Sterile Packing for Syringe Components Using Porous Rigid Container
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Solution Overview
Problem
Current sterilization methods for syringe components, such as gamma radiation and water vapor sterilization, face challenges in ensuring perfect sterilization performance during transport and storage, and maintaining the integrity of the packaging, particularly for syringe manufacturers who rely on specialized subcontractors.
Innovation Solution
A sterile packing system comprising a rigid container with multiple small holes and a porous, non-rigid material for water vapor sterilization, sealed in a flexible airtight envelope, which allows for effective diffusion of sterilization fluid and maintains sterility during transport, and includes a connection ring for aseptic transfer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If gamma radiation sterilization is used, then sterilization is achieved, but specialized subcontractors are required and manufacturing complexity increases
Solution Approach 1:
The patent replaces gamma radiation sterilization with water vapor sterilization, substituting a complex industrial sterilization system with a simpler thermal sterilization process that can be performed in-house without specialized subcontractors
Solution Approach 2:
The invention changes the sterilization parameter from radiation to water vapor temperature and humidity control, allowing sterilization to be performed using conventional autoclave equipment rather than specialized radiation facilities
2Adaptability or versatility
If flexible packing is used, then packing adaptability is improved, but sterilization fluid penetration and sterilization performance are compromised
Solution Approach 1:
The patent applies different material properties to different parts of the packaging system: the outer envelope uses flexible material for adaptability, while the inner container uses rigid porous material optimized for sterilization fluid penetration, creating local quality differentiation that satisfies both requirements
Solution Approach 2:
The invention uses a composite packaging structure combining flexible outer envelope material with rigid inner container material having specific porosity characteristics, creating a multi-material system that simultaneously provides adaptability and sterilization effectiveness
3Strength
If rigid container is used, then packing integrity is improved, but sterilization fluid diffusion is restricted
Solution Approach 1:
The patent employs a rigid porous container material that maintains structural integrity while providing controlled porosity for water vapor sterilization fluid diffusion, simultaneously satisfying both mechanical strength and sterilization effectiveness requirements
4Object-affected harmful factors
If non-porous packing material is used, then microbial contamination is blocked, but sterilization fluid penetration is prevented
Solution Approach 1:
The invention uses porous packaging material with controlled pore size that allows water vapor sterilization fluid to penetrate through while maintaining barrier properties against microbial contamination, resolving the contradiction between sterilization access and contamination protection
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
Ensures effective sterilization of syringe components, preserves the integrity of the packed items, and immediately indicates any loss of sterility or packaging integrity, enhancing the efficiency and reliability of the sterilization process.
Implementation Method 1
The material of said at least one first membrane comprises pores whereof the size can go from 2 to 15 microns... allow a sufficient diffusion of the sterilization fluid inside said non-rigid part
Implementation Method 2
creating a vacuum inside said at least one envelope, and sealing this at least one envelope around the container while the vacuum inside said at least one envelope is maintained
Implementation Method 3
sterilizing the container using said sterilization fluid... preferred to the radiation sterilization method because it is well-received by the pharmaceutical industry
Data Source
Figure 1~4
Figure 5~7
Figure 8~9
AI summary
This sterile packing includes: - a container (2) for holding the at least one object (5) to be sterilized and having an inlet opening (11 ) and a discharge opening (13) via which said at least one object (5) may pass into and out of said container (2), said container (2) comprising a rigid part (6) having a bored peripheral wall with a multitude of small holes (10) having dimensions lower than those of the said at least one object (5), and a non-rigid part (7) in a material porous to the sterilizing fluid and non-porous to microbial contamination, said non-rigid part (7) being able to contain said rigid part (6) and to be sealed thereon; and - at least one envelope (4) made in a flexible and airtight material, which is vacuum sealing fitted on said container (2).