Standard Operating Procedure for Colloid Mill.
The purpose of this SOP is to develop a standard procedure for operating the Colloid Mill.
This SOP applies to the Colloid Mill used in the liquid manufacturing area of the production section.
3.1 Machine Operator is responsible for operating the Colloid Mill.
3.2 Manufacturing Pharmacist is responsible for the implementation of this SOP.
3.3 The Head Of Production is responsible for ensuring the implementation of the current SOP.
3.4 Q.A. Officer monitors the compliance of this SOP.
4.1 Area Pharmacist shall ensure that Colloid Mill & all its parts are properly cleaned.
4.2 Assemble the Colloid Mill parts, adjust the hopper in its place and take line clearance from the Quality Assurance officer.
4.3 Close the valve of the hopper & add suspension or slurry to be milled in the hopper as mentioned in BMR.
4.4 Insert the wire plug of the colloid mill into the socket & press the On button.
4.5 Mill the Suspension at specifications mentioned in BMR and collect in the container placed below the discharging end.
4.6 Pass all the suspension through the colloidal mill & at the end press the Off button.
4.7 Remove the wire plug, Affix ‘To be cleaned label’ and record the activity in the logbook of the colloid mill.
5.1 SOP: Standard Operating Procedure
5.2 BMR: Batch Manufacturing Record
5.3 QA: Quality Assurance