Standard Operating Procedure for Homogenizer.
1.0 Purpose
The purpose of this SOP is to develop a standard procedure for operating the Mixing Homogenizer.
2.0 Scope
This SOP is applicable for the Mixing Homogenizer used in the granulation area for binder preparation, in the coating area for preparation of coating suspension & in the liquid manufacturing area of the production section
3.0 Responsibility
3.1 Machine Operator is responsible for operating the Homogenizer.
3.2 Production Pharmacist is responsible for the implementation of this Standard Operating Procedure.
3.3 The HOP is responsible for ensuring the implementation of the current SOP.
3.4 Quality Assurance Officer monitors the compliance of this SOP.
4.0 Procedure
4.1 Relevant area Pharmacist shall ensure that the Homogenizer
& the area is properly cleaned.
4.2 Production Pharmacist shall ensure that the line clearance is awarded & product-related labels are attached to the equipment & area.
4.3 Ensure that air pipes are connected to the specific connectors of the homogenizer for lifting the homogenizer shaft up & down.
4.4 Insert the wire plug into the wall-mounted socket & press the ON button.
4.5 Open the air supply valve & press the Up button for lifting the shaft of the homogenizer.
4.6 Place the cleaned container below the homogenizer shaft & press the Down Button.
4.7 Add Solvent & other materials according to the BMR & start its operation by adjusting the RPMs mentioned in BMR.
4.8 After completion of the mixing process stop working by pressing the Off button, press the up button to lift the shaft & remove the container.
4.9 Press the down button to bring its shaft back, Press the Off Button & remove the wire.
4.10 Attach the ‘To be cleaned’ label to the homogenizer, record the activity in the logbook of the Homogenizer and sign it.
5.0 Abbreviations
5.1 SOP: Standard Operating Procedure
5.2 BMR: Batch Manufacturing Record
5.3 QA: Quality Assurance
5.4 HOP:Head Of Production
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