1.0 OBJECTIVE: To lay down a procedure for cleaning of paste preparation kettle.
2.0 SCOPE: This SOP applies to the cleaning of the paste preparation kettle in the production area.
3.0 RESPONSIBILITY:
Operator, Officer, Executive –Production Department.
Manager – Production Department.
4.0 PROCEDURE: This is a cleaning procedure for Change over of one batch to the next batch/ product with ascending potency, a product with different actives/color / descending potency, or after the maintenance of contact parts.
4.1 Replace the ‘TO BE CLEANED’ status label with the ‘UNDER CLEANING’ status label on the paste preparation vessel with the date and signature of the Production Officer.
4.2 Enter the cleaning start time of the paste preparation vessel in the equipment usage log sheet.
4.3 Remove the detachable portion of the lid and the stirrer.
4.4 Load 50 – 60 Liters of purified water into the vessel and warm the water by opening the hot water inlet valve and soaking for 15 minutes.
4.5 Scrub the inside, outside of the vessel, and lid of the vessel with a nylon scrubber to remove the adhered material.
4.6 Rotate the handwheel anticlockwise to tilt the vessel and drain the water.
4.7 Clean the inside, outside, steam cable, the lid of paste preparation vessel, and stirrer with 15 to 20 liters of purified water.
4.8 Dry the paste preparation vessel, lid, and stirrer with the help of a dry lint-free duster.
4.9 Wipe the paste preparation vessel and all the parts of the vessel with 70%w/w IPA solution.
4.10 Rotate the handwheel towards the clockwise direction to bring the vessel to the original position.
4.11 Fix the stirrer and keep the lid over the paste preparation vessel.
4.12 Affix label on the vessel as “CLEANED” with date and signature of the Production Officer.
4.13 If the paste preparation vessel is idle for 72 hours or more, then Wipe all the parts of the paste preparation vessel with 70% w/w IPA solution.
4.14 Replace the previous ‘CLEANED’ status label with the current date ‘CLEANED’ status label with the date and signature of the production officer.
4.15 Record the cleaning completion time of paste preparation vessel in equipment usage log book.
Related SOP: SOP on Peristaltic Pump
5.0 ABBREVIATION (S) :
IPA: Iso Propyl Alcohol
SOP: Standard Operating Procedure
w/w :Weight / weight
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