Standard Operating Procedure for Propeller Mixer.
The purpose of this SOP is to develop a standard procedure for operating the Propeller Mixer.
This SOP is applicable for the propeller Mixer used in the granulation,coating & liquid manufacturing area of the production section.
3.1 Machine Operator is responsible for operating the Propeller Mixer.
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.
4.1 Pharmacist shall ensure that the Propeller Mixer & the area is properly cleaned.
4.2 Production Pharmacist shall ensure that the Propeller Mixer & Area is labeled with Cleaned label status.
4.3 Before starting the operation of Propeller Mixer, affix product-related labels to the Propeller Mixer & Area and take line clearance from the QA officer.
4.4 After line Clearance, rotate the lifting handle of the propeller mixer to lift the propeller blades.
4.5 Place a mixing container below the propeller blades & bring down the blades.
4.6 Add required quantity of Solvent in container as mentioned in BMR.
4.7 Insert Wire plug of Propeller mixer into the socket & press On button.
4.8 Adjust the RPMs of the Propeller Mixer and add materials to be mixed according to the BMR.
4.9 When required mixing operation is completed press Of button,remove wire plug,lift propeller blades up & remove mixing container.
4.10 Attach Propeller Mixer ‘to be cleaned’ label and record the activity in the logbook of the Propeller Mixer and sign it.
5.1 SOP: Standard Operating Procedure
5.2 BMR: Batch Manufacturing Record
5.3 QA: Quality Assurance
5.4 HOP:Head Of Production