Compressed air quality requirements in pharmaceutical industry
DateTime：2025-09-24Source：u-air chainHits：
Compressed air is a critical utility in pharmaceutical manufacturing, but its quality directly impacts drug safety and compliance. Stringent standards govern its purity to mitigate contamination risks, with ISO 8573-1 and GMP (Good Manufacturing Practice) serving as global benchmarks.
Key contaminants targeted include solid particles, water, oil, and microorganisms. For direct drug contact, solid particles must meet ISO 8573-1 Class 1 (≤0.1μm, ≤1000 particles/m³) to avoid physical adulteration. Water control is equally vital—direct contact scenarios demand a pressure dew point of ≤-70℃ (Class 1) to prevent microbial growth and chemical reactions with drug components. Oil content, encompassing mist, vapor, and liquid, must stay below 0.01mg/m³ (Class 1) to avoid toxic chemical contamination.
Requirements vary by application. Direct contact with drugs/raw materials mandates the highest purity: Class 1 for particles, water, and oil, plus sterility—critical for processes like powder pneumatic conveying and filling. Indirect contact (e.g., packaging cleaning) relaxes standards slightly but still restricts contaminants to prevent transfer via surfaces. Non-contact uses (e.g., pneumatic equipment) focus on oil/water control to protect machinery.
To comply, manufacturers deploy multi-stage filtration, adsorption/freeze dryers, and end-point sterilizing filters (0.2μm pore size). GMP further requires regular monitoring of particle count, oil content, dew point, and microbial load, with documented validation of equipment performance.
Adhering to these requirements is non-negotiable, as compromised compressed air can lead to drug recalls, health hazards, and regulatory penalties—reinforcing its role as a cornerstone of pharmaceutical quality assurance.
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2025-08-24
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