Piercable Closure With Permeable Membrane for Autoclave Sterilization
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Solution Overview
Problem
Existing pierceable closures for medication containers require clean room production to ensure sterility due to impermeable metal or aluminum foils, limiting sterilization methods to autoclaving, which can cause deformation and uneven sealing, and do not allow for adequate sterilization of the area underneath the foil.
Innovation Solution
A pierceable closure with a sterile cover made of metal or aluminum foil that includes a water vapor-permeable film or membrane within the fastening area, allowing moisture to pass through for sterilization and maintaining stability against temperature deformations, enabling autoclaving without additional work steps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If metal or aluminum foil is used as sterile cover, then stability against temperature deformations and high sealing temperature capability are improved, but sterility of the area underneath the foil cannot be ensured
Solution Approach 1:
The sterile cover is segmented into two functional layers: an outer metal or aluminum foil layer providing mechanical stability and temperature resistance, and an inner water vapor-permeable membrane layer enabling sterilization. This segmentation allows each layer to perform its specific function without compromising the other.
Solution Approach 2:
The sterile cover uses a composite structure combining metal or aluminum foil with a water vapor-permeable membrane. This composite material approach integrates the advantages of both materials: the foil provides dimensional stability and heat resistance, while the membrane allows moisture and steam penetration for effective autoclaving sterilization.
2Reliability
If foil without aluminum or metal content is used, then environment for sterilization can be created, but mechanical stability and cold deformability are reduced
Solution Approach 1:
The invention combines a metal or aluminum foil base layer with a water vapor-permeable membrane overlay. The foil provides the necessary mechanical strength and stability, while the membrane layer enables sterilization by allowing moisture and steam to pass through, thus achieving both mechanical integrity and sterilization capability.
3Reliability
If clean room production is used to ensure sterility, then adequate sterility is achieved, but production complexity and cost increase
Solution Approach 1:
The sterile cover is designed with an integrated water vapor-permeable membrane that enables sterilization to be performed as a preliminary action during the autoclaving process. This eliminates the need for complex clean room production environments, as sterility can be achieved through standard autoclaving procedures performed before final product assembly.
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 the area underneath the foil during autoclaving, maintains stability against temperature deformations, and allows for high sealing temperatures, producing clear and leak-free sealing seams while maintaining the advantages of metal or aluminum foils.
Implementation Method 1
which is sealed against germs with a water vapor-permeable foil or membrane. During the autoclaving process, the moisture can pass through the opening in the aluminum foil and the water vapor-permeable membrane arranged there
Implementation Method 2
the advantages of metal or aluminum foils and water vapor-permeable foils are combined. During the autoclaving process, the moisture can pass through the opening in the aluminum foil... good plastic cold deformation of the cover is maintained, that is to say, for example, holding tabs for pulling off the film can experience the desired permanent deformation after folding
Data Source
AI summary
A piercable closure (1), such as a cap for a bottle for infusion solutions, has a peelable and sealable foil as a sterile cover (3) of the piercable location (2), which is configured as a metal or aluminum foil, and which is connected or sealed to the closure (1) in a peelable at a distance around the piercable location (2). This cover (3) has at least one aperture or one opening (5) within the fastening region (4) to which the same is applied, wherein the aperture or opening is closed in a sterile manner by means of a foil or membrane (6) that is permeable to water vapor such that the closure (1) can be sterilized by means of autoclaving even beneath this cover (3) (FIG.).