Standard Operating Procedure for Gel Homogenizer Operation

1) Purpose

The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Gel Homogenizer used in the manufacturing of ocular dosage forms.

2) Scope

This SOP applies to the Gel Homogenizer used in the production of sterile ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the operation, cleaning, and maintenance of the Gel Homogenizer. The equipment operator is responsible for following the procedure, and the maintenance team is responsible for regular maintenance and calibration.

4) Procedure

4.1 Preparation

1. Ensure the homogenizer and surrounding area are clean and sanitized.
2. Verify that all necessary materials and equipment are available and within expiry dates.
3. Check that the homogenizer is connected to the appropriate power supply and is functioning properly.

4.2 Operation

1. Turn on the homogenizer and allow it to perform its self-checks.
2. Load the gel into the homogenizer’s feed system.
3. Set the desired parameters (speed, time, temperature) on the homogenizer control panel.
4. Initiate the homogenization process by pressing the start button on the machine.
5. Monitor the homogenization process to ensure uniformity and consistency of the gel.
6. Once homogenization is complete, discharge the homogenized gel into the designated containers.
7. Inspect the homogenized gel for quality and consistency.

4.3 Post-Operation

1. Turn off the