SOP ON CLEANING OF BLISTER PACK MACHINE
1.0 SCOPE:
Applicable to Blister Pack Machine (Pharmapack 240 SS) manufactured by Precision Gears Ltd.
Applicable to Blister Pack Machine (Pharmapack 240 SS) manufactured by Precision Gears Ltd.
2.0 RESPONSIBILITY:
Operator, Production Officer.
Operator, Production Officer.
3.0 PROCEDURE:
3.1 AT THE TIME OF BATCH CHANGE OVER / AT THE END OF SHIFT
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)