Abstract: The connection, assembly, or fill of two or more pre-sterilized components having at least one terminal end each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field. Using a low-voltage electron beam instrument, such as the MIN-EB™, a suitable sterile field sphere can be created. The terminal ends of the multiple components remain within the sterile field sphere until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

Abstract: What is disclosed is an apparatus and method for assembling a reconstitution assembly (1) having a reconstitution device (10) having a first end connected to a flexible diluent container (12), the reconstitution device (10) having a second end connected to a drug vial (14). The reconstitution device (10) and containers, such as drug vials (14) or diluent bags (12), are loaded onto positioning assemblies (27) on a conveyor (90). The positioning assemblies (27) are conveyed to sterilization booths (270). Sterilization fields are generated within the sterilization booths (270), and the containers are sterilely connected to the reconstitution device (10) within the sterile fields.

Abstract: The connection, assembly, or fill of two or more pre-sterilized components having at least one terminal end each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field. Using a low-voltage electron beam instrument, such as the MIN-EB™, a suitable sterile field sphere can be created. The terminal ends of the multiple components remain within the sterile field sphere until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

Abstract: The connection, assembly, or fill of two or more pre-sterilized components having at least one terminal end each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field. Using a low-voltage electron beam instrument, such as the MIN-EB™, a suitable sterile field sphere can be created. The terminal ends of the multiple components remain within the sterile field sphere until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

Abstract: The connection, assembly, or fill of two or more pre-sterilized components 10, 12 having at least one terminal end 14 each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components 10, 12 together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field 60. Using a low-voltage electron beam instrument 54, such as the MIN-EB™, a suitable sterile field sphere can be created. The terminal ends 14 of the multiple components 10, 12 remain within the sterile field sphere 60 until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

Abstract: What is disclosed is an apparatus and method for assembling a reconstitution assembly (1) having a reconstitution device (10) having a first end connected to a flexible diluent container (12), the reconstitution device (10) having a second end connected to a drug vial (14). The reconstitution device (10) and containers, such as drug vials (14) or diluent bags (12), are loaded onto positioning assemblies (27) on a conveyor (90). The positioning assemblies (27) are conveyed to sterilization booths (270). Sterilization fields are generated within the sterilization booths (270), and the containers are sterilely connected to the reconstitution device (10) within the sterile fields.

Abstract: What is disclosed is an apparatus and method for assembling a reconstitution assembly (1) having a reconstitution device (10) having a first end connected to a flexible diluent container (12), the reconstitution device (10) having a second end connected to a drug vial (14). The reconstitution device (10) and containers, such as drug vials (14) or diluent bags (12), are loaded onto positioning assemblies (27) on a conveyor (90). The positioning assemblies (27) are conveyed to sterilization booths (270). Sterilization fields are generated within the sterilization booths (270), and the containers are sterilely connected to the reconstitution device (10) within the sterile fields.

Abstract: The connection, assembly, or fill of two or more pre-sterilized components 10,12 having at least one terminal end 14 each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components 10,12 together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field 60. Using a low-voltage electron beam instrument 54, such as the MIN-EB™, a suitable sterile field sphere can be created. The terminal ends 14 of the multiple components 10,12 remain within the sterile field sphere 60 until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

Abstract: The present invention claims a method of producing sterile prefilled syringe bodies. The method comprises the steps of providing a syringe body. The syringe bodies are sterilized and transferred to a sterile environment. While the syringe bodies are maintained in a sterilized condition as they are transferred to the sterile environment. A fluid substance is provided and introduced into the syringe body while the syringe body is within the sterile environment. The fluid substance is also sealed within the syringe body while the syringe body is within the sterile environment.

Abstract: A syringe having a syringe body of a norbornene and ethylene copolymer, the body defining a chamber for containing water and having an opening, a plunger seal of a halobutyl-based elastomer sealing the opening; and wherein the syringe meets all requirements of the United States Pharmocopoeia for sterile water for injection.

Abstract: The connection, assembly, or fill of two or more pre-sterilized components having at least one terminal end each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field. Using a low-voltage electron beam instrument, such as the MIN-EB™, a suitable sterile field sphere can be created. The terminal ends of the multiple components remain within the sterile field sphere until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

Abstract: The connection, assembly, or fill of two or more pre-sterilized components having at least one terminal end each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field. Using a low-voltage electron beam instrument, such as the MIN-EB™, a suitable sterile field sphere can be created. The terminal ends of the multiple components remain within the sterile field sphere until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

Abstract: Methods are disclosed for sterilizing a selected portion of a product and for assembling a sterile product from two or more parts which can not be sterilized with the same form of sterilization. A sterile product produced by these methods is also disclosed. The method for sterilizing may include sterilizing a selected portion of the product by exposing the selected portion to an electron beam, while shielding the remainder of the product from the radiation of the electron beam. The method of assembling a sterile product from two or more component parts may include the steps of sterilizing the first part of the product, isolating a portion of the first part from the remainder of the first part, attaching the second part to the isolated portion of the first part, and exposing the isolated portion to a form of sterilization which is deleterious to the remainder of the first part, while shielding the remainder of the first part from such form of sterilization.

Abstract: Methods are disclosed for sterilizing a selected portion of a product and for assembling a sterile product from two or more parts which can not be sterilized with the same form of sterilization. A sterile product produced by these methods is also disclosed. The method for sterilizing may include sterilizing a selected portion of the product by exposing the selected portion to an electron beam, while shielding the remainder of the product from the radiation of the electron beam. The method of assembling a sterile product from two or more component parts may include the steps of sterilizing the first part of the product, isolating a portion of the first part from the remainder of the first part, attaching the second part to the isolated portion of the first part, and exposing the isolated portion to a form of sterilization which is deleterious to the remainder of the first part, while shielding the remainder of the first part from such form of sterilization.