Blister Packaging Machine, Purpose :

Blister Packaging Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of the Blister Packaging Machine (Model: HM-V3) in order to comply with cGMP standard.

Blister Packaging Machine, Scope :

The scope of the procedure is applicable to the Blister Packaging Machine (Model: HM-V3) at the Production area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

N/A.

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Operator

[][]Set Up, Operation and cleaning of the Blister Packaging Machine (Model: HM-V3)
[][]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

Precautions :

Safety

[][]Never run the machine with its door open.
[][]Use face mask, rubber gloves and protective clothing during handling of materials.
[][]Keep the switches “OFF” during break-time and at the end of the job.
[][]Care must be taken to ensure that the drive units and accessory parts cannot be switched on inadvertently after servicing or maintenance work.

Special Instruction

[][]Be sure that the power switches are “OFF” position.
[][]Beware of the high temperature of “Sealing top mold” during cleaning and if possible, allow it to cool down completely.
[][]Should not use methanol or other organic solvent like ethanol, carbon tetrachloride, thinner, benzene etc. to clean plastic doors and other parts of the machine.
[][]Water should not be used to clean metal parts of the machine.
[][]Care should be taken to ensure that no water enters inside the motor.
[][]Corrosive materials should not be used to clean the machine.
[][]Heavy parts should not dismantle alone, always taken help from others.
[][]Machine chiller purified water level should be check fifteen days interval and purified water should be change every three months interval.
[][]Carefulness should be taken about heavy parts handling.

Machine Assembling

[][]Switch on the main power supply of the machine.
[][]Check the draw in of the base film and the lid foil.
[][]Check Compressed air valve open and air pressure above 6 bars.
[][]Turn control panel key “ON”.
[][]Push reset button and press main button.
[][]Press setup button to show password for entering product list.
[][]Select Specific product from product list and press main button.
[][]Adjust draw off length by pressing inching switch according to advance length.
[][]Check the emergency push buttons, safety switches of the safety guards/glass doors.
[][]Press Main button and enter into information and positioning the machine according to following parameter-
[][]Forming station
[][]Sealing station
[][]Embossing
[][]Cooling station
[][]Perforation / Slitting station.

[][]Set following change parts by push inching switch-
Forming
Perforation / Slitting
Cutter
[][]Set following change parts carefully-
Pre-heating
Guide rail
Sealing upper-lower plate.
Embossing
Cooling Plate
Pulling Station
Feeding Tray

[][]Push reset button and checks the machine accurately by inch the inching switch press.
[][]Set bottom foil & lid foil and cutting shall be adjusted by inching switch on manual mode with press-
Heater.
Chiller.
Draw off.
Sealing lift.
[][]Press “Start” button and run machine to check the pocket forming and batch code embossing.
[][]Insert tablets or capsules on the pocket of PVDC/PVC/ALU film on the guide rail and perform a leak test operation of those strips to ensure proper sealing.
[][]Press manual mode and “OFF” all button only the following button shall “ON”
Heater.
Chiller and
Sealing lift.
[][]Convert manual mode to auto mode for running the machine.
[][]After completed the all parts setting, check that every parts are setting properly & proper place.
[][]Ensure that every screw nuts are tight properly.
[][]Set batch code with the respective digit.
[][]Emboss batch code and show Quality Assurance Officer for approval.

Machine Operation

[][]Ensure that area and equipment are clean and suitable to start the operation.
[][]Before starting the blister machine use surgical gloves, nose mask etc.
[][]Set different change parts like forming plate, sealing plate, code embossing, guid rail, cooling plate etc. in proper position.
[][]Set the top Foil (Alu foil) & Bottom Foil (PVC, PVDC & Alu foil) correctly.
[][]Open the compressed air valve & ensure that the air pressure is above 6 bars. Check & ensure that the compressed air is free from moisture.

[][]Temperature for PVDC preheating 110-140ºc and sealing 150-180ºc and for slitting are 60-80ºc & embossing Alu 70-80 ºc, temperature for Alu sealing 160-180 ºc and embossing 70-90 ºc maintained .
[][]Tablets and Capsules are placed manually to the PVDC forming or Alu forming pocked. Different packs are produced for different products by forming, feeding, sealing, punching and discharging.
[][]Machine should be observed very carefully during blistering operation.
[][]Press the stop button in machine after completes the blister operation.
[][]Record the machine operation start time and end time & other parameters in the ‘Equipment Log Book’ .

Dismantling of Change Parts

[][]Change parts should be removed sequentially from the machine with the help of others.
[][]Feeding Tray should be removed by loosing screw nuts.
[][]Guide Rail should be removed by loosing nuts.
[][]Forming Set (Upper & Lower Plate) should be removed by loosing screw nuts.
[][]Cutter should be removed by loosing nuts.
[][]Sealing Upper Plate should be removed by loosing clamp lock.
[][]Sealing Lower Plate should be removed by loosing screw nuts.
[][]Cooling Plate should be removed by loosing screw nuts.
[][]Perforation/ Slitting should be removed by loosing screw nuts.
[][]Heating Plate (In-case of Alu-PVC) should be removed by loosing nuts.
[][]Embossing Plate should be removed by loosing screw nuts and clamp lock.
[][]Change parts should be kept on clean pallets with “TO BE CLEANED” label.

Machine Cleaning

[][]All documents, previous product container and any materials should be removed from the room.
[][]The dust should be cleaned around the machine with the help of vacuum cleaner.
[][]The surface of the machine should be cleaned with lint free cloths with Purified Water or defined cleaning solution starting from top to downwards sequentially at first ceiling, wall, machine and floor.
[][]Safety covers (Door) should be cleaned by the use of wetted smooth lint free cloth with purified water.
[][]Glass and plastic materials should be cleaned by lint free smooth cloth with purified water.
[][]The machine should be moped with a lint free cloth using purified water.
[][]Finally, the machine should be moped with dried lint free cloth.
[][]Record should be taken in equipment machine log book.
[][]Machine accessories should be transferred to the wash room.
[][]“CLEANED” label should be attached to the machine.
[][]Change parts should be dismantled and kept on a clean trolley or pallets with status label and kept the trolley on the washing room for the cleaning at the end of product run.
[][]After cleaning completion the change parts should be stored in tool store with “CLEANED” label.

Annexure:

Annexure I Equipment Use Log Book

ROPP Cap Sealing Machine, Purpose :

ROPP Cap Sealing Machine, The purpose of this SOP is to describe the Operation and cleaning procedure of ROPP Cap Sealing Machine (Model: PPM-35) in order to comply with cGMP standard.

ROPP Cap Sealing Machine, Scope :

The scope of the procedure is applicable to the ROPP Cap Sealing Machine (Model: PPM-35) at the Production area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

N/A.

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Operator

[][]Setting, operation and cleaning of the Cap Sealing Machine (Model: PPM-35)
[][]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

Procedure:

Precaution:

[][]Ensure that area & equipment are clean and suitable to start the operation.
[][]Use protective suit, surgical gloves, head gear, cotton mask, and safety goggles during sealing operation.
[][]In case of emergency, press the emergency switch to stop the machine.

Machine Assembling

[][]Set the base of the machine by specific nut and attach the bottle adjuster.
[][]Set the sealing wheel according to the neck diameter of the bottle.
[][]Fix the bottle size by moving the base.

Machine Operation

[][]Load the bottle on the SS table.
[][]Fix the plastic stopper and aluminum cap on the empty bottle.
[][]Turn on the main switch of the machine.
[][]Take a bottle on the base.
[][]Seal it by the moving sealing wheel.
[][]Check the leakage by leak test apparatus.
[][]If sealing is accurate then another eight empty bottle have to seal.
[][]Take them again for leak test.
[][]Continue the sealing operation if sealing is accurate.
[][]Turn off the all switch gradually after complete the sealing operation.
[][]Record the machine start & end time and other parameters in the ‘Equipment Log Book’

Machine Dismantling

[][]Turn the main switch off.
[][]Dismantle the parts like moving sealing wheel, bottle adjuster unit and transfer them to the wash bay.

Machine cleaning

[][]Remove dusts from the machine with a vacuum cleaner. Collect dust from machine body.
[][]Clean all the machine parts with dry lint free cloth.
[][]Use potable water to clean the machine body and holding screw.
[][]Use hot water to clean all the product contact parts & finally rinse with purified water.
[][]Clean and swab all the parts with lint free cloth to remove water.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters on the ‘Equipment Log Book’.

Auger Filling Machine, Purpose :

Auger Filling Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of Auger filling Machine (Model: GZF30B) in order to comply with cGMP standard.

Auger Filling Machine, Scope :

The scope of the procedure is applicable to the Auger filling machine (Model: GZF30B) at the Production area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]PLC = Programmable Logic Controller.

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Operator

[][]Setting, operation and cleaning of the Auger filling Machine (Model: GZF30B)
[][]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

Procedure:

Precaution:

[][]Ensure that area & equipment are clean and suitable to start the operation.
[][]Before entering the filling room use protective suit, surgical gloves, head gear, cotton mask, and safety goggles during filling operation.
[][]Do not insert hands inside the hopper during operation; keep the hopper closed after loading.
[][]Make sure that powder is not deposited in hopper, dosing unit and other parts of the machine that must be observed very carefully.
[][]In case of emergency, press the emergency switch to stop the machine.

Machine Assembling

[][]Set the dosing unit by specific nut and attach the supporting parts of dosing unit.
[][]Set the powder hopper with its supporting parts.
[][]Fix the size of the bottle on the machine.
[][]Set the parameters of the machine such as Set Quantity, Actual Quantity and Output on the PLC.

Machine Operation

[][]Load the bottle on the SS table.
[][]Load the powder in hopper and close the lid of hopper.
[][]Turn on the main switch of the machine.
[][]Turn on the vibrator switch.
[][]Mix the powder in the hopper by rotating stick.
[][]Set the filled weight on the PLC.
[][]Adjust the filled weight by pressing leg punch in the empty glass bottle.
[][]Check the fill weight of eight bottles after setting the volts in dose wheel.
[][]Continue the filling operation if fill weight is accurate.
[][]Turn off the all switch gradually after complete the filling operation.
[][]Record the machine start & end time and other parameters in the ‘Equipment Log Book’

Machine Dismantling

[][]Turn the main switch off.
[][]Collect the powder from the hopper and dosing unit by vacuum cleaner.
[][]Dismantle the parts like hopper, auger and dosing unit and transfer them to the wash bay.

Machine cleaning

[][]Remove dusts from the machine with a vacuum cleaner. Collect dust from the hopper, dosing unit, operation panel and machine body.
[][]Clean all the machine parts with dry lint free cloth.
[][]Use potable water to clean the machine body, all product contact parts and holding screw.
[][]Use hot water to clean all the product contact parts.
[][]Finally rinse the machine body, all product contact parts, holding screw and other parts with purified water.
[][]Clean and swab all the parts and the machine body with lint free cloth to remove water.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters on the ‘Equipment Log Book.

Annexure:

Annexure I Equipment Use Log Book

Capsule Polishing Machine, Purpose :

Capsule Polishing Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of the Capsule Polishing Machine (Model: SF-40N) in order to comply with cGMP standard.

Capsule Polishing Machine, Scope :

The scope of the procedure is applicable to the Capsule Polishing Machine (Model: SF-40N) at the Production area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

N/A.

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Operator

[][]Set up, operation and cleaning of the Polishing Machine (Model: SF-40N)
[][]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

Precautions :

[][]Make sure that the main power switch is OFF position before and after operation.
[][]Ensure that area & equipment are clean and suitable to start the operation.
[][]Before entering the capsule polishing room use protective suit, surgical gloves, head gear, cotton mask, and safety goggles during polishing operation.
[][]Do not insert hands inside the hopper during operation.
[][]Make sure that capsule is not deposited in hopper and other parts of the machine that must be observed very carefully.
[][]In case of emergency, press the emergency switch of the main encapsulation machine to stop the machine.

Machine Assembling

[][]Set the capsule polishing brush by specific nut and attach the SS cover of the machine.
[][]Set the capsule hopper.
[][]Fixed the empty capsule shell feeder on the machine.
[][]Set the air pressure of the machine.

Machine Operation

[][]Turn ON the main switch of the machine. Then turn ON the switch of the capsule polishing machine.
[][]Turn on the air pressure valve and adjust the air pressure 0.15 to 0.2 bars.
[][]Load the capsule on the hopper.
[][]Check the capsule is polishing accurately.
[][]Continue the polishing operation if capsule polishing is accurate.
[][]Turn OFF all switch gradually after complete the polishing operation.
[][]Record the machine operation parameters in the ‘Equipment Log Book’

Machine Dismantling

[][]Turn the main switch OFF.
[][]Collect the dust from the hopper by vacuum cleaner.
[][]Dismantle the parts like hopper, machine cover, brush and empty shell feeder and transfer them to the wash bay.

Machine Cleaning

[][]Remove dusts from the machine with a vacuum cleaner. Collect dust from the hopper machine body.
[][]Clean all the machine parts with dry lint free cloth.
[][]Use potable water to clean the machine body, all product contact parts and holding screw.
[][]Use hot water to clean all the product contact parts like capsule polishing brush.
[][]Finally rinse the machine body, all product contact parts, holding screw and capsule polishing brush with purified water and dry the brush properly after cleaning.
[][]Clean and swab all the parts and the machine body with lint free cloth to remove water.
[][]After final cleaning affix the ‘CLEANED’  label.
[][]Record the cleaning parameters in the ‘Equipment Log Book.

Annexure:

Annexure I Equipment Use Log Book

Capsule Filling Machine , Purpose :

Capsule Filling Machine , The purpose of this SOP is to describe the setting, operation and cleaning procedure of the Capsule Filling Machine (Model: SF-40N) in order to comply with cGMP standard.

Capsule Filling Machine , Scope :

The scope of the procedure is applicable to the Capsule Filling Machine (Model: SF-40N) at the Production area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]N/A.

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Operator

[][]Set up, operation and cleaning of the Capsule Filling Machine (Model: SF-40N)
[][]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.

Procedure :

Precautions :

Safety

[][]Never run the machine with its door open.
[][]Use face mask, rubber gloves and protective clothing during handling of materials.
[][]Keep the switches “OFF” during break-time and at the end of the job.

Special Instruction

[][]Ensure the Capsule Filling machine is properly cleaned.
[][]Compressed air pressure should be set at 6 kg/cm².
[][]Filters on the dry vacuum must be cleaned regularly. Vacuum should be used for cleaning.
[][]Do not use water or a solvent to wash filters on the vacuum.
[][]Never wash filters with water.
[][]Lubricate all moving parts as per schedule.
[][]Use correct lubricants for all moving parts.
[][]Never repair, adjust, clean or lubricate any moving parts while the machine is in motion.

Machine Assembling

[][]Open the site glass of all sides
[][]Set the desired side pusher and tighten the set screws.
[][]Set the desired race way and tighten the set screws.
[][]Set the desired feeder and tighten the set screws.
[][]Set the block and tighten the set screws.
[][]Adjust the side pusher and down pusher.
[][]Press “up” button on the display and make powder hopper in maximum height.
[][]Install the desired dose filling plate.

Adjust the dosing device.

Align the stop plate with the tamping pin holes. Insert the tamping pins and pull the stop plate to lock around the neck of the pins. Tighten the four set screws.
For alignment of dosing disk with set plate-
Loosen the dosing disk set screws.
Insert six adjustment bars through the holes on the set plate.
Adjust the position of the dosing disk until all six adjustment bars fall freely into the disk holes
[][]Tighten set screws without moving the disk.
[][]Check the alignment with six adjusting bars to see if all bars fall freely without touching the disk hole wall.
[][]Turn the machine 2-3 revolutions by the hand wheel to see the adjustment bars fall freely at all six points.
[][]Adjust the tamping pins into the set plate holes and adjust set screws.
[][]Adjust the closing pin holder and joint plate depending on the capsules size.
[][]Adjust height of dosing disk (0.5mm).
[][]Check the correct setting of change parts listed below
Upper capsule segment
Lower capsule segment
Capsule feeder
Race way
Side pusher
Capsule stopper plate
Size ring
Dose filling plate (for pellet)
Tamping pins (for powder)
Dosing disk (for powder).

Machine Operation

[][]Check the cleanliness of the filling machine. Give clearance to run the machine.
[][]Switch ON the main power switch.
[][]Open compressed air supply valve.
[][]On the control power of automatic data controller.
[][]Race machine through a few steps via the hand wheel of the main drive.
[][]Charge capsule hopper with empty capsule shell.
[][]Clear capsule locking at capsule magazine.
[][]Turn key switch MANUAL MODE to INCHING.
[][]Switch on vacuum Press the illuminated pushbutton VACUUM

Powder Station

[][]Charge powder container with powder
[][]Adjust powder height mechanical tamping pin adjustment
[][]Adjust powder filling level height on dosing disk
[][]Run machine in inch mode for 6-7 turnings until all segments are filled with capsules Press the pushbutton START Subsequent check capsule weight.
[][]If necessary, adjust the capsule weight by adjusting the tamping pin and the powder height.

Pellet Filling Station

[][]Charge pellet hopper with pellet.
[][]Open the shutter > moving it upwards
[][]Start operation of the pellet station.
[][]Run machine through several cycles in inch mode >press the pushbutton START and then check capsule weight with pellets.
[][]Let the machine running >Press the pushbutton START
[][]Check again capsule weight and correct if necessary.
[][]Start machine in automatic mode.

Control machine running

[][]Stop automatic mode > Press key STOP.
[][]Shut Off compressed air supply.
[][]Clean the machine as per current version of SOP.

Machine Cleaning

[][]Take the main switch to OFF position.
[][]Remove the pellet hopper by removing four screws.
[][]Remove pellet doser by removing four nuts.
[][]Remove the discharge chute by removing two nuts.
[][]Rotate the hand wheel, situated at the lower portion of right side of the machine, to bring capsule segment no. 1 to backside of the machine.
[][]Remove the upper capsule segment one by one by removing two nuts using allen key. Clean them with dry cloth, then tape water & finally rinse with purified water and keep them in their respective box.
[][]Remove the lower capsule segment one by one by removing two nuts using allen key from the two centering pins. Clean them with dry cloth, then tape water & finally rinse with purified water and keep them in their respective box.
[][]Loosen two set screws and remove the block of shell doser.
[][]Loosen two set screws and remove the feeder. Clean using compressed air.
[][]Loosen two set screws and remove the race way. Clean using compressed air.
[][]Loosen two set screws and remove the side pusher. Clean using compressed air.
[][]Keep the shell feeder, race way and side pusher in their respective box.
[][]Remove the capsule stopper plate by removing two nuts.
[][]Remove size ring, clean and set the desired size ring.
[][]Remove any loose powder inside the cleaning segment holes by blowing compressed air and by applying vacuum.
[][]Disassemble the upper part of the granules doser, dose controller and dose filling plate. Clean them with organic solvent like isopropyl alcohol. (For pellets).
[][]Loosen the coupling for the agitator screw and driving shaft. (For powder)
[][]Remove dust from the agitator screw, driving shaft and powder tank with clean cloth. Wash them 2-3 times with potable water then rinse with purified water. Wipe them with dry clean cloth. Allow drying in air conditioned room.
[][]Loosen the set screws and remove the fastening plate by lifting and tilting. Clean the fastening plate with cloth, then tape water & finally rinse with purified water and keep them in their respective box
[][]Loosen the set screws and remove the dosing disk and chamber. Clean the dosing disk and chamber with cloth, then tape water & finally rinse with purified water and keep them in their respective box
[][]Loosen the lock screws, turn the adjusting screws all the way up and lift the pin holder to remove thirty pins with the holder.
[][]To remove pins from the holder, loosen the set screws, pull the stop plate forward, and remove pins. Clean them with tape water & finally rinse with purified water and keep them in their respective box
[][]After final cleaning affix the ‘CLEANED’  label.
[][]Record the cleaning parameters in the ‘Equipment Log Book’

Annexure:

Annexure I Equipment Use Log Book

Tablet Coating Machine, Purpose:

Tablet Coating Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of Tablet Coating Machine (Model: FC-39) in order to comply with cGMP standard.

Tablet Coating Machine, Scope:

The scope of the procedure is applicable to the Tablet Coating Machine (Model: FC-39) at the Production area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]PLC : Programmable Logic Controller.
[][]CIP : Clean In Place.

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Operator

[][]Setting, operation and cleaning of the Tablet Coating Machine (Model: FC-39)
[][]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

Procedure: Tablet Coating Machine

Precaution:

[][]Ensure the outlet duct is open.
[][]Ensure the inlet duct is open.
[][]Keep the doors closed during operation and after completion of job.
[][]Check air pressure.
[][]Use face mask, rubber gloves and protective clothing during handling of materials.

Machine Assembling

[][]Before operation assemble the machine accessories that are necessary for operation.
[][]Place the spray gun at the holding arm. Then, enter the spray gun holding arm into the coating pan.
[][]Connect the peristaltic pump with the spray gun.
[][]Test whether coating pan rotates smoothly without any abnormal noise after activation. Check that rotation direction is correct.

Machine Operation.

[][]Switch on the Machine.
[][]Unlock and open the inlet port cover of the machine.
[][]Load tablets into the coating pan. Total tablet load should not exceed the maximum working load and should not be less than the minimum working load.
[][]Securely close the coating pan chamber cover and clamp.
[][]Pan motor ‘‘ON/OFF’ from the PLC.
[][]Warm up the tablets without spraying on the tablet bed.
[][]Start spraying phase by pressing the pump start button in manual mode or Spray key in Auto mode. Adjust dosing volume by changing the rpm of the peristaltic pump.
[][]After spraying, stop the Spray by pressing Pump ON/OFF button. Dry the tablets until required.
[][]Unload the tablets from the coating pan when desired tablet temperature is attained.
[][]Record the machine operation start time & end time and other parameters on the ‘Equipment Log Book’

Machine Dismantling

[][]Remove the spray system and dismantle.
[][]Remove the pan outlet dumber.

Machine Cleaning: Tablet Coating Machine

[][]Switch off outlet damper, outlet blower, pan motor.
[][]Open all safety doors.
[][]Switch on the peristaltic pump by pressing “Switch on button”.
[][]Wash the inside of tube by spraying with hot water.
[][]Then wash the tube with purified water.
[][]Pass compressed air through tube to dry inside of tube.
[][]Clean the Spray gun nozzle with hot water and soft brush.
[][]Now discharge the water with dissolved materials.
[][]Now hot water is applied inside the chamber through CIP system to remove materials fixed hardly on the chamber surface.
[][]Re-wash the machine with purified water as required through CIP system.
[][]Wash the machine with lint free cloth.
[][]Clean inlet ports, discharge port, mixing chamber and external surface with potable water, hot water & purified water.
[][]Wipe the water droplets with lint free cloth, and dry the machine with compressed air.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters on the ‘Equipment Log Book’

Annexure:

Annexure I Equipment Use Log Book

Tablet Metal Detector ,Purpose:

Tablet Metal Detector , The purpose of this SOP is to describe the setting, operation and cleaning procedure of MET 30+ Pharmaceutical Metal Detector Machine in order to comply with cGMP standard.

Tablet Metal Detector , Scope:

The scope of the procedure is applicable to the MET 30+ Pharmaceutical Metal Detector Machine at the Production area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]N/A.

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Operator

[][]Operation and cleaning of the MET 30+ Pharmaceutical Metal Detector
[][]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

Procedure:

Precaution :

[][]Use face mask, rubber gloves and protective clothing during handling of materials.
[][]Ensure Electric line is properly connected.

Machine Assembling

[][]Set the discharge chute into the main body of the machine.
[][]Set the rejected tablet containing bucket in the lower part of the machine.
[][]Adjust the alignment of the machine with respect to main machine.
[][]Ensure all the settings are properly done.

Machine Operation

[][]Connect electrical cable to the machine.
[][]Switch ON the main power of the machine.
[][]Set the programs from the control panel of the machine.
[][]Pass the tablet through the discharge chute and reject the tablet having metallic content.
[][]Record the machine start & end time and other parameters in the ‘Equipment Log Book’

Machine Dismantling

[][]Switch OFF the main power of the machine.
[][]Remove the discharge chute.
[][]Remove the bucket from the lower part of the machine.

Machine Cleaning

[][]Remove dusts from the machine with a vacuum cleaner.
[][]Clean all the machine parts with dry lint free cloth.
[][]Use potable water to clean the machine body.
[][]Use hot water to clean all the product contact parts.
[][]Finally rinse the machine body, all product contact parts.
[][]Clean and swab all the parts and the machine body with lint free cloth to remove water.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters on the ‘Equipment Log Book’

Annexure:

Annexure I Equipment Use Log Book

Spare Parts , Purpose:

Spare Parts , To lay down the procedure for Cleaning, Labeling & Storage of spares in spare parts room at the Production Area.

Spare Parts , Scope:

This SOP is applicable for the Production Area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

N/A.

Responsibilities:

[][]The Roles and Responsibilities are as follows :

Operator

[][]To follow the laid down procedure

Executive, Production

[][]To monitor and check the procedure is followed

Manager, Production

[][]To implement this correctly

Manager, Quality Assurance

[][]To approve the Document

Procedure :

General Instructions

[][]Store all the clean and dry spare parts in the lockers or on the racks in separate polythene bags. Never keep any parts in the spare parts room without covering them.
[][]All the equipment parts stored in the spare parts room must be affixed with properly filled status label to identify the parts and its cleaning status.
[][]Production supervisor must regularly check the status label to avoid any error in the labeling.

Storing of utensils and accessories

[][]Store all the clean utensils and accessories in the lockers or in the racks in the separate polythene bags. Never keep any parts in the spare parts room without covering them.
[][]All the equipment parts stored in the spare parts room must be affixed with properly filled status label to identify the parts and its cleaning status.
[][]Record the use of utensils and accessories in the ‘Spares Use Register Book’ (Annexure I).
[][]Production supervisor must regularly check the status label to avoid any error in the labeling.

Storing of Dies and punch boxes

[][]Wipe the outside of the boxes with clean duster, then with 70% IPA solution (if necessary). Clean the dies and punches according to the Tablet Compression Machine SOP.
[][]Record the use of dies and punches in the ‘Spares Use Register Book’ for using dies and punches. Check the condition of punches before issuing and receiving.
[][]Storing of different size change parts of capsule filling machine
[][]Keep the clean and dry machine parts in the spare parts room in separate polybag and affix with properly filled status label.
[][]Record the use of Capsule Filling Machine change parts (e.g. Cutter, forming channel etc.) in the ‘Spares Use Register Book’.

Storing of blister change parts

[][]Wipe the outside of the boxes with clean cloth, then with 70% IPA solution (if necessary).
[][]Keep the clean and dry blister change parts in the locker dedicated for blister change parts.
[][]If there is no spare space in the locker keep the change parts in a polybag with proper status label and then place in clean pallet.
[][]Record the use of Blister parts (e.g. Cutter, forming channel etc.) in the ‘Spares Use Register Book’. Check the condition of blister parts before issuing and receiving.

Annexure:

Annexure I Spare Parts Usage Log Register

Tablet Dedusting Machine, Purpose:

Tablet Dedusting Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of SEJONG Tablet Dedusting Machine in order to comply with cGMP standard.

Tablet Dedusting Machine, Scope:

The scope of the procedure is applicable to the SEJONG Tablet Dedusting Machine at the Production area  of XX  Pharmaceuticals Limited.

Definitions / Abbreviation:

N/A

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Operator

[][]Setting, operation and cleaning of the Machine
[][]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 :

[][]Use face mask, rubber gloves and protective clothing during handling of materials.
[][]Ensure electric and air line are properly connected.
[][]Machine Assembling
[][]Set the perforated plate in machine.
[][]Fixed the upper lid properly by holding screw.
[][]Ensure all the screws are connected properly.

Machine Operation

[][]Connect electrical cable of Dedusting Machine to the main compression machine.
[][]Connect compressed air line to Dedusting Machine.
[][]Switch ON the main power of Dedusting Machine.
[][]Adjust the vibration level by tuning volume.
[][]During tablet compression tablet passes through the discharge chute of compression machine to the Dedusting machine.
[][]Record the machine start & end time and other parameters in the ‘Equipment Log Book’

Machine Dismantling

[][]Switch OFF the main power of the Dedusting Machine.
[][]Remove the compressed air line from the Dedusting Machine.
[][]Open the upper lid of the machine.
[][]Remove the perforated plate of the machine.

Machine Cleaning

[][]Remove dusts from the machine with a vacuum cleaner.
[][]Clean all the machine parts with dry lint free cloth.
[][]Use potable water to clean the machine body, all product contact parts and holding screw.
[][]Use hot water to clean all the product contact parts.
[][]Finally rinse the machine body, all product contact parts, holding screw and other parts with purified water.
[][]Clean and swab all the parts and the machine body with lint free cloth to remove water.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters on the ‘Equipment Log Book’

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’