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.

Abstract: A container for storing a pharmaceutical composition includes a body portion having an elastomeric material, and an inner lining having a thermoplastic material covering at least a portion of an inner surface of the body portion. The container forms an internal chamber for storing the pharmaceutical composition, where the internal chamber is bounded by the inner surface of the body portion. The inner lining provides a barrier between the elastomeric material and the pharmaceutical composition, thus protecting the pharmaceutical composition. Associated methods of storing the pharmaceutical composition within the container, as well as manufacturing the container, are also described.

Abstract: A container for storing a pharmaceutical composition includes a body portion having an elastomeric material, and an inner lining having a thermoplastic material covering at least a portion of an inner surface of the body portion. The container forms an internal chamber for storing the pharmaceutical composition, where the internal chamber is bounded by the inner surface of the body portion. The inner lining provides a barrier between the elastomeric material and the pharmaceutical composition, thus protecting the pharmaceutical composition. Associated methods of storing the pharmaceutical composition within the container, as well as manufacturing the container, are also described.

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.

Abstract: A method for manufacturing at least one elastomeric article is provided. The method includes placing into a mold an assembly of an uncured elastomeric sheet, a first film fully covering the elastomeric sheet and a second film covering the first film, such that the second film is in contact with and positioned between the first film and an interior surface of the mold. The method further includes curing the assembly in the mold, such that the first film is laminated onto the elastomeric sheet thereby forming the at least one elastomeric article.

Abstract: A method for manufacturing at least one elastomeric article is provided. The method includes placing into a mold an assembly of an uncured elastomeric sheet, a first film fully covering the elastomeric sheet and a second film covering the first film, such that the second film is in contact with and positioned between the first film and an interior surface of the mold. The method further includes curing the assembly in the mold, such that the first film is laminated onto the elastomeric sheet thereby forming the at least one elastomeric article.

Abstract: A multi-material, cryogenic, elastomeric closure is provided for sealing a container for samples of cryophilic biological materials, pharmaceuticals or the like. The closure includes at least one cryophilic elastomer having a glass transition temperature (Tg) below the cryogenic temperature to which the sample is to be subjected and at least one non-cryophilic elastomer having a Tg above the cryogenic temperature. The cryophilic and non-cryophilic elastomers are present in such a manner as to maintain a complete seal of the container opening at the cryogenic temperature.