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USD 3188
Instructions For Use
TM
PadMixer
1000 Premium Mixer
Filtration. Separation. Solution.
SM
020-17467-00 Instructions For Use PadMixer 1000 Premium RevD

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Summary of Contents for Pall PadMixer 1000 Premium

  • Page 1 USD 3188 Instructions For Use PadMixer 1000 Premium Mixer Filtration. Separation. Solution. 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 2: Table Of Contents

    5.10 Emptying the mixing biocontainer ................. 35 5.11 Emergency stops ....................37 Cleaning, maintenance and inspection activities ............ 38 Cleaning ....................... 38 Maintenance and inspection ................. 38 Retrieving a lost password ..................38 www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 3 Uploading a new PLC code ................... 41 General machine specifications ................47 Materials ....................... 47 Capacity ........................ 47 Noise level ......................47 Operating temperature ..................47 Service ........................47 Warranty ........................48 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 4: Introduction

    If some of the procedures do not suit your needs, please consult your Pall distributor before finalizing your system. Use of this product in a manner other than in accordance with Pall’s current recommendations may lead to injury or product loss.
  • Page 5: Touch Screen Operation

    Table with Set and Actual process parameters o RPM: Mixing speed expressed in revolutions per minute o Mixing time: expressed in hours : minutes : seconds o Alternation time: expressed in hours : minutes : seconds 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 6 The mixer will not stop in the zero position, but in this case the mixing head can easily be manually turned to the zero position in order to disconnect the mixing biocontainer. www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 7: Select Recipe

    This recipe number then appears on the main screen as active recipe number. 4.3.2. Test Mode In the Test Mode s c r e e n the setting values of the active recipe can be changed during mixing. This requires a password. 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 8 By pushing the “Main menu” button the main menu appears again. When the “Test mode” button is pushed, a new password can be entered. If the password is correct the Test Mode menu appears. www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 9: Settings

    Here again a password is required. The following screen with the adjustable parameters appears upon correct entry of the password. Figure 7: Menu “ Settings” Pushing a button shows the corresponding settings. 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 10 At the same time this recipe number from the “Select recipe” menu (see above) is set to match this recipe number. 4.3.3.2 Change password The password requested when choosing the “Test mode” and “Settings” options can be changed here. www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 11 Figure 10: Message when incorrect password By pushing the “Settings” button the settings menu appears again. The following screen appears with an error message if the new password does not correspond with its confirmation: 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 12 The default password that is installed on new systems is 0000 or 1234. The „master‟ password to enter all menus, including the Factory settings is a 5 digit password. Contact your Pall distributor for more information. www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 13 The working hours indicate the period of time during which the mixer is working, in other words the period of time during which the start button on the main screen is active. 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 14 Note that the data for the last completed recipe remain available for reprinting, if necessary, by pushing the “Printer” button on the main screen. Figure 16: Screen to change the Printer settings www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 15 Note: as the system will automatically move down, no object should be present. The display will mention following warning message. Press OK to carry out the calibration. Figure 18: Warning message for calibration 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 16 Entering the menu of the Factory settings is not possible with the first level password. A master password is required (5 digits). Contact your Pall distributor for more information. Figure 19: Screen to change the Factory settings shows these factory settings.
  • Page 17: Inflate

    4.3.6. Reset This resets all error messages, for example after using the emergency stop. 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 18: Troubleshooting

    If the technician has activated the “Manual operation” feature in the “factory settings” screen, a “Manual” button will appear at the bottom of this menu. The following screen appears if this button is pushed. Figure 22: Screen to manually modify machine status www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 19: Error Messages

    Emergency stop module error  Emergency stop button is pressed Information As mentioned earlier, contact information about Pall can be consulted by touching the information icon situated in the top right-hand corner of most screens. 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 20 Figure 24: Supplier contact information www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 21: Installation And Use Of Mixing Biocontainer

    Figure 25: Drain port and vacuum folded mixing biocontainer The drain tube, is introduced through the opening in the bottom plate of the mixing tank. Figure 26: Installation of a 50L PadMixer biocontainer in the mixing tank 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 22 Confirm that the drain is fully closed by sliding the locking collar up until it clicks, then pulling down firmly on the blue BarbLock®* to close the drain, and sliding the locking collar down again to lock it (Figure 29). www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 23: Filling The Mixing Biocontainer

    Filling the mixing biocontainer The biocontainer can now be filled with liquid and/or powder. This can be done with the mixing tank already under the machine or free-standing (e.g. in a separate room). 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 24 After the first 10 - 20L the mixing biocontainer can be pulled gently towards the four corners of the mixing tank. Figure 30: Filling first 10-20L in mixing biocontainer www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 25 The mixing biocontainer corners are properly positioned in the corners of the mixing tank. From now on the filling speed can be increased and manual manipulation is not required anymore. Figure 31: Correctly installed mixing biocontatiner, partially filled 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 26: Setting The Mixing Angle On The Drive Unit

    In general an angle of 10 or 12.5° will be more than sufficient to obtain an efficient mixture. Therefore Pall strongly recommends to not use an angle above 12.5°. www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 27: Connecting The Mixing Biocontainer To The Drive Unit

    For a 200 and 500L mixing tank use the positioning spacers provided with the drive unit to facilitate the centering of the mixing tanks. A 1000L does not require spacers as the tank fits in between the frame (left, right and back) 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 28 Once the central connector in the mixing biocontainer reaches the machine it must be slightly lifted to ensure fixation. Figure 35: Lifting of mixing connector This lifting also allows the stainless steel mixing stick to be inserted in the connection cylinder. www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 29 In this case, gently push the mixing stick in the cylinder, and close the cylinder. The cylinder must be turned clockwise until one cannot turn further by normal manual force (this is almost one half rotation of 180 degrees). 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 30 Figure 38: Inserting the mixing stick in the connection cylinder and closing the cylinder www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 31: Adding Powders

    Adding powders By using a Pall’s Powder Handling Bag, powders can be transferred into the mixing biocontainer in a contained manner. The powder handling bag and the mixing biocontainer have the same size HDPE sanitary connector.
  • Page 32: Creating A Recipe

    In order to run the system without excessive vibration and hence possible damage to the drive and mixing biocontainer, Pall strongly recommends to use a limited mixing speed and angle combination for the larger mixing biocontainer sizes. An overview with the recommended RPM limits for the different mixing biocontainers is shown in Table 2.
  • Page 33: Acceleration And Deceleration Limitations

    In the “Select Recipe” menu one can see the desired height (bottom left) and the actual height (bottom right). 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 34: Inflating The Mixing Biocontainer

    One can also stop the inflation manually (by the touch screen) as soon as the mixing biocontainer is visually sufficiently deployed as shown in Figure 41. www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 35: Starting The Mixing Cycle

    If fitted, the EZ Drain valve should be opened by pushing the locking collar upwards until it clicks, then pushing up on the blue BarbLock®* to open the drain, and pulling the locking collar down again to lock it (Figure 42). 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 36 Remove the EZ Drain clip (if used) then carefully lift the empty mixing biocontainer out of the tank. Dispose of the mixing biocontainer according to applicable EH&S policies and regulations. www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 37: Emergency Stops

    Mixing will also immediately stop if the protective front cover is opened during mixing. In both cases the compressed air supply is cut off as well if the „Inflate‟ function is active at that time. 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 38: Cleaning, Maintenance And Inspection Activities

    (RPM’s, mixing angle used, etc..), so the changeover time is not specified. These parts can be ordered at PALL-Lifesciences. The cleaning and maintenance of the machine can only be conducted when the machine has been turned off.
  • Page 39: Adjusting The Inflation Pressure

    To change the pressure, the inflation must be switched on and the outlet tubing (towards the bag) must be kept closed. Only then the manometer will indicate the outgoing pressure on the display. 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 40: Replacing The Motor

    Remove the head shield until the point where also the emergency button can be removed. Figure 46: View of the head of the machine without the cover www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 41: Uploading A New Plc Code

    Turn off the main power the mixing system. Open the back of the touch screen box (4 screws). Open the CF-card slot and insert the CF- card. Figure 48: Inserting the CF card 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 42 Following screen appears in the language that has been preset: Figure 49: Code Import/Export screen (example when Japanese is selected) If the screen is not preset to English, select English: Figure 50: Code Import/Export screen (example when English is selected) www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 43 Press on the button “Download CF->Display”. Following screen appears: Figure 51: Code Import screen Press on the button “Start”. Following screen appears: Figure 52: Confirmation screen code import 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 44 After a few minutes, the following screen appears: Figure 54: Code import completion screen Press on the button “Back” In the next screen press “Back” again. In the next screen press “Exit”. The following screen appears: www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 45 Press on the right upper corner to enter a second field of Factory Settings. The following screen shows the preferred standard settings that concern the error message in case of on RPM deviations: 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 46 Perform a calibration of the spindles. The installation is complete. Note: Remove the CF-Card from the slot, and close the slot when the system is powered off! Close the back plate of the Touch screen box. www.pall.com/biopharm 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 47: General Machine Specifications

    For information about applicable patents, visit www.pall.com/patents *BarbLock® is a registered trademark of Saint-Gobain Corporation. (Pall logo), Pall and PadMixer are trademarks of Pall Corporation. ® indicates a trademark registered in the USA. © Pall Corporation 2015. 020-17467-00 Instructions For Use PadMixer 1000 Premium RevD...
  • Page 48: Warranty

    Pall liability under any warranty is limited solely to replacing, or issuing credit for the Allegro systems that may become defective during the Warranty Period.

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