Presterilization

Presterilization is a set of preparatory activities applied to medical devices and other items before they undergo a sterilization process. The aim is to reduce bioburden, improve sterilant penetration, and preserve the integrity of items so that the subsequent sterilization achieves the required sterility assurance level. Presterilization practices are a key component of the broader sterilization workflow used in healthcare facilities, pharmaceutical manufacturing, and related industries.

Typical presterilization steps include cleaning to remove soil and organic material, drying, and inspection for damage or remaining debris; disassembly of complex devices to expose all surfaces or lumens; reassembly and placement in packaging materials compatible with the chosen sterilization method; and labeling and traceability to ensure proper load identification. In some settings, a disinfection step may occur prior to cleaning or as part of an integrated decontamination process. The exact sequence depends on the device design, the sterilization method, and applicable guidelines.

Quality control during presterilization focuses on reducing residual bioburden and verifying that items meet acceptance criteria before sterilization. Packaging materials, indicators, and documentation play a role in ensuring process compatibility and traceability. The choice of presterilization requirements is influenced by the sterilization method (for example, steam, ethylene oxide, hydrogen peroxide plasma, or irradiation) because different methods require different levels of cleanliness, dryness, and residue control.

Standards and guidance from bodies such as ISO 17665, AAMI ST79, and relevant national regulations describe expectations for presterilization cleaning, handling, and verification as part of a validated sterilization process. In practice, facilities tailor presterilization procedures to device type, risk, and regulatory environment while maintaining documentation for quality assurance and patient safety.