Standard Operating Procedure for Compressed Air System Maintenance
1) Purpose
The purpose of this SOP is to establish procedures for the maintenance of compressed air systems used in the manufacturing of dental dosage forms to ensure air quality and compliance with regulatory standards.
2) Scope
This SOP applies to all compressed air systems used for manufacturing processes involving dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Facilities Management Department is responsible for conducting maintenance of the compressed air system. The Quality Assurance (QA) Department is responsible for verifying compliance with this SOP.
4) Procedure
4.1 Routine Maintenance
4.1.1 Develop a schedule for routine maintenance activities based on manufacturer’s recommendations and regulatory requirements.
4.1.2 Inspect compressed air system components including compressors, filters, dryers, and distribution lines for leaks, contamination, or malfunction.
4.1.3 Clean or replace filters and filter elements as per maintenance schedule.
4.2 Calibration and Testing
4.2.1 Calibrate monitoring and control instruments such as pressure gauges and dew point meters as per calibration schedule.
4.2.2 Perform air quality testing including microbial and particulate matter analysis according to established procedures.
4.3 Lubrication and Oil Checks
4.3.1 Lubricate compressor and system components as recommended by the manufacturer.
4.3.2 Check and replace compressor oil and lubricants as per maintenance schedule.
4.4 Emergency Response
4.4.1 Respond promptly to compressed air system failures, pressure drops, or contamination events.
4.4.2 Document emergency response activities and any corrective actions taken.
4.5 Record Keeping
4.5.1 Maintain records of all compressed air system maintenance activities, including inspections, repairs, lubrications, and testing results.
4.5.2 Document any deviations from maintenance procedures and corrective actions taken.
4.6 Validation and Verification
4.6.1 Validate compressed air system performance through periodic testing and validation activities.
4.6.2 Verify air quality parameters to ensure compliance with specified standards and requirements.
5) Abbreviations, if any
QA – Quality Assurance
ISO – International Organization for Standardization
6) Documents, if any
Compressed Air System Maintenance Log
Air Quality Test Reports
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
ISO 8573 – Compressed Air Quality Standard
8) SOP Version
Version 1.0