PACKAGING MATERIALS AND STERILIZATION
Despite advances in health care, hospital infections are still an important problem today. Selection and proper application of medical device sterilization is one of the most important factors in preventing hospital infections. Packing is done to ensure sterility is maintained until the time of use of sterile medical devices. The most important step in packaging is choice of packaging material. At this stage, the following steps need to be considered:
- compatibility with the structure of the medical device
- Compatibility with sterilization method
- Compatibility with sterilizer performance
- Standard performance for every use
- Resistance to tears and punctures
- Creating a barrier against external factors (moisture, dust, biological load, etc.)
- Allowing the sterilization to circulate in the package
- Not reacting with sterilizing agent
- Toxic substance free
- Ease of use
There should also be symbols on the packaging that indicate the important points to note about the storage and usage conditions of the product.
Two packages are used in the medical device packaging. The first package should be sealed and sterilized aluminum packaging to prevent medical device contamination; The second package is a medical paper package used to protect the sterile package from contamination.
1. Aluminum Packaging
There are parameters to be considered in the selection of aluminum packaging and after packaging. These can be listed as follows:
- The packaging must be suitable for sterilization and must maintain sterility afterwards.
- Packaging should be easy to open.
- No channels or openings should be formed at the sealing point of the packaging.
- No tears, scratches or holes on the packaging.
- There should not be any delamination or separation at the packaging point.
- There should not be leakage.
2. Medical Paper + Film Sterilization Package Material
Medical paper and film are suitable for steam, ethylene oxide, formaldehyde and hydrogen peroxide gas plasma sterilization. The micro pores in the paper section open when the autoclave reaches a temperature of 55 ° C. Ethylene oxide is opened to allow gas entry. At the end of the sterilization process, the temperature decreases and pores return to the original state and continues to be a barrier for bacteria entry. The paper surface allows the passage of the sterilant, the film surface allows the material to be visible. Medical paper and film have important points to observe after packaging. These can be listed as follows:b
- The texture must be homogeneous and integral.
- There should not be deformation in the sealing channels.
- It should be easy to notice when there are non-adhesive points during sealing process.
- It should be waterproof.
- It should be resistant to physical forces.
- There should not be deformation after sterilization.
- Particles should not occur in the process of opening.