Maternal Wellness Resources

A sterilant is a chemical agent or physical process capable of destroying all forms of microbial life, including highly resistant bacterial endospores, fungi, and viruses, resulting in a state of sterility. This distinguishes it from disinfectants and sanitizers, which only reduce microbial populations to safe levels on surfaces or objects. Chemical sterilants are used in applications where absolute microbial elimination is critical, such as in medical devices, pharmaceutical manufacturing, and certain laboratory settings. Common chemical sterilants include ethylene oxide (EtO) gas, which penetrates packaging to sterilize heat-sensitive devices; hydrogen peroxide gas plasma or vaporized hydrogen peroxide; glutaraldehyde and ortho-phthalaldehyde (OPA) solutions for immersion; and peracetic acid solutions. Each has specific advantages regarding material compatibility, cycle time, and safety concerns.

The selection and application of a sterilant depend on the material being treated, the required sterility assurance level (SAL), and safety protocols. Medical device sterilization is the largest application, where EtO remains a workhorse for items that cannot withstand the heat and moisture of steam sterilization (autoclaving). Sterile processing departments in hospitals use liquid chemical sterilants for delicate endoscopes and surgical tools. In the pharmaceutical and biotechnology industries, sterilants are used to decontaminate isolators, filling lines, and production areas. Physical sterilants like gamma radiation and electron beam are also used for single-use medical products. Due to the inherent toxicity and hazards of chemical sterilants (e.g., EtO is flammable, toxic, and a carcinogen; glutaraldehyde is an irritant), their use requires stringent engineering controls, monitoring, and occupational safety measures. The field continuously evolves toward safer, faster, and more environmentally friendly methods while ensuring the highest level of patient and product safety.