Standard Operating Procedure for Compressed Air Monitoring

1) Purpose

This SOP outlines the procedures for monitoring the quality of compressed air used in pharmaceutical manufacturing processes.

2) Scope

This SOP applies to the monitoring of compressed air systems throughout the pharmaceutical manufacturing facility to ensure compliance with quality standards and regulatory requirements.

3) Responsibilities

The Facilities or Engineering department is responsible for monitoring the compressed air system. Quality Assurance (QA) oversees the process and ensures compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Sampling Points

1. Identify critical points in the compressed air distribution system for sampling (e.g., compressor outlet, after filtration).
2. Ensure sampling points are representative of the entire compressed air system.

4.2 Testing Parameters

1. Perform testing for key parameters including particulate matter, oil aerosols, moisture content, and microbial contamination.
2. Use validated methods and calibrated instruments for accurate measurement of each parameter.

4.3 Microbiological Testing

1. Conduct microbiological testing to verify the absence of objectionable microorganisms in compressed air.
2. Follow compendial methods or validated in-house methods for microbiological testing.

4.4 Trend Analysis

1. Analyze monitoring data over time to identify trends and deviations from established limits.
2. Investigate any deviations and implement corrective actions as necessary to maintain the quality of compressed air.

4.5 Documentation

1. Document all compressed air monitoring activities, including sampling, testing, results, and corrective actions, in designated logbooks or electronic systems.
2. Prepare monitoring reports summarizing findings and trends for review by QA and regulatory agencies.
3. Review and approve monitoring reports to ensure compliance with regulatory requirements and internal procedures.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

Compressed Air Monitoring Protocol, Monitoring Records, Testing Reports, Trend Analysis Reports

7) Reference, if any

Regulatory guidelines such as ISO 8573-1:2010 Compressed Air – Part 1: Contaminants and Purity Classes, FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice

8) SOP Version

Version 1.0