Microbiology analysis — Non-sterile products

Microbiology is the science concerned with bacteria, yeasts, moulds and viruses: this dictionary definition defines the field of investigation to which the control of non-sterile products should apply. To date, the main standards and monographs in force have focused mainly on bacteria, yeasts and molds, and little on viruses.

Yet water, for example, as the raw material for many formulas or manufacturing processes, or as a cleaning agent, is a perfect vector for transporting this type of micro-organism. In this study, therefore, we shall confine ourselves to quantifying the first three types of micro-organisms, leaving virology to fill the gap.

For regulatory or economic reasons, the presence of mesophilic flora needs to be investigated and quantified in a wide range of healthcare products: drugs and their starting or process raw materials, cosmetics and their starting or process raw materials, dietetic products, nutraceuticals and medical devices.

Regardless of the regulatory texts followed, the approach is the same, and we will successively describe the quantitative methods used, the techniques for searching for specified germs, the solutions and culture media used, and finally the neutralizing agents required when the product under study has antimicrobial power. We will then look at the various rapid techniques and preservatives.