Atmospheric Plasma Treatment for Low-Leachables Polymer Surfaces
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Solution Overview
Problem
Conventional flexible and disposable polymer bags used in the bioprocess industry for sterile fluid storage and transport can contaminate biological materials due to extractables and leachables from the polymers, especially when handling caustic materials or processing at elevated temperatures, which affects the quality and sterility of the contents.
Innovation Solution
The method involves treating a flexible polymer substrate with an atmospheric pressure plasma beam from an inert gas with a power greater than 90 W, scanning the plasma over the substrate surface to reduce the concentration of extractable and leachable compounds, such as Bis(2,4-ditert-Butylphenyl) phosphate (bDtBPP), by forming a treated substrate surface with reduced overall extractable and leachable content.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If conventional flexible polymer bags are used for sterile fluid storage and transport, then the bags are inexpensive and adaptable, but they contaminate biological materials via extractables and leachables from the polymers
Solution Approach 1:
The patent applies atmospheric pressure plasma treatment to modify the surface parameters of the polymer substrate. By controlling plasma power (>90 W), gas composition (inert gas), and treatment duration, the surface chemical composition is changed to reduce extractables and leachables while maintaining the bulk polymer properties and bag functionality
Solution Approach 2:
The patent replaces conventional chemical treatments or high-energy sterilization methods with atmospheric pressure plasma treatment. This substitution provides a milder, more controlled surface modification process that reduces harmful extractables without compromising the polymer integrity or requiring complex chemical handling
2Productivity
If the polymer bags are processed at elevated temperatures to improve manufacturing, then manufacturing efficiency increases, but the extractables and leachables from polymers increase, affecting biological material quality
Solution Approach 1:
The patent applies plasma treatment as a preliminary surface modification step before the polymer bags come into contact with biological materials. This pre-treatment reduces the concentration of extractables and leachables on the surface, preventing contamination during subsequent high-temperature processing or biological applications
Solution Approach 2:
The plasma treatment changes the surface parameters of the polymer by introducing functional groups and cross-linking surface molecules. This creates a more stable surface layer that resists releasing extractables and leachables even when the bulk material is exposed to elevated temperatures during manufacturing or use
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 approach results in a treated polymer substrate surface with a greater than 70% reduction in total extractable and leachable content compared to untreated surfaces, enhancing the biocompatibility and sterility of the bags by minimizing harmful compounds that can contaminate biological materials.
Implementation Method 1
establishing an atmospheric pressure plasma beam from an inert gas using a power of greater than about 90 W, directing the plasma beam toward a surface of the flexible polymer substrate
Data Source
AI summary
A method for treating a flexible plastic substrate is provided herein. The method includes establishing an atmospheric pressure plasma beam from an inert gas using a power of greater than about 90W, directing the plasma beam toward a surface of the flexible polymer substrate, and scanning the plasma beam across the surface of the polymer substrate to form a treated substrate surface.