Standard Operating Procedure for Ultrasonic Homogenizer

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Ultrasonic Homogenizer used in the pharmaceutical manufacturing of otic dosage forms to ensure effective homogenization of liquid formulations.

2) Scope

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

3) Responsibilities

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

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Ultrasonic Homogenizer for cleanliness and integrity before use.
4.1.1.2 Ensure the probe and vessel are clean and free of contaminants.
4.1.1.3 Verify that all safety devices and interlocks are functioning properly.

4.1.2 Preparation
4.1.2.1 Clean and sanitize the Ultrasonic Homogenizer and surrounding area.
4.1.2.2 Set up the homogenization vessel and ensure all utilities (water, power) are connected.
4.1.2.3 Calibrate the Ultrasonic Homogenizer according to manufacturer specifications.

4.2 Operation
4.2.1 Homogenization Process
4.2.1.1 Start the Ultrasonic Homogenizer and adjust settings as per formulation requirements.
4.2.1.2 Place the formulation into the homogenization vessel and ensure proper immersion of the probe.
4.2.1.3 Monitor homogenization progress and adjust parameters (amplitude, time) if needed.

4.2.2 Quality Checks
4.2.2.1 Perform visual checks for homogeneity and particle size distribution.
4.2.2.2 Conduct additional tests as required by batch specifications.
4.2.2.3 Record all critical parameters and observations during the homogenization process.

4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the homogenization process and remove the formulation from the vessel.
4.3.1.2 Clean and sanitize the Ultrasonic Homogenizer and homogenization vessel thoroughly.
4.3.1.3 Perform post-operation checks to ensure no residual material in the Ultrasonic Homogenizer.

4.3.2 Maintenance
4.3.2.1 Disassemble and clean the probe and vessel after each use.
4.3.2.2 Perform regular maintenance checks on power supply and probe integrity.
4.3.2.3 Document all maintenance activities and update maintenance records accordingly.

5) Abbreviations, if any

QC: Quality Control
SOP: Standard Operating Procedure

6) Documents, if any

Batch records for each homogenization batch
Maintenance records
Calibration records for the Ultrasonic Homogenizer

7) Reference, if any

Manufacturer’s manual for the Ultrasonic Homogenizer
Pharmacopeial guidelines for pharmaceutical homogenization processes

8) SOP Version

Version 1.0