Syringe and gasket systems
Inventors
Abrams, Robert S. • Kelly, Kenneth Wade • Taha, Ahmad • Hunt, Benjamin • Lilly, Brian Russell • Kibele, Ralf
Assignees
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Publication Number
US-12179002-B2
Publication Date
2024-12-31
Expiration Date
Abstract
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.
Core Innovation
The invention relates to a silicone oil-free matched syringe and plunger system in which a gasket comprises an elastic material and at least a circumferential outer surface portion carrying a fluoropolymer film. The gasket is formed with laser-formed continuous channels that extend around the entire circumference of the circumferential outer surface of the gasket.
The underlying concept addresses container closure integrity (CCI) and plunger friction-related performance, including break loose force, glide force, and sticktion, over shelf life. The use of the continuous channels in the fluoropolymer film on the gasket outer surface portion is directed to improving liquid CCI over time while maintaining consistent break loose and glide forces, without silicone oil.
A process is described for making the continuous channels in the film residing on the gasket. A portion of one end of a mandrel is inserted into an internal cavity of the gasket, the gasket is secured to the mandrel, and the mandrel with the secured gasket is positioned in proximity to a laser; a laser beam is applied to selected locations on the film surface portion while rotating the mandrel, thereby producing one or more continuous channels extending around the entire circumference of a circumferential outer surface of the gasket.
After production, the document describes post-production inspection and dimensional control, including testing and inspection to verify container closure integrity, plunger-force behavior, and subvisible particle characteristics. The approach includes 100% vision inspection, laser micrometry, and dimensional tolerancing, along with testing using container closure integrity and additional measurements for sub-visible particles.
Claims Coverage
The partial content identifies one independent claim directed to a process for making continuous channels in a film on a circumferential outer surface portion of a gasket, extending around the full circumference. Dependent claims refine the channel and lip geometry and add constraints related to film material, laser position control, and gasket dimensional tolerance and particle-count measurements.
Laser-formed circumferential continuous channels in a gasket film via rotating mandrel
A process comprising inserting a portion of one end of a mandrel into an open cavity of the gasket, securing the gasket to the mandrel, positioning the mandrel and secured gasket in proximity to a laser, and applying a laser beam to selected locations on a surface portion of the film residing on the circumferential outer surface portion of the gasket while rotating the mandrel and secured gasket along the mandrel's longitudinal axis to produce one or more continuous channels in the film, the channels extending around the entire circumference of a circumferential outer surface of the gasket.
Syringe seal with lip feature produced as part of channel geometry
At least one lip can be placed in a tubular syringe barrel to create a seal with the inner surface of the barrel.
Servo-motor-based laser position control relative to mandrel and gasket
The laser position relative to the mandrel and secured gasket is controlled using a servo-motor.
Fluoropolymer film for the gasket surface portion
The film used on the gasket circumferential outer surface portion is a fluoropolymer film.
Dimensional tolerance and particle-count limits for the gasket
Using a gasket that has specified dimensional tolerances and contains fewer than 300 particles of 2 micron size or larger, measured by light obscuration (LO) or microflow imaging (MFI).
Overall claim coverage centers on forming circumferential continuous channels in a film on a gasket outer surface portion by laser beam application while rotating a mandrel, with dependent refinements that add lip-based sealing for a tubular syringe barrel, servo-motor laser positioning control, use of a fluoropolymer film, and gasket dimensional tolerance plus sub-visible particle-count constraints.
Stated Advantages
Improved container closure integrity (CCI) for liquid over time.
Maintains consistent break loose force and glide force over shelf life.
Provides silicone oil-free performance for a matched syringe and plunger system.
Documented Applications
A matched syringe and plunger system using an elastomeric gasket with a fluoropolymer film and laser-formed continuous channels to improve container closure integrity (CCI) and maintain plunger-force performance over shelf life.
Using produced lip features placed in a tubular syringe barrel to create a seal with the inner surface of the barrel.
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