Standard Operating Procedure for Using Autoclave
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the autoclave used in the manufacturing of otic dosage forms to ensure effective sterilization of equipment and materials.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the autoclave in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the autoclave as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the sterilization process and verifying results.
Maintenance Personnel: Responsible for maintaining the autoclave in proper working condition.
4) Procedure
4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the autoclave is on a stable, level surface.
4.1.1.2 Check that the autoclave chamber is clean and free of any debris.
4.1.1.3 Verify that the autoclave is properly calibrated and functioning.
4.1.2 Loading the Autoclave
4.1.2.1 Arrange the items to be sterilized in the autoclave trays, ensuring there is space between them for steam circulation.
4.1.2.2 Place the trays inside the autoclave chamber.
4.1.2.3 Close and secure the autoclave
4.1.3 Sterilization Process
4.1.3.1 Select the appropriate sterilization cycle and set the required parameters (temperature, pressure, and time).
4.1.3.2 Start the autoclave and monitor the cycle parameters.
4.1.3.3 Allow the cycle to complete and ensure the autoclave reaches the required conditions for sterilization.
4.1.3.4 After the cycle is complete, allow the autoclave to cool down before opening the door.
4.1.4 Unloading the Autoclave
4.1.4.1 Open the autoclave door carefully to avoid burns from steam.
4.1.4.2 Remove the sterilized items using heat-resistant gloves.
4.1.4.3 Allow the items to cool before handling further.
4.2 Calibration
4.2.1 Daily Check
4.2.1.1 Perform a daily check of the autoclave’s pressure gauge and temperature 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 autoclave 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 autoclave chamber regularly to prevent buildup of residue.
4.3.1.2 Inspect the door gasket and replace if worn or damaged.
4.3.2 Troubleshooting
4.3.2.1 If the autoclave 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
Sterilization log
Maintenance log
7) Reference, if any
Manufacturer’s manual for the autoclave
Regulatory guidelines for equipment calibration and sterilization
8) SOP Version
Version 1.0
