Standard Operating Procedure for Using Vortex Mixer

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the vortex mixer used in the manufacturing of otic dosage forms to ensure effective mixing of liquid products.

2) Scope

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

3) Responsibilities

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

4) Procedure

4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the vortex mixer is on a stable, level surface.
4.1.1.2 Check that the mixer is clean and free of any debris.
4.1.1.3 Verify that the mixer is properly calibrated and functioning.

4.1.2 Loading the Mixer
4.1.2.1 Prepare the liquid product to be mixed as per the batch record.
4.1.2.2 Place the container with the liquid product securely on the vortex mixer platform.
4.1.2.3 Ensure that the container is balanced and centered on the platform.

4.1.3 Mixing Process
4.1.3.1 Select the appropriate mixing speed and duration as per the batch record.
4.1.3.2 Start the mixer and initiate the mixing process.
4.1.3.3 Monitor the mixture to ensure uniform blending of the liquid product.
4.1.3.4 After the mixing cycle is complete, stop the mixer.

4.1.4 Unloading the Mixer
4.1.4.1 Carefully remove the container from the vortex mixer platform.
4.1.4.2 Transfer the mixed product to the next stage of production or testing.

4.2 Calibration
4.2.1 Daily Check
4.2.1.1 Perform a daily check of the mixer’s settings and indicators.
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 vortex 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 mixer and all parts regularly to prevent contamination.
4.3.1.2 Inspect the mixer for any signs of wear or damage and replace parts as necessary.

4.3.2 Troubleshooting
4.3.2.1 If the mixer displays error messages or fails to reach the required conditions, 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 vortex mixer
Regulatory guidelines for equipment calibration and maintenance

8) SOP Version

Version 1.0