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<a href="https://www.hzbocon.com/products/industry-eto-sterilizer">Ethylene oxide (EO) sterilization</a> is widely utilized in industrial settings for medical devices. &nbsp;This method, known for its lower temperature requirements, exhibits high compatibility with various materials commonly used in medical device manufacturing, including plastics, polymers, metals, and glass. &nbsp;Its efficacy stems from a chemical reaction (alkylation) with the DNA of microorganisms such as bacteria, viruses, molds, yeasts, and even insects. &nbsp;Careful consideration must be given to potential limitations in products, materials, coatings, bonds, or packaging when designing a cycle.
Temperature plays a crucial role in cycle design. &nbsp;Selecting the highest tolerable temperature for the product is essential for an efficient and cost-effective process. &nbsp;However, potential impacts on product materials or packaging due to elevated temperatures should be evaluated, and some level of caution is recommended. &nbsp;<a href="https://www.hzbocon.com/product-list/ethylene-oxide-sterilizer">EO sterilization</a> typically operates within the range of 90&deg;F to 135&deg;F. &nbsp;Each 18&deg;F increase doubles the lethality rate, potentially leading to reduced EO residue levels and shorter aeration times. &nbsp;Cold temperatures can also achieve lethality but require longer EO exposure times. &nbsp;The flexibility in operating temperature makes <a href="https://www.hzbocon.com/products/industry-eto-sterilizer">EO sterilization</a> suitable for products with diverse devices, components, and materials.
Water vapor is vital for enhancing bacteria deactivation. &nbsp;It improves EO penetration by increasing material porosity and drives the alkylation reaction within bacterial DNA. &nbsp;Maintaining relative humidity levels above 30% is advised for consistent process lethality. &nbsp;However, exposure to steam should be limited for moisture-sensitive materials. &nbsp;The maximum specification for steam addition should be determined based on any product or packaging limitations.
Vacuum depth is another critical factor affecting EO sterilization. &nbsp;Deep vacuum cycles are more efficient in achieving optimal EO penetration into products and packaging, especially for designs with long lumens. &nbsp;However, physical limitations in product and packaging design may influence the cycle pressure profile, necessitating adjustments to accommodate certain materials and products.
The concentration of ethylene oxide also significantly impacts sterilization. &nbsp;Operating concentrations typically range from 400 mg/l to 800 mg/l. &nbsp;Beyond this range, higher concentrations bring adverse effects without substantial improvements in lethality. &nbsp;Therefore, selecting the EO concentration should balance achieving the required sterility assurance level with minimizing residual EO levels in the product.
Before formally validating product sterility assurance, it's crucial to verify that the proposed cycle design has no significant adverse impact on the final product and packaging. &nbsp;Conducting stability and functionality studies on samples exposed to multiple test cycles using a &lsquo;worst-case&rsquo; version of the proposed design helps mitigate risk.
Following the verification of cycle design appropriateness for the product and packaging, validation of the medical device(s) sterility should be performed in accordance with ISO 11135:2014. &nbsp;Additionally, confirming safe EO levels in the product should align with ISO10993/7:2008.
In conclusion, the ability to variably adjust process parameters positions ethylene oxide as a flexible solution for sterilizing a wide array of medical devices and materials, contributing to its sustained growth as a major sterilization technology.

Why Use Ethylene Oxide (EO) For Sterilizing Medical Devices？

Publish Time：2024-01-18