Standard Operating Procedure for Gel Mixing System

1) Purpose

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

2) Scope

This SOP applies to the Gel Mixing Equipment used in the production of sterile ocular gels within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the operation, cleaning, and maintenance of the Gel Mixing Equipment. The machine 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 equipment and surrounding area are clean and sanitized.
2. Verify that the necessary raw materials and consumables are available and within expiry dates.
3. Check that the equipment is connected to the appropriate power supply.

4.2 Operation

1. Turn on the equipment and allow it to perform its self-checks.
2. Load the raw materials into the mixing vessel according to the formulation requirements.
3. Set the desired mixing parameters (speed, time, temperature) on the control panel.
4. Initiate the mixing process by pressing the start button.
5. Monitor the mixing process to ensure uniform consistency and homogeneity.
6. Once mixing is complete, discharge the gel into suitable containers for further processing.

4.3 Post-Operation

1. Turn off the equipment and disconnect it from the power supply.
2. Clean all contact parts and the surrounding area as per the cleaning procedure.
3. Record the operation details in the equipment logbook.

4.4 Maintenance

1. Regularly inspect the equipment for wear and tear.
2. Lubricate moving parts as per the manufacturer’s recommendations.
3. Perform calibration checks as per the schedule.
4. Replace any worn-out parts promptly.

5) Abbreviations, if any

None

6) Documents, if any

1. Equipment logbook
2. Maintenance record
3. Calibration record

7) Reference, if any

GMP Guidelines for pharmaceutical production and equipment handling.

8) SOP Version

Version 1.0