Standard Operating Procedure for Using Magnetic Hotplate Stirrer
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the magnetic hotplate stirrer in the pharmaceutical manufacturing of otic dosage forms to ensure the effective and safe mixing and heating of solutions.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of magnetic hotplate stirrers in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the magnetic hotplate stirrer as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the temperature and mixing speed to ensure they remain within the required range.
Maintenance Personnel: Responsible for maintaining the magnetic hotplate stirrer in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the magnetic hotplate stirrer for cleanliness and integrity before use.
4.1.1.2 Ensure that the temperature and speed control devices are functional and calibrated.
4.1.1.3 Check that the hotplate surface is clean and free of any residue.
4.1.2 Preparation
4.1.2.1 Clean the hotplate surface with a suitable disinfectant.
4.1.2.2 Place the magnetic
4.1.2.3 Position the container on the hotplate and secure it if necessary.
4.2 Operation
4.2.1 Setting the Controls
4.2.1.1 Turn on the magnetic hotplate stirrer and set the desired temperature and mixing speed according to the procedure.
4.2.1.2 Allow the hotplate to reach the set temperature before starting the mixing process.
4.2.1.3 Monitor the mixing process to ensure uniform mixing and heating.
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate personal protective equipment (PPE) when handling the magnetic hotplate stirrer and hot solutions.
4.2.2.2 Avoid touching the hotplate surface while it is in use to prevent burns.
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 magnetic hotplate stirrer and allow it to cool down before cleaning.
4.3.1.2 Remove the container and magnetic stir bar from the hotplate.
4.3.1.3 Document any deviations in temperature, mixing speed, or process conditions.
4.3.2 Cleaning and Maintenance
4.3.2.1 Regularly clean the hotplate surface and control panel with a suitable disinfectant.
4.3.2.2 Inspect the stir bar for any signs of wear or damage and replace it as necessary.
4.3.2.3 Calibrate the temperature and speed control devices periodically to ensure accuracy.
4.3.2.4 Document all cleaning and maintenance activities in the magnetic hotplate stirrer log.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
6) Documents, if any
Magnetic hotplate stirrer log
Temperature and speed monitoring records
7) Reference, if any
Manufacturer’s manual for the magnetic hotplate stirrer
Pharmacopeial guidelines for mixing and heating solutions in pharmaceutical manufacturing
8) SOP Version
Version 1.0