2026-04-15Views：
the pharmaceutical industry's quality requirements for compressed air strictly follow GMP (Good Manufacturing Practice for Pharmaceuticals), which aims to ensure that the pharmaceutical production process is not contaminated and patient safety. Its core standards can be summarized in the following four areas:
in order to meet the above quality requirements, the design, verification and maintenance of the compressed air system shall comply with the following specifications:
according to the degree of contact between compressed air and drugs, GMP standards have different requirements for different scenarios:
| Application Scenarios | cleanliness requirements | key Control Indicators |
|---|---|---|
| direct contact with drugs | sterile preparation Class A area | microorganism ≤ 1CFU/m & sup3, dew point ≤-40 ℃, oil content ≤ 0.01 mg/m & sup3; |
| indirect contact but in clean area | non-sterile preparation Class D area | microorganism ≤ 100CFU/m & sup3, dew point ≤-40 ℃, oil content ≤ 0.1 mg/m & sup3; |
| power drive | general production area | oil content ≤ 0.1 mg/m & sup3, dew point ≤-20 ℃ |
the GMP standard for compressed air in the pharmaceutical industry ensures that the air quality meets the production needs of sterile and non-sterile preparations through multi-stage filtration, strict monitoring and system verification. Its core lies in preventing pollution and ensuring drug safety, which needs to be combined with comprehensive measures such as equipment selection, pipeline design, online monitoring and regular maintenance.
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