Standard Operating Procedure for Using Ultrasonic Cleaner
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the ultrasonic cleaner used in the manufacturing of otic dosage forms to ensure thorough cleaning of small parts and equipment.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the ultrasonic cleaner in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the ultrasonic cleaner as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the cleaning process and verifying cleanliness standards.
Maintenance Personnel: Responsible for maintaining the ultrasonic cleaner in proper working condition.
4) Procedure
4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the ultrasonic cleaner is on a stable, level surface.
4.1.1.2 Fill the cleaner tank with the appropriate cleaning solution as specified.
4.1.1.3 Verify that the cleaner is plugged in and all safety features are functional.
4.1.2 Loading the Cleaner
4.1.2.1 Disassemble the parts or equipment to be cleaned according to manufacturer guidelines.
4.1.2.2 Place the parts or equipment securely in the ultrasonic cleaner basket.
4.1.3 Cleaning Process
4.1.3.1 Set the appropriate cleaning cycle time and temperature as per the cleaning requirements.
4.1.3.2 Start the ultrasonic cleaner and allow the cleaning cycle to complete.
4.1.3.3 Monitor the cleaning progress to ensure thorough removal of contaminants.
4.1.3.4 After the cycle is complete, remove the parts promptly to prevent recontamination.
4.1.4 Rinse and Dry
4.1.4.1 Rinse the cleaned parts thoroughly with clean water to remove any residual cleaning solution.
4.1.4.2 Dry the parts using lint-free cloths or allow them to air dry in a clean environment.
4.2 Calibration
4.2.1 Daily Check
4.2.1.1 Perform a daily check of the ultrasonic cleaner’s settings and functionality.
4.2.1.2 Verify the effectiveness of the ultrasonic waves and heating elements.
4.2.1.3 Record the results in the equipment log.
4.2.2 Monthly Calibration
4.2.2.1 Conduct a full calibration of the ultrasonic cleaner 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 ultrasonic cleaner tank and lid regularly to prevent buildup of contaminants.
4.3.1.2 Inspect and replace cleaning solution and filters as recommended by the manufacturer.
4.3.2 Troubleshooting
4.3.2.1 If the ultrasonic cleaner fails to operate or shows signs of malfunction, refer to the manufacturer’s manual for troubleshooting.
4.3.2.2 Contact maintenance personnel for repairs if necessary.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Cleaning log
Maintenance log
7) Reference, if any
Manufacturer’s manual for the ultrasonic cleaner
Regulatory guidelines for equipment calibration and maintenance
8) SOP Version
Version 1.0