The clean area of the pharmaceutical industry has strict standards for the water content of compressed air, mainly in accordance with the international standard ISO 8573-1:2010 and industry norms (such as GMP). The following are the specific technical requirements:
1. water content standard
- pressure dew point
- general Requirements: Dew point of compressed air shall be ≤-40 ℃ (corresponding to water content of about 0.11 g/m & sup3;).
- High Demand Scenarios(such as sterile preparations): dew point should be ≤-70 ℃ (corresponding to water content of about 0.003 g/m & sup3;).
- Basis ISO 8573-1:2010 Class II standard, GB/T 13277.1-2023 stipulates that the dew point of Class 1 compressed air is ≤-70 ℃.
- Liquid water limit
- free liquid water shall not be present in the compressed air pipeline and shall be controlled by condensate drainage.
2. oil content standard
- total oil content: ISO 8573-1 Class 1 standard is ≤ 0.01 mg/m & sup3;(commonly used in medicine and food industry).
- High Demand Scenarios: It needs to reach Class 0 (total hydrocarbon content ≤ 0.003 mg/m & sup3;) and pass specific inspection and verification.
3. relative humidity and temperature
- relative humidity: It needs to be controlled between 40% and 60%.
- Temperature usually controlled at 18-26°C to meet the requirements of the pharmaceutical production process.
4. Microorganisms and Particulate Matter Control
- microorganisms: Compressed air entering the sterile area shall be sterilized and filtered, and the microbial limit shall be ≤ 1 CFU/m & sup3;.
- Particulate matter: It shall meet the standard of suspended particles in clean area, such as the number of particles ≥ 0.5μm in Class A area ≤ 3520 particles/m & sup3;.
5. detection and verification
- detection method oil content using infrared spectroscopy (ISO 8573-5) or gas chromatography (ASTM D6228).
- Monitoring frequency: The new system is tested every 3 months, and the mature system is tested every 6 months to 1 year.
6. industry standard basis
- domestic Standards the appendix of Good Manufacturing Practice (GMP)2010 requires that the water content of compressed air should meet the secondary standard of ISO 8573 (water content <0.1 mg/m & sup3;).
- International Standards: ISO 8573-1:2010 and GB/T 13277.1-2023 have clear provisions on the classification of compressed air quality.
Summary
the water content of compressed air in the clean area of the pharmaceutical industry should be strictly controlled at the dew point ≤-40 ℃ (high requirement scene ≤-70 ℃), and at the same time, it should meet the comprehensive standards of oil content, microorganism and particulate matter, so as to ensure the quality and safety of the pharmaceutical production environment. Enterprises need to regularly test and optimize the compressed air system, in line with GMP and international standards.
