Standard Operating Procedure for Mixing Tank
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Mixing Tank used in the pharmaceutical manufacturing of otic dosage forms to ensure thorough and consistent mixing of ingredients.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the Mixing Tank in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the Mixing Tank as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring and verifying the quality of mixing.
Maintenance Personnel: Responsible for maintaining the Mixing Tank in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Mixing Tank for cleanliness and integrity before use.
4.1.1.2 Ensure that all valves, fittings, and agitators are clean and free from residue.
4.1.1.3 Verify that the tank is calibrated and operating within specified parameters.
4.1.2 Preparation
4.1.2.1 Clean and sanitize the Mixing Tank and surrounding area.
4.1.2.2 Check and prepare all raw materials and ingredients required for mixing.
4.1.2.3 Ensure that the tank is properly connected to utilities and ready for operation.
4.2 Operation
4.2.1 Mixing Process
4.2.1.1 Power on the Mixing Tank and set the mixing parameters.
4.2.1.2 Load raw materials into the tank according to the formulation.
4.2.1.3 Initiate the mixing process, ensuring thorough blending of all ingredients.
4.2.2 Monitoring
4.2.2.1 Monitor the mixing process closely to ensure uniformity and consistency.
4.2.2.2 Adjust mixing parameters as necessary to maintain desired mixing conditions.
4.2.2.3 Record all critical parameters during the mixing process.
4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the mixing process and transfer the mixture to designated containers or further processing steps.
4.3.1.2 Clean and sanitize the Mixing Tank 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 Mixing Tank.
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 mixing process
Calibration records for the Mixing Tank
7) Reference, if any
Manufacturer’s manual for the Mixing Tank
Pharmacopeial guidelines for pharmaceutical manufacturing processes
8) SOP Version
Version 1.0
