SOP for Operation of Spray Dryers for Nasal Powders

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

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

Date	Equipment ID	Cleaning Agent	Operator Initials	QA Approval
DD/MM/YYYY	Equipment Name	Cleaning Solution Used	Operator Name	QA Name