Abstract: A sterile filling machine and related method are provided for sterile filling a container with a substance. The container includes a resealable stopper or portion and a chamber for receiving the substance therein. The sealed, empty containers are subjected to radiation capable of penetrating through the resealable portion and chamber for sterilizing the container. The previously sterilized containers are then transported through another sterilizing chamber, such as an e-beam chamber, to sterilize the penetrable surface. A filling member is moved into engagement with the resealable portion to pierce the sterilized penetrable surface of the resealable portion and inject the substance through the filling member and into the chamber of the container. Energy is then transmitted onto the stopper to hermetically re-seal the penetration in the resealable portion.

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 needle assembly and is adjustable to receive a plurality of 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 vials that are to be filled concurrently and adjusting an assembly to include at least one needle assembly and at least one seal assembly. A number of the needle assemblies and the seal assemblies equals the number of vials.

Abstract: A dispenser for holding multiple doses of fluids or other substances, and for dispensing the substances, has a vial, a flexible bladder received within the vial, and a variable volume storage chamber formed between the bladder and vial. A filling valve is coupled in fluid communication with the storage chamber and defines (1) a normally closed, fluid-tight position hermetically sealing the storage chamber from the ambient atmosphere, and (2) an open position allowing the passage of fluid through the valve both to evacuate the storage chamber and to introduce fluid through the valve to fill the storage chamber. A pump is coupled in fluid communication with the storage chamber for pumping fluids out of the storage chamber. A dispensing valve is coupled in fluid communication with the pump and defines (1) a normally closed, fluid-tight position preventing the passage of fluid out of the dispenser, and (2) an open position for dispensing pumped fluid therethrough.

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.

Abstract: A container and method for filling same. The container includes a penetrable and resealable portion that is resealable, and a container body having a sealed empty chamber in fluid communication with the penetrable and resealable portion for receiving therein a substance. The container also includes a base, a mid-portion, and an upper portion axially spaced from the base on an opposite side of the mid-portion relative to the base. Each of the base and upper portion define a laterally-extending dimension greater than a maximum laterally-extending dimension of the mid-portion. The method of filling the container includes penetrating the penetrable and resealable portion with an injection member and introducing a substance into the chamber, withdrawing the injection member while engaging the base of the body to substantially prevent upward movement of the body, and applying energy to the penetrable and resealable portion to form a gas-tight seal.

Abstract: A one-way valve is connectable in fluid communication with a fluid-receiving chamber, such as a dilution chamber or a mixing chamber for diluting or mixing a perishable food product, such as a milk product or chocolate product, and forming a substantially fluid-tight seal therebetween. The valve comprises a relatively rigid valve seat, and a relatively flexible valve member overlying the valve seat and forming an axially-elongated, normally-closed valve opening therebetween defining an inlet at one end of the valve seat, an outlet at an opposite end of the valve seat, and an axially-extending seal therebetween that forms a fluid-tight seal between the inlet and outlet of the normally-closed valve opening. An axially-extending valve body is radially spaced relative to the valve member and forms a space therebetween allowing fluid-flow therethrough for cleaning the valve and the fluid-receiving chamber.

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: Device and method for needle penetrating and filling a chamber with a predetermined substance, and hermetically resealing a resulting needle hole in the device by applying radiation thereto. The needle penetrable and resealable portion defines a predetermined wall thickness in an axial direction thereof, and may include a thermoplastic that substantially prevents the formation of particles released into the chamber from the needle penetrable and resealable portion during penetration by and withdrawal of the needle. Such thermoplastic may include a predetermined amount of pigment that allows the thermoplastic to substantially absorb laser radiation at a predetermined wavelength, substantially prevent the passage of radiation through the predetermined wall thickness thereof, and hermetically seal a needle aperture formed in the needle penetration region thereof in a predetermined time period.

Abstract: An aseptic fluid connector having a first connector including a first fluid passageway for receiving a fluid therein; a first port in fluid communication with the first fluid passageway for passage of the fluid therethrough; and a first deflecting member. The first deflecting member includes a first engaging portion radially spaced relative to the first port, and a first valve movable between a closed position and an open position with movement of the first engaging portion between a non-deflected position and a deflected position, respectively. In the non-deflected position, the first valve is located in the closed position forming a fluid-tight seal between the first valve and first port and preventing the passage of fluid therethrough, and in the deflected position, the first valve is located in the open position allowing the aseptic passage of fluid through the first port.

Abstract: A dispenser for dispensing a substance, such as a pharmaceutical, ophthalmic, dermatological, cosmeceutical, cosmetic or other product, has a body with a variable-volume storage chamber for storing the product. A dispensing portion of the dispenser is connected with the body and has a compression chamber in fluid communication with the storage chamber for receiving substance therefrom, and an outlet aperture coupled in fluid communication with the compression chamber. A one-way valve of the dispenser includes an axially-extending valve seat and an axially-extending flexible valve cover seated on the valve seat and defining a normally-closed, axially-extending seam therebetween forming a fluid-tight seal between the valve cover and valve seat. The flexible valve cover is movable relative to the valve seat and the seam is connectable in fluid communication with the outlet aperture to allow the passage of substance through the seam and out of the dispenser.

Abstract: A device for storing and dispensing a substance includes a storage chamber for the substance. The container includes a passageway in fluid communication with the storage chamber. The container includes a pierceable wall located on an opposite side of the passageway relative to the storage chamber. The device includes a one-way valve assembly including a piercing portion. At least one of the piercing portion and the pierceable wall is movable relative to the other between a first position wherein the pierceable portion is not piercing the pierceable wall, and a second position wherein the pierceable portion is piercing the pierceable wall allowing the flow of substance from the storage chamber. A removable member is disposed intermediate the valve and the container that prevents movement of at least one of the piercing portion and pierceable wall to the second position until the removable member is removed.

Abstract: Disclosed is a container and method for filling same. The container includes a thermally resealable portion that is fusible in response to thermal energy, and a container body having a sealed empty chamber in fluid communication with the resealable portion for receiving therein a substance. The container also includes a base, a mid-portion, and an upper portion axially spaced from the base on an opposite side of the mid-portion relative to the base. Each of the base and upper portion define a laterally-extending dimension greater than a maximum laterally-extending dimension of the mid-portion. The method of filling the container includes penetrating the resealable portion with an injection member and introducing a substance into the chamber, withdrawing the injection member while engaging the base of the body to substantially prevent axial movement of the body, and applying thermal energy to the resealable portion to thermally fuse the penetrated region thereof.

Abstract: A device defining a chamber for receiving a substance and a thermoplastic portion in fluid communication with the chamber is provided along with a method of filling and sealing the substance within the chamber. The thermoplastic portion defines a penetrable region that is penetrable by a filling member and is heat resealable to hermetically seal an aperture therein by applying laser radiation at a predetermined wavelength and power. The thermoplastic portion comprises a thermoplastic body defining a predetermined wall thickness and includes a styrene block copolymer, an olefin and a predetermined amount of pigment allowing the body to absorb laser radiation at the predetermined wavelength, substantially prevent the passage of radiation through the predetermined wall thickness, and hermetically seal the aperture in the penetrable region in a predetermined time period.

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 device and related method are provided for lyophilizing a substance within the device and storing therein the lyophilized substance. The device is penetrable by a needle for filling the device with the substance to be lyophilized, and a resulting needle hole in the device is laser resealable by transmitting thereon laser radiation from a laser source. The device defines a chamber for receiving therein the substance to be lyophilized. A needle penetrable and laser resealable portion of the device is pierceable with a needle to form a needle aperture therethrough to fill the chamber with the substance to be lyophilized through the needle, and is laser resealable to hermetically seal the needle aperture by applying laser radiation thereto.

Abstract: A device and method are provided for needle penetrating and filling a chamber with a predetermined substance, and laser resealing a resulting needle hole in the device. A needle penetrable and laser resealable portion of the device is pierceable with a needle to form a needle aperture therethrough to fill the chamber through the needle, and is laser resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto. The needle penetrable and laser resealable portion defines a predetermined wall thickness in an axial direction thereof, and includes a thermoplastic that substantially prevents the formation of particles released into the chamber from the needle penetrable and laser resealable portion during penetration by and withdrawal of the needle.