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)