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 of manufacturing a medical component includes molding a first member of the medical component from an elastomeric material. The first member includes a first end defined by a closed base wall, an opposing second end which is an open end, a sidewall extending between the first and second ends, and an internal recess to receive at least one electronic device. The method further includes positioning the electronic device within the recess of the first member to form an assembly, such that the electronic device is received in an inverted open cavity defined by the sidewall. The method further includes applying a protective film on the second end of the first member, such that the protective film covers an exposed surface of the electronic device. In addition, the method includes overmolding the assembly with the elastomeric material to form the medical component having the electronic device embedded therein.

Abstract: An assembly for a container to be filled with a pharmaceutical drug is provided. The assembly includes a first component and a second component. The first component has at least one electronic device fully embedded therein, a first end provided with a first engagement feature and an opposing second end. The second component has a second engagement feature configured to engage the first engagement feature of the first component.

Abstract: A method of manufacturing a medical component includes molding a first member of the medical component from an elastomeric material. The first member includes a first end defined by a closed base wall, an opposing second end which is an open end, a sidewall extending between the first and second ends, and an internal recess to receive at least one electronic device. The method further includes positioning the electronic device within the recess of the first member to form an assembly, such that the electronic device is received in an inverted open cavity defined by the sidewall. The method further includes applying a protective film on the second end of the first member, such that the protective film covers an exposed surface of the electronic device. In addition, the method includes overmolding the assembly with the elastomeric material to form the medical component having the electronic device embedded therein.

Abstract: A system for manufacturing elastomeric components is provided. The system may include a molding station having a mold configured to receive an elastomeric material, form a pad that includes a plurality of untrimmed elastomeric components, and cure the pad. The system may further include an automated marking station comprising a laser and a camera. The automated marking station may be configured to remove the cured pad from the molding station, present the cured pad to the laser to form a mark on each of the untrimmed elastomeric components, and present the cured pad to the camera to capture an image of each mark. A process for manufacturing the elastomeric components is also provided.

Abstract: A method of manufacturing a medical component includes preparing a first sheet of an elastomeric material, arranging at least one electronic device in the first sheet of elastomeric material to obtain an elastomeric preform, and arranging the elastomeric preform in a mold and molding the elastomeric preform therein to cure the elastomeric material and form the medical component having the at least one electronic device embedded therein.

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 plunger assembly is configured for slidable advancement through a reservoir of a vessel containing a material to be administered. The plunger assembly includes a plunger rod having a distal end configured to be inserted into the reservoir. An elastomeric plunger extending from the distal end of the plunger rod is configured to sealingly engage a sidewall of the reservoir. At least one printed circuit board is embedded within the plunger, and at least one electronic component is electrically connected with the at least one printed circuit board.

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 medical component is provided which includes a first portion formed of a first elastomeric material having at least one taggant embedded or incorporated therein, and a second portion formed of a second elastomeric material. The at least one taggant has a first diffusivity relative to the first elastomeric material and a second diffusivity relative to the second elastomeric material. The second diffusivity is less than the first diffusivity.

Abstract: A medical device component is provided. The medical device component may include a body having a first surface being at least partially formed from a markable material having a first color, the markable material having a characteristic that an area exposed to laser irradiation of a predetermined wavelength of ultraviolet light changes to a second color different from the first color; a film covering at least a portion of the first surface of the body, the film having a transmittance at the predetermined wavelength of ultraviolet light of at least 5%; and a visible mark on the markable material at the first surface of the body covered by the film. The visible mark may include one or more areas of the markable material at the first surface having the second color. Methods of manufacturing the medical device component are also provided.

Abstract: A plunger assembly is configured for slidable advancement through a reservoir of a vessel containing a material to be administered. The plunger assembly includes a plunger rod having a distal end configured to be inserted into the reservoir. An elastomeric plunger extending from the distal end of the plunger rod is configured to sealingly engage a sidewall of the reservoir. At least one printed circuit board is embedded within the plunger, and at least one electronic component is electrically connected with the at least one printed circuit board.

Abstract: A medical component is provided which includes a first portion formed of a first elastomeric material having at least one taggant embedded or incorporated therein, and a second portion formed of a second elastomeric material. The at least one taggant has a first diffusivity relative to the first elastomeric material and a second diffusivity relative to the second elastomeric material. The second diffusivity is less than the first diffusivity.

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: An assembly for a container to be filled with a pharmaceutical drug is provided. The assembly includes a first component and a second component. The first component has at least one electronic device fully embedded therein, a first end provided with a first engagement feature and an opposing second end. The second component has a second engagement feature configured to engage the first engagement feature of the first component.

Abstract: A method of manufacturing a medical component includes preparing a first sheet of an elastomeric material, arranging at least one electronic device in the first sheet of elastomeric material to obtain an elastomeric preform, and arranging the elastomeric preform in a mold and molding the elastomeric preform therein to cure the elastomeric material and form the medical component having the at least one electronic device embedded therein.