Standard Operating Procedure for Operation of Autoclaves
1) Purpose
The purpose of this SOP is to outline the procedures for the safe and effective operation of autoclaves used for sterilizing equipment, media, and other materials in the manufacturing facility.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of autoclaves within the facility.
3) Responsibilities
3.1 Autoclave Operator
– Operate autoclaves according to this SOP.
– Monitor and document each sterilization cycle.
3.2 Maintenance Personnel
Perform regular maintenance and calibration of autoclaves.
Address any mechanical issues promptly.
3.3 Quality Assurance (QA) Personnel
Validate and verify autoclave performance.
Ensure compliance with regulatory standards.
4) Procedure
4.1 Preparation for Sterilization
4.1.1 Ensure that materials to be sterilized are compatible with autoclave conditions.
4.1.2 Load materials into the autoclave, ensuring even distribution and avoiding overloading.
4.2 Operation
4.2.1 Select the appropriate sterilization cycle based on the type of materials.
4.2.2 Start the autoclave and monitor the cycle parameters (temperature, pressure, time).
4.3 Monitoring and Documentation
4.3.1 Use autoclave indicators (e.g., biological, chemical) to verify sterilization effectiveness.
4.3.2 Record each cycle’s parameters, including start and end times, temperature, pressure, and indicator results.
4.4 Unloading
4.4.1 Allow the autoclave to cool before opening the door.
4.4.2 Carefully unload sterilized materials and inspect them for any signs of damage or incomplete sterilization.
4.5 Maintenance and Calibration
4.5.1 Perform routine maintenance according to the manufacturer’s recommendations.
4.5.2 Calibrate the autoclave regularly to ensure accurate performance.
5) Abbreviations, if any
– QA: Quality Assurance
6) Documents, if any
– Sterilization Cycle Records
– Autoclave Maintenance Log
– Calibration Certificates
7) Reference, if any
– ISO 17665-1: Sterilization of Health Care Products – Moist Heat
– FDA Guidance for Industry: Sterilization Process Validation
8) SOP Version
Version 1.0
