transmitters Interlock LEDs Mixer Operation Ready LED Emergency Stop in Hose Barb Gas Inflation Port Mixer Bag Pressure Gauge Impeller Speed and Direction Controls Variable Speed Drive VSD Inflation and Vent Control ...

Страница 6: ...ed PSU Polysulfone in Fluid Inlet Port in Gas Exhaust Port 3 in Powder Addition Port in Fluid Inlet Ports 2 e g acid base in Powder Addition Port Mixer Biocontainer PSU Low Volume Mixer Impeller in Gas Inflation Port in Sensor Port in Sample Port in Sensor Ports 2 Probe Manifold Clip Drive Coupling PSU in Flush Port Outlet PSU Low Volume Mixer Impeller ...

Страница 7: ... Bag Vent using optional 12 mm pneumatic hose if collecting exhaust nitrogen 4 BAG VENT 2 Upstream Bag Vent using optional 12 mm pneumatic hose if collecting exhaust nitrogen Optional Connections Figure 6 Optional sensor and comms connections UCI INNER FACE FRONT PORT 1 PORT 2 Used for connecting appropriate sensor cables at manufacture depending on mixer configuration PORT 3 PORT 4 Used for conne...

Страница 8: ... the other end to the Allegro MVP system allows the impeller to be started and stopped the speed adjusted and the motor direction to be reversed remotely For further information on how to operate these functions please refer to the instructions for use of the Allegro MVP system Note If the remote control cable is removed the port plug must be re attached to enable normal operation from the UCI key...

Страница 9: ... of heat transfer fluid The heat transfer fluid flow rate is adjusted according to the pressure ratings of the Allegro jacketed mixer tote Typical pressure drop is shown above CAUTION Ensure the feed and return lines are isolated and depressurized prior to removal The heat transfer fluid is drained through the jacketed tote drain valve following the operation using the low point drain for heating ...

Страница 10: ...m is shipped with the weight of the tote lifted off the load cells by means of 4 half nuts that are rotated upwards on transit bolts This protects the load cells from shock and vibration during transit The 4 nuts must be wound down the transit bolts to allow the tote to sit freely on the load cells before any measurements are attempted The transit bolts must not be removed full perform ance is obt...

Страница 11: ...any liquids or solids added after this point will be displayed Likewise if the user wishes to only weigh a proportion of the compounds being added pressing the tare key again just before that addition will allow this setting the display back to zero The tare button can be pressed multiple times each time removing the last added weight from the display in readiness for the next to be added and meas...

Страница 12: ...11 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 ...

Страница 13: ...ng These can damage the single use system Inspect system for damage Do not use if damaged Allegro single use mixer systems are typically double bagged Remove system carefully from packaging www pall com biopharm 12 1 Check packaging is undamaged prior to opening 2 Open the box and discard the protective packaging according to local regulations ...

Страница 14: ... 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 6 Pull the top face of the outer bag to tear down the sides to reveal the single use mixer system Remove outer bag 7 Carefully turn the system over to expose the drive shaft coupling ...

Страница 15: ... power and check that the power light comes on WARNING Power must be ON to control bag pressure during operation 1 Apply wheel locks to the mixer tote 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 ...

Страница 16: ...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 connected to appropriate ports and be free from blockage or restriction to ensure proper regulation of air pressure during operation ...

Страница 17: ...9 As the system inflates the shaft coupling will move towards the bottom of the tote Align the shaft coupling sample line and outlet tubing with the ports on the bottom of the tote see next picture 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 Drive coupling port Outlet tubing port Outlet t...

Страница 18: ... the shaft coupling is correctly located the 2 SHAFT light is illuminated on the UCI If the light is not on refer to troubleshooting SHAFT interlock pin which will activate the UCI light when the SUS is in the correct position 12 Close and secure the door and check DOOR interlock light is illuminated 13 Turn the BAG INFLATION switch to the ON position ...

Страница 19: ...Check all lights are on and the variable speed drive is energized shows STOP on the display 1 Turn the BAG INFLATION switch to the OFF position 2 Unscrew the plug from the non aseptic sensor port on the Allegro mixer biocontainer 3 Insert appropriate sensor e g conductivity into the sensor port and screw in to hand tight Note this should be sufficient to create a fluid seal during operation typica...

Страница 20: ...attached to the single use system and the male Kleenpak sterile connector on the bellows assembly and follow the Kleenpak sterile connector instructions Pall document reference number USD 2233 to make the sensor connection 2 Connect the male and female Kleenpak sterile connectors peel strips still in folded position strips facing up by clicking them together inspecting the locating regions on both...

Страница 21: ...r by pushing the sensor into the mixer biocontainer collapsing the bellows 7 Engage the end of the bellows in to the sensor support bracket to maintain optimum sensor position in the mixer 1 Connect a suitable fluid addition line to the mixer inlet line and add fluid WARNING Filling phase must be observed to ensure pressure does not exceed specifications as outlined below Approximate fill volume c...

Страница 22: ...eration 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 To set the speed for the rotation use the panel to increase the figure to the desired value The direction of rotation is set as either FWD or REV FWD Clockwise Up flow REV Counter clockwise Downflow To change from curren...

Страница 23: ...port on the mixer A When connected the red clip B on the powder bag can be removed to dispense the powder into the fluid Some powder bags have a flush line WARNING 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 ...

Страница 24: ...ce the mixer is empty Bag Inflation Then OFF Then VENT and to continue mixing can be switched to Vent to allow during dispensing the collapse of the bag prior to removal mixed volume Once Vent has been selected the top of the bag should be gently pushed down into the mixer tote to free the top hat from the upper gasket to vent the biocontainer and allow removal OFF ON until fluid dispensed To keep...

Страница 25: ...ating correctly by carefully switch operating it manually to check that it is working 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 interlock LED is LED on the UCI power light is illuminated GREEN NOT illuminat...

Страница 26: ...support mm in Materials of Construction Tote Acrylic Perspex 304 Stainless Steel Acrylic Perspex 304 Stainless Steel Frame 304 Stainless Steel 304 Stainless Steel 304 Stainless Steel 304 Stainless Steel Wheels Nylon Stainless Steel Nylon Stainless Steel Nylon Stainless Steel Nylon Stainless Steel Weighing Platform N A N A 20 20 Accuracy g Gas connections Supply Cabinet Vent 10 mm Pneumatic tubing ...

Страница 27: ...al the following critical spares should be considered to be held in stock since failure of these items in use will prevent use of the mixing system Component replacement instructions can be obtained from Pall Advanced Separations Systems PASS engineering group Please contact Pall To isolate the mixer before disconnection or maintenance work Switch off electrical power supply at the main isolating ...

Страница 28: ... that Allegro hardware and systems manufactured by Pall when properly stored and installed and operated at ratings specifications and design conditions will be free from defects in material and workmanship during their shelf life 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 Peri...

Страница 29: ...t the single use system when controlled collapsing the mixer system prior to removal from the system Switch in FILL position 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 ...

Страница 30: ...29 20 Appendix 2 Wiring Diagrams 21 Appendix 3 General Assembly Drawings ...

Страница 31: ...www pall com biopharm 30 ...

Страница 32: ...31 ...

Страница 33: ...www pall com biopharm 32 ...

Страница 34: ...33 ...

Страница 35: ...www pall com biopharm 34 ...

Страница 36: ...calibration buffers for a range of pH values Conditioning pH electrodes are shipped with the electrodes moist Prior to using your electrode for the first time follow these three steps to condition your electrode 1 Remove the protective cap or rubber boot from the bottom of the sensor and rinse the electrode with distilled or deionized water 2 Place the electrode in a beaker containing one of the l...

Страница 37: ...cover the glass bulb and replenish as needed to keep the bulb moist From http www coleparmer com TechLibraryArticle 550 Corporate Headquarters Port Washington NY USA 1 800 717 7255 toll free USA 1 516 484 5400 phone biopharm pall com e mail European Headquarters Fribourg Switzerland 41 0 26 350 53 00 phone LifeSciences EU pall com e mail Asia Pacific Headquarters Singapore 65 6389 6500 phone sgcus...

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