Welded Sealing Arrangement for Sterile Container Puncture Sites
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Solution Overview
Problem
Existing container sealing arrangements, particularly those using rubber inserts or thermoplastic elastomers, face issues with microbial contamination and fluid ingress due to gaps formed during the sealing process, which complicates sterilization and limits their suitability for multiple uses.
Innovation Solution
A sealing arrangement featuring a welded or bonded connection of the sealing material to the container or cap, using thermoplastic elastomers, eliminates gaps by ensuring a direct contact with the container surface, thereby preventing bacterial migration and fluid ingress, and allows for sterilization without adhesives or fillers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If rubber inserts are pressed onto the container head by mechanical structure, then the sealing function is provided, but gaps always remain between the insert and container head, leading to microbial contamination and fluid ingress
Solution Approach 1:
The patent replaces the mechanical pressing system with a thermal bonding system. The sealing material is bonded to the container head using heat and pressure in a welding process, eliminating the need for mechanical retention structures that create gaps. This thermal bonding approach creates a gap-free connection that prevents microbial contamination and fluid ingress while maintaining the sealing function.
2Reliability
If thermoplastic elastomer sealing material is applied to fit snugly along the container wall, then sealing is improved, but gaps cannot be avoided reliably and fluid may be drawn in by capillary action
Solution Approach 1:
The patent replaces mechanical fitting with thermal welding. The sealing material is welded directly to the container head surface, creating a monolithic structure without gaps. This eliminates capillary action pathways that would otherwise allow fluid to be drawn into the sealing interface during suction processes.
Solution Approach 2:
The patent changes the bonding mechanism from mechanical (contact pressure) to thermal (heat and pressure during welding). This parameter change transforms the sealing material-container head interface from a potential gap-prone mechanical joint to a fused, gap-free welded connection that prevents fluid ingress through capillary action.
3Reliability
If autoclave process is used to sterilize the contact surface, then sterility is ensured, but the container system is only suitable for thermally stable products that can withstand high temperatures
Solution Approach 1:
The patent performs sterilization during the welding process itself, before the container is filled or sealed. The welding heat simultaneously bonds the sealing material to the container head and sterilizes the contact surface, eliminating the need for a separate autoclave process. This preliminary sterilization allows the container to be used with thermally sensitive products that cannot withstand autoclave temperatures.
4Adaptability or versatility
If rubber inserts are used in BFS containers, then resealing after opening becomes possible, but the manufacturing process becomes substantially more costly and sterilizing the rubber parts is necessary
Solution Approach 1:
The patent uses sealing material made from the same polymer family as the container (polyolefins), creating a homogeneous material system. This eliminates the need for separate rubber insert sterilization processes and reduces manufacturing complexity. The sealing material can be processed and bonded in the same production line as the container, maintaining cost-effectiveness while providing resealing capability.
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 solution enhances sterility protection by eliminating gaps and reducing the risk of contamination, enabling the container to be reused without the need for additional disinfection steps and maintaining sterility over extended periods.
Implementation Method 1
The invention is based on the idea that the sealing material is fixedly connected to the container or to a container part, such as a cap, by a welded or bonded connection
Implementation Method 2
The invention is based on the idea that the sealing material is fixedly connected to the container or to a container part, such as a cap, by a welded or bonded connection
Implementation Method 3
The puncture site in the sealing material can be sealed off again after a product has been removed from the container
Data Source
AI summary
A sealing arrangement is for a container (1) and/or container part, such as a closure cap placed onto the container (1). The interior of the container (1) is used to accommodate a medium, particularly a fluid bottled in a sterile manner, which can be removed from the container (1) by a removal device such as a syringe needle. The removal device penetrates sealing material (9) connected to the container. The sealing material (9) is fixedly connected to the outside (7) of the container (1) and/or container parts facing the environment by a fused and/or adhesively bonded connection.