Sterilizing Pre-filled Syringes with Impermeable Protective Containers
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
The challenge lies in sterilizing pre-filled syringes within medical kits without contaminating their contents, particularly when using ethylene oxide, which can penetrate plastic syringe materials and leave toxic residues, posing risks for pediatric and neonatal patients.
Innovation Solution
A process involving a protective container impermeable to moisture and sterilizing agents, housing the pre-filled syringe, and packaging it within a bacterially impermeable package, allowing for convenient sterilization while minimizing the ingress of sterilizing gases, such as ethylene oxide, and its contaminants.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pre-filled syringes are sterilized using ethylene oxide, then sterilization is achieved, but toxic residues contaminate the syringe contents
Solution Approach 1:
The syringe is divided into separate components: the syringe body and the plunger assembly. The plunger assembly is removed before sterilization, allowing the syringe body to be sterilized without contaminating the contents. This segmentation enables selective sterilization of only the necessary components.
Solution Approach 2:
The plunger assembly is extracted from the syringe body before sterilization. This extraction removes the source of contamination (the plunger that would trap ethylene oxide residues) while allowing the syringe body to be properly sterilized. The plunger is reinserted after sterilization to maintain system integrity.
2Reliability
If pre-filled syringes are sterilized using heat or steam, then sterilization is achieved, but heat-sensitive or moisture-sensitive products are damaged
Solution Approach 1:
The plunger assembly is extracted before sterilization, which removes the barrier that would prevent sterilizing agents from reaching the syringe body. This allows use of gentler sterilization methods that won't damage heat-sensitive or moisture-sensitive products while still achieving effective sterilization.
Solution Approach 2:
The sterilization process uses modified parameters (lower temperatures, alternative sterilizing agents) that are compatible with heat-sensitive and moisture-sensitive products. By changing the sterilization parameters rather than using standard high-heat or high-moisture methods, the system achieves sterilization without damaging the contents.
3Reliability
If pre-filled syringes are sterilized using chemical agents, then sterilization is achieved, but residual chemicals remain in the syringe
Solution Approach 1:
The plunger assembly is extracted before chemical sterilization. This extraction creates a pathway for chemical agents to reach and sterilize the syringe body while preventing the chemicals from being trapped in the plunger-syringe interface. The plunger is reinserted after sterilization to maintain system integrity.
Solution Approach 2:
A sterile barrier or protective coating is used as an intermediary between the syringe body and the chemical sterilizing agents. This intermediary allows the chemicals to sterilize the syringe body while preventing direct contact with and contamination of the syringe contents. The barrier is removed or deactivated after 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 approach enables the sterilization of pre-filled syringes in a single step, reducing residual sterilizing agents to acceptable levels, thus ensuring the safety of medical kits for sensitive patient populations and simplifying the sterilization process.
Implementation Method 1
a protective container impermeable to moisture and/or sterilizing agents
Implementation Method 2
chemical sterilization, i.e. the sterilization of devices using ethylene oxide or alternatively nitrogen oxide, ozone, peracetic acid, chlorine, chlorine dioxide, hydrogen peroxide or other materials
Data Source
AI summary
According to the invention, there is provided a medical apparatus including: one or more sterile pre-filled syringe; one or more first protective container including the one or more sterile pre-filled syringe, wherein the one or more first protective container is impermeable to moisture and/or sterilizing agents; a second protective container including one or more medical components and the one or more first protective container; and a package impermeable to bacteria including the second protective container.