Standard Operating Procedure for Maintenance of Spray Dryers

1) Purpose

The purpose of this SOP is to establish guidelines for the maintenance and operation of spray dryers in pharmaceutical manufacturing facilities to ensure efficient drying processes and product quality.

2) Scope

This SOP applies to all spray dryers used within the facility premises.

3) Responsibilities

The Facilities Management Department is responsible for implementing and adhering to this SOP. The Spray Dryer Technician or designated personnel are responsible for the maintenance and operation of spray dryers.

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for spray dryers based on manufacturer recommendations and operational requirements.
   2. Inspect dryer components such as atomizers, heaters, air filters, and drying chambers regularly for wear, cleanliness, or contamination.
2. Cleaning and Sanitization
   1. Follow standard operating procedures for cleaning and sanitizing spray dryers to prevent cross-contamination and ensure product integrity.
   2. Use approved cleaning agents and methods suitable for dryer materials.
3. Performance Verification
   1. Conduct performance verification tests to ensure spray dryers operate within specified parameters such as inlet air temperature, drying rate, and product particle size distribution.
   2. Calibrate equipment controls as per calibration procedures.
4. Emergency Procedures
   1. Develop and maintain emergency response procedures for spray dryer malfunctions, overheating, or other incidents.
   2. Train personnel on emergency shutdown procedures and containment protocols.
5. Documentation and Reporting
   1. Maintain accurate records of equipment inspections, maintenance activities, performance tests, and calibration results.
   2. Document any incidents, repairs, or adjustments made to the spray dryers.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Preventive Maintenance Schedule, Cleaning and Sanitization Procedures, Performance Verification Reports, Emergency Procedures Manual, Calibration Records

7) Reference, if any

Manufacturer’s recommendations for spray dryer maintenance, industry guidelines for drying processes, regulatory requirements for equipment cleanliness and performance, and local safety regulations.

8) SOP Version

Version 1.0