SOP for Sejong compression machine

Details of Turrets are as follows:

Make	Sejong	Sejong	Sejong	Sejong	Sejong	Sejong
Tooling	D	B	BB	BB	BB	D
Station	49	61	73	73	73	49

4.         PRECAUTIONS:

4.1      Ensure that during cleaning electrical supply is disconnected and fittings are

               covered with polybag.

4.2            Wear protective gears like hand gloves & nose masks while handling the material.

4.3            Avoid putting hand and tools inside the machine during operation. Avoid cleaning

                of the machine while in operation.

4.4     Visually check and ensure that safety guards are closed before starting the operation.

4.5           Visually check and ensure that continuous lubrication is functioning properly through                  out the machine run.

4.6           Avoid over tightening of the die locking screw during machine setting.

4.7            Always start the machine with inching mode only.

4.8          Ensure that during downward movement of the Turret on the machine, it should not

                be touch to any parts of the machine in case of turret changes.

4.9          Ensure that before lifting of the Turret, disk lifting shaft is being properly fixed in lift

               column insert in case of turret changes.

4.10       In case of power failure, start the machine in same mode after restoration.

4.11         Whenever starting the machine after each break, discard the tablets of 2 to 3 rounds.

5.            PROCEDURE:

5.1             CLEANING PROCEDURE: -

5.1.1         Type A

5.1.1.1     Remove the compressed tablets and rework of previous product

               from compression cabin.

5.1.1.2     Remove the previous label and dispose off by tearing.

5.1.1.3   Keep the equipment status label with ‘ TO BE CLEANED, DO NOT USE’

   underneath in poly bag and affix it on the equipment.

5.1.1.4     Disconnect the electrical power supply by removing plug from socket and

               clean electrical fitting and control panel with cloth. Cover them with polybags.

5.1.1.5     Remove all the side covers of the machine.          

5.1.1.6    Open the acrylic doors.

5.1.1.7    De-dust the machine and machine parts by vacuum.

5.1.1.8    Removal of Y-piece, hoppers and flexible connections: -

·   Remove the flexible connection between Bunker and Y-piece

·   Remove the flexible connections between Y-piece and hoppers, check

   visually for integrity.

·   Remove Y-piece and hoppers.

·   Remove the powder hopper gaskets (silicone) between hoppers and feeders.

·    Remove the powder sensors attached with acrylic hopper pipes.

·   Keep the flexible connection, silicone gasket, Y-piece and hopper on s. s. trolley.

5.1.1.9     Remove discharge chutes by loosing bolt. Disconnect air tubes.

                               

5.1.1.10   Remove ejection scrapper assemblies.

5.1.1.11   Removal of feeder(For both stations): -                        

·   Release feeder lock bolt. Detach coupling by loosing bolt and take off mechanical   feeder from machine.

                    

·   Keep the feeder on S.S. trolley.

·   Remove scraper from Feeder base.

·   Remove the bolt of feeder cover.

·   Remove the feeder cover.

·   Remove the star wheel of the feeder.

·   Remove the lower feeder plate.

·   Dedust the feeder assembly with the help of vacuum.

·   Keep the feeder assembly in s.s trolley.

5.1.1.12   Removal of feeder base(For both stations):-

                                   

·   Remove fixed bolt of Feeder base.

·   Remove the Feeder base.

5.1.1.13  Removal of upper punches: -

·   Remove s.s upper punch safety guards.

·   Loosen the pivot bolt for loosening the upper punch safety rail.

·   Take out the upper punch safety rail.

·   Rotate the turret manually by using hand wheel for removal of dust cups

   and upper punches.

5.1.1.14  Loosen Suction brackets and remove.

5.1.1.15  Keep the dust cups, upper punches, discharge chutes, suction brackets and s.s upper

               punch safety guards on s.s.trolley.

5.1.1.16  Removal of lower punches: -

·   Remove s.s lower punch safety guards.

·   Loosen the pivot bolt.

·   Take out the lower punch safety rail.

·   Rotate the turret manually by using hand wheel.

·   Remove the punches one by one through the hole and keep them on s.s. trolley.

5.1.1.17  Removal of dies: -

·   Remove the die locking screws with the help of Allen key.

·   Place the die hammer through lower punch bore.

·   Gently tap the die till it comes out.

·   Rotate the turret manually by using hand wheel.

·   Repeat the above procedure to take out all the dies.

·   Keep them on s.s. trolley.

·   Remove the hosepipes.

5.1.1.18 Remove Joint Suction line and power Return Box line for Double-layer-tablet.

5.1.1.19  Transfer the dismantled hopper, Y-piece, flexible

               connections, silicone gasket, rotary feeder, discharge chute,

               hosepipe connection, s.s upper & lower punch safety guards to the washing

               area for cleaning

               Clean all the above parts with purified water and wipe with lint free cloth.

               Clean powder return hopper for Double-layer-tablet.

5.1.1.20 Clean upper punches, lower punches and dies with 70% Isopropyl alcohol

               (IPA) by scrubbing with lint free cloth, if required use nylon brush for scrubbing.

               Wipe with lint free cloth.

               Clean the feeder base and ejection scrapper assembly with 70% IPA.

               (Procedure for preparation of 10 Liters 70% v/v IPA solution: Take 7 Lt. Of IPA. Make

               up the volume to 10 Lt., using purified water).

5.1.1.21 Clean upper punch bores, lower punch bores and die bores with 70% IPA by     scrubbing with nylon brush and lint free cloth. Wipe with lint free cloth.

5.1.1.22 Clean turret with 70% IPA by scrubbing with nylon brush and lint free cloth.

               Wipe with lint free cloth.

5.1.1.23 Clean the die screws by dipping in 70% IPA v/v. Wipe them with lint free cloth.

5.1.1.24 Clean side covers of the machine and other non-contact parts with

               wet cloth (dipped in purified water). Wipe with cloth.

5.1.1.25  Wipe out the external and internal surface of the machine with cloth.

5.1.1.26  Reclean the control panel and electrical fittings with cloth (if required).

5.1.1.27  After cleaning visually examine all the punches and dies for damages and cleanliness. If punches found damaged discard the same and record the activity in punch destruction record.

5.1.1.28  If the punches and dies are not required for subsequent use, lubricate them

               with relevant lubricating liquid and transfer them in s.s. trolley of punch cabinet in tool                room. 

5.1.1.29 Ensure that proper weight cam is fixed.

5.1.1.30  Ensure by visual inspection for absence of any residue of previous

   product or batch or extraneous matter. If any residue of previous

   product or batch or extraneous matter is found then reclean the

   compression machine/the relevant parts using above procedure until the

   compression machine/the relevant parts are devoid of any residue/ extraneous

   matter as per visual inspection.

5.1.1.31  Intimate to Quality Assurance (QA) for inspection of the equipment.

5.1.1.32   Record the activity in equipment logbook. (Type-A) and equipment cleaning checklist

QAFP-1372

5.1.1.33  After cleaning destroy the previous label on the equipment

              and affix the label with ‘ CLEANED, INSPECT BEFORE USE’ tag on the

              equipment. Also mention on the label the date for recleaning according

              the SOP on Hold Time (T-031).

               FREQUENCY OF CLEANING

·      During product-to product change over.

·      At the end of a product campaign if it exceeds the time limit as per SOP No.: -T-031.

·      If cleaned equipment is kept idle for more than the hold time for such

                 equipment (refer SOP No.: -T-031)

·     After ten batches of the same product        

     

5.1.2         Type B

5.1.2.1    Exhaust the hopper and feeder by running the machine.

5.1.2.2    Remove the flexible connection and bunker from the machine.

5.1.2.3    Remove the compressed tables and rework of previous batch from the

   compression cubicle.                      

5.1.2.4    Cross the previous label from the machine.

5.1.2.5    Open the acrylic doors.

5.1.2.6    Remove granules and tablets from machine by vacuum. Dispose off the

   tablets and granules, if any, as per SOP NO. QA-035.                                

5.1.2.7                Collect the tablets from rework container, dispose off the collected tablets as

               per SOP QA-035.

5.1.2.8    Wipe out all the contact parts with lint free cloth. Wipe out non-contact parts

               with cloth and check visually for cleanliness.

5.1.2.9    Ensure by visual inspection for absence of any residue of previous

   batch or extraneous matter.

   If any residue of previous batch or extraneous matter is found then

   reclean the compression machine/ relevant parts, using above procedure

   until the compression machine/the relevant parts are devoid of any

   residue/ extraneous matter as per visual inspection.

5.1.2.10  Intimate to Quality Assurance (QA) for inspection of the equipment.

5.1.2.11  Before starting the next batch operation, remove the previous label and dispose

off by tearing.

5.1.2.12   Affix status label of ‘EQUIPMENT IN USE FOR’ with the new batch status

               on the equipment.

5.1.2.13   Record the activity in equipment log book (Type-B) and equipment cleaning checklist

QAFP-1372

               FREQUENCY OF CLEANING:

·     During batch to batch change over

5.1.3       TYPE-D: -

5.1.3.1    For major mechanical maintenance job involving the contact parts of the

               equipment (when in operation, remove the product therein) clean as

               Type-A procedure.

5.1.3.2     When new equipment or equipment after any modification is received, clean

               the equipment as per its Type-A cleaning procedure. This is to be done after

               passivation, wherever applicable.

5.1.3.3    Record the activity in equipment logbook (Type-D).

5.2          TURRET CHANGE (IF REQUIRED)

5.2.1       TURRET, WHICH IS TO BE DISPLACED FROM THE MACHINE: -

5.2.1.1    Open acrylic doors.

5.2.1.2    Detach connector for powder sensor on Hopper acryl pipe from Upper frame of both Stations.

5.2.1.3    Remove hopper of both Stations from M/C.

5.2.1.4    Remove discharge chutes by loosing bolt. Disconnect air tubes.

5.2.1.5    Remove the ejection scrapper assembly of both Stations from the machine.

5.2.1.6    Release feeder lock bolt. Detach coupling by loosing bolt and take off mechanical   feeder of both station.

5.2.1.7     Remove scraper of both Stations from Feeder base.

5.2.1.8     Remove the feeder base of both Stations by loosening the bolts.

5.2.1.9     Disassemble Turret from Rail body by:-

·         Loosing rail body hole bolt.

·         And down the Holder key by loosing bolt.   

5.2.1.10     Loosen Suction bracket and remove.

5.2.1.11   Remove all guards from M/C.

5.2.1.12   Remove lower safety rail of Station 1 and 2.

5.2.1.13   Remove upper safety rail of station 1.

5.2.1.14   Adjust position of Upper and Lower roller.

·         Put Lower roller down up to 9mm (Working on Operation screen)

·         Connect Turret JOG S/W to Connector of main body,turn S/W on.

·         Lift Upper Roller at its maximum.

5.2.1.15      Disconnect all the sensors and also oil lubrication tubes from the Turret.

5.2.1.16     Remove the ejection assembly, weight cam and weight assembly.

5.2.1.17     Remove cam head bracket by losing bolt.

5.2.1.18     Remove the s.s cover of the lifting device by loosening the screw.

5.2.1.17    Remove the circular s.s plate cover from the Turret by loosening the screws.

5.2.1.18    Remove power lock by opening bolts.

5.2.1.19    Loose lifting shaft until it is separated completely from bolts.

5.2.1.20   Put down the lifting device up to minimum position.

5.2.1.21   Hook up the lifting shaft of the Turret so that it can be placed into the lift column insert of the lifting device.

5.2.1.22 Lift up the Turret up to maximum position by using the up switch of the Jog switch.

5.2.1.23Positioned the Turret table exactly near the machine so that turret can be placed

               on it.

5.2.1.24Move out the disk through slide rail.

5.2.1.25Put Down the Turret until it can be placed exactly on the turret table by pressing

               down switch of the Jog switch.

5.2.1.26Hook up the lifting shaft of the turret and remove it from the lift column insert.

5.2.1.27Keep the turret table in designated place with turret and change parts.

5.2.2       TURRET, WHICH IS TO BE FIXED ON THE MACHINE: -

5.2.2.1     Take the Turret table containing Turret and required change parts from

               designated place.

5.2.2.3    Loosen the lifting shaft of the Turret until the lifting shaft gets free.

5.2.2.4    Take the Turret table near the machine and positioned the Turret table exactly

               near the machine so that lifting shaft of the turret can be fix on the lift column

               insert and fix it.

5.2.2.5    Lift up the Turret by pressing up switch of the Jog switch until it get the

               maximum position.

5.2.2.6    Pull the Turret inside slowly so that it can be fix on the machine.

5.2.2.7     Put Down the Turret until it can be placed exactly on the machine by pressing

               down switch of the Jog switch.

5.2.2.8     Check the alignment of the bolts and gears coupling, if it is not in correct position

               then align it by using hand wheel.

5.2.2.9     Fix the Turret on the machine by tightening the four rail body hole bolts at base of the        Turret and tighten up holder key bolt.

5.2.2.10   Hook up the lifting shaft of the turret and remove it from the lift column insert.

5.2.2.11   Take the lifting device to upper most position by pressing up switch of the Jog switch.

5.2.2.12   Tighten the lifting shaft.

5.2.2.13   Tighten power lock bolts.

5.2.2.14   Tighten cam head bracket

5.2.2.15   Cover the lifting shaft by tightening the circular s.s. plate.

5.2.2.16   Cover the lifting device by s.s cover and tighten it with screw.

5.2.2.17   Connect all the sensors and oil lubrication tubes on the turret.

5.2.2.18   Fix the weight assembly, weight cam and ejection assembly.

5.2.2.19   Fix Suction bracket

5.2.2.20   Adjust position of Upper and Lower roller

5.2.2.21   Fix lower safety rail of Station 1.

5.2.2.22   Disconnect the Jog switch from Jog switch connector.

5.2.2.23   Check the machine for free movement by rotating the machine using hand wheel.

5.3          MACHINE SETTING: -

5.3.1         Take the dies and punches suitable for required product from the tool room.

5.3.2         Check visually for cleanliness of the dies punches.           

5.3.3         FIXING OF THE DIE FOR CIRCULAR PUNCHES: -

5.3.3.1    Apply liquid paraffin on the periphery of the die.

5.3.3.2    Insert the die in die bore only one at a time.

5.3.3.3     With the help of die hammer (insert through upper punch hole) gently apply

pressure by tapping until the die flushes with the turret as per perception of

finger movement on the turret.

5.3.3.4     Repeat the above process for fixing all the dies by rotating the hand wheel manually.

5.3.3.5     Tighten the die locking screw gently with help of suitable torque wrench.

5.3.4         FIXING OF THE DIE WITH SHAPED PUNCHES: -

5.3.4.1    Apply liquid paraffin on the periphery of the die.

5.3.4.2    Insert the die in die bore only one at a time.

5.3.4.3    Ensure that upper punches are provided with key on shank. Check the

               punches visually and record it.

5.3.4.4     Unscrew the take off piece.

5.3.4.5     Insert the upper punch and align the upper punch tip with die pocket.

5.3.4.6    Push gently the die in die bore by upper punch so that it can take proper position

                in die bore.

5.3.4.7     Take out the upper punch from upper punch guide hole.

5.3.4.8    With the help of die hammer (insert through upper punch hole) gently apply pressure                           by tapping until the die flushes with the turret as per perception of the

                  finger movement on the turret.

5.3.4.9      Insert the upper punches into the upper punches guide hole and

                  check the alignment of upper punch tip with die pocket. Tighten the die

                  partially by using suitable torque wrench.

5.3.4.10    Repeat the above procedure for fixing of all dies and upper punches by rotating the             hand wheel manually.

5.3.4.11 Check that each punch is moving freely and dropping on its own weight

5.3.4.12     Check that upper punches are moving freely through upper cam track.

5.3.4.13     Tighten the die locking screw gently with help of suitable torque wrench to

   the maximum applying pressure.

5.3.4.14    Fix the take off piece at its proper position.

5.3.5          FIXING OF LOWER PUNCHES: -

5.3.5.1              Apply thin layer of the liquid paraffin on the punches.

5.3.5.2       Check the punches visually and record it.

                  Insert the lower punch in to lower punch-guiding hole.

5.3.5.3      Check and ensure that suitable size of powder filling CAM is fixed

   required for proposed product.

5.3.5.4       Insert the lower punch in to lower punch bore.

5.3.5.5       Fix the other punches in the same manner by rotating the hand wheel manually.

5.3.5.6       After fixing of all the punches place the lower punch safety rail to its position

                  and tight the pivot bolts. .

5.3.5.7       Check that lower punches moving freely through lower cam track.

5.3.5.8       Tighten the anti-turning screws, if required with the help screwdriver so that punches

                  do not rotate in its hole.

5.3.6          FIXING OF CIRCULAR UPPER PUNCHES: -

5.3.6.1        Apply a thin layer of liquid paraffin on the punch head.

5.3.6.2        Check visually that all the upper punches guide hole are cleaned.

5.3.6.3       Check the punches visually and record it.

                  Insert the upper punches into the upper punches guide hole.

5.3.6.4      Check that each punch is moving freely and dropping on its own weight

5.3.6.5       Fix the upper punch safety rail to its position, tighten the pivot bolts.

5.3.6.6       Check that upper punches are moving freely through upper cam track.

5.3.7          After fixing dies & punches check for their free movement by rotating the hand

                  wheel manually.

5.3.8         Check all the dust cup visually and record it.

                  Fix the dust cup to all the upper punches tip (if applicable) and rotate the machine

      by hand wheel manually to check whether the dust cups are properly fixed.

5.3.9           Fix the ejection scrapper assembly.

5.3.10        Fix the feeder base.

5.3.11        FIXING OF ROTARY FEEDER: -

5.3.11.1   Assemble the parts of the feeder assembly.

5.3.11.2   Ensure that feeder blades are moving freely.

5.3.11.3   Place the feeder on the feeder stand.

5.3.11.4    Attach coupling of mechanical feeder. Tighten feeder lock bolt.

5.3.11.6     Align the scrapper plate and tighten the same.

5.3.11.7   Check the ejection of the lower punch so that it does not touch the ejection plate.

5.3.11.8    Fix discharge chutes and suction brackets

5.3.12      for Double-layer-tablet.

·         Fix Tablet checker cylinder with double layer tablet rail at the position of Ejection rail of station 1.

·         Fix suction line and power return box line.

5.3.13     ADJUSTMENT OF THE Y-PIECE , HOPPER AND flexible connections: -

·   Fix the Y-piece and hopper.

·   Fix the flexible connection between Bunker and Y-piece

·   Fix the flexible connection between Y-piece and hopper, check

   visually for integrity.

·   Fix the powder sensors attached with acrylic hopper pipes.

·   Fix the silicone gasket between hopper and feeder.

·   Take approval of QA personnel for the cleaned and assembled machine before

   further usage, after QA’s approval affix the ‘ APROVED FOR USE’ tag on

   the ‘CLEANED, INSPECT BEFORE USE’ tag of the equipment status label

   already on the equipment.

                 (Fix this label in Batch Manufacturing Record before using the equipment for

                 further processing).

·   Record the activity in equipment log book and Punch and dust cup checking record

 (QAFP-1370).

5.4             PROGRAMMING:

5.4.1          Switch on the main of electrical pendant.

5.4.2          Switch on the main on electrical panel.

5.4.3          Start the air supply.

5.4.4          Rotate the key located in the left side of the human machine interface (HMI).

5.4.5          Initial screen will appear on touch screen.

5.4.6          Touch “log in “on HMI.

5.4.7          Enter user ID with the help of keyboard.

5.4.8          Touch tab of keyboard to enter the password. And enter the password with the

                  help of keyboard

5.4.9          Touch the enter of keyboard to save the user id and password.

5.4.10        Touch ok of log in screen to enter in “operation” menu.

5.4.11        After Log In  following function keys will appear:

5.4.11.1     Operation Key : production parameter and system configuration is set

   in this key.

5.4.11.2     Station 1, Station 2              : Production condition is setting window for selecting of Double discharge production or Double layer production.

5.4.11.2.1   Tightness Key  : Measured Value of upper and lower punch tightness

   is displayed.

5.4.11.2.2   Safety Measures  :When Alarm is noticed user can check which part is

   the cause for alarm.

5.4.11.2.3   Product Parameter : Production parameters, related variables, and system configuration can be checked in this parameter.

5.4.11.2.4 Auto Weight Control - A.W.C. : A.W.C. values are displayed in

                  this  function.

5.4.11.2.5 A.W.C. parameters : Parameters for A.W.C. are set in this function.

5.4.11.2.6  Report : Data of machine operation history is printed in this function.

5.4.11.2.7  Supervisor Manage : Limit of each level of operation can be checked

                  in this level.

5.4.11.2.8 Machine Config : This is machine configuration set by manufacture.

5.4.11.2.9 Screen Print: Present activated section can be printed out through

                  this icon.

5.4.11.2.10      Product Print : Production report can be printed out through this icon.

5.4.11.2.11 Pressure Print :Individual punch data are displayed and printed out in

                  this session.

5.4.12         OPERATION MENU: -

5.4.13        To set Turret / Disc speed

·   Touch” disk speed set up”.

·   “Disk speed set up” sub screen will appear.

·   Set the required speed with the help of /  buttons.

·   Touch  to increase the turret revolutions per minute. (RPM).

·   Touch  to decrease the turret RPM.

·   Touch” close” on disk speed set up sub screen to go back in operation menu.

5.4.14  To set Feeder Speed

·   Touch “Feeder speed set up”.

·   “Feeder speed set up” sub screen will appear.    

5.4.15     In Manual mode: -

·   Touch” MANUAL” to enter in manual mode.

·   Touch  to increase the RPM.

·   Touch  to decrease the RPM.

·   Touch “ON” to start the feeder.

·   Touch” OFF” to stop the feeder.

·   Touch “INCHING” to run the feeder in inching mode.

5.4.16     In Auto mode:

·   Touch, “AUTO” to enter in auto mode.

·   Set the required percentage speed with respect to turret speed by /       buttons.

·   Touch  to increase the % speed.

·   Touch  to decrease the % Speed.

·   Touch” close” to go back in operation menu.

5.4.17  To set time reset

·   Touch” time reset”.

·   Are you sure sub screen will appear to confirm.

·   Touch” yes” to reset the time.

·   Touch” no” if reset is not required.

5.4.18   To set filling depth (weight setting) Touch, “Filling depth set up”.

  

5.4.19 

·   “Filling depth setup” sub screen will appear.

·   Touch the respective cam, which is set in the machine.

·   Set the required filling depth by using / buttons.

·   Touch  to increase the filling depth. (Weight)

·   Touch  to decrease the filling depth. (Weight)

·   Touch “close” to go back in operation.

5.4.20     To set pre pressure (penetration and thickness)

5.4.20.1  setting of penetration: -

                         

·   Touch the “Pre section set up” of pre pressure screen.

·   “Pre penetration, Pre-Thickness Set up” sub screen will appear.

·  

·   Set the penetration depth value by using /  buttons.

·   Touch  to increase the penetration depth.

·   Touch  to decrease the penetration depth.

5.4.20.2    Setting of prethickness: -

·   Set the prethickness of tablet by adjusting the height of pre pressure roll.

       (Position of lower punch into die) with / buttons.

                                               

·   Touch  to increase the pre thickness of the tablet.

·   Touch  to decrease the prethickness of the tablet.

·   Touch “close” to go back in operation menu.

5.4.21     To set main pressure (penetration and thickness): -

5.4.21.1  Setting of penetration: -

                             

·   Touch the “Main section set up”.

·   “Main penetration, Main-Thickness Set up” sub screen will appear.

·   Set the penetration depth value by using/ buttons.

·   Touch  to increase the penetration depth.

·   Touch  to decrease the penetration depth.

5.4.21.2.   Setting of main thickness: -

·   Set the main thickness of tablet by adjusting the height of main pressure roll

      (Position of lower punch into die) with / buttons.

               

·   Touch  to increase the main thickness of the tablet.

·   Touch  to decrease the main thickness of the tablet.

·   Touch “close” to go back in operation menu.

5.4.22   To set Air Pressure: -

·   Touch “Air pressure set up”.

·   “Air pressure set up” sub screen will appear.

·   Set the low limit by using  / buttons.

·   Touch  to increase the air pressure value.

·   Touch  to decrease the air pressure value.

·   Touch “close” to go back in operation menu.

5.4.23        To set Oil Lubrication: -

·   Touch” Oil lubrication set up”.

·   “Oil lubrication set up “sub screen will appear.  

·   Set the values of Interval time in minutes and Oil supply time in seconds

      by touching    / buttons.

·   Touch  to increase the value.

·   Touch  to decrease the value.

·   Touch “ENABLE” to supply the oil according to set value automatically.

·   Touch” disable” to supply the oil individually to each section manually by

   Touching S1 - Upper punch, S2 - Lower punch , and S3- Lower punch head.

·   Touch” close” to go back in operation menu.

5.4.24   To set the Target Quantity: -

·   Touch” Target Quantity”.

·   “Target quantity set up” screen will appear.         

·   Set the value of required target quantity by touching  / buttons.

·   Touch  to increase the value.

·   Touch  to decrease the value.

·   Touch the check box on the target quantity function.   On touching - √ will appear         in box.

·   To reset the counter touch  to set the value to zero.

·   Touch “close” to go back in operation menu.

5.4.25        To set the Powder Status: -

·   Touch “Powder status” .

·   Powder status set up sub screen will appear.       

·   The time to run the machine from the moment when the powder sensor is    detecting the shortage of powder can be set by touching  / buttons.

·   Touch  to increase the value.

·   Touch to decrease the value.

·   Touch “ENABLE” to activate this function on.

·   Touch “disable” to proceed without this function .

·   Touch “close” to go back in operation menu.

5.4.26        To set initial reject and sampling gate setup:-

· touch” Initial reject”.

· “Initial reject setup” sub screen will appear.

· For Initial Reject-

· Initial time period for which tablets are going to reject can be set by using

   / buttons.

· touch  to increase initial time reject.

· Touch  to decrease initial time reject.

· Touch  to on rejection function.

· Touch  to off the rejection function

· For sampling gate –

· Touch  to operate sampling gate automatically according to set value 

· Touch   to operate sampling gate manually regardless of set value.

· Touch JOG to operate sampling gate. JOG function is working in the manual mode.

·   Wait Time: - sampling interval time.

·   Touch  to increase the value.

·   Touch to decrease the value.

· Open Time: - How long sampling gate is opened.

·   Touch  to increase the value.

·   Touch to decrease the value.

· Touch” close” to go back in operation menu.

5.4.27    To set buzzer:-

·   Touch “Buzzer”.

·   “Buzzer setup” sub screen will appear.

·   The buzzer will sound When the alarm is working, the sounding condition

     can be turned On and OFF and  by touching  and  buttons.

·   Touch “close” to go back in operation menu.

5.4.28 Safety message alarm set up: -      

· the cause of alarm is displayed through this mode with red indication against the          cause.

· Attend the cause indicated by alarm..

· Touch alarm reset button to reset the alarm.           

5.4.29 SETTING OF AWC PARAMETERS.         

           

5.4.29.1 REF (reference value): Calculated reference value with set amount of rotation

               in calibration. This can be set with  buttons.

5.4.29.2 HSP ( High Stop pressure ) : If the pressure is higher than HSP machine stops. The        set value is indicated with percentage of REF.value.  This can be set with    buttons.

5.4.29.3 LSP ( Low Stop pressure ) : If the pressure is lower than LSP machine stops.  

               Set value is indicated with percentage of REF.value.  This can be set

               with     buttons.

5.4.29.4 HEP (High Eject pressure ):If the pressure is higher than HEP correspondent tablet

               is rejected     by AWC .If HEP  corresponded tablets are continuously ejected by

               AWC ,machine     stops. The set   value for machine stoppage can be set

               by     window. Similarly if   particular punch is rejected

               continuously due to HEP machine    stops automatically, the   tablet amount in

               same punch for machine stop condition    can be set with      window.

5.4.29.5 LEP ( Low Ejection Pressure  ):If the pressure lower than  LEP correspondent tablet

               is rejected     by AWC .If LEP corresponded tablets are continuously ejected

               by AWC    machine  will   stop. The set   value for machine stoppage can be

               set by       window. Similarly if   particular punch is rejected

               continuously due to HEP machine       stops automatically, the   tablet amount

               in same punch for machine   stop condition    can be set with  window                      

5.4.29.6 HCP (High Control Pressure): If mean pressure value is higher than HCP, AWC              system decreases filling depth with weight rail control. Counting amount  for stop   condition of HSP is set by  window.

5.4.29.7 LCP ( Low Control Pressure ): If mean pressure value is lower than LCP ,

               AWC system decreases filling depth with weight rail control. Counting amount 

               for stop condition of LSP is set by  window.    

5.4.30      Empty punch option can be used for production situation where in full set of punch is     not in use. In such case registered punch data is ignored for all calculations.

5.4.31         For SD, PRE COMPRESSION, MEAN PASS VALUE ETC.

5.4.32       FOR DOUBLE LAYER TABLET

·   Touch 

·   Remove tick (Ö) by touching station 1 and use of air gun.

·   Mark tick (Ö) by touching station 2 and use of air gun.

·   Program moves to the mode for double layer tablet automatically if  (Ö) does not apper on the use of air gun in station 1.

·   The range of filling depth moves to the range of 5mm to 16mm in station 2.

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          

5.5             OPERATING PROCEDURE: -

5.5.1         Remove the previous label from the machine and affix the status

               labels of ‘EQUIPMENT IN USE FOR’ on the machine and relevant equipment.

5.5.2       Visually check the cleanliness of the machine.

5.5.3       Write the product name and batch no. on the area status plate.

5.5.4       Bring the Bunker with lubricated granules in compression cubicle.

5.5.5       Lift and place the Bunker exactly above the compression machine by LPU.

5.5.6       Place the metal detector, de-dusting machine and container for tablet

               Collecting in proper position.

5.5.7      Fix the flexible connections between Y-piece and hopper.

5.5.7        Fix the flexible connections between hopper and Bunker.

5.5.8       Load the material into hopper by opening valve of BUNKER.

5.5.9       Start the feeder in manual mode until sufficient powder is fill up in feeder.

5.5.10     Set the feeder in auto mode.

5.5.11       SET THE FOLLOWING PARAMETER AS PER THE INSTRUCTION IN THE BATCH MANUFACTURING RECORD (BMR).

5.5.12     WEIGHT ADJUSTMENT: -

·   Before setting the parameter ensure that weight( fill depth) is minimum.

·   Set  the weight by setting fill depth per instructions given in step 5.4.19.

5.5.13     THICKNESS AND HARDNESS: -

·   Before setting the parameter ensure that thickness is maximum and

                  hardness is minimum.

·   Set the thickness and hardness as per instructions given in step 5.4.20 & 5.4.21.

5.5.14     START-UP AND RUN

5.5.14.1 Run the machine and destroy the tablets of initial 2-3 rounds/until tablets are

               devoid of any obvious defects..

5.5.14.2  Keep separately and label as non-recoverable rework to all the tablets

                  produced till the adjustments for setting the physical parameters is done.

5.5.14.3  After setting of physical parameters, collect the initial compressed tablets

                  in continuation(Initial sample size of compressed tablets will depend upon

                  the no. of stations) .

5.5.14.4  Check the thickness and weight of 10 representative tablets using the

                  digimatic caliper and balance lying in the compression cubicle. 

                  For the other parameters (Like Friability, Hardness, Disintegration

                  test& weight variation) put the tablets sample in  a self locking polybag and

                  check the parameters by using instruments of In process quality control room.

 5.5.14.5    Record the observations of physical parameters in BMR. 

5.5.14.6     Continue compression of tablets subject to compliance with appearance and

                  physical parameters.

5.5.14.7     Acquire the reference pressure on the AWC screen and ‘ON’ the AWC. Then

   Set and apply the AWC parameters by using step 5.4.30.

5.5.14.8     Perform the challenge test for AWC by inducing lower/ higher than prescribed

                  limit for main pressure for a product enter the results in QAFP-1334.

Conduct the challenge test once in a month. If the planned down-time for the machine is more than a month, conduct the challenge test at the start of the next product.

5.5.14.9     Collect the tablets in a container after passing through the

                  de-dusting machine and metal detector before transferring to the drums.

5.5.14.10   If any punch damage is observed during compression, by checking the

     tablet appearance and AWC stop alarm, check the tablets in rejection box of the                     metal detector for the broken part. Pass the   tablets from immediate previous                container and ongoing container through metal detector again.

5.5.14.11   Discard the tablets of rejection box of metal detector. 

5.5.14.12  Record the activity in equipment log and BMR.

5.6            FOR DOUBLE LAYER TABLET: -

·         Fill the hopper and feeder of station 1 with powder.

·      Set  the weight by setting fill depth per instructions given in step 5.4.19.

·         Set the thickness and hardness as per instructions given in step 5.4.20 & 5.4.21

·         Push the weight checker button and collect tablet.

·         Check the weight and thickness of tablet.

·         Fill the hopper and feeder in station 2.

·      Set  the weight by setting fill depth per instructions given in step 5.4.19.

·         Set the thickness and hardness as per instructions given in step 5.4.20 & 5.4.