1.0 SCOPE:
Applicable to Compression machine manufactured by Cadmach Machinery Company Pvt. Ltd.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 MACHINE AT THE TIME OF BATCH CHANGE OVER/ AT THE END OF SHIFT
3.1.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.1.2 Verify that the machine is switched ‘OFF’.
3.1.3 Change the status board of the cubicle.
3.1.4 Open the acrylic covers of the machine and suck the accumulated powder from the
feed frame and other contact parts of the machine with the help of vacuum cleaner.
3.1.5 Open the cover of the De duster and clean it with vacuum cleaner.
3.1.6 Remove both the hoppers. Clean them with the help of vacuum cleaner followed by dry lint free cloth.
3.1.7 Suck the accumulated powder on the machine platform with the help of vacuum cleaner and clean the same with dry lint free cloth.
3.1.8 Remove both the feed frame and clean them using vacuum cleaner.
3.1.9 Remove the upper punches individually and wipe them with dry lint free cloth.
3.1.10 Refit the upper punches properly.
3.1.11 Fix the feed frames to their respective positions. Place both the hoppers properly.
3.1.12 Clean the acrylic covers, frames and the body part of the machine using dry lint free cloth.
3.1.13 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ to the machine.
3.1.14 Fill the Equipment Cleaning Checklist
3.1.15 Enter the details in the ‘Equipment usage log’
Note: If jamming of lower punches observed then remove and clean them using lint free cloth.
3.2 AT THE TIME OF PRODUCT CHANGE OVER / EXPIRY OF USE BEFORE DATE
3.2.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.2.2 Verify that the machine is switched ‘OFF’.
3.2.3 Release the compression pressure by turning the lever in Anticlockwise direction.
3.2.4 Remove hoppers, feed frames, tablet discharge chute and transfer them in a virgin polythene bag on a trolley. Affix the ‘TO BE CLEANED’ label to the trolley. Transfer the trolley to the washing area.
3.2.5 Clean the parts using about 20 kg of potable water followed by scrubbing with nylon scrapper dipped in 0.1% Sodium Lauryl Sulphate solution.
3.2.6 Wash the parts with about 20 kg of Potable water and finally rinse with about 20 kg of Purified Water.
3.2.7 Wipe the parts with dry lint free cloth and dry them using compressed air.
3.2.8 Remove the dust extraction nozzles, dust extraction pipes, and transfer them in a virgin polythene bag on a trolley. Affix the ‘TO BE CLEANED’ label to the trolley. Transfer the trolley to the washing area.
3.2.9 Clean the parts using 15 kg of potable water followed by scrubbing with nylon scrapper dipped in0.1% Sodium Lauryl sulphate solution.
3.2.10 Wash the parts with 20 kg of potable water and finally rinse with 15 kg of Purified water.
3.2.11 Wipe the parts with a dry lint free cloth and then using compressed air.
3.2.12 Remove the powder adhered to the turret and the machine using vacuum cleaner.
3.2.13 Remove all the upper punches and collect them in a tray. Clean all the upper punches with the help of dry clean lint free cloth. Wiping with a lint free cloth dipped in 70% Isopropyl alcohol followed by dry lint free cloth.
3.2.14 Lubricate the punches using food grade oil/grease and place them to their holder.
3.2.15 Release the screws holding the anti-turning screws.
3.2.16 Carefully unscrew the lower punch inserting assembly remove the punch inserting block. Remove all the lower punches one by one and collect them in a clean tray.
3.2.17 Clean all the lower punches with the help of dry clean lint free cloth. Wiping with a lint free cloth dipped in 70% Isopropyl alcohol followed by dry lint free cloth. Lubricate the punches using food grade oil/grease and place them to their holder.
3.2.18 Clean all the upper and lower shank holes with soft nylon brush dipped in 70 % Isopropyl Alcohol. Clean these shank holes with dry lint free cloth.
3.2.19 Unscrew the die-locking screws and remove the dies one after other by pressing from bottom with the help of die rod. Collect the dies in a clean tray.
3.2.20 Clean all the dies with the help of dry clean lint free cloth. Wiping with a lint free cloth dipped in 70% Isopropyl Alcohol followed by dry lint free cloth. Lubricate the dies using food grade oil/grease and place them to their holder.
3.2.21 Clean all the shank holes and die holes with soft nylon brush dipped in 70 % Isopropyl Alcohol followed by dry lint free cloth.
3.2.22 Clean the powder from the turret with the help of vacuum cleaner.
3.2.23 Clean the upper cam track and the lower cam track assembly using soft nylon wire brush soaked in 70% Isopropyl alcohol followed by wiping with dry clean lint free cloth.
3.2.24 Clean with the help of dry clean lint free cloth the upper pressure assembly, turret cover, top and bottom side of the machine and acrylic safety guards followed by cleaning with wet lint free cloth dipped in purified water. Clean the same with dry lint free cloth.
3.2.25 Open the side guards of the machine and clean the bottom side of the machine to remove the adhered powder dust with the help of vacuum cleaner.
3.2.26 Check the bottom floor below the machine and remove and clean any left over of the previous product.
3.2.27 Check and ensure that difficult to clean parts, grub screws, are free from any
accumulated powder dust. Remove it with the help of fine pointed needle and wipe with dry lint free cloth.
3.2.28 Clean the motor cover, the variable pulley cover, clutch drive, front operating panel and clean them using clean soft dry cloth.
3.2.29 Bring the punches and dies of the specified size and shape as mentioned in the Batch Manufacturing Record (BMR).
3.2.30 Clean the dies and punches with a lint free cloth followed by wiping with lint free cloth dipped in 70% Isopropyl alcohol.
3.2.31 Place the dies one after another in to the die pockets, initially press with thumb and finally fix them using tommy till the upper surface of the dies flushes with turret surface.
3.2.32 Tight the die screw properly.
3.2.33 Remove the punch-inserting block, rotate the turret slowly with the help of hand wheel so the punch guide hole is exactly aligned above the punch-loading hole.
3.2.34 Insert the lower punch into the guide hole. Push the punch to its highest position and ensure it drops freely under its own weight. Insert the nylon plug into the lower punch-locking hole and fix the anti turning spring strip. Carefully rotate the turret and fix the remaining lower punches in the same way.
3.2.35 Fix both the feed frames and hoppers properly and connect the dust extraction ports.
3.2.36 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ label to the machine.
3.2.37 Fill the Equipment Cleaning checklist
3.2.38 Enter the details in the ‘Equipment usage log’
Sunday, April 26, 2009
Thursday, April 23, 2009
CLEANING OF COLLOID MILL
1.0 SCOPE:
Applicable to colloid mill manufactured by Bombay engineering company.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.2 Switch ‘OFF’ the main power supply to the machine.
3.3 Remove the hopper, recirculation assembly, ring, stator and rotor.
3.4 Clean the each part using about 30 kg of potable water followed by scrubbing with nylon scrubber dipped in 0.1% Sodium Lauryl Sulphate solution.
3.5 Clean the each part with about 30 kg of Potable water and finally rinse with about 30 kg of Purified Water.
3.6 Wipe the parts with dry lint free cloth and dry them using compressed air.
3.7 Clean the outer surface of the machine with the help of wet lint free cloth dipped in 0.1% Sodium Lauryl Sulphate solution followed by wet lint free cloth dipped in purified water.
3.8 Wipe it with a dry lint free cloth.
3.9 Assemble the hopper, recirculation assembly, ring, stator and rotor.
3.10 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ to the machine.
3.11 Fill the Equipment Cleaning Checklist
3.12 Enter the details in the ‘Equipment usage log’
Applicable to colloid mill manufactured by Bombay engineering company.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.2 Switch ‘OFF’ the main power supply to the machine.
3.3 Remove the hopper, recirculation assembly, ring, stator and rotor.
3.4 Clean the each part using about 30 kg of potable water followed by scrubbing with nylon scrubber dipped in 0.1% Sodium Lauryl Sulphate solution.
3.5 Clean the each part with about 30 kg of Potable water and finally rinse with about 30 kg of Purified Water.
3.6 Wipe the parts with dry lint free cloth and dry them using compressed air.
3.7 Clean the outer surface of the machine with the help of wet lint free cloth dipped in 0.1% Sodium Lauryl Sulphate solution followed by wet lint free cloth dipped in purified water.
3.8 Wipe it with a dry lint free cloth.
3.9 Assemble the hopper, recirculation assembly, ring, stator and rotor.
3.10 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ to the machine.
3.11 Fill the Equipment Cleaning Checklist
3.12 Enter the details in the ‘Equipment usage log’
CLEANING OF CARTON OVER PRINTING MACHINE
1.0 SCOPE:
Applicable to Carton Over Printing machine manufactured by Nimach.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.2 Switch ‘OFF’ the main power supply to the machine.
3.3 Remove the coding stereos of previous batch / product and hand over the same to the concerned Production Officer.
3.4 Clean the ink roller with lint free cloth dipped in thinner.
3.5 Clean the machine with the help of wet lint free cloth followed by dry lint free cloth.
3.6 Clean the stereo roller with lint free cloth dipped in thinner.
3.7 Switch ‘ON’ the machine and take a blank run, if any abnormal sound is observed rectify the same prior to start.
3.8 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ to the machine.
3.9 Fill the Equipment Cleaning Checklist
3.10 Enter the details in the ‘Equipment usage log’
Applicable to Carton Over Printing machine manufactured by Nimach.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.2 Switch ‘OFF’ the main power supply to the machine.
3.3 Remove the coding stereos of previous batch / product and hand over the same to the concerned Production Officer.
3.4 Clean the ink roller with lint free cloth dipped in thinner.
3.5 Clean the machine with the help of wet lint free cloth followed by dry lint free cloth.
3.6 Clean the stereo roller with lint free cloth dipped in thinner.
3.7 Switch ‘ON’ the machine and take a blank run, if any abnormal sound is observed rectify the same prior to start.
3.8 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ to the machine.
3.9 Fill the Equipment Cleaning Checklist
3.10 Enter the details in the ‘Equipment usage log’
CLEANING OF CAPSULE INSPECTION MACHINE
1.0 SCOPE:
Applicable to capsule inspection machine manufactured by Pam Pharmaceutical and Allied Machinery Company Limited.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 AT THE TIME OF BATCH CHANGE OVER / AT THE END OF SHIFT
3.1.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.1.2 Switch ‘ON’ the machine.
3.1.3 Clean the hopper, vibratory pan, rejection collection box, and powder collection box and base tray with vacuum cleaner and wipe it with dry lint free cloth.
3.1.4 Clean the rollers with vacuum cleaner followed by dry lint free cloth.
3.1.5 Clean the body of the machine with dry lint free cloth.
3.1.6 Clean the control panel and the electrical connections with a dry lint free cloth.
3.1.7 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ label to the machine.
3.1.8 Fill the Equipment Cleaning Checklist
3.1.9 Enter the details in the ‘Equipment usage log’
3.2 AT THE TIME OF PRODUCT CHANGE OVER / EXPIRY OF USE BEFORE DATE.
3.2.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.2.2 Verify that the machine is switched ‘OFF’.
3.2.3 Dismantle the hopper and remove the rejection collection box, powder collection box, exit chute Teflon scrapper and base tray.
3.2.4 Shift the hopper, rejection collection box, powder collection box, exit chute, teflon scrapper and the base tray into the washing area.
3.2.5 Wash the hopper with about 20 kg Potable water followed by 0.1 % Sodium Lauryl Sulphate solution using nylon scrubber.
3.2.6 Rinse the parts with 20 kg of Potable water. Finally rinse the parts with 20 kg of Purified water.
3.2.7 Wipe the hopper with dry lint free cloth, use compressed air if required for drying of the hopper.
3.2.8 Wash each of the rejection collection box, powder collection box, Teflon scrapper, and exit chute and base tray with about 10 kg Potable water followed by 0.1 % Sodium Lauryl Sulphate solution using nylon scrubber.
3.2.9 Rinse each of the above parts with 10 kg of Potable water. Finally rinse all the parts with 10 kg of Purified water.
3.2.10 Wipe the surface of each above mentioned parts with wet lint free cloth followed by dry lint free cloth, use compressed air if required for drying of the same parts.
3.2.11 Remove the knobs of roller conveyor guard.
3.2.12 Switch ‘ON’ the main.
3.2.13 Remove the rollers, which are being placed after the guide plate of roller chain assembly by pushing each roller to one end to take it out of chain pin on the other end by slanting it slightly.
3.2.14 Start the roller chain by pressing the foot paddle and bring the next rollers to the above-mentioned position and repeat the Step no. 3.13 till all the rollers are removed.
3.2.15 Collect the rollers in a polyethylene bag and shift them to wash area..
3.2.16 Flush the rollers with about 20 kg Potable water and wipe the rollers with lint free cloth dipped in 0.1% Sodium Lauryl Sulphate solution.
Note: Do not rub the rollers vigorously with hard brush / nylon scrubber.
3.2.17 Rinse the rollers with 20 kg of Potable water. Finally rinse the rollers with 20 kg of Purified water.
3.2.18 Wipe the rollers with dry lint free cloth and finally dry the rollers by using compressed air.
3.2.19 Clean the outer body, vibratory pan, conveyer guard, mirror& tube light frame with a moist lint free cloth dipped in 0.1% Sodium Lauryl Sulphate solution followed by moist lint free cloth dipped in Purified water.
3.2.20 Wipe the outer body, vibratory pan, conveyer guard, mirror& tube light frame with wet lint free cloth followed by dry lint free cloth.
ASSEMBLING:
3.2.21 Assemble the hopper, rejection collection box, and Teflon scrapper, dust collection box on Machine.
3.2.22 Insert one end of roller on chain pin, press it against same chain pin, bring other end of roller in alignment with chain pin on opposite chain and release the roller so that it sits over the opposite chain pin. Ensure that the roller rotates freely over chain pins.
3.2.23 Repeat step no. 3.22 till all the rollers are fitted.
3.2.24 Place the roller conveyor guard and fix the knobs.
3.2.25 Place the product exit chute and base tray to their respective position.
3.2.26 Adjust tension of roller conveyor chains, if required, by setting eccentric pins on driven sprockets.
3.2.27 Ensure proper tension of polyurethane rope by raising or lowering its guide bracket.
3.2.28 After cleaning, switch ‘OFF’ the mains. Remove the ‘TO BE CLEANED’ LEBEL, and affix ‘CLEANED’ label.
3.2.29 Fill the Equipment Cleaning checklist
3.2.30 Enter the details in equipment usage & cleaning log
Applicable to capsule inspection machine manufactured by Pam Pharmaceutical and Allied Machinery Company Limited.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 AT THE TIME OF BATCH CHANGE OVER / AT THE END OF SHIFT
3.1.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.1.2 Switch ‘ON’ the machine.
3.1.3 Clean the hopper, vibratory pan, rejection collection box, and powder collection box and base tray with vacuum cleaner and wipe it with dry lint free cloth.
3.1.4 Clean the rollers with vacuum cleaner followed by dry lint free cloth.
3.1.5 Clean the body of the machine with dry lint free cloth.
3.1.6 Clean the control panel and the electrical connections with a dry lint free cloth.
3.1.7 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ label to the machine.
3.1.8 Fill the Equipment Cleaning Checklist
3.1.9 Enter the details in the ‘Equipment usage log’
3.2 AT THE TIME OF PRODUCT CHANGE OVER / EXPIRY OF USE BEFORE DATE.
3.2.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.2.2 Verify that the machine is switched ‘OFF’.
3.2.3 Dismantle the hopper and remove the rejection collection box, powder collection box, exit chute Teflon scrapper and base tray.
3.2.4 Shift the hopper, rejection collection box, powder collection box, exit chute, teflon scrapper and the base tray into the washing area.
3.2.5 Wash the hopper with about 20 kg Potable water followed by 0.1 % Sodium Lauryl Sulphate solution using nylon scrubber.
3.2.6 Rinse the parts with 20 kg of Potable water. Finally rinse the parts with 20 kg of Purified water.
3.2.7 Wipe the hopper with dry lint free cloth, use compressed air if required for drying of the hopper.
3.2.8 Wash each of the rejection collection box, powder collection box, Teflon scrapper, and exit chute and base tray with about 10 kg Potable water followed by 0.1 % Sodium Lauryl Sulphate solution using nylon scrubber.
3.2.9 Rinse each of the above parts with 10 kg of Potable water. Finally rinse all the parts with 10 kg of Purified water.
3.2.10 Wipe the surface of each above mentioned parts with wet lint free cloth followed by dry lint free cloth, use compressed air if required for drying of the same parts.
3.2.11 Remove the knobs of roller conveyor guard.
3.2.12 Switch ‘ON’ the main.
3.2.13 Remove the rollers, which are being placed after the guide plate of roller chain assembly by pushing each roller to one end to take it out of chain pin on the other end by slanting it slightly.
3.2.14 Start the roller chain by pressing the foot paddle and bring the next rollers to the above-mentioned position and repeat the Step no. 3.13 till all the rollers are removed.
3.2.15 Collect the rollers in a polyethylene bag and shift them to wash area..
3.2.16 Flush the rollers with about 20 kg Potable water and wipe the rollers with lint free cloth dipped in 0.1% Sodium Lauryl Sulphate solution.
Note: Do not rub the rollers vigorously with hard brush / nylon scrubber.
3.2.17 Rinse the rollers with 20 kg of Potable water. Finally rinse the rollers with 20 kg of Purified water.
3.2.18 Wipe the rollers with dry lint free cloth and finally dry the rollers by using compressed air.
3.2.19 Clean the outer body, vibratory pan, conveyer guard, mirror& tube light frame with a moist lint free cloth dipped in 0.1% Sodium Lauryl Sulphate solution followed by moist lint free cloth dipped in Purified water.
3.2.20 Wipe the outer body, vibratory pan, conveyer guard, mirror& tube light frame with wet lint free cloth followed by dry lint free cloth.
ASSEMBLING:
3.2.21 Assemble the hopper, rejection collection box, and Teflon scrapper, dust collection box on Machine.
3.2.22 Insert one end of roller on chain pin, press it against same chain pin, bring other end of roller in alignment with chain pin on opposite chain and release the roller so that it sits over the opposite chain pin. Ensure that the roller rotates freely over chain pins.
3.2.23 Repeat step no. 3.22 till all the rollers are fitted.
3.2.24 Place the roller conveyor guard and fix the knobs.
3.2.25 Place the product exit chute and base tray to their respective position.
3.2.26 Adjust tension of roller conveyor chains, if required, by setting eccentric pins on driven sprockets.
3.2.27 Ensure proper tension of polyurethane rope by raising or lowering its guide bracket.
3.2.28 After cleaning, switch ‘OFF’ the mains. Remove the ‘TO BE CLEANED’ LEBEL, and affix ‘CLEANED’ label.
3.2.29 Fill the Equipment Cleaning checklist
3.2.30 Enter the details in equipment usage & cleaning log
CLEANING OF BOTTLE WASHING MACHINE
1.0 SCOPE:
Applicable to bottle washing machine manufactured by Pharmalab.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 MACHINE AT THE TIME OF BATCH CHANGE OVER / AT THE END OF SHIFT.
3.1.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.1.2 Switch ‘OFF’ the main power supply to the machine.
3.1.3 Clean fiber sheet, transparent PVC sheets, Teflon bottle inverters, jet nozzles and interconnective hose pipes with the help of dry lint free cloth.
3.1.4 Clean bottle inverter holding plate, SS sheet with the help of dry lint free cloth.
3.1.5 Clean top cover and main body with the help of dry lint free cloth.
3.1.6 Clean control panel with the help of dry lint free cloth.
3.1.7 Clean tanks with the help of dry lint free cloth.
3.1.8 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ to the machine.
3.1.9 Fill the Equipment Cleaning Checklist
3.1.10 Enter the details in the ‘Equipment usage log’
3.2 AT THE TIME OF PRODUCT CHANGE OVER / EXPIRY OF USE BEFORE DATE
3.2.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.2.2 Switch ‘OFF’ the main power supply to the machine.
3.2.3 Remove fiber sheet, transparent PVC sheets, teflon bottle inverters, jet nozzles and interconnective hose pipes and transfer them in a virgin polythene bag on a trolley. Affix the ‘TO BE CLEANED’ label to the trolley. Transfer the trolley to the washing area.
3.2.4 Clean the each part using about 20 kg of potable water followed by scrubbing with nylon scrubber dipped in 0.1% Sodium Lauryl Sulphate solution.
3.2.5 Wash the each part with about 20 kg of Potable water and finally rinse with about 20 kg of Purified Water.
3.2.6 Wipe the parts with dry lint free cloth and dry them using compressed air.
3.2.7 Remove bottle inverter holding plate, SS sheet. Transfer them in a virgin polythene bag on a trolley. Affix the ‘TO BE CLEANED’ label to the trolley. Transfer the trolley to the washing area.
3.2.8 Clean the each part using about 20 kg of potable water followed by scrubbing with nylon scrapper dipped in 0.1% Sodium Lauryl Sulphate solution.
3.2.9 Wash the each part with about 20 kg of Potable water and finally rinse with about 20 kg of Purified Water.
3.2.10 Wipe the parts with dry lint free cloth and dry them using compressed air.
3.2.11 Clean top cover and main body and the tanks with the help of wet lint free cloth dipped in 0.1% Sodium Lauryl Sulphate solution followed by wet lint free cloth dipped in purified water.
3.2.12 Clean control panel with the help of wet lint free cloth dipped in 0.1% Sodium Lauryl Sulphate solution followed by wet lint free cloth dipped in purified water.
3.2.13 Wipe it with a dry lint free cloth.
3.2.14 Refix the cleaned parts to the machine.
3.2.15 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ label to the machine.
3.2.16 Fill the Equipment Cleaning checklist
3.2.17 Enter the details in the ‘Equipment usage log’
Applicable to bottle washing machine manufactured by Pharmalab.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 MACHINE AT THE TIME OF BATCH CHANGE OVER / AT THE END OF SHIFT.
3.1.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.1.2 Switch ‘OFF’ the main power supply to the machine.
3.1.3 Clean fiber sheet, transparent PVC sheets, Teflon bottle inverters, jet nozzles and interconnective hose pipes with the help of dry lint free cloth.
3.1.4 Clean bottle inverter holding plate, SS sheet with the help of dry lint free cloth.
3.1.5 Clean top cover and main body with the help of dry lint free cloth.
3.1.6 Clean control panel with the help of dry lint free cloth.
3.1.7 Clean tanks with the help of dry lint free cloth.
3.1.8 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ to the machine.
3.1.9 Fill the Equipment Cleaning Checklist
3.1.10 Enter the details in the ‘Equipment usage log’
3.2 AT THE TIME OF PRODUCT CHANGE OVER / EXPIRY OF USE BEFORE DATE
3.2.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.2.2 Switch ‘OFF’ the main power supply to the machine.
3.2.3 Remove fiber sheet, transparent PVC sheets, teflon bottle inverters, jet nozzles and interconnective hose pipes and transfer them in a virgin polythene bag on a trolley. Affix the ‘TO BE CLEANED’ label to the trolley. Transfer the trolley to the washing area.
3.2.4 Clean the each part using about 20 kg of potable water followed by scrubbing with nylon scrubber dipped in 0.1% Sodium Lauryl Sulphate solution.
3.2.5 Wash the each part with about 20 kg of Potable water and finally rinse with about 20 kg of Purified Water.
3.2.6 Wipe the parts with dry lint free cloth and dry them using compressed air.
3.2.7 Remove bottle inverter holding plate, SS sheet. Transfer them in a virgin polythene bag on a trolley. Affix the ‘TO BE CLEANED’ label to the trolley. Transfer the trolley to the washing area.
3.2.8 Clean the each part using about 20 kg of potable water followed by scrubbing with nylon scrapper dipped in 0.1% Sodium Lauryl Sulphate solution.
3.2.9 Wash the each part with about 20 kg of Potable water and finally rinse with about 20 kg of Purified Water.
3.2.10 Wipe the parts with dry lint free cloth and dry them using compressed air.
3.2.11 Clean top cover and main body and the tanks with the help of wet lint free cloth dipped in 0.1% Sodium Lauryl Sulphate solution followed by wet lint free cloth dipped in purified water.
3.2.12 Clean control panel with the help of wet lint free cloth dipped in 0.1% Sodium Lauryl Sulphate solution followed by wet lint free cloth dipped in purified water.
3.2.13 Wipe it with a dry lint free cloth.
3.2.14 Refix the cleaned parts to the machine.
3.2.15 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ label to the machine.
3.2.16 Fill the Equipment Cleaning checklist
3.2.17 Enter the details in the ‘Equipment usage log’
CLEANING OF BOTTLE DRYING MACHINE
1.0 SCOPE:
Applicable to the bottle drying machine manufactured by Metalchem Industries.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 MACHINE AT THE TIME OF BATCH CHANGE OVER / AT THE END OF SHIFT.
3.1.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.1.2 Switch ‘OFF’ the main power supply to the machine.
3.1.3 Open the door and remove the trolley and the trays out of the drying chamber. Clean them with the help of dry lint free cloth.
3.1.4 Clean the body (inside and outside) with the help of dry lint free cloth.
3.1.5 Clean the panel board, top portion and both the doors of the machine with the help of dry lint free cloth.
3.1.6 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ to the machine.
3.1.7 Fill the Equipment Cleaning Checklist
3.1.8 Enter the details in the ‘Equipment usage log’
3.2 AT THE TIME OF PRODUCT CHANGE OVER / EXPIRY OF USE BEFORE DATE
3.2.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.2.2 Switch ‘OFF’ the main power supply to the machine.
3.2.3 Open the door and remove the trolley and the trays out of the drying chamber. Affix the ‘TO BE CLEANED’ label to the trolley. Transfer the trolley to the washing area.
3.2.4 Clean the trolley and trays using about 20 kg of potable water followed by scrubbing with nylon scrubber dipped in 0.1% Sodium Lauryl Sulphate solution.
3.2.5 Wash the parts with about 20 kg of Potable water and finally rinse with about 20 kg of Purified Water.
3.2.6 Wipe the parts with dry lint free cloth and dry them using compressed air.
3.2.7 Clean the body (inside and outside) with the help of wet lint free cloth dipped in 0.1% Sodium Lauryl Sulphate solution followed by wet lint free cloth dipped in purified water.
3.2.8 Clean control panel, top portion with the help of wet lint free cloth dipped in 0.1% Sodium Lauryl Sulphate solution followed by wet lint free cloth dipped in purified water.
3.2.9 Wipe it with a dry lint free cloth.
3.2.10 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ label to the machine.
3.2.11 Fill the Equipment Cleaning checklist
3.2.12 Enter the details in the ‘Equipment usage log’
Applicable to the bottle drying machine manufactured by Metalchem Industries.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 MACHINE AT THE TIME OF BATCH CHANGE OVER / AT THE END OF SHIFT.
3.1.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.1.2 Switch ‘OFF’ the main power supply to the machine.
3.1.3 Open the door and remove the trolley and the trays out of the drying chamber. Clean them with the help of dry lint free cloth.
3.1.4 Clean the body (inside and outside) with the help of dry lint free cloth.
3.1.5 Clean the panel board, top portion and both the doors of the machine with the help of dry lint free cloth.
3.1.6 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ to the machine.
3.1.7 Fill the Equipment Cleaning Checklist
3.1.8 Enter the details in the ‘Equipment usage log’
3.2 AT THE TIME OF PRODUCT CHANGE OVER / EXPIRY OF USE BEFORE DATE
3.2.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’
3.2.2 Switch ‘OFF’ the main power supply to the machine.
3.2.3 Open the door and remove the trolley and the trays out of the drying chamber. Affix the ‘TO BE CLEANED’ label to the trolley. Transfer the trolley to the washing area.
3.2.4 Clean the trolley and trays using about 20 kg of potable water followed by scrubbing with nylon scrubber dipped in 0.1% Sodium Lauryl Sulphate solution.
3.2.5 Wash the parts with about 20 kg of Potable water and finally rinse with about 20 kg of Purified Water.
3.2.6 Wipe the parts with dry lint free cloth and dry them using compressed air.
3.2.7 Clean the body (inside and outside) with the help of wet lint free cloth dipped in 0.1% Sodium Lauryl Sulphate solution followed by wet lint free cloth dipped in purified water.
3.2.8 Clean control panel, top portion with the help of wet lint free cloth dipped in 0.1% Sodium Lauryl Sulphate solution followed by wet lint free cloth dipped in purified water.
3.2.9 Wipe it with a dry lint free cloth.
3.2.10 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ label to the machine.
3.2.11 Fill the Equipment Cleaning checklist
3.2.12 Enter the details in the ‘Equipment usage log’
Thursday, April 9, 2009
EQUIPMENT LINE CLEARANCE CONVEYOR BELT
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx
3.2 Ensure that the Conveyor Belt as per the SOP: PRCL: xxxxx
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product / batch.
3.5 Ensure that accessories of previous product/batch are removed.
3.6 Check the Temperature and Relative Humidity of the packing hall and enter the same in the Batch Packing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Packing Record (BPR).
3.8 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Conveyor Belt, format PRLC:xxxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx
3.2 Ensure that the Conveyor Belt as per the SOP: PRCL: xxxxx
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product / batch.
3.5 Ensure that accessories of previous product/batch are removed.
3.6 Check the Temperature and Relative Humidity of the packing hall and enter the same in the Batch Packing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Packing Record (BPR).
3.8 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Conveyor Belt, format PRLC:xxxxx
Wednesday, April 8, 2009
EQUIPMENT LINE CLEARANCE COLLOID MILL
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx
3.2 Ensure that Colloid mill is cleaned as per the SOP: PRCL:xxxxx.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.8 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.9 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.10 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Colloid mill, format PRLC:xxxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx
3.2 Ensure that Colloid mill is cleaned as per the SOP: PRCL:xxxxx.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.8 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.9 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.10 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Colloid mill, format PRLC:xxxxx
EQUIPMENT LINE CLEARANCE CARTON OVERPRINTING MACHINE
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGNxxxx.
3.2 Ensure that the Carton Overprinting Machine as per the SOP: PRCL: xxxxx.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that accessories of previous product/batch are removed.
3.6 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch packing Record (BPR).
3.7 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.8 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Carton Overprinting Machine, format PRLC:xxxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGNxxxx.
3.2 Ensure that the Carton Overprinting Machine as per the SOP: PRCL: xxxxx.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that accessories of previous product/batch are removed.
3.6 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch packing Record (BPR).
3.7 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.8 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Carton Overprinting Machine, format PRLC:xxxxx
EQUIPMENT LINE CLEARANCE CAPSULE INSPECTION MACHINE
1.0 SCOPE:
To provide the guidelines for the effective line clearance of the Capsule inspection machine.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxx.
3.2 Ensure that the Capsule inspection belt is cleaned as per the SOP: PRCL:xxxxx; Point No: 3.1, for Batch change over/at the end of shift or as per the SOP: PRCL: xxxxx; Point No: 3.2, for Product change over/ Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Ensure that the balance is verified as per the SOP: QAGN:xxxx.
3.7 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.8 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.9 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.10 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Capsule inspection belt, format PRLC:xxxxx
To provide the guidelines for the effective line clearance of the Capsule inspection machine.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxx.
3.2 Ensure that the Capsule inspection belt is cleaned as per the SOP: PRCL:xxxxx; Point No: 3.1, for Batch change over/at the end of shift or as per the SOP: PRCL: xxxxx; Point No: 3.2, for Product change over/ Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Ensure that the balance is verified as per the SOP: QAGN:xxxx.
3.7 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.8 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.9 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.10 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Capsule inspection belt, format PRLC:xxxxx
Saturday, April 4, 2009
EQUIPMENT LINE CLEARANCE BOTTLE LABELING MACHINE
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx
3.2 Ensure that Bottle labeling machine is cleaned as per the SOP: PRCL:xxxxx
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that accessories of previous product/batch are removed.
3.6 Check the Temperature and Relative Humidity of the cubicle and enter the same in the Batch Packing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Packing Record (BPR).
3.8 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Bottle labeling machine, format PRLC:xxxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx
3.2 Ensure that Bottle labeling machine is cleaned as per the SOP: PRCL:xxxxx
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that accessories of previous product/batch are removed.
3.6 Check the Temperature and Relative Humidity of the cubicle and enter the same in the Batch Packing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Packing Record (BPR).
3.8 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Bottle labeling machine, format PRLC:xxxxx
EQUIPMENT LINE CLEARANCE BOTTLE LABELING MACHINE
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx
3.2 Ensure that Bottle labeling machine is cleaned as per the SOP: PRCL:xxxxx
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that accessories of previous product/batch are removed.
3.6 Check the Temperature and Relative Humidity of the cubicle and enter the same in the Batch Packing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Packing Record (BPR).
3.8 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Bottle labeling machine, format PRLC:xxxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx
3.2 Ensure that Bottle labeling machine is cleaned as per the SOP: PRCL:xxxxx
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that accessories of previous product/batch are removed.
3.6 Check the Temperature and Relative Humidity of the cubicle and enter the same in the Batch Packing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Packing Record (BPR).
3.8 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Bottle labeling machine, format PRLC:xxxxx
EQUIPMENT LINE CLEARANCE FLUID BED DRYER (CAPACITY-200 KG)
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx
3.2 Ensure that the Fluid Bed Dryer (Capacity-200 kg) is cleaned as per SOP: PRCL:xxxxx; Point No: 3.1, for batch change over/at the end of shift or as per SOP: PRCL: xxxxx; Point No: 3.2, for product change over/expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that the finger bag is cleaned and is of correct product. Check and record the integrity of the finger bag in the integrity checklist of the finger bag (PRCL:xxxxx)
3.6 Ensure that all the gloves and accessories of previous product/batch are removed.
3.7 Ensure that gloves and accessories box is cleaned.
3.8 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.3.9 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.10 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.11 Record the observations in the format PRLC:xxxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for fluid Bed Dryer (Capacity-200 kg), format PRLC:xxxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx
3.2 Ensure that the Fluid Bed Dryer (Capacity-200 kg) is cleaned as per SOP: PRCL:xxxxx; Point No: 3.1, for batch change over/at the end of shift or as per SOP: PRCL: xxxxx; Point No: 3.2, for product change over/expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that the finger bag is cleaned and is of correct product. Check and record the integrity of the finger bag in the integrity checklist of the finger bag (PRCL:xxxxx)
3.6 Ensure that all the gloves and accessories of previous product/batch are removed.
3.7 Ensure that gloves and accessories box is cleaned.
3.8 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.3.9 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.10 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.11 Record the observations in the format PRLC:xxxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for fluid Bed Dryer (Capacity-200 kg), format PRLC:xxxxx
EQUIPMENT LINE CLEARANCE ELEVATOR AND TIPPER
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx
3.2 Ensure that the Elevator and tipper is cleaned as per SOP: PRCL:xxxxx
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product / batch.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.8 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Elevator and tipper, format PRLC:xxxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx
3.2 Ensure that the Elevator and tipper is cleaned as per SOP: PRCL:xxxxx
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product / batch.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.8 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Elevator and tipper, format PRLC:xxxxx
EQUIPMENT LINE CLEARANCE EMPTY CAPSULE SORTER (ECS-100)
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxx.
3.2 Ensure that Empty capsule sorter machine is cleaned as per the SOP: PRCL:xxxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxxxx Point No: 3.2, for Product change over/Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.8 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Empty capsule sorter, format PRLC:xxxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxx.
3.2 Ensure that Empty capsule sorter machine is cleaned as per the SOP: PRCL:xxxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxxxx Point No: 3.2, for Product change over/Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.8 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Empty capsule sorter, format PRLC:xxxxx
EQUIPMENT LINE CLEARANCE DRY SYRUP FILLING
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN.xxxxx.
3.2 Ensure that Dry syrup filling machine is cleaned as per the SOP: PRCL:xxxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxxxx; Point No: 3.2, for Product change over/Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product/ batch.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Ensure that gloves and accessories box is cleaned.
3.7 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.8 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.9 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.10 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Dry syrup filling machine, format PRLC:xxxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN.xxxxx.
3.2 Ensure that Dry syrup filling machine is cleaned as per the SOP: PRCL:xxxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxxxx; Point No: 3.2, for Product change over/Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product/ batch.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Ensure that gloves and accessories box is cleaned.
3.7 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.8 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.9 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.10 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Dry syrup filling machine, format PRLC:xxxxx
EQUIPMENT LINE CLEARANCE DE-DUSTING AND POLISHING (DP-100)
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx.
3.2 Ensure that De-dusting and polishing machine is cleaned as per the SOP: PRCL:xxxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:017/A; Point No: 3.2, for Product change over/Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.8 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for De-dusting and polishing, format PRLC:xxxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx.
3.2 Ensure that De-dusting and polishing machine is cleaned as per the SOP: PRCL:xxxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:017/A; Point No: 3.2, for Product change over/Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.8 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for De-dusting and polishing, format PRLC:xxxxx
EQUIPMENT LINE CLEARANCETABLET DE-DUSTER
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx
3.2 Ensure that the Tablet deduster is cleaned as per SOP: PRCL:xxxxx Point No: 3.1, for batch change over/at the end of shift or as per SOP: PRCL: xxxxx Point No: 3.2, for product change over/expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.8 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Tablet deduster, format PRLC:xxxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx
3.2 Ensure that the Tablet deduster is cleaned as per SOP: PRCL:xxxxx Point No: 3.1, for batch change over/at the end of shift or as per SOP: PRCL: xxxxx Point No: 3.2, for product change over/expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.8 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Tablet deduster, format PRLC:xxxxx
EQUIPMENT LINE CLEARANCE DEBLISTERING MACHINE
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx.
3.2 Ensure that the Deblistering Machine as per the SOP: PRCL: xxxxx; Point No: 3.1, for batch change over/at the end of shift or as per SOP: PRCL: xxxxx; Point No: 3.2, for product change over/expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all containers, documents, labels, gloves and accessories of previous product/batch are removed and status displayed on the status board.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Packing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Packing Record (BPR).
3.8 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Deblistering Machine, format PRLC:xxxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx.
3.2 Ensure that the Deblistering Machine as per the SOP: PRCL: xxxxx; Point No: 3.1, for batch change over/at the end of shift or as per SOP: PRCL: xxxxx; Point No: 3.2, for product change over/expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all containers, documents, labels, gloves and accessories of previous product/batch are removed and status displayed on the status board.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Packing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Packing Record (BPR).
3.8 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Deblistering Machine, format PRLC:xxxxx
EQUIPMENT LINE CLEARANCE CONVEYOR BELT
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx
3.2 Ensure that the Conveyor Belt as per the SOP: PRCL: xxxxx
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product / batch.
3.5 Ensure that accessories of previous product/batch are removed.
3.6 Check the Temperature and Relative Humidity of the packing hall and enter the same in the Batch Packing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Packing Record (BPR).
3.8 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Conveyor Belt, format PRLC:xxxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxxx
3.2 Ensure that the Conveyor Belt as per the SOP: PRCL: xxxxx
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product / batch.
3.5 Ensure that accessories of previous product/batch are removed.
3.6 Check the Temperature and Relative Humidity of the packing hall and enter the same in the Batch Packing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Packing Record (BPR).
3.8 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Conveyor Belt, format PRLC:xxxxx
Wednesday, April 1, 2009
EQUIPMENT LINE CLEARANCE COMPRESSION MACHINE (27 STATION)
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxx
3.2 Ensure that the Compression Machine is cleaned as per the SOP: PRCL:xxxx; Point No: 3.1, for Batch change over/at the end of shift or as per the SOP: PRCL:xxxx; Point No: 3.2, for Product change over/ Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Ensure that the punch set is fixed as per standard specification of respective product.
3.7 Check the cleanliness of the dedusting machine.
3.8 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.9 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.10 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.11 Record the observations in the format PRLC:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Compression Machine, format PRLC:xxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxx
3.2 Ensure that the Compression Machine is cleaned as per the SOP: PRCL:xxxx; Point No: 3.1, for Batch change over/at the end of shift or as per the SOP: PRCL:xxxx; Point No: 3.2, for Product change over/ Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Ensure that the punch set is fixed as per standard specification of respective product.
3.7 Check the cleanliness of the dedusting machine.
3.8 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.9 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.10 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.11 Record the observations in the format PRLC:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Compression Machine, format PRLC:xxxx
EQUIPMENT LINE CLEARANCE COMPRESSION MACHINE (35 STATION)
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxx
3.2 Ensure that the Compression Machine is cleaned as per the SOP: PRCL: xxxx Point No: 3.1, for Batch change over/at the end of shift or as per the SOP: PRCL: xxxx Point No: 3.2, for Product change over/ Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Ensure that the punch set is fixed as per standard specification of respective product.
3.7 Check the cleanliness of the dedusting machine.
3.8 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.9 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.10 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.11 Record the observations in the format PRLC:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Compression Machine, format PRLC:xxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxx
3.2 Ensure that the Compression Machine is cleaned as per the SOP: PRCL: xxxx Point No: 3.1, for Batch change over/at the end of shift or as per the SOP: PRCL: xxxx Point No: 3.2, for Product change over/ Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Ensure that the punch set is fixed as per standard specification of respective product.
3.7 Check the cleanliness of the dedusting machine.
3.8 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.9 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.10 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.11 Record the observations in the format PRLC:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Compression Machine, format PRLC:xxxx
EQUIPMENT LINE CLEARANCE COLLOID MILL
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxx
3.2 Ensure that Colloid mill is cleaned as per the SOP: PRCL:xxxx.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.8 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.9 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.10 Record the observations in the format PRLC:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Colloid mill, format PRLC:xxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxx
3.2 Ensure that Colloid mill is cleaned as per the SOP: PRCL:xxxx.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.8 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.9 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.10 Record the observations in the format PRLC:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Colloid mill, format PRLC:xxxx
EQUIPMENT LINE CLEARANCE CARTON OVERPRINTING MACHINE
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxx
3.2 Ensure that the Carton Overprinting Machine as per the SOP: PRCL: xxxx.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that accessories of previous product/batch are removed.
3.6 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch packing Record (BPR).
3.7 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.8 Record the observations in the format PRLC:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Carton Overprinting Machine, format PRLC:xxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxx
3.2 Ensure that the Carton Overprinting Machine as per the SOP: PRCL: xxxx.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that accessories of previous product/batch are removed.
3.6 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch packing Record (BPR).
3.7 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.8 Record the observations in the format PRLC:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Carton Overprinting Machine, format PRLC:xxxx
EQUIPMENT LINE CLEARANCE CAPSULE INSPECTION MACHINE
1.0 SCOPE:
To provide the guidelines for the effective line clearance of the Capsule inspection machine.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGNxxxx
3.2 Ensure that the Capsule inspection belt is cleaned as per the SOP: PRCL:xxxx; Point No: 3.1, for Batch change over/at the end of shift or as per the SOP: PRCL: xxxx; Point No: 3.2, for Product change over/ Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Ensure that the balance is verified as per the SOP: QAGN:xxxx.
3.7 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.8 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.9 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.10 Record the observations in the format PRLC:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Capsule inspection belt, format PRLC:xxxx
To provide the guidelines for the effective line clearance of the Capsule inspection machine.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGNxxxx
3.2 Ensure that the Capsule inspection belt is cleaned as per the SOP: PRCL:xxxx; Point No: 3.1, for Batch change over/at the end of shift or as per the SOP: PRCL: xxxx; Point No: 3.2, for Product change over/ Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Ensure that the balance is verified as per the SOP: QAGN:xxxx.
3.7 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.8 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.9 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.10 Record the observations in the format PRLC:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Capsule inspection belt, format PRLC:xxxx
EQUIPMENT LINE CLEARANCEBOTTLE WASHING MACHINE
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxx
3.2 Ensure that Bottle washing machine is cleaned as per the SOP: PRCL:xxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxxx; Point No: 3.2, for Product change over/Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.8 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Bottle washing machine, format PRLC:xxxx
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGN:xxx
3.2 Ensure that Bottle washing machine is cleaned as per the SOP: PRCL:xxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxxx; Point No: 3.2, for Product change over/Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.8 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Bottle washing machine, format PRLC:xxxx
EQUIPMENT LINE CLEARANCE BOTTLE DRYING MACHINE
1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGNxxxx.
3.2 Ensure that Bottle drying machine is cleaned as per the SOP: PRCL:xxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxxx; Point No: 3.2, for Product change over/Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.8 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Bottle drying machine, format PRLC:xxxx.
To provide guidelines to ensure effective line clearance of the area and equipment.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the area is cleaned as per SOP: PRGNxxxx.
3.2 Ensure that Bottle drying machine is cleaned as per the SOP: PRCL:xxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxxx; Point No: 3.2, for Product change over/Expiry of use before date.
3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated.
3.4 Ensure that all the cervices and near by area is free from previous product.
3.5 Ensure that all the gloves and accessories of previous product/batch are removed.
3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record.
3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
3.8 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance Officer.
3.9 Record the observations in the format PRLC:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Bottle drying machine, format PRLC:xxxx.
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