Anhui Maijie Sterilization Technology Co., Ltd., located in the Hefei High-Tech Industrial Development Zone, Anhui Province, is a high-tech enterprise specializing in sterilization technical services and solutions for the medical device and biopharmaceutical industries. Its industry classification falls under “Disinfection and Sterilization Services” (National Economic Industry Classification Code: M7492) within the broader category of “Specialized Technical Services.” The company is currently in the initial stage of scaled operations, with registered capital of RMB 5 million fully paid-in.  

The company’s core business covers research, development, and industrial application of multimodal sterilization processes—including ethylene oxide (EO), gamma-ray/electron-beam irradiation, and hydrogen peroxide—and primarily serves manufacturers of Class II and Class III sterile medical devices, in vitro diagnostic reagent producers, and biopharmaceutical enterprises. Its customer base spans over 120 companies across the Yangtze River Delta and central China regions.  

Core capabilities include:  
- Establishment of an EO sterilization validation laboratory compliant with YY/T 0681.1–2022 and ISO 11135:2014 standards, equipped with a fully automated parameter monitoring system and a biological indicator analysis platform;  
- Engineering implementation of the “Rapid Prediction Method for EO Residuals Based on Temperature-Humidity Coupling Model” (Invention Patent No. ZL202311529876.4), reducing standard aeration time from 14 days to within 72 hours;  
- Leading development of the provincial standard “Anhui Provincial Specification for Ethylene Oxide Sterilization Services” (DB34/T 4567–2023), and serving as an observer member of the National Standardization Technical Committee on Disinfection (SAC/TC200).  

Certifications and qualifications held include:  
- ISO 13485:2016 Quality Management System Certification (Certificate No. Q50125000289R0M, valid until January 2028);  
- “Medical Device Production License” issued by the Anhui Provincial Medical Products Administration (License No. Wan Xie Sheng Chan Xu 20230087), authorizing “Sterilization Services (Ethylene Oxide).”  

Representative achievements include:  
- Serving as the lead entity for sub-projects under the Anhui Provincial Department of Science and Technology’s Key R&D Program for three consecutive years, and establishing the province’s first cloud-based traceability platform for sterilization parameters;  
- Providing EU MDR-compliant EO sterilization services conforming to EN ISO 11135:2014 for an orthopedic implant manufacturer in Wuhu, supporting CE certification of its products and market entry into Germany and Poland;  
- Collaborating with the Hefei Comprehensive National Science Center Institute for Major Health Research in 2025 to establish the “Joint Laboratory for Sterility Assurance,” conducting pilot-scale validation of low-temperature plasma sterilization.