Ensuring the microbiological quality of medicines and foods is a vital requirement to protect the health of the patient and consumer. This is an issue that SIAD’s Research Department has been following for more than two decades, and whose work has led to the development of a verification protocol capable of assessing the microbiological quality of gases.
The SIAD method, the first of its kind in Italy, not only certifies that the gases produced by the industrial group are pure but,in the absence of specific regulations, it has now become a reference for the microbiological aspect of the European Industrial Gases Association, which has included it in the document: “Microbiological quality of medical and food gases review – Scientific Report”.
The current scenario and the SIAD initiative
At present, there are no specific regulatory references, either with respect to parameters to be detected or with respect to analytical aspects or limits to be met, in order to ascertain the microbiological quality of medicinal and food gases.
Although there is no indication of this, SIAD has decided to carry out periodic inspections by subjecting its gases to periodic analysis,with the aim of ascertaining the microbiological content of the entire production chain and thus confirming their safety for use. This activity began in 2000 when internal research was initiated.
Since there were no reference standards, as a first step, it was necessary to develop a method, which did not exist up to that point, which involved setting up the sampling system, finding the methodology for taking the samples, and defining the analytical parameters and specifications to be complied with.
Gas analysis and risk factors.
In the evaluation of possible critical issues, all elements that could pose a risk factor for the final gas quality at the production stage were considered. Attention has been paid not only to all the major chemical and physical parameters, but also to the presence of living organisms that could be an element of gas contamination: bacteria and fungi, in particular moulds.
Although there are no specific treatments in gas production processes for microbiological control, the chemical and physical conditions in the production stages are unfavorable for the proliferation of microorganisms: we refer in particular to very high temperatures up to over 900 degrees centigrade, or very low down to almost – 200 degrees Celsius, at high pressures up to 200 bar, as well as the almost total absence of moisture.
Under these conditions, gases can hardly be a vehicle for living forms.
Since, however, there are extremophilic microorganisms (i.e., able to live under extreme conditions) and sporigenic microorganisms (able to survive such conditions in a quiescent form) in nature, it is not possible to certify for certain the absence of microorganisms in gases.
For this reason, SIAD’s Research technicians have been performing gas sampling on production plants and containers dedicated to different uses for more than 20 years now: food and medical cylinder and cylinder for home carbonating drinking water with CO2.
Findings over the years confirm the characteristic value of the microbiological quality of gases, in other words, gases are not vehicles for microbiological contamination.
Microbiological gas quality, a database more than 20 years old
Checks are carried out periodically, and the sheer volume of data collected over the years has made it possible to gradually refine the model and collect a significant amount of data, which is essential for the processing stage and a starting point for further investigation.
Starting in 2022, research activities will be further developed: a dedicated biology laboratory is planned in the SIAD Group’s new Research Department “The Gases of Life” in Osio Sopra (BG), where molecular biology techniques will be used to further investigate the microbiological quality of gases.
Continuing studies on the microbiological quality of gas, SIAD will further contribute to scientific knowledge on the topic and, as has been already done withThe document “Microbiological quality of medical and food gases review – Scientific Report”, published byEIGA, the European Industrial Gases Association, will continue to increase knowledge related to the microbiological quality of gases with other publications.
