Standard Operating Procedure for Operation of Spray Dryers for Nasal Powders
1) Purpose
This SOP outlines the procedures for operating spray dryers to produce nasal powder formulations. The spray drying process helps achieve consistent particle size and moisture content for nasal powder delivery systems.
2) Scope
This SOP applies to all personnel involved in the operation of spray dryers used for the production of nasal powders at [Company Name].
3) Responsibilities
- Operators: Responsible for setting up, operating, and monitoring the spray dryer to ensure the correct particle size and moisture content.
- Quality Assurance (QA): Ensures that the final product meets the required quality specifications, including particle size and moisture content.
- Maintenance Team: Responsible for the upkeep and calibration of the spray dryer to ensure efficient operation.
4) Procedure
4.1 Pre-Operation Setup
4.1.1 Inspection of Spray Dryer
- Visually inspect the spray dryer for any signs of damage or contamination. Ensure the equipment has been cleaned and is free of residues from previous batches.
- Ensure all seals, gaskets, and nozzles are in good condition and properly installed. Report any issues to the maintenance team.
- Document the pre-operation inspection in the equipment log.
4.1.2 Setup Parameters
- Set the spray dryer parameters, including inlet temperature, outlet temperature, airflow rate, and atomization pressure, according to the formulation’s specifications. Record these settings in the Batch Manufacturing Record (BMR).
- Ensure the powder collection system is in place and functioning properly.
4.2 Operation of Spray Dryer
4.2.1 Start-Up Procedure
- Start the spray dryer by powering on the unit and adjusting the settings to match the parameters specified in the BMR. Monitor the inlet and outlet temperatures closely.
- Once the dryer reaches the desired temperature, begin feeding the liquid formulation into the atomizer using the peristaltic pump or feed system.
- Monitor the atomization process to ensure uniform spray droplet formation and consistent drying.
4.2.2 In-Process Checks
- Perform regular checks on the particle size and moisture content of the collected powder. Randomly sample 10% of the powder batch for particle size and moisture content testing.
- Record the results in the in-process testing log. Adjust spray drying parameters if necessary to achieve the desired product specifications.
4.3 Post-Operation Activities
4.3.1 Shutdown Procedure
- Stop the feed pump and allow the remaining powder to be collected. Once complete, stop the atomization and airflow systems.
- Turn off the spray dryer and allow the unit to cool down before disassembling any parts for cleaning.
4.3.2 Cleaning of Spray Dryer
- Disassemble any removable parts of the spray dryer, such as the atomizer and powder collection system. Clean all parts using an approved cleaning agent and rinse with sterile water.
- Document the cleaning process in the cleaning log and submit for QA review before the next operation.
4.4 Maintenance of Spray Dryer
4.4.1 Routine Maintenance
- Inspect the spray dryer weekly for wear and tear on parts such as nozzles and atomizers. Replace any worn parts as needed to prevent breakdowns during operation.
- Record routine maintenance activities in the maintenance log.
4.4.2 Annual Calibration
- Calibrate the spray dryer’s temperature and pressure control systems annually to ensure accurate operation. Document calibration results in the calibration log.
5) Abbreviations, if any
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
6) Documents, if any
- Batch Manufacturing Record (BMR)
- In-Process Testing Log
- Cleaning Log
- Maintenance Log
- Calibration Log
7) References, if any
- Manufacturer’s equipment manual
- Internal SOP for cleaning and maintenance
8) SOP Version
Version 1.0
Annexure
1. In-Process Testing Log Template
| Date | Batch No. | Particle Size (µm) | Moisture Content (%) | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Particle Size Measured | Moisture Content Measured | Operator Name | QA Name |
2. Cleaning Log Template
| Date | Equipment ID | Cleaning Agent | Operator Initials | QA Approval |
|---|---|---|---|---|
| DD/MM/YYYY | Equipment Name | Cleaning Solution Used | Operator Name | QA Name |