SOP for Environmental Monitoring by Non Viable Air Particle Count
1. Purpose
To establish a standard procedure for monitoring non-viable airborne particulate matter in controlled manufacturing areas to ensure compliance with ISO 14644, EU GMP Annex 1, and regulatory requirements for sterile manufacturing.
2. Scope
This SOP applies to all classified cleanroom areas (Grade A, B, C, and D) of the manufacturing facility, including production rooms, gowning areas, and airlocks.
3. Responsibility
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Microbiologist/Analyst: Perform particle monitoring, record results, report deviations.
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QC/QA: Review data, trend results, and evaluate excursions.
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Engineering: Support corrective actions related to HVAC and cleanroom systems.
4. Materials & Equipment
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Calibrated airborne Particle Counter (capable of measuring ≥0.5 µm & ≥5.0 µm).
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Sampling tubing, probe, and tripod (if applicable).
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Cleanroom garments and PPE.
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Data recording sheets / EM logbook / electronic system.
5. Procedure
5.1 Preparation
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Verify that the particle counter is within calibration and clean.
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Transfer equipment into the cleanroom via material airlock following gowning procedures.
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Allow the particle counter to stabilize (if required by manufacturer).
5.2 Sampling Locations & Frequency
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Grade A (critical areas): Continuous or per batch during aseptic operations.
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Grade B (background areas): Daily during production.
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Grade C & D (support areas): At defined intervals (weekly/monthly or as per risk assessment).
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Location selection: Based on risk assessment, covering critical points (filling, compounding, aseptic connections, LAF/isolator areas, gowning).
5.3 Sampling Procedure
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Position sampling probe at working height (0.8–1.2 m above floor), close to the critical zone.
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Set sample volume according to ISO 14644 (minimum 1 m³ per location unless otherwise justified).
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Start monitoring and record readings for ≥0.5 µm and ≥5.0 µm particle sizes.
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Avoid blocking airflow or unnecessary movement near the probe during measurement.
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Record location, date, time, sample volume, and results.
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On completion, transfer equipment out of the cleanroom following exit procedures.
5.4 Acceptance Criteria (as per ISO 14644-1 / EU GMP Annex 1)
| Grade | ≥0.5 µm (particles/m³) | ≥5.0 µm (particles/m³) |
|---|---|---|
| A | 3,520 | 20 (should be considered zero during operations) |
| B | 3,520 | 29 |
| C | 352,000 | 2,900 |
| D | 3,520,000 | 29,000 |
5.5 Post-Monitoring
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Save electronic data or attach printouts to monitoring record.
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Review results against alert and action limits.
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Report deviations/excursions to QA immediately.
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Investigate and implement corrective actions where required.
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Clean particle counter and store in designated area.
6. Precautions
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Use only calibrated and validated equipment.
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Do not handle the sampling probe with bare hands.
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Do not obstruct unidirectional airflow.
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Ensure minimal personnel movement during sampling.
7. Documentation
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Record all results in Environmental Monitoring Logbook or electronic system.
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Maintain trend reports (monthly/quarterly) for regulatory compliance.
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Document deviations and corrective actions.
8. References
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ISO 14644-1: Cleanrooms and Associated Controlled Environments
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EU GMP Annex 1 (2022): Manufacture of Sterile Medicinal Products
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USP <1116>: Microbiological Control & Monitoring of Aseptic Processing Environments
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WHO TRS Annex 6