Different methods are cited and discussed in international guides relating to Good Manufacturing Practices (GMP) annexed to the respective Pharmacopoeia.
NB : the choice of the sterilisation method is up to the manufacturer, who must be able to demonstrate its validity, its appropriateness for the product and its expected effectiveness.
STERILISATION METHODS CURRENTLY AVAILABLE
There is no right or wrong technology: they all give excellent results if they are well adapted to the material being treated, including packaging, load, environment …).
1. Chemical means
3. Sterilising micro-nanofiltrations
4. Heat treatments
The bacteria has contact under specific conditions with one or more molecules that usually destroy the metabolism and especially the bacterial core.
These treatments are described as “cold” sometimes, although sometimes temperature is used as a catalyst to accelerate the reaction. They exist in a continuous or discontinuous flow.
They provide a bombardment (more or less high-energy electromagnetic radiation) thereby destroying the core internal structures.
The “cold” or continuous treatments are carried out on site or more frequently by a specialised service provider.
This is an oxidation by combustion in the presence of energy and oxygen. The integrity of molecular structures is deteriorated. It is carried out continuously or by batch, with heat transfer fluids bieng most common: air and steam.
No action on the bacteria, the sieving effect separates and retains micro-organisms upstream of the filters, according to the theoretical pore size..