Blister Packaging for Dialyzers with Deformable Recess
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Solution Overview
Problem
Existing filter module/dialyzer packaging systems experience uncontrolled volume reduction during sterilization, leading to relative movements that can damage the sterile barrier, resulting in high material and process costs without ensuring 100% oxygen-free conditions.
Innovation Solution
A sterile filter module/dialyzer packaging unit using a hard/soft blister pack with a plastic molded lower part and a shrink film upper part, where the filter module/dialyzer is fixed by form fit, minimizing air and oxygen, allowing for gamma radiation sterilization with reduced volume reduction and enhanced stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an absorber is used to bind molecular oxygen in the primary packaging, then oxygen-free conditions are achieved for sterilization, but the volume of the packaging reduces uncontrollably causing relative movements that can damage the sterile barrier
Solution Approach 1:
The invention applies preliminary anti-action by providing a deformable recess in the lower part of the packaging that anticipates and compensates for the volume reduction caused by oxygen absorption. The recess is designed to deform in a controlled manner to accommodate the shrinking packaging material, preventing uncontrolled relative movements that could damage the sterile barrier.
Solution Approach 2:
The invention utilizes parameter changes by designing the lower part with a deformable recess that changes its shape and volume in response to the oxygen absorption process. The recess transforms from a larger initial volume to a smaller final volume, matching the packaging material's volume reduction and maintaining stable positioning throughout the sterilization process.
2Strength
If thicker foils are used to counteract volume reduction, then packaging mechanical resilience is improved, but product costs increase
Solution Approach 1:
The invention employs flexible shells and thin films by using a deformable recess in the lower part that can flex and adapt to volume changes. This flexible design eliminates the need for thicker, more expensive foils while maintaining adequate mechanical resilience to protect the sterile barrier during oxygen absorption and sterilization.
Solution Approach 2:
The invention applies parameter changes by modifying the physical state and shape of the recess in the lower part to accommodate volume reduction. Instead of increasing material thickness, the solution changes the geometric parameters of the recess to maintain structural integrity with the same or reduced material quantity.
3Reliability
If an oxygen-reduced atmosphere is used during packaging, then volume reduction is reduced, but 100% oxygen freedom cannot be guaranteed requiring absorber use anyway
Solution Approach 1:
The invention applies preliminary anti-action by pre-designing the deformable recess structure that will handle volume reduction regardless of the oxygen removal method used. This preliminary structural preparation allows the use of simple oxygen-reduced atmosphere packaging without requiring complex additional measures, while still achieving 100% oxygen-free conditions through the addition of a simple absorber.
4Adaptability or versatility
If standardized connectors and protective caps are included on the filter module, then application requirements are met, but packaging complexity and damage risk increase
Solution Approach 1:
The invention employs flexible shells and thin films by using the deformable recess in the lower part to accommodate the standardized connectors and protective caps. The flexible recess adapts to the complex geometry of these components without requiring complex rigid packaging structures, simplifying the overall packaging design while maintaining protection.
Solution Approach 2:
The invention applies local quality by providing targeted protection and accommodation for the standardized connectors and protective caps through the specifically designed deformable recess. The recess provides localized adaptation to these components' shapes and positions, allowing standardized application requirements to be met without increasing overall packaging complexity.
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 packaging securely fixes the filter module/dialyzer, reducing relative movements and maintaining the sterile barrier integrity while lowering production costs by minimizing the oxygen absorber capacity and ensuring efficient sterilization.
Implementation Method 1
the upper film (7) is fixed hermetically sealed to the lower part (6)
Implementation Method 2
binding of molecular oxygen in the closed system of the primary packaging results in a reduction in volume or negative pressure
Implementation Method 3
This is usually done by absorbing the oxygen with a suitable carrier, a so-called getter
Implementation Method 4
Some medical devices, especially filter modules/dialyzers, may need to be sterilized under oxygen-free conditions
Data Source
Figure 1~4
AI summary
The invention relates to a sterile filter module/dialyzer packaging comprising a filter module, preferably a dialyzer (2), sterilely packaged in a primary packaging (1) with a substantially cylindrical central section (23) and a filter module connection (15, 16) formed at the end of the central section (23), wherein the primary packaging (1) is a blister packaging with a plastic molded part forming a receptacle (5) for the filter module (2) as a lower part (6) and an upper film (7) closing the receptacle (5) for the filter module (2) with this, wherein the upper film (7) is hermetically sealed to the lower part (6) and the filter module (2) is fixed at least partially by a form fit.