Procedure for Operation of 37 Stations Double Rotary Compression Machine

1.0 Objective: To lay down a procedure for the operation of 37 stations double rotary compression machine.
2.0 Scope: This procedure is applicable to the operation of 37 station double rotary compression machines in the production department.
3.0 Responsibility:
Officer, Executive – Production Department
Manager – Production Department

4.0 Procedure:
4.1 Ensure that the equipment and area are cleaned and place the ‘UNDER PROCESS’ label duly filled and signed on the machine and record all the observations in the equipment usage log sheet as per SOP “Making Entries in Equipment Usage Log Book“.
4.2 Collect the punch set as per specifications in the respective BMR from the compression spire room and record the issuance in the “Die Punches Utilization Record“.
4.3 Clean the die punch set with 70 % IPA (70 ml IPA + 30 ml water) before installing it on the compression machine.

4.4 Setting of the round die punches:
4.4.1 Fix the dies in die cavities.
4.4.2 Ensure that the die is fixed at the same level as the turret.
4.4.3 Place lower punch in lower punch bores such that it rests on the cam and tightens the anti-turning Teflon plugs.
4.4.4 Place upper punch in upper punch bores.
4.4.5 Turn the flywheel and set all die punches on the compression machine by following step no. 4.4.1 to 4.4.5.
4.4.6 Ensure that the punch should move freely inside the punch bore and die during the fixing of upper and lower punches.

4.5 Setting of other than round die punches:
4.5.1 Fix the die in the die cavity.
4.5.2 Place the upper punch in the upper punch bore and hold it with your hand. Align the tip of the punch to the respective die and tap gently with the upper punch to position the die in the cavity.
4.5.3 Ensure that the upper punch is freely moving in the respective die.
4.5.4 Remove the upper punch and fix the dies in die cavities.
4.5.5 Ensure that the die is fixed at the same level as the turret.
4.5.6 Tighten the die locking screws. Cover the die locks with the SS cover provided.
4.5.7 Ensure that the upper punch is free in the respective die.
4.5.8 Remove the take-off piece from the cam track.
4.5.9 Rest the upper punch on the cam track. Turn the flywheel and set all the dies and punches in the same fashion.
4.5.10 Remove the upper punch near the take-off piece slot and fix the take-off piece.
4.5.11 Place the upper punch back into the upper punch bore and tighten the punch locking screw.
4.5.12 Place lower punches in lower punch bores.
4.5.13 Fix the anti-turning Teflon plugs by tightening the spring plates.

4.6 Setting of force feeder:
4.6.1 Mount the powder scrapper by tightening the screw at the rear side of the force feeder and tablet ejecting the scrapper at the front side of the force feeder.
4.6.2 Mount the recircular band on the turret.
4.6.3 Mount the force feeder on the feeder support platform and clamp it in position with a quick release clamp and tighten the locking knobs.
4.6.4 Connect the feeder housing to the feeder drive shaft by spring-loaded feeder coupling assembly.
4.6.5 Touch feeder jog switch on MMI and ensure the correct fitting of the force feeder.

4.7 Fitting of hopper and connector:
4.7.1 Fit the hopper in its place by screwing the bolt at the top.
4.7.2 Fit the butterfly valve in the hopper connecter to regulate the flow of powder.
4.7.3 Fit one end of the hopper connector on the inlet pipe on the top of feeder bowls and the other end of the hopper connecter to the hopper spout.
4.7.4 Fit the tri-clover clamp between the hopper connector and hopper spout to prevent disturbance of the connectors.

4.8 Setting of cam and doser:
4.8.1 Initially keep the cam loose and after setting two or three die punches, fix the cam.
4.8.2 Ensure the cam is not touching any part of the machine and then fix the doser.

4.9 Recipe Edit / Save / Delete:
4.9.1 Turn ‘ON’ the mains. MMI will turn ‘ON’. The opening screen will open.
4.9.2 Touch ‘LOG IN’ on the control panel. The security control screen will open.
4.9.3 Touch ‘LOG IN’ on MMI. The keypad will open. Enter the password.
4.9.4 Touch ‘MAIN MENU’ on MMI. The main menu screen will open with the following menu:

• Machine Control – Machine Status
• Turret control – Recipe Management
• Feeder Control – Batch Data
• Compaction force – Technical data
• Lubrication Control – Security Control

4.9.5 Touch ‘RECIPE MANAGEMENT’ on MMI. The recipe management screen will open.
4.9.6 Load product name, the shape of a tablet, size (Round / Other), thickness, weight, hardness, main tablet thickness (mm), and compaction force (kN) as per respective BMR.
4.9.7 Touch ‘SAVE’ on MMI. The keypad will open. Give a suitable name/code for the loaded recipe. For confirmation touch ‘ENTER’. The recipe will save in PLC.
4.9.8 To load an already existing recipe touch ‘VIEW’ on MMI. A loaded recipes list will open. Select the recipe and then touch ‘ESC’. A warning message will appear. Touch ‘YES’. The selected recipe will be loaded.
4.9.9 To delete a recipe touch ‘DELETE’ on MMI. A loaded recipes list will open. Select the recipe and then touch ‘ESC’. A warning message will appear. Touch ‘YES’. The selected recipe will be deleted.

4.10 PLC Operation:
4.10.1 Turn ‘ON’ the mains and compressed air. The opening screen will open on MMI.
4.10.2 Touch ‘LOGIN’ on the control panel. The security control screen will open.
4.10.3 Touch ‘LOGIN’ on MMI. The keypad will open. Enter the password.
4.10.4 Touch ‘MAIN MENU’ on MMI. The main menu screen will open with the following menu:

• Machine Control – Machine Status
• Turret control – Recipe Management
• Feeder Control – Batch Data
• Compaction force – Technical data
• Lubrication Control – Security Control

4.10.5 Touch ‘MACHINE STATUS’ on MMI. Machine status-1 screen will open the current status of the following:

• Turret Motor – LH Feeder Motor
• RH Feeder Motor – LH Doser Assembly Position
• RH Doser Assembly Position – Hydraulic Motor Status
• Lubrication Oil Level – Air Pressure Status
• Emergency Push Button – Machine Guard

4.10.6 Touch ‘MACHINE STATUS’ on MMI. Machine status-1 screen will open the current status of the following:

• Guard Selection – Batch Size Continuous
• Machine Selection Mode – Main Set Pressure Status
• Tablet Counting Proximity Switch Position

4.10.7 Ensure that the machine status is mentioned in step no. 4.10.5 and 4.10.6 should be OK before starting the machine.
Note: The green color of individual status shall consider OK and the red color of individual status shall consider “NOT OK”.
4.10.8 Touch “MAIN MENU’ on MMI. The main menu screen will open.
4.10.9 Aline vertical deduster next to the outlet chute of the compression machine and metal detector next to the outlet chute of the vertical deduster.
4.10.10 Place the S.S. container lined with a double polybag next to the metal detector outlet chute.
4.10.11 Load granules in the RHS and LHS hopper.
4.10.12 Turn ‘ON’ the compressed air supply.
4.10.13 Select ‘TWO LAYER TABLET / STD. LAYER TABLET’ as per respective BMR on MMI.
4.10.14 Touch ‘START’ to start the force feeder on MMI on the force feeder sub-screen. The force feeder will start.
4.10.15 Touch ‘CLUTCH ENGAGE’ on MMI on the main drive sub-screen. Clutch will engage.
4.10.16 Touch and hold ‘JOG’ on MMI on the main drive sub-screen. The machine will run till the jog key is engaged. Run the machine in jog mode and collect the compressed tablets on LHS and RHS stations.
4.10.17 Check the weight then thickness and then hardness of the individual tablet.
4.10.18 Ensure that the weight, thickness, and hardness of individual tablets are within the limit specified in the respective BMR. If not.
4.10.18.1 Set the by turning weight adjustment dial gauge in a clockwise direction to increase the weight and anticlockwise direction to decrease the weight.
4.10.18.2 Set the thickness by turning the tablet thickness controller in the + direction to increase the thickness and reduce the hardness and in the – direction to decrease the thickness and increase the hardness.
4.10.19 After setting weight and thickness, ensure friability and D.T. of the tablets are as per specification in respective BMR for LHS and RHS station.
4.10.20 Record all the observations in respective BMR.
4.10.21 Reject the tablets compressed during machine setting.
4.10.22 Operate the metal detector and vertical deduster as per SOP “Operation of Metal Detector“.
4.10.23 Then touch ‘START’ on MMI on the main drive sub-screen. The machine will start running.
4.10.24 To increase or decrease turret RPM touch ‘+ / -‘ on MMI on the main drive sub-screen.
4.10.25 To increase or decrease force feeder RPM touch ‘+ / -‘ on MMI on the Feeder Control sub-screen.
4.10.26 To increase or decrease compaction force touch ‘+ / -‘ on MMI on the guard’s interlock sub-screen.
4.10.27 Touch ‘STOP’ to stop the machine and turn ‘OFF’ mains and compressed air.

4.11 Manual Operation
4.11.1 Turn ‘ON’ the mains and compressed air. MMI will turn ‘ON’.
4.11.2 Load the granules in LHS and RHS hooper. Set the vertical deduster and metal detector by the following step no. 4.10.9 to 4.10.10 and operate by the following step no. 4.10.22.
4.11.3 Press and hold the ‘JOG’ key on the control panel to run the machine in jog mode.
4.11.4 Press the ‘START’ button to run the machine continuously.
4.11.5 Turn the RPM knob clockwise to increase the turret RPM and anticlockwise to reduce the turret RPM.
4.11.6 Press the green compaction force button to decrease the compaction force and the red button to increase the compaction force.
4.11.7 Press the ‘STOP’ button. The machine will stop. Turn ‘OFF’ mains and compressed air.

4.12 At the end of operation affix the ‘TO BE CLEANED’ label duly filled and signed on the machine and record all the observations in the equipment usage log sheet as per SOP “Making Entries in Equipment Usage Log Book”.

5.0 Abbreviations:
SOP: Standard operating procedure
IPA: Isopropyl alcohol
ml: Milliliter
BMR: Batch manufacturing record
RPM: Rotations per Minute
mm: Millimeter
kN: Kilo Newton
MMI: Men machine interface
DT: Disintegration test
SS: stainless steel
RHS: Right-hand side
LHS: Left-hand side