Focus on Packaging and Sterilization Compliance

On June 5, 2026, the "2026 Special Training Session on Compliance Control of Packaging and Sterilization Processes for Terminal Sterilization Medical Devices", hosted by Zhuhai Medical Device Industry Association and undertaken by Shenzhen Jinnan Medical Testing Technology Co., Ltd., was successfully held in Zhuhai. It attracted over 50 R&D, quality, regulatory affairs and production leaders from medical device enterprises, who gathered to discuss the compliance requirements and practical applications of packaging and sterilization processes for terminal sterilization medical devices.

This training focuses on the high-frequency concerns of packaging and sterilization processes for terminal sterilization medical devices in regulatory review and on-site inspection for production licensing, and conducts thematic sharing around three core sections: sterile barrier materials, packaging system aging and simulated transportation, and ethylene oxide sterilization process validation.

Focus on Application Trends of Sterile Barrier Systems

Mr./Ms. Chen from Dongguan Anbao Medical Packaging Technology Co., Ltd. delivered a speech themed Selection and Application Trends of Sterile Barrier Systems. He/She systematically shared the performance characteristics and application scenarios of sterile barrier materials such as Tyvek® and medical dialysis paper. Combined with emerging fields including AI medical devices, minimally invasive interventional devices and medical aesthetic implant products, he/she analyzed in detail the applicable scenarios and development trends of different packaging forms such as FFS automatic packaging materials, paper-plastic bags, header bags, middle-seal bags and blister boxes. In-depth discussions on the direction of green and sustainable packaging under the ESG framework were also conducted.

In-depth Analysis of Key Links in Packaging Validation

Mr./Ms. Xiao from Shenzhen Jinnan Medical Testing Technology Co., Ltd. centered on the theme Terminal Sterilization Medical Devices — Packaging System Aging and Simulated Transportation. In accordance with standards including ASTM D4169 and YY/T 0681.15, he/she elaborated on core links in the testing process such as assurance level selection, distribution cycle setting and sample preprocessing, and provided specific improvement suggestions based on typical cases like drop damage, stacking collapse and concentrated impact failure.

Master Core Requirements for Sterilization Process Validation

Mr./Ms. Liu, Technical Director of Shenzhen Jinpai Medical Packaging Sterilization Service Co., Ltd., shared insights on Core Key Points of Ethylene Oxide Sterilization Process Validation. He explained the planning phase (master product selection, product family and processing group division, process parameter setting), the full implementation process (from protocol development, PCD preparation to sterilization execution and laboratory testing), as well as post-validation review and maintenance requirements. He emphasized the re-validation triggering conditions for product changes, new product additions and equipment deviations, providing guidance for enterprises to establish a scientific and standardized sterilization management system.

Jointly Build the Medical Device Sterility Assurance System

The on-site interaction at the training was highly active. Participating enterprises generally stated that the course content combines regulatory authority and practical depth, forming a complete technical closed loop covering sterile barrier system design, packaging validation and sterilization validation, which serves as an important reference for product R&D, registration application and quality management.
Going forward, Anbao Medical Packaging will continue to follow the development trends in the field of medical device sterile barrier systems, and work with industry partners to promote technological innovation in medical device packaging and the improvement of compliance capabilities, so as to safeguard the safety of medical device products.