1.0 Objective: To lay down a procedure for the operation of 35- a station double rotary compression machine.
2.0 Scope: This procedure is applicable to the operation of 35- a station double rotary compression machine 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.
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 as per the Equipment Usage Log Book.
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 by using a Tommy.
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 the 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 the 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 by using a Tommy.
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 feed frame and hopper
4.6.1 Mount the circular band on the turret.
4.6.2 Mount the feed frame on the feeder support platform and fix it in position with nuts and tighten the locking knobs.
4.6.3 Fit the hopper in its place by screwing the bolt at the top.
4.7 Setting of cam and doser
4.7.1 Initially keep the cam loose and after setting two or three die punches, fix the cam.
4.7.2 Ensure the cam is not touching any part of the machine and then fix the doser.
4.8 Operation
4.8.1 Aline vertical deduster next to the outlet chute of the compression machine and metal detector next to the outlet chute of the vertical deduster.
4.8.2 Place the SS container lined with a double polybag next to the metal detector outlet chute.
4.8.3 Load granules in the RHS and LHS hoppers and cover both hoppers.
4.8.4 Turn ‘ON’ the main switch.
4.8.5 Insert key in reset lock and turn to reset position. The screen will show zero product count.
4.8.6 Turn the flywheel to check for any loose parts.
4.8.7 Press the ‘START’ button on the control panel. Turn engage/disengage lever to engage position. The machine will start.
4.8.8 To run the machine in inch mode press the start and stop buttons alternately.
4.8.9 Check the weight then thickness and then hardness of the individual tablet.
4.8.10 Ensure that the weight, thickness, and hardness of individual tablets are within the limit specified in the respective BMR. If not,
4.8.10.1 Set the by-turning weight adjustment lever in a clockwise direction to increase the weight and in an anticlockwise direction to decrease the weight.
4.8.10.2 Set the thickness by turning the tablet thickness lever in a clockwise direction to increase the thickness and decrease the thickness turn the lever in an anticlockwise direction.
4.8.11 After setting weight and thickness check friability and DT of the tablets as per specification in respective BMR for LHS and RHS stations.
4.8.12 Record all the observations in respective BMR.
4.8.13 Reject the tablets compressed during machine setting.
4.8.14 Operate the metal detector and vertical deduster as per SOP.
4.8.15 To increase the turret RPM turn the rotary RPM knob in a clockwise direction and to decrease the turret RPM turn the rotary RPM knob in an anticlockwise direction.
4.8.16 Press ‘STOP’ to stop the machine.
4.9 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 “Equipment Usage Log Book“.
Related SOP: Indent, Inspection, and Maintenance of Punches and Dies
6.0 Abbreviation (S):
SOP: Standard operating procedure
IPA: Isopropyl alcohol
ml: Milliliter
BMR: Batch manufacturing record
RPM: Rotations per Minute
DT: Disintegration test
SS: stainless steel
RHS: Right-hand side
LHS: Left-hand side
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