Bacteria-free packaging refers to the device packaging with microbial barrier performance to ensure that the aseptic state of the device can be maintained within a certain period of time after sterilization, which can be sterilized and safely opened for use. So what are the basic requirements for bacteria-free packaging design?

1. Maintenance requirements for sterility

It has the vital function of providing and maintaining products - aseptic performance characteristics and maintenance within the validity period.

2. Packaging integrity requirements

Sealing integrity, Airtight integrity

3. Biocompatibility requirements of packaging materials

Considering its direct or indirect contact with the device, the requirements on biocompatibility must be met. For the dissolution of toxic substances in ISO10993, when there is liquid in sterile packaging, the impact of some dissolved substances must be evaluated.

4. Stability requirements of packaging materials

Maintain the stability of mechanical and chemical properties of packaging materials within the validity period, and maintain the integrity of sterile packaging system

5. Compatibility requirements for sterilization process

It is required that the packaging integrity will not be affected due to sterilization during different sterilization processes

6. Compatibility requirements with products

The natural property of the device and the compatibility with the product are reflected in the protective requirements for the product

7. Convenient / clean opening requirements

The extraction process is simple and convenient. The requirements for clean opening are directly related to the requirements for product sterility. For example, the sealing strength of the opening part of the sterile packaging system should be moderate.