Standard Operating Procedure for Using Overhead Stirrer
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the overhead stirrer in the pharmaceutical manufacturing of otic dosage forms to ensure effective and safe mixing of materials.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of overhead stirrers in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the overhead stirrer as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the mixing speed and ensuring it remains within the required range.
Maintenance Personnel: Responsible for maintaining the overhead stirrer in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the overhead stirrer for cleanliness and integrity before use.
4.1.1.2 Ensure that the speed control devices are functional and calibrated.
4.1.1.3 Check that the stirring paddle and shaft are clean and free of any residue.
4.1.2 Preparation
4.1.2.1 Clean the stirring paddle and shaft with a suitable disinfectant.
4.1.2.2 Attach the stirring paddle to the overhead stirrer securely.
4.2 Operation
4.2.1 Setting the Controls
4.2.1.1 Turn on the overhead stirrer and set the desired mixing speed according to the procedure.
4.2.1.2 Lower the stirring paddle into the container to start the mixing process.
4.2.1.3 Monitor the mixing process to ensure uniform mixing and prevent splashing.
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate personal protective equipment (PPE) when handling the overhead stirrer and materials to be mixed.
4.2.2.2 Avoid touching the stirring paddle or shaft while the stirrer is in use to prevent injury.
4.2.2.3 Follow all safety protocols to prevent spills or accidents.
4.3 Post-operation
4.3.1 Shutting Down
4.3.1.1 Turn off the overhead stirrer and remove the stirring paddle from the container.
4.3.1.2 Clean the stirring paddle and shaft with a suitable disinfectant.
4.3.1.3 Document any deviations in mixing speed or process conditions.
4.3.2 Cleaning and Maintenance
4.3.2.1 Regularly clean the stirring paddle, shaft, and control panel with a suitable disinfectant.
4.3.2.2 Inspect the stirring paddle for any signs of wear or damage and replace it as necessary.
4.3.2.3 Calibrate the speed control devices periodically to ensure accuracy.
4.3.2.4 Document all cleaning and maintenance activities in the overhead stirrer log.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
6) Documents, if any
Overhead stirrer log
Speed monitoring records
7) Reference, if any
Manufacturer’s manual for the overhead stirrer
Pharmacopeial guidelines for mixing materials in pharmaceutical manufacturing
8) SOP Version
Version 1.0