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020-17467-00 Instructions For Use PadMixer 1000 Premium RevD

www.pall.com/biopharm

4

1. Introduction

The purpose of this manual is to inform the users about the safe and correct use of the
PadMixer 1000 Premium. This  includes  all  persons  who  have  the  task  of  installing,
commissioning,  adjusting,  maintaining,  cleaning,  repairing, transporting or  scrapping the
machine. Before using this machine all persons involved should  thoroughly read and
understand the user manual. All safety precautions and safety provisions in use in the
company must be known and respected.

This user manual must always be available near the machine. It is very important that all
instructions are carefully followed and, where appropriate, they should be incorporated into
the user’s standard operating procedures. 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. Pall cannot accept liability for such injury or loss.

2. Safety warnings

Operation outside the specifications defined in this manual may cause personal injury

and result in damage to the equipment.

No operations (cleaning, maintenance, ...) may be performed on the machine if the

machine is not switched off. Protections around moving parts may not be removed.

3. Assembly and commissioning

It is not permitted to move the machine when a tank and/or mixing biocontainer is connected
to it. To move the machine push it from the backside.

Do not attempt to move the machine by pushing/pulling the mixing head.

Required facilities:

Electricity:

The system 701024 can be used on a single phase net of 220V.
The system 701039 can be used on a single phase net of 110V.
The fuse present in the local power supply cabinet has to be minimum
16Ampère, with a curve C or curve D.
In case a differential switch is present in the local power supply
cabinet, it has to be type A or type B.

Compressed air:

Min. 3 bar, max. 8 bar.
Use of nitrogen is permitted.
The connection of the system to the compressed air system is effected
by connecting a  6 mm ID compressed air hose to the compressed air
coupling closest to the rear of the  machine.
A compressed air cable is provided on the coupling closest to the front
of the machine  with a fast coupling to be connected to the mixing
biocontainer.
The outgoing pressure (to the mixing biocontainer) can be adjusted by
means of the manometer  underneath the mixing head cover plate. This
pressure is preset to a maximum of  500 mbar.

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Содержание PadMixer 1000 Premium

Страница 1: ...020 17467 00 Instructions For Use PadMixer 1000 Premium RevD Filtration Separation Solution SM Instructions For Use PadMixerTM 1000 Premium Mixer USD 3188 ...

Страница 2: ...ixing biocontainer 21 5 2 Filling the mixing biocontainer 23 5 3 Setting the mixing angle on the drive unit 26 5 4 Connecting the mixing biocontainer to the drive unit 27 5 5 Adding powders 31 5 6 Creating a recipe 32 5 6 1 Guidelines to define the correct connection height 32 5 6 2 Mixing speed and mixing angle limitations 32 5 6 3 Acceleration and deceleration limitations 33 5 7 Height adjustmen...

Страница 3: ...placing the printer roll 38 6 5 Adjusting the inflation pressure 39 6 6 Replacing the motor 40 6 7 Uploading a new PLC code 41 7 General machine specifications 47 7 1 Materials 47 7 2 Capacity 47 7 3 Noise level 47 7 4 Operating temperature 47 8 Service 47 9 Warranty 48 ...

Страница 4: ...njury and result in damage to the equipment No operations cleaning maintenance may be performed on the machine if the machine is not switched off Protections around moving parts may not be removed 3 Assembly and commissioning It is not permitted to move the machine when a tank and or mixing biocontainer is connected to it To move the machine push it from the backside Do not attempt to move the mac...

Страница 5: ...nderlying function or to change the underlying adjustment Also the start pause and stop symbols can be touched to perform their function The following symbol appears in the top left corner on different screens and can be used to return to the previous screen and finally to the main menu Start up screen A screen saver appears when the main power switch is switched on The main screen is shown when t...

Страница 6: ... pushed the mixer decelerates in accordance with the set deceleration time The actual data remain valid so that the recipe can be continued with the remaining actual values when the Start button is pushed again If the Stop button is pushed the mixer decelerates and the actual values are deleted In both cases the mixer always returns to the zero position This is the position where connecting the mi...

Страница 7: ...rs on top It may be changed by keying the number A small numeric keypad appears with which a number may be entered To enter a number via the numerical keypad first push CLR clear to delete the old value then enter the new value Alternatively the recipe number can be increased or decreased by 1 using the up and down arrows The data of the selected recipe are shown under the recipe number Pushing th...

Страница 8: ...If the password you entered is incorrect the following screen appears with an error message Figure 5 Message when incorrect password entered 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 ...

Страница 9: ...ecipe and the new values are immediately executed The executed changes will only apply during this test mode The initial values of the recipe will not be changed 4 3 3 Settings This shows the menu in which the different mixing parameters can be changed Here again a password is required The following screen with the adjustable parameters appears upon correct entry of the password Figure 7 Menu Sett...

Страница 10: ...istance to the floor depends on the type of mixing tank and mixing biocontainer used This height should be determined when a recipe is created The mixing system will not be able to start unless the system is installed at its correct height to avoid a too high or too low position The min Height value can be entered in 2 ways either by entering the value in mm or by placing physically installing the...

Страница 11: ...then the new password and the confirmation thereof If the old password is incorrect the following screen appears with the error message 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 ...

Страница 12: ...ries for the existing password and the new password are correct Figure 12 Message when new password is activated If this screen appears the new password is activated Pushing the Settings button returns the user to the settings menu 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 Contac...

Страница 13: ...ng hours are given here for information The indication of the total working hours top row cannot be reset in other words the total counter from the first moment that the machine was started The indication of the working hours since the last reset bottom row can be reset by pushing the button situated on the right Figure 14 Screen to view and reset the Working hours The working hours indicate the p...

Страница 14: ... screen Also the time and date can be set Figure 15 Screen to change the Time settings 4 3 3 6 Printer setting The data for the completed recipe can be printed out on the printer On the following screen the choice can be made to print out the data on completion of each recipe automatically or not Note that the data for the last completed recipe remain available for reprinting if necessary by pushi...

Страница 15: ...the height measurement through the spindles need to be calibrated By pressing the calibrate spindles button the system will go to its lowest possible position typically 675mm and will reset itself It is at any time possible to perform an additional calibration in case the system height mentioned on the display does not match with the actual height Figure 17 Screen to view the spindle location sett...

Страница 16: ...to change the Factory settings shows these factory settings In the lower right hand corner of the screen one can see the current active password Figure 19 Screen to change the Factory settings When pressing the right arrow one can modify some additional parameters related to an alarm that the system can give when during mixing the actual RPM deviates from the set value One can define the time befo...

Страница 17: ...r if the mixing biocontainer is emptied and the detection is released the compressed air will reactivate after a delay of three seconds The emergency stop is pressed The protective front cover is opened 4 3 5 Print This prints out the data for the last finished recipe To print the last recipe make sure the mixing system has completely stopped rotating Note the total mixing time stated on the label...

Страница 18: ... defective This function is intended solely for the technician carrying out troubleshooting on the machine Figure 21 Screen to consult the status of the machine inputs When pushing the Outputs button a menu appears that displays the status of the outputs inflation valve fan If the technician has activated the Manual operation feature in the factory settings screen a Manual button will appear at th...

Страница 19: ...mplete list of error messages Figure 23 Screen to consult and reset alarms The error messages can be reset by pushing the reset button in the main menu or alternatively by pushing the reset button in the list of error messages The following malfunctions corresponding error messages may occur Protective front cover is open Frequency regulator error Emergency stop module error Emergency stop button ...

Страница 20: ...020 17467 00 Instructions For Use PadMixer 1000 Premium RevD www pall com biopharm 20 Figure 24 Supplier contact information ...

Страница 21: ...er port In case of a liquid liquid mixing biocontainer the powder port is replaced by a second filling tube The mixing biocontainers are packed under vacuum and folded in such a way that the drain port is the lowest point of the 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 Figu...

Страница 22: ...s an EZ Drain fitment position it in the drain port cutout install the drain insert plate see above Figure 15 and then snap the EZ Drain clip over the fitment OUTSIDE the tank Figure 27 and Figure 28 Figure 27 EZ Drain clip installation Figure 28 EZ Drain clip installed outside the tank Confirm that the drain is fully closed by sliding the locking collar up until it clicks then pulling down firmly...

Страница 23: ...terile application should be done only via a sterilizing grade vent filter integral to the mixing biocontainer OPTIONAL Any sensors pH conductivity probe etc should be installed before filling the mixing biocontainer A temperature pt 100 probe can be installed after since it is not fluid contact 5 2 Filling the mixing biocontainer The biocontainer can now be filled with liquid and or powder This c...

Страница 24: ...ontainer starting of the mixing However different applications or processes can have a different mixing biocontainer handling sequence Make sure that the clamp on the drain tubing is closed and that the clamps on the filling tubing are open Connect the filling tube to the liquid supply and start filling It is important that the filling of the first liters of water happens gently to be able to posi...

Страница 25: ...iocontainer where the bottom is properly installed 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 ...

Страница 26: ...gh stress on the film The angle can be changed by unlocking the 2 fixation pins at the back and by pushing pulling the mixing head in another angle while keeping the 2 other fixation pins in the front unlocked Figure 32 Setting the mixing angle The life time of a mixing biocontainer will decrease with increasing mixing angle as there are more stresses on the mixing sleeve In general an angle of 10...

Страница 27: ... slides over the white plate Figure 33 Inserting the mixing stick The mixing tank can now be rolled under the system Ensure that the protective front cover is open that the connection cylinder is in the zero position pointing towards the front and that the outer cylinder is open This cylinder can be turned open manually in the counterclockwise direction The mixing tank can now be slowly positioned...

Страница 28: ... 1000L containers to damage the machine two PTFE strips are present to stop the mixing tank 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 ...

Страница 29: ...connector The outer cylinder can now be turned clockwise to secure the mixing stick in the connection cylinder The liquid inside the mixing biocontainer might push back the mixing paddle which could make the rotation of the cylinder difficult 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 norma...

Страница 30: ...020 17467 00 Instructions For Use PadMixer 1000 Premium RevD www pall com biopharm 30 Figure 38 Inserting the mixing stick in the connection cylinder and closing the cylinder ...

Страница 31: ...ting of the air inside the mixing biocontainer will be required when it will be filled with liquid 5 5 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 Hang the powder handling bag on the steel hook Install the hook in such...

Страница 32: ...edefined The easiest way to define the connection height is to measure the distance from the floor to the bottom of the tank and to add a certain height depending on the mixing biocontainer size These values are stated in the table below Table 1 Calculation to determing the correct connection height Nominal biocontainer size L Recommended connection level Distance between floor to bottom of tank m...

Страница 33: ...g of the system when the system starts or when the alternation is used we recommend to set the acceleration and deceleration times as indicated in the table below Table 3 Recommended acceleration and deceleration limitations in function of speed RPM range Minimal Acceleration time sec Minimal Deceleration time sec 30 70 3 1 70 110 5 3 110 150 10 5 5 7 Height adjustment Select the recipe that will ...

Страница 34: ...ent the stirring mechanism from rubbing against the side wall during mixing resulting in possible damage to the mixing biocontainer Connect the inflation tubing of the mixing biocontainer to the compressed air supply and activate the inflation via the touch screen Once the mixing biocontainer reaches a certain volume the top of the mixing biocontainer will press against the detection sensor and th...

Страница 35: ...mixing biocontainer s contents may be drained and the empty mixing biocontainer responsibly disposed of The following general guidelines apply and should be used in conjunction with all safety and environmental regulations appropriate for the process and location To discharge the mixing biocontainer connect the drain hose to an appropriate receptacle then open the drain tubing clamp If fitted the ...

Страница 36: ...d can be recovered by gently lifting the mixing biocontainer so as to direct the residual liquid to the drain Close all clamps and detach the mixing biocontainer from all external connections To disconnect the biocontainer from the machine the outer connection cylinder must be turned open again counter clockwise and the mixing tank can be removed from under the machine Remove the EZ Drain clip if ...

Страница 37: ...lem occurs during mixing the emergency stop button can be pressed and the mixing will immediately stop 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 ...

Страница 38: ... to perform the spindle calibration when the system displays the message to do so With the technical binder a list of spare parts is supplied These are mainly parts that are wearing parts although the wearing is very limited The changeover time is very much depending on the way the mixing system is used RPM s mixing angle used etc so the changeover time is not specified These parts can be ordered ...

Страница 39: ...late This pressure is pre set to a maximum of 500 mbar If however a higher air flow rate is required this pressure can be adjusted There is no risk for creating an overpressure inside the bag since the bag detections will stop the inflation in time Note however that a too high gas flow might cause issues if certain filters are present on the gas inlet tubing or if the gas inlet tubing has a very s...

Страница 40: ... at the inside of the head and temporarily disconnect the cables Remove the full head shield This shield is mounted with six screws two are positioned in the head connector plate and four are positioned in the inside of the head gearbox space Only the emergency stop is still mounted to the head shield Remove the head shield until the point where also the emergency button can be removed Figure 45 P...

Страница 41: ... PLC When a new code is uploaded some old information that is stored in the program will be lost Therefore note all Recipe settings and Factory settings so that these can be edited when the new code is installed Load the new or modified PLC code on a CF card Compact Flash 2 files 1 folder should be loaded onto the CF card so not under another directory or folder The following type of files and fol...

Страница 42: ...ext on the lower left corner The information screen appears with several buttons at the bottom of the screen Press on the button CF USB New buttons appear Press on the button CF_Start 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 s...

Страница 43: ...s For Use PadMixer 1000 Premium RevD 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 ...

Страница 44: ...n Yes The downloading will start Following screen appears Figure 53 Code import monitoring screen 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 ...

Страница 45: ... password as desired Reinstall all recipe settings Reinstall the Factory settings as shown on following screen Figure 56 Factory settings The serial number of the machine can be found on the tag plate of the unit 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 dev...

Страница 46: ...ll the spindle settings as shown on following screen only the Maximum Height needs to be added Figure 58 Settings spindles 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 ...

Страница 47: ...mixing speed is set at 30 RPM the maximum speed is 150 RPM 7 3 Noise level The machine generates a noise level of less than 75 dB 7 4 Operating temperature The ambient operating temperature is 0 C to 50 C For more details consult the equipment specification 8 Service The mixing tank was developed exclusively for mixing fluids and solids in fluids in specially designed disposable mixing biocontaine...

Страница 48: ... when properly stored and installed and operated as per the specifications and design conditions stated in this document 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 AllegroTM systems that may become defective during the Warranty Period ...

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