HK1135361A - Ready to drink container with nipple and needle penetrable and laser resealable portion, and related method - Google Patents

Description

Ready-to-drink container with nipple and needle penetrable and re-laser sealable portion and related methods

Cross Reference to Related Applications

Priority of U.S. provisional application No.60/790,684, filed 2006, month 4, day 10, the contents of U.S. provisional application No.60/790,684 are incorporated by reference in their entirety as part of this disclosure.

Technical Field

The present invention relates to a container having a container closure penetrable by a needle for filling the container with a product and resealable to seal the product within the container, the container including a nipple for dispensing the product within the container, and related methods of making and filling such containers.

Background

Prior art needle penetrable and laser resealable containers include a thermoplastic elastomer ("TPE") stopper or plug portion that is penetrable by a needle to fill the container with product through the needle and that is resealable to the resulting needle hole by application of laser radiant heat thereto to seal the product within the container. One disadvantage of such TPE stoppers is that they can be difficult to use with fat containing liquid products, such as infant or toddler formula, or other milk-based or low acid products. For example, many TPE materials contain leachables that may leach into the fat containing liquid product or otherwise may undesirably alter the taste of the product.

Conventional containers and conventional systems for aseptically filling containers with fat containing liquid products, such as infant or toddler formula or other milk-based or low acid products, utilize containers having an opening and a screw cap or other similar type of cap that is secured over the opening after aseptically filling the container with the product. In some such systems, the open container is pre-sterilized by flushing the interior and exterior surfaces of the open container with a fluid sterilant, such as peroxide vapor or vaporized hydrogen peroxide, to sterilize the food contact surfaces. The container is then flushed with hot sterile air to re-evaporate any fluid sterilant that condenses on the container surfaces and to flush away the sterilant. After flushing with hot sterile air, the open container is filled with the desired product through the opening of the container and, after filling, the container is capped to seal the product within the container. Typically, the sterilization, flushing, filling and capping processes are all performed within the same sterile zone of the filling system.

One disadvantage of this type of filling system is that it can be difficult to remove all of the fluent sterilant on the interior surfaces of the container, thereby leaving a residue of hydrogen peroxide-like sterilant within the container and thus contaminating the product filled into the container. If the residue level is high enough, the product must be discarded. In addition, the sterilant residues may also negatively affect the taste or gustatory of the product.

Another disadvantage of this prior art system is that: because the sterilization, flushing, filling and capping processes are all performed within the same sterile zone, the apparatus for creating the sterile zone tends to be relatively large and complex. Moreover, because the product is openly filled (i.e., poured into the opening of the container), the product is not contained as well within the sterile zone as expected, thereby creating hygiene issues within the sterile zone. Such devices may require more frequent cleaning than desired, for example, due to the accumulation of sterilant and/or product residue within the sterile zone. Cleaning such large and complex devices can result in significant down time and expense. Thus, such prior art systems may have undesirably short run times between cleaning and sterilization of the sterile zone. Another disadvantage of such a system is that: because they sterilize, fill, and seal the package within the same enclosure and sterile field, if any portion of the system fails, the entire system must undergo cleaning in place ("CIP") and sterilization in place ("SIP") procedures prior to restart, which may further result in significant downtime and expense.

Another disadvantage of this prior art system is that: the container is filled directly prior to capping, which results in a poor closure seal due to the presence of wet product at the sealing surface or interface.

A further disadvantage of the prior art containers and systems for filling containers with fat-containing liquid products, such as infant or baby formulas, or other milk-based or low-acid products, is that: in order to drink or dispense a product, a screw cap or other type of closure must first be removed from the opening of the container. The product is then poured into another container, such as a baby bottle with a nipple, or the container closure with the nipple is screwed onto the opening of the container. Not only can these procedures be inconvenient and time consuming, but they can also result in spillage and/or contamination of the product.

Another disadvantage of this prior art system is that: in many cases, the product must be sterilized after filling by a retort process that may undesirably alter the taste of the product.

It is therefore an object of the present invention to overcome one or more of the above-mentioned disadvantages and drawbacks of the prior art.

Disclosure of Invention

According to a first aspect, the present invention relates to a container for storing a product, wherein the container is penetrable by an injection member like a filling needle for aseptically filling the container with the product through the injection member, and a resulting penetration hole in the container is thermally resealable to seal the product within the container. The container includes a body defining a chamber for containing a product and a container closure for sealing the product within the container. The container closure comprising a seal forming a substantially fluid-tight seal between the container closure and the body and a nipple connectable in fluid communication with a chamber, wherein the container closure seals the chamber from ambient atmosphere during storage of product in the chamber and can be opened to dispense product from within the chamber; and a penetrable and thermally resealable portion penetrable by the injection member for aseptically filling the chamber with the product through the injection member and thermally resealable to seal the product within the chamber.

According to another aspect, the container closure comprises one of: (i) a penetrable and thermally resealable portion, (ii) a nipple, or (iii) a penetrable and thermally resealable portion and nipple.

According to another aspect, the nipple includes a sealing member movable between a first position sealing the nipple and a second position opening the nipple and allowing product in the storage chamber to be dispensed through the nipple. In one embodiment of the invention, the sealing member is frangibly connected to the nipple such that in said first position the sealing member is connected to the nipple and in said second position the sealing member is separated from the nipple to form at least one opening in the nipple to allow product to be dispensed therethrough. In certain embodiments of the invention, the container closure defines a central region and the nipple is laterally spaced relative to the central region.

According to another aspect, the nipple is defined by a first material portion that forms an interior surface in fluid communication with the chamber and defines at least a majority of a surface area of the container closure that may contact any product within the chamber. The penetrable and thermally resealable portion is defined by a second material portion that satisfies at least one of the following conditions: (i) overlying the first material portion and unable to contact any product within the chamber, and (ii) forming a substantially smaller surface area of the container closure that can contact any product within the chamber than the first material portion.

In one embodiment of the invention, the product is a fat-containing liquid product; the subject does not leach more than a predetermined amount of leachables into the fat containing liquid product and does not undesirably alter the taste of the fat containing liquid product; the first material portion does not leach more than a predetermined amount of leachables into the fat containing liquid product or undesirably alter the taste of the fat containing liquid product; and the predetermined amount of leachables is less than about 100 PPM.

The container closure preferably further comprises a sealing portion engageable with the body prior to aseptically filling the chamber with the product and forming a substantially dry seal between the container closure and the body. In one embodiment of the invention, the container closure further comprises a securing portion connectable to the body for securing the container closure to the body. In some embodiments of the invention, the retainer portion is threadably or snap-fit onto the body. In one such embodiment, the securing element is more rigid than and is interposed between the nipple and the penetrable and resealable portion.

According to another aspect, the container closure includes an injection member contacting surface that contacts the injection member during withdrawal of the injection member from the penetrable and resealable portion to remove product thereon. In certain embodiments of the invention, the injection member contacting surface extends around a peripheral portion of the injection member and is in contact with the injection member. Preferably, the injection member contacting surface is located below the penetrable and thermally resealable portion and is defined by the first and/or second material portions. In certain embodiments of the present invention, the second material portion is compressed inwardly in the region of penetration thereof to facilitate resealing of the perforation formed therethrough.

In some embodiments of the invention, the first material portion is selected from the group comprising: (i) low mineral oil or mineral oil free thermoplastics; (ii) a low mineral oil or mineral oil free thermoplastic having a hardness in the range of about 20 Shore A to about 50 Shore A; (iii) liquid injection moldable silicone; and (iv) silicone.

In certain embodiments of the present invention, the penetrable and thermally resealable portion is a thermally resealable thermoplastic elastomer to seal the perforation by application of laser radiation of 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 of the predetermined wavelength and substantially prevents radiation from passing through the predetermined wall thickness thereof, and (iii) a predetermined color and opacity that causes the laser radiation of the predetermined wavelength and power to seal the perforation in a predetermined time that is less than or equal to about 5 seconds without burning the predetermined color and opacity of the second material portion.

Also in certain embodiments of the present invention, the penetrable and thermally resealable portion is a thermally resealable thermoplastic elastomer to seal the perforations by application of laser radiation of a predetermined wavelength and power thereto, and comprises (i) a styrenic block polymer; (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 radiation from passing through its predetermined wall thickness, and allows the pinhole to be sealed in a predetermined time that is less than or equal to about 5 seconds; and (iv) a predetermined amount of lubricant that reduces friction at the interface of the injection element and the second material portion during penetration of the injection element.

Also in certain embodiments of the present invention, the penetrable and thermally resealable portion is a thermally resealable thermoplastic elastomer to seal the perforations by application of laser radiation of a predetermined wavelength and power thereto, and includes (i) a first polymeric material having a weight in a range of about 80% to 97% that defines a first elongation; (ii) a second polymeric material in a range of about 3% to about 20% by weight defining a second elongation that is less than the first elongation of the first polymeric material; (iii) an amount of pigment that allows the second material portion to substantially absorb laser radiation at the predetermined wavelength and substantially prevent radiation from passing through its predetermined wall thickness, and allows the perforation to be sealed in a predetermined time that is less than or equal to about 5 seconds; and (iv) an amount of lubricant that reduces friction at the interface of the injection element and the second material portion during penetration of the injection element.

In some embodiments of the invention, the container closure further comprises a first relatively rigid container closure element mounted on the body, a substantially fluid-tight seal formed between the first relatively rigid container closure element and the body, and a second relatively rigid container closure element mounted on the first relatively rigid container closure element. At least a portion of the nipple and/or the penetrable and thermally resealable portion is secured between the first and second relatively rigid container closure elements. In some such embodiments, the nipple defines a bottom extending around a perimeter of the nipple and seated between the first and second relatively rigid container closure elements, and the needle penetrable and thermally resealable portion defines a bottom seated between the first and second relatively rigid container closure elements. In some such embodiments, each base is compressed between first and second relatively rigid container closure elements.

According to another aspect, the present invention relates to a container for storing a product, wherein the container is penetrable by an injection member like a filling needle for aseptically filling the container with the product through the injection member, and a resulting penetration hole in the container is thermally resealable to seal the product within the container. The container includes: a first means for providing a chamber containing the product; and second means for closing the chamber of the first means. The second means comprises third means for forming a substantially fluid-tight seal between the first means and the second means; fourth means inserted in the mouth of the user and through which the product is sucked out of the chamber by the mouth; fifth means for sealing the fourth means during storage of the product in the chamber and opening the fourth means prior to dispensing the product; and sixth means for allowing the injection member to penetrate the second means to fill the chamber with product through the injection member and for heat-resealing the second means to seal the product within the chamber.

In certain embodiments of the invention, the first device is a container body; the second device is a container closure; the third means is a sealing element; the fourth device is a nipple; the fifth means is a sealing member movable between a first position sealing the nipple and a second position opening the nipple and allowing product in the storage chamber to be dispensed through the nipple; whilst the sixth means is a penetrable and thermally resealable elastic portion that is penetrable by the injection member for aseptically filling the chamber with the product through the injection member and that is thermally resealable for sealing the product within the chamber by laser radiation applied thereto.

The invention also relates to an assembly comprising a container as described above in combination with a filling device. The filling device includes a needle manifold including a plurality of needles spaced from one another and movable relative to the container support for penetrating a plurality of containers mounted on the support within the filling device, filling the containers with the needles, and withdrawing the needles from the filled containers. The filling apparatus further includes a plurality of laser optic assemblies, wherein each laser optic assembly is connectable to a source of laser radiation and focuses substantially on a point of penetration on the penetrable and resealable portion of the respective container closure to thereby apply laser radiation thereto and reseal the respective needle penetration aperture.

According to one embodiment of the present invention, a filling apparatus includes a housing defining an inlet end, an outlet end, and a sterile zone therebetween. The conveyor of the apparatus is located at least partially within the sterile zone and defines a plurality of container positions thereon for supporting and moving containers through the sterile zone in a direction from the inlet end toward the outlet end. A fluid sterilant station is located within the sterile zone and is connected in fluid communication with the source of fluid sterilant for delivering fluid sterilant to the container closures of respective containers supported on the conveyor within the fluid sterilant station and sterilizing the exposed penetrable and thermally resealable portions of the respective container closures. One or more sterilant removing stations are located in the sterile zone between the fluid sterilant station and the outlet end of the housing and are connected in fluid communication with a source of gas for delivering gas to the containers supported on the conveyor in the sterilant removing station to flush the fluid sterilant from the containers. The needle manifold and laser optic assembly are located within the sterile zone between the sterilant removal station and an outlet end of the housing for receiving the sterilized containers from the sterilant removal station.

In one embodiment of the invention, the fluid sterilant is hydrogen peroxide. In one embodiment of the present invention, the filling apparatus further comprises a sterile gas source connected in fluid communication with the sterile zone for creating an overpressure 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 the flow of fluid sterilant from flowing onto the containers adjacent the needle manifold. In one embodiment of the invention, the conveyor comprises a plurality of pivotally mounted container supports engaging opposite sides of each container supported thereon opposite one another and substantially isolating a container sterile portion located on the container supports from a container portion located below the container supports to thereby prevent contaminants from a lower portion of the containers from contaminating the sterile upper portion of the containers.

According to another aspect, the present invention is directed to a method of filling a container with a product, storing the product within the container, and dispensing the product from the container. The method comprises the following steps:

(i) providing a container comprising a container body, a container closure sealing the chamber from ambient atmosphere, a first portion penetrable by the injection element and thermally resealable upon removal of the injection element, and a second portion forming a nipple in fluid communication with the chamber, wherein the container body defines a sealed sterile cavity chamber for containing a product, the nipple being openable to dispense the product from the chamber and sealable to ambient atmosphere during storage of the product in the chamber;

(ii) inserting an injection member through the first portion of the container and aseptically directing the product through the injection member and into the chamber;

(iii) withdrawing the injection element from the first portion of the container;

(iv) heat-resealing the perforation thus formed in the first portion of the container and sealing the chamber and the product contained therein from the ambient atmosphere;

(v) aseptically storing the product within a sealed chamber; and

(vi) the nipple is opened, the nipple is inserted into the user's mouth, and product is dispensed through the nipple and into the user's mouth.

In certain embodiments of the invention, the method further comprises the step of storing the product within the sealed chamber for a period of at least five days.

In some embodiments of the invention, the method further comprises the steps of:

(vii) installing sealed empty containers on a conveyor belt and moving the conveyor belt through the sterile zone;

(viii) delivering a fluid sterilant to at least the exposed portion of the first portion of the container within the sterile zone and sterilizing at least the exposed portion with the fluid sterilant;

(ix) delivering gas within the sterile zone onto the portion of the container exposed to the fluid sterilant, flushing at least the exposed portion of the first portion of the container with said gas and forming at least a penetration zone substantially free of the first portion of the fluid sterilant;

(x) Penetrating said penetration zone of the first portion with a filling needle connected in fluid communication with the source of product and directing the product through the needle and into the chamber;

(xi) Withdrawing the filling needle from the first portion of the container; and

(xii) Laser radiation is applied to the pin hole thus formed in the first portion and the first portion is heat resealed and the product within the chamber is aseptically sealed.

In some embodiments of the invention, the product is a fat-containing liquid product and the method further comprises the steps of: providing a container body that does not leach more than a predetermined amount of leachables into the fat containing liquid product and does not undesirably alter the taste of the fat containing liquid product; providing a container closure assembly comprising a second portion defining an interior surface forming at least a majority of a surface area of the container closure and in fluid communication with the chamber, the interior surface being contactable with any fat containing liquid product contained within the chamber and not leaching more than a predetermined amount of leachables into or undesirably altering the taste of the fat containing liquid product. It is preferred that the predetermined amount of extractables is about 100PPM and the first portion meets at least one of the following conditions: (i) overlying the second portion and being incapable of contacting any fat-containing liquid product contained within the chamber, and (ii) forming a container closure surface area that is substantially smaller than the second portion and that is capable of contacting any fat-containing liquid product contained within the chamber.

In certain embodiments of the present invention, the method further comprises directing an overpressure of sterile gas within the sterile zone and directing at least a portion of the sterile gas in a direction generally of flow from the outlet end toward the inlet end of the sterile zone to prevent the fluid sterilant from contacting the container during needle filling.

One advantage of the present invention is that the product is aseptically filled, i.e., filled into sealed, empty sterile containers through needles and other injection members and laser resealed the resulting perforations. The user can then drink directly from the aseptically filled and stored container through the teat, which is sealed during the storage and shelf life of the container to maintain the sterility of the product.

Other advantages of the present invention will become apparent from the following detailed description of the presently preferred embodiments and the accompanying drawings.

Drawings

Fig. 1 is an upper perspective view of a first embodiment of the container of the present invention.

Fig. 2 is a cross-sectional view of the container of fig. 1.

Fig. 3 is an exploded cross-sectional view of the container of fig. 1.

Fig. 4 is a partial cross-sectional view of a nipple of the container of fig. 1.

Fig. 5 is a top plan view of the nipple of fig. 4.

Fig. 6 is a partial cross-sectional view of the nipple of fig. 4 showing the frangibly connected sealing element.

Fig. 7 is a cross-sectional view of a second embodiment of the container of the present invention.

Fig. 8 is an exploded cross-sectional view of the container of fig. 7.

Fig. 9 is an exploded cross-sectional view of a third embodiment of the container of the present invention.

Fig. 10 is a cross-sectional view of the container of fig. 9.

Fig. 11 is an exploded cross-sectional view of the container of fig. 9.

Fig. 12 is an exploded perspective view of a fourth embodiment of the container of the present invention.

Fig. 13 is a cross-sectional view of the container of fig. 12.

Fig. 14 is an exploded cross-sectional view of the container of fig. 12.

Fig. 15 is a side view of an apparatus for needle filling and laser resealing a container.

Fig. 16 is a perspective view of the device of fig. 15.

Detailed Description

In fig. 1-3, a container embodying the present invention is indicated generally by the reference numeral 10. As described further below, the container 10 may be penetrated by an injection member, like a filling needle, for aseptically filling the container with a product through the injection member, and the resulting penetration hole in the container may be thermally resealed, e.g., by application of laser energy thereto, to seal the product within the container. The container 10 includes a body 12 and a container closure 16, the body 12 defining a chamber 14 for containing a product, the container closure 16 including a sealing portion 18, the sealing portion 18 extending around a periphery of the container closure and forming a substantially fluid tight seal between the container closure and the body 12. The nipple 20 of the container closure 16 is in fluid communication with the chamber 14. As described further below, the nipple 20 seals the chamber 14 from the ambient atmosphere during storage of the product in the chamber, and in preparation for drinking, the nipple 20 may be opened to dispense the product from the chamber therethrough. The container closure 16 further includes a penetrable and thermally resealable portion or stopper 22. As described further below, the stopper 22 is penetrable by the injection member for aseptically filling the chamber 14 with the product therethrough, and is thermally resealable, such as by application of laser radiation thereto, to seal the product within the chamber. The container closure 16 further includes a securing portion in the form of a cap 24 attachable to the body 12 for securing the container closure to the body. In this embodiment, the closure cap 24 includes a plurality of internal threads 26, while the body includes a plurality of corresponding external threads 28 to threadably secure the container closure to the body. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the container closure may be secured to the body in any of numerous other ways that are currently known, or that later become known, such as by snap-fitting (snip-fit). For example, the container closure or body may include one or more raised portions that are received in one or more recesses of the body or container closure to secure them together.

As can be seen, in this embodiment, the sealing element 18 and the teat 20 are integrally formed with each other in the first material portion 30. In this embodiment, the plug 22 is formed from a second material portion that is formed from a different material than the first material portion 30. As can be seen, the first material portion 30 defines a recess 32 in its approximate center region for receiving therein a plug seat 34 formed in the cap 24, and the plug 22 is received in the plug seat 34. The stopper seat 34 defines an injection member aperture 36 formed in a bottom wall thereof for receiving therethrough an injection member, such as a filling needle, during needle filling of the container 10. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the stopper, nipple, and seal may be formed of the same material and/or may be integrally formed with one another, such as by co-molding (co-molding). For example, if desired, the plug 22 may be molded onto the first material portion 30, or vice versa, or one material portion may be stacked onto the other material portion and the two material portions may be mechanically compressed together, such as by other vessel closing components. In each case, the layers of the first and second material portions are sealed together, for example by mechanical compression, co-moulding or insert moulding, to prevent bacteria from spreading between the two layers and into the product inside the chamber 14.

The first material portion 30 further defines an injection member contact surface 38, the injection member contact surface 38 being aligned with the injection member aperture 36 of the cap 24 and contacting the injection member during movement of the injection member through the stopper 22 to dislodge therefrom any product residue on the injection member as it is withdrawn from the stopper. In this embodiment, the injection member contacting surface 38 is formed by the inner annular surface of a substantially cylindrical boss (boss)40, the boss 40 extending downwardly from a bottom wall 42 of the plug recess 32. As can be seen, the bottom wall 42 of the plug recess forms a barrier between the plug 22 and the chamber 14 and thereby substantially prevents any contact between the plug and the product stored within the chamber 14. Although the bottom wall 42 is penetrated by the injection member, it is only necessary to re-heat-seal the stopper 22 in order to seal the product in the chamber. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, injection member contacting surface 38 may take any of numerous different shapes that are currently known, or that later become known, and/or may be formed of a second material portion, a closure cap, or vice versa.

As representatively shown in fig. 4-6, the nipple 20 includes a sealing member 44, the sealing member 44 being movable between a first position (as shown) sealing the nipple and a second position (not shown) opening the nipple and allowing product in the storage chamber 14 to be dispensed therethrough. In this embodiment, the sealing element 44 is connected to the nipple 20 at a frangible portion 46, the frangible portion 46 extending between the nipple tip and a hand-engageable portion or handle 48 of the sealing element. 4-6, the sealing member 44 is connected with the nipple to thereby seal the interior of the nipple and thus the chamber 14 and the product contained therein from the ambient atmosphere. However, as shown in phantom in FIG. 6, the frangible portion 46 of the sealing element 44 is breakable substantially along the phantom line 50. Also shown in fig. 6, the dashed line 50 is located in an annular recess 52 formed in the interior of the nipple tip. In operation, to drink product from the container, the user manually engages the handle 48 and pulls the sealing element 44 away from the nipple 20. Upon application of sufficient force, the frangible portion 46 breaks away from the nipple 20 substantially along the dashed line. As shown in fig. 6, the sealing member defines an internal elongated recess or aperture 54 in fluid communication with the interior of the nipple 20 and the chamber 14. Thus, when the sealing member 44 is removed, the aperture 54 extends through the nipple tip and defines a drinking and venting orifice to allow product to flow outwardly through the nipple and air or other gas to flow into the chamber through the nipple. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the sealing element and nipple may take any of numerous different configurations that are currently known, or that later become known. For example, the sealing element may be formed by a plug that is received within a fluid aperture formed in the teat and is manually engaged and removed when the product is ready to be drunk. Alternatively, the sealing element may take the form of a projection or nipple formed on the teat which is cut or removed from the teat to expose one or more underlying fluid flow apertures through the teat.

In a presently preferred embodiment of the invention, the product contained within the storage chamber is a fat containing liquid product. The fat-containing liquid product may be any of numerous different products that are currently known, or that later become known, including, but not limited to, infant or toddler formula, growing-up milk, cream, half-blends of both (half and halfs), yogurt, ice cream, juice, syrup, dressings, milk-based or dairy-containing products, liquid nutritional products, liquid health products, and pharmaceutical products. As can be seen in fig. 2, the first material portion 30 defines an interior surface forming at least a majority of the surface area of the container closure 16 in fluid communication with the storage chamber 14 that can contact any fat-containing liquid product within the storage chamber and does not leach more than a predetermined amount of leachables into the fat-containing liquid product or undesirably alter the taste perception of the fat-containing liquid product. In this embodiment, the first material portion 30 is located beneath the plug 22 and cap 24 and thus defines substantially all of the surface area of the container closure that may contact any fat containing liquid product within the storage chamber 14.

The term "leachables" is used herein to refer to any chemical compound (volatile or non-volatile) that leaches into the product in the container from the components of the container during the useful shelf life of the product. A typical leachable to be avoided in connection with fat containing liquid nutritional products like infant or baby formulas is mineral oil. Thus, as noted below, in exemplary embodiments of the present invention, the first material portion 30 is free of mineral oil, or contains a very small amount of mineral oil, so as not to leach mineral oil into the fat-containing liquid nutritional product, or substantially leach mineral oil into the fat-containing liquid nutritional product (i.e., if any mineral oil is leached into the product, any amount is below the maximum amount permitted by applicable regulatory guidelines for the respective product, such as FDA or LFCA guidelines). In accordance with the present invention, the container closure 16 does not leach more than a predetermined amount of leachables into the product. The predetermined amount of leachables is less than about 100PPM, preferably less than or equal to about 50PPM, and most preferably less than or equal to 10 PPM.

The second material portion or plug 22(i) overlies the first material portion 30 as shown such that the first material portion forms a barrier between the plug or second material portion and the product within the storage chamber 14, or (ii) forms a surface area of the container closure 16 that can contact any fat containing liquid product within the storage chamber 14 that is substantially smaller than the first material portion 30. As indicated above, the second material portion or stopper 22 is penetrable by the needle for aseptically filling the storage chamber 14 with the fat containing liquid product, and the resulting needle hole in the second material portion 22 is thermally resealable, e.g., by application of laser radiation thereto, after needle withdrawal to seal the fat containing liquid product within the storage chamber.

One advantage of the container 10 is that the sealing portion 18 of the first material portion 30 is sealed to the body 12 prior to filling the storage chamber 14 with the product and thus forms a dry seal between the container closure and the body. Thus, the container 10 provides much higher seal integrity than prior art containers that seal the lid after filling the container, thereby resulting in a more likely formation of a less reliable "wet" seal.

As also typically shown in fig. 2, the stopper 22 defines an opposing convex upper surface 44, the opposing convex upper surface 44 defining a needle penetration and heat resealable region of the stopper. In this embodiment, the opposing lobes are rounded and substantially dome-shaped. In addition, the plug 22 is co-molded with the cap 24, such as by molding the plug within the plug recess 34 of the cap, or vice versa. It is preferred that an annular gap be formed between the periphery of the plug 22 and the adjacent wall of the cap 24 and/or that the periphery of the plug 22 not be connected to the adjacent wall of the cap 24 in order to allow differential thermal expansion and contraction of the plug and cap, and to substantially prevent any such differential thermal expansion and contraction from altering the shape of the plug or affecting the ability to form a high integrity seal when thermally resealing a puncture hole formed by a needle or other injection member. One advantage of forming a needle penetrable and heat resealable stopper in a configuration that defines, for example, a dome or other curvilinear shape, is that the stopper material (i.e., the needle penetrable and heat resealable portion) remains in a compressed state and is therefore substantially self-resealing. Thus, when the injection element, e.g. a filling needle, is removed, the stopper itself compresses the needle hole thus formed, thereby closing and substantially closing said needle hole. Thus, a high integrity seal can be obtained when heat resealing, for example, by applying laser or light energy thereto. On the other hand, if the plug material is in tension, such as may occur if the periphery of the plug material is connected to the first material portion or cap, it may prevent a thermal resealing of the resulting needle hole and/or may prevent the formation of a high integrity seal. If desired, a device (not shown) may be used to place the needle penetration region of the stopper in compression during needle filling. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, while significant advantages may be obtained from constructing the stopper or having the needle penetration region of the stopper in a compressed state, these and other aspects of the stopper may take any of numerous different shapes and/or configurations that are currently known, or that later become known. Furthermore, the plug need not be co-moulded with the cap or the first material portion. For example, the plug may be press fit within a plug recess of the cap or secured within the recess by adhesive, ultrasonic welding, or other securing mechanisms that are currently known, or that later become known. Alternatively, the penetrable and resealable portion may be integrally formed with and of the same material as the first material portion.

In fig. 7 and 8, another container embodying the present invention is indicated generally by the reference numeral 110. The container 110 is substantially similar to the container 10 described above with reference to fig. 1 to 6, and therefore like reference numerals preceded by the numeral "1" are used to indicate like elements. The primary difference between the container 110 and the container 10 is that an injection member contacting surface 138 and associated projection and cylindrical wall 140 are formed at the bottom of the stopper 122. Further, the bottom wall 142 of the plug recess 21 of the second material portion 30 defines a hole 137, the hole 137 being for penetrating a projection of the cylindrical wall 140 accommodating the plug. In some cases, this embodiment may be easier to mold than the embodiments described above.

In fig. 9 through 11, another container embodying the present invention is indicated generally by the reference numeral 210. The container 210 is substantially similar to the containers 10 and 100 described above with reference to fig. 1-8, and therefore like reference numerals beginning with the numeral "2" or beginning with the numeral "2" instead of the numeral "1" are used to indicate like elements. The primary difference between container 210 and containers 10 and 110 is that the components of container closure 216 are assembled by mechanical compression. The container closure 216 further includes a first relatively rigid container closure element 256 mounted on the body 212, a sealing element 218 forming a substantially fluid tight seal between the first relatively rigid container closure 256 and the body 212, and a second relatively rigid container closure element formed by a cap 224, the cap 224 being mounted on the first relatively rigid container closure element 256 with the plug 222 and the bottom of the nipple 220 sandwiched and thereby secured between the cap 224 and the container closure element 256. If desired, the sealing member 218 may be secured to the first relatively rigid container closure member 256, such as by ultrasonic welding, the use of adhesives, co-molding, or any of numerous other attachment mechanisms that are currently known, or that later become known. The nipple 220 defines a peripheral flange 258 extending around a peripheral portion of the bottom of the nipple, the peripheral flange 258 being secured and compressed between the first and second relatively rigid container closure elements 256 and 244, respectively, to form a fluid-tight seal therebetween. Likewise, the plug 222 defines a peripheral flange 260, the peripheral flange 260 being secured and compressed between the first and second relatively rigid container closure elements 256, 244, respectively, to form a fluid-tight seal therebetween. The first relatively rigid container closure element 256 defines a substantially cylindrical projection 262 received in the bottom of the nipple 220 to support the nipple and a fluid flow aperture 264 extending through the projection for allowing fluid communication between the nipple 220 and the chamber 214. As shown in fig. 10, the cap 224 defines a first circular recess or groove 266 in the underside thereof for receiving the peripheral flange 258 of the nipple 220 therein and compressing the nipple flange 258 after the container closure 216 is attached to the body 212. The cap 224 further defines a second circular recess or groove thereunder for receiving the peripheral flange 260 of the plug 222 therein and compressing the plug flange 260 after the container closure 216 is attached to the body 212. The first relatively rigid container closure element 256 defines a sealing wall 270, the sealing wall 270 being spaced laterally relative to the receptacle 236 and the nipple projection 264 and extending about a major portion of their peripheries for contacting the plug flange 260 and the nipple flange 258, respectively, and thereby facilitating the formation of a liquid-tight seal between each of the plug and nipple and the container closure element. The cap 224 defines a nipple aperture 272 for receiving the nipple 220 therethrough and a receptacle 234 for receiving the plug 222 therein. The cover 224 defines a first connecting flange 226 extending around the bottom of the perimeter of the cover and the body 212 defines a second connecting flange 228 extending around the perimeter of the mouth of the body. The first connection flange 226 defines a tapered, axially exposed surface to facilitate sliding of the first connection flange 226 over the second connection flange 228 to snap-fit the cap 224 onto the body 212 and fixedly attach the container closure 216 to the body 212. The axial distance between the first connecting flange 226 and the underside of the cap 224 is set to define a substantially predetermined compression of the peripheral flange 258 of the nipple 220 and the peripheral flange 260 of the plug 222 to effect a fluid-tight seal when the cap 224 is snap-fitted onto the body 212. As can be seen, the container body 212 defines a shape that is axially more elongated than the container bodies 10 and 110 described above. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the components of the container body and container closure may take any of numerous different shapes and/or configurations that are currently known, or that later become known.

In fig. 12 through 14, another container embodying the present invention is indicated generally by the reference numeral 310. The container 310 is substantially similar to the containers 10, 110 and 210 described above with reference to fig. 1 to 11, and therefore reference numerals beginning with the number "3" or beginning with the number "3" instead of the number "1" or "2" are used to indicate like elements. The primary difference between container 310 and container 210 is the geometry of the container closure member. As can be seen, the first relatively rigid container closure element 356 includes a first connection flange 326, the first connection flange 326 extending around a peripheral bottom portion of the first container closure element to snap-fit and thereby secure the container closure 316 to the body 213. Further, the first material portion 330 defines a plug recess 332 for receiving the plug 322 therein and defines a bottom wall 342, the bottom wall 342 forming a barrier between the plug and the chamber 314 and thus substantially preventing any contact between the plug and any product received within the chamber 314. In the presently preferred embodiment of the invention, the material forming the first material portion 330 is sufficiently resilient to substantially reseal itself after penetration by a filling needle or like injection member, and thus substantially prevent any contact between the stopper and the product contained within the chamber 314 even after penetration by the needle and the bottom wall 342. The first material portion 330 also defines an injection member contacting surface 338 and an associated projection 340 extending downwardly from the bottom wall 324 of the plug recess 332. The peripheral flange 360 of the plug 322 defines an annular recess formed at the junction of the flange and the plug body, and the first container closure element 324 defines a corresponding annular projection formed at the inner edge of the recess 368 that is received within the annular recess of the plug to effect a fluid-tight seal. The second relatively rigid container closure member or cap 324 overlies and is secured to the first container closure member 356. In this embodiment, and as best shown in fig. 12, the first container closure member 356 includes a pair of attachment tabs 357 that are laterally spaced from one another on an upper surface of the first container closure member 356. The first material portion 330 includes a pair of protrusion holes (boss apertures) 359 for receiving the connection protrusion 357 therethrough. In this embodiment, connection projection 357 is secured to second container closure 324 by ultrasonic welding; however, the two container closure elements may be secured to one another in any of numerous other ways that are currently known, or that later become known. As can be seen, the body 312 of the container defines a different shape than the container bodies described above, and includes a relatively narrow central region to facilitate gripping of the container body. As representatively shown in phantom in fig. 13, the container 310 further includes a cap 325, the cap 325 being removably attached to the body 312 and/or the container closure 316 and forming a fluid-tight seal. The cap 325 is of a type known to those of ordinary skill in the pertinent art that seals at least the nipple 320 and the stopper 322 with respect to ambient atmosphere, preferably the entire container closure 316 as described, and forms a barrier that substantially prevents the transmission of oxygen and vapor. Each of the other embodiments of the containers (10, 110, and 210) described above preferably also include the same or similar top cover.

The sterile, empty container and closure assembly 10 can be needle filled and heat resealed in accordance with the teachings of any of the following patent applications and patents, which are hereby incorporated by reference in their entirety as part of the present disclosure: U.S. patent application No.10/766,172 entitled "medicament vial with heat-sealable lid, and apparatus and method for filling the vial" filed on 28.1.2004, which is a continuation-in-part application of similarly-named U.S. patent application No.10/694,364 filed on 27.10.2003, U.S. patent application No.10/694,364 is a continuation-in-part application of similarly-named co-pending U.S. patent application No.10/393,966 filed on 21.3.2003, U.S. patent application No.10/393,966 is a continuation-in-part application of similarly-named U.S. patent application No.09/781,846 filed on 12.2.2001, U.S. patent No.6,604,561 filed on 12.8.12.2003, U.S. patent No.6,604,561 claims the benefit of similarly-named U.S. provisional patent application No.60/182,139 filed on 11.2.2000; similarly named U.S. provisional patent application No.60/443,526, filed on 28/1/2003; U.S. provisional patent application No.60/484,204, filed on 30/6/2003, entitled similar names; U.S. provisional patent application No.10/655,455 entitled "sealed container and method of making and filling the same" filed on 3.9.2003; U.S. patent application No.10/983,178 entitled "adjustable needle filling and laser sealing apparatus and method" filed 11/5/2004; U.S. patent application No.11/070,440 entitled "apparatus and method for needle filling and laser resealing" filed on 3/2/2005; U.S. patent application No.11/074,513 entitled "apparatus for welding and assembling stoppered containers and filling said containers," filed on 7/3/2005; U.S. patent application No.11/074,454 entitled "method for welding and assembling a stoppered container and filling said container" filed on 7.3.2005; and U.S. patent application No.11/339,966 entitled "container closure having a needle penetrable and resealable upper portion and a lower portion compatible with fat containing liquid products, and related methods," filed on 25.1.2006.

As noted above, the second material portion or plug 22 is preferably co-molded with the cap 24, such as by molding the second material portion over the cap. Furthermore, the second material portion 30 may be co-moulded with the cap and the plug, for example by moulding the second material portion on top of the cap, or vice versa. If desired, the container closure may be molded in the same mold as the container body, or may be molded in an adjacent molding machine, and at least one of the container closure and body may be assembled within or adjacent to the mold in accordance with the teachings of commonly-assigned (common-assigned) U.S. patent application nos. 11/074,454 and 11/074,513, and U.S. provisional patent application No.60/727,899, entitled "apparatus and method for aseptic demolding", filed 10/17/2005, which is incorporated by reference herein, with U.S. provisional patent application No.60/727,899 being expressly incorporated by reference herein as part of this disclosure. [ renewed to include a complete demolding unit ]. One advantage of the method is that the container is substantially closed at the time of formation to define a sealed, empty sterile chamber, and the container is never opened (during filling, resealing and shelf life) until the product is dispensed. Thus, a rather high level of sterility assurance can be achieved.

In fig. 15 and 16, a typical needle filling and laser resealing means for filling and resealing the container of the present invention is generally indicated by reference numeral 58. The apparatus 58 comprises a closed loop or endless conveyor 60 for indexing (index) and thereby transporting the containers through the apparatus. Although represented by reference numeral 10 in fig. 15 and 16, they may equally be any of the other containers (containers 110, 210, and 310) disclosed herein or any of numerous other types of containers embodying one or more aspects of the present invention. The containers 10 fed into the apparatus 58 by the conveyor 60 include container closures 16 secured to the body 12, but do not include the above-mentioned caps. The inner chamber 14 of each container is rendered sterile, for example by assembling the container in a mold and/or in a sterile zone within or adjacent to the mold as described in any of the co-pending patent applications incorporated by reference above, by emitting radiation, such as gamma or electron beam radiation, on the sealed, empty container closure and body combination, or by applying a fluid sterilant, such as vaporized hydrogen peroxide. The apparatus 58 includes an elongated housing 62 defining a sterile zone 64 within the interior thereof, with the conveyor 60 on which the containers 10 are placed passing through the housing 62. The term "sterile zone" as used herein is within the meaning of the applicable regulatory guidelines as promulgated, for example, by the FDA (united states food and drug administration) or other country or applicable regulatory agency, and including applicable low acid canned food ("LACF") regulations, and is preferably defined by a commercial sterile zone maintained sterile by an overpressure of sterile air in a manner known to those of ordinary skill in the relevant art. In this embodiment, the housing 62 includes side walls formed from transparent panels to allow an operator to view the interior of the device. However, if desired, the side walls may be opaque, or may include a different arrangement of opaque and transparent portions than shown. As shown, one or more side panels may be mounted to the housing frame by hinges 61 in order to pivot the respective side panel outwardly to provide access into the housing, for example for maintenance and/or repair. Otherwise, the side walls and top wall of the housing 62 are sealed from the ambient atmosphere to maintain the sterility of the sterile zone 64.

The apparatus 58 includes an entrance transfer station 66 at its entrance end through which the conveyor 60 passes to transfer containers 10 mounted on the conveyor 60 into the sterile zone 64. A sterilization station 68 is located within housing 62 and includes one or more sterilization heads 70 connected to a source (not shown) of a fluid sterilant, such as hydrogen peroxide, vaporized hydrogen peroxide sterilant ("VHP"), or other fluid sterilant now known or hereafter known, sterilization heads 70 for delivering the fluid sterilant to the exterior surfaces of the containers for sterilization thereof, wherein housing 62 is located immediately downstream of inlet transfer station 66 in the direction of conveyor movement (clockwise in fig. 15 and 16). The apparatus 58 further includes a first sterilant removing station 72 downstream of the sterilizing station 68 in the direction of belt travel and a second sterilant removing station 74 downstream of the first sterilant removing station 72 within the housing 62. Each sterilant removing station 72, 74 includes one or more respective sterilant flushing heads 76, the sterilant flushing heads 76 being adapted to deliver sterile hot air or other gas onto the exterior surfaces of the containers at a sufficient temperature, flow rate and/or volume for a sufficient period of time to substantially completely remove the fluid sterilant from the exterior surfaces of the containers. Vaporized hydrogen peroxide can condense at least partially on the surfaces of the containers and/or conveyor belt, and it is therefore desirable to flush these surfaces with sterile hot air or other gas to re-vaporize any condensed hydrogen peroxide and flush it out of the sterile zone. In a presently preferred embodiment, the temperature of the sterile air is at least about 60 ℃; however, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the temperature may be set as desired or otherwise required for a particular application. A needle filling station 78 is located within the housing 62 downstream of the second sterilant removing station 74 for needle filling each container 10 with product from a product filling tank 80, and first and second laser resealing stations 82 and 84, respectively, are located downstream of the needle filling station 78 for laser resealing the needle aperture thus formed in the stopper of the container after filling the container and withdrawing the needle. An exit transfer station 86 is located downstream of the laser resealing stations 82, 84 for transferring the filled containers 10 on the conveyor 60 out of the sterile zone 64. After leaving the sterile zone 64, the containers 10 are capped and ready for transport.

The overpressure of sterile air or other gas is provided by a sterile gas source 88 comprising one or more suitable filters, such as HEPA filters, for sterilizing the air or other gas prior to introduction into the sterile zone 64. A fluid line 90 is connected in fluid communication between the sterile air source 88 and the sterile zone 64 for introducing sterile air into the sterile zone. The apparatus 58 includes one or more vacuum pumps or other vacuum sources (not shown) mounted within the apparatus' bottom support 87 and of the type known to those of ordinary skill in the relevant art. A vacuum source is connected in fluid communication with the exhaust manifold at the inlet transfer station 66 and the exhaust manifold at the outlet transfer station 86 for drawing air and fluid sterilant from the sterile zone 64 and exhausting it through the catalytic converter 92 and exhaust pipe 94. The catalytic converter 92 is of a type well known to those of ordinary skill in the pertinent art for decomposing the discharged hydrogen peroxide into water and oxygen. In this embodiment, exhaust manifolds are mounted at the bottom of the inlet and outlet stages and extend into the bottom support 87. As can be seen, the exhaust manifolds at the inlet and outlet stations 66 and 86 draw sterile air and fluid sterilant from the sterile zone 64 and non-sterile ambient air within the inlet or outlet stations, respectively, into exhaust channels (not shown) provided in the bottom support 87. As a result, any non-sterile ambient air (including any other ambient gases or contaminants) in the inlet and outlet stations is drawn into the exhaust manifold and is thereby prevented from entering the sterile zone 64 to maintain the sterility of the sterile zone. Also, any sterile air or sterilant is substantially prevented from being recirculated within the sterile zone and instead is drawn into the exhaust manifold after passing over the containers and/or conveyor sections located within the sterile zone. If desired, one or more exhaust manifolds may be provided at the bottom of the sterile zone (i.e., below the conveyor 60 or between the upper and lower portions of the conveyor 60) for substantially exhausting the air and fluid sterilant and avoiding the creation of any "dead" zones that may undesirably collect air and/or fluid sterilant. In one embodiment of the present invention, the flow of sterile air within the sterile zone 64 is controlled so that the air flows generally in the direction from right to left in FIG. 15 (i.e., in the direction from the needle filling station 78 toward the sterilization station 68) to thereby prevent any fluid sterilant from flowing into the needle filling and laser resealing stations 78, 82 and 84. This flow pattern may be achieved by creating a higher vacuum at inlet station 66 than at outlet station 86. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, this or other desired flow pattern may be created within the sterile zone in any of numerous different ways that are currently known, or that later become known.

In this embodiment, the conveyor 60 includes a plurality of flight (flight) or similar gripping mechanisms 96 that grip each container 10 at or below the neck finish (i.e., the peripheral region immediately below the mouth of the body 12, or at or below the junction of the container closure 16 with the body 12) of the container, or other desired container region. The link plates 96 are pivotally mounted on a belt 98, the belt 98 defining a closed loop and being rotatably mounted on rollers 100 disposed on opposite sides of the apparatus relative to each other. One or more drive motors or control devices (not shown) may be mounted within the base support 87 and connected to one or both of the rollers 100 for rotatably driving the conveyor belt 60 and controlling movement of the containers 10 therethrough in a manner known to those of ordinary skill in the relevant art. Each link plate 96 of the conveyor 60 includes a plurality of container engagement recesses 102, the container engagement recesses 102 being laterally spaced from one another and configured for engaging respective necks or other desired portions of containers to support the containers on the conveyor. Although the container engagement recesses 102 are depicted as semi-circular to engage the container 10, they may likewise be formed in any of numerous different shapes that are currently known, or that later become known, to accommodate any desired container shape, or as desired. The link plates 96 further define a plurality of vent apertures 104 laterally spaced from one another and formed between and adjacent the container engagement recesses 102. The vent holes 104 are positioned to allow sterile air and fluid sterilant to flow over the portion of the containers 10 above the flight 96 of the conveyor and in turn pass through the conveyor before being discharged through the vent manifold. In this embodiment, the exhaust holes 104 are provided in the form of long slots; however, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the vent may take any of numerous different configurations that are currently known, or that later become known. Preferably, the flight 96 laterally engages the neck of the container 10 and effectively isolates the sterile portion of the container above the flight from the portion of the container below the flight, which may not be sterile or may include a surface portion that is not sterile.

The conveyor 60 defines an inlet end 106 for receiving the containers 10 to be fed into the apparatus and an outlet end 108 for removing filled and laser resealed containers from the apparatus. As can be seen, adjacent flights 96 disposed at the entrance and exit ends 106 and 108, respectively, rotate relative to each other on a segment above the rollers 100, thereby defining a loading gap 110 at the entrance end of the conveyor belt and an unloading gap 112 at the exit end of the conveyor belt. Thus, at the inlet end, the containers 10 can be fed into the loading gap 110 at their sides and received in the container engagement recesses 102 of the respective flight 96. Thus, as the conveyor belt 60 rotates in a clockwise direction in fig. 15 and 16, the opposing link plates 96 rotate relative to each other, thereby engaging the containers 10 between the opposing pockets 102 of adjacent link plates. Also, at the outlet end 108, the formation of an unloading gap 112 between the respective flights 96 allows for removal of containers loaded thereon from the conveyor. Any of numerous different devices that are currently known, or that later become known, may be employed to automatically, semi-automatically, or manually load and/or unload containers onto the conveyor. In addition, the filled containers may be capped after exiting the sterile zone using any of numerous different means that are currently known, or that later become known. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the conveyor belt, the means for clamping the containers on the conveyor belt, and/or the means for driving and/or controlling the conveyor belt may take any of numerous different configurations that are currently known, or that later become known.

In this embodiment, each flight 96 of the conveyor is configured to hold four containers 10 laterally spaced from one another. Thus, in this embodiment, each sterilizing head 70 disposed within the sterilizing zone 70 includes two sterilant manifolds 114 and four sterilizing nozzles 116 mounted on each sterilant manifold. Each sterilizing nozzle 116 is positioned above a corresponding container location on the conveyor to direct the fluid sterilant onto the corresponding container. Likewise, each sterilant flushing head 76 disposed within the sterilant removing stations 72 and 74 includes two flushing manifolds 118, and each flushing manifold 118 includes four flushing nozzles 120. Each flush nozzle 120 is positioned above a respective container location on the conveyor belt to direct sterile heated air or other gas onto the respective container to re-vaporize (if necessary) and flush away the fluid sterilant. In this embodiment, the conveyor 60 is indexed (index) by two rows of containers (or flights) at a time, so that at any one time two rows of containers are sterilized in the respective stations, needle filled and laser resealed, and four rows of containers are flushed in two sterilant removing stations (i.e., the first sterilant removing station 72 performs a first flush while the second sterilant removing station 74 performs a second flush of the same containers). At the completion of each such cycle, the conveyor is indexed forward (or clockwise in fig. 15 and 16) by a distance corresponding to the two rows of containers, and the cycle is repeated. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the apparatus may define any desired number of stations, any desired number of container positions within each station, and any desired number of apparatuses may be used to accomplish a desired container throughput, if desired.

The needle filling station 78 includes a needle manifold 122, the needle manifold 122 including a plurality of needles 124 spaced from one another and movable relative to the flight 96 on the conveyor belt for penetrating the plurality of containers 10 mounted on the conveyor belt portion within the filling station, filling the containers with the needles, and withdrawing the needles from the filled containers. Each laser resealing station 82 and 84 includes a plurality of laser optic assemblies 126 and each laser optic assembly is disposed above a respective container location of a conveyor flight within the respective laser resealing station. Each laser optic assembly is connectable to a source of laser radiation (not shown) and focuses substantially on a penetration point on the stopper 22 of the respective container 10 to apply laser radiation thereto and reseal the respective needle aperture. Also in this embodiment, each laser resealing station 82 and 84 further includes a plurality of optical sensors (not shown). Each optical sensor is mounted adjacent a respective laser optic assembly 126 and focused substantially on the laser resealed area of the plug 22 of the respective laser optic assembly and generates a signal indicative of the temperature of the laser resealed area, thereby testing the integrity of the heat seal.

In one embodiment of the present invention, the non-coring filling needle 124 defines a dual channel (i.e., a dual chamber needle) wherein one channel introduces material into the storage chamber 14 while the other channel draws displaced air and/or other gases out of the storage chamber. In another embodiment, a first non-coring needle introduces the substance into the chamber while a second non-coring needle (preferably mounted on the same needle manifold for simultaneous piercing of the plugs) is spaced laterally from the first needle and withdraws displaced air and/or other gases from the chamber. In another embodiment, a groove is formed in the outer surface of the needle to vent displaced gas out of the storage chamber. In one such embodiment, a cylindrical sleeve surrounds the grooves to prevent the septum material from (partially or otherwise) plugging or clogging the grooves and thereby preventing air and/or other gases within the container from being vented therethrough. In each case, the channels or conduits may be connected to a dual head (or channel) peristaltic pump such that one channel injects product into the storage chamber while the other channel withdraws displaced air and/or other gases from the storage chamber. Also in some embodiments of the invention, the product substantially completely fills the chamber (or fills to near or substantially contact the inner surface of the first material portion 30, but not the plug).

In this embodiment of the invention, the stopper (or penetrable and thermally resealable portion) is preferably made of a thermoplastic/elastomer blend and may be of the same material as described in the above-incorporated co-pending patent applications and/or patents. Thus, in one such embodiment, the stopper (or penetrable and thermally resealable portion) is a thermally resealable thermoplastic elastomer to seal the needle aperture by application of laser radiation of 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 of the predetermined wavelength and substantially prevents the passage of radiation through the predetermined wall thickness thereof, and (iii) a predetermined color and opacity that allows the laser radiation of the predetermined wavelength and power to seal the needle aperture formed in the needle penetration region thereof within a predetermined time of less than or equal to about 5 seconds without burning the predetermined color and opacity of the needle penetration region.

In one embodiment, the stopper (or penetrable and thermally resealable portion) is a thermally resealable thermoplastic elastomer to seal the pinhole by application of laser radiation of a predetermined wavelength and power thereto, and comprises (i) a styrenic block polymer; (ii) an olefin; (iii) a predetermined amount of pigment that allows the second material portion to substantially absorb laser radiation of a predetermined wavelength and substantially prevent radiation from passing through its predetermined wall thickness, and allows sealing of a needle hole formed in its needle penetration region in a predetermined time of less than or equal to about 5 seconds; and (iv) a predetermined amount of lubricant that reduces friction at the contact surface of the needle with the second material portion during needle penetration. In one such embodiment, the second material portion includes less than or equal to about 40% (by weight) styrene block polymer, less than or equal to about 15% (by weight) olefin, less than or equal to about 60% (by weight) mineral oil, less than or equal to about 3% (by weight) pigment, and any processing aid of the type known to one of ordinary skill in the relevant art. The term "pigment" is used herein to denote any of a number of different substances or molecular arrangements that enable a material or portion of material located within it to substantially absorb laser radiation of a predetermined wavelength and, in turn, convert the absorbed energy into heat to melt the corresponding material or portion of material and reseal the pores therein.

In one embodiment, the stopper (or penetrable and thermally resealable portion) is a thermally resealable thermoplastic elastomer to seal the needle aperture by application of laser radiation of a predetermined wavelength thereto, and includes (i) a first polymeric material in a range of about 80% to about 90% by weight and defining a first elongation; (ii) a second polymeric material ranging in weight from about 3% to about 20% and defining a second elongation less than the first elongation of the first polymeric material; (iii) an amount of pigment that allows the second material portion to substantially absorb laser radiation of a predetermined wavelength and substantially prevent radiation from passing through its predetermined wall thickness, and allows sealing of a needle hole formed in its needle penetration region in a predetermined time of less than or equal to about 5 seconds; and (iv) an amount of lubricant that reduces friction at the interface of the needle and the second material portion during needle penetration.

In one embodiment of the invention, the pigment is under the trademark Lumogen from BASFAktiengesellschaft, Lord Viishhong, Germany^TMSolid product of IR 788. The Lumogen IR product is a highly transparent selective near-infrared absorber designed to absorb semiconductor laser light having a wavelength near about 800 nm. In this example, the Lumogen pigment is added to the elastomer mixture in an amount sufficient to convert the radiation to heat and to melt the plug material to a depth preferably equal to a pinhole depth of at least about 1/3 to about 1/2 in less than or equal to about 5 seconds, preferably less than about 3 seconds, and most preferably less than about 1-1/2 seconds. The Lumogen IR 788 pigment has a high absorbance at about 788nm and thus for this embodiment the laser preferably emits radiation at about 788nm (or about 800 nm). One advantage of the lumogen ir pigment is that very small amounts of such pigments can be added to the elastomer mixture to complete laser resealing at the desired or expected resealing depth over the time period described, and thus, if desired, the needle penetrable and laser resealable stopper may be transparent or substantially transparent. This can be an important aesthetic advantage. In one embodiment of the invention, the elastomer is mixed withThe composition is added to a Lumogen IR color at a concentration of less than about 150ppm, preferably in the range of about 10ppm to about 100ppm, and most preferably in the range of about 20ppm to about 80 ppm. In this embodiment, the power level of the 800nm laser is preferably less than 30 watts, or in the range of about 8 watts to about 18 watts.

In one embodiment of the invention, the substance or product contained within the storage chamber is a fat-containing liquid product, such as infant or toddler formula, and the stopper, the second material portion, the first container closure element, any other components of the container closure that are in potential direct contact with the product stored within the chamber, and the body 12 are selected from the following materials: (i) regulatory approval materials related to the nutritional food, preferably materials that are regulatory approved at least for indirect and preferably direct contact with the nutritional food, (ii) materials that do not leach undesirable levels of contaminants or non-regulatory approved leachables into the fat-containing liquid product, such as mineral oil, and (iii) materials that do not undesirably alter the taste (not including the unpleasant aroma impact) of the fat-containing liquid product to be stored in the container. In certain embodiments of the present invention, the penetrable and thermally resealable portion provides less or reduced barrier properties than the first material portion, and thus the first material portion and/or the top cap are selected to provide the requisite barrier properties for the container closure in order to store the product contained therein.

In embodiments of the invention where the product is a fat containing liquid nutritional product, such as an infant or toddler formula, typical materials for the stopper (penetrable and thermally resealable portion or first portion) are selected from the group consisting of: GLS 254-071, GLS LC254-071, GLSLC287-161, GLS LC287-162, C-Flex R70-001, C-Flex R70-005+ about 62.5ppm Lumogen, C-Flex R70-005+ about 75ppm Lumogen, Evoprene TS 25254213, Evoprene SG 9484213, Evoprene G968-4179+ about 0.026% carbon black, Evoprene G968-4179+ about 62.5ppm Lumogen, and Cawiton7193, any of the variations thereof, or similar thermoplastic elastomers. In one such embodiment, the body 12 is an injection molded PP/EVOH multilayer. In another such embodiment of the present invention,the body 12 is blow molded, for example by extrusion blow molding, and is a HDPE/EVOH multilayer. In some such embodiments, the first material portion 30 is selected from the group consisting of: (i) low mineral oil or mineral oil free thermoplastics; (ii) a low mineral oil or mineral oil free thermoplastic defining a predetermined hardness; (iii) liquid injection moldable silicone; and (iv) silicone. The predetermined hardness is in the range of about 20 Shore A to about 50 Shore A, preferably in the range of 25 Shore A to about 35 Shore A. In some such embodiments, the first material portion is made of polyethylene, HDPE/TPE blend or layers, or PP/TPE blend or layers. Also in some such embodiments, the cap is made of Celcon^TMA PP/EVOH multilayer, an HDPE/EVOH multilayer or blend, or an HDPE/EVOH multilayer or blend. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, these materials are only exemplary, and many other materials that are currently known, or that later become known, may likewise be used.

As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, many changes and modifications may be made to the above-described or other embodiments of the present invention without departing from the scope as defined in the appended claims. For example, the nipple, stopper and other components of the container may be made of any of numerous different materials that are currently known, or that later become known, in order to perform their functions and/or depending on the application of the container, including the product to be stored within the container. For example, the nipple may take any of numerous different nipple configurations and may be made of any of numerous different nipple materials that are currently known, or that later become known. As a further example, the penetrable and thermally resealable material may be a blend of any number of different materials to achieve any number of different performance goals. For example, any of the thermoplastic elastomers described above may be mixed with, for example, glass beads or other insert beads to enhance absorption of laser radiation and/or reduce or eliminate particle formation upon penetration by a needle. Further, rather than forming the stopper or penetrable and thermally resealable portion from a different material than the first material portion (or nipple), beads or particles of thermally resealable material may be mixed with the cross-linked elastomeric material (that would otherwise form the first material portion) to thereby form a material mixture that is needle penetrable, thermally resealable, and does not leach more than a predetermined amount of leachables into the product stored within the chamber. Further, the body and container closure may take any of numerous different shapes and/or configurations and may be adapted to receive and store within the storage chamber any of numerous different substances or products that are currently known, or that later become known, including, but not limited to, any of numerous different food and beverage products including low acid or fat containing liquid products, such as, but not limited to, milk, evaporated milk, infant formula, growing up milk, condensed milk, cheese, semi-blends of the two, yogurt and ice cream (including milk and non-milk substances, such as soy-based ice cream), other liquid nutritional products, liquid health products, juices, syrups, coffee, catsup-types, mustard and mayonnaise dressings, soups and pharmaceuticals. Furthermore, although described herein with reference to liquid products, the containers and filling devices and methods are equally applicable to gaseous, powder, and semi-solid products. The detailed description of the preferred embodiments is, therefore, to be taken in an illustrative rather than a restrictive sense.

Claims (43)

1. A container for storing a product, wherein the container is penetrable by an injection member for aseptically filling the container with the product through the injection member and whereby a perforation formed in the container is thermally resealable to seal the product within the container, the container comprising:

a body defining a chamber for containing the product; and

a container closure including a seal forming a substantially fluid-tight seal between the container closure and the body and a nipple connectable in fluid communication with the chamber, wherein the container closure seals the chamber from ambient atmosphere during storage of the product in the chamber and is openable to dispense the product therefrom; and

a penetrable and thermally resealable portion penetrable by the injection member to aseptically fill the chamber with the product through the injection member and thermally resealable to seal the product within the chamber.

2. The container of claim 1, wherein the nipple includes a sealing member movable between a first position sealing the nipple and a second position opening the nipple and allowing product in the storage chamber to be dispensed through the nipple.

3. The container of claim 2, wherein the sealing member is frangibly connected to the nipple such that in the first position the sealing member is connected to the nipple and in the second position the sealing member is separated from the nipple to form at least one opening in the nipple to allow product to be dispensed therethrough.

4. A container as defined in claim 1, wherein the nipple is defined by a first material portion forming an interior surface in fluid communication with the chamber and defining at least a majority of a container closure surface area that may contact any product within the chamber, and the penetrable and thermally resealable portion is defined by a second material portion that meets at least one of the following conditions: (i) overlying the first material portion and unable to contact any product within the chamber, and (ii) forming a substantially smaller surface area of the container closure that can contact any product within the chamber than the first material portion.

5. The container of claim 4, wherein the product is a fat-containing liquid product; the subject does not leach more than a predetermined amount of leachables into the fat containing liquid product and does not undesirably alter the taste of the fat containing liquid product; the first material portion does not leach more than a predetermined amount of leachables into or undesirably alter the taste of the fat containing liquid product, and the predetermined amount of leachables is less than about 100 PPM.

6. The container of claim 1 wherein the container closure further comprises a seal engageable with the body prior to aseptically filling the chamber with the product and forming a substantially dry seal between the container closure and the body.

7. The container of claim 1, wherein the container closure further comprises a securing portion connectable to the body for securing the container closure to the body.

8. The container of claim 7, wherein the retainer is at least one of threadably engaged and snap-fit to the body.

9. A container as defined in claim 7, wherein the securing element is more rigid than and between the nipple and the penetrable and resealable portion.

10. A container as defined in claim 4, further comprising an injection member contacting surface that contacts the injection member during withdrawal of the injection member from the penetrable and resealable portion to substantially remove product thereon.

11. The container of claim 10, wherein the injection member contacting surface extends around a peripheral portion of the injection member and contacts the injection member.

12. A container as defined in claim 11, wherein the injection member contacting surface is located below the penetrable and thermally resealable portion.

13. A container as defined in claim 12, wherein the injection member contacting surface is defined by at least one of the first and second material portions.

14. The container of claim 4, wherein the first material portion is selected from the group consisting of: (i) low mineral oil or mineral oil free thermoplastics; (ii) a low mineral oil or mineral oil free thermoplastic having a hardness in the range of about 20 Shore A to about 50 Shore A; (iii) liquid injection moldable silicone; and (iv) silicone.

15. The container of claim 4 wherein the second material portion is a heat resealable thermoplastic elastomer to seal the perforation by application of laser radiation of 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 of the predetermined wavelength and substantially prevents radiation from passing through the predetermined wall thickness thereof, and (iii) a predetermined color and opacity that causes the laser radiation of the predetermined wavelength and power to seal the perforation in a predetermined time of less than or equal to about 5 seconds without substantially burning the predetermined color and opacity of the second material portion.

16. The container of claim 4, wherein the second material portion is a heat resealable thermoplastic elastomer to seal the perforations by application of laser radiation of a predetermined wavelength and power thereto, and comprises (i) a styrene block polymer; (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 radiation from passing through its predetermined wall thickness, and allows the perforation to be sealed in a predetermined time that is less than or equal to about 5 seconds; and (iv) a predetermined amount of lubricant that reduces friction at the interface of the injection element and the second material portion during penetration of the injection element.

17. The container of claim 4, wherein the second material portion is a heat resealable thermoplastic elastomer to seal the perforations by application of laser radiation of a predetermined wavelength and power thereto, and includes (i) a first polymeric material in a range of about 80% to 97% by weight, defining a first elongation; (ii) a second polymeric material in a range of about 3% to about 20% by weight defining a second elongation that is less than the first elongation of the first polymeric material; (iii) an amount of pigment that allows the second material portion to substantially absorb laser radiation at the predetermined wavelength and substantially prevent radiation from passing through its predetermined wall thickness, and allows the perforation to be sealed in a predetermined time that is less than or equal to about 5 seconds; and (iv) an amount of lubricant that reduces friction at the interface of the injection element and the second material portion during penetration of the injection element.

18. The container of claim 4, wherein the first material portion defines a perforation, the second material portion overlies the perforation, and the perforation comprises less than about 10% of the surface area of the first material portion exposed to the chamber.

19. The container of claim 4, wherein the first material portion is completely interposed between the second material portion and any product stored within the chamber to prevent contact between the first material portion and the product during storage of the product within the container.

20. The container of claim 4, wherein the first material portion is co-molded with the second material portion.

21. A container as defined in claim 4, wherein the second material portion is compressed inwardly at least in the needle penetration region to facilitate resealing a needle aperture formed therethrough.

22. The container of claim 21, wherein the second material portion is generally dome shaped.

23. An assembly comprising the container of claim 1; a filling device comprising a needle manifold including a plurality of needles spaced from one another and movable relative to a container support for penetrating a plurality of containers mounted on the support within the filling device, filling the containers through the needles, and withdrawing the needles from the filled containers; and a plurality of laser optic assemblies, wherein each laser optic assembly is connectable to a source of laser radiation and substantially focused at a penetration point on the penetrable and resealable portion of the respective container closure for applying laser radiation thereto and resealing the respective needle penetration aperture therein.

24. The assembly as recited in claim 23, further comprising:

a housing defining an inlet end, an outlet end, and a sterile zone therebetween;

a conveyor belt located at least partially within the sterile zone and defining a plurality of container positions thereon for supporting and moving containers through the sterile zone in a direction from the inlet end toward the outlet end;

a fluid sterilant station located within the sterile zone and connected in fluid communication with a source of fluid sterilant for delivering fluid sterilant onto the container closures of respective containers supported on a conveyor within the fluid sterilant station and sterilizing the exposed penetrable and thermally resealable portions of the respective container closures; and

at least one sterilant removing station located in the sterile zone between the fluid sterilant station and the outlet end of the housing and connected in fluid communication with the gas source for delivering gas to the containers supported on the conveyor in said at least one sterilant removing station to flush the fluid sterilant from the containers;

wherein the needle manifold and laser optic assembly are located within the sterile zone between the at least one sterilant removal station and an outlet end of the housing for receiving sterilized containers from the at least one sterilant removal station.

25. The assembly of claim 24, wherein the fluid sterilant is hydrogen peroxide.

26. The assembly of claim 24, further comprising a sterile gas source for creating an overpressure of sterile gas within the sterile zone and connected in fluid communication with 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 the flow of fluid sterilant from flowing onto the containers adjacent the needle manifold.

27. The assembly of claim 24, wherein the conveyor comprises a plurality of pivotally mounted container supports that engage opposite sides of respective containers disposed thereon and substantially isolate a container sterile portion located on the container supports from a container portion located below the container supports to thereby prevent contaminants in a lower portion of the containers from contaminating the sterile upper portion of the containers.

28. A container as defined in claim 1, wherein the container closure defines a central region and the nipple is laterally spaced relative to the central region.

29. The container of claim 1, defining a sealed, empty sterile chamber ready to contain the product therein.

30. The container of claim 1, further comprising a cap coupled to at least one of the body and the container closure and forming a substantially fluid-tight seal therebetween, wherein the cap seals at least the nipple from ambient atmosphere and forms a barrier that substantially prevents transmission of oxygen and vapor through the cap.

31. A container as defined in claim 1, wherein the container closure further comprises a first relatively rigid container closure member mounted on the body, a substantially fluid-tight seal formed between the first relatively rigid container closure member and the body, and a second relatively rigid container closure member mounted on the first relatively rigid container closure member, and wherein at least a portion of at least one of the nipple and the penetrable and thermally resealable portion is secured between the first and second relatively rigid container closure members.

32. A container as defined in claim 31, wherein the nipple defines a bottom portion extending around a perimeter of the nipple and seated between the first and second relatively rigid container closure members, the needle penetrable and thermally resealable portion defining a bottom portion seated between the first and second relatively rigid container closure members.

33. The container of claim 32, wherein each base is compressed between first and second relatively rigid container closure elements.

34. The container of claim 1, wherein the container closure comprises one of: (i) a penetrable and thermally resealable portion, (ii) a nipple, or (iii) a penetrable and thermally resealable portion and nipple.

35. A container for storing a product, wherein the container is penetrable by an injection member for aseptically filling the container with the product through the injection member and whereby a perforation formed in the container is thermally resealable to seal the product within the container, the container comprising:

a first means for providing a chamber containing a product; and

a second means for enclosing the chamber of the first means; wherein the second means comprises third means for forming a substantially fluid-tight seal between the first means and the second means; fourth means for inserting into the mouth of the user and sucking the product out of the chamber through it with the mouth; fifth means for sealing the fourth means during storage of the product in the container and opening the fourth means prior to dispensing the product; and

sixth means for allowing the injection member to penetrate the second means to fill the chamber with product through the injection member and for allowing the second means to be heat resealed to seal the product within the chamber.

36. A container as defined in claim 35, wherein the first means is a container body, the second means is a container closure, the third means is a sealing member, the fourth means is a nipple, the fifth means is a sealing member movable between a first position sealing the nipple and a second position opening the nipple and allowing product within the storage chamber to be dispensed through the nipple, the sixth means is a penetrable and thermally resealable elastomeric portion penetrable by the injection member for aseptically filling the chamber with the product through the injection member and thermally resealable to seal the product within the chamber with laser radiation applied thereto.

37. A method for filling a container with a product, storing the product within the container, and dispensing the product from the container, the method comprising the steps of:

providing a container comprising a container body defining a sealed sterile cavity for containing a product, a container closure sealing the cavity from ambient atmosphere, a first portion penetrable by the injection element and thermally resealable upon removal of the injection element, and a second portion forming a nipple connectable with the cavity in fluid communication with ambient atmosphere during storage of the product in the cavity and openable to dispense the product from the cavity through the nipple;

inserting an injection member through the penetrable and thermally resealable portion of the container and aseptically introducing the product through the injection member and into the chamber;

withdrawing the injection element from the first portion of the container;

heat-resealing the perforation thus formed in the first portion of the container and sealing the chamber and the product contained therein from the ambient atmosphere;

aseptically storing the product within the sealed chamber; and

the nipple is opened, the nipple is inserted into the user's mouth, and the product is dispensed through the nipple and into the user's mouth.

38. The method of claim 37, further comprising the step of aseptically storing the product within the sealed chamber for a period of at least five days.

39. The method of claim 37, further comprising the steps of:

mounting the sealed empty containers on a conveyor belt, and moving the conveyor belt through the sterile zone;

delivering a fluid sterilant to at least the exposed portion of the first portion of the container within the sterile zone and sterilizing at least said exposed portion with the fluid sterilant;

delivering gas within the sterile zone onto the portion of the container exposed to the fluid sterilant, flushing at least the fluid sterilant from said exposed portion of the first portion of the container with said gas and forming at least a penetration zone substantially free of the first portion of the fluid sterilant;

penetrating the penetration zone of the first portion with a filling needle connected in fluid communication with a source of product and directing the product through the needle and into the chamber;

withdrawing the filling needle from the first portion of the container;

laser radiation is applied to the pin hole thus formed in the first portion and the product within the sealed chamber are heat-sealed again.

40. The method of claim 37, wherein the product is a fat-containing liquid product, and further comprising the steps of:

providing a container body that does not leach more than a predetermined amount of leachables into the fat containing liquid product and does not undesirably alter the taste of the fat containing liquid product; providing a container closure assembly comprising a second portion defining an interior surface in fluid communication with the chamber that forms at least a majority of a surface area of the container closure, the interior surface being contactable with any fat containing liquid product contained within the chamber and not leaching leachables into or undesirably altering the taste of the fat containing liquid product beyond a predetermined amount, wherein the predetermined amount of leachables is about 100PPM, and a first portion at least one of: (i) overlying the second portion and being incapable of contacting any fat-containing liquid product contained within the chamber, and (ii) forming a substantially smaller surface area of the container closure than the second portion that can contact any fat-containing liquid product contained within the chamber.

41. The method of claim 39 further comprising moving the filled container outside the sterile zone and capping the container outside the sterile zone, the capping overlying at least the exposed portions of the first and second portions and sealing the first and second portions from the ambient atmosphere.

42. The method as defined in claim 39, further comprising introducing an overpressure of sterile gas within the sterile zone and directing at least a portion of the sterile gas in a direction of flow generally from the outlet end toward the inlet end of the sterile zone to prevent the fluent sterilant from contacting the container during needle filling.

43. The method of claim 37, wherein the container closure comprises one of: (i) a first portion, (ii) a second portion, or (iii) a first portion and a second portion.