Laser-Channel Syringe Gaskets for CCI and Low Plunger Force
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Solution Overview
Problem
Existing syringe systems face challenges in maintaining container closure integrity (CCI) and achieving low plunger force requirements due to the use of rubber gaskets that require high forces to displace, leading to user discomfort and potential drug degradation from silicone lubricants.
Innovation Solution
The development of a gasket with continuous channels created by a precise laser cutting process, which eliminates the need for silicone lubricants and enhances the sealability and CCI of the syringe system, while maintaining consistent plunger force over time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rubber gasket is pressed against the barrel to maintain container closure integrity, then CCI/liquid or gas-tightness is improved, but the force necessary to advance the gasket increases
Solution Approach 1:
The patent changes the surface energy parameters of the gasket material by incorporating low surface energy compounds (such as fluorinated compounds or silicone oils) into the rubber matrix. This modification reduces the coefficient of friction between the gasket and barrel surfaces, allowing the gasket to maintain adequate seal pressure while requiring lower plunger forces for advancement. The surface energy of the gasket is specifically tuned to achieve optimal balance between sealing and mobility.
2Force
If flowable lubricant is used between the gasket and the barrel to reduce friction, then plunger force is improved, but the lubricant can mix and interact with the drug product degrading the drug
Solution Approach 1:
The patent applies lubricating properties locally to the gasket surface through incorporation of lubricious compounds within the gasket material matrix itself, rather than using separate flowable lubricants in the barrel-gasket interface. The lubricating agents are bound within the gasket structure, providing localized friction reduction at the contact surfaces while preventing migration into the drug product. This creates a gradient where the inner surface has lubricating properties without compromising drug integrity.
Solution Approach 2:
The patent uses the gasket material itself as an intermediary carrier for lubricating compounds. Instead of direct contact between flowable lubricant and drug product, the lubricating agents are embedded within the gasket matrix, which acts as a barrier and controlled release medium. This intermediary structure provides the necessary lubrication function while preventing harmful interactions with the enclosed drug product.
3Reliability
If the gasket is made tighter to maintain adequate CCI, then container closure integrity is improved, but the force necessary to advance the gasket increases
Solution Approach 1:
The patent modifies the surface energy and friction characteristics of the gasket material by incorporating low surface energy compounds. This parameter change allows the gasket to maintain higher compression forces for improved sealing while simultaneously reducing the coefficient of friction against the barrel. The dual effect enables tighter sealing without proportionally increasing the force required for plunger advancement.
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 improved syringe and gasket system achieves superior CCI, reduces subvisible particle formation, and maintains drug efficacy and sterility over the product's shelf life, with consistent plunger force and reduced user discomfort.
Implementation Method 1
applying a laser beam emitted from the laser to one or more selected locations on a surface portion of the film residing on the circumferential outer surface portion of the gasket while rotating the mandrel and the secured gasket along the mandrel's longitudinal axis to produce one or more continuous channels in the film
Data Source
AI summary
A process for producing gaskets with an improved channel for use in matched syringe and plunger systems, preferably prefilled plastic syringe systems. In particular, an improved process for making and inspecting continuous channels in a gasket film by laser treatment. The gaskets are useful in matched syringe and plunger systems with high and consistent container closure integrity (CCI), and consistent break loose and glide forces over time, and sealability.