This Technical Bulletin details EIGA’s position concerning the microbiological quality of gases used in medical, pharmaceutical and food applications. It is intended to assist in providing answers to both end users of the gases and to Regulatory Authorities questioned about the microbiological quality of gases.
Analysis studies, carried out by the gases industry, have shown that the levels of microbiological contamination of compressed, liquefied and cryogenic gases are well below the levels specified in the European Pharmacopoeia Chapter 5.1.4.
EIGA companies have performed testing for microbiological activity to verify that the microbiological level complies with the European Pharmacopeia acceptance criteria. These are summarized in EIGA Doc 232 Microbiological Quality of Medical and Food Gases Review - Scientific Report.
Analytical measurement data confirm that the microbiological quality of gases are well below the European Pharmacopeia acceptance criteria for non-sterile products for inhalation use.
Based on the review of the above documents it is not required to monitor the quality of gases compared to the acceptance limits of the European Pharmacopoeia.