CA2602222A1 - Container closure with overlying needle penetrable and sealable portion and underlying portion compatible with fat containing liquid product, and related apparatus and method - Google Patents

Abstract

A container and method are provided for storing fat containing liquid products. The container includes a body defining a storage chamber for receiving the product, and a container closure. A first material portion forms at least most of the surface area overlying the storage chamber that can contact any product therein. Neither the body nor the first material portion leach more than a predetermined amount of leachables into the product or undesirably alter a taste profile thereof. A needle penetrable and resealable second material portion either (i) overlies the first material portion and cannot contact any product within the storage chamber, or (ii) forms a substantially lesser surface area overlying the storage chamber that can contact any product therein in comparison to the first material portion. A sealing portion is engageable with the body to form a substantially dry hermetic seal between the container closure and body.

Description

THERMALLY RESEALABLE PORTION ANI) UNDERLYING PORTION
COMI'ATIBLL WITH FAT CONTAINING LIQUID PRODUCT, AND RELATEI) METI-IOD
Cross-Reference To Priority Application [00011 This patent application claims priority to U.S. Provisional Patent Application Serial No. 60/647,049, filed January 25, 2005, entitled "CON'I'AINIJR WITH
NEEDLE
I'r;NETRABI.,E AND THERMALLY RESEALABLE STOPPER, SNAP-RING, AND
CAP FOR SECURING STOPPER AND SNAP-RING "I'O CONTAINER AND
REMOVING SAML TI-IERCPROM", which is hereby expressly incorporated by reference in its entirety as part of the present disclosure.

Field Of The Invention

[0002] The present invention relates to containers having container bodies and stoppers for sealing openings in the container bodies, such as containers havinl;
polynieric stoppers that are needle peiietrable for filling the closed bodies with liquids, such as fat containing liquid iiutrition products, and that are laser resealable f'or laser resealing the iieedle penetrated region of the stopper.

I3nc1;ground Of The Invention (00031 Prior art needle penetrable and laser resealable containers include thermoplastic elastomer ("'I'PE") stoppers or portions of stoppers that are needle penetrable to needle fill the containers with a product, and are thermally resealable at the resulting needle lloles by applying lasei- radiatioal tliereto to hermetically seal the product within thc containers. An exeulplary such container aiid stopper is disclosed in commonly assigned U.S.
I'atent No.
6,604,561. One of the drawbacks ofsuch "I'PE stoppers is that they can be difficult to use with fat colltaEnlng liquid prodUcts, such as infant or baby fori3iulas, or other milk-based or low acid products. I'or exaniple, many such "['Pl.; materials contain leachables that can leach into the fat coiitaining product, or otherwise can u desirably alter a taste profile of the product.

10004] Conventional containers and systems for aseptically Iilling containers with fat containing liquid products, such as infant or baby formulas, or other milk-based or low acid products, employ a container liaving an open mouth and a screw cap or other type of cap that is secured to the open motith after aseptically filling the container with the product. In many such systems, the open containers are pre-sterilized by flushing the interior and exterior surfaces of the open containers with a fluid sterilant, such as peroxide vapor or vaporized hydrogen peroxide, to sterilize the food contacting surfaces. Then, the containers are flushed with heated sterile air in order to re-vaporize any fluid sterilant that condenses on the container surfaces and to flush away the sterilant. After flushing with lieated sterile air, the open containers are filled through the open anouths of the containers witli the desired product, and after filling, the containers are capped to seal the product within the containers. Typically, the sterilizing, flushing, filling and capping processes are all performed within the same sterile zone of the filling system.

[0005] One of the drawbacks of this type of Iilling systena is that it can be difficult to remove all of the fluid sterilant from the interior surfaces of the containers, tlius leaving sterilant residue, such as hydrogen peroxide, within the containers and thereby contaminating the product filled into the containers. lf the level of residue is sufficiently high, the product must be discarded. .A.lternatively, the sterilant residue can negatively affect the taste or taste profile of the product.

100061 Another drawback of such prior art systems is that because the sterilizing, Ilushing, filling and capping processes are all performed within the same sterile zone, the apparatus forming the sterile zone tencis to be relatively large and complex.
Moreover, because the product is open filled (i.e., poured into the open mouths of the containers), the product is not as well contalned wltllm the sterile zone as otherwlse desired, thus creating hybiene problems witliin the sterile zone. Such apparatus can recluire cleaninb more frequently than desired due, for example, to the collection of sterilant and/or product residue within the sterile zone. Cleaninb such large and complex apparatus can result in substantial down time and expense. As a result, such prior art systems can have undesirably short run times between cleaning and sterilization of the sterile zone. Yet anotlier clrawback of sueh systenls is that because they sterilize the paekabing,f11I and seal apparatus all within the same enclosure and sterile zone, if any part of the systein goes down, the entire system must be subjected to clean in place ("CIP") and sterilize in place ("SIP") procedures prior to re-starting, which can further contribute to substantial down time and expense.

[00071 Yet another drawbaclc of such prior art systenis is that the containers are filled inimediately prior to capping resulting in poor closure seals due to the presence of wet product at the sealing surfaces or interfaces.

100081 Another drawback of such prior art systenis is that in many cases product ]nust be sterilized after filling by employing a retort process that can undesirably alter the taste of the product.

100091 Accordingly, it is an object of the present lnventlon to ovel'conle one or nlore of the above-described drawbacks and disadvantages of the prior art.

Summary Of The Invention [00010] In accordance witll a first aspect, the present invention is directed to a container for storing a fat containing liquid product. Tlie container is penetrable by a needle for aseptically filling a storage chamber of the container through the needle with the fat containing liquid product, and the resulting needle hole is thermally resealable to seal the fat containing liquid product within the container. I'he container comprises a body def7ning a storage chambel' tllereln for recelving the fat containing liquid pI'oduct and a filst aperture in fluid communication with the storage chaiaiber. The body does not leach more than a predeternlined an-Iount of leachables into the fat containinl; liquid product and does not undesirably alter a taste profile of the fat containing liquid product. A
container closure assembly of the containel- includes a stopper receivable within the first aperture for llermetically sealing the storage clianlber. 'T'hc stopper inclucles a first material portion deflnlnb an lnternal surface in fluld communication wttl1 the storage chamber fol'nilnb at least most of the surface area of the contalnel' closCire that can contact any fat containing liquid product within the storage chamber. "I'lie first matcrial portion does not leach more tllan a predeternllned an7oLlnt of leachables into the fat Contalnlng l1ClLild pt'oduct or undesirably alter a taste profile of the fat containing liquid product, The predetermined amount of leachables is less than about 100 parts per Inillion ("PI'M.' ), is preferably less than or equal to about 50 PPM, and most preferably is less than or equal to about 10 PPM.
A second material portion of the stopper either (i) overlies the iirst material portion and eannot contact atiy fat containing liquid product within the storage eliamber, or (ii) forms a substantially lesser surface area of the container closure that can contact any fat containing liquid product within the storage chamber in comparison to the first material portion. The second material portion is needle penetrable for aseptically filling the storage cllainber with the fat containing liquid product, and a resulting needle aperture formed in the second material portion is thermally resealable to seal the fat containing liquid product within the storage chamber. A sealing portion of the container closure asseinbly is engageable with the body prior to aseptically filling the storage chamber with the fat containing liquid product to thereby form a substantially dry hermetic seal between the container closure and body. A securing melnber or cap is connectable between the stopper and body for securing the stopper to the body.

1000111 In one embodiment of the present invention, the first material portion is selected fi=om the group ineluding (i) a low mineral oil or mineral oil free thernloplastic; (ii) a low mineral oil or mineral oil free thermoplastic defining a predeterniined durometer; (iii) a liquid injection moldable silicone; and (iv) a silicone. The predetermined durometer is within the range ot'about 20 Shore A to about 50 Shore A, and preferably is within the range of about 25 Shore A to about 35 Shore A.

(00012] In one embodiment of the present invention, the second inaterial portion is a thermoplastic elastomer that is heat resealable to liernietically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto.
'T'he secolld nlaterlal portlon defines (7) a predetet'nlnled wall t111c1<ness, ((7) a predCtelnllned color and opacity that substantially absorbs the laser radiation at the predeterniined wavelength and stlbstantlally prevents the passage of the radiation thI'ough the pI'edeternllned wall t117C1<ness thereof, and (iii) a predetermined color and opacity that catises the laser radiation at the predeter-nined wavelength and power to hermetically seal the needle aperture formed in the needle penetration region thereof in a predetermined time period of less than or equal to about 5 seconds and substantially without burning the needle penetration region.
[00013] In one embodiment of the invention, the second znaterial portion is a thermoplastic elastomer that is heat resealable to hermetically seal the needle apei-ture by applying laser radiation at a predeterniined wavelength and power thereto. The second material portion includes (i) a styrene block copolymer; (ii) an olefin; (iii) a predetermined amount of pigment that allows the second material portion to substantially absorb laser radiation at the predetermined wavelength and substantially prevent the passage of radiation through the predetermined wall thickness thereof, and liermetically seal the needle aperture formed in the needle penetration region thereof in a predetermined time period of less than or equal to about 5 seconds; and (iv) a predetermined anlount of ltibricant that reduces frietion forces at an interface of the needle and second material portion during needle penetration thereof [00014) In one embodinient of the invention, the second material portion is a fihermoplastic clastomer that is heat resealable to hermetically seal the needle aperture by applying laser -=adiation at a predetermined wavelength and power thereto. The second material portion includes (i) a first polymeric material in an amount within the range of about 80% to about 97% by weight and dei:ining aflrst elongation; (ii) a second polynieric material in an amount within the range of about 3% to about 20% by weight and defining a second clongation that is less than the first elongation of the f3-st polynieric material; (iii) a pign-ient in an mount that allows the second material portion to substantially absorb laser radiation at the predetermined wavelength and substantially prevent the passage of radiation through the predetermined wall thickness thereof, and hermetically seal a needle aperture fornied in the needle penetration region thereof in a predeterinined time period of less tlian or equal to about 5 seconds; and (iv) a lubricant in an amount that -=educes i:i=iction forces at an interface of the needle and second material portiou during needle penetration thereof.

[0001.5] In one embociinient of the invention, the first inaterial portion defines a second aperture, the second material portion overlies the seconci aperture, and the second aperture constitutes less than about 15% of the surface area of the first material portion exposed to the storage chamber. In one such enlbodiment, the second aperture constitutes less than about 10% of the surface area of the first material portion exposed to the storage chamber.
In another embodiment of the present invention, the first material portion is interposed entirely between the second material portion and any fat containing liquid product stored witllin the storage chainber to thereby prevent contact between the second material portion and fat containing liquid product during storage thereof in the container. In one embodiment of the inventioii, the first material portion is co-molded witli the second material portion. In one such enlbodiinent, either the first material portion or the second material portion is over-molded to the other. In one embodiment of the invention, the second material portion defines a relatively raised portion, and at least one of the first and second material portions defines a relatively recessed portion spaced laterally relative to the relatively raised portion. The relatively raised contiguration inherently laterally compresses the needle penctration region to facilitate resealing thereof. In one such embodiment, the relatively raised portion is substantially dome shaped.

1000161 In one embodiment of the invention, the securing member is a cap movable between a first position engaging the body and securing the stopper to the body, and a second position spaced away from the body and engaged with the stopper for removing the container closure fi=ain the body. Also in a currently preferred enlbodiment, the first material portion defines a peripheral flange that is releasably connectable to the body. In one such enibodiment, the peripheral flange includes a plurality of peripheral flange portions angularly spaced relative to each other. Preferably, either the peripheral flange or the body defines a raised securing surface, and the other defznes a corresponding recessed securing surface engageable with the raised surface for securing the peripheral Ilange and the body to each other. In one embodiment of the invention, the stopper is snap fit to the body, and the securing member or cap is threadedly engabeable witll the body.

[000171 In accordance witli another aspect, the present invention is directed to a method for aseptically needle filling and laser resealing a container wlth a fat contalning liquid product. The method comprises the following steps:

(i) providing a container including a body defining a sterile storage chamber therein for receiving the fat containing liquid product and a first aperture in fluid communication with the storage- chamber, whei=ein the body does not leach more than a predetermined amount of leachables into the fat containing liquid product and does not undesirably alter a taste profile of the fat containing liquid product; and a container closure assembly including a stopper receivable within the first aperture for llermetically sealing the storage chamber, wherein the stopper includes a first material poi-tion defining an internal surface in fluid communication with the storage chamber forming at least most of the surface area of the container closure that can contact any fat containing liquid product within the storage chamber and that does not leach more than a predetermined amount of leachables into the fat containing liquid product or undesirably alter a taste profile of the fat containing liquid product, and a second material portion that eitller (a) overlies the first material portion and cannot contact any fat containing liquid product within the storage cllamber, or (b) fornls a substantially lesser surface area of the contaitler closure that can contact any f'at containing licluid product within the storage cllamber in comparison to the first material portion. The predeternlined amount of leachables is less than about 100 PPM, is preferably less tllan or equal to about 50 PPM, and most pref'erably is less tllatl or equal to about 10 PPM. 'l,lle second material portion is needle penetrable for aseptically fillinb the storage chanlber with the fat containing licluid product, and a resulting needle aperture fornied in the second material portion is tllermally resealable to seal the fat containing liquid product within the storage cllainber;

(ii) illouiltiilg the sCaled, empty coiltaiilei' defining a sterile storage cll'ciTnber oil a conveyor, and moving the conveyoi= tlirough a sterile zoile;
(iii) transnlitting within the sterile zone a fluid sterilailt onto at least an exposed portion of'the stopper of'the container and, in turn, steriliring with the fluid sterilant at least the exposed portion of the stopper of the coiltainer;
(iv) transmitting witllin the sterile zone a heated gas onto the portion of the containei= exposed to the fluid sterilant, fltishing away witll the lleated gas the fltiid sterilant f'rom at least the exposed portion of tlle stopper of the container and, in turn, forming a needle penetration region of the stopper substantially free of fluid sterilant;

(v) penetrating the needle penetration region of the stopper with a tilling needle coupled in fluid communication with a source of the fat containing liquid product, and introducing fat containing liquid product through the needle and into the storage chamber;
(vi) withdrawing the filling needle from the stopper; and (vii) applying laser radiation to a resulting needle hole in the stopper to thermally reseal the second inaterial portion and, in turn, liermetically seal the fat containing liquid product within the storage ehamber.

[00018] In one embodiment of the present invention, the nlethod further comprises moving the filled container outside of the sterile zone, and applying outside of the sterile zone a cap to the container that overlies at least an exposed portion of the stopper of the container. 'f'he method also preferably further comprises directing an over pressure of sterile gas witliin the sterile zone, and directing at least a portion of the sterile gas in a flow direction generally fi=oni an outlet end toward an inlet end of the sterile zone to, in turn, prevent f7uid sterilant fi=om contacting a container during needle filling thereof'.

1000191 One advalitabe of the present invention is that the needle penetrable and laser resealable portion of the stopper defined by the second material portion is isolated, or substantially isolated from the fat containing liquid product by the first material portion that does not leach into (or leaches less than a predetermined amount), or i.mdesirably affect the taste profile of the product. As a result, the containers of the present invention can be needle filled and laser resealed without the above-described probleins encountered using prior art needle penetrable and laser resealable stoppers formed in whole or in part with 'I'I'I; or other naaterials that contain leachables when used in connection with fat eontaining liqtrid products.

[00020] Yet another advantage of tlle present invention is that the stopper is scaled to the container body prior to filling the container, thereby forming a dry seal between the stopper and body and avoiding the seal integrity problems encountered with "wet" seals in the prior art.

1n0021] nnotller advantage ofthe present lnventlon is that because the fat contalnlng liquid product is needle f7lled through a stopper lnto a sealed, empty, sterlle coiltainer, tllere is significantly better product containinent within the sterile zone in coinparison to the above-described liquid food iilling systems, thus requiring less frequent cleaning of the sterile zone and enabling longer run tiines between cleaning and sterilization of the sterile zone than encountered in such prior art.

[00022] Yet another advantage of the present invention is that container sterilization is de-linked fronl container filling since the interior of the sealed, empty container is sterilized prior to introducing the container into the sterile zone for tilling. As a result, the closed containers do not require the post-filling assembly required with prior art liquid food containers and systerns, thus enabling the filling apparatus to be significantly smaller, less complex, and more efficient. In addition, the sealed containers can be manufactured off-site froin the filling apparatus to thereby avoid problems associated with space constraints in manufactui'ing and filling facilities.

1000231 Another advantage of the present iriventioii is tltat the product can be aseptically filled into sealed, empty sterile containers, thus avoiding the need to sterilize the product by retoi=t after filling and the negative effects of i=etort on the filled product.

1000241 Other advaiatages of the present invention and/or of the currently preferred embodiments thereof will becoine niore readily apparent in view of the following detailed description of the curreiltly preferred Cinbodiinei7ts and accoinpanying drawings.

Brief Description Of The Drawings 1000251 FIGS. 1A, 1 B, and l C are a series of side elevational views of a container embodying the present invention illustrating respectively (i) the container body itseli', (ii) the container body with the stopper snap-fit thereto, and (iii) the contaiiler body with the stopper and securing ineinber threadedly engaged to the body.

[000261 FIG. 2 is a partial, cross-sectional view of the assembled container of FIGS. I n, 1 I3 and IC.

[00027] FIG. 3A is a side elevational view of an apparatus einbodying the present invention 1'or neeclle fillinb and laser resealing the containers of F1GS. I
A, I. B, 1 C and 2.

[00028] FIG. 3B is a perspective view of the apparatus of FIG. 3A.

[000291 rIG. 4 is a partial, perspective cross-sectional view of another embodinient of a container of the present invention wherein the stopper is threadedly engaged with thebody, and the cap is snap fit to the stopper.

[00030] FIG. 5 is a partial, perspective cross-sectional view of another embodiment of a container of the present invention wlaerein the securing member is in the form of a disk overlying the stopper and fixedly secured thereto.

Detailed Description Of The Currently Preferred >Lmbodiments [000311 In FIGS. 1 A, 1 B, 1 C and 2, a containei= embodying the present invention is indicated generally by the reference numeral 10. "I'he container 10 comprises a body 12 defining a storage chaiiiber 14 therein for receiving a substance, such as a fat containing liquid product, and a first aperture 16 in fluid communication with the storage chamber 14.
A container closure 15 includes a stopper 18 receivable within the first apertuu=e 16 for hermetically sealing the storage chanaber 14 with respect to the ambient atmosphere, and a securing member or cap 20 for securing the stopper to the body. As described Iurther below, the stoppei= 18 inciudes a first inaterial portion 22 and a second material portion 24. The first material portion 22 is connectable between the stopper 18 and body 12 for securing the stopper to the body, and in the illustrated embodinient, def:ines a sccond aperture 25 for exposing a predetermined portion of the second material portion 24 therethrough. As can be seen, the 17irst material portion 22 detines an internal suriace in fluid coiniminication wit11 the storage chamber 14 forming at least most of the surface area of the container closure 15 that can contact any fat containing liquid product within the storage cilamber and that does not leach niore than a pi=edeterinined aniount of leachables into the -fat colataining liquid product or i.lndesirably alter a taste profile of the fat containing l1Clllld product.
Tlle fat contalnin-licluid product inay be any of numerous different products that are currently known, or that later become known, including without Ilmltatlon infant or baby form.ulas, growing-up Inilks, milks, creams, half'-and-llalfs, yogurts, ice creanns, jtuces, syrups, condiments, milk-based or Inilk-containlne products, liC]llld nUtrltiotl prodUcts, lIqUId health care products, and pllarmacelltical pt'oducts. 'l 11C term "leachable" is used hereln to nlean ai3y cileinlcal compound (volatile or non-volatile) that leaches into the product witliin the container from a component of the container during the period of storage through expiry of the product. An exemplary leachable to be avoided in connection with fat containing liquid nutrition products, such as inf~ant or baby formulas, is mineral oil. Accordingly, as indicated below, in the exemplary embodiments of the present invelation, the first material portion 22 does not contain mineral oil, or contains sufficiently low aniounts of mineral oil such that it does not leach mineral oil into the fat containing liquid nutrition product, or substantially does not ]each mineral oil into the fat containing liquid nutrition product (i.e., if any mineral oil is leached into the product, any such amount is below the maximuln anlount permitted under applicable regulatory guidelines for the respective product, such as FDA or LFCA
guidelines). In accordance with the present invention, the second lmterial portion 22 and the body 12 each do ilot leach more than a predetermined amount of leachables into the product.
The predetel7nlilecl ainount of leachables is less than about 100 PPM, is preferably less than or equal to about 50 PI?M, and lnost preferably is less than or equal to about 10 PI'M.

[00032] The second inateriai portion 24 either (i) overlies at least a portion of the fil-st material portion 22, or (ii) forms a substantially lesser surface area, if any, of the container closure 15 that can contact any fat containing liquid product within the storage chamber 14 in comparison to the -first material portion 22. In addition, the second material portion 24 is needle penetrable for aseptically filling the storage chamber 14 with the fat containing liquid product, and a resultiilg needle hole formed in the secoild material portion 24 after wlthdrawing the needle is tllermally resealable to seal the fat contalillilg hqtild prodUct within the storage chamber. As shown typically in FIG. 6, the second material portion 22 of the stopper defines an annular groove 27 forn-led in a peripheral flange portion tllereof, and the end portioli of the container body 12 is received therein to form a substatttially hermetic seal between the stopper and bocly.

[00033] One advantage of the present invention is that the stopper 18 is sealed to the body 12 prioi' to filling the storage cllambel' 14 with the product, and therefore a dry seal is formed between the stopper and body. As a result, the containers of the present invention can provide signif icantly higher seal integrity in comparison to prior art containers in which the cap is sealed after filling the container thus giving rise to a signil'icantly higller likelihoocl of forming a less reliable "wet" seal. Yet another advantage of the illustrated embodiment of the invention is that the stopper 18 is assembled and sealed to the body 12 by inserting or pressing the stopper into the mouth or opening 16 of the body. Accordingly, the rotational or screwing motions encountered in prior art containers are avoided within the sterile zone, thus simplifying the assenlbly process within the sterile zone, and thereby enabling an increased level of sterility assurance and reduced complexity within the sterile zone in comparison to prior art containers wherein the seals are created by screwing a cap onto a container body. If desired, however, the stoppers can be threadedly or rotatably attached and/or the caps can be applied to the containers within the sterile zone if for some reason this is desired or otherwise required.

[00034] The securing meinber or cap 20 is movable between a first position engaging the body 12 and securing the stopper 18 to the body, and a second position spaced away fi=om the body 12 for exposing the second aperture 16 and allowing access to the substance within the storage cliamber 14. In the first position, the cap 20 is engaged with the stopper 18 for renioving the assembled container closure froin the body, In the eanbodinlent of the present invention wherein the product stored witliin the container is a fat containing liquid nutrition product, such as a baby or infant formula, a nipple (not shown) of a type known to those of ordinary skill in the pertinent art may be threadedly attached to the threads 44 or otherwise attached to the body 12 to allow a baby or child to drink the product within the storage chamber through the nipple.

(00035] As shown typically in FIG. 2, the second material portlon 24 is superimposed over the first material portion 22. In the illustrated enlbodinietat, the first material portion 22 and second material portion 24 are co-molded, such as by over-molding the second material portion to the first niaterial portion, or vice-versa. 1-Iowever, as niay be recognized by those of ordinary skill in the pertinent art based on the teachings lierein, the first and second inaterial portions may be thermally fused or otherwise assembled in any of numerous different ways that are current known, or that later become known. Altllough in the illustrated embodiment a small portion of the second anaterial portion 24 is exposed to the storage chanlber 14, ii' desired, the first material portion 22 may completely underlie the second material portion 24 and/or otherwise fully isolate the second material portion from the storage chamber 14 and product stored thei=ein.

100036] As also shown typically in FIG. 2, the second material portion 24 defines a relatively raised portion 26 overlying the second aperture 25 of the first inaterial portion 22, and a relatively recessed portion 28 spaced laterally relative to, and surrounding the relatively raised portion. 'fhe raised portion 26 defines the needle penetration and thermally resealable region of the second material portion 24. In the illustrated embodiment, the relatively raised portion is substantially dome sllaped. One advantage of forming the needle penetrable and thermally resealable portion 26 in a relatively raised configuration, such as a dome shape, is that the septuin material (i.e., the needle penetrable and therinally resealable portion) is maintained in compression, and thus is substantially self-resealinb.
Accordingly, when the filling needle (not shown) is renloved, the septum conlpresses itself about the resulting needle hole, thus closing or substantially closing the needle hole. As a result, when tllermally resealed, such as by the application of laser-or light energy thereto, a high integrity seal may be obtained. If, on the other hand, the septum materlal is in tension, such as inay occur if the septum material is attached about its periphery to the first material portion, it may prevent thermal resealing of the resulting needle hole and/or may prevent the fornlation of a high integrity seal. If desired, a device (not sllown) can be employed to place the needle penetration region of the stopper in compression during needle filling thereof. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, althoubh there can be significant advantages derived from the illustrated septuni configuration, or otherwise from placing the needle penetration region of the septum into conipression to facilitate resealing thereof, 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.

(00037] Tlie first material portion 22 defines a peripheral flange 30 that is releasably connectable to the body 12. In the illustrated embodiment, and as shown typically in FIG. 1, the peripheral flange 30 includes a plurality of periplleral f7ange portions 32 angularly spacecl relative to eacli other with angularly-extending gaps 34 formed therebetween.
As a result, the peripheral f7ange portions 32 are radially flexible to facilitate fornling a snap-fit l3 coniiection between the peripheral flange and the body. As shown typically in FIG. 6, each peripheral flange portion 32 defines an angularly-extending raised securing surface 36, and the body 12 defines a corresponding angularly-extending recessed securing surface 40 that is engageable with the raised surface 36 for securing the peripheral flange and body to each other. In the illustrated embodiment, the peripheral flange 30 is snap fit to the body 12.
I-lowever, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, other conilecting mechanisms or structures that are currently known, or that later become known, equally may be used. As also shown typically in FIG. 6, the securing member or cap 20 defines an annular recess 42 for receiving therein the exterior edges of the peripheral flange portions 32 to thereby interlock the first inaterial portion 22 and cap 20 to each other when the cap is moved into the second or closed position. "I'he body 12 defines first threads 44 and the securing Inember or cap 20 defines second threads 46 that threadedly engage each other to secure the cap to the body.

[00038] As can be seen, the second material portion 24 overlies the first material portion 22, and the first material portion substantially isolates the second material portion relative to the storage chambei= 14 and thus relative to the product contained within the storage chainber.
I'referably, substantially the only portion of the second material portion 24, if any, exposed to the storaf;e chainber 14 (or the product contained tlierein) is the poi=tion 26 overlying the second aperture 25. In the illustrated embodiment, the second aperture 25 preferably constittites less than about 15% of the surface area of the first material portion 22 exposeci to the storage chamber 14 or product contained thereiil, and inost preferably constitutes less than about 10% of the surf'ace area of the fiist material portion 22 exposed to tlie storage cllainber or pi'odtlct contained tllereln. As iildlcateCl above, if desired, the f-irst material portion 22 may conipletely underlie the second material portion 24 to thereby eliminate the second aperture 25 and/or otherwise ftilly isolate the second material portion froni the storage chainbeC 14 and/or prodtict stored therein.

[000391 As can be seen, the securing menlber or cap 20 includes a frangible portion 48 that is snap-fit and thereby interloclced with a peripheral ilange 50 forined on the body 12, and that franbibly coi1nects the cap to the body to thereby pi'ovide a tainper-evident oi' tamper-proof closure.

[000401 As indicated above, the second material portion 24 is preferably co-molded with the first material portion 22, such as by over-molding the second material portion to the first material portion. In addition, the stopper 18 may be molded in the sanie mold as the container body 12, and at least one of the stopper and the body may be assembled within or adjacent to the mold in accordance with the teachings of commonly-assigned U.S. Patent Application Serial Nos. 11/074,454 and 11/074,513 incorporated by reference below, and U.S. Provisional Patent Application serial no. 60/727,899 filed October 17, 2005, entitled "Sterile Dc-Molding Apparatus And Method", which is hereby expressly incorporated by reference as part of the present disclosure.

[00041] In addition, the sterile, empty stopper and body assemblies are needle filled and thermally resealed in accordance with the teachings of any of the following patent applications and patents that are hereby incorporated by reference in their entireties as part of the present disclosure: U.S. Patent Application Serial No. 10/766,172 filed January 28, 2004, entitled "Medicanient Vial Having A Heat-Sealable Cap, And Apparatus and Method For Filling The Vial", which is a continuation-in-part of similarly titled U.S.
Patent Application Serial No. 10/694,364, filed October 27, 2003, which is a continuation of similarly titled co-pending U.S. Patent Application Serial No. 10/393,966, filed March 21, 2003, which is a divisional of similarly titled U.S. Patent Application Serial No. 09/781,846, filed February 12, 2001, now U.S. Patent No. 6,604,561, issued August 12, 2003, which, in turn, claims the benefit of similarly titled U.S. Provisional Application Serial No.
60/182,139, filed February 1], 2000; similarly titled U.S. Provisional Patent Application No. 60/443,526, filed Januaiy 28, 2003; similarly titled U.S. Provisional Patent Application No. 60/484,204, filed June 30, 2003; U.S. Patent Application No. 10/655,455; filed September 3, 2003, entitled "Sealed Containers And Methods Of Making And Filling Same"; U.S. Patent Application Serial No.
10/983,178 filed November 5, 2004, entitled "Adjustable Needle Filling and Laser Scaling Apparatus and Method; U.S. I'atent Application Serial No. 11/070,440 filed March 2, 2005, entitleci "Apparatus and Method for Needle Pilling and Laser Resealing"; U.S.
Patent Application Serial No. 11/074,513 filed March 7, 2005, entitled "Apparatus for Molding and Assembling Containers with Stoppers and Filling Same; ancl U.S. Patent Application Scrial No. 11/074,454 filed March 7, 2005, entitled "Method for Molding ancl Assembling Containers with Stoppers anci Filling Sanie".

[000421 In FIGS. 3A and 3B, an exeinplary needle filling and laser resealing apparatus for use in filling and resealing the containers of the present invention is indicated generaliy by the reference nunlera158. 'T'he apparatus 58 includes a closed loop or endless conveyor 60 for indexing and thereby conveying the containers 10 tllrough the apparatus.
The containers that are fed by the conveyor 60 into the apparatus 58 include the stoppers 18 sealed to the openings 16 of the bodies 12, but do not include the caps 20 (FIG. 2). The interior chamber 14 of each container is sterile, such as by assembling the stoppers and containers in the mold and/or within a sterile zone witliin or adjacent to the mold as described in any of the co-pending patent applications incorporated by reference above, by transmitting radiation, such as gamma or ebeam radiation, onto the sealed, empty stopper and body assembly, or by employing a fluid sterilant, such as vaporized hydrogen peroxide. The apparatus 58 includes an elongated housing 62 defining within it a sterile zone 64 and through which the conveyor 60 with the containers 10 located thereon passes. The ter=ni "sterile zone" is used herein within the meaning of the applicable regulatory guidelines as pronlulgated, for exanlple, by the FDA (tlae tlnited States Food and Drug Adininistration) or other national or applicable regulatory agency, and including applicable Low Acid Canned Food ("LACF") regulations, and is preferably defuled by a commercially sterile area that is maintained sterile by means of an over pressure of sterile air in a manner known to those of ordinary skill in the pertinent art. In the illustrated embodiment, the housing 62 includes side walls foi-med by see-through panels in order to allow an operator to view the intertor of the apparatus. If desired, llowever, the side walls could be opaque, or could include an arrangement of opaque and see-through portions different than that shown. As shown, one or more of the side panels may be imunted to the housing frame by hinges 61 in order to pivot the respective side panel outwardly to access the interior oi'the housing to, for example, perform maintenance and/or repairs. Otherwise, the side and top walls of the housing 62 are sealed with respect to the ainbient atmosphere to maintain the sterility of the sterile zone 64.

100043] The apparatus 58 Includes on its inlet end an inlet transter stataon 66 tl7roug17 which the conveyor 60 passes for transferring the containers 10 mounted on the conveyor 60 into the sterile zone 64. A sterilizing statlon 68 is located within the housing 62 immediately downstreanl of the Inlet transf'er station 66 in the Clirectlon of conveyor movement (clockwise in FIGS. 3A and 3B) and includes one or more sterilizing heads 70 coupled to a source of fluid sterilant (not shown) sueh as a hydrogen peroxide, vaporized hydrogen peroxide sterilant ("VHI'") or other fluid sterilant that is currently or later known, for translnitting the fluid sterilant onto the exterior surfaces of the containers to sterilize the exterior surfaces.
The apparatus 58 further includes within the housing 62 a first sterilant removing station 72 located downstream of the sterilizing station 68 in the direction of conveyor movement, and a second sterilant removing station 74 located downstream of the first sterilant removing station 72. Each sterilant removing station 72, 74 'rncludes one or nlore respective sterilant flushing heads 76 t:or transmitting heated sterile air or otller gas over the exterior surfaces of the containers at a sufficient temperature, flow rate and/or volume, and for a sufficient time period to substantially entirely remove the fluid sterilant tllerefi=om. "I'he vaporized peroxide may condellse at least in part on the surfaces of the containers and/or conveyor, and therefore it is desirable to flush sucll surfaces with a heated, sterile air or other gas to re-vaporize any condensed hydrogen peroxide and flusli it out of the sterile zone. In the currently preferred embodiment, the tenlperature of the sterile air is at least about 60 C;
however, as may be recognized by those of ordinary skill in the pertinent art based on the teacllings llerein, the temperature may be set as desired or otherwise required by a particular application. A. needle filling station 78 is located w'tthin the llousing 62 downstream of the second sterilant removing station 74 for needle filling each container 10 with product from a product fill tank 80, and first and second laser resealing stations 82 and 84, respectively, are located downstrealn of the needle filling station 78 for laser resealing the resulting needle holes fortned in the stoppers of the contalt7ers after filling the colltalllCrs alld w(thdrawing the needles. 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 otit of the sterile zone 64.
After exiting the sterile zone 64, the containers 10 are capped with the caps or securing members 20 and ready for slilplilellt.

[00044] The over pressure of sterile air or other gas is provided by a sterile gas source 88 including one or more suitable filters, sucll as HEPA filters, for sterilizing the air or other gas prior to introdueing sanie into the sterile zone 64. A fluid conduit 90 is coupled in f]uid colniiiunlcation between the sterile air soUCce 88 and the sterile zone 64 for directing the sterile air Illto the sterile zone. TIIe apparatus 58 tncltlcles one or niore vacliulIl pumps or other vacuum sources (not shown) mounted within a base support 87 of the apparatus and of a type known to those of ordinary skill in the pertinent art. The vacuuni source(s) are coupled in fluid communication with an exhaust manifold at the inlet transfer station 66 and an exhaust manifold at the exit transfer station 86 for drawing the air and fluid sterilant out of the sterile zone 64 and exhausting same through a catalytic converter 92 and exhaust conduit 94. The catalytic converter 92 is of a type known to those of ordinary skill in the pertinent art to break down the exhausted hydrogen peroxide into water and oxygen. In the illustrated embodiment, the exhaust manifolds are inounted at the base of the inlet and outlet stations and extend into the base support 87. As can be seen, the exhaust manifolds at the inlet and outlet stations 66 and 86, respectively, draw into the exhaust passageways located within the base support 87 (not shown) both sterile air and fluid sterilant fi=om the sterile zone 64, and non-steriie ainbient air located either within the inlet station or outlet station. As a result, any ambient non-sterile air (including any other ambient gases or contanlinants) in the inlet and outlet stations are drawn into the exhaust manifolds, and thereby prevented from entering the sterile zone 64 to inaintain the sterility of the sterile zone. Similarly, any sterile air or sterilant is substantially prevented from being re-circulated within the sterile zone, and instead, is drawn into the exhaust manifolds after passage over the containers and/or conveyor portion located within the sterile zone. If desired, one or more exhaust inanifolds may be located at the base of the sterile zone (i.e., beneath the conveyor 60 or between the overlying and tlnderlyn'1g portions of the conveyor 60) for fully exhausting the air and fluid sterilant and otherwise for avoiding the creation of any "dead" zones where air and/or fluid sterilant inay undesirably collect. In one enlbodiment of the present invention, the flow of sterile air within the sterile zone 64 is controlled to cause the air to flow generally in the direction 1'ronl rlgllt to le1l in FIG. 3A (i.e., in the direction f:rom the needle filling station 78 toward the sterilizing station 68) to tliereby prevent any fluid sterilant from flowing into the needle filling and laser resealing stations 78, 82 and 84. This flow pattern niay be effected by creating a hlgher vacuunl at the inlet station 66 in comparison to the outlet station 86.
However, as inay be recognized by those of ordinary skill in the pertinent art based on the teachings lierein, this 1low pattern or other desired flow patterns may be created within the sterile zone in any of numerous different ways that are currently known, or that later become known.

1000451 In the illustrated enlbodinlent, the conveyor 60 includes a plurality of flights or like holding mechanisms 96 that clamp each container 10 at or below its neck finish (i.e., at the peripheral region immediately below the mouth or opening 16 of the body 12) or other desired container region. The f7ights 96 are pivotally mounted on a belt 98 defininl; a closed loop and rotatably mounted on rollers 100 located on opposite sides of the apparatus relative to each other. One or more drive motors and controls (not shown) may be nlounted within the base support 87 and are coupled to one or both rollers 100 for rotatably driving the conveyor 60 and, in turn, controlling movement of the containers 10 througll the apparatus in a manner known to those of ordinary skill in the pertinent art. Each flight 96 of the conveyor 60 includes a plurality of container-engaging recesses 102 laterally spaced relative to each other and configured for engaging the respective necks or other desired portions of the containers 10 to support the containers on the conveyor. Altllough the container-engagillg recesses 102 are illustrated as being semi-circular in order to engage the containers 10, tlley equally Inay be fornled in any of numerous different shapes that are currently known, or that later become known, in order to acconlnlodate any desired container shape, or otllerwise as desired. The flights 96 furtller define a plurality of vent apertures 104 that are laterally spaced relative to each otller, and are formed between and adjacent to the contailler-engaging recesses 102. The vent apertures 104 are provided to allow tlle sterile air and fluid sterilant to flow over the portions of the containers 101ocated above the flights 96 of the conveyor and, in turn, through the collveyor prior to being exhausted t111'ougll the exhaust manifolds.

In the illustrated embodiment, the vent apertures 104 are provided in the form of elongated slots; however, as may be recognized by those of'ordinary skill in the pertinent art based on the teachings herein, the vent apertures may take any of numerous different configurations that are currently lcnown, or that later become known. Preferably, the flights 96 laterally engage the neck portions of the containers 10, and effectively isolate the sterile portiolls of the containers above the f]igllts from the portions of the containei-s located below the flights that may not be sterile, or that nlay include surface portions that are not sterile.

[000461 "I'he conveyor 60 defines an inlet end 106 for receiving the containers 10 to be fecl into the apparatus, and an outlet end 108 for renlovinb the filled and laser resealeci containers fronl the apparatus. As call be seen, the acljacent flights 96 located at the inlet and outlet ends 106 and 108, respectively, are pivoted relative to each otllel' upon passage over the rollers 100 to thereby define a loading gap 110 at the inlet end of the conveyor and an unloading gap 112 at the outlet end of the conveyor. Accordingly, at the inlet end, the containei's 10 may be fed on their sides into the loading gap 110 and received within the container-engaging recesses 102 of the respective f7ight 96. Then, as the conveyor 60 is rotated in the clockwise direction in FIGS. 3A and 3B, the opposing flights 96 are pivoted toward each other to thereby engage the containers 10 between the opposing recesses 102 of adjacent flights.
Similarly, at the outlet end 108, the formation of the unloading gap 112 between the respective fligllts 96 allows the containers loaded thereon to be removed fi=om the conveyor.
Any of numerous different devices for automatically, semi-automatically, or manually loading and/or unloading the containers onto the conveyor that are currently known, or that later become known, may be employed. In addition, any of numerous different apparatus that are currently known, or that later become known, may be employed to cap the filled containers after exiting the sterile zone. As may be recognized by those of ordinary skill in the pertinent art based on the teacliings herein, the conveyor, the devices for holding the containers onto the conveyor, and/or the apparatus for driving and/or controlling the conveyor may take any of numerous diff'erent contigurations that are currently known, or that later become known.

[000471 In the illustrated embodiment, each flight 96 of the conveyor is confgured to hold four containers 10 spaced laterally relative to each otller. Accordingly, in the illustrated embodiment, each sterilizing head 70 loeated within the sterilizing station 70 includes two sterilant mamfolds 114, and f:our sterilizing nozzles 116 mounted on each sterilant manifold.
Each sterilizing nozzle 1.16 is located over a respective container position on the conveyor to direct fluid sterilant onto the respectlve contalner. Slnnlarly, each sterilant flushing liead 76 located within the sterilant removing stations 72 and 74 incfudes two flushinb manifolds 118, and each f7ushing manifold 118 includes four flushing noziles 120. Elach f7ushing nozzle 120 is located over a respective container position on the conveyor to direct heated sterile air or other gas onto the respective eontainer to re-vaporize if necessary and flush away the fluid sterilant. In the illustrated embodimeilt, the conveyor 60 is indexecl by two rows of containers (or f7ights) at a time, such that at any one tiine, two rows of containers are each being sterilized, needle filled, and laser resealed within the respective stations, and four rows of containers are being flushed within the two sterilant removing stations (i.e., the first sterilant renloving station 72 applies a first flush, and the second sterilant renloving station 74 applies a second flush to the same containers). Wllen each such cycle is completed, the conveyor is indexed forward (or clockwise in FJGS. 3A and 3B) a distance corresponding to 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 if desired, any desired number of apparatus may be employed to achieve the desired throughput of containers.

[00048] The needle filling station 78 conlprises a needle manifold 122 including a plurality of needles 124 spaced relative to each other and movable relative to the flights 96 on the conveyor 60 for penetrating a plurality of containers 10 mounted on the portion of the conveyor within the filling station, l'illing the containers through the needles, and withdrawing the needles fi=onl the filled containers. l;ach of the laser resealing stations 82 and 84 conlprises a plurality of laser optic assemblies 126, and each laser optic assenlbly is located over a respective container position of the conveyor flights located within the respective laser rescaling station. Each laser optic assembly is connectable to a source of laser radiation (not sllown), and is focused substantially on a penetration spot on the second material portion 24 of the stopper 18 of the respective container 10 for applying laser radiation thereto and resealing the respective needle aperture. Also in tlle illustrated enlbodiment, eacll laser resealing station 82 and 84 further conlprises a plurality of optical sensors (not shown). Each optical sensor is mounted adjacent to a respective laser optic assembly 126 and is focused substantially on the laser resealed region of a stopper 18 of the respective laser optic assembly, and generales signals indicative of the temperatiire of the laser resealed region to thei-eby test tile integrity of the thermal seal.

1000491 In one embodiment of the present lnventlon, a non-coring filling needle 124 defines dual channels (i.e., a double lunlen needle), wherein one cllannel introduces the substance into the storage chamber 14 and the other channel withdraws the displaced air and/or other gas(es) fronl the storage chamber. In another embodiment, a fii=st non-coring needle introdttces the substance into the chamber and a secoald non-coring needle (preferably nloullted on the sanie needle manl'1'old fOr SInlUltaneously plcrein(y the stopper) is laterally spaced relative to the first needle and withdraws the displaced air and/or otlier gas(es) from the chamber. In another embodiment, grooves are formed in the outer surface of the needle to vent the displaced gas from the storage chamber. In one such embodiment, a cylindrical sleeve surrounds the grooves to prevent the septum material from filling or blocking the grooves (partially or otherwise) and thereby preventing the air and/or other gases within the container from venting therethrough. In each case, the channels or passageways may be coupled to a double head (or channel) peristaltic pump such that one passageway injects the product into the storage chaniber, while the othez= passageway simultaneously withdraws the displaced air and/or other gases from the storage chamber. In some embodiments of the present 3nvention, there is preferably a substantially zero pressure gradient between the interior of the filled storage chamber 14 and the ambient atmosphere. Also in some etnbodiinents of the present invention, the substance substantially entirely fills the storage ehamber (or is filled to a level spaced closely to, or substantially in contact with the interior surface of the first material portion 22, but not in contact with the exposed portion 26 of the second material portion 24).

100050] As sliown typically in FIGS. 1A-1C, in one embodiment of the invention, the body 12 defines a base 52, a mid-portion 54, and an upper portion 56 axially spaced fironl the base on an opposite side of the mid-portion relative to the base, and eacli of the base and upper portion derine a laterally-extending dimension greater than ainaxinlum laterally-extending dimension of the mid-portion. As a result, as also shown typically in FIGS. 1A-1 C, in the illustrated embodiment, the assembled container defines a substantially diabolo or spool shape. During needle filling and resealing, the container engaging recesses 102 of the flights 96 engage the mid-portion 54 of the body 12 immediately below the upper portion 56.
Accordingly, the.upper portion 56 of the body is engageable with the upper surface of the respective ilight or otlier container support for substantially preventing axial movcinent of the body relative thereto during at least one of needle penetration and withdrawal with respect to the stopper, and the base 52 o1'the body 12 is engageable with the lower surface of the respective fligllt or other container support for substantially preventing axial movenient of the body relative thereto during at least one oi'needle penetration and withdrawal with respect to the stopper.

[00051) In the illustrated embodiment of the prescnt invention, the second inaterial portion 24 is preferably inade of a thermoplastic/elastomer blend, and may be the same material as those described in the co-pendinl; patent applications and/or patents incorporated by referencc abovc, Accordingly, in one such embodiment, the second material portion 24 is a thernloplastic elastomer that is heat resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto, and defines (i) a predetermined wall thickness, (ii) a predeternlined color and opacity that substantially absorbs the laser radiation at the predetermined wavelength and substantially prevents the passage of the radiation through the predetermined wall thickness thereof, and (iii) a predetermined color and opacity that causes the laser radiation at the predetermined wavelength and power to herEnetically seal the needle aperture forined in the needle penetration region thereof in a predetermined time period of less than or equal to about 5 seconds and substantially without burning the needle penetration region.

1000521 In one embodiment, the second material portion 24 is a thermoplastic elastonler that is heat resealable to llermetically seal the needle aperture by applying laser radiation at a predeterniined wavelengtli and power thereto, and includes (i) a styrene block copolymer; (ii) an olefin; (iii) a predetermined amount of pigment that allows the second material portion to substantially absorb laser radiation at the predetermined wavelength and substantially prevent the passage of radiation through the predetermined wall thickness thereof, and hermetically seal the needle aperture formed in the needle penetration region tllereof in a predeternlined tinie period of less than or equal to about 5 seconds; and (iv) a predetermined amount of lubricant that reduces friction forces at an interface of the needle and second material portion durlng needle penetration tllereof. In one sucl7 enlbodin7ent, the second znaterial portion includes less than or equal to about 40% by weight styrene block copolymer, less than or equal to about 15% by weigllt olefin, less than or equal to abotlt 60% by welglit n7lneral oil, and less than or eclual to about 3% by weight pibinent and any processing additives of a type known to those of ordinary skill in the pertlnent al't.

[000531 In one cmbodinient, the second nlaterial portion 24 is a thermoplastic elastomer that is heat resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power tliereto, anci includes (i) a first polynleric material in aii amount within the range of about 80% to about 97% by weight and defining a first elongation; (ii) a second polymeric material in an amount within the range of about 3% to about 20% by weight and defining a second elongation that is less than the first elongation of the first polymeric material; (iii) a pil;nient in an mount that allows the second material portion to substantially absorb laser radiation at the predetermined wavelengtll and substantially prevent the passage of radiation through the predetermined wall thickness thereof, and hermetically seal a needle aperture formed in the needle penetration region fihereof'in a predetermined time period of less than or equal to about 5 seconds; and (iv) a lubricant in an amount that reduces friction forces at an interface of the needle and second material portion during needle penetration thereof.

[00054] In one e3nbodinlent of the invention, the piginent is sold under the brand name Lumogen*rm IR 788 by BASF Aktiengesellschaft of Ludwigshafen, Germany. "fhe Lumogen IR products are highly transparent selective near infrared absorbers designed for absorption of'radiation fronl semi-conductor lasers with wavelengths near about 800 nm.
In this embodiment, the Lunlogen pigment is added to the elastomeric blend in an anlount sufficient to convert the radiation to lleat, and nlelt the stopper material, preferably to a depth equal to at least about 1/3 to about %2 of the depth of the needle hole, within a tinie period of 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 is highly absorbent at about 788 nn1, and therefore in connection with this embodiinent, the laser preferably transnaits radiation at about 788 nm (or about 800 nm). One advantage of the Lumogen IR

pigment is that very small amounts of this pigment can be added to the elastomeric blend to achieve laser resealing within the time periods and at the resealing depths recluired or otherwise desired, and therefore, if'desired, the needle penetrable and laser resealable stopper may be transparent or substantlally transparent. 'I'his may be a significant aesthetic advantage. In one emboctiment of the anventlon, the Lumogen IIZ 788 pigment is added to the elastomerie blend in a concentration of less than about 150 ppm, is preferably within the range of about 10 ppm to about 100 ppm, ancl most preferably is within the range of about 20 ppm to about 80 ppm. In this embodiment, the power level of the 800 nm laser is preferably less than about 30 Watts, or within the range of about 8 Watts to about 1.8 Watts.

[000551 In one embodiment of the present invention, the substance or product contained within the storage chamber is a fat containing liquid product, such as infant or baby forniula, and the first material portion 22, the second material portion 24, and the body 12 each are selected fi=om materials (i) that are regulatory approved for use in connection with nutritional foods, and preferably are regulatory appi-oved at least for indirect contact, and preferably for direct contact witla nutritional foods, (ii) that do not leach an undesirable level of contaminants or non-regulatory approved leachables into the fat containing product, such mineral oil, and (iii) that do not tuldesirably alter the taste profile (including no undesirable aroma impact) of the fat containing liquid product to be stored in the container. In certain embodiments of the invention, the needle penetrable and thermally resealable second material portion 24 provides lesser or reduced barrier properties in comparison to the first matei=ial portion, and therefore the first material portion 22 and/or over cap 20 are selected to provide the requisite barrier properties of the container closure 15 for purposes of storing the product to be contained therein.

[00056] In the enlbodlment of the present invention wherein the product is a fat containing liquid nutrition product, sueh as an inf.'ant or baby formula, exemplary materials for the second material portion 24 are selected from the group including GLS 254-071, C-Flex R70-001, I3voprene 'I'S 2525 4213, Evoprene SG 948 4213 and Cawiton 7193, modifications of' any of the foregoing, or similar thermoplastic elastomers. In one such embodiment, the body 12 is an injection molded multi-layer of PP/EVOH. In another such embodiment, the body 12 is blow niolded, such as by extrusion blow molding, and is an I-IDPE/L;VOH
multi layer.
In some such embodiments, the first material portion 22 is selected from the group including (1) a low nllneral oil or mineral oil ti=ee thermoplastic; (ii) a low niineral oil or mineral oil free thermoplastic defining a predetermined durometer; (iii) a liquid iijJection moldable silicone;
and (iv) a silieone. 'l"he predetermined duronieter is within the range of about 20 Shore A to about 50 Shore A, and preferably is within the range of about 25 Shore A to about 35 Shore A. In some stich embodinaents, the first materiaf portion is formed of polyethylene, an I-IDPL;/T'PE blend or niulti layer, or a PP/TPE blend or multi layer. Also in some sucli enlbodUnents, the seetu=ing member or cap 20 is made of a plastic sold under the trademark Celcon"'m, a PP/LVOI I multi layer, an HDPE/EVOI-I multi layer or blend, or a I-Il:)PEVOFI
multi layer or blend. As may be recognized by those or ordinary skill in the pertinent art based on the teachlngs herein, these materials are only exemplary, and numerous other materials that are currently known, or that later become knowii, equally may be used.
100057] In FIG. 4, another container embodying the present inventioi2 is indicated generally by the reference number l 10. The container 110 is substantially similar to the container 10 described above, and therefore like numbers preceded by the number "l" are used to indicate like elements. "rhe primary difference of the container 110 in comparison to the container 10 is that the first material portion 122 of the stopper 118 includes a periplleral flange 132 defining internal felnale threads 146 that threadedly engage niale threads 144 on the body 112 to threadedly secure the stopper to the body. In this embodiment, the seal between the stopper and body can be fornled in any of numerous different ways that are currently known, or that later become known, including, for example, by a "plug" seal, a "valve" seal, or a "direct" seal between the top edge of the body and a gasket formed on the stopper. In the latter case, the gasket can be formed by the second material portion 124 at the time of co-4nolding the first and second niaterial portions 122 and 124, respectively, or at the time of over-molding the second material portion 124 to the first material portion 122. In this embodinient, the cap 120 does not secure the closure 115 to the body 112, but rather is snap fit at 133 to the depending flange 132 of the first material portion 122 and provides the requisite barrier properties for the container closure (i.e., an oxygen and nloisture-vapor transmission ("MVT") barrier). In the illustrated embodiment, as can be seen, the snap fit connection 133 is formed by an annular protuberance on the cover 120 received within a corresponding annular groove on the flange 132. 1-lowever, as may be recognized by those of ordinary skill in the pertinent art based on the teacliings herein, the cap 120 niay be fixedly secured to the stopper 118 in any of nunaerous different ways that are currently known, or that later become known. Also in this embodiment, a frangible tamper evident ring 148 is formed at the base of'the depending flange 132 of the first material portion 122 of the stopper 118 and slides over a tamper evident ridge 150 of'the body 112 to releasably ellgage the tamper evident ring and cap to the body.

(000581 In I;IG. 5, another contalner embodylnb the p]'esellt lnventlon is ]ndlcated generally by the reference number 210. T'he contalne]' 2101s substantially similar to the container 110 described above, and therefore like reference nunlerals preceded by the numeral "2" instead of the numeral "1" are used to indicate the same or similar ele-nents.
The primary difference of the container 210 in comparison to the container 110 described above is that the container 210 does not include a conventional cap, but rather includes a barrier disk 220 that is received within a recess 221 formed in the upper surface of the first material portion 222 of the stopper 218. As can be seen, the barrier disk 220 overlies the container closure 215 and forms a seal between the first material portion 224 and the ambient atmosphere to thereby provide the requisite barricr properties between the storage chamber 214 and ambient atmosphere. In the illustrated embodiment, the barrier disk 220 is fixedly secured to the first material portion 222 of the stopper 218 such as by ultrasonic or induction welding or sealing. However, as may be recognized by those of ordina-y skill in the pertinent art based on the teachings herein, the barrier disk can be fixedly secured to the stopper in any of numerous different ways that are currently known, or that later become known. As witll the caps of the embodiments described above, the barrier disk 220 is assembled to the stopper 218 after needle filling and laser resealing the stopper, and pre,ferably outside of the sterile ~rlling zone.

[000591 As may be recognized by those skilled in the pertinent art based on the teachings herein, numerous changes and modifications may be made to the above-described and other embodinlents of'the present invention without departing from its scope as defined in the appended claims. For example, the first and second material portions, body and cap may be made of any of numerous different materials that are currently known, or that later beconie known for perfonxling their functions and/or depending on the container application(s), including the product to be stored within the container. In addition, the body and container closui-c nlay take any of numerous different shapes and/or configurations, and niay be adapted to receive and store within the storage cliamber any of numerous different substances or prodLlcts that are cu17'ently known or that later beconle known, including without limitation, any of numerous different food and beverage produc(s, including low acid or fat containing liquid prodticts, such as milk-based products, Includlllb wlthout Iln'lltatlon milk, evaporated nlilk, infant formula, growing-up m-lks, condensed mllk, cream, half and-hall;
yogu-=t, and ice Cream (InelCldlng dairy ancl non-diary, such as soy-basecl ice cream), other ltCluld nutrltloil products, l1quld healthcare products, )ulce, syrul), cof'fee, condJn'lcnts, such as Icetchup, mE-stard, and mayonnaise, and soup, and pharmaceutical products.
Accordinbly, this detailed description of preferred embodiments is to be taken in an illustrative, as opposed to a limiting sense.

Claims (23)

What is claimed is:

1. A container for storing a fat containing liquid product, wherein the container is penetrable by a needle for aseptically filling a storage chamber of the container through the needle with the fat containing liquid product, and the resulting needle hole is thermally resealable to seal the fat containing liquid product within the container, the container comprising:

a body defining a storage chamber therein for receiving the fat containing liquid product and a first aperture in fluid communication with the storage chamber, wherein the body does not leach more than a predetermined amount of leachables into the fat containing liquid product and does not undesirably alter a taste profile of the fat containing liquid product; and a container closure assembly including:

a stopper receivable within the first aperture for hermetically sealing the storage chamber, wherein the stopper includes a first material portion defining an internal surface in fluid communication with the storage chamber forming at least most of the surface area of the container closure that can contact any fat containing liquid product within the storage chamber and that does not leach more than the predetermined amount of leachables into the fat containing liquid product or undesirably alter a taste profile of the fat containing liquid product, wherein the predetermined amount of leachables is less than about 100 PPM, and a second material portion that at least one of (i) overlies the first material portion and cannot contact any fat containing liquid product within the storage chamber, and (ii) forms a substantially lesser surface area of the container closure that can contact any fat containing liquid product within the storage chamber in comparison to the first material portion, wherein the second material portion is needle penetrable for aseptically filling the storage chamber with the fat containing liquid product, and it resulting needle aperture formed in the second material portion is thermally resealable to seal the fat containing liquid product within the storage chamber;

a sealing portion engageable with the body prior to aseptically filling the storage chamber with the fat containing liquid product and forming a substantially dry hermetic seal between the container closure and body; and a securing member connectable between the stopper and body for securing the stopper to the body.

2. A container as defined in claim 1, wherein the first material portion is selected from the group including (i) a low mineral oil or mineral oil free thermoplastic; (ii) a low mineral oil or mineral oil free thermoplastic defining a durometer within the range of about 20 Shore A
to about 50 Shore A; (iii) a liquid injection moldable silicone; and (iv) a silicone.

3. A container as defined in claim 1, wherein the second material portion is a thermoplastic elastomer that is heat resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto, and defines (i) a predetermined wall thickness, (ii) a predetermined color and opacity that substantially absorbs the laser radiation at the predetermined wavelength and substantially prevents the passage of the radiation through the predetermined wall thickness thereof, and (iii) a predetermined color and opacity that causes the laser radiation at the predetermined wavelength and power to hermetically seal the needle aperture formed in the needle penetration region thereof in a predetermined time period of less than or equal to about 5 seconds and substantially without burning the needle penetration region.

4. A container as defined in claim 1, wherein the second material portion is a thermoplastic elastomer that is heat resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto, and includes (i) a styrene block copolymer; (ii) an olefin; (iii) a predetermined amount of pigment that allows the second material portion to substantially absorb laser radiation at the predetermined wavelength and substantially prevent the passage of radiation through the predetermined wall thickness thereof, and hermetically seal the needle aperture formed in the needle penetration region thereof in a predetermined time period of less than or equal to about 5 seconds; and (iv) a predetermined amount of lubricant that reduces friction forces at an interface of the needle and second material portion during needle penetration thereof.

5. A container as defined in claim 1, wherein the second material portion is a thermoplastic elastomer that is heat resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto, and includes (i) a first polymeric material in an amount within the range of about 80% to about 97% by weight and defining a first elongation; (ii) a second polymeric material in an amount within the range of about 3% to about 20% by weight and defining a second elongation that is less than the first elongation of the first polymeric material; (iii) a pigment in an mount that allows the second material portion to substantially absorb laser radiation at the predetermined wavelength and substantially prevent the passage of radiation through the predetermined wall thickness thereof, and hermetically seal a needle aperture formed in the needle penetration region thereof in a predetermined time period of less than or equal to about 5 seconds; and (iv) a lubricant in an amount that reduces friction forces at an interface of the needle and second material portion during needle penetration thereof.

6. A container as defined in claim 1, wherein the first material portion defines a second aperture, the second material portion overlies the second aperture, and the second aperture constitutes less than about 10% of the surface area of the first material portion exposed to the storage chamber.

7. A container as defined in claim 1, wherein the first material portion is interposed entirely between the second material portion and any fat containing liquid product stored within the storage chamber to thereby prevent contact between the second material portion and fat containing liquid product during storage thereof in the container.

8. A container as defined in claim 1, wherein the first material portion is co-molded with the second material portion.

9. A container as defined in claim 1, wherein the second material portion is compressed inwardly in at least the needle penetration region thereof to facilitate resealing a needle hole formed therethrough.

10. A container as defined in claim 9, wherein the second material portion is approximately dome-shaped to compress itself inwardly.

11. A container as defined in claim 1, wherein the first material portion defines a peripheral flange that is releasably connectable to the body, the peripheral flange includes a plurality of peripheral flange portions angularly spaced relative to each other, and at least one of the peripheral flange and the body defines a raised securing surface, and the other defines a corresponding recessed securing surface engageable with the raised surface for securing at least one of the peripheral flange and the body to the other.

12. A container as defined in claim 1, wherein the first material portion defines a peripheral flange, and at least one of the peripheral flange and securing member defines a relatively raised surface, and the other defines a relative recessed surface for receiving therein the relatively raised surface and interlocking the stopper and securing member to each other.

13. A container as defined in claim 1, wherein the stopper is snap fit to the body, and the securing member is threadedly engageable with the body.

14. An assembly comprising a container as defined in claim 1; a filling apparatus comprising a needle manifold including a plurality of needles spaced relative to each other and movable relative to a container support for penetrating a plurality of containers mounted on the support within the filling apparatus, filling the containers through the needles, and withdrawing the needles from the filled containers; and a plurality of laser optic assemblies, wherein each laser optic assembly is connectable to a source of laser radiation, and is focused substantially on a penetration spot on the second material portion of the respective stopper for applying laser radiation thereto and resealing the respective needle aperture.

15. An assembly as recited in claim 14, further comprising:

a housing defining an inlet end, an outlet end, and a sterile zone between the inlet and outlet ends;

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

a fluid sterilant station located within the sterile zone and coupled in fluid communication with a source of fluid sterilant for transmitting fluid sterilant onto the stopper of a respective container supported on the conveyor within the fluid sterilant station and sterilizing an exposed second material portion defining the needle penetration region of the respective stopper; and at least one sterilant removing station located within the sterile zone between the fluid sterilant station and the outlet end of the housing, and coupled in fluid communication with a source of heated gas for transmitting the heated gas onto a container supported on the conveyor within the at least one sterilant removing station to flush away fluid sterilant on the container;

wherein the needle manifold and laser optic assemblies are located within the sterile zone between the at least one sterilant removing station and the outlet end of the housing for receiving the sterilized containers therefrom.

16. An assembly as defined in claim 15, wherein the fluid sterilant is hydrogen peroxide.

17. An assembly as defined in claim 15, further comprising a source of sterile gas coupled in fluid communication with the sterile zone for creating an over pressure of sterile gas within the sterile zone, and means for directing a flow of sterile gas substantially in a direction from the outlet end toward the inlet end of the housing to thereby prevent fluid sterilant from flowing onto containers located adjacent to the needle manifold.

18. An assembly as defined in claim 15, wherein the conveyor includes a plurality of pivotally mounted container supports that engage opposing sides of a respective container supported thereon relative to each other, and substantially isolate a sterile portion of the container located above the container supports relative to a portion of the container located below the container supports to thereby prevent any contamination on the lower portion of the container from contaminating the sterile upper portion of the container.

19. A container for storing a fat containing liquid product, wherein the container is penetrable by a needle for aseptically filling a storage chamber of the container through the needle with the fiat containing liquid product, and the resulting needle hole is thermally resealable to seal the fat containing liquid product within the container, the container comprising:

a body defining a storage chamber therein for receiving the fat containing liquid product and a first aperture in fluid communication with the storage chamber, wlierein the body does not leach more than a predetermined amount of leachables into the fat containing liquid product and does not undesirably alter a taste profile of the fat containing liquid product; and a container closure assembly including:

a stopper receivable within the first aperture for hermetically sealing the storage chamber, wherein the stopper includes first means for defining an internal surface in fluid communication with the storage chamber forming at least most of the surface area of the container closure that can contact any fat containing liquid product within the storage chamber and that does not leach more than the predetermined amount of leachables into the fat containing liquid product or undesirably alter a taste profile of the fat containing liquid product, wherein the predetermined amount of leachables is about 100 PPM, and second means for at least one of (i) overlying the first material portion and not contacting any fat containing liquid product within the storage chamber, and (ii) forming a substantially lesser surface area of the container closure that can contact any fat containing liquid product within the storage chamber in comparison to the first means, wherein the second means is needle penetrable for aseptically filling the storage chamber with the fat containing liquid product, and a resulting needle aperture formed in the second means is thermally resealable to seal the fat containing liquid product within the storage chamber;

third means engageable with the body prior to aseptically filling the storage chamber with the fat containing liquid product and forming a substantially dry hermetic seal between the container closure and body; and fourth means connectable between the stopper and body for securing the stopper to the body.

20. A container as defined in claim 19, wherein the first means is a first material portion of the stopper, the second means is a second material portion of the stopper, the third means is a sealing portion of the stopper, and the fourth means is a securing member.

21. A method for aseptically needle filling and laser resealing a container with a fat containing liquid product, comprising the following steps:

providing a container including a body defining an empty, sterile storage chamber therein for receiving the fat containing liquid product and a first aperture in fluid communication with the storage chamber, wherein the body does not leach more than a predetermined amount of leachables into the fat containing liquid product and does not undesirably alter a taste profile of the fat containing liquid product; and a container closure assembly including a stopper received within the first aperture and hermetically sealing the empty storage chamber, wherein the stopper includes a first material portion defining an internal surface in fluid communication with the storage chamber forming at least most of the surface area of the container closure that can contact any fat containing liquid product received within the storage chamber and that does not leach more than a predetermined amount of leachables into the fat containing liquid product or undesirably alter a taste profile of the fat containing liquid product, wherein the predetermined amount of leachables is about 100 PPM, and a second material portion that at least one of (i) overlies the first material portion and cannot contact any fat containing liquid product received within the storage chamber, and (ii) forms a substantially lesser surface area of the container closure that can contact any fat containing liquid product received within the storage chamber in comparison to the first material portion;

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

transmitting within the sterile zone a fluid sterilant onto at least an exposed portion of the stopper of the container and, in turn, sterilizing with the fluid sterilant at least the exposed portion of the stopper of the container;

transmitting within the sterile zone a heated gas onto the portion of the container exposed to the fluid sterilant, flushing away with the heated gas the fluid sterilant from at least the exposed portion of the stopper of the container and, in turn, forming a needle penetration region of the stopper substantially free of fluid sterilant;

penetrating the needle penetration region of the stopper with a filling needle coupled in fluid communication with a source of the fat containing liquid product, and introducing fat containing liquid product through the needle and into the storage chamber;

withdrawing the filling needle from the stopper; and applying laser radiation to a resulting needle hole in the stopper to thermally reseal the second material portion and, in turn, hermetically seal the fat containing liquid product within the storage chamber.

22. A method as defined in claim 21, further comprising moving the filled container outside of the sterile zone, and applying outside of the sterile zone a cap to the container that overlies at least an exposed portion of the stopper of the container.

23. A method as defined in claim 21, further comprising directing an overpressure of sterile gas within the sterile zone, and directing at least a portion of the sterile gas in a flow direction generally from an outlet end toward an inlet end of the sterile zone to, in turn, prevent fluid sterilant from contacting a container during needle filling thereof.