Standard Operating Procedure for Using Steam Generator
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the steam generator in the pharmaceutical manufacturing of otic dosage forms to ensure efficient steam production for sterilization and other processes.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of steam generators in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the steam generator as per this SOP.
Quality Control (QC) Personnel: Responsible for verifying the efficiency of the steam production process and ensuring compliance with regulatory standards.
Maintenance Personnel: Responsible for maintaining the steam generator in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the steam generator for cleanliness and integrity before use.
4.1.1.2 Ensure that the water supply, steam lines, and control panel are functional and clean.
4.1.1.3 Check that the pressure gauges and safety valves are in good working condition.
4.1.2 Preparation
4.1.2.1 Fill the water reservoir with purified water.
4.1.2.2 Ensure that the steam lines are properly connected and
4.1.2.3 Turn on the power supply to the steam generator.
4.2 Operation
4.2.1 Setting the Controls
4.2.1.1 Set the desired temperature and pressure on the control panel.
4.2.1.2 Start the steam generation process and monitor the pressure and temperature gauges.
4.2.1.3 Adjust the controls if necessary to maintain a steady rate of steam production.
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate personal protective equipment (PPE) when handling the steam generator and steam lines.
4.2.2.2 Avoid touching the hot components or standing near steam vents during operation to prevent burns.
4.2.2.3 Follow all safety protocols to prevent steam leaks or accidents.
4.3 Post-operation
4.3.1 Shutting Down
4.3.1.1 Turn off the steam generator and allow the pressure to drop before disassembly.
4.3.1.2 Drain any remaining water from the reservoir and steam lines.
4.3.1.3 Document any deviations in temperature, pressure, or process conditions.
4.3.2 Cleaning and Maintenance
4.3.2.1 Regularly clean the water reservoir, steam lines, and control panel with a suitable cleaner.
4.3.2.2 Inspect the steam generator for any signs of wear or damage and service it as necessary.
4.3.2.3 Calibrate the temperature and pressure settings periodically to ensure accuracy.
4.3.2.4 Document all cleaning and maintenance activities in the steam generator log.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
6) Documents, if any
Steam generator log
Temperature and pressure records
7) Reference, if any
Manufacturer’s manual for the steam generator
Pharmacopeial guidelines for steam production and sterilization processes in pharmaceutical manufacturing
8) SOP Version
Version 1.0