Procedure for Compressed Air Quality Testing
1) Purpose
The purpose of this SOP is to outline the procedure for testing the quality of compressed air used in pharmaceutical manufacturing to ensure it meets specified standards for purity and cleanliness.
2) Scope
This SOP applies to all areas within the facility where compressed air is used in pharmaceutical production processes, requiring regular testing to comply with regulatory requirements and internal specifications.
3) Responsibilities
Facility Engineering: Responsible for conducting compressed air quality testing.
Quality Assurance (QA) Department: Responsible for oversight and review of testing procedures.
4) Procedure
4.1 Sampling Points Identification:
4.1.1 Identify critical sampling points where compressed air quality will be tested (e.g., points of use, distribution lines).
4.1.2 Ensure sampling points represent different areas and usage levels within the facility.
4.2 Sampling Method:
4.2.1 Prepare sampling equipment, including air samplers and sterile containers, following sterilization and calibration procedures.
4.2.2 Use a validated method to collect compressed air samples, ensuring samples are representative of actual usage conditions.
4.2.3 Collect samples at specified time intervals or as per schedule based on facility requirements.
4.3 Testing Parameters:
4.3.1 Analyze compressed air samples for key parameters such as particle count, microbial content (if applicable), moisture content, and oil content.
4.3.2 Use validated analytical methods and equipment (e.g., particle counter, microbial sampler) to determine compliance with defined specifications.
4.3.3 Record environmental conditions (e.g., temperature, pressure) during sampling and testing.
4.4 Data Analysis:
4.4.1 Interpret test results and compare them against acceptance criteria specified in pharmacopeial standards or facility specifications.
4.4.2 Evaluate trends over time to identify potential deviations or changes in compressed air quality.
4.4.3 Investigate any out-of-specification results and implement corrective actions as necessary.
4.5 Reporting:
4.5.1 Document all testing activities, including sampling locations, methods, results, and actions taken, in the Compressed Air Quality Test Report.
4.5.2 Provide summary reports to QA for review and approval.
4.5.3 Maintain records of all testing documentation in accordance with facility procedures and regulatory requirements.
5) Abbreviations, if any
QA: Quality Assurance
6) Documents, if any
Compressed Air Quality Test Report
Calibration Records for Testing Equipment
Analytical Method Validation Records
7) Reference, if any
ISO 8573 – Compressed Air Specifications
FDA Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing
8) SOP Version
Version 1.0
