Multilayer Sterilization Test Pack With Precise Embedded Channels
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Solution Overview
Problem
Existing sterilization indicator test packs face challenges in efficiently controlling manufacturing tolerances and achieving continuous, fast production due to thermoforming processes, leading to variations in channel formation and slow batch manufacturing.
Innovation Solution
A multilayer test pack design utilizing a thin-film channel lamina with a recessed channel covered by a seal layer, allowing for precise control of channel dimensions and continuous manufacturing through methods like microreplication, enabling efficient and continuous bonding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If thermoforming processes are used to form channels in sterilization test packs, then the manufacturing process is simple, but the channel dimension tolerances are poor and production is slow
Solution Approach 1:
The test pack structure is divided into separate functional layers: a channel lamina layer that forms the channel network, a seal layer that seals the indicators, and an indicator layer. This segmentation allows each layer to be manufactured independently with high precision using microreplication, then bonded together in a continuous process, resolving the contradiction between precision and productivity.
Solution Approach 2:
The channel lamina is pre-formed with recessed channels using microreplication technology before assembly. This preliminary action ensures precise channel dimensions are achieved in the forming step, and subsequent bonding operations simply join pre-prepared components, maintaining both precision and continuous production capability.
2Productivity
If batch manufacturing is used for sterilization test packs, then manufacturing flexibility is maintained, but production efficiency is low
Solution Approach 1:
The invention enables continuous manufacturing by bonding the channel lamina and seal layer together in an ongoing process rather than batch operations. Multiple layers can be continuously fed and bonded, significantly increasing production efficiency while the modular layer design maintains manufacturing flexibility for different configurations.
3Manufacturing precision
If thick film channels are used in test packs, then manufacturing is easier, but channel tolerance control is poor
Solution Approach 1:
The invention uses thin-film channel lamina where the channel network is formed as a recessed pattern in a thin layer. This thin-film approach, combined with microreplication technology, provides excellent tolerance control for channel dimensions while the flexibility of thin films allows for complex channel configurations that would be difficult with thick sections.
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
The multilayer design achieves high precision in channel dimensions, facilitating reliable sterilization monitoring with minimized pack size and efficient manufacturing processes.
Implementation Method 1
the seal surface is bonded to the bonding surface by thermal bonding or adhesive bonding
Implementation Method 2
the seal surface is bonded to the bonding surface by thermal bonding or adhesive bonding
Data Source
AI summary
The disclosed multilayer test pack comprises a channel lamina to form a recessed channel, and then a seal layer covers the recessed channel to form an embedded channel. By providing the recessed channel in a thin-film channel lamina, the recessed channel tolerances are better controlled. Further, using thin films for the channel lamina, which can be formed into a roll, allows for a continuous unrolling and continuous bonding to a seal layer.