Standard Operating Procedure for Autoclave Sterilization

1) Purpose

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

2) Scope

This SOP applies to the Autoclave Sterilizer used for sterilizing equipment, components, and products 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 Autoclave Sterilizer. 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 autoclave and surrounding area are clean and sanitized.
2. Verify that all items to be sterilized are clean and properly loaded into the autoclave trays.
3. Check that the autoclave is connected to the appropriate power and water supply.

4.2 Operation

1. Turn on the autoclave and allow it to perform its self-checks.
2. Load the trays into the autoclave chamber.
3. Select the appropriate sterilization cycle and parameters (temperature, pressure, time) on the control panel.
4. Initiate the sterilization cycle by pressing the start button.
5. Monitor the cycle to ensure that the correct parameters are maintained throughout the process.
6. Once the cycle is complete, allow the autoclave to cool down before opening the chamber.
7. Remove the sterilized items and transfer them to a sterile area for further processing.

4.3 Post-Operation

1. Turn off the autoclave and disconnect it from the power and water supply.
2. Clean the chamber and trays as per the cleaning procedure.
3. Record the sterilization details in the equipment logbook.

4.4 Maintenance

1. Regularly inspect the autoclave 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