Standard Operating Procedure for Using High Shear Mixer

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the high shear mixer used in the manufacturing of otic dosage forms to ensure effective and consistent mixing of formulations.

2) Scope

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

3) Responsibilities

Operators: Responsible for correctly operating the high shear mixer as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the mixing process and verifying results.
Maintenance Personnel: Responsible for maintaining the high shear mixer in proper working condition.

4) Procedure

4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the high shear mixer is on a stable, level surface.
4.1.1.2 Check that all parts of the mixer are clean and properly assembled.
4.1.1.3 Verify that the mixer is properly calibrated and functioning.

4.1.2 Mixing Process
4.1.2.1 Prepare the ingredients or formulation to be mixed.
4.1.2.2 Load the ingredients into the mixing chamber.
4.1.2.3 Select the appropriate speed and time settings for the mixing process.
4.1.2.4 Start the mixer and monitor the process.
4.1.2.5 Allow the mixing cycle to complete.
4.1.2.6 Once the cycle is complete, stop the mixer and remove the mixed product.

4.2 Calibration
4.2.1 Daily Check
4.2.1.1 Perform a daily check of the mixer’s speed and time settings.
4.2.1.2 Record the results in the equipment log.

4.2.2 Monthly Calibration
4.2.2.1 Conduct a full calibration of the high shear mixer monthly using standard test methods.
4.2.2.2 Document the calibration results and any adjustments made.

4.3 Maintenance
4.3.1 Routine Maintenance
4.3.1.1 Clean the mixing chamber and all parts regularly to prevent contamination.
4.3.1.2 Inspect the mixer for any signs of wear or damage.

4.3.2 Troubleshooting
4.3.2.1 If the mixer displays error messages or fails to operate correctly, refer to the manufacturer’s manual for troubleshooting steps.
4.3.2.2 Contact maintenance personnel if the issue cannot be resolved.

5) Abbreviations, if any

QC: Quality Control
SOP: Standard Operating Procedure

6) Documents, if any

Mixing log
Maintenance log

7) Reference, if any

Manufacturer’s manual for the high shear mixer
Regulatory guidelines for equipment calibration and maintenance

8) SOP Version

Version 1.0