Cleaning validation of a sterilization/inertization autoclave [Cleaning validation di un'autoclave di sterilizzazione/inertizzazione]

In specific pharmaceutical productions, like the commercially available biotechnology-derived products, the inertization and overall residual elimination of previous production lines are essential for reutilizing machinery or accessories with safety. It is well-known how easily- desassembled or cleaned-in-place machinery must previously be inertized and subsequently washed up to the required limit of safety. If it is not present an inertization system, a common sterilization autoclave often represents a necessary step to whom many plant implements have to be subjected before re- using in the production line. The sterilization and/or inertization processes of an autoclave are surely keep under control by means of the validation process, but the cleaning of the same autoclave after an inertization cycle is less investigated. The purpose of this work is the cleaning validation of an autoclave employed both in the sterilization and inertization processes. Thus, specific tests have been enacted after each inertization cycle in order to examine the eventual presence of organic residues. Furthermore, relating to the production necessities and to the allowed safety limit Standard Operating Procedures (SOP) have been validated.