According to European Pharmacopeia, the medicinal air is defined as :
' The medicinal air is compressed air with an oxygen value comprised between 20,4% minimum and 21,4% v/v maximum.'
ResponsabilityThe hospital pharmacist is responsible for the delivery of the gas with the status of medical device, as well as a drug. He is responsible for the quality of the gas that will be administered to the patient. The gas quality may be altered gas between the gas source (for example a bottle) and the point of use. It is therefore necessary, the pharmacist checks the quality of gas at regular intervals, at the point of delivery to the patient.
A check should be done after each new installation or modification as well as in routine at an interval to be determined by the pharmacist.
Legal aspect :-European Directive 93/42/EEG concerning medical devices.
That means:
-A mandatory control (pharmacopoeia analysis) should be performed after each new installation or extension (medical gases) as well as routine assessment by the pharmacist. In most cases, minimum 1 per year (2 samples) on all networks.
Air specification according to the air medicinal monograph:Physico-chemical analyzes by EP monograph medicinal air (1238: 01/2008)
O2 value | 20,4%-21,4% ( v/v) |
H2O value (Dew point)* | ≤67 ppm v/v ou ≤-40°C |
CO2 value | ≤500 ppm v/v |
CO value | ≤ 15 ppm v/v |
COV value | ≤ 0,1 mg/m3 |
NO value | ≤2 ppm v/v |
NO2 value | ≤ 2 ppm v/v |
SO2 value | ≤1 ppm v/v |
BACTERIOLOGIE BPF/GMP EDITION 2011-8 Bis Microbiological contamination | CLASSES BPF |
Recomended limits when 'in activities' | | | | |
Air : | A | B | C | D |
ufc/m3 | < 1 | 10 | 100 | 200 |
(ufc = unit forming colony)