1.0 OBJECTIVE:
To lay down the cleaning procedure for capsule filling line.2.0 SCOPE:
This SCP shall be applicable for capsule filling line in filling and polishing area in Production department.3.0 RESPONSIBILITY:
3.1 Execution : Operator3.2 Checking : Pharmacist and Above
4.0 ACCOUNTABILITY:
HOD-Production5.0 PROCEDURE:
5.1 Switch “OFF” the main and disconnect the supply card.5.2 Disconnect all line attachment.
5.3 AIR DISPLACEMENT UNIT (ADU 100)
5.3.1 Remove suction hose pipe from the cylindrical chamber and open the cover.5.3.2 Detach the filter bag, empty the contents in the polythene bag. Put the filter bag in a clean polythene bag and transfer to general washing area with “To be cleaned” status label.
5.3.3 Ensure that all of the powder from bag is removed and clean the filter bag with 5 liter potable water followed by 2.5 % “Teepol” solution and then with 10 liter potable water. Finally, rinse with 5 liter purified water.
5.3.4 Clean the inner portion of the cylindrical chamber with the help of dry clean lint-free cloth.
5.3.5 Reassemble the bag and close the cover.
5.3.6 Affix “Cleaned” label.
5.4 SORTER ELEVATOR(SE 100)
5.4.1 Ensure that all empty capsule removed from the machine.5.4.2 Clean the inner and outer portion of the sorter elevator with the help of dry lint-free cloth and wipe it with 70 % v/v Isopropyl Alcohol (IPA) solution.
5.4.3 Affix clean label.
5.5 AUTOMATIC CAPSULE FILLING MACHINE (AF 90T)
5.5.1 Ensure that all the material removed from the machine.5.5.2 Remove the hopper tamping pins, ejection guide plate and closing pins and clean with 70 % v/v Isopropyl Alcohol (IPA).
5.5.3 Clean the turret with lint-free cloth and wipe it with 70 % v/v Isopropyl Alcohol (IPA).
5.5.4 Clean all the guard with lint-free cloth.
5.5.5 Reassemble all the accessories.
5.5.6 Affix “Cleaned” label.
5.6 DEDUSTING WITH POLISHING UNIT (DP 100)
5.7 Ensure that entire capsule removed from the unit.5.8 Clean the inner portion of dedusting and polishing unit with compressed air and the outer portion with a lint-free cloth and wipe it with 70 % v/v solution of Isopropyl Alcohol (IPA).
5.9 Affix “Cleaned” label.
5.7 COMPACT AIR DISPLACEMENT UNIT (CADU 100)
5.7.1 Remove suction hose pipe from the cylindrical chamber and open the cover.5.7.2 Detach the filter bag, empty the contents in the polythene bag. Put the filter bag in a clean polythene bag and transfer to general washing area with “To be cleaned” status label.
5.7.3 Ensure that all of the powder from bag is removed and clean the filter bag with 5 liter potable water followed by 2.5 % “Teepol” solution and then with 10 liter potable water. Finally rinse with 5 liter purified water.
5.7.4 Clean the inner portion of the cylindrical chamber with the help of dry clean lint-free cloth.
5.7.5 Reassemble the bag and close the cover.
5.7.6 Affix “Cleaned” label.
5.8 MINI FILLED CAPSULE SORTER (MCS 100)
5.8.1 Ensure that all capsule removed from it.5.8.2 Remove the plate sorter and drum sorter from it.
5.8.3 Clean the plate sorter and drum sorter with 2.5% “Teepol” and then with potable water, finally rinse with purified water.
5.8.4 Finally wipe out with 70 % solution of Isopropyl Alcohol (IPA).
5.8.5 Affix “Cleaned” label.
5.9 EMPTY CAPSULE SORTER (ECS 100)
5.9.1 Ensure that all capsules removed from it and cleaned with lint-free cloth.5.9.2 Finally wipe out with 70 % solution of Isopropyl Alcohol (IPA).
5.9.3 Affix “Cleaned” label.
5.10 Connect the all line attachment and affix “CLEANED” label and fill the record “Equipment Log Book”.
5.11 Re-clean if not used within 72 hours.
6.0 ABBREVIATION:
SCP : Standard Cleaning ProcedureIPA : Isopropyl Alcohol
ADU : Air Displacement Unit
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Capsule filling machine sop
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