1. The formation of a sterile barrier system requires the following requirements:
2. The sterilization medium should be able to effectively penetrate the medical packaging materials.
3. In the sterile barrier system, the sterilization medium can be effectively sterilized.
4. Medical packaging materials should be able to protect the surgical instruments inside the package.
5. Medical packaging materials should be able to discharge the sterilization medium.
6. The sterile barrier system formed by medical packaging materials should be able to ensure its sterility. From the time of sterilization to the time of opening, the inside should always be sterile.
1.ISO 11607-1, 11607-2
2.EN 868 series standard
3.ASTM-various experimental methods
The above standards are currently the most commonly used standards for sterile barrier systems.
Two tests are required to validate a sterile barrier system:
1. Physical tests to demonstrate the stability of the material and the effectiveness of the sterilization period.
2. Microbial barrier test to demonstrate the effectiveness of the packaging material for bacteria inhibition.
For packaging materials such as paper-plastic bags, it is necessary to check the seal integrity and seal strength. Detection methods include: sealing performance dye test, visual inspection and peeling test.
The most important indicator of microbial barrier experiments is BFE (Bacterial Filtration Efficiency), which is the efficiency of bacterial filtration.
For non-woven bags and rigid containers, because they do not use sealed packaging, there is no need for seal integrity testing, and their sterile barrier system testing requires the use of microbial aerogels for testing the entire sterilization package.
Remarks: EN ISO 11607-1:2014 has new changes to the definition of microbial barriers, but the basic performance requirements for the sterile barrier system to be transported, dispensed, stored, etc. have not changed.
2. Types of sterile barrier systems
The sterile barrier system is mainly divided into three categories.
1. A disposable sterile barrier system that achieves a sterile barrier function through a sealed package. Such as paper plastic bags.
2. A disposable or reusable packaging material that achieves a sterile barrier function through a closed package. Such as textiles.
3. A reusable microbial barrier system that achieves a sterile barrier function through a valve or filter element. Such as a rigid container.
For flexible packaging, the microorganisms are blocked by the bypass path formed during the packaging process. The rigid container is subjected to microbial barrier by its own valve structure, labyrinth structure and the like.
All three sterile barrier systems have strict testing standards to detect their materials and bacteriostatic effects.
3. Aseptic barrier system test method
Physical experiments on disposable packaging materials include: material weight, tensile strength, and the function of its microbial barrier, and stripping experiments are required to test seal strength. Different experiments are required depending on the material.
The experiment was designed based on the material of the sterile barrier system and the principle of inhibition of bacteria.
For reusable rigid containers, the above requirements also need to be met. Since they are not sealed as a sterile barrier system, there is no need to test the sealing performance, but the bacteriostatic structure needs to be tested.