I. Core Standards of Reference
The pharmaceutical industry has stricter compressed-air quality requirements than general industrial applications, primarily based on ISO 8573‑1 “Compressed Air — Part 1: Contaminants and Quality Classes” and the GMP regulations of various countries. Among these, ISO ISO 8573‑1 Class 0 represents the highest cleanliness level currently available, specifically designed for sterile processes and direct contact with pharmaceuticals or packaging, requiring particle, moisture, and oil content to meet “zero-risk” detection limits.
II. Key Parameter Control Ranges
- Particulate Matter: ≥0.1 μm particles, ≤20 per cubic meter (Class 0); conventional GMP areas may accept Class 2 (≥0.5 μm, ≤10⁵/ m³)
- Dew Point: typically required to be ≤− 70 °C (pressure dew point), ensuring no condensate forms
- Total Oil Content: includes oil mist, oil vapor, and liquid oil; Class 0 requires<0.01 mg/ m³, and oil vapor must not be detectable
- Microbial Limits: Compressed air used in sterile processes must undergo sterile filtration (0.22 μm), and the filtered gas should meet<1 CFU/ m³, with regular monitoring of airborne and settled microorganisms
III. Validation and Continuous Monitoring Highlights
The compressed air system must undergo installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). The validation scope includes multi-point sampling tests, continuous dew point and oil content monitoring, microbial challenge testing, and stability assessment under worst-case operating conditions. During routine operation, pressure, temperature, filter differential pressure, and periodic third-party test reports shall be recorded.