In the highly regulated medical device manufacturing sector, 最終目標是在保持材料完整性的同時實現可重複的無菌狀態. 對於超過 20 年, Hangzhou Bocon has been at the forefront of designing and manufacturing comprehensive industrial EtO sterilizer machine 系統. With hundreds of successful installations across 44 國家, we provide complete, life-long turnkey solutions—including preconditioning rooms, 曝氣室, conveyors, and EO waste gas scrubbers.

1. Strict Regulatory Compliance & Certification

A reliable sterilization cycle is built on a foundation of uncompromised quality standards. Bocon’s equipment undergoes rigorous quality control to meet the stringent demands of international regulatory bodies. Our systems guarantee:

• 國際標準化組織 11135 遵守: Full support for the parametric release of medical devices.
• Global Certifications: Equipment is certified under CE, 國際標準化組織 13485, 和ISO 9001.
• 安全 & Design Codes: Full compliance with EN 1422, Pressure Equipment Directive (PED), and ATEX explosion protection standards where applicable.
• Data Integrity: Electronic records and data management functions comply with global data integrity requirements, ensuring complete traceability.

2. Chamber Construction & Leak Testing Beyond Standards

The structural integrity of an ETO sterilization chamber dictates both workplace safety and sterilization efficacy. All Bocon sterilization chambers are constructed utilizing medical-grade, corrosion-resistant materials designed for a service life exceeding 30 年.

Note on Leakage: The leakage standard outlined in ISO 11135 is considered a minimum baseline. Bocon strictly adheres to a much higher internal standard, ensuring that after stabilization at 80Kpa, the pressure change will not exceed 2Kpa over a full 12-hour period.

3. Precision Environmental Control (溫度 & 濕度)

An effective ETO process relies on penetrating all medical products (excluding non-metallic ones, which are suitable for surface sterilization). To achieve this, precise control over the microclimate is required. We utilize optimized heating, vacuum, and circulation systems that not only reduce utility consumption but also ensure absolute uniformity.

• Precondition Room Accuracy: Temperature control accuracy is ±3℃, temperature uniformity is ±3℃, and humidity uniformity is ±5%RH.
• Sterilizer Chamber Accuracy: Temperature control accuracy is ±2℃, temperature uniformity is ±2℃, and humidity uniformity is ±5%RH.
• Air Circulation: The internal circulation system operates at > 60 times/hour, maintaining flawless uniformity throughout the entire cycle.
• Mapping Support: Comprehensive Temperature, Relative Humidity (相對濕度), and Gas Concentration mapping support is fully available.

4. Modular Design & Turnkey Scope of Supply

Manufacturing facilities require scalable solutions. Bocon systems are designed with modular expansion options. A complete turnkey EO sterilization solution includes the main sterilizer, advanced preconditioning rooms, 曝氣室, automated conveyors, and environmental scrubbers.

Every project is backed by comprehensive technical documentation (provided entirely in English) and robust validation support. We execute a 工廠驗收測試 (胖的) prior to shipment and a comprehensive 現場驗收測試 (SAT) post-installation.

5. Unmatched After-Sales Service & Maintenance

Downtime in medical device manufacturing is costly. Leveraging two decades of engineering experience, Bocon systems are designed for easy maintenance access. We provide life-long maintenance, a dedicated preventive maintenance (PM) schedule, and related technical consultation.

Our commitment is backed by a guaranteed service response time of within 12 小時 and a performance guarantee aligned directly with agreed specifications.