Standard Operating Procedure for Agitator

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Agitator used in the pharmaceutical manufacturing of otic dosage forms to ensure effective mixing and agitation of materials.

2) Scope

This SOP applies to all personnel involved in the operation and maintenance of the Agitator in the pharmaceutical manufacturing facility.

3) Responsibilities

Operators: Responsible for correctly operating the Agitator as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the quality of mixing.
Maintenance Personnel: Responsible for maintaining the Agitator in proper working condition.

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Agitator for cleanliness and integrity before use.
4.1.1.2 Ensure that all agitator blades, shafts, and seals are clean and free from residue.
4.1.1.3 Verify that the agitator is calibrated and operating within specified parameters.

4.1.2 Preparation
4.1.2.1 Clean and sanitize the Agitator and surrounding area.
4.1.2.2 Check and prepare all materials and ingredients required for agitation.
4.1.2.3 Ensure that the agitator is properly connected to utilities and ready for operation.

4.2 Operation
4.2.1 Mixing Process
4.2.1.1 Power on the Agitator and set the agitation parameters.
4.2.1.2 Load materials into the vessel or tank as per the formulation.
4.2.1.3 Initiate the agitation process, ensuring thorough mixing and dissolution.

4.2.2 Monitoring
4.2.2.1 Monitor the agitation process closely to ensure uniformity and consistency.
4.2.2.2 Adjust agitation parameters as necessary to maintain desired mixing conditions.
4.2.2.3 Record all critical parameters during the agitation process.

4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the agitation process and transfer the mixture to designated containers or further processing steps.
4.3.1.2 Clean and sanitize the Agitator and associated equipment thoroughly.
4.3.1.3 Perform post-operation checks to ensure no residual product or contamination issues.

4.3.2 Maintenance
4.3.2.1 Regularly inspect and clean all parts of the Agitator.
4.3.2.2 Perform preventive maintenance tasks as recommended by the manufacturer.
4.3.2.3 Keep maintenance records and document any issues or repairs performed.

5) Abbreviations, if any

QC: Quality Control
SOP: Standard Operating Procedure

6) Documents, if any

Maintenance records
Batch records for each agitation process
Calibration records for the Agitator

7) Reference, if any

Manufacturer’s manual for the Agitator
Pharmacopeial guidelines for pharmaceutical manufacturing processes

8) SOP Version

Version 1.0