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ISO 11135 Certified ETO Sterilizer
As a leading manufacturer of advanced ethylene oxide sterilization systems, Hangzhou Riches Engineering Co., Ltd. provides high-performance and fully compliant solutions designed for global medical device companies, pharmaceutical producers, hospitals, and industrial users. Our ISO 11135 Certified ETO Sterilizer is engineered for demanding low-temperature sterilization applications where heat-sensitive and moisture-sensitive products require reliable, validated, and repeatable sterilization results.
Features
(1) Sterilization Mechanism
Ethylene oxide eliminates microorganisms through an alkylation reaction, disrupting DNA and RNA structures and preventing microbial reproduction. This mechanism ensures complete sterilization even for complex-shaped or multilayer packaged items.
(2) Standard Process Flow
Pre-conditioning – adjusts temperature and humidity of products to optimize EO penetration.
Vacuuming – removes air from the chamber, enhancing gas diffusion efficiency.
Gas Injection & Exposure – EO gas is introduced at controlled pressure, humidity, and concentration for 1–6 hours depending on the load.
Gas Removal & Aeration – residual EO is extracted and decomposed through catalytic devices into CO₂ and H₂O to ensure operator and environmental safety.
Validation & Monitoring – biological and chemical indicators verify sterilization effectiveness, and EO residue levels comply with international limits (≤4 μg/cm²).
Application：
Medical & Healthcare Industry
Suitable for sterilizing a wide range of heat-sensitive devices:
Surgical instruments, scissors, scalpels
Endoscopes and minimally invasive equipment
Catheters, infusion sets, syringes
Non-woven medical consumables: gauze, bandages, wound care products
Implantable devices: artificial bones, pacemakers, surgical power systems
Pre-packaged diagnostic kits and laboratory supplies
Riches Engineering is an innovative manufacturer specializing in ethylene oxide sterilization technology. Our core team consists of senior engineers with years of experience in the pharmaceutical and medical device industries. We offer:
Professional EO sterilization system design
Turnkey project implementation
Compliance support for ISO 11135 validation
Comprehensive after-sales service and technical guidance
As a trusted supplier in the global sterilization market, Riches delivers reliable, efficient, and regulation-compliant EO sterilization solutions that help customers achieve safe production and high-quality outcomes.
FAQ
Why Choose Our ISO 11135 Certified ETO Sterilizer?
Certified for ISO 11135 application requirements
Designed for demanding medical device manufacturers
High repeatability and excellent chamber sealing
Optimized process control for low operational costs
Scalable solutions for small laboratories to mega sterilization centers
Can the sterilization chamber size be customized to fit our production capacity?
Yes. We offer full customization of chamber dimensions, including small-batch laboratory sizes, mid-sized production models, and large industrial chambers. Our engineers evaluate your product categories, daily sterilization volume, and available installation space to design a chamber that maximizes efficiency and meets ISO 11135 validation requirements.
Do you support customized sterilization cycles for different medical device materials?
Absolutely. We tailor process parameters-temperature, humidity, EO concentration, exposure time, and vacuum depth-based on your material properties such as polymers, electronics, composites, or multilayer packaging. Customized cycle development is performed according to ISO 11135 guidelines, ensuring a repeatable SAL ≤10⁻⁶ and safe EO residue levels.
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