Abstract:
A lyophilization device configured for use in a lyophilization process has a body defining a chamber for receiving a liquid to be lyophilized, and a stopper creating a liquid-tight seal between the chamber and ambient atmosphere to form a sealed, empty sterile chamber. The stopper is adapted so that the chamber may be sterile filled with the substance through the stopper. A fluid passageway is formed through the stopper, through which the chamber is evacuated. The substance is lyophilized, the fluid passageway is closed, and the lyophilized substance is hermetically sealed 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:
A container including a body defining an outflow opening and at least one chamber adapted for storing a product, such as a fat containing liquid product, and a container closure including a primary seal for hermetically sealing the product within the chamber during storage. The container closure includes a sealing member forming a substantially fluid-tight seal between the container closure and the body, and a dispensing member in fluid communication with the chamber. The container closure and body move relative to each other between a first position where the primary seal is seated about the outflow port to hermetically seal the product in the chamber during storage, and a second position where the primary seal is displaced from the outflow port to allow product to pass from the chamber through the outflow port and into dispensing member to dispense the product.
Abstract:
A container and method are provided for storing fat containing liquid products. The container includes a body defining a storage chamber for receiving the product, and a container closure. A first material portion forms at least most of the surface area overlying the storage chamber that can contact any product therein. Neither the body nor the first material portion leach more than a predetermined amount of leachables into the product or undesirably alter a taste profile thereof. A needle penetrable and thermally resealable second material portion either (i) overlies the first material portion and cannot contact any product within the storage chamber, or (ii) forms a substantially lesser surface area overlying the storage chamber that can contact any product therein in comparison to the first material portion. A sealing portion is engageable with the body to form a substantially dry hermetic seal between the container closure and body.
Abstract:
Apparatus for molding and filling a device having a body defining an opening in communication with an interior chamber for receiving a substance therein, and a closure including a penetrable and resealable portion for sealing the opening and substance received in the device. A mold includes within the aseptic chamber plural mold cavities shaped to form the closure and 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 body and closure is movable relative to the mold to engage and de-mold the substantially sterile closures and 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.
Abstract:
Device and method for lyophilizing a substance within the device and storing therein the lyophilized substance. The device defines a chamber for receiving therein the substance to be lyophilized, a penetrable and resealable portion of the device is penetrable or pierceable by a needle for filling the device with the substance, and a resulting hole therein is resealable by transmitting radiation from a radiation source thereon. A filter is connectable in fluid communication between an interior and exterior of the chamber for permitting fluid to flow therethrough in a direction from the interior to the exterior of the chamber, and for substantially preventing contaminants from flowing therethrough in a direction from the exterior to the interior of the chamber.
Abstract:
A pouch connector includes a safety cap having a cap base portion and a main connector disposed opposite the safety cap. The main connector and safety cap are configured to receive a portion of a pouch therebetween. The main connector includes a piercing member for piercing the pouch, an actuating portion for actuating the piercing member and a main connector base portion. The piercing member is configured to pierce through a portion of the pouch so as to provide fluid communication between a substance inside the pouch and the interior of the main connector. A polymeric membrane is coupled to at least one of the cap base portion and the main connector base portion.
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:
An apparatus and method are provided for molding sterile parts. The apparatus has a first mold portion and a second mold portion. At least one of the first and second mold portions defines a mold cavity configured to receive a molten plastic and form therefrom at least one molded part At least one of the first and second mold portions 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 first and second mold portions and permitting the passage of a fluid sterilant therein. A fluid source that contains or otherwise generates a fluid sterilant, such as vaporized hydrogen peroxide, is connectable in fluid communication with the fluid passageway for introducing the sterilant into the fluid passageway with at least one of the first and second mold portions in the open position, and in turn 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.