Multilayer Film with Polyamide 612 for Medical Pouch Bubble Prevention
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Solution Overview
Problem
Medical solution pouches face challenges in preventing the formation of bubbles or foam during high-temperature autoclaving, which can lead to contamination and failure in meeting sterility standards.
Innovation Solution
A multilayer film incorporating polyamide 612, calcium stearate, or their combination in one or more layers, along with fatty amides, to prevent the migration of film components into the solution, thereby reducing or eliminating foam formation, while maintaining essential properties like heat-resistance, optical clarity, and mechanical strength.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional multilayer films are used for medical pouches, then heat-resistance and mechanical strength are achieved, but bubbles or foam form in the solution during autoclaving
Solution Approach 1:
The patent extracts and removes the harmful component (foam-blowing agents) from the film composition. By eliminating these specific additives that cause bubble formation during autoclaving, the invention prevents the harmful effect while maintaining the necessary heat-resistance and mechanical properties through alternative film formulations.
Solution Approach 2:
The patent changes the chemical composition parameters of the film by selecting specific polymer materials and their ratios that do not generate foam during high-temperature sterilization. This involves adjusting the film's compositional parameters to achieve both heat-resistance and bubble-free performance during autoclaving.
2Manufacturing precision
If film components migrate into the solution during autoclaving, then foam formation occurs, but this compromises solution purity and sterility
Solution Approach 1:
The invention extracts and eliminates the migrating components (foam-blowing agents) from the film structure. By removing these specific substances that migrate into the solution during autoclaving, the patent prevents both foam formation and solution contamination, thereby maintaining manufacturing precision and solution purity.
Solution Approach 2:
The patent uses barrier layers or intermediate layers in the multilayer film structure that prevent the migration of film components into the medical solution. These intermediary layers act as protective barriers during autoclaving, stopping the transfer of harmful substances while allowing the film to maintain its heat-resistance properties.
3Ease of manufacture
If standard film formulations are used, then heat-sealing and abuse-resistance are provided, but the bubble test is failed
Solution Approach 1:
The patent changes the compositional parameters of the film by selecting specific heat-sealable polymers and their formulations that do not contain foam-blowing agents. This parameter adjustment allows the film to maintain ease of heat-sealing manufacture while achieving compliance with the bubble test requirement for medical pouches.
Solution Approach 2:
The invention uses composite multilayer film materials that combine heat-sealable layers with barrier layers. This composite structure provides both the ease of manufacture through heat-sealing capability and the bubble test compliance by using materials that do not generate foam during autoclaving.
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 film effectively passes the bubble test as per the Chinese State Drug Package Container Material Standard, ensuring the medical solution pouches remain sterile and contamination-free, with reduced foam formation and no blooming of additives during autoclaving.
Implementation Method 1
The inventors have discovered that the presence of polyamide 612 or calcium stearate, or a combination thereof in one or more layers of the film can help prevent residuals and other components of the film from migrating through the film and into the contents of the pouch.
Implementation Method 2
The primary functions of the outer layer are to provide heat-resistance to the pouch during heat-sealing and heat-sterilization
Implementation Method 3
Steam is generally used as the heat-transfer medium. Heat-sterilization is normally performed by the manufacturer and/or packager of the medical solution prior to sending the packaged medical solution to the end user
Data Source
AI summary
The present invention provides a multilayer film for forming medical solution pouches that help prevent or reduce the presence of bubbles or foam in the solution after heat sterilization. In particular, the present invention provides a multilayer film for forming medical solution pouches that are capable of passing the bubble test as set forth in the Chinese State Drug Package Container Material Standard No. YBB00112005. In particular, the present invention provides a multilayer film in which polyamide 612 or calcium stearate component has been incorporated as an anti-foaming agent. The presence of polyamide 612 or calcium stearate in one or more layers of the film helps prevent the formation of foam in the solution after heat sterilization.