“Ensuring Quality and Compliance: Validation of Compressed Air Used in Pharmaceutical Processes”
Validation of Compressed Air frame
1. Introduction
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Importance of compressed air in pharmaceutical manufacturing.
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Regulatory expectations (e.g., EU GMP Annex 1, ISO 8573, WHO guidelines).
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Role of compressed air in cleanroom environments, product contact areas, and equipment operation.
2. Why Compressed Air Validation is Important
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Risk of contamination (particulate, microbial, oil, and moisture).
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Critical utility that can directly or indirectly affect product quality.
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Regulatory scrutiny during audits/inspections.
3. Applicable Guidelines and Standards
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ISO 8573 (Parts 1–7): Contaminant classes for particles, water, and oil.
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EU GMP Annex 1: Cleanroom and air quality standards.
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WHO TRS, FDA expectations (as part of a validated utility system).
4. Key Validation Parameters
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Particulate matter
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Microbial contamination
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Oil content (vapor & liquid)
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Water content (dew point)
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Pressure and flow validation (optional but recommended)
5. Validation Strategy
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Risk assessment-based approach.
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Define qualification phases:
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DQ (Design Qualification)
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IQ (Installation Qualification)
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OQ (Operational Qualification)
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PQ (Performance Qualification)
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6. Sampling and Testing
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Point-of-use sampling techniques.
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Frequency and location of sampling.
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Use of calibrated instruments and microbial sampling devices.
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Test methods in line with ISO 8573.
7. Acceptance Criteria (Typical Values)
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Particulate: Class 1 or 2 per ISO 8573-1
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Oil content: ≤ 0.01 mg/m³
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Microbial limits: NMT 1 CFU/1000 L (or site-specific limits)
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Dew point: ≤ –40 °C (dry conditions)
8. Documentation and Reporting
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Validation protocols and reports.
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Log sheets, test results, certificates of calibration.
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Deviation handling and CAPA (if out-of-spec).
9. Re-Validation and Monitoring
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Periodic re-validation (e.g., annually or based on risk).
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Continuous or routine monitoring at critical points.
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Trending of results and review during QA audits.
10. Conclusion
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Compressed air validation ensures product and process safety.
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Integral part of the pharmaceutical QMS.
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Essential for GMP compliance and regulatory approval.
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