Pharmacopoeial Requirements for Compressed Air in Pharmaceutical Enterprises

Regulatory basis for compressed air in the Chinese Pharmacopoeia

The General Principles in the current edition of the Pharmacopoeia of the People’s Republic of China9201 Guiding Principles of the Good Manufacturing Practice (GMP) for Pharmaceuticalsand9231 Pharmaceutical Water and Clean GasesIt explicitly identifies compressed air as one of the critical process gases that directly affect pharmaceutical quality. Its quality must be commensurate with the level of contact with the drug product, and it must not introduce microorganisms, oil, particulates, or harmful chemical impurities.

Core indicators of clean compressed air

• Microbial limit: It must comply with aseptic processing requirements and is typically controlled at ISO 8573-1:2010 Class 2 or higher.
• Oil contentTotal hydrocarbons ≤ 0.01 mg/ m³ (Equivalent to ISO 8573-1) Class 1);
• Particulate matter: Number of particles ≥0.5 μm ≤ 3.5 × 10⁴ per m³ (corresponding to ISO Class 2);
• Moisture dew point: Pressure dew point ≤− 40℃ (Some aseptic filling processes require ≤−) 70℃);
• Regular verification: Includes system risk assessment, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and periodic revalidation.

Key Points for GMP Implementation in Pharmaceutical Companies

Enterprises shall establish management procedures for compressed air systems, covering design and selection, filtration configurations (including pre-filtration, activated carbon adsorption, fine oil removal, drying, and terminal sterilization), monitoring frequency, and record retention. All compressed air branch lines that come into contact with pharmaceuticals must be equipped with sampling ports, and physicochemical and microbiological tests shall be conducted according to a predetermined schedule.