For the assessment of the microbiological quality of food and medical gases there are no specific normative references, either for parameters to detect and for the analytical aspects, or for limits to be respected. However, there is a reference in the European Pharmacopoeia with parameters and limits for non-sterile products for inhalation use, that fit well with the topic.
The scope of this scientific report specifically covers the microbiological quality requirements for gases used for medical, pharmaceutical and food applications. It covers compressed and liquefied gases supplied in high pressure cylinders, and cryogenic liquids supplied by tankers into bulk storage tanks or in portable cryogenic containers.
It covers the quality of the gas up to the point of delivery into the customer’s storage tank or at the outlet valve in high pressure cylinders or portable cryogenic containers. It does not address the quality of the gas once it has been distributed to the usage point via the customer’s pipeline system. It does not cover medicinal or food grade gases that are produced using either Pressure Swing Adsorption (PSA) or Air compressing plants on the customer’s premises.
This scientific report is based on a bibliographic search on scientific articles on the matter.
This publication relates only to the microbiological quality of the gas and does not cover the external condition of the container.
This scientific report is intended as support to the EIGA TB02, Microbiological Quality of Medical, Pharmaceutical and Food Grade Gases and is for use by EIGA Members and national regulatory authorities involved in the regulation of manufacturing of medical, pharmaceutical and food gases.