Medical blister packaging

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 sterile packaging:

1. There should be a documented medical aseptic packaging system design and development procedure.

2. The sterile barrier system should provide products 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 ) Product quality and structure;

( 3 ) The existence of sharp edges and protrusions ;

( 4 ) Physical and other protection needs ;

( 5 ) The sensitivity of the product to specific risks , such as radiation, humidity, mechanism vibration, static electricity, etc .;

( 6 ) The number of products in each medical aseptic packaging system;

( 7 ) Packaging label requirements;

( 8 ) Environmental restrictions;

( 9 ) Limitation of product validity period;

( 10 ) Transportation and storage environment;

( 11 ) Sterilization adaptability and residues.

4. The structure of the components that provide closed components for the sterile fluid circuit on the product should be identified and specified, including but not limited to : material, appearance, size, etc.

5. The results of the process of designing and developing medical aseptic packaging should be recorded, verified and approved before the product is released.

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