Standard Operating Procedure for Using Ultrasonic Bath
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the ultrasonic bath in the pharmaceutical manufacturing of otic dosage forms to ensure effective cleaning and degassing of equipment and materials.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of ultrasonic baths in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the ultrasonic bath as per this SOP.
Quality Control (QC) Personnel: Responsible for verifying the cleanliness and effectiveness of the ultrasonic cleaning process.
Maintenance Personnel: Responsible for maintaining the ultrasonic bath in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the ultrasonic bath for cleanliness and integrity before use.
4.1.1.2 Ensure that the ultrasonic transducers, tank, and control panel are functional and clean.
4.1.1.3 Check that the cleaning solution or solvent is sufficient and appropriate for the intended use.
4.1.2 Preparation
4.1.2.1 Fill the ultrasonic bath tank with the appropriate cleaning solution or solvent.
4.1.2.2 Ensure that the items to be cleaned
4.1.2.3 Set the temperature and timer on the control panel according to the cleaning protocol.
4.2 Operation
4.2.1 Setting the Controls
4.2.1.1 Turn on the ultrasonic bath and set the desired temperature and cleaning cycle duration.
4.2.1.2 Start the ultrasonic cleaning process and monitor the cleaning progress.
4.2.1.3 Adjust the settings if necessary to optimize cleaning efficiency.
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate personal protective equipment (PPE) when handling the ultrasonic bath and cleaning solutions.
4.2.2.2 Avoid direct contact with the cleaning solution or solvent to prevent skin irritation.
4.2.2.3 Follow all safety protocols to prevent spills and accidents during operation.
4.3 Post-operation
4.3.1 Shutting Down
4.3.1.1 Turn off the ultrasonic bath and drain the cleaning solution or solvent.
4.3.1.2 Remove the cleaned items from the ultrasonic bath and rinse them with clean water if necessary.
4.3.1.3 Clean the ultrasonic bath tank and transducers with a suitable cleaner and rinse thoroughly.
4.3.2 Cleaning and Maintenance
4.3.2.1 Regularly clean the ultrasonic bath tank and transducers with a suitable cleaner to remove residues.
4.3.2.2 Inspect the ultrasonic transducers for any signs of wear or damage and replace them as necessary.
4.3.2.3 Calibrate the temperature and timer settings periodically to ensure accuracy.
4.3.2.4 Document all cleaning and maintenance activities in the ultrasonic bath log.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
6) Documents, if any
Ultrasonic bath log
Cleaning solution or solvent usage records
7) Reference, if any
Manufacturer’s manual for the ultrasonic bath
Pharmacopeial guidelines for cleaning processes in pharmaceutical manufacturing
8) SOP Version
Version 1.0