Compression machine, Purpose :
Compression machine, The purpose of this SOP is to describe the Operation and cleaning procedure of CAMBERT Tablet Compression Machine (Model: KMP DB8) in order to comply with cGMP standard.
Compression machine, Scope :
The scope of the procedure is applicable to the CAMBERT Tablet Compression Machine (Model: KMP DB8) at the Product Development area of XX Pharmaceuticals Pvt. Limited.
Definitions / Abbreviation:
[][]None
Responsibilities:
[][]The roles and responsibility is as follows:
Operator/Supervisor Product Development
[][]Operation and cleaning of the CAMBERT Tablet Compression Machine (Model: KMP DB8)
[][]Maintaining operation and cleaning log book
Executive/ Sr. Executive Product Development
[][]Checking and ensuring that the operation and cleaning is performed according to the SOP.
[][]Checking the log book.
[][]Preparation and timely review of the SOP.
General Manager, Engineering
[][]Preparation of maintenance schedule and maintenance of the machine.
Manager, Quality Assurance
[][]Ensure that the SOP reflects actual operation, cleaning and maintenance procedure.
[][]Approve the SOP against XX Pharmaceuticals Ltd. Master documents and current regulatory requirements.
[][]Implementation of the SOP.
Procedure: Compression machine
[][]Machine Assembling
[][]Remove the site glass of all sides
[][]Setting of Die
[][]Ensure that the die pockets are cleaned.
[][]Smear the die with food grade oil and place n the die pocket of the die table.
[][]Press the die down with finger to locate accurately the die in the die pocket.
[][]Once the die is located enter the die bar through the upper punch guide hole and allow to drop from a height of 70 – 80 mm approximately.
[][]The die will enter in the pocket apply additional force through die bar until the die is fully down on the die pocket.
[][]In order to set the shaped die enter the upper punch first and align the die cavity with the upper punch and gently push the die with the punch to enter in the die pocket, then apply additional force to fully down the die in the die pocket.
[][]Ensure that the top face of the die is perfectly flash with the die table.
[][]Tighten the die screw with the allen key. Ensure that the die is flash with the die table after tightening. Do not run the machine if die screw is not properly tightened.
[][]Use four blank dies ( four for B tooling and four for D tooling separately) in respective die cavity and install in the same procedure.
Setting of lower punch
[][]Remove the R.H. lower panel to access punch loading plug
[][]Remove the punch loading plug from the middle plate by just pushing it from bottom.
[][]Rotate the turret slowly with the help of hand wheel and align punch guide hole with the punch loading plug cavity.
[][]Insert the punch in to guide hole. Push the punch to its highest position and ensures it drops freely under its own weight. Tighten the punch holding plug with a screw driver.
[][]Carefully rotate the turret by means of the hand wheel until the punch is clear of the loading port.
[][]Set all the lower punch in the same way.
[][]Install the Punch loading plug in the middle plate.
Setting of upper punch
[][]Ensure that the punch guide holes and punches are clean.
[][]Place the punches in the punch holes and check that each punch is free to move in its guide and capable of dropping in to the cam track by its own weight.
[][]Rotate the turret at least one full turn by fly wheel to recheck to ensure that the upper punches enter the die bores without tipping and they run freely throughout the cam system.
[][]In order to set shaped punches (other than round) remove the punch take out plate for upper punch. Then place the punch in the punch holes and observe that the punch is fitted with the die without any friction, than rotate the fly wheel until the upper punch is removed to the punch head fitted position.
[][]Set all the punches in the same manner, then refit the punch take out plate in position.
[][]Rotate the machine manually through fly wheel to ensure that die punch are set correctly and the machine can be run without any friction.
[][]Install the force feeder in front of the machine. Ensure that no part is in touch with the main turret. Tighten the bolts of force feeder. Rotate the machine manually through fly wheel to ensure machine rotates without hindrance.
[][]Install the tablet ejection chute at the right side of the machine. Ensure that no part of the machine is in contact with the turret. Tighten the screw so that the ejection chute.
[][]Install the hopper above the force feeder.
[][]Connect the coupling with the feeder drive, shaft. Lock the coupling.
[][]Check that all nut bolts are tightened correctly.
[][]Install the R.H lower panel and the site glass. The machine is ready to use.
Machine Operation
[][]Rotate the machine through fly wheel and check that there is no abnormal sound in the machine
[][]Connect the main electric supply with the socket.
[][]Turn the machine on off switch to right direction, main drive and feeder drive button light will lights will illuminate to indicate machine is supplied with proper electric supply.
[][]Remove the R.H lower panel and keep the weight adjustment and thickness adjustment wheel at lower position, install the R.H. lower panel.
[][]Keep the speed adjustment knob at low and press the main drive button to ensure that the machine runs without any abnormal noise or hindrance.
[][]Press the main drive off switch, turret will stop.
[][]Remove the lid of the hoper and pour powder in the hoper, Push the feeder drive button feeder will start, wait until powder is transferred to the filling area.
[][]Fix the upper punch penetration wheel at its desired position (from 2 to 6 mm) depending on the punch and product type. Do not change the position of the wheel during operation.
[][]Fix the precompression wheel at its desired position (from 2 to 4), do not change the position of pre compression wheel during operation.
[][]Push the main drive button, turret will start, ensure that the powder are filled accurately in the die cavity.
[][]Rotate the thickness adjustment wheel clockwise until the powders take the shape of tablet.
[][]Adjust the weight of the tablet by rotating the filling depth adjustment wheel clockwise. Clockwise rotation will decrease the tablet weight and anticlockwise rotation will decrease the weight of the tablet.
[][]After desired tablet weight is achieved, adjust the thickness of the tablet. Clockwise rotation of thickness adjustment wheel will decrease the thickness and anticlockwise rotation will increase the thickness.
[][]Tablet hardness will also be adjusted by the thickness adjustment wheel. Clockwise rotation of the wheel will increase the hardness and anticlockwise rotation will decrease the hardness.
[][]Once tablet of desired quality is achieved set the turret speed. Turret speed can be adjusted by the speed adjustment knob. Clockwise rotation of the knob will increase the speed and anticlockwise rotation will decrease the speed.
[][]With any change in the turret speed, feeder speed is also needed to adjust. Clockwise rotation of the feeder speed adjustment knob will increase and anticlockwise rotation will decrease the feeder speed.
[][]Check the tableting parameters (Weight, Hardness and thickness) while turret speed is increased or decreased. Adjust the weight and thickness if necessary.
[][]Rotate the tablet counting key at right side. Counter will start counting the tablets. To watch counting in number of tablet in display place the counter knob at number of tablet position and to watch the turret speed place the counter knob at RPM position.
[][]To stop the turret, press turret off button and to stop the feeder drive, press feeder drive stop button.
[][]To stop the machine instantly, rotate the main switch at left position, machine will stop.
Machine Dismantling
[][]Remove the site glass in front side of the machine.
[][]Remove to material lock from the force feeder, place a poly bag and on the force feeder, excess materials will be flown in to the poly bag.
[][]Switch off the machine, Remove the main power supply form the socket.
[][]Adjust the filling depth wheel and thickness adjustment wheel at the lowermost position
[][]Loosen the ejection chute holding screw and remove the ejection chute
Remove the hoper.
[][]Unlock the feeder drive shaft from the coupling and keep aside. Loosen the force feeder holding screw then remove the force feeder.
[][]Remove the upper punches
[][]Remove the lower RH panel and punch loading plug.
[][]Rotate the machine manually and align the lower punch with the punch loading cavity.
[][]Loosen the punch holding plugs. Punch will automatically come out of the cavity, if required press gently downward and collect the punch.
[][]Remove all the lower punch in the same manner.
[][]Loosen all the die locking screw up to maximum limit.
[][]Enter the die bar from the punch loading cavity. Align the die with the cavity then gently apply pressure upward to remove the die. If necessary apply force through tamping. Die will come out of the die cavity. Remove all the die in the same manner.
[][]Install the lower RH Panel
Machine Cleaning
[][]If the machine doesn’t used within 15 days after cleaning, then the machine should be cleaned on the 15th day.
[][]Remove dusts from the machine with a vacuum cleaner. Collect dust from the turret, punch holding cam, operation panel and machine body.
[][]Clean all the machine parts with dry lint free cloth. Clean the die cavity & die holding plug with a flush brush. Use brush to clean any material sticking in the machine parts, screw and knobs.
[][]Use potable water to clean the turret, machine body, cam, punch holding cavity operation panel, die cavity and die holding screw.
[][]Use hot water to clean all the above mentioned body parts & finally rinse with purified water.
[][]Clean and sob with lint free cloth all the parts to dry any water in the machine body.
[][]Attach RH panel and site glass and stick a cleaned label in the machine.
Cleaning of die and punches
[][]Clean the die and punch with lint free cloth to remove any particle in the die and punch.
[][]Flash the die hole with flash brush and use brush to clean any particle sticking with the die and punch.
[][]Clean the die and punch with potable water, use brush if necessary.
[][]Clean the die and punch with hot water and finally rinse with purified water.
[][]Sob any water present in the die and punch with lint free cloth.
Smear the die and punches with food grade oil and store in the die punch cabinet.
Cleaning of force feeder
[][]Remove the screws of force feeder and open the cover of feeder housing
[][]Remove the paddle and paddle key from the machine and collect dust particle from the feeder housing with vacuum cleaner.
[][]Clean all the parts with lint free cloth.
[][]Clean all the parts with potable water, use Teflon brush if necessary
[][]Clean all machine parts with hot water and then rinse with purified water.
[][]Remove any water particle from the parts with lint free cloth.
[][]Assemble the paddle and cover in the feeder housing and take in a poly bag. Attach a cleaned label in the bag and store in the machine parts cabinet
Cleaning of hopper and ejection chute
[][]Clean all the powder with lint free cloth
[][]Use potable water to clean the hopper and the ejection chute, use Teflon brush where necessary.
[][]Clean the machine with hot water, then rinse with purified water.
[][]Clean and sob out any water remaining in the machine parts with lint free cloth.
[][]Wrap the change parts with poly bag, attach cleaned label in the poly bag and store in the machine parts cabinet.
Annexure: Compression machine
Annexure – I: Operation and cleaning log book.