Standard Operating Procedure for Using Planetary Mixer
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the planetary mixer used in the manufacturing of otic dosage forms to ensure thorough mixing of semi-solid and viscous products.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the planetary mixer in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the planetary mixer as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the mixing process and verifying the uniformity of the mixture.
Maintenance Personnel: Responsible for maintaining the planetary mixer in proper working condition.
4) Procedure
4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the planetary mixer is on a stable, level surface.
4.1.1.2 Check that the mixer bowl and mixing tools are clean and free of any debris.
4.1.1.3 Verify that the mixer is properly assembled and all safety guards are in place.
4.1.2 Loading the Mixer
4.1.2.1 Prepare the ingredients and follow the formulation as per the batch record.
4.1.2.2 Place the mixer bowl securely on the mixer base.
4.1.2.3 Attach the appropriate mixing tool (e.g., paddle, dough hook) as required.
4.1.3 Mixing Process
4.1.3.1 Start the mixer and set the speed and mixing time as per the batch record.
4.1.3.2 Add ingredients gradually as specified in the formulation.
4.1.3.3 Monitor the mixing process to ensure thorough blending of ingredients.
4.1.3.4 Stop the mixer and scrape down the sides of the bowl as necessary.
4.1.4 Unloading the Mixer
4.1.4.1 Turn off the mixer and remove the mixing tool and bowl.
4.1.4.2 Transfer the mixed product to the next stage of production or packaging.
4.2 Calibration
4.2.1 Daily Check
4.2.1.1 Perform a daily check of the mixer’s settings, speed controls, and safety features.
4.2.1.2 Record the results in the equipment log.
4.2.2 Monthly Calibration
4.2.2.1 Conduct a full calibration of the planetary mixer 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 mixer bowl, mixing tools, and external surfaces regularly.
4.3.1.2 Lubricate moving parts and inspect for wear or damage.
4.3.2 Troubleshooting
4.3.2.1 If the mixer malfunctions or operates abnormally, refer to the manufacturer’s manual for troubleshooting steps.
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
Mixing log
Maintenance log
7) Reference, if any
Manufacturer’s manual for the planetary mixer
Regulatory guidelines for equipment calibration and maintenance
8) SOP Version
Version 1.0
