Basic requirements for sterilization packaging materials for medical devices

Commonly used medical device sterilization packaging materials include medical packaging paper, non-woven Tyvek, various plastic films, medical blister boxes, and aluminum-plastic composite materials. Although the materials are diverse, they have basic requirements. It can be roughly summarized as follows:

1) Basic performance
Including basic physical and mechanical performance indicators, such as air permeability, barrier properties, various mechanical strengths, etc.; chemical properties such as environmental stability, solvent resistance, etc.; optical properties such as transparency and haze, etc.; there are others such as high temperature resistance , Radiation resistance and other properties related to the sterilization process.


1) Microbial barrier
For materials used for sterilization packaging of medical devices, microbial barrier properties must be met, because the prerequisite for the establishment of a "sterile barrier system" is that packaging materials and different packaging materials are formed through a specific process (usually heat sealing) The sealing system must be able to block microorganisms.

2) Compatibility with the sterilization process
The difference between the sterilization packaging of medical devices and other packaging is that the packaging system has to go through a pre-designed sterilization process after completing the sealing process, which must consider the adaptability of the packaging material itself to the sterilization process.

1) Non-toxic
For materials used in the medical field, non-toxicity is also one of the basic requirements. This non-toxicity can be manifested in two aspects. The first aspect is in the field of microorganisms and medicine, such as microbial compatibility, cytotoxicity, etc., which need to be proved by relevant microorganisms and medical experiments. This is more Glue composition for the surface of some packaging materials.