Tablet Compression Machine, Purpose :
Tablet Compression Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of SEJONG Tablet Compression Machine (Model: MRC-30N) in order to comply with cGMP standard.
Tablet Compression Machine, Scope :
The scope of the procedure is applicable to the SEJONG Tablet Compression Machine (Model: MRC-30N) at the Production area of of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]PLC : Programmable Logic Controller.
[][]RPM : Rotation Per Minute.
Responsibilities:
[][]The roles and responsibilities are as follows:
Operator
[][]Setting, operation and cleaning of the SEJONG Tablet Compression Machine (Model: MRC-30N).
[][]Maintaining Equipment Log Book.
Executive, Production
[][]To monitor and check the laid down procedure.
Manager, Production
[][]To implement this correctly.
Manager, Quality Assurance
[][]To approve the Document.
Annexure:
N/A.
Procedure:
Precaution:
[][]Check for leakage of oil & the connection state.
[][]Check for proper locking of the dies with die setting pin.
[][]Check the assembling of die & punch set.
[][]The cover doors must be kept in close position during operation.
[][]Check the setting components like thickness, weight, hardness & other parameters.
[][]Use face mask, rubber gloves and protective clothing during handling of materials.
Machine Assembling
[][]Open the site doors of all side.
[][]Keep available all the dies, punches & other necessary parts near the machine.
Setting of Die
[][]Ensure that the die pockets are cleaned.
[][]Smear the die with food grade oil and place in the die pocket.
[][]Press the die down with finger to locate accurately in the die pocket.
[][]Once the die is located, enter the die insert bar through the upper punch guide hole and allow dropping.
[][]The die will enter in the pocket; apply additional force through die insert 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 bore with the upper punch tip and gently push the die with the punch to enter in the die pocket, then apply additional force through die insert bar 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 setting pin with the torque after greasing the tip of die setting pin. Ensure that the die is flash with the die table after tightening. Do not run the machine if die setting pin is not properly tightened.
[][]Set all blank dies (D tooling) in respective die pocket in the same procedure by rotating the turret manually with the help of hand wheel.
Setting of lower punch
[][]Take out the change rail and put the lower punch through the lower space of the change rail. At this time grease thinly on the head of punch.
[][]Move the disk (turret) to the next station through rotating with hand wheel. Make the punch movement smoothly not to be stuck in the down rail.
[][]Assemble every punch with same method.
[][]Assemble the change rail.
Setting of upper punch
[][]Ensure that the punch guide holes and punches are clean.
[][]Take out the change rail and put the upper punch through the upper space of the change rail.
[][]Place all the punches in the punch holes by rotating the disk (turret) with the hand wheel 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 hand wheel to recheck to ensure that the upper punches enter the die bores without any friction and they run freely throughout the cam system.
[][]Install the mechanical force feeder, scrapers & other parts of the machine. Ensure that no part is in touch with the main disk (turret). Tighten the bolts of mechanical force feeder. Rotate the machine manually through hand wheel to ensure machine rotates without hindrance.
[][]Install the tablet ejection chute of the machine. Ensure that no part of the machine is in contact with the turret. Tighten the screw of the ejections chute.
[][]Install the side covers.
[][]Install the hopper above the mechanical force feeder.
[][]Connect the coupling with the feeder drive, shaft. Lock the coupling.
[][]Connect the powder sensor with the hopper.
[][]Check that all nut bolts are tightened correctly.
[][]Close all side doors. The machine is ready to use.
Machine Operation
[][]Rotate the machine through hand wheel and check that there is no abnormal sound in the machine.
[][]Ensure the connection of air supplying line.
[][]Switch on the main power on the back of machine.
[][]Again switch on the key of the operation box bottom part by turning the key clockwise.
[][]Login the password.
[][]If the screen is touched and there is no alarm in the machine the screen will be conversed into OPERATION PANEL mode. When the alarm is working, the screen will show SAFETY MESSAGE mode.
[][]Rotate the machine through hand wheel and check that there is no abnormal sound in the machine.
[][]Ensure the connection of air supplying line.
[][]Switch on the main power on the back of machine.
[][]Again switch on the key of the operation box bottom part by turning the key clockwise.
[][]Login the password.
[][]If the screen is touched and there is no alarm in the machine the screen will be conversed into OPERATION PANEL mode. When the alarm is working, the screen will show SAFETY MESSAGE mode.
Operation Panel Setting
Operation condition
[][]FEEDER CONTROL (select AUTO/HAND/INCH mode)
[][]FEEDER CONTROL (RPM control for HAND mode)
[][]DUST COLLECTOR (ON/OFF switch)
[][]TARGET QUANTITY (ON/OFF switch)
[][]POWDER ALARM (powder sensor ON/OFF switch)
[][]BUZZER (ON/OFF switch)
[][]MAIN MOTOR CONTROL (disk RPM control)
Set Panel Setting
[][]In order to set the product condition converse into SET PANEL mode through touching SET PANEL button in bottom of the screen.
Product condition
[][]PRETHICKNESS (Thickness setting in the pre-pressure station)
[][]FILLING DEPTH (Tablet weight setting)
[][]MAIN THICKNESS (Tablet thickness setting)
[][]SELECT CAM (Cam selection)
[][]FEEDER RPM % (In AUTO mode, RPM setting)
[][]POWDER SUPPLY TIME (Time setting from powder shortage alarm to machine stop)
[][]TARGET QUANTITY (Target quantity setting)
[][]OIL LUBRICATION SETTING (Punch lubrication setting)
[][]HELP MODE (Description of touch screen function)
Tablet weight control
[][]In case that the weight is not accurate, generally the weight is adjusted through the touch screen. But, besides of that the small amount of powder filling can be adjusted with the speed of mechanical feeder agitator, also Tablet thickness control
[][]Tablet thickness is adjusted by lower roll’s height and it is operated through touch screen.
Hardness control
[][]Hardness is adjusted by following methods-
[][]Control compressing force in pre & main pressure section
Inch operation
[][]Before starting the production, INCH operation is recommended though the operation box.
[][]Control pre & main thickness with the maximum value.
[][]Set pre & main thickness according to the production data.
[][]If every configuration is ready, check SAFETY MESSAGE screen.
[][]If there is any problem in the machine, solve the problem with proper method.
[][]After setting variables like filling cam selection, pressure, filling depth, penetration depth, tablet thickness and etc run the machine. Especially, for the safety, before starting the product, inching operation should be done.
[][]Inch the mechanical feeder for a few seconds to distribute the granules uniformly within the die bore.
[][]Off the manual mode.
[][]On the auto mode.
[][]Inch the machine one revolution & check the weight.
[][]Adjust the filling depth to get the required weight. (If necessary).
[][]Adjust the thickness controller to get the required hardness and thickness.
[][]Record the machine start & end time and other parameters in the ‘Equipment Log Book’
Machine Dismantling
[][]Open the site doors of the machine.
[][]Place a poly bag on powder outlet; remove the material lock from the mechanical force feeder, and on the mechanical force feeder, excess materials will be flown in to the poly bag.
Switch off the machine.
[][]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 and powder sensor carefully.
[][]Unlock the feeder drive shaft from the coupling and keep aside. Loosen the mechanical force feeder holding screw then remove the mechanical force feeder.
[][]Remove the upper punch change rail.
[][]Remove the upper punches.
[][]Remove the lower punch change rail.
[][]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 setting pins up to maximum limit.
[][]Enter the die insert bar through the lower punch loading cavity. Then gently apply pressure upward to remove the die. Die will come out of the die pocket. Remove all the dies in the same manner.
Machine Cleaning
[][]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 bore, die pocket & die table with a flush brush. Use brush to clean any material sticking in the machine parts, pin and knobs.
[][]Use potable water to clean the turret, machine body, cam, punch holding cavity, die, die setting pin and other parts.
[][]Use hot water to clean all the above mentioned body parts & finally rinse with purified water.
[][]Clean and swab all the parts with lint free cloth to remove water.
[][]Close site doors and affix 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 bore 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.
[][]Remove 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 mechanical force feeder
[][]Remove the screws of mechanical 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 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 mentioned parts with hot water and then rinse with purified water.
[][]Clean and remove 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.
[][]Record the cleaning parameters on the ‘Equipment Log Book’
