Abstract:
An assembly includes a support and drive assembly, a first structure and a second structure. The first structure is in operable communication with and supported by the support and drive assembly. The first structure includes at least one filling or needle assembly and is adjustable to receive a plurality of filling or needle assemblies. The second structure is supported by the support and drive assembly. The second structure includes at least one seal assembly and is adjustable to receive a plurality of seal assemblies. A method includes determining a number of containers or vials that are to be filled concurrently and adjusting an assembly to include at least one filling or needle assembly and at least one seal assembly. A number of the filling or needle assemblies and the seal assemblies equals the number of containers or vials.
Abstract:
A container including a nozzle and body depending therefrom. The body is preferably tubular and defines an interior which retains a product to be dispensed. A cap engages the nozzle to prevent inadvertent release of the product. In order to dispense the product, the cap is removed and pressure is applied to the body and the nozzle allows release of the product. The nozzle releases the product without exposing the remaining product to the external atmosphere, thus the sterility of the interior of the body is maintained and the shelf life of the product is increased. The nozzle includes an inner body, coupled to the tubular body, surrounded by a flexible outer cover. A seam between the inner body and flexible outer cover forms a one-way release valve wherein a portion of the seam remains closed during dispensing the product.
Abstract:
An apparatus and method are provided for formulating and aseptically filling liquid products. A first liquid source includes at least one first liquid component; a second liquid source includes at least one second liquid component; and a container includes a body defining an empty, sterile storage chamber therein that is sealed with respect to ambient atmosphere. The container is introduced into a sterile filling chamber. A first filling member coupled in fluid communication with the first liquid source is placed in fluid communication with the storage chamber of the container located in the sterile filling chamber, and the first liquid component is aseptically introduced through the first filling member and into the storage chamber. A second filling member coupled in fluid communication with the second liquid source is placed in fluid communication with the storage chamber of the container located in the sterile filling chamber, and the second liquid component is aseptically introduced through the second filling member and into the storage chamber and, in turn, the first and second liquid components are combined into a liquid product formulation within the sterile chamber of the container. The first and second filling members are withdrawn from fluid communication with the storage chamber of the container located within the sterile filling chamber, and the filled storage chamber is sealed with respect to ambient atmosphere to hermetically seal the liquid product formulation within the storage chamber of the container.
Abstract:
An apparatus and method for sterile filling comprises de-contaminating a needle penetrable surface of a device including a needle penetrable septum and a sealed chamber in fluid communication with the needle penetrable septum. A filling needle penetrates the needle penetrable septum, introduces substance through the filling needle and into the chamber and is, in turn, withdrawn from the septum. A liquid sealant is applied to the penetrated region of the septum. Radiation or energy is applied to the liquid sealant to cure the liquid sealant from a liquid phase to a solid phase.
Abstract:
A dispenser for dispensing a fluid includes a rigid vial that has a main fluid chamber containing a fluid, and a pump assembly that is in fluid communication with the main fluid chamber and is configured to dispense a predetermined quantity of fluid from the main fluid chamber. A flexible bladder is provided which is located within the main fluid chamber and is configured to expand to fill the ullage created within the main fluid chamber during dispensing of fluid by the pump assembly. The resilient bladder tends to force itself outwardly toward the rigid vial and, in turn, increases the pressure within the main fluid chamber in comparison to the interior of the bladder to thereby prevent the ingress of air or vapors through the bladder or otherwise into the main fluid chamber.
Abstract:
A stopper and container body are molded in the same molding machine. An assembly device, such as a pick and place robot, transfers the stopper from one mold cavity into the opening in the container body located within another mold cavity, or vice versa, to assemble the stopper and container body. Then, the assembled container body and stopper are removed from the molding machine and transported to a needle filling and laser resealing station for filling and laser resealing. A laminar flow source directs a substantially laminar flow of air or sterile gas over the mold surfaces, stoppers and container bodies, and assembly device, to prevent contamination during assembly.
Abstract:
A method for sterilizing a container is provided where a penetrable septum of a sealed empty device is penetrated with an injection member. A fluid sterilant is then injected through the injection member and into an interior chamber of the device. The fluid sterilant is allowed to reside within the chamber a sufficient amount of time to render the chamber either sterile or bactericidal. Product can then be introduced through the septum into the sterile or bactericidal chamber. The resulting penetration aperture is then resealed to hermetically seal the product within the chamber.
Abstract:
A sterile enclosure contains a transfer module defining a window. A port covers the window to maintain the inside of the enclosure as a sealed and sterile environment. A sliding, heated cutting element mounted on the port serves to sterilize and sever a portion of a sterile transfer bag assembly attached to the port. Preferably, the excised portion of the sterile transfer bag assembly is affixed to the port when the port opens. The sliding cutting element remains extended and heated to prevent contamination when the port is open. Further, a heating element is mounted about the window in order to sterilize around the opening when the port is open.
Abstract:
At least one of first and second mold portions defines a mold cavity to receive molten plastic and form therefrom at least one molded part, and is movable relative to the other between (i) a closed position for sealing the mold cavity or cavities and molding at least one part therein, and (ii) an open position defining a fluid passageway between the mold portions and permitting the passage of a fluid sterilant therein. A fluid sterilant source is connectable in fluid communication with the fluid passageway for introducing the sterilant therein in the open position, contacting with the sterilant the surfaces of the first and second mold portions forming the fluid passageway and located adjacent to the at least one mold cavity, but not contacting an interior surface of a molded part within the mold cavity, to sterilize the exposed mold surfaces and thereby prevent contamination of the molded part.