Standard Operating Procedure for Using Sonicator
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the sonicator in the pharmaceutical manufacturing of otic dosage forms to ensure effective mixing, dispersion, and degassing of materials.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of sonicators in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the sonicator as per this SOP.
Quality Control (QC) Personnel: Responsible for verifying the effectiveness of the sonication process.
Maintenance Personnel: Responsible for maintaining the sonicator in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the sonicator for cleanliness and integrity before use.
4.1.1.2 Ensure that the sonication probe, vessel, and control panel are functional and clean.
4.1.1.3 Check that the samples or materials to be sonicated are properly prepared.
4.1.2 Preparation
4.1.2.1 Place the sample vessel or container securely in the sonicator bath.
4.1.2.2 Fill the sonicator bath with water or suitable solvent to the required level.
4.1.2.3 Set the sonication parameters
4.2 Operation
4.2.1 Setting the Controls
4.2.1.1 Turn on the sonicator and set the desired sonication parameters.
4.2.1.2 Start the sonication process and monitor the sample for uniform mixing or dispersion.
4.2.1.3 Adjust the parameters if necessary to achieve the desired sonication effect.
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate personal protective equipment (PPE) when handling the sonicator and samples.
4.2.2.2 Avoid direct contact with the sonication probe or hot surfaces during operation.
4.2.2.3 Follow all safety protocols to prevent spills or sample contamination.
4.3 Post-operation
4.3.1 Shutting Down
4.3.1.1 Turn off the sonicator and remove the sample vessel from the sonication bath.
4.3.1.2 Clean the sonication probe and vessel with a suitable solvent to remove any residues.
4.3.1.3 Document any deviations in sonication parameters or process conditions.
4.3.2 Cleaning and Maintenance
4.3.2.1 Regularly clean the sonicator bath and probe with a suitable cleaner to prevent build-up.
4.3.2.2 Inspect the sonication probe for any signs of wear or damage and replace it as necessary.
4.3.2.3 Calibrate the sonication parameters periodically to ensure consistency.
4.3.2.4 Document all cleaning and maintenance activities in the sonicator log.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
6) Documents, if any
Sonicator log
Sonication parameters records
7) Reference, if any
Manufacturer’s manual for the sonicator
Pharmacopeial guidelines for sonication processes in pharmaceutical manufacturing
8) SOP Version
Version 1.0