Dialysis for Development of Sterilization Packaging of Medical Devices in China

Based on the understanding and analysis of ISO11607, EN868 series and GB19633 (equivalent to ISO11607), the author believes that it can be divided into two parts: primary packaging and subsidiary packaging. In general, sterilization pouches of medical device products refers to the initial packaging of the product, that is, the part that directly contacts with the product and forms the barrier of microbial barrier. The subsidiary packaging is mainly concerned with the storage and circulation of the product during its life cycle. Packaging, design, protection, convenience, traceability and packaging costs related to the carton, plastic bags, labels, bar codes, printing, trays and containers and other content. This article only concerned with the initial packaging of medical equipment sterilization products.

    The main materials for sterilization packaging are Paper-Poly Pouch, Poly Pouch, Medical-Grade Paper, Form-Filled Film, (Tray) and the most medical equipment packaging characteristics of a material is DuPont's Tyvek, a non-woven materials based on 100% HDPE materials.

    Thus, medical equipment sterile packaging is also a soft plastic packaging materials as the main category, and its important difference is: the requirements of medical equipment packaging materials are very high, in addition to meet the conventional protection and isolated from the outside world Environmental basic packaging performance, but also stressed the continued stability of material properties, as well as from the sterilization requirements and extended from the sterilization way compatibility, material microbial barrier and non-toxic, these special requirements are sufficient to block that engaged in general industrial products and food packaging enterprises to enter the field of medical device packaging.

    Of course, users of the medical device products are relatively fixed and professional, and therefore does not attach great importance to product sales packaging design, which is common and flexible packaging design, such as high-end food, medicine and fine craft packaging difference, and reflected in the packaging of medical device product design does not pay attention to the color of the bright and complex patterns, but only a label nature of the informative content.

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