Sterilizability

Sterilizability is the capacity of an object or material to undergo a sterilization process and achieve sterilization under defined conditions. It is evaluated during product design and manufacture to determine appropriate sterilant, process, and packaging.

Common sterilization methods include steam sterilization (autoclave), dry heat, ethylene oxide gas, hydrogen peroxide-based gas plasma, vaporized peracetic acid, and irradiation (gamma or electron beam). Some methods are unsuitable for heat- or moisture-sensitive materials.

Validation and assurance: Successful sterilization is demonstrated by achieving a predefined sterility assurance level, often 10^-6 for medical devices. Validation uses biological indicators and chemical indicators, along with packaging and load configuration. Process validation includes challenge devices, worst-case cycles, and periodic revalidation.

Standards and regulation: International standards cover sterilization processes (for example ISO 11135 for ethylene oxide, ISO 17665 for moist heat, ISO 14937 for general sterilization requirements). Regulatory bodies such as the U.S. FDA and the EU CE marking require validated sterilization processes and biocompatibility and packaging controls.

Distinctions: Sterilizability is a capability; sterility is the state of being free from viable microorganisms under defined conditions after treatment. Sterilization differs from disinfection and antisepsis in that it aims to eliminate all forms of viable microorganisms.