The Sterilization Center is dedicated to providing high-standard, highly reliable ethylene oxide (EO) sterilization services for the medical device industry. Relying on a professional
team, advanced facilities, and a strict quality system, we ensure the sterility and safety of your products.
Core Advantages:
Certification and Compliance Assurance: We have obtained EN ISO 11135:2014 certification. This standard represents the international common requirements for the development,
validation, and routine control of ethylene oxide sterilization processes. It ensures that every step of our sterilization process—from development and validation to daily operations
—complies with the most stringent international norms.
Ample Capacity, Timely Delivery: With an annual sterilization capacity of 70,000 cubic meters, we can efficiently handle large-volume orders, ensuring the smooth and stable operation
of your product supply chain.
Expert Team, Technical Support: The center is staffed with a team of professional sterilization engineers. They are well-versed in EO sterilization principles, process control, and equipment
qualification (e.g., Installation Qualification IQ, Operational Qualification OQ, Performance Qualification PQ). They provide comprehensive technical support throughout the entire process,
from training and validation to sterilization.
Low-Temperature Simulation, Challenging Limits: We are equipped with specialized freezing equipment that can simulate year-round low-temperature conditions during validation. This
allows us to challenge the impact of low-temperature environments on sterilant penetration, ensuring that even under extreme cold conditions, your products (especially complex lumen
devices) achieve the intended sterilization effect.
Complete Service Chain: In addition to the core sterilization process, we also offer a one-stop service package including aeration, inspection, warehousing, and logistics transportation,
helping you simplify supply chain management.