Because in recent years, high degree of attention to social concerns health problems, so our government introduced many policies to provide strong support for the development of medical industry, but also issued a series of quality norms, in order to ensure that enterprises in the design and production process with the medical products of all kinds of pollutants have a reference standard, which greatly stimulated the development of China's medical industry.
Requirements for designing medical aseptic packaging:
1. There should be a documented design and development procedure for the medical aseptic packaging system.
2. The sterile barrier system should be provided in a sterile manner.
3. The design and development of medical aseptic packaging systems should consider many factors, including but not limited to:
( 1) Customer requirements;
( 2 ) the quality and structure of the product;
( 3 ) the presence of sharp edges and protrusions ;
( 4 ) the need for physical and other protection ;
( 5 ) The sensitivity of the product to specific risks , such as radiation, humidity, mechanical vibration, static electricity, etc.;
( 6 ) the number of products in each medical aseptic packaging system;
( 7 ) packaging label requirements;
( 8 ) Environmental restrictions;
( 9 ) the limitation of the validity period of the product;
( 10 ) transportation and storage environment;
( 11 ) Sterilization adaptability and residue.
4. The structure of the product to provide a closed component for the sterile fluid path shall be identified and specified, including but not limited to : material, appearance, size, etc.
5. The results of the process of designing and developing a medical aseptic package should be documented, verified and approved prior to release.
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