CLEANING OF BOPP TAPE DISPENSER

1.0 SCOPE:
Applicable to BOPP tape dispenser manufactured by ITW Signode India Limited.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Ensure that the machine labeled as ‘TO BE CLEANED’ (LBPR:xxxx).
3.2 Switch ‘OFF’ the main power supply to the machine.
3.3 Remove both the BOPP tape rolls.
3.4 Clean the cutting blades with wet lint free cloth followed by dry lint free cloth.
3.5 Clean the body of the machine with dry lint free cloth.
3.6 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ (LBPR:xxxx) to the machine.
3.7 Fill the Equipment Cleaning checklist (QAP:xxxx).
3.8 Enter the details in the ‘Equipment usage log’ (SOP: PRGN:xxxxx)

CLEANING OF BLISTER PACK MACHINE 240SS

1.0 SCOPE:
Applicable to Blister Pack Machine (Pharmapack 240 SS) manufactured by Precision Gears Ltd.
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’ (LBPR:xxx). Enter the details in the ‘Equipment usage log’ (PRGN:xxxx).
3.1.2 Switch ‘OFF’ the main power supply to the machine.
3.1.3 Close compressed air valve and cooling water for the machine.
3.1.4 Compressed air should not be used for cleaning blister pack machine.
3.1.5 Remove overprinting polymer stereos/coding metal stereos (whichever is applicable) of previous batch. Destroy the polymer stereos by cutting into pieces/give the metal stereos to the concerned Production Officer (whichever is applicable) . Incase part batch is packed, retain the stereos. Record the same in Batch Packing Record.
3.1.6 Clean the ink pelt with a lint free cloth dipped in thinner (if applicable).
3.1.7 Remove tablets, if any, left in hopper, bowl, chute, rotary brush feeder, guide track, feeding channel, back sieve plate, machine body, machine conveyor and the surrounding area, the area below the machine body and vacuum pump. Weigh and destroy these tablets /capsules in the container for tablets/capsules disposal.
3.1.8 Remove Aluminum/ PVC/ PVDC film roll from foil holder assembly.
3.1.9 Remove the empty HDPE containers, scrap of previous batch from the cubicle.
3.1.10 Clean the pressure-sealing roller (PSR) with soft brass wire brush.
3.1.11 Clean the bowl, hopper, rotary brush feeder / feeding channel, back sieve plate and in feed roller with wet lint free cloth followed by dry lint free cloth.
3.1.12 Clean the body of machine, utility box and conveyor belt with wet lint free cloth followed by dry lint free cloth.
3.1.13 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ (LBPR:xxxx) to the machine.
3.1.14 Fill the Equipment Cleaning Checklist (QAP:xxxx).
3.1.15 Enter the details in the ‘Equipment usage log’ (PRGN:xxxx).
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’ (LBPR:xxxx). Enter the details in the ‘Equipment usage log’ (PRGN:xxxx).
3.2.2 Switch ‘OFF’ the main power supply to the machine.
3.2.3 Close compressed air valve and cooling water for the machine.
3.2.4 Remove overprinting polymer stereos/coding metal stereos (whichever is applicable). Destroy the polymer stereos by cutting into pieces/give the metal stereos to the concerned Production Officer (whichever is applicable).
3.2.5 Clean the ink pelt with a lint free cloth dipped in thinner (if applicable).
3.2.6 Remove tablets/capsules, if any, left in hopper, bowl, chute, rotary brush feeder, guide track, back sieve plate, machine body, machine conveyor and the surrounding area, the area below the machine body and vacuum pump. Weigh and destroy these tablets /capsules in the container for tablets/capsules disposal.
3.2.7 Remove Aluminum / PVC/ PVDC film roll from foil holder assembly.
3.2.8 Remove the empty HDPE containers, scrap of previous batch from the cubicle.
3.2.9 Clean the pressure-sealing roller (PSR) with soft brass wire brush.
3.2.10 Remove the bowl, hopper, rotary brush feeder / feeding channel, back sieve plate, blister forming roller (BFR), counter sealing roller (CSR), punching tool, indexing rachet, and in feed roller and clean the same with 10 kg of Potable water followed by scrubbing with 0.1 % Sodium Lauryl Sulphate solution.
3.2.11 Clean the above parts with 10 kg of Potable water to remove the traces of cleaning solution. Finally rinse the above parts with 10 kg of Purified water.
3.2.12 Dry the above parts using dry lint free cloth/compressed air.
3.2.13 Keep all above parts except hopper in a polyethylene bag and label it as ‘CLEANED’ (LBPR:xxxx).
3.2.14 Fix the hopper to the machine.
3.2.15 Remove the back gears and back coding printing (BCP) gears and clean with wet lint free cloth followed by dry lint free cloth. Apply food grade oil to it and keep it in a polyethylene bag. Keep it along with the other change parts.
3.2.16 Clean the body of machine, utility box and conveyor belt with wet lint free cloth followed by dry lint free cloth.
3.2.17 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ (LBPR:xxxx) to the machine.
3.2.18 Fill the Equipment Cleaning checklist (QAP:xxxx).
3.2.19 Enter the details in the ‘Equipment usage log’ (PRGN:xxxx)

CLEANING OF AUTOMATIC CAPSULE FILLING (AF-90T) MACHINE

1.0 SCOPE:
Applicable to Automatic Capsule Filling (AF-90T) 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’ (LBPR:xxxx). Enter the details in the ‘Equipment usage log’ (PRGN:xxxx).
3.1.2 Switch ‘ON’ the main power supply to the machine.
3.1.3 Clean the machine with vacuum cleaner to remove the empty capsules.
3.1.4 Clean the machine with vacuum cleaner to remove the powder from the platform.
3.1.5 Clean the empty capsule hopper with dry lint free cloth.
3.1.6 Clean the powder hopper inside using vacuum cleaner and outside with dry lint free cloth.
3.1.7 Clean the slug collection box using vacuum cleaner.
3.1.8 Clean the machine body, acrylic doorframes, acrylic doors and the top of the machine with dry lint free cloth.
3.1.9 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ (LBPR:xxxx) to the machine.
3.1.10 Fill the Equipment Cleaning Checklist (QAP:xxxx).
3.1.11 Enter the details in the ‘Equipment usage log’ (PRGN:xxxx).
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’ (LBPR:xxxx). Enter the details in the ‘Equipment usage log’ (PRGN:xxxx)
3.2.2 Switch ‘ON’ the mains and control panel of the machine.
3.2.3 Open the compressed air valve and adjust the pressure, it should be 6 to 7 kg/sq.cm.
3.2.4 Press the hand wheel inside and rotate the same till one station comes to the position of station no. 7.
3.2.5 Unscrew and remove the clamping plates. Push out the cap and the body bushes by pressing from below.
3.2.6 Clean the clamping plates, cap and the body bushes with about 10 kg of Potable water followed by scrubbing with nylon scrubber dipped in 0.1% Sodium Lauryl Sulphate (SLS) solution.
3.2.7 Rinse the above parts with about 10 kg of Potable water. Finally rinse the above parts with about 10 kg of Purified water.
3.2.8 Dry the parts with compressed air followed by wiping with clean lint free cloth.
3.2.9 Unscrew capsule hopper-clamping knobs and lift up and remove the hopper.
Unscrew the reservoir clamping knobs and life up and remove the reservoir.
3.2.10 Unscrew and remove horizontal finger assembly.
3.2.11 Unscrew the magazine assembly on the loader shaft. Lift the magazine assembly off from the shaft.
3.2.12 Clean the capsule hopper, capsule reservoir, magazine assembly and horizontal finger assembly each with about 10 kg of Potable water followed by scrubbing with nylon scrubber dipped in 0.1% Sodium Lauryl Sulphate (SLS) solution
3.2.13 Rinse the above parts each with about 10 kg of potable water and finally rinse each with about 10 kg of Purified water.
3.2.14 Wipe them using dry lint free cloth and dry using compressed air, keep them over a pallet
3.2.15 Release the locking screw of the powder hopper stirrer and remove it. Unscrew the powder hopper and remove it from its support base.
3.2.16 Clean the powder hopper and stirrer with about 10 kg of Potable water followed by scrubbing with nylon scrubber dipped in 0.1% Sodium Lauryl Sulphate (SLS) solution.
3.2.17 Rinse the above parts each with about 10 kg of Potable water and finally rinse each with about 10 kg of Purified water.
3.2.18 Wipe them using dry lint free cloth and keep them over a pallet,dry using compressed air.
3.2.19 Unscrew the tamping blocks and pull them out off the plate. Unscrew the bolts and remove the plate. Unscrew the tamping pins from their respective blocks.
3.2.20 Unscrew the wiper block fitted with powder tub cover plate.
3.2.21 Remove the dosing disc by loosening the six bolts.
3.2.22 Clean the tamping pins and the blocks with about 5 kg of Potable water followed by scrubbing with nylon scrubber dipped in 0.1% Sodium Lauryl Sulphate (SLS) solution.
3.2.23 Rinse the above parts each with about 5 kg of Potable water and finally rinse each with about 5 kg of Purified water.
3.2.24 Wipe them using dry lint free cloth. Use compressed air if necessary.
3.2.25 Clean the tamping block plate and wiper block fitted with powder tub cover plate with about 10 kg of Potable water followed by scrubbing with nylon scrubber dipped in 0.1% Sodium Lauryl Sulphate (SLS) solution.
3.2.26 Rinse the above parts each with about 10 kg of Potable water and finally rinse each with about 10 kg of Purified water.
3.2.27 Wipe them using dry lint free cloth. Use compressed air if necessary.
3.2.28 Rotate the machine by hand wheel and bring the sector plate to its bottom most position.
3.2.29 Unscrew the 14 closing pins.
3.2.30 Unscrew the ejection guide plate and remove all 14 ejection pins.
3.2.31 Clean the ejection guide plate closing pins and capsule ejection pins with about 5 kg of Potable water followed by scrubbing with nylon scrubber dipped in 0.1% Sodium Lauryl Sulphate (SLS) solution.
3.2.32 Rinse the above parts each with about 5 kg of Potable water and finally rinse each with about 5 kg of Purified water.
3.2.33 Wipe them using dry lint free cloth. Use compressed air if necessary.
3.2.34 Remove the dosing disc support pad and ADU-100 connection pipes.
3.2.35 Clean the dosing disc support pad and ADU-100 connection pipes with about 5 kg of Potable water followed by scrubbing with nylon scrubber dipped in 0.1% Sodium Lauryl Sulphate (SLS) solution.
3.2.36 Rinse the above parts each with about 5 kg of potable water and finally rinse each with about 5 kg of Purified water.
3.2.37 Wipe them using dry lint free cloth. Use compressed air if necessary.
3.2.38 Clean the slug collection box and un-opened capsule collection box with about 2 kg of Potable water followed by scrubbing with nylon scrubber dipped in 0.1% Sodium Lauryl Sulphate (SLS) solution.
3.2.39 Rinse the above parts each with about 2 kg of Potable water and finally rinse each with about 2 kg of Purified water.
3.2.40 Wipe them using dry lint free cloth. Use compressed air if necessary.
3.2.41 Clean The Hosepipes With 2 Kg Of Potable Water Followed By Passing 0.1% Sodium Lauryl Sulphate (SLS) Solution.
3.2.42 Rinse the hosepipes with 4 kg of Potable water for 2 times (for each part). Finally rinse it with about 2 kg of Potable water followed by 2 kg of Purified water (for each part).
3.2.43 Dry the hosepipes using compressed air and wipe out the outer part with a dry lint free cloth.
3.2.44 Clean the machine body, acrylic doorframes and acrylic doors using vacuum cleaner followed by wet lint free cloth.
3.2.45 Wipe the above parts with lint free cloth dipped in 0.1 % Sodium Lauryl Sulphate solution followed by wiping with a wet lint free cloth. Wipe the above parts with lint free cloth dipped in purified water.
3.2.46 Dry the machine body, acrylic doorframes and the acrylic doors using a dry lint free cloth.
ASSEMBLING: TURRET ASSEMBLY
3.2.47 Place the cap bushes to their respective holders as per the size mentioned in the BMR and screw the clamping plates.
NOTE: do not tighten the screws excessively as this can wrap the clamping plates.
EMPTY CAPSULE LOADER ASSEMBLY:
3.2.48 Assemble the rectifying blocks of required capsule size on the locating dowel pins and tighten the screws. Check the alignment. Assemble the horizontal blades.
3.2.49 Turn the machine hand wheel until the shaft is at its lowest position; fix the magazine on the loader follower shaft. Tighten the bolts firmly.
3.2.50 Align the reservoir pins with the holes of mounting plate and clamp by the knobs.
3.2.51 Place the capsule hopper and tighten the knobs.
POWDER TUB ASSEMBLY:
3.2.52 Place the powder plate support plate on the locating dowel pins and fix all the ADU-100 pipes.
3.2.53 Place the dosing disc of the required thickness as mentioned in the BMR and screw the six bolts (do not tighten it fully).
3.2.54 Place the wiper block assembly of the required size and tighten the screw.
3.2.55 Place the tamping block holding plate and screw the same. Assemble the temping blocks with appropriate tamping pins and place the no. 6 tamping block to its position.
3.2.56 Align the tamping pin with dosing disc by slightly rotating the hand wheel clockwise /anti clockwise by slightly shifting the position of dosing disc so that the tamping pins enter the dosing disc freely. At this position tighten the six bolts of the dosing disc.
3.2.57 Place the rest tamping blocks to their respective positions. Rotate the hand wheel and make a complete rotation. Place the acrylic tub cover.
3.2.58 Reassemble the closing pins on the sector plate. Closing pins are to be aligned with gauge sleeves provided with respect to cap and body bush holders.
3.2.59 Assemble the ejection guide plate and align it to avoid capsule damage.
3.2.60 Place the slug collection box and empty capsule collection box and fix the screw.
3.2.61 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ (LBPR:xxxx) to the machine.
3.2.62 Fill the Equipment Cleaning Checklist(QAP:xxxx).
3.2.63 Enter the details in the ‘Equipment usage log’ (PRGN:xxxx)

CLEANING OF AIR DISPLACEMENT UNIT (ADU-100)

1.0 SCOPE:
Applicable to Air Displacement Unit (ADU-100) 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 CAHNGE OVER / AT THE END OF SHIFT
3.1.1 Ensure that the machine labeled as ‘TO BE CLEANED’ (LBPR:xxx). Enter the details in the ‘Equipment usage log’ (PRGN:xxxx).
3.1.2 Check that the machine is switched ‘OFF’.
3.1.3 Remove the top cover along with the filter bag assembly and sucker rod of the machine by removing the four toggle clamps.
3.1.4 Remove the rubber seal ring and the hosepipes.
3.1.5 Remove the filter bag and clean the filter bag of ADU-100 machine with help of compressed air at service floor.
3.1.6 Clean the powder-collecting chamber using vcuum cleaner.
3.1.7 Wipe the hosepipes with dry lint free cloth.
3.1.8 Wipe the outer body of the machine with dry lint free cloth.
3.1.9 Fix the filter bag on the shaker assembly.
3.1.10 Place the top cover of the chamber and fix the bakelite knob.
3.1.11 Fix the hosepipes properly.
3.1.12 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ (LBPR:xxxx) to the machine.
3.1.13 Fill the Equipment Cleaning Checklist (QAP:xxxx).
3.1.14 Enter the details in the ‘Equipment usage log’ (PRGN:xxxxx).
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’ (LBPR:xxx). Enter the details in the ‘Equipment usage log’ (PRGN:xxxx).
3.2.2 Check that the machine is switched ‘OFF’.
3.2.3 Remove the top cover along with the filter bag assembly and sucker rod of the machine by removing the four toggle clamps.
3.2.4 Remove the rubber seal ring and the hosepipes.
3.2.5 Remove the filter bag and clean the filter bag of ADU-100 machine with help of compressed air at service floor.
3.2.6 Dismantle the powder collecting chamber, transfer it to the washing area.
3.2.7 Flush the powder-collecting chamber with about 20 kg of Potable water followed by scrubbing with nylon scrubber dipped in 0.1 % Sodium Lauryl Sulphate solution.
3.2.8 Clean the powder-collecting chamber with about 20 kg of Potable water followed by scrubbing with nylon scrubber dipped in 0.1 % Sodium Lauryl Sulphate solution.
3.2.9 Rinse the powder-collecting chamber with about 20 Kg of Potable water
3.2.10 Finally rinse the above part with about 10 kg of Purified water.
3.2.11 Dry the powder-collecting chamber with compressed air followed by wiping with wet lint free cloth followed by dry lint free cloth.
3.2.12 Flush the top cover filter ring assembly with about 20 kg of Potable water followed by scrubbing with nylon scrubber dipped in 0.1 % Sodium Lauryl Sulphate solution.
3.2.13 Clean the top cover filter ring assembly with about 20 kg of Potable water followed by scrubbing with nylon scrubber dipped in 0.1 % Sodium Lauryl Sulphate solution.
3.2.14 Rinse the top cover filter ring assembly with about 20 Kg of Potable water.
3.2.15 Finally rinse the above part with about 10 kg of Purified water.
3.2.16 Dry the top cover filter ring assembly with compressed air followed by wiping with clean dry lint free cloth.
3.2.17 Dry the top cover filter ring assembly with compressed air followed by wiping with clean dry lint free cloth.
3.2.18 Clean the hosepipes using water jet and scrub the outer part with nylon scrubber.
3.2.19 Flush with sufficient amount of Potable water followed by Purified water.
3.2.20 Dry the hosepipes with compressed air followed by wiping with clean lint free cloth.
3.2.21 Wipe the outer surface of the machine with moist lint free cloth dipped in 0.1% Sodium Lauryl Sulphate solution.
3.2.22 Finally wipe the outer surface of the machine with a dry lint free cloth.
3.2.23 Transfer all the clean parts near to the machine.
3.2.24 Fix the filter bag on the shaker assembly.
3.2.25 Place the rubber seal ring on the edge of the powder-collecting chamber and place the shaker assembly over it.
3.2.26 Place the top cover of the chamber and fix the bakelite knob.
3.2.27 Fix the hosepipes properly.
3.2.28 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ (LBPR:xxxx) to the machine.
3.2.29 Fill the Equipment Cleaning checklist (QAP:xxxxx).
3.2.30 Enter the details in the ‘Equipment usage log’ (SOP: PRGN:xxxxx)

CLEANING OF THE ACCESSORIES

1.0 SCOPE:
Applicable to all the accessories used in the production area.
2.0 RESPONSIBILITY:
Operator, Production Officer.
3.0 PROCEDURE:
3.1 Keep all the accessories on a SS Table trolley and label the trolley as ‘TO BE CLEANED’ (LBPR:xxx) and transfer the trolley in the washing area. Clean the accessories as per the following procedure.



3.2 Dry all the accessories using dry lint free cloth and keep them on SS Table trolley.
3.3 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ (LBPR:xxxx) to the trolley.
3.4 Keep the accessories in a polyethylene bag and put the ‘CLEANED’ (LBPR:xxxx) label.

EQUIPMENT LINE CLEARANCE VACUUM CLEANER

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 Vacuum cleaner 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: PRCLxxxx; 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 / 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 Manufacturing / Packing Record (BMR/BPR).
3.8 After checking all above points and the BMR/BPR, 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 Vacuum cleaner, format PRLC:xxxx

EQUIPMENT LINE CLEARANCE TRY DRYER

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 Try dryer 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 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:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Try dryer, format PRLC:xxxxx

EQUIPMENT LINE CLEARANCE TABLET INSPECTION BELT

1.0 SCOPE:
To provide the guidelines for the effective line clearance of the Tablet inspection belt.
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 Tablet 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 Tablet inspection belt, format PRLC:xxxx

EQUIPMENT LINE CLEARANCE STRIP PACKING 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 strip packing 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 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 Aluminum foils, 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 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:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Strip Packing Machine, format PRLC:xxxx

EQUIPMENT LINE CLEARANCE VIBRATORY SIFTER (30ӯ)

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 Vibratory Sifter (30ӯ) is cleaned as per the SOP: PRCLxxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCLxxxx; 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 sieves are cleaned, of correct product and check the integrity.
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.
3.9 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:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Vibratory Sifter, format PRLC:xxxxx

EQUIPMENT LINE CLEARANCE SIFTER CUM MULTIMILL

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 Sifter Cum Multimill is cleaned as per SOP: PRCL:xxxx; Point No: 3.1, for batch change over/at the end of shift or as per 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 the vent filter fixed is of correct product.
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.
3.9 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:xxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Sifter Cum Multimill, format PRLC:xxxxx

EQUIPMENT LINE CLEARANCE SHIPPER STRAPPING 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 Shipper strapping machine is cleaned as per 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 / batch.
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:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Shipper strapping machine, format PRLC:xxxx

EQUIPMENT LINE CLEARANCE SORTER ELEVATOR (SE-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: PRGNxxx
3.2 Ensure that Sorter elevator is cleaned as per the SOP: PRCL:xxx Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxx 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:xxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Sorter elevator, format PRLC:xxx

EQUIPMENT LINE CLEARANCE ROPP CAP SEALING 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 ROPP cap sealing machine is cleaned as per the SOP: PRCL:xxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxx; 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 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 PRLCxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for ROPP cap sealing machine, format PRLC:xxx

EQUIPMENT LINE CLEARANCE ROPP CAP SEALING 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 ROPP cap sealing machine is cleaned as per the SOP: PRCL:xxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxx; 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 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:xxxx.
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for ROPP cap sealing machine, format PRLC:xxx.

EQUIPMENT LINE CLEARANCE RAPID MIXER GRANULATOR (CAPACITY-700 L)

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 the Rapid Mixer Granulator (Capacity-700 kg) is cleaned as per SOP: PRCLxxx Point No: 3.1, for batch change over/at the end of shift or as per SOP: PRCL: xxx 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 vent filter fixed is of correct product.
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:xxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Saizoner Mixer Granulator (Capacity-700 L), format PRLC:xxx

LINE CLEARANCE PROCEDURE FOR DISPENSED MATERIAL HOLDING AREA

1.0 SCOPE:
To provide guidelines to ensure effective line clearance of the area.
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 all containers, documents and labels of previous product / batch are removed.
3.3 Ensure that the gloves and accessories of previous product/batch are removed.
3.4 Ensure that the balance verification is done as per the SOP: QAGNxxx
3.5 Check the Temperature and Relative Humidity of the cubicle and enter the same in the Batch Manufacturing Record.
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 Manufacturing Record (BMR).
3.7 Record the observations in the format PRLC:xxxx
4.0 ENCLOSURES:
4.1 Line Clearance Checklist for Raw Material Staging Area, format PRLC:xxx

EQUIPMENT LINE CLEARANCE RAPID PACK MACHINE (RP-250)

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 the Rapid Pack Machine (RP-250) is cleaned as per the SOP: PRCL:xxx; Point No: 3.1, for Batch change over/At the end of shift or as per SOP: PRCL:xxx; 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 PVC/PVDC/Aluminum foils, 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 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:xxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Rapid Pack Machine (RP-250), format PRLC:xxx

EQUIPMENT LINE CLEARANCE PLANETARY MIXER (CAPACITY-350 L)

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 the Planetary mixer (Capacity-350 kg) is cleaned as per SOP: PRCL:xxx Point No: 3.1, for batch change over/at the end of shift or as per SOP: PRCL: xxx 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:xxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Planetary Mixer, format PRLC:xxx

EQUIPMENT LINE CLEARANCE STEAM JACKETED PLANETARY MIXER(CAPACITY-100 L)

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 Steam Jacketed Planetary Mixer is cleaned as per the SOP: PRCL:xxx.
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:xxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Steam Jacketed Planetary Mixer, format PRLC:xxx

EQUIPMENT LINE CLEARANCE OCTAGONAL BLENDER 2000 L

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 the Octagonal blender (Capacity-2000 L) is cleaned as per SOP: PRCL:xxx; Point No: 3.1, for batch change over/at the end of shift or as per SOP: PRCL: xxx; 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:xxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Octagonal Blender
(Capacity-2000 L), format PRLC:xxx

EQUIPMENT LINE CLEARANCE OCTAGONAL BLENDER 500 L

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 the octagonal blender (Capacity-500 L) is cleaned as per SOP: PRCL:xxxx; Point No: 3.1, for batch change over/at the end of shift or as per 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 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).
3.7 After checking all above points and the BMR, 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 Octagonal Blender
(Capacity-500 L), format PRLC:xxxx

EQUIPMENT LINE CLEARANCE NEOCOTA

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 Neocota is cleaned as per the SOP: PRCL:xxx.
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 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:xxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Neocota, format PRLC:xxx.

EQUIPMENT LINE CLEARANCE MULTIMILL

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: PRGNxxxxx
3.2 Ensure that Multimill 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: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 the screens are cleaned, of correct product and check the integrity.
3.6 Ensure that all the gloves and accessories of previous product/batch are removed.
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 Multimill, format PRLC:xxxx

EQUIPMENT LINE CLEARANCE MEASURING CUP FEEDING 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 the Measuring cup feeding machine is cleaned as per SOP: xxx; Point No: 3.1, for batch change over/at the end of shift or as per 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 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:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Measuring cup feeding machine, format PRLC:xxxx

EQUIPMENT LINE CLEARANCE MEASURING CUP FEEDING 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 the Measuring cup feeding machine is cleaned as per SOP: PRCL:xxx; Point No: 3.1, for batch change over/at the end of shift or as per SOP: PRCL: xxx; 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 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:xxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Measuring cup feeding machine, format PRLC:xxx

EQUIPMENT LINE CLEARANCE METAL DETECTOR (DSP-3)

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 the Metal Detector as per the SOP: PRCL: 047; Point No: 3.1,for Batch change over/at the end of shift or as per the SOP: PRCLxxxx Point No: 3.1, 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 metal detector (DSP-3), format PRLC:xxxx

EQUIPMENT LINE CLEARANCE MINI CAPSULE SORTER (MCS-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:xxx
3.2 Ensure that Mini capsule sorter machine is cleaned as per the SOP: PRCL:xxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxx; 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:xxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Mini capsule sorter, format PRLC:xxx

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: PRGNxxx
3.2 Ensure that Bottle labeling machine 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 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:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Bottle labeling machine, format PRLC:xxxx.

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:xxxx
3.2 Ensure that Bottle labeling machine 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 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:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Bottle labeling machine, format PRLC:xxxx

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:xxxx
3.2 Ensure that the Fluid Bed Dryer (Capacity-200 kg) is cleaned as per SOP: PRCL:xxxx; Point No: 3.1, for batch change over/at the end of shift or as per 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 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:xxxx)
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:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for fluid Bed Dryer (Capacity-200 kg), format PRLC:xxx

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:xxxx
3.2 Ensure that the Elevator and tipper is cleaned as per 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 / 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:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Elevator and tipper, format PRLC:xxxx

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: PRGNxxxx
3.2 Ensure that Empty capsule sorter 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:xxx; 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:xxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Empty capsule sorter, format PRLC:xxx

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: PRGNxxxx
3.2 Ensure that Dry syrup filling 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:xxx; 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 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:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Dry syrup filling machine, 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:xxxx
3.2 Ensure that Dry syrup filling machine is cleaned as per the SOP: PRCL:xxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxx; 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:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Dry syrup filling machine, format PRLC:xxx

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:xxx
3.2 Ensure that De-dusting and polishing 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 De-dusting and polishing, format PRLC:xxxx.

EQUIPMENT LINE CLEARANCE TABLET 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: PRGNxxxx
3.2 Ensure that the Tablet deduster is cleaned as per SOP: PRCLxxxx; Point No: 3.1, for batch change over/at the end of shift or as per 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 PRLCxxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Tablet deduster, format PRLC:xxx

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: PRGNxxx
3.2 Ensure that the Deblistering Machine as per the SOP: PRCL:xxx; Point No: 3.1, for batch change over/at the end of shift or as per SOP: PRCL:xxx 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:xxx.
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Deblistering Machine, format PRLC:xxx.

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:xxxx
3.2 Ensure that the Conveyor Belt as per the SOP: PRCL:xxx.
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:xxxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Conveyor Belt, format PRLC:xxxx

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:xxx
3.2 Ensure that the Compression Machine is cleaned as per the SOP: PRCL: xxx; Point No: 3.1, for Batch change over/at the end of shift or as per the SOP: PRCL: 008/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 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:xxx
4.0 ENCLOSURE:
4.1 Line Clearance Checklist for Compression Machine, format PRLC:xxx

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:xxx
3.2 Ensure that the Compression Machine is cleaned as per the SOP: PRCL: xxx; 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:xxx
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:xxx

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:xxx
3.2 Ensure that the Carton Overprinting Machine as per the SOP: PRCL:xxx
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:xxx