Standard Operating Procedure for Using Double Cone Blender

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the double cone blender used in the manufacturing of otic dosage forms to ensure uniform blending of ingredients.

2) Scope

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

3) Responsibilities

Operators: Responsible for correctly operating the double cone blender as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the blending process and verifying uniformity.
Maintenance Personnel: Responsible for maintaining the double cone blender in proper working condition.

4) Procedure

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

4.1.2 Loading the Blender
4.1.2.1 Measure and prepare the ingredients to be blended as per the batch record.
4.1.2.2 Open the blender’s loading port and add the ingredients.
4.1.2.3 Close and secure the loading port.

4.1.3 Blending Process
4.1.3.1 Select the appropriate blending time and speed settings as per the batch record.
4.1.3.2 Start the blender and monitor the blending process.
4.1.3.3 Allow the blending cycle to complete as per the specified time.
4.1.3.4 After the cycle is complete, stop the blender and allow it to come to a complete stop.

4.1.4 Unloading the Blender
4.1.4.1 Open the blender’s unloading port.
4.1.4.2 Carefully remove the blended ingredients and transfer them to appropriate containers.
4.1.4.3 Close and secure the unloading port.

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

4.3.2 Troubleshooting
4.3.2.1 If the blender 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

Blending log
Maintenance log

7) Reference, if any

Manufacturer’s manual for the double cone blender
Regulatory guidelines for equipment calibration and maintenance

8) SOP Version

Version 1.0