Apparatus for molding and filling a container having a container body defining an opening in communication with an interior chamber for receiving a substance therein, and a container closure including stopper receivable within the opening for sealing the opening and substance received in the contain
Apparatus for molding and filling a container having a container body defining an opening in communication with an interior chamber for receiving a substance therein, and a container closure including stopper receivable within the opening for sealing the opening and substance received in the container. A mold includes within the aseptic chamber plural mold cavities shaped to form the container closure and container body, and substantially sterile surfaces extending about and contiguous to the peripheries of the mold cavities. An assembly device including end-of-arm tooling having an engaging portion engageable with each of the container body and container closure is movable relative to the mold to engage and de-mold the substantially sterile container closure and container bodies from the mold cavities. Flexible barriers are coupled to the mold and the tool to substantially prevent the passage of contaminants from the molding machine and tool therethrough.
대표청구항▼
What is claimed is: 1. A method for molding and filling a container having a container body defining an opening in communication with an interior chamber for receiving a substance therein, and a container closure including a stopper for sealing the opening and substance received in the container, c
What is claimed is: 1. A method for molding and filling a container having a container body defining an opening in communication with an interior chamber for receiving a substance therein, and a container closure including a stopper for sealing the opening and substance received in the container, comprising the following steps: (a) providing at least one barrier enclosure defining at least one aseptic chamber; at least one mold including within at least one aseptic chamber at least one first mold cavity shaped to form at least one of a container body and a container closure; and at least one tool including a tool engaging portion located within at least one aseptic chamber and movable relative to the at least one mold; (b) molding in the at least one first mold cavity at least one of a container body and container closure; (c) opening the mold to de-mold the at least one of a molded container body and container closure; (d) maintaining at least one first surface of the mold extending about the first mold cavity substantially sterile at least during opening of the mold to prevent any contaminants from contacting the at least one of a molded container body and container closure during de-molding thereof; (e) directing a flow of sterile air into the at least one aseptic chamber, including into a space formed between opposing surfaces of the mold during opening thereof, and across the at least one first surface of the mold and any exposed surface of the at least one of a container body and container closure; (f) moving the tool engaging portion of the tool into the space formed between opposing surfaces of the mold, engaging with the tool engaging portion the at least one of a molded container body and container closure and de-molding same with the tool engaging portion, and directing a flow of sterile air over at least the tool engaging portion and at least one of a molded container body and container closure during de-molding thereof; (g) providing at least one first flexible barrier coupled to the mold between the at least one first sterile surface and a molding machine and substantially preventing the passage of contaminants from the molding machine therethrough; (h) providing at least one second flexible barrier coupled to the tool between the at least one engaging portion and a base portion of the tool and substantially preventing the passage of contaminants from the base portion of the tool therethrough; (i) assembling at least one of a sterile container body and container closure to the other into a sealed, empty sterile container; and (j) penetrating the stopper and introducing a substance therethrough and into the interior chamber of the container, and thermally resealing a penetrated region of the stopper. 2. A method as defined in claim 1, further comprising maintaining the at least one first surface of the mold extending about the first mold cavity substantially sterile by heating said at least one surface to a temperature sufficient to destroy any germs thereon. 3. A method as defined in claim 1, further comprising the step of assembling with the tool within at least one aseptic chamber the substantially sterile container closure and container body into a sealed, empty sterile container, and transferring with the tool the container to at least one of a transfer station and a needle filling and thermal resealing station. 4. Apparatus for molding and filling a container having a container body defining an opening in communication with an interior chamber for receiving a substance therein, and a container closure including a stopper for sealing the opening and substance received in the container, comprising: at least one barrier enclosure defining at least one aseptic chamber; at least one mold including within at least one aseptic chamber at least one first mold cavity shaped to form at least one of the container closure and container body, and at least one first substantially sterile surface extending about the at least one first mold cavity; at least one tool located within at least one aseptic chamber and including an engaging portion engageable with at least one of a container body and container closure located within the at least one first mold cavity, wherein at least one of the first mold cavity and tool is movable relative to the other for engaging and de-molding at least one of a substantially sterile container closure and container body from the at least one first mold cavity; at least one source of sterile air in fluid communication with the at least one aseptic chamber and directing a flow of sterile air into the aseptic chamber and over the first sterile surface for maintaining the sterility of said surface and the container closure and container body during de-molding thereof; at least one first flexible baffler coupled to the mold between the at least one first sterile surface and a molding machine and substantially preventing the passage of contaminants from the molding machine therethrough; at least one second flexible barrier coupled to the tool between the at least one engaging portion and a base portion of the tool and substantially preventing the passage of contaminants from the base portion of the tool therethrough; and a needle filling and thermal resealing station configured to receive a sealed, empty sterile container, and including (i) at least one needle that is movable between a first position for penetrating the stopper and introducing a substance from the needle therethrough and into the interior chamber of the container body, and a second position spaced away from the stopper; and (ii) a thermal source for thermally sealing a needle penetrated region of the stopper upon withdrawal of the needle therefrom. 5. Apparatus as defined in claim 4, wherein the at least one mold includes within at least one aseptic chamber at least one first mold cavity shaped to form the container body, at least one second mold cavity shaped to form the container closure, at least one first substantially sterile surface extending about the first mold cavity, at least one second substantially sterile surface extending about the at least one second mold cavity, and two first flexible barriers, wherein one of the first flexible barriers is coupled to the mold between the at least one first sterile surface and a molding machine and substantially prevents the passage of contaminants from the molding machine therethrough, and the other first flexible baffler is coupled to the mold between the at least one second sterile surface and a molding machine and substantially prevents the passage of contaminants from the molding machine therethrough. 6. Apparatus as defined in claim 5, wherein the mold includes a first mold portion and a second mold portion, the first mold portion defines the first sterile surface, the second mold portion defines the second sterile surface, and at least one of the first mold portion is movable relative to the second mold portion between a closed position for molding at least one of the container body and container closure, and an open position with the first and second sterile surfaces spaced relative to each other and defining a portion of the aseptic chamber therebetween. 7. Apparatus as defined in claim 5, wherein the first sterile surface extends about a periphery of the first mold cavity, and the second sterile surface extends about a periphery of the second mold cavity. 8. Apparatus as defined in claim 7, further comprising at least one third substantially sterile surface extending about a periphery of the engaging portion of the tool. 9. Apparatus as defined in claim 4, wherein the at least one first substantially sterile surface is defined by a heated surface. 10. Apparatus as defined in claim 9, wherein the heated surface is defined by a ceramic surface. 11. Apparatus as defined in claim 9, further comprising at least one heating source thermally coupled to the heated surface. 12. Apparatus as defined in claim 11, further comprising at least one temperature sensor operatively coupled to the at least one heating source and adapted to sense the temperature of the heated surface, and wherein the at least one heating source is responsive to the at least temperature sensor to control the temperature of the heated surface. 13. Apparatus as defined in claim 4, further comprising at least one assembly device including the at least one tool, wherein the at least one assembly device and tool are configured to (i) de-mold a substantially sterile container closure from at least one first mold cavity, (ii) de-mold a substantially sterile container body from at least one first mold cavity, (iii) assemble within at least one aseptic chamber the substantially sterile container closure and container body into a sterile, sealed empty container, and (iv) transfer the sterile, sealed empty container to at least one of a transfer station and the needle filling and thermal resealing station for needle filling with a substance and thermally resealing the filled container. 14. Apparatus as defined in claim 4, wherein the tool includes at least one vacuum port in fluid communication with the engaging portion for drawing a vacuum through the port and, in turn, releasably securing at least one of a substantially sterile container closure and container body thereto. 15. Apparatus for molding and filling a container having a container body defining an opening in communication with an interior chamber for receiving a substance therein, and a container closure including a stopper for sealing the opening and substance received in the container, comprising: first means for forming at least one enclosed aseptic chamber; second means located within at least one aseptic chamber and defining at least one mold cavity for forming at least one of the container closure and container body; third means for forming at least one first substantially sterile surface region extending about the at least one first mold cavity; fourth means located within at least one aseptic chamber and movable relative to the third means for engaging and de-molding at least one of a substantially sterile container closure and container body from the at least one first mold cavity; fifth means coupled in fluid communication with the at least one aseptic chamber for directing a flow of sterile air into the aseptic chamber and over the third means and fourth means for maintaining the sterility of the container closure and container body during de-molding thereof; sixth means for preventing the passage of contaminants from a molding machine therethrough and into the at least one aseptic chamber; seventh means for preventing the passage of contaminants from a base portion of the fourth means therethrough and into the aseptic chamber; and eighth means for receiving a sealed, empty sterile container body and container closure assembly, penetrating the stopper and introducing a substance therethrough and into the interior chamber of the container body, and thermally resealing a penetrated region of the stopper. 16. Apparatus as defined in claim 15, wherein: the first means is defined by at least one baffler enclosure; the second means is defined by at least one mold; the third means is defined by at least one sterile surface extending about a periphery of the least one mold cavity; the fourth means is defined by an end-of-arm tool including an engaging portion engageable with at least one of a container body and container closure; the fifth means is defined by at least one source of sterile air in fluid communication with the at least one aseptic chamber; the sixth means is defined by at least one flexible baffler; the seventh means is defined by at least one flexible barrier; and the eighth means is defined by a needle filling and thermal resealing station.
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