Sterilisability

Sterilisability is the property of an item—such as a medical device, laboratory instrument, packaging material, or consumable—that describes its ability to undergo a validated sterilization process to achieve a defined level of sterility without compromising its function or integrity. In practice, sterilisability depends on the material composition, design features, and the compatibility of the item with the chosen sterilant and cycle.

Common sterilization methods include steam sterilization (moist heat in autoclaves), dry heat, ethylene oxide gas, hydrogen peroxide plasma, gamma irradiation, and electron beam irradiation. Some items are sensitive to heat, moisture, or certain chemical residues and require low-temperature or alternative methods. The choice of method is influenced by the item’s materials, geometry, lumens or hollow spaces, and packaging requirements.

Validation and quality assurance involve demonstrating that a sterilization process reliably achieves the desired sterility level, typically represented by a sterility assurance level (SAL) of about 10^-6 for many medical devices. This is supported by biological indicators, chemical indicators, process monitoring, and routine verification. Standards organizations provide specific guidelines for each method (for example, standards addressing moist-heat sterilization, ethylene oxide, and radiation sterilization).

Packaging and handling are integral to sterilisability, as improper packaging can compromise sterility or prevent the sterilant from reaching the item. Repeated sterilization cycles may affect material properties, connectors, seals, or coatings, so durability and performance after sterilization are often evaluated during product development and quality control.

In healthcare and laboratory settings, sterilisability informs selection, validation, and regulatory compliance to ensure patient and product safety.