Standard Operating Procedure for Using Spray Dryer
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the spray dryer used in the manufacturing of otic dosage forms to convert liquid formulations into dry powder form.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the spray dryer in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the spray dryer as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the drying process and verifying product specifications.
Maintenance Personnel: Responsible for maintaining the spray dryer in proper working condition.
4) Procedure
4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the spray dryer is on a stable, level surface in a well-ventilated area.
4.1.1.2 Verify that all connections, including inlet and outlet ports, are properly secured.
4.1.1.3 Check that the drying chamber and filters are clean and free of debris.
4.1.2 Setting Up
4.1.2.1 Prepare the liquid formulation according to the batch record and adjust viscosity if necessary.
4.1.2.2 Set the appropriate inlet air temperature and feed rate based on product specifications.
4.1.2.3 Ensure that safety guards and interlocks are in place before starting.
4.1.3 Drying Process
4.1.3.1 Start the spray dryer and gradually introduce the liquid feed into the drying chamber.
4.1.3.2 Monitor the drying parameters including inlet temperature, outlet temperature, and product flow.
4.1.3.3 Adjust process parameters as needed to achieve desired moisture content and particle size.
4.1.3.4 Collect the dried powder product using the cyclone separator or other collection methods.
4.1.4 Shutdown
4.1.4.1 After completing the drying process, gradually reduce the feed rate and then stop the spray dryer.
4.1.4.2 Clean the drying chamber and filters immediately to prevent product buildup.
4.2 Calibration
4.2.1 Daily Check
4.2.1.1 Perform a daily check of the spray dryer’s temperature and airflow settings.
4.2.1.2 Verify the accuracy of the temperature sensors and flow meters.
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 spray dryer 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 drying chamber, filters, and nozzles regularly to prevent clogging.
4.3.1.2 Inspect seals and gaskets for wear and replace as necessary.
4.3.1.3 Lubricate moving parts according to manufacturer recommendations.
4.3.2 Troubleshooting
4.3.2.1 If the spray dryer fails to achieve proper drying or shows abnormal readings, refer to the manufacturer’s manual for troubleshooting.
4.3.2.2 Contact maintenance personnel for repairs if issues cannot be resolved.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Drying log
Maintenance log
7) Reference, if any
Manufacturer’s manual for the spray dryer
Regulatory guidelines for equipment calibration and maintenance
8) SOP Version
Version 1.0
