sop for Cleaning of Ointment Mfg Vessel

1.0 Objective
To lay down a procedure for cleaning of Ointment Manufacturing Vessel.
2.0 Scope
This Standard Operating Procedure is applicable for cleaning of ointment

Manufacturing vessel at abc company.
3.0 Responsibility
3.1 Operator / Manufacturing Chemist.
3.2 Head-Quality Assurance
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
PE : Production External
QC : Quality Control
QA : Quality Assurance
SLS : Sodium Lauryl Sulphate
5.0 Procedure
5.1 Before Cleaning:
5.1.1 Ensure that all utilities are disconnected such as electricity, steam, water etc.
5.1.2 Ensure that all moving parts are properly covered.
5.1.3 Ensure that all gauges and meters, control panel, sensors, motors etc are properly

covered and removable parts are removed.
5.1.4 Ensure that in sensitive places dry cleaning is done.
5.1.5 Prepare 10.0 liter 2.5% SLS solution (dissolve 0.250 kg SLS in10.0 liter of raw water).
5.2 Cleaning:
5.2.1 The vessels are normally washed in the four wash cycles. CIP SYSTEM is provided with three tanks system.
5.3 First Wash
5.3.1 First wash all S.S. parts of the ointment manufacturing vessel with raw water.
5.3.2 Scrap all the edges of the vessel with non particle spreading material.
5.3.3 Ensure that there is nothing except water inside the vessel.
5.3.4 Start the agitator.
5.3.5 Run for 5 minutes
5.3.6 Open the bottom valve.
5.3.7 Start the inline homogenizer and recalculates the water into the ointment manufacturing vessel.
5.3.8 After running the inline homogenizer for 5 minutes, stop the homogenizer and

then close the Bypass valves in the pipeline.
5.3.9 After that open the bottom outlet valve of the ointment manufacturing vessel and drain

out the water with main drain pipeline of the cleaning pipeline.
5.4 Second Wash
5.4.1 First wash all S.S. parts of the ointment manufacturing vessel with detergent water.
5.4.2 Scrap all the edges of vessel with non particle spreading material.
5.4.3 Ensure that there is nothing except detergent water inside the vessel.
5.4.4 Start the agitator.
5.4.5 Run for 5 minutes.
5.4.6 Start the inline homogenizer and re circulate the detergent water into the ointment manufacturing vessel.
5.4.7 After running the inline homogenizer for 5 minutes, stop the homogenizer and then close

the bypass valves in the pipeline.
5.4.8 After that open the bottom outlet valve of the ointment vessel and drain out the detergent water

with main drain pipeline of the cleaning pipeline.
5.5 Third Wash
5.5.1 The forth wash is with DM water.
5.5.2 The procedure is to be repeated in the above sequence.
5.5.3 Send the sample to Q.C. for wash water analysis and after getting approval

from Q.C. then label it as ‘CLEANED’
6.0 Forms and Records
6.1 None
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Production Department
8.0 History