1.0 Objective
- To describe the procedure for Operation and Cleaning of Colloid Mill.
2.0 Scope
- This SOP is applicable for colloid mill machine in production department at Boostyourpharmagyan Pharmaceutical Limited.
3.0 Responsibility
3.1 Operator Production
- To perform Operation and Cleaning of of Colloidal Mill.
3.2 Officer/Executive Production
- To monitor that correct procedure is being followed during Operation and Cleaning of Colloidal Mill.
3.3 Officer IPQA / Above:
- To verify that correct procedure is followed during Operation and Cleaning of Colloidal Mill.
4.0 Accountability
- Head-Production shall be responsible for the compliance of this SOP.
5.0 Procedure
5.1 Precaution
- Use all the PPEs before operate the Colloidal mill.
- Never use grease or oil on inside of the main housing.
- Ensure that electric supply should be disconnecting before cleaning.
5.2 Operation
- Check the cleanliness of the colloid mill.
- There should not be any traces of the previous product.Close the outlet valve of Colloid Mill.
- Switch “ON” the main power supply of Colloid Mill and start the Colloidal Mill by pushing ‘Green’ button.
- Ensure that the direction of rotation of the mill must be clockwise.
- Fill the hopper with material as prescribed in the applicable BMR.
- Continues the operation as mentioned in applicable BMR.
- Open the outlet valve and collect the homogenized solution in a suitable container.
- Continue the operation till the total material is processed.
- Switch “OFF” the colloid mill. Switch “OFF” the main power supply.
- Affix “TO BE CLEANED” label on it.
- Record the activity in equipment
5.3 Cleaning:
Type-A Cleaning
- Ensure that power supply to the machine is disconnected.
- Clean the outer surface of the machine with wet cloth and then dry lint free cloth.
- Clean the surrounding area.
- Record the activity in equipment logbook.
- Affix the cleaned label.
Type-B Cleaning
- Pour purified water in it and switch “ON” the machine and let the liquid to circulate for few minutes and then drain it.
- Scrub the inner surface of the feed hopper and SS pipe with nylon scrubber till it is clean.
- Pour purified water in it and switch “ON” the machine and let the liquid to circulate for few minutes and then drain it.
- Pour purified water in it and switch “ON” the machine and let the liquid to circulate for few minutes and then drain it and repeat the process till to get the clear water.
- Swipe the water with a clean dry lint free cloth.
- Clean the remaining parts of the machine with a wet cloth followed by clean dry lint free cloth.
- Clean the electric parts of the machine with dry cloth.
- Clean the surrounding area.
- Record the activity in equipment logbook.
- Affix the cleaned label.
6.0 List of Annexure
NA
7.0 Reference
- Standard operating procedure for recording of equipment logs.
- Standard operating procedure for cleaning of Equipment.
8.0 Reason of Revision
Not Applicable (New SOP).
9.0 Abbreviations
- SOP - Standard Operating Procedure
- IPQA - In-process Quality Assurance
- QA - Quality Assurance
- PPEs - Personnel Protective Equipment’s
- i.e. - That is