Smooth film laminated elastomer articles

Inventors

KRIZAN, Jason • Duriez, Douglas R. • Fang, Liang • Drake, Kerry

Assignees

West Pharmaceutical Services Inc

Abstract

An elastomeric article for sealing a container includes an elastomeric body having an external sidewall surface and an external crown surface and a first fluoropolymer film layer having an internal surface and an external surface. The internal surface of the first fluoropolymer film layer is laminated to an entirety of the external sidewall and crown surfaces of the elastomeric body. The external crown surface of the first fluoropolymer film layer includes a drug contact surface configured to contact a drug contained in the container and the external sidewall surface including a sealing surface for contacting an interior surface of the container. The external surface of the first fluoropolymer film layer is substantially free of striations.

Core Innovation

The invention relates to a silicone-free, smooth film-laminated elastomeric container closure in which an elastomeric body has an external sidewall surface and an external crown surface, and a fluoropolymer film layer is laminated to the external sidewall surface and the external crown surface. The fluoropolymer film layer includes a drug contact surface positioned over the external crown surface and configured to contact a drug contained in the container, and a sealing surface positioned over the external sidewall surface and configured to contact an interior surface of the container. The external surface of the fluoropolymer film layer is substantially free of striations.

The invention addresses avoiding silicone oils in container closures, including issues associated with extractables and leachables, outgassing, and regulatory teaching away from silicone use. It further targets container/closure integrity risk in silicone-free systems, where defects and roughness can lead to leakage or gas percolation. A laminated fluoropolymer film is used such that the closure achieves improved integrity while maintaining a lubricious inert barrier over the relevant contact surfaces.

The invention also defines quantitative surface morphology requirements for the sealing surface using surface roughness characterized by peak density, with thresholds that depend on Gaussian filter parameters. The laminated film structure yields a mirror-like, striation-free exterior surface with controlled surface morphology during compression molding and demolding, with reported measurements using confocal/profile roughness and helium leak testing used to show improved closure integrity and surface characteristics, along with improved force performance under dry and wet conditions.

Claims Coverage

The partial content provides three independent claims. Across these independent claims, the main inventive features include an elastomeric sealing body with a laminated fluoropolymer or polymer film layer that provides a drug contact surface and a sealing surface, requiring the film’s external surface to be substantially free of striations, and requiring the sealing surface to meet specified peak-density roughness thresholds when characterized with Gaussian filters of 2.0 microns and 0.08 microns.

Across the independent claims, the coverage centers on an elastomeric container-sealing article in which a film layer is laminated to the elastomer’s external sidewall and external crown surfaces, creating a drug contact surface and a sealing surface. All independent claims require the film’s external surface to be substantially free of striations and require quantitative sealing-surface roughness peak-density thresholds based on Gaussian filtering.

Stated Advantages

Documented Applications