# Sterilization Methods Source: https://lso-inc.com/sterilization-validation-services/sterilization-methods/ --- [Book a Sterilization Readiness Consult](https://lso-inc.com/solutions/sterilization-validation/#intake-form) FDA-Registered Manufacturing Facility ISO 13485 Certified Quality System 12 Cleanrooms Class 5–8 125,000+ Sq Ft Regulated Manufacturing 3 Facilities CA | NH | Costa Rica ISO 17025 Accredited Packaging Lab Sterilization refers to any process that effectively kills or eliminates transmissible agents (such as fungi, bacteria, viruses, spore forms, etc.) from a surface, equipment, article of food, medication or biological culture medium. Sterilization can be achieved through application of heat, chemicals, irradiation, high pressure or filtration. Medical devices are sterilized initially at the time of manufacturing and if reusable must be be routinely sterilized and validated to conform to regulatory standards. The sterilization method chosen is based on the product’s ability to withstand heat and extent of sterilization required. The sterilization process for a newly manufactured device is inclusive of but not limited to the following steps: Cleaning, Packaging, Sterilization and Sterilization monitoring. In addition to these, resuable devices also require Decontamination and periodic revalidations/dose audits. PROCESSSTERILIZATION METHOD Heat/High Pressure Wet/Steam Sterilization Chemical Ethylene Oxide (EtO) Radiation Gamma Sterilization E-Beam Sterilization ### Cleaning This involves the removal of debris and other matter on the device surface that would hinder full penetrtation of the sterilization process. Cleaning is performed through the use of basic cleaning supplies such as water, detergent and alcohol. ### Packaging Devices are pre-packaged before they are put through the sterilization process. This is done so that after sterilization, products aren’t exposed to the elements, and therefore remain sterile at the time of use. Specialized pakaging/pouches are used which allow the sterilizing agent such as rays/heat/chemicals to penetrate and purify the device, but also protect the device from external contaminants. ### Sterilization Process The method of sterilization is chosen based on the product’s compatibility with heat and chemicals. To attain the recommended sterility levels, the device must be exposed to the sterilizing agent (steam, chemical, hot air, etc) for an appropriate length of time. Popular methods of sterilization are listed in the table below: ### Sterilization Monitoring The sterilization process and its effectiveness can be monitored through the use of Indicator Tape and by performing Spore Tests/Biological Indicator tests respectively. Indicator tape is typically attached to the package/pouch undergoing sterilization and changes color, indicating that desired sterility levels/conditions have been met. The tape does not inform us however of the extent of microbial kill on the device. This is done through spore tests. ## Related Sterilization Services Validation, methods, and end-to-end sterilization processing for medical devices. [ ### Contract Sterilization EtO, steam, gamma, and e-beam sterilization through an integrated in-house and partner network. See contract sterilization](https://lso-inc.com/sterilization-validation-services/contract-sterilization/) ### Sterilization Validation ISO 11135 / 11137 / 17665 cycle validation, including microbial challenge and biological indicator testing. See validation services](https://lso-inc.com/sterilization-validation-services/overview/medical-device-validation/) ### EtO Sterilization In-house EtO sterilization with 3M chambers for fast, compliant single-lot release. See EtO sterilization](https://lso-inc.com/sterilization-validation-services/services/eto-sterilization/) ### Steam Sterilization In-house steam sterilization for thermally stable devices and drug-delivery components. See steam sterilization](https://lso-inc.com/sterilization-validation-services/services/steam-sterilization/) ### Gamma & E-Beam Sterilization Gamma and electron-beam sterilization with validation under ISO 11137. See gamma & e-beam](https://lso-inc.com/sterilization-validation-services/services/gamma-e-beam-sterilization/) ### Loaner Kit Processing Cleaning, packaging, kitting, sterilization, and distribution for OEM loaner kit programs. See loaner kit processing](https://lso-inc.com/sterilization-validation-services/loaner-kit-processing/) ### Validation Testing Services Bioburden, endotoxin, cytotoxicity, EO residual, microbial ID, and sterility testing. See validation testing](https://lso-inc.com/sterilization-validation-services/validation-testing-services/) ## Ready to get started? Talk to a specialist about sterilization methods. [Book a Sterilization Readiness Consult](https://lso-inc.com/solutions/sterilization-validation/#intake-form) [Explore Solutions](https://lso-inc.com/#solutions)