초록 ▼

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 c

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 The first and second filling members are withdrawn from fluid communication with the storage chamber of the container located within the sterile filling chamber, and the filled storage chamber is sealed with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.

대표청구항 ▼

1. An apparatus for formulating and aseptically filling liquid products, comprising: a first liquid source including at least one first liquid component;a second liquid source including at least one second liquid component;a container including a body defining at least one empty, sterile storage cha

1. An apparatus for formulating and aseptically filling liquid products, comprising: a first liquid source including at least one first liquid component;a second liquid source including at least one second liquid component;a container including a body defining at least one empty, sterile storage chamber therein that is sealed with respect to ambient atmosphere;a sterile filling chamber;a first filling member coupled in fluid communication with the first liquid source, movable relative to the container located within the sterile filling chamber, and connectable in fluid communication with the sealed, sterile storage chamber of the container for aseptically introducing the at least one first liquid component through the first filling member and into the storage chamber;a second filling member coupled in fluid communication with the second liquid source, movable relative to the container located within the sterile filling chamber, and connectable in fluid communication with the sealed, empty sterile storage chamber of the container for aseptically introducing the at least one second liquid component through the second filling member and into the storage chamber and, in turn, combining, within the sterile storage chamber of the container, the at least one first and at least one second liquid components into a liquid formulation hermetically sealed with respect to ambient atmosphere in the storage chamber; anda sterilization apparatus that sterilizes, at a cold or about ambient temperature, a heat labile first or second liquid component. 2. An apparatus as defined in claim 1, wherein the container further includes at least one needle penetrable and resealable portion in fluid communication with the storage chamber; and the first filling member comprises a first filling needle coupled in fluid communication with the first liquid source and movable relative to the at least one needle penetrable and resealable portion of the container for aseptically introducing the at least one first liquid component through the first filling needle and into the storage chamber; the second filling member comprises a second filling needle coupled in fluid communication with the second liquid source and movable relative to the at least one needle penetrable and resealable portion of the container for aseptically introducing the at least one second liquid component through the second filling needle and into the storage chamber and, in turn, combining the at least one first and the at least one second liquid components into a liquid formulation; and a radiation or energy source for applying radiation or energy to hermetically seal the liquid formulation within the storage chamber. 3. An apparatus as defined in claim 2, wherein the container includes a plurality of needle penetrable and resealable portions in fluid communication with the at least one storage chamber of the container connectable in fluid communication with a plurality of sources of liquid components for introducing a plurality of different liquid components into the at least one storage chamber. 4. An apparatus as defined in claim 3, wherein the container includes a plurality of storage chambers, and each storage chamber includes at least one needle penetrable and resealable portion in fluid communication therewith. 5. An apparatus as defined in claim 2, wherein the penetrable and resealable portion is thermally resealable, and the radiation or energy source is a laser source connectable in thermal communication with the at least one penetrable and resealable portion. 6. An apparatus as defined in claim 1, wherein the at least one first liquid component is heat labile, the at least one second liquid component is not heat labile, and the apparatus further comprises (i) a filtration sterilization apparatus coupled in fluid communication with the first liquid source for sterilizing the at least one first liquid component by filtration prior to introducing the at least one first liquid component through the first filling member, and (ii) a thermal sterilization apparatus for thermally sterilizing the at least one second liquid component prior to introducing the at least one second liquid component through the second filling member. 7. An apparatus as defined in claim 1, further comprising a first filling station including at least one of the first filling member, and a second filling station including at least one of the second filling member. 8. An apparatus as defined in claim 7, further comprising at least one pump drivingly coupled to the first and second filling members for pumping the components therethrough. 9. An apparatus as defined in claim 8, wherein the at least one pump comprises a first pump drivingly coupled to the first filling member, and a second pump drivingly coupled to the second filling member. 10. An apparatus as defined in claim 7, wherein the container further includes at least one needle penetrable and resealable portion in fluid communication with the storage chamber, and each of the first and second filling stations includes a needle manifold with a plurality of needles defining the respective at least one of the first and second filling members spaced relative to each other and movable relative to a container support for penetrating a plurality of containers mounted on the support, for filling the containers through the needles, and for withdrawing the needles from the filled containers; and a plurality of assemblies, wherein each assembly is connectable to a source of radiation or energy, and is directed substantially onto the needle penetrable and resealable portion of a respective container for applying radiation or energy thereto and resealing a needle hole therein. 11. An apparatus as defined in claim 10, wherein the wherein the penetrable and resealable portion is thermally resealable, and the assembly is a laser assembly connectable to a source of laser radiation, and is focused on the penetration spot for applying laser radiation thereto and thermally resealing the needle hole therein. 12. An apparatus as defined in claim 1, further comprising: a housing defining an inlet end, an outlet end, and the sterile filling chamber is located between the inlet and outlet ends;a conveyor located at least partially within the sterile filling chamber and defining a plurality of container positions thereon for supporting and moving containers in a direction from the inlet end toward the outlet end through the sterile filling chamber;a fluid sterilant station located within the sterile filling chamber and coupled in fluid communication with a source of fluid sterilant for transmitting fluid sterilant onto at least an exposed portion of a respective container supported on the conveyor within the fluid sterilant station and sterilizing the exposed portion of the container; andat least one sterilant removing station located within the sterile filling chamber between the fluid sterilant station and the outlet end of the housing, and coupled in fluid communication with a source of heated gas for transmitting heated gas onto a container supported on the conveyor within the at least one sterilant removing station to flush away fluid sterilant on the container;wherein the first and second filling members are located within the sterile filling chamber between the at least one sterilant removing station and the outlet end of the housing for receiving the sterilized containers therefrom. 13. An apparatus as defined in claim 12, wherein the fluid sterilant is hydrogen peroxide. 14. An apparatus as defined in claim 12, further comprising a source of sterile gas coupled in fluid communication with the sterile filling chamber for creating an over pressure of sterile gas within the sterile filling chamber, and means for directing a flow of sterile gas substantially in a direction from the outlet end toward the inlet end of the housing to thereby prevent fluid sterilant from flowing onto containers located adjacent to at least one of the first and second filling members. 15. An apparatus as defined in claim 14, wherein the conveyor includes a plurality of pivotally mounted container supports that engage opposing sides of a respective container supported thereon relative to each other, and substantially isolate a sterile portion of the container located above the container supports relative to a portion of the container located below the container supports to thereby prevent any contamination on the lower portion of the container from contaminating the sterile upper portion of the container. 16. An apparatus as defined in claim 14, wherein the at least one first liquid component is heat labile, the at least one second liquid component is not heat labile, and the apparatus further comprises (i) a filtration sterilization apparatus coupled in fluid communication with the first liquid source for sterilizing the at least one first liquid component by filtration prior to introducing the at least one first liquid component through the first filling member, and (ii) a thermal sterilization apparatus for thermally sterilizing the at least one second liquid component prior to introducing the at least one second liquid component through the second filling member. 17. An apparatus as defined in claim 1, wherein the container includes at least one penetrable and thermally sealable portion that is a thermoplastic elastomer that is heat sealable to hermetically seal at least one penetration aperture therein by applying laser radiation at a predetermined wavelength and power thereto, and defines (i) a predetermined wall thickness, (ii) a predetermined color and opacity that substantially absorbs the laser radiation at the predetermined wavelength and substantially prevents the passage of the radiation through the predetermined wall thickness thereof, and (iii) a predetermined color and opacity that causes the laser radiation at the predetermined wavelength and power to hermetically seal the penetration aperture in a predetermined time period of less than or equal to about 5 seconds and substantially without burning the penetrable portion. 18. An apparatus as defined in claim 1, wherein the container includes at least one penetrable and thermally sealable portion that is a thermoplastic elastomer that is heat sealable to hermetically seal a penetration aperture therein by applying laser radiation at a predetermined wavelength and power thereto, and includes (i) a styrene block copolymer; (ii) an olefin; (iii) a predetermined amount of pigment that allows the penetrable portion to substantially absorb laser radiation at the predetermined wavelength and substantially prevent the passage of radiation through a predetermined wall thickness thereof, and hermetically seal a penetration aperture formed therein in a predetermined time period of less than or equal to about 5 seconds; and (iv) a predetermined amount of lubricant that reduces friction forces at an interface of the first and second filling members and the penetrable portion. 19. An apparatus as defined in claim 1, wherein the container includes at least one penetrable and thermally sealable portion that is a thermoplastic elastomer that is heat sealable to hermetically seal a penetration aperture therein by applying laser radiation at a predetermined wavelength and power thereto, and includes (i) a first polymeric material in an amount within the range of about 80% to about 97% by weight and defining a first elongation; (ii) a second polymeric material in an amount within the range of about 3% to about 20% by weight and defining a second elongation that is less than the first elongation of the first polymeric material; (iii) a pigment in an amount that allows the second material portion to substantially absorb laser radiation at the predetermined wavelength and substantially prevent the passage of radiation through a predetermined wall thickness thereof, and hermetically seal a penetration aperture formed in the penetrable region thereof in a predetermined time period of less than or equal to about 5 seconds; and (iv) a lubricant in an amount that reduces friction forces at an interface of the first and second filling members and the penetrable portion. 20. An apparatus as defined in claim 1, further comprising first sterilization apparatus for sterilizing the at least one first liquid component, and second sterilization apparatus for separately sterilizing the at least one second liquid component. 21. An apparatus as defined in claim 20, wherein the at least one first liquid component is heat labile, the at least one second liquid component is not heat labile, the first means is a filter, and the second means is a thermal sterilization apparatus. 22. An apparatus as defined in claim 20, wherein at least one of the at least one first and the at least one second liquid components is heat labile, and the respective first or second sterilization apparatus does not damage, destroy or decompose the heat labile components. 23. An apparatus as defined in claim 1, wherein the container includes a thermoplastic portion in fluid communication with the chamber, the thermoplastic portion defining a penetrable region that is pierceable with a needle to form an aperture therethrough, and is resealable to hermetically seal the aperture, wherein the thermoplastic portion includes (i) a first polymeric material in a first amount by weight including a styrene block copolymer and defining a first elongation; (ii) a second polymeric material in a second amount by weight that is less then the first amount, including at least one of an ethylene alpha-olefin, a polyolefin, and an olefin, and defining a second elongation that is less than the first elongation; and (iii) a lubricant in an amount that reduces friction forces at an interface of a needle and the thermoplastic portion during penetration thereof.