IPC분류정보
국가/구분 |
United States(US) Patent
등록
|
국제특허분류(IPC7판) |
|
출원번호 |
US-0894224
(2010-09-30)
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등록번호 |
US-8132600
(2012-03-13)
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발명자
/ 주소 |
- Py, Daniel
- Assion, Norbert
- Houle, Nathaniel
- Sahoo, Debashis
- Willey, M. Jeffrey
- Hartman, Eric E.
- Guthy, John
|
출원인 / 주소 |
- Medical Instill Technologies, Inc.
|
대리인 / 주소 |
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인용정보 |
피인용 횟수 :
2 인용 특허 :
28 |
초록
▼
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
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.
대표청구항
▼
1. A method for aseptically needle filling and laser resealing a container with a fat containing liquid product, the container including a body defining an empty, sterile storage chamber therein for receiving the fat containing liquid product, wherein the body does not leach more than a predetermine
1. A method for aseptically needle filling and laser resealing a container with a fat containing liquid product, the container including a body defining an empty, sterile storage chamber therein for receiving the fat containing liquid product, wherein the body does not leach more than a predetermined amount of leachables into the fat containing liquid product and does not undesirably alter a taste profile of the fat containing liquid product; a container closure; a first material portion overlying the storage chamber and defining an internal surface in fluid communication with the storage chamber forming at least most of the surface area overlying the storage chamber that can contact any fat containing liquid product within the storage chamber and that does not leach more than the predetermined amount of leachables into the fat containing liquid product or undesirably alter a taste profile of the fat containing liquid product, wherein the predetermined amount of leachables is less than about 100 PPM; a second material portion that at least one of (i) overlies the first material portion and cannot contact any fat containing liquid product within the storage chamber, and (ii) overlies the storage chamber and forms a substantially lesser surface area overlying the storage chamber that can contact any fat containing liquid product within the storage chamber in comparison to the first material portion; the method comprising the following steps: mounting the sealed, empty container on a conveyor, and moving the conveyor through a sterile zone;transmitting within the sterile zone a fluid sterilant onto at least an exposed portion of the second material portion of the container and, in turn, sterilizing with the fluid sterilant at least the exposed portion of the second material portion of the container;transmitting within the sterile zone a heated gas onto the portion of the container exposed to the fluid sterilant, flushing away with the heated gas the fluid sterilant from at least the exposed portion of the second material portion of the container and, in turn, forming a needle penetration region of the second material portion substantially free of fluid sterilant;penetrating the needle penetration region of the second material portion with a filling needle coupled in fluid communication with a source of the fat containing liquid product, and introducing fat containing liquid product through the needle and into the storage chamber;withdrawing the filling needle from the second material portion; andapplying laser radiation to a resulting needle hole in the second material portion to thermally reseal the second material portion and, in turn, hermetically seal the fat containing liquid product within the storage chamber. 2. A method as defined in claim 1, further comprising moving the filled container outside of the sterile zone, and applying outside of the sterile zone a cap to the container that overlies at least an exposed portion of the second material portion of the container. 3. A method as defined in claim 1, further comprising directing an overpressure of sterile gas within the sterile zone, and directing at least a portion of the sterile gas in a flow direction generally from an outlet end toward an inlet end of the sterile zone to, in turn, prevent fluid sterilant from contacting a container during needle filling thereof. 4. A method comprising the following steps: mounting a sealed, empty container on a conveyor, wherein the container includes a body defining an empty, sterile storage chamber therein for receiving a fat containing liquid product; a container closure; a sealing portion forming a substantially dry hermetic seal between the container closure and body; a first material portion overlying the storage chamber and defining an internal surface in fluid communication with the storage chamber forming at least most of the surface area overlying the storage chamber that can contact any fat containing liquid product subsequently filled into the storage chamber; and a second material portion that at least one of (i) overlies the first material portion and cannot contact the fat containing liquid product subsequently filled into the storage chamber, and (ii) overlies the storage chamber and forms a substantially lesser surface area overlying the storage chamber that can contact the fat containing liquid product subsequently filled into the storage chamber in comparison to the first material portion;penetrating a needle penetration region of the second material portion with a filling needle coupled in fluid communication with a source of a fat containing liquid product, and introducing the fat containing liquid product through the needle and into the storage chamber;withdrawing the filling needle from the second material portion;applying radiation to a resultant needle hole in the second material portion to hermetically seal the fat containing liquid product within the storage chamber;leaching less than a predetermined amount of leachables from the body into the fat containing liquid product and preventing the body from undesirably altering a taste profile of the fat containing liquid product filled into the storage chamber; andleaching less than the predetermined amount of leachables from the first material portion into the fat containing liquid product and preventing the first material portion from undesirably altering a taste profile of the fat containing liquid product filled into the storage chamber, wherein the predetermined amount of leachables is less than about 100 PPM. 5. A method as defined in claim 4, further comprising the steps of: moving the conveyor with the container mounted thereon through a sterile zone; andsterilizing at least an exposed portion of the second material portion of the container within the sterile zone. 6. A method as defined in claim 5, further comprising the steps of: transmitting within the sterile zone a fluid sterilant onto at least an exposed portion of the second material portion of the container and, in turn, sterilizing with the fluid sterilant at least the exposed portion of the second material portion of the container; andtransmitting within the sterile zone a heated gas onto the portion of the container exposed to the fluid sterilant, flushing away with the heated gas the fluid sterilant from at least the exposed portion of the second material portion of the container and, in turn, forming a needle penetration region of the second material portion substantially free of fluid sterilant. 7. A method as defined in claim 4, wherein the first material portion is selected from the group including (i) a low mineral oil or mineral oil free thermoplastic; (ii) a low mineral oil or mineral oil free thermoplastic defining a durometer within the range of about 20 Shore A to about 50 Shore A; (iii) a liquid injection moldable silicone; and (iv) a silicone. 8. A method as defined in claim 4, wherein the second material portion is a thermoplastic elastomer that is heat resealable to hermetically seal the needle hole 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 needle hole formed in the needle penetration region thereof in a predetermined time period of less than or equal to about 5 seconds and substantially without burning the needle penetration region. 9. A method as defined in claim 4, wherein the second material portion is a thermoplastic elastomer that is heat resealable to hermetically seal the needle hole 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 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 the needle hole formed in the needle penetration region thereof 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 needle and second material portion during needle penetration thereof. 10. A method as defined in claim 4, wherein the second material portion is a thermoplastic elastomer that is heat resealable to hermetically seal the needle hole 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 needle hole formed in the needle penetration 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 needle and second material portion during needle penetration thereof. 11. A method as defined in claim 4, wherein the first material portion defines an aperture, the second material portion overlies the aperture, and the aperture constitutes less than about 10% of the surface area of the first material portion exposed to the storage chamber. 12. A method as defined in claim 4, further comprising the step of interposing the first material portion entirely between the second material portion and any fat containing liquid product filled into the storage chamber and thereby preventing contact between the second material portion and fat containing liquid product during storage thereof in the container. 13. A method as defined in claim 4, further comprising the step of co-molding the first material portion with the second material portion. 14. A method as defined in claim 4, further comprising the step of compressing the second material portion inwardly in at least the needle penetration region thereof to facilitate resealing a needle hole formed therethrough. 15. A method as defined in claim 4, wherein the second material portion is approximately dome-shaped to compress itself inwardly. 16. A method as defined in claim 4, wherein the first material portion defines a peripheral flange that is releasably connectable to the body, the peripheral flange includes a plurality of peripheral flange portions angularly spaced relative to each other, and at least one of the peripheral flange and the body defines a raised securing surface, and the other defines a corresponding recessed securing surface engageable with the raised surface, and further comprising the step of securing at least one of the peripheral flange and the body to the other by engaging the raised securing surface and correspondingly recessed securing surface. 17. A method as defined in claim 4, wherein the container further comprises a securing a securing member connectable between the container closure and body for securing the container closure to the body, the first material portion defines a peripheral flange, and at least one of the peripheral flange and securing member defines a relatively raised surface, and the other defines a relative recessed surface, and further comprising the step of receiving within the peripheral flange the relatively raised surface and interlocking the first material portion and securing member to each other. 18. A method as defined in claim 4, further comprising snap fitting the first material portion to the body, and threadedly engaging a securing member between the container closure and body. 19. A method as defined in claim 4, further comprising mounting a plurality of containers on the conveyor, wherein the mounting step comprises mounting the containers onto container supports therefor, filling the containers through a plurality of needles spaced relative to each other and movable relative to the container supports by penetrating the containers therewith, withdrawing the needles from the containers; focusing a plurality of laser optic assemblies substantially on resultant needle holes in the second material portions of the containers, applying laser radiation from the laser optic assemblies thereto, and resealing the needle holes. 20. A method as defined in claim 19, further comprising: moving the conveyor though a sterile zone located between an inlet end and an outlet end of a housing in a direction from the inlet end toward the outlet end;transmitting, at a fluid sterilant station within the sterile zone, a fluid sterilant from a fluid sterilant source onto at least an exposed portion of the second material portion including the needle penetration region and sterilizing at least the exposed portion; andtransmitting, within at least one sterilant removing station located within the sterile zone between the fluid sterilant station and the outlet end of the housing, a heated gas from a heated gas source onto a container to flush away fluid sterilant thereon;wherein the needles and laser optic assemblies are located within the sterile zone between the at least one sterilant removing station and the outlet end of the housing for receiving the sterilized containers therefrom. 21. A method as defined in claim 20, wherein the fluid sterilant is hydrogen peroxide. 22. A method as defined in claim 20, further comprising creating an overpressure of sterile gas from a source of sterile gas coupled in fluid communication with the sterile zone, and directing a flow of the sterile gas within the sterile zone 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 the needles. 23. A method as defined in claim 20, 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 portion of the container located below the container supports from contaminating the sterile portion of the container. 24. A container for storing a fat containing liquid product, wherein the container is penetrable by a needle for aseptically filling a storage chamber of the container through the needle with the fat containing liquid product, and a resulting needle aperture is radiation resealable to seal the fat containing liquid product within the container, the container comprising: a body defining a storage chamber therein for receiving the fat containing liquid product, wherein the body does not leach more than a predetermined amount of leachables into the fat containing liquid product and does not undesirably alter a taste profile of the fat containing liquid product;a container closure;a first material portion overlying the storage chamber and defining an internal surface in fluid communication with the storage chamber forming at least most of the surface area overlying the storage chamber that can contact any fat containing liquid product within the storage chamber and that does not leach more than the predetermined amount of leachables into the fat containing liquid product or undesirably alter a taste profile of the fat containing liquid product, wherein the predetermined amount of leachables is less than about 100 PPM;a second material portion that at least one of (i) overlies the first material portion and cannot contact any fat containing liquid product within the storage chamber, and (ii) overlies the storage chamber and forms a substantially lesser surface area overlying the storage chamber that can contact any fat containing liquid product within the storage chamber in comparison to the first material portion, wherein the second material portion is needle penetrable for aseptically filling the storage chamber with the fat containing liquid product, and a resulting needle aperture formed in the second material portion is radiation resealable to seal the fat containing liquid product within the storage chamber;a sealing portion engageable with the body prior to aseptically filling the storage chamber with the fat containing liquid product and forming a substantially dry hermetic seal between the container closure and body; anda securing member connectable between the container closure and body for securing the container closure to the body. 25. A container as defined in claim 24, wherein the first material portion is selected from the group including (i) a low mineral oil or mineral oil free thermoplastic; (ii) a low mineral oil or mineral oil free thermoplastic defining a durometer within the range of about 20 Shore A to about 50 Shore A; (iii) a liquid injection moldable silicone; and (iv) a silicone. 26. A container as defined in claim 24, wherein the first material portion defines an aperture, the second material portion overlies the aperture, and the aperture constitutes less than about 10% of the surface area of the first material portion exposed to the storage chamber. 27. A container as defined in claim 24, wherein the first material portion is interposed entirely between the second material portion and any fat containing liquid product stored within the storage chamber to thereby prevent contact between the second material portion and fat containing liquid product during storage thereof in the container. 28. A container as defined in claim 24, wherein the first material portion is co-molded with the second material portion. 29. A container as defined in claim 24, wherein the second material portion is compressed inwardly in at least the needle penetration region thereof to facilitate resealing a needle hole formed therethrough. 30. A container as defined in claim 29, wherein the second material portion is approximately dome-shaped to compress itself inwardly. 31. A container as defined in claim 24, wherein the first material portion defines a peripheral flange that is releasably connectable to the body, the peripheral flange includes a plurality of peripheral flange portions angularly spaced relative to each other, and at least one of the peripheral flange and the body defines a raised securing surface, and the other defines a corresponding recessed securing surface engageable with the raised surface for securing at least one of the peripheral flange and the body to the other. 32. A container as defined in claim 24, wherein the first material portion defines a peripheral flange, and at least one of the peripheral flange and securing member defines a relatively raised surface, and the other defines a relative recessed surface for receiving therein the relatively raised surface and interlocking the first material portion and securing member to each other. 33. A container as defined in claim 24, wherein the first material portion is snap fit to the body, and the securing member is threadedly engageable with the body. 34. A container as defined in claim 24, wherein the container closure includes the second material portion. 35. A container as defined in claim 34, wherein the container closure includes the first material portion. 36. A container closure as defined in claim 24, wherein the body defines an aperture in fluid communication with the storage chamber, the container closure includes the first and second material portions and the first and second material portions are receivable within the aperture for hermetically sealing the storage chamber. 37. An assembly comprising a container as defined in claim 24, a filling apparatus comprising a needle manifold including a plurality of needles spaced relative to each other and movable relative to a container support for penetrating a plurality of containers mounted on the support within the filling apparatus, filling the containers through the needles, and withdrawing the needles from the filled containers; and a plurality of assemblies connectable to a source of radiation for applying radiation to the second material portion and resealing the needle aperture. 38. An assembly as recited in claim 37, further comprising: a housing defining an inlet end, an outlet end, and a sterile zone between the inlet and outlet ends;a conveyor located at least partially within the sterile zone 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 zone;a fluid sterilant station located within the sterile zone and coupled in fluid communication with a source of fluid sterilant for transmitting fluid sterilant onto at least an exposed portion of the second material portion of a respective container supported on the conveyor within the fluid sterilant station and sterilizing at least the exposed portion of the second material portion defining the needle penetration region of the respective second material portion; andat least one sterilant removing station located within the sterile zone 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 the 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 needle manifold and assemblies are located within the sterile zone between the at least one sterilant removing station and the outlet end of the housing for receiving the sterilized containers therefrom. 39. An assembly as defined in claim 38, wherein the fluid sterilant is hydrogen peroxide. 40. An assembly as defined in claim 38, further comprising a source of sterile gas coupled in fluid communication with the sterile zone for creating an over pressure of sterile gas within the sterile zone, 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 the needle manifold. 41. An assembly as defined in claim 38, 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 portion of the container located below the container supports from contaminating the sterile portion of the container.
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