Blister Packaging Pressure Compensation for Sterile Barrier Integrity
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Solution Overview
Problem
Existing filter module/dialyzer packaging systems experience uncontrolled volume reduction due to oxygen absorption, 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 hard blister packaging design with a pressure compensation section that deforms to accommodate volume changes while maintaining overall stability, allowing for precise adaptation to the filter module/dialyzer shape and eliminating relative movements, thereby ensuring the integrity of the sterile barrier.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a getter is used to absorb oxygen in the primary packaging, then oxygen-free conditions are achieved, but the packaging volume reduces uncontrollably causing relative movements that can damage the sterile barrier
Solution Approach 1:
The patent introduces a pressure compensation section with specifically reduced wall thickness (0.5-2 mm) in localized areas of the blister packaging, while other sections maintain normal thickness (1-3 mm). This local differentiation allows controlled volume adjustment in specific regions without compromising the overall structural integrity and sterile barrier function of the packaging.
Solution Approach 2:
The patent changes the physical parameter of the packaging material by creating sections with different wall thicknesses. The pressure compensation section has reduced thickness (0.5-2 mm) compared to other sections (1-3 mm), enabling these areas to deform and accommodate volume changes caused by oxygen absorption, while maintaining overall packaging stability.
2Strength
If thicker foils are used to prevent volume reduction, then packaging strength is improved, but material costs and process costs increase
Solution Approach 1:
Instead of uniformly increasing foil thickness throughout the packaging, the patent applies thicker foil (1-3 mm) only where structurally necessary, while using thinner foil (0.5-2 mm) in pressure compensation sections. This localized approach maintains packaging strength where needed while reducing material costs in areas where flexibility is required.
Solution Approach 2:
The patent divides the blister packaging into multiple sections with different thickness characteristics: stable sections with normal thickness for structural support, and pressure compensation sections with reduced thickness for volume adjustment. This segmentation allows the packaging to achieve both strength and cost-effectiveness by optimizing material usage in different functional zones.
3Reliability
If an oxygen-reduced atmosphere is used during packaging, then oxygen absorption is reduced, but 100% oxygen-free conditions cannot be guaranteed
Solution Approach 1:
The patent creates an inert environment within the primary packaging by using a getter to actively absorb oxygen, achieving 100% oxygen-free conditions necessary for sterilization. The pressure compensation mechanism allows this oxygen absorption process to occur without compromising packaging integrity, thereby ensuring complete oxygen removal while maintaining sterile barrier function.
4Stability of the object's composition
If trays are used to provide form fit, then packaging stability is improved, but device complexity and material costs increase
Solution Approach 1:
The patent merges the functions of the blister packaging and the tray into a single integrated structure. The molded blister itself provides the form-fit and stability functions that would otherwise require a separate tray, while the pressure compensation sections enable volume adjustment without additional components. This consolidation reduces packaging structure complexity and material costs while maintaining stability.
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 solution minimizes damage to the sterile barrier, reduces manufacturing costs by eliminating the need for trays, and enables efficient automation and stackability, ensuring the sterile integrity of the packaging during storage and transportation.
Implementation Method 1
a getter (17) arranged in the receiving space (5) for absorbing oxygen
Data Source
Figure 1~5
AI summary
The invention relates to a sterile packaging unit of a medical filter module, comprising a filter module (2) sterilely packaged in a primary packaging (1), wherein the primary packaging (1) is designed as a blister pack with a molded part (6) having a receiving space (5) for the filter module (2) and a lid part (7) arranged on the molded part (6) and hermetically sealing the receiving space (5), wherein the primary packaging (1) has a getter (17) for binding molecular oxygen present in the receiving space (5) and the filter module (2) is mounted by positive locking against the molded part (6).