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Standard Operating Procedure for Operation and Cleaning of Tablet Compression Machine, the basic principle behind the compression machine is the hydraulic pressure.

Tablet Compression Machine

1.0   Objective :

• • To lay down the procedure for cleaning and operation of Tablet Compression Machine (35 Station).       

2.0   Scope :

• • This SOP is applicable in Manufacturing Area Tablet at pharmaceutical drug manufacturing plant.

3.0   Responsibility :

• • Production Chemist /Operator : To follow the procedure

• • Head Production : For SOP compliance

4.0   Procedure – Tablet Compression Machine

• • Product change over (Type A) :

• • Change the status of area & equipment and ensure that dully filled and signed status label is affixed on the equipment as per SOP for Status Labeling.

• • Release the pressure before cleaning the machine.

• • Switch ‘’OFF’’ electrical supply, remove all adhering powder on the machine with the help of vacuum dust extraction pipe.

• • Use Compressed Air gun to remove dust from inner area.

• • Remove the hopper, feed frame, Tablet chutes, extraction points, granule scraper, Studs and kept them in a SS trolley cover with polybag & take it to washing area through unclean equipment room.

• • Clean the machine parts thoroughly with sufficient potable water by using with nylon scrubber & finally rinse with Purified water followed by drying with compressed air.

• • Remove the upper punches, lower punches and dies carefully, clean them thoroughly with 70% IPA & store them in punches & dies cabinet as per SOP for Punches and Dies.

• • Remove the following parts from the machine & clean them with 70 % IPA & dry with lint free cloth.

• • Clean the upper cams with 70 % IPA & dry with lint free cloth.

• • Clean the worm gear of the machine and lifting cam.

• • Mop all the external surface of machine with 70 % IPA and dry with dry lint free cloth & internal surface with dry lint free cloth.

• • Clean the upper turret guide, lower turret guide and die pocket with 70 % IPA followed nylon brush and lint free cloth.

• • Clean the oil cups, extractions pipe & electrical cables with dry lint free cloth.

• • Mop Acrylic Cover of machine first with wet lint free cloth and followed by dry lint free cloth.

• • Inform to QA to take the swab sample and send it QC for testing along with the filled format “Swab Test Intimation Slip / Analysis Report” as per SOP.

• • After analysis QC chemists enter the details in “Swab Test Intimation Slip / Analysis Report” and send it back to production.

• • If the report is OK, then affix dully filled and signed status label.

• • If the report is not OK, then repeat the above procedure.

• • Clean the area as per SOP.

• • Enter the details in the Equipment log.

• • Validity of cleaned Equipment is 72 Hours.

• • If cleaned equipment hold time exceeds the validity of 72 hours then before starting the next process, clean the equipment as per SOP.

• • Batch change over (Type B):

• • Change the status of area & Equipment.

• • Clean the outer surface of tablet compression machine with clean lint free cloth.

• • Mop all the parts with dry and clean lint free cloth.

• • If the processing of next batch takes more than 48 hours then clean the equipment following point 5.1 (Type A cleaning).

• • Enter the details of cleaning in Logbook.

• • Operation of Tablet Compression Machine :

• • Ensure that the tablet compression machine is clean and status label is affixed on the tablet compression machine.

• • Check the proper working of HVAC system by checking the pressure differential of area, temperature and RH.

• • Ensure that the workmen are properly gowned using snood and hand gloves.

• • Get the line clearance from QA Personnel before starting the operation.

• • Set the machine as per product specification and check the following:

• • • Ensure that the die and punch set used are of appropriate size and shape as specified in the applicable Batch Manufacturing Record.

• • • Check each punch and die individually for any damage.

• • • Ensure the cleanliness of feed frame, hopper, dies and punches used.

• • • Open the metallic piece (For capsule shape) provided on the top plate over the turret for free entry of the upper punch in the die.

• • • Place the die in the hole and an upper punch on the same die through the upper punch guide hole and ensure the free entry of the upper punch in the die.

• • • Remove the upper punch and fix the die properly in the die hole with the help of a metallic rod.

• • • Tighten the die locking screw. No excessive force should be applied in tightening the die locking screws to prevent distortion of the turret.

• • Insert the lower punch through the lower punch guide hole and ensure its free movement in the Rotate the turret with the help of flywheel and insert the upper punch in its guide hole.

• • Repeat the steps for remaining sets.

• • Fix the metallic piece (for capsule shape) back in the top piece over the turret.

• • Check the compacting pressure registered on the pressure gauge.

• • Check the oil leveling all the drip lubricators.

• • Ensure that all the guards are closed and interlocked.

• • Check the tablet take OFF plate.

• • Check the upper punch for its correct setting.

• • Always rotate the turret, at least 2-3 revolutions, with the help of hand wheel manually before running the machine on power.

• • Set the de-dusting and metal detector machine correctly below the tablet discharge chute and operate the machine as per SOP before running the machine.

• • Properly identified bin/ container containing the product granules. Granules load in to the hoppers of the tablet compression machine

• • Start the machine drive.

• • Engage the machine by pressing the switch situated on the front side of the machine.

• • The turret should start its motion.

• • Set the average weight and thickness of tablet.

• • After checking all the specified parameters run the machine at its operational speed.

• • Set & start the tablet counter.

• • After completion of work release the pressure.

• • Switch ‘’OFF’’ the mains.

• • After completion of activity change the status of area and affix dully filled and signed status label on the tablet compression machine.

• • Clean the tablet compression machine following above procedure.

• • Enter the details in BMR and in Equipment Log.

5.0   Annexure – Tablet Compression Machine

Annexure-I : Flow chart of Tablet Compression machine

Annexure-II: Cleaning checklist for Tablet Compression Machine

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