The quality of the medical or medicinal air, as well as for some specific gases, must be in line with the different pharmacopeias, and also meet the GMP guidances.
There are 3 main organisations responsible for pharmacopeias: European Directorate for the Quality of Medicines (EDQM) - responsible for the European Pharmacopeia (Ph Eur);
United States Pharmacopeial Convention - responsible for the US Pharmacopoeia (USP) ; Ministry of Health and Welfare - responsible for the Japanese Pharmacopoeia (JP)
The air quality, according to European Pharmacopeia, is based the breathing air quality, with tighter connstraints for oil vapor content, water vapor content, and carbon monoxide. In addition, the values for nitrogen monoxide and dioxide, and sulfur dioxide must be monitored.
The GMP are used to provide the acceptable level for microbiological organisms such as fungi, yeast and bacteria. The quantity is expressed in CFU.
The number of particles is compared to the ISO 8573:2010 to obtain a minimum class 2 target
The protocole used to qualify the air is part of the company QA manual.
The results are then controlled by FDA, USP, ANSM, JP or Ph Eur auditors.
The same quality of air is used for cosmetic or food industries.