Cycloolefin Polymer Medical Container Sterilization
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Solution Overview
Problem
Conventional medical containers sterilized with radioactive rays, such as electron rays, lead to protein denaturation and oxidation of amino acid residues in protein solutions, compromising their stability and physiological activity during storage.
Innovation Solution
Sterilizing cycloolefin polymer-made medical containers with high-pressure steam instead of radioactive rays, and packaging the protein solutions in oxygen-impermeable materials with deoxygenating agents and light-blocking packaging to prevent denaturation and oxidation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the container is sterilized by irradiation with radioactive rays such as electron rays, then the container can be sterilized effectively, but the protein in the protein solution formulation undergoes oxidization of amino acid residues, polymerization, and anionization leading to denaturation
Solution Approach 1:
The patent changes the sterilization parameter from radioactive ray irradiation to high-pressure steam sterilization. This parameter change eliminates the harmful oxidative effects on amino acid residues while maintaining effective sterilization, thereby preventing protein denaturation, polymerization, and anionization.
Solution Approach 2:
The patent replaces the electromagnetic/radiation-based sterilization system with a thermal-mechanical sterilization system using high-pressure steam. This substitution eliminates the generation of radicals that cause protein oxidation while achieving complete sterilization through heat and pressure.
2Ease of operation
If the container is made from cycloolefin polymer, then the container is light, not easily damaged, and has excellent handling property, but the container cannot be heat-sterilized with high-pressure steam after filling with protein solution formulation
Solution Approach 1:
The patent applies preliminary sterilization of the cycloolefin polymer container using high-pressure steam before filling with the protein solution formulation. This preliminary action allows the container to be sterilized at high temperature while preventing the protein from undergoing denaturation, as the protein is not yet in the container during the heat sterilization process.
3Reliability
If the container is sterilized before filling with protein solution formulation, then the container can be sterilized effectively, but radicals remain in the container causing oxidization of amino acid residues in the protein during storage
Solution Approach 1:
The patent changes the sterilization parameter from radioactive ray irradiation to high-pressure steam sterilization. This parameter change eliminates the generation of persistent radicals in the container material, thereby preventing oxidization of amino acid residues during storage while maintaining effective sterilization.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This method significantly reduces protein denaturation and oxidation, maintaining the stability and activity of protein solutions over long-term storage by minimizing radical content and oxygen exposure.
Implementation Method 1
sterilized with high-pressure steam
Implementation Method 2
has a radical content of 2.2×1015 radical/g or less as measured using an electron spin resonance spectrometer
Implementation Method 3
packaged in a substantially oxygen-impermeable packaging material
Implementation Method 4
packaged in oxygen-impermeable materials with deoxygenating agents
Implementation Method 5
packaging material having a light-blocking property
Data Source
AI summary
A medical container for accommodating a protein solution formulation, in which the medical container is formed from a cycloolefin polymer, sterilized with high-pressure steam, and suppresses oxidization of amino acid residues in a protein in a protein solution formulation accommodated in the medical container.