WO2013055988A1 - Liner-based shipping and dispensing containers for the substantially sterile storage, shipment, and dispense of materials - Google Patents

Abstract

A. liner-based assembly including an overpack, a liner disposed within the overpack, and a filling connector securable to at least one of the overpack and the liner and ineloding a membrane for substantially aseptic filling. The membrane may be an elastomeric stopper, which may be configured, for re-sealing with or without the assistance of heat The !iner-based assembly may further include a dispense connector that is operably connected with the overpack and/or the li.oer. The dispense connector may comprise or be operably connected to a one-way valve, the one-way valve having. -an elastomeric portion defining an opening and generally operably coupled with a plug member positioned within the- opening. In a closed position, the elastomeric portion may be sealed against the plug member, and when a pressure is applied against the elastomeric portion, the elastomeric portion may flex in a manner configured -to permit only one- way flow through the opening.

Description

LMEM BI) SiOPP!NG A 0 MSiTOS!HG CONTAINERS FOR THE SUBSTAN IALLY STEKiLl $TGMAC¾ SOI MEHT, AMI BMPM O

ATEMALS

^'Field- -of the InveatS n

C©0 j The present disclosure relates to novel and advantageous, shipping and dispensing systems. Parhcuiariy., the present disotasnre relates to novel and advantageous Ihwr-based systems for the substantially sterile storage, shipment, arid dispense of rnaieriajs used in the hio eehno!ogy and haB J eeutfeal industries, and. which. In some cases, may be completely or substantially disposable..

Baekgrawad of the Iwewt!oii

[0023 Numerous materials, such as eidture media, h ffes, reagents arid oilier biological materials, tor example, are used: extensively by feiotech companies, for example, i research and development, vaccine creation anc! ¾sags, protein production abet purifcaiion, and t e de opmePt of other biologies.. To he sate and eff c ive fpt their Intended vise, as well as to

materials must be pure and sterile.:

p03| Containe sy^terns. may he used in the biopharraaeeutieai. md other industrieS_s for storing,, shipping;, Hi ¾g_S: reacting, proce

sndi. a those deserihe above. Such m errais are often

mnst be maintained in a sterile environment Aeeoi dinglyi, any container system used: with, such materials must fee substantialiy airtight to preven contamination and t prevent escape of the material into the outside errwopmest Further a container system: must: be s^'¾¾ sterile,, reliable and leak proof, such that it may withstand the stresses o shipping, and dispense..

[004] Container systems that are used to store and dispense the types of materials described above, as well, as other H o ^hased cont nts;, typically include a. container of same kind,, and/or a liner., a cap that ma he used to seal and; p otect the contents of the storage system when, the contents are not being dispensed, and a connector that may be used to dispense the contents from the container, However,

- I - tmditionaJ storage and: dispense container systems are typ call}^«0 c«a^;fi ¾red to permit for the safe and secure shipment of the types of materials deseriherl_s particularly not in a disposable container system. Specifi cally. sneh a-a h n i dispensers may net adequately maintain or ensiire the purity of the contents of the dispenser anxh for example, are unable to keep gas or other c ntaminants from getting into the Contents stored in the liner. Similarly, in. cases vsk&m the materia! being transferred, is noxious or harrafel, with traditional

to- permit for the safe ^■ d secure shipment the user may be undedrah!y exposed to the material during transfer; OQSJ Accordingly, there is a need for a dispense that limits o substantially e!usinaie eontai^inaiion and or degradation of the contents of the dispenser. :Further et₅ a need exists for isolating the contents of a dispenser from the environment from the point of filling to final dispense of the contents.

Brief Summary of ike tm on

[QQU The present d sei«s¾ e_!: in one eisbodiineat, relates t a liner-based assembly for use with- ressure dispense. The liner-based, assembly may include an. o ver aelv_j liner disposed within the overpaek, and a fillin eorffieetor thai is separable to at least one: o the: overpaek and the liner, the connector incJnding a membrane for substantially aseptic filling. The membrane., in some eases,, may he re»sealaMe elasiomerie stopper, which may be configured for re-sealing with or without the assistanee of !teat. The; liner and overp&ek eonhi he irradiated for sterility. The Mner- baseri assembly ma ferther include a dispense connector that is^; operably co nected with the overpaek and/or the liner, oyer the filling connector. The dispense connector may comprise or be opsrabl connected to a one-way valve. The one-way valve may have am elastomerie portio defining an opening and generally operafaly coupled with a plug mernber positioned, within the o e The plug momfeer may be relatively stiff as compared to the eiastomeric portion, hi a closed pos on_J: theekstonw c portkm may be sealed against the: ping em½r, and when pressure is applied against the elastonierie portion, the elastomerie portion may flex: in a manner configured to peniut only one-wa flo through the opening. The liner may he configured to collapsible away from the overpaeie daring pressure dispense. l¾fthefmore,. the Hnertaseii assembly may me!nde a portable pressure source for press¾rizing an aii!wlaj- space between the overpaei:. and liner for collapsing the liner and dispensing the contents thereof, ^:

fOftTJ The: present disclosure, in anothe CrnbodirBent, relates to a method for providing: a sterile iransportip and pressure dispense system, The method includes providing an overpaek and/a liner disposed within the overpaek; irradiating the overpaek and ner for sterility; and¹ securing a connector to at least one of the overpaek and the liner, the connector including a membrane, which i some cases may he an clasfoniertc stopper, for substantially aseptic Siling. Again, the membrane ma be a re-sealable elastpmeric stopper. The method may fur&ar include filling the liner by piercing the e!astomerie stopper with a needle and passing a material through the needle int the liner, U on completion of filling, the needle may be removed, and in some eases heat xa&y be applied to assist in repealing the elastoraeric stopper. Also upon completion of filling the User, headspae gas niay be removed from the interior of the liner; A. one-way v¾f e may be provided on. the connector for peinnitmg he ds ace gas to pass in one direction ou of the liner. The metho may also iricliide providing a dispense connector that is operably connected -with the overpaek and/or t e hper, the dispense connector comprising or eperabty connected to a one-way valve. A portable pressure source, may be provided Hot pressurising a annular space between the overpaek and liner. The portable pressure sonrce may be, for example, a disposable compressed gas cartridge,

j$0$| hi another embodiment, the present digelo re relates to a iiner^ ased assembly lor use with pressur dispense.. The hner-basec! assembly ma ibciude an overpaek, a liner disposed within lire oveiTjaek, the liner configured for collapsing away iroin the overpaek u on the Introduction of a gas or fluid into an annular space between the overpaek and liner, and a dispense connector that is securahk to at least one of the overpaek and the liner, the dispense connector comprising a passage in fluid communication with the annular space an comprising or operabl connected to a oneway dispense valve in fluid communication with an interior of the liner. The; one-way valve may include an elastomeric portion defining an opening and generally operably coupled with a plug member positioned, within the opening, the plug, member being relatively stiff as compared to the elastomeric portion, i closed position, the elasionierjc portion may be sealed against the plug member, and. when a pressure is applied against th ^; e!asto erio portion, the elastomerfe portio fraay flex to a nianner eonfigared to pemiit only one-way flow through the opening, in tm embodiments, the liner an overpaek may he ir adiatecL

f099] While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art irojir the i¾ilewiiig detailed description^ wlieli s ows a d describes illustrative embo ments of the disclosure. As will be realized, the various, embodiments of the present disclosure are capable of modifications in various obviou aspects, all without departing from the spirit an scope of the present disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not rostrietive.

Brief Pese ptloM of the Dr ings 01 J Whil the spec fication concludes ith claims partiei arfy pointing out and distinctl claiming the shh ect matter tfi is regarded: a forrnin the yariops embodiments of the present disclosure, it s believed that; the disc!os¾re will be better understood ίτοηΐ ^'the · Mte$Si-¾ ^' d^mptiofr taken, ih conjunction with, the aecoiripaiiying Figures, in whieh:

£011 J. HQ, I s a eross-seetional: view of: a slipping arid, dispensing: system according to one emhodifflent of the present disclosure,

12] PLC! 2 is a. cross-sectlona! view of a, outlet valve of a dispense: connector aecordiog to one embodiment of the present disclosure,

[013] FIG, 3 is a dispense system schematic according to one embodiment of the present disclosure.

ft) 14} FIG. 4 is dispense system schein atie according to another embodiment of the presest disclosure.

015] FIG. 5 shows a. shippi g and storage system for use with indirect pressure dispense acasrdiog to one embod Ba©itof the .^resent disclosure.

[016] FIG. 6 shows statistics relate to the indireet pressure dispense method shown in FIG, 5 provided in graphical fo m in accordance with one embodiment of the present disclosure. [017] FI0. ? is a eross-sechodal view of & s¾pp¾g an d spens ng, s stem ineln ing a. pa^aglng element acco α¾¾ to one ento en of the present disclosure that.

Detailed Descri tion 18| The present disclosur relates to ovd and advanta eous dipping and dispensing systems. More art cularly., the present disclosure relate t© novel and advantageous liiier-based systems fcr use, some em odiments, with materials that must maintain their parity, or some high level of purity during ship ing- md/m dispense., wherein, in some cases, the 3ia«F-fease system may he completely or substantially disposable. Per example, he shipping an dispense system of the present disclosure, ¼ one aspect, may be eonfi sred for a single use and or remain sufestastklt air-tight for use n. industries that use materials that must remain: substantially pure, oneontaminated, andy^'or sterile, such as man materials Med in, fer example, the hiopnamraeentieai. mandfaeiariing and _;¾aJytical^' processes industries. Ex mples of sonie f the types of materials that may be used with ea botliments of the present disclosure include, but ar not limited to, reagehts^ b ffers,- cell . eultee media, err other sterile media. Applications may iaelud¾_: but are not limited to, sterile media tansfer, vaccine marofiieture, fillin

l:mMaGe jt eai process fluid transfer, high cpniainment operatioas, in- toeess pooling, and trausterring buffers. It how ver, recognised tfcat embodim ents of the present disclosure may also be used with a vari et of materials ¾ a Variety of different industries. ¾r example, dispensers o the present disclosure ma contain, but are not limited in use to: ultraprrre liquids, such as acids, solvents_* bases,, photoresists, slurries, detergents, cleanin formijiations, dopants, ^•feorganie,. oi¾anie, metal organies, TEGS, and biological solutions, :DHA anil A solvents: and reagents, pharmaceuticals, nanomaterials (including for e mple^, iullerenes, inorganic nO artieles, sol-gels, and other eeramiesh and radioactive chemicals; pestieides/t¾tlli¾ers; ints glosses^^ etc> power washing fluids- lubricants fer use in ¾e antomobile or aviation industry, for example; food produeis, such m but not limited to, eondirnent¾ cooking oils, and soft drinks, for example^* reagents or oilier materials: tor use in the biomedical or research industry; hazardous materials used b ibe mil tary, for examp e; polyufetbaKes:; agroehemioa s; .i&ite&M diejiicals; cosmetic chenu^'eals; petroieiini a&tl ϊ¾Μβέ«ι¾ adhe i^es; sealants; health, and oral hygiene: products and toiletry products; or any other material thai may be dispensed, by pressure dispense, for example, aterials t ai ma be used with enihodmients of the present disclosure may have any viscosity, including high viscosity and le viscosit fluids. Those sidlled in the art will recognize the benefits of the disclosed e hodTOeat,_*. and ere&re will reeo il¾e the suitability of the disclosed embodiments to various: industries and for the transportation and dispense of various products.

[0193 The use, creation, and or storage of some xirateriais that may be used with, embedments of the present -disclosure- may he snbjeet to various rules._s regulation and/or standards.. Accordingly, in gome embe inieuis of the present disclosure, the liner- based syste and/or the use of the liner-based system may meet gpideliBes set by the United States Pharmacopeia ("USP , Bpedfically, some embodiments of the present disclosure, ma he suitable to meet Class Vi iJSP guidelines to ensure bioeon^atibility with plastics, USFs official Reference Standards are highly eh aracierized specimens of dru substances, exeipienfS; impurities, degradation products, dietary mipplemenls, compendial, reagents* and performance calibrators. They are specified for use in conducting official !JSP-¾F tests and ass s, OSP also provides Reference S and ds specified: in the. Food Chemicals Cod x as well as authentic substances, high^qualify clienheal s m les^ as a service to n lytical clinical, paarmaeeutiea mid research laboratories, llHP's Reference Standards are used in. more man 13:0 countries around the world, IJSP Inference Standards that are based directly on official mono raphs ill the USB--NF, whose standards and procedures are enforceable by the ILS, Food and Drug Administration (FDA)* are recognized as official standards in the IXS,, and their use is effective in demonstrating eomplianec with statutory requirements,

£020] In- other embodiments^ various components or all. components of the shipping and dispensing systems of the present disclosure the i er may he, of may also be, animal, derived component free 'ADCF"). ^'Using A CF J tstiA-ma fee. I portant, fo example,, because bovine spongiform eneephalopaihy ("BSE") and its potential to affect humanit lia ernerged. as serious concern, Accordingly, suppliers of many essential animal -so arced components used in cell culture and fermentation roce ses ib example, £>ee& <?:^: eos nied .sboui.

ViruS!¾s also, CM he present in raw materials deri ed torn; animal origins.. Many Important: drug an vaccine products are made By mammalian cell culture: or bacterial fefirseittation, so fhe r biological safety is paramount. However, it is very difficult to ensure- thai- any material from; an animal source carries no infection. Even the rigorous cleaning methods designed to minimize earry-over of bioiiazards: from one batch to the next is m guarantee: of safety, Thys the nse of ACDF materials for storing, shipping - and dispensing biological and/o biopharinaeeutica! media may be advantageous,

[021] The Ime^ase systems of the present disclosure may hold up to approximately 2:00 liters, in some emhodinrents. Alternatively, the liner-based systems may hold «p to approxirnafoiy 20 liters, Alternativel , the Jiner-hased systems ma held approximately I to S liters, or loss, it will be appreciated that the referenced container sizes are examples only and that the liner-based systems of the present disclosure may be readily adapted fer use with a wide variety of sized and shaped shipping and dispensing containers . Tie; entire litter-based sy tem .: of me present disclosure may he used a sin i e- tfcne: a d then disposed of in s me emto iments. In other embodmieute, the 0verpaek,_: for exampk, may he reused whil ike liner and or any connectors may he used onl a single time.

[022] Figia-e I Illustrates one embodiment of liner-based shipping and dispens system I OC) of the present diseiosure, in some em odiBie is, die shipping and. dispense system 100 may include an overpaek 1Q2,_: a h^'nef 104, and e: of more connectors or connector assemblies, which may be, fo example, a filling connector and/o a dispensing connector or CGnneetor assembly, as will be described in mrther detail below,

{92$] The. overpaek 1:92 may include an overpaek wall an interior cavit

108, and a nion!h 310,. 1¾e overpaek 1.02 may fee co prised of any snitabte material or combination of materiaiSj f example but not limited t ,. one or more polymers, including plastics, nylons, EVQ¾ polyolefes, or other natural or synthetle polymers, in fa mer embodiments, the overpaek. 1Q2 ma be: nianufactored using po!ye&ylene terephthalate (PET), polyethylene naphthalate (FIN), poly butyfene 2_;6-naphthalate) (PBM), polyethylene (ΨΈ), linea low-density ;palyethyierie (LLDPE), low-density polyethylene (LOPE), medium-density polyethylene MDPE), high-density polyethylene (HDPE), poly rft fylerfe (P ), and/o a fluoropolymer, such as bin not limited to, olyeitior0trIiluQro€ithyieac CPC FS3},. palyt ^raflftoras byleas (PTFE), fliiOr ffiited ethylene propyl erM (FBl¾ a d erf yo alkox (PFA.), The oyerpaek 102 may be of airy suitable shape or configuration, such as* hut net liniited to, a bottle, a ean_S: a drum, etc, I024J As described above, the srsipping_; aud dispense system 100 may inclnde a line 104, which may he disposed within the overpack 11)2:. The line ! 04 may include a litier wail 1 12, ai inteiior cavity 114, and¹ a mo th 116, The month 1 1 of the liner 104 raay include a fitment pot lion 18. The fitment portion 118 t y he -made o the same or different material than the rest of the liner 104 and may be ^'harder* mom resilient, and/or less flexible: than the rest of the liner . The fitment portion 1 18 may include threads 120 that may couple with co plenicniary mreads on a connector or connector assembly (¾iseussci more fully below},. it is appreciated, however, that the -fitment portion 118 may alternatively or additionally include any other m eans for coupling with a connector, such as but not Κ«ηί©ΐ! to, snap-fit or fficti o_^fit nieans, hayonei means, or any other suitable mechanism, or combination of meehaa sms for coupling, as. will be appreciated by those skilled m the art. _: I some embodiments, . a connector or connector assembly may couple to, or may also eonp!eto, the; mouth 11 of the overpack 102,

[026] In.^' some ^: embodiments, the liner 1 4 m y he a eollaps e liner ikaf is substanti lly flexible, while in other embodiments; the liner may be somewhat rigid but sill eolls siblCi e.g. j a rigid collapsible liner, The lifter 104 may be marmiaeiored ss¾g any suit able matefM or i»mbinaiion of matofiafe, such as but not limited to_4: any of the materials or combination of materials listed above with respect to the overpaefc 102. However, the overpack 102 and liner 104 need: not be manufactured from the same materials. In some embodimenis, the material or materials selected, and me thiefciess of that material or those material may detefmine the rigidit of the li net 104, The liner J 04 ma have One or more layers and may have any desirable thickness, A liner 104 ma have a thickness of, for example, from about 0,05 mm to about 3 mrn^ or any other suitable thickness,

'the liner 104 may be configured to comprise any desirable shape that is appealing to the user, and dr assists in the collapse of the lifter. The liner 104, in some embodiiricnts, may be dimensioned and shaped to substantially conform to t e interior of the overpack 102, As sivefo, the liner W2 may have- a relative simplistic design with generally smooth outer SBT%5S>,_. or Ihe liner may ave a relatively complicated: design including, for example but .-not- limited to,. indentations Π&όχ protrusions:. In some e bodmients, the H wall 1 12 ma include a generall textured surface in order to minimize adhesion. For example, in some embodiments, the surface may include a plurality of bumps, scales, or profeeiions_? which may each: have an appropriate size, for example, but not limited t% imm. atxiut 0.S - 100 p.m. Tcxiiaa¾ing features ma be spaced any suita^'bk distance from one another, in some embodiments, the texturizing. may comprise a 'framework:, such as a lattice or scaffold, t&r. ex m l _* Examples of some suitable texturiang features are described ' greater detail in IX SL

Patent Applii, No. -61/334,00 . titled, "Fluid Processing Components with Texture Surface for Decreased Adhesion arid Related Methods," filed. !a 1 , 2010, wfcieh Is hereby incorporated by reference herein hi its ehhreiy. The liner 104. may have a relatively thin liner wall 112, as compared to the fhicfcne& of the overpack wall 106·. la some embodinieats,. the liner 102 may be flexible such that th li er wall 112 may be readily collapsed, such a¾ by vacuum tbrmtgh the mouth .1.16 o ; by pressure beiweeu the liner wall, 3 .2 and overpack wall. 1Q6, referred to: herein as the annular space therebetween. 027 The liner ί 04, in a ri&er embodiment may have a shape, when inflated or filled, ^'that is diffcreti froni, but complimentary y¾¾ me shape of the overpack 102 sueh that it may he disposed^ thereut 1» some embodiments, the liner 114 may be rerpovahly attached to the interior of the overpack wall 1.02. The line 104 may provide a barrier, such as a -j s^'- ¾ri^r₉. ^'against ^'4riw^'.gasi^' migral&m- fe¾R..^'the- attnatar space between the h!ier wall 112 and the overpack: wall 106, Accordingly, the: liaer 104 ma generally ensure and/or malutain. the purity of the corh Hts wimiu fee liner,

[0281 la some embodiments:, particularly where sterility of the contents of the liner must be substantially mamtainec ,. the line 102 m y be comprised of a material that may help ensure or maintain a sterile environment lor the contents^' disposed in the liner. For example, in some emhodiments the liner may be comprised of T S imanufaetu ed b ATM! of Danbury, Connecticut, or any other suitable maiertaS, As noted above, in some embodiments, the Imer 104 may comprise multiple layers:. The multiple layers may comprise one or more different polymers or othe suitable materials. In some embo iments, the tMckness, ply, .and/or the composition of the: liner and/of the layers of the liner may allow for the secure and substantially uneontanj-inated shipment of the contents of the liner-based system of the present disclosure by limitin or eSimmating typical weakiiesses or problems associated with traditional liners or packages, such as, for example weld team, pia holes, gas entoinnieat and/or any other means of contamination. Similarly, or in ad ition, the liner 104 may also contribute to the secur and substantially uncontaminated shipment of the contents of the s pping and dispense spfem 100 of the present disclosure by configuring, the liner to substantially^' eonftrr to the shape; of me overpack hen the: liner is Siled, thereby reducing $fa$ amount of movement of the contents; during shipping. Further, in embodiments where the liner substantially conforms ί the shape of the everpack, the amount of movement of the liner during shipment may be reduced or substantially reduced, advantageously reducing or ei;i mi nath¾ the occurrence of itr ho leg ,

[029] lire overpack 102; and: liner 104 may each be manufeetared using arty suitable manufaotor ftg process, such, as but not limited to, injection blow maiding, injection, stre ch blow molding,, extrttsion, efc and ma each he. maniihaeture as single component or may be. a combination of multiple components;. In. some. embo i ents; the o^:v"er acfc 102 a d liner 104 ma be blow molded in a nested fashion., also referred to herein as eo-hfe molde . Examples of I er-based systems and .methods utilisin co- blow molding techniques have been: described in greater detail in U>S. Prov. Appl. No, §U5 M>^'$ 7_> titled ''N sted Slow Molded finer and Qverpack anil Metbods of Maldng Sarn©,^M filed Jul 12, 20]: 1, which is hereby incorporated herein by reference in its entirety. In some embodiments line may be blow molded into an already formed: overpack, whereby the overpack may function as the mold for the liner, and may be reiferred to herein as ^dn l blow niolding," which is described in further detail¹ in U.S, Ptov, AppL No, 61 703,986,_. b ed ¾ner~haseci SWpptog ,¾¾d-^'Djs ^isii5g^: S.ysi&ns ^5' i¾.ed September 21, 2012, which is hereby incorporated herein by referenee in its entirety. In such embodiments, the overpack may be manufactured by any suitable process.

[630] Examples of the type o liners and everpaeks. that may be used are disclosed mote detail in: international FCT AppL No, PG /USll/SSSSS:, titled, "Substantially Rigid. Collapsible Line**. Containe and/or liner for Replacing Glass

1 , 2(111;, International PCT Appl. No. PCr US:l¾5S560, titled,: "Nested Blow Molded. Liner and Dverpaek aiid Methods: . of Making Same/' fled October 10, 201 1 International PCT Appl. No. PCT/US! 1/64141, titled 'Oenerally Cylindrieaily-Shape Lifter for Us i Pressure Dispense Systems and

filed. December 9, 2QU; U,S. Prov. Appl No. 61/468,832, titled "Oner-Based Dispensst/'- filed March 29, 2011; U.S. Prov. Appl. No, 61/525,54(1 titled 'Tiner^ase Dispensing Systems." filed August: 19, 2011; U.S. Pi¾v. Appl No. 61/703,995, titled 'X ie -h sed Shipping: aid Dispensing; Systems,"¹¹ filed Se enyher 21, 2012; LLS> Pat Appl No. 11/915,996, titled "Fluid Storage and Dispensing Systems and Processes," fife lone 5_S 2006; International PCX Appl No. PCrr/USlO/51786, titled "Material Storage an Dispensing System and Method With Degassing Assembly,^* ' tiled October 1, 2010,: International PCX Appl, No, POX/USl 0/41629, llSL Pat. No. 7,335,72:1, IIS, Pat. Appl No. ί ί/912,629, U.S. Pat. Appl, Me, 12/302,257, and International PCX Appl/No, PCT/US08/S52 , eash. of which is hereby intj r or¾te : by refe enee herein in i is entirety. The o verpaek 102 an liner 104 ferns© with the shipping and dispense system 100 of the present diseiosiure ma inelnde any of the embodiinents, fea urjes, and/or enhancements disclosed in _. any of the above noted applications, including,

3~dinienslonai, welded, ntolded, gussetecl, and/or non-gusaeted liners, and/or liners that contain folds and/or litters that comprise: methods for limiting or elmrinating ehofee-ofX and_: Kners sold under the brand name GW k^ b ATMX hie. for example,

£031J As: described above, the liner 104 may inclu e -a fitment portion 118, which, may inckide coupling means, such as but not limited to, threads 120_» for coupling ith eompleMeniary thre ds on a connector or connector assembly. Various types of connectors or connector assemblies ma be utilized with the shipping and dispensing system 100^· of the present disclosure, hi ©ne embodiment, the shipping: and dispensing system 100 may include one or both of a shipping and filling conneetor and. a dispense connector assembly, each of which is described more fully below.

0321 As illustrated in Figure 1, a shipping and tilling connector 122 of the present disclosure,, in some embodiments, may include complementary thread 1:24 that may couple with threads 120 on the fitment portio 1 18 of the liner 104, As with fiteent portion it ls^: appreciated, however, feat the: cenaeetof 122 m y alternatively or additionally include any other means for couplin with one or mare portion of (be finer- based system., such as but not limite -to, snap-fit or fiiefion-fit me¾fts, bayonet means, or any other suitable: mechanism Or combination of mechanisms for eormlipg, as will be appreciated by those skilled in the art,

£033] In some embodiments, ffre connecter 122 may he^■..confi ure , for aseptic filling of the interior eavity 114 of the liner 104, in some embodiments, connector 122 may include a membrane 126 through which aseptic filling may be accomplished. The membrane 126 may b¾. for example, a re-sealable stopper made from an eiastomerle material,, such that ¾ filling tube: or need¾ sneh as but not limited to a mm~corir * needle., may be passed through the membrane for filling the liner 104. Upon removal of the filling tube or needl , the elasiomeric material of the membrane .126 may reseal, mereh eliminating, or substantiall eliminating getm iPgfess to the lifter 104, In some cPibddiraeHts, the; membrane 126 reselling m¾ be assisted with the use of heat, such as hf laser. S uch a connector 122 permitting, aseptic filling can elinunate the Peed: for costly and complex, isolators, Rather, the shipping: arid dis ense: system 100, -or mo e paiiiculariy, the overpse¾ 102 and/or liner 04 may he -sterile and_: irradiated, thereby themselves heconring; the isolators. In general,, with some such embodiments o connector 1.2¾ at no time during filling: arid shipping of the filled liner are the cpnients within the interior cavity 1 14 of the line 104 exposed to the external envhoninerit, eoPipletely or swbstanhai y preventing contaminatieri of tire contents. In one embodiment, the shipping arid filling connector 122 may or may be similar to, filling connectors sold under the brand riairie intact ' ^' Sterile Filling System by Medical Instill Technologies, inc. of New Milforcl, CX. While a -connecter having a membrane of an eksteffierie substance is described, it will be understood that any suitable Class VI plastic, or eowihinafioas firereofi for example, may be used ¾> provide a sterile eomiector within the spirit and scope of the present disclosure.

[034] A dispense, connector or assembly may, o may also be used with embodiments of the present disclosure, in some eases, the dispense assembl may comprise a dispense connector, features f r dispensing by pressure dispense, and/or a one-way -disease ya ve. la some embodiments, dispense connector may include dispensing features, as Well as

those described bov , ¾erefey allowing the same connector to be used for bodrfiO&g anddispe se, wMle; n other cases, the dispense .eonneetor -may be a separate connector fern the connecter used to fill the liner based system. Acco dingly,_: the dispense connector may be directly coupled to or over the connec or 122 used to: fill &Qt ^'ship. the container in some embodiments. Ixi other embodiments where the dispense connector is se arate from tbe connector 122 used to fill and/o ship, some or all of the fill andlor shipping connecter may be removed; ironi the liner md overpaek system before coupling the dispense connector thereto. The dispense connector may be comprised of any suitable material such as metal ,_: plastic, or any other material or combination of tnatedala, in some embodiments, the dispense connector may be comprised of a material that may be suitable lor use a sterile env r^meat, s m those listed above, o aay o&er sisiiab e material, or combination of materials;

[035] The dispense assembly ma a]$o include features used to dispense the contents of he liner based system. In some embodiments, the dispense assembly may be configured to woris. with: e?d sting_: static systems, fbr instance existing pressare-dispense systems that may not- be portable, i other embodiments, the dispense system ma be configured .to be substantially completely portable. Generally,, dis ensing features of the d s ense; assembly may inelude. a pressurizing gas inlet that generally permits a gas pressure .in-line to be inserted: through or coupled with. the. dispense connestor and be In fluid cdmrnTOication ith the anntflar. space between the liner 104 and the oveipack ^"102. in sueh a system,; a fluid, gas, or other suitable substance may be introduced into the annular space, thereby pushing the contents of the filled liner 1.04 out of the liner 104. The dispense assembly may also include one or more ports that may include dip tubes that may extend, any suitable distance into the interior of the liner 104 that may. fee used, for example_* to puncture- the membt&he 126 on the fill connecter 1 2 in embodiments where the dispense connector may be coupled to or over the illleonEiee or 122.

|03β] The dispense assembly may also inefude a one-way dispense valve -200 as shown in Bigitte I som enibodiments the dispense valve 200 may act as a rion- contamination barrier, protectin the contents of the liner during dispense iforn air, moisture, bacteria and/or an other harmful contaminants. The one-way valve 200 ma generally only allow material 10 flow in one direction, i.e. out. of the: valve and not back into the liner, during dispense. In th s. way,, the one-way valve 200 ftmet ons siisilar y to the arterial valve in th cardiovaseular system. The one-way vaive 20O may include an elastoroerie portion 202: thai am be coupled to and: abut u against a plug 204 of the valve. The plug 204 may be relatively stiff as compared to the elastotnerie pnfiion. 202.. As may be see in Figure ¾· h som embodiments the elastomeric portion 202 may generally snrroxind an outlet tube 206, lo example. The elastoinerie portion 20.2 may generally taper to provide a relatively smaller dispense opening 210, in which the plug 204 may be osition^ The plug 204 may generally seal the dispense end of the elastomerie portion 202 when contents are not being dispensed. In use, the one-way valve 200 may be used to dispense materials n a substantially aseptie manner, Durin pressure dispense, the contents of the liner may be directed to ard the one-wa valve 200, thereby creating pressure on the valve 200, The pressure created by the farce of the material on the valve 200 may cause the eJastomerie portion 202 to open, The material m then pass through tie valve 200 as a result of the pressure applied to the material, ensuring that there; is direct flo in only the dispense direction 2 0. As the desired ainonni of material is d.is a $«d_$: the:

:§V€¾t¾3 may be turned off,_: causing the elastornerie portion 202 to close m on itself be inning with . the thicte poriion at the base; 2 B, thereby allowing no higres , and s¾aeezin out the: remaining i teriai in the val ve 200. m one embodiment, the dispense eonneetor may he, or may ¾e sij¾il f to, dispense connectors; or dispense valves sold under the brand mt Pure-Dose ^!¾ O e- Way Vise -Elastic. Valve by Mediea! Instill Teehnelogies, Ine. of New ilford, CT. In oilie emhodknents, the valve may be composed of an othe suitable material, including any other plastic or combination of plasties or other materials. |03T] Filling eonneetorsi and dispense connectors and/or valves, such as those life the connectors sold under the brand names intaet^TM Sterile Fillin System and Pure- Dose™ One- ay Viseo-0astie Valve by

described in detail in: U.S. Fat No. 7,997,447; U.S. Pal No. ?,99¾S97;_: U,S>_. Pat No. 7,980,275^* U.S.. Pat. No. 7,97S:,4S3; Ό Pat. No. 7,967,034; U.S, Pat No. 1&66 4% U.S. Pat .No. 7_?954,5 1 ; U,S. Pat No. 7,88-6,937; US.. Pat No, 7,874,129.;: U.S. Pat. No. 7,861,750; U.S. Pat. No, 7₅8¾0S1 U.&. Pat. No, 7,845,517; U.S. Pat No. 7,810,677; U.S, Pat, No, 7,798* 18S; U.S. Pat No. 7,780,023; U.S. Pat Mo. 7,77 ,60 ; /U.S. Pat. No. 7,7:26,357; U,5, Pat No. , 78, 8 : .US. Pat. No.:7,66«,390; US, Pat No. ,665,923; U.S. Pat . 7,631 ,291; ILS. Pat No, ?:,637:,401; U.S. Pat, o, 7,6 7,40ο O.S. Pat No, 7_.J28_?18 - US. Pat. No, 7,56:8,509· U.S. Fat. No,. 7,5S6:_f066;; US, Pat No. 7,4:10,050; V Pat. No. 7,331,944; U.S. Pat. No. 7,322,491 ; U,S, Pat. No. 7,270,15¾ and U.S. Pat No, 7,077,176; U.S. Pat, No, 7_>000;_:806^~, each of which is hereby incorporated, by reference herein in it errtirery.

|Q38J The- liner-based system may afeo include features for helping prevent or limit «hoke-o f Generall speaking, ehoke^oif may be described as; what occurs when, a liner nitimately collapses: on itself, or a strnctnre internal to the liner, to form a choke p int disposed above a substantia! amoant of liqirjd,. When choke-off occurs, it may proGl ide: eornplete utilization of the liquid disposed: within the liner, which can be a dghifieafit problem, as marly materials osed in the

industry, for example,, ca , be ve expensive. A variety of ^•ways of preventing or

d,

an in ematlon i: filing date of Jamiary 30, 2D08, which is hereby incorporated herein by reference in its entirety. Additional way of preventing:; or handling choke-off are described in ί¾Μ8ίί ί 8ί PCT Appi No. PCi7USi 1755551, titled, "Substantially ¾g¾ Collapsible . lifter, Container and/or l ner for Replacing Olass Bottle¾ and Enhanced Flexible Oners," filed October ]0,_: 2011, which \ms prey¾o«sly incorporated herein by ref&renee in i s entirety,

{039] In use, in some embodiments, a liner-based system ma arrive at a first filling site, for example, wife the system fully assembled including an overpaefc 102, liner 104, ar lliin connector 122, I some oases., the overpaek 102, liner 104, and/or the connecto may be irradiated and sterilize at a niaauiaeturing site, such that mat the sieri!iMfioii proeess may not need to be performed at the filling: site. As part of the sterilization, process, the liner may be evacuated arid therefore ma be in a collapsed state and may inotede suhstantiaiiy m gases and be ready for filling opon arrival, for example, at the fill site, In other embodiments, the filling connector 122 may be provided at the fill. site and/or the overpack 102, Mm. 10 vand/or filling, connector may be irradiated and/or stei¾ed at the fill site poor to .filling, .

[§40] At the fill site, the ffiing eorrneetor 122 may be used to asepticatly ill. the contents of the liner, As explained above, in some embodiments the filling connector may be configured to comprise a closed needle fhat may pu cture a membrane thai may seal the liner. Once the needle has passed th ou h the membrane, the needle may open, to allow materia! to be introduced into the liner in sterile manner. Alter the. fill is complete, in some embodiments,, any headspaee may he removed fro the liner. Headspaee generally refer to any gas space in a liner, for example,, that may exist above the material stored bribe liner, Headspaee may be nndesirable bec use: it may allow for some of the headspaee gas to enter the material, thereby contaminatin the material, limiting or eliminating headspaee may be partieuiafly Iniportani: for systems that may be transported, ^"Tire movement of the material in the liner that, m oeevr when headspaee is present may cause foami g, bubbling, stress, protei damage, and/or. gas contamination ¾f the imateriaL, for ex ample, whieh can fee hi ghly undesirable when maintaining the purity of the contents of the .system is: crucial The headspaee may fee removed by introducing: a suitable gas of fluid into ths annrdar space bet een the. liner and the overpack. Tile ihereased pressure- in the annular space may pnsh the liner i upon itself thereb forcing ou any excess gas in the liner. This may be accomplishe i some embodiments by including s¾rilfe outlet valve, tor example* as part of fie fill connector 1 2 that may allow any headspaee to be removed, and. eapiured in an isolated part of the fill eoanecittf 122, for example. In some embodiments^ the outlet valve may be a oneway valve that may only allow headspaee gas io move out of the liner and may not allo it back into the liner, hi other embodiments headspaee may be removed at trie dispense Ideation prior to dispense.

[041 j Gnee the liner hid,- been filled, and in some embodiments, the headspaee lias been substantiall removed- the filling connector may pesg j as described above, thereby aseptieally sealing; the liner 1.04 In some cases, the; system 100 may then be shipped to a second site, white in other cases, Che filled system may be stored, at the; first si te prior to di spense at a subsequent time at the first site. £042] Prior to dispense;,, d spense connector or dispense connector assembly may be coupled to the sysi ai, 100, In some embodiments, the headspaee gas may be removed at fc dispense site just prior to dispense,: fo example, substantially i the same■ manner as explained feove> Depending on the embodiment being used, in some eases the fill connector may also include features used for dispense, and therefore anotlier connector- may not need to.- be added to the system for dispense. In other embodiments;, however, some portion, or all of the fill connector may be r mold from the finer find ovefpaek and the dispense connector and/or assembly may be coupled thereto for dispense. In still other cffih dimo Sj a dispense connector and/or dispense assembly may he eoupled. to or over the fill connector. In e bodiments where t e: dispense connector ma be coupled to o over the fill connector, a portion of the dispense connector may pimeture the fill connector membrane 126 o as to allow access to the material of the liner for dispense. Once the dispense connector andfer dispense assembly have been o erably eoopled to the liner 10 and/or o er ae : 102,: dispense ma occur, Dispense may be. by pressure dispense, as discussed in more detail below.

j¾4S] In some emhodknents, after dispense^ the dispense connector and/Or assembly, the liner, and/or the overpack ma he disposed of Ifewever, in other etnhodiiuents, one or more of the dispense Oonn ctof¾sseinb]¾ Kner, or overpac i may he cleaned,, steriliaed^aPd reused in another cycle.

|04 Hgore 3 generall sh how the system. of the present disclosure may operate durin !iqpid dispense,, specifically pressure dispense, according, to one embodiment. One: end of a gas pressure in-line 306 ay be connected to the pressurizing gas inlet fitting of a dispense connector 36Ό, while the other end may be connected to a pfessuriised. gas or fluid source 3 0, In one embodiment, the gas or fluid source 340 may be regulated to piish pressurized gas or fluid into the area ill the annular space betwee ibe inside wall of the- containe 320. and the outside wall of the line 3 0, As can be seen, as the amount of gas or fluid increases in the space between the wall of the container 320 and the wall of the liner 310, the collapsible line 312 will begin to collapse in upon itself, which will force the contents M of the liner 312 up through the dispense eonnector 360, In some embodii¾ent _s th dispense coiinector 360 may include a ope-way dispense val Cj while In other embodiments^ a one-way outlet: valve 362 may he distant fr m, hut operably coupled to, the -dispense- connector 360. Pressurized gas CM^* fluid may eondrnie to be

dispensed.. Once liquid dispense has been completed and/or the liner 312 has been substantially

the dispense connector ^' O which in some embodiments may also release the pressure gas in the aBjaular space between the mside wall of fee container 320 and the inside wail of the liner 310. As discussed above, in some embodiments, the liner and or the connector may fee removed and disposed of while the overpack may be cleaned, sterilized, and reused. In other einbodirnenis the overpack may als be disposed of after a single us ,

[045] in ome embodiments, the controlled and varied in rodnetion of pressurized gas or liquid into the annular space between the inside of the container wall 320 and the outside of the liner wall 310 may be osed to mix the contents of the liner. In some such embodiments, headspaee may not be removed prior to fni ng so as to allow room f&f- mixing. A controlled -cycle of pressurl¾arieB and depressnrizaiion resulting in compression and .relaxaiion of the liner may cause the contents of the liner to mix, fist example. In. use, this embodiment would allow for the sterile mixing of the. contents of the liner ithout the need for impellers or paddles. Because introducin objects into the interior o the imer may increase the risk of eoniammation, not needin to introduce impellers or paddles into the liner may advantageously hel minimize the risk of contamination. In other embodime s: tw eontamer may be used for niising two or more materials.

£046] The use of pressure dispense may be advantageous over methods currently used in relevan industries, such as dispense, b peristaltic pumps. The use of pumps to dispense the eontsnts of a liner may cause bubbling and stress o the material and the System, which may be i ^ii Me^'b^ e-'the purity of fee contents of the liner may be crucial. The use of pressure dispense may help avoid or eliminate thes problems. Further, in some cases a higher of dispense ma be achieved by pressure dispense as opposed to pum dispense.

[047] As explained above, in some embodiments, the entire storage and dispense system, ma be configured to be portable, as shown in figured, hi some embodiments of a portable si age a» ispense sys em 400 a: pressure mm 46-0 may fee meluded as pari of the dispense: assembly€20. 1¾e pr essprs mwm 460 may be used to ressure dispense the contents of the liner 412 ^'by forcing a gas, for example., into the annular sp e feetweeii die inner wall of the overpael 420 arsi tbe Outer svM 410 of the liner 4) 2. i pressure sonree 460, in. sortie embodiments, may be connected directly to, or be integral with t e dispense eonneetM as shown in Figure 4 by any suitable mariner, while in othe embodtmeiits,. the pressro source may be remotely connec to die dmp ose connector via any suitable means,, for example tubing or hosing, In some embodiments, the press«i¾ mwc® 460 may comprise a carbon dioxide {C<¾)₍ nitrogen (Ms), or oilier disposable compressed gas cartridge, fo example. In still other embodiments, tile pressure sowee: may be generally hee ly detaehaMy eonnecfed integrally connected to ie dispense assembly. While parbeiilar em diments have been described .herein;, if will be understood that the pressure, souree may be positioned at any suitable place on. and/or nea th dispense by any suitable means. While the pressure source ¾as bees discussed as a disposable cartridge for use wi h a disposable system, in other embodiments the pressure sonree may be any su ta le or k own pressure source to «¾ieh the dispenser may he operabi connected.. Is some cnibodirnents, a user m activate the dispensing sy m. by activating the pressure source. The essure s nre© may be activated_., or turned "o ,'" In a variety of sdiahle ways, §)t example hoi not limited to,, via- a ^'button, . §i:p-swhel¾ sliding swtteh, or any other suitable actuator or combination of actuators, hi some embodiments, ch.- as in a fully disposable nd¾r reeyela^'b^'ie_: e rrbojimea wherein, the pressure s t i»a : ϊα ^ jfcr mt ¾, a C¾ % or © her disposable compresse ps cartridge, the pressure source may be activated by acdvahng die compressed gas cartridge as w ld be understood ^"by those skilled in the art. In some embodi n s,; activating the pressure source ma cause the contents of the liner or dispensing system to be dispensed. n still furflier embodiments, tbe contents of the Kner or dispensing system may be dispensed continuously until the pressure soirrce is deactivated: or, in the ease of a compressed gas c rt id e_s for c m l e, nntil the contents of me pressure: sonrce are entirel or substantiall depleted, and/or 1 the contents of the liner e substantially depleted or are otherwise down to a desired level. In. some embodiments the: one-way dispense vaiv-e 48D, as described above, may be eoupted to the ispense connecter 42¾ while in other embodiments the one-way dis e se valve 480 may be remote ik>i» the dispense connector 420 but may be operabty coupled thereto by any suitable means,, such as tabing, for exanip!e<

[048] In one embodiment, the portable pressure soitree 460 ma be, or may be similar to, &e portable pressure source and dispense systems sold under the brand name lap- A -Draft by Siurman BG, LLC of Woodland Park, CO, whleh have traditionally been used to maintain and dispense earbonaied beverages. G nerall ^ as the liquid stored in the container to which the ap^A-Dtaft system is attached, is poured through the Tap-A~ Draft dispense connector, g¾s_$ such as C(¼, Mttoiis, or Argon, Is allowed to enter the container to .maintain the ressor© within the container. Such portable pressure source and dispense systems, like the pressure dispense assemblies sold nder the brand nauie Tap- A- r ft by Siu an BO:, LLC, are f rther described in detail in: U.S.. Pat No, 5395..0.12; US. Pat o,: 5, 43,1.86; U.S. Pat. No. 5,97¾713; U,S, Pat. No. 6,036,054; IIS. Pat. No. 7,84S,S22- . Pat. No. B5S2,72¾ U.S. Publ No. 2009/0242044· and U.S. Publ. No. 2011/01 7406, each of which is hereby. incorporated by reference herein in its entirety. |M9J in another embodi ent, the liner stray first be filled with a solid material, for example, hut not limited to, a peptide,, API. etc. The solid may take up relatively little space within the liner. The liner-based system ma then be -stored, or h other cases shipped to another site, whereupon the liner may he filled wit a sterile liquid. In order to dissolve the solid in the liquid, the liner may be shaken or otherwise moved. The contests of the liner may then fee dispensed or shipped to another location for dispense. In use, such a embodiment may be substantially similar to the embedments described above. Using such, an embodimeHt would allow a user to avoid having to transfer the solid material to a new eoiitainer fo sterile mixing, thereby riupiwiizing the risk of ebfitamitiatiort d savin time, labor, and any associated eiisis_¾ for example. Alternatively, two or m.are containers may be used to mix. the contents of one or more liners.

{O50| in seme embodiments, a. dispenser as disclosed herein may include more than one liner that may contai diflerent materials. Tile dispense assembl may include a eoimector/cover that may connect to or align with the fitments of each of the liners. Alternatively, one lifter ma comprise two or more c¾mparh¾erif that may contain .different ^'materials.. te dispense assembly may draw the, material fwm some of all of the liners.aud ma m¾ the material prior to or at the time the material is dispensed from the dispenser,, for e $*n k¾. such that the resulting material that is dispensed out of the dispenser may be a mixte¾ of the contents of. all or some of the liners. In some s ch embodiments, the one or more l&ers may no be completely filled, and/or headspace ma not be removed, and/or headspace may be tntrodueed into the liners to allo for m ftg room in one or more liners.

[051] This embodiment ay also be advantageously used with sishstaness thai may be unstable and require a catalyst to. cure. .Accordingly, one !mer may contain the substance and another liner may contain the catalyst, thereby allowing a mixture of both t he applied, mnitiple liner embodiments,, the ratio of the material of each liner that is included in the mixture may he controlled by a variety of means, for example,, by varying the pressure applied, by varying the s ze

as a ¾s>¾¾k, by varying the ske of the channels th o g the eonnector eover, by varying the sjfee of any diptube(s) used, or any other suitable method or combination of methods,

:S2j in some dispenser embodiments, the liner, over ael¾ and/or cimn e ois may be configured tor h g Sow .dis ense o dispense of contents of relatrvei higher viscosity, in one embodiment,: such high Sow or high viseo¾ dispense can be achieved b providing larger orifice: sizes in the liner, overpsefe, . and/or dispensing a&sernhly, which would allow for higher flow rates or the larger flo paths for materials with rdativeiy higher viscosity

|0S3] I¾bodiments of liners of the present disclosure, in some eases, may be dispensed at pressures less man ahdW 1 DO si, or awe preferably at pressures less than about SO psi, and still more preferably at pressures less than about .20 psL In some cases, the contents of the l ners: of some ert odimentS_j however, may be dispensed at sigiiifcantly lower pressures, as may he desirable, depending on me intended use o application involved..

[ JS I hi additional embodiments, a. dispense assembly, including the connector, may also include control components to control the incoming gas and outgoing liquid. For ^'exam le* a controller ca be operably coupled to control components to control the dispense of the liquid from the liner. Gne or more transducers may also be included in some^■"embo iments to senseths irilet and/Or outlet^■■ pressure.- In: this regard, such ..control components -may b& u il zed to detect when the inter is near empty... Means for controllin such dispense of fluid horn the liner and deiec ining when a line - nears em ty are described for example in U.S.. Patent Number 7_»i7¾Q@6, entitled "Liquid. Dispensing System:/' issued February 6, -2G07 and PCT Application Number PCT/1JS07/7Q9I 1, entitled "liquid I>isp^siii -.S^te^:Ei«oftip -sing Gas Removal,^*' with an international fiiirsg date of Jane 1 1, .2007, each of w ich is. hereby mca^rate herein by reference: in its entirety and International Patent Application No, PCT TJS201.^'1/035558, previously incorporated by refereftce-iii_. its; entirety.

[055j In an additional or alternative embodiment., shown in Figure 5, m. ernpty detect mechanism may include a liner and overpaek system. 502 that may be operably connected to an indirect pressure dispensing assembly 504. The dispense assembly 50 niay include a pressure transduce or sensor 506, a pressure solenoid or other control valve 500, and a vent sdl Po o oilier control valve 510. A. inicrocontrc Uerimay be used to control the pressure solenoid 508- aridi'or the vent solenoid _: 510. the outlet liquid pressure may be read and measured by the pressure ; transducer 506, If the pressure is t low, fe, lower than a set value, the pressure solenoid SOg may ¼ turned en for a period of time thereb causing mom press ridng gas or Othe substance to: be introduced into the annular space between the overpaek. and User and raising the: outlet liquid pressure. If tir pressure is too . high, i.e. higher than, a predetermined value, the vent solenoid 510 ma he turned an tor a period: of time (JP-^ somewhat relieving me pressure in the annular space between the overp¾ck and liner,, and thus the: Outlet liqui pressure. s -may Be seea in Figure &, as the contents of the liner sear erapty, the liquid pressure drops 610. The drop In liquid pressure triggers the pressure solenoid to turn on for a longer period of time. The increase In me time that me pressure solenoid is turned on (P_ejj) rises rapidly a the liner nears -empty 612, Accordingly, the atnount of time that the pressure valve is on (P_aii) may be used, to determine when the endpoirit of the dispense has been reacb ,

[056] Alternatively or: additionally, the frequency of the ¾ff switehmg of the: inlet pressure solenoid, may be; monitored. A indicated above, as the liner approaches empty, the inlet pressure will need to increase in order to -maintain the constant liquid outlet pressur The inlet essu e solenoid may thus svsdtph on/off at a higher frequenc as the liner nears empty to permit the required amount of pressnrissd gas into the annrdar space between the liner and the -container. This frequency of the on ff switching can be a useful empty detect indicator. Empty detect meehaiusms such as those disclosed herein, may help save time and energy, and eons -equentiy money.

105?] After dispense is completed or substantially completed^' and the liner is empty or substantially empty, ike end-user may dispose of the liner-based system,, and/or recycle or reuse some or all of the liner-based system, including some or all of tire eiosure cormeclfir^■ assembly, hi orde to assist in making the dispenser described herein more sustain ble, the dispensers or one or more ©omponents thereof including any over-pack, Iin.er(s), handles, etc.. may be manwlaetured from biodegradable materials o biodegradable polymers,, including but not limited to: po!yhydro^yalfeanoaies (PHAs), like poly-3-hydroxybniyrat© (PHB), polyhydroxy valerate (PHV), and poiyhydroxyhexanoaie (PRH); polylaefe aci (PLA ; polybutylene sueeinate (PBS); poiyeaorolactone (PCL); polyanhyclrides: polyvinyl alcohol: starch derivatives; cellulose ester¾ like cellulose acetate an nitrocellulose and their derivatives (edhjloid)^* etc. Similarly, In ome embodiments, and if suhabk for the industry application, the dispensers or one or more components thereof may be manufacture from materials thai can he recycled or recovered, and in some embodiments, used in another process by the same or a differ ent end user, thereby allowing mc end us«r ^s) to lessen their impact: on the environment or lower their overall emissions. For example, in one embodiment, the dispensers or one or mere components thereof may be manufactured from/ materials that may be incinerated.; stieh that the heat generated iheret !n may be captured axsd incorporated or used in another process by me same or different end user. In general th dispensers or one or more components thereof may he manufactured from: materials that can be reeyeled or that may be cmiverte l into raw materials that may be used agaiit fQ68| In one embodiment of the present disclosnre a storage and dispense system 7QQ may nclude an additional, optional packaging elawent 72¾ in. which the liner and overpaek _; 7Q2 may be post tioned;. The packaging element -7$Q may be ei t store, 'ans ort, andi'or carry the liner and overpaek ?Q¾ in. some eases relati vely easily, The packaging element 720 may generally be a. box configured from a corrugated material, such as but not limited iff cardboard. Ho e er, in other enibodimeni¾ the packaging element.720 may be comprise ^' of any suitab I e material or eon lnaiion of materials including aper, wood, met l;, glass, or las ic, tor example, ft pa«kagih¾ d mx 720 may include one or mnre reinforcing, elements 730 that may rovide supper t and/or stability for the liner and overpack 702 disposed therein. A einforcin e!ernent 730 may be positioned at any a pr p iate or desired height in the packaging element 720.. -For example, as may be seen in Figure 7, one. reinforcing element 730. ma be ovided near the top of the body of the overpack and liner 702. Ho wever, in. other erafeodtmentS_j one or more retrrl¾reing. elements may be positioned at other areas of the overpack, lor example at the bottom of the overpaek, or the middle of the overpack, In still another emhodnneni, the rsinfordng element rnay generally fill snbstanb ally all of. or some portio of the space not takers p by the liner and overpack. The reinforcing element(s) 730 May fee comprised of any suitable material or combination of materials, such: as but not limited to the materials listed above for fie packaging element. In some:

the remainder of the paefeaging elernent 720, allirougl; use of the sa e materials, is not necessary. The packaging element 720 ma also have . one ¾r more handles ¾r handle

andior earry, The packaging

may be a generally rectangular box, as. shown, A plumiity of systems, such as those- :8ho n in Figure 7, tnay be easily and conveniently packed for storage and r shipping due to the rectangular bo¾ shape of the. packaging element. Additionally, the packaging element may ffalker protect the liner and overpack disposed therein from exposure, sneh as exposure to potentially harmful tlY rays,

£0693 in some embodiments, inelndin packaging eleaient 720, the liner and overpack system may not include a handle: or chim because the storage unit 720 may provide handle siots/epeniags and the support otherwise provided^' hy the ehime, Accordingly, a cost associated with the liner and overpaek related io the handle and/or chime may be reduced or eliminated in sueii embodimeiits, Nonetheless, is other embodim nts, the liner and overpack may still inefode a handle end/or ch me hi embodiments Inclu ing a. packaging element. mj in still further embodiments, eo-hlow molded or nested preforms and liners, m m te described: in Intematiorial PCT Appl No. PCT/OSf 1/55560, titled, "Nested Blow Molded liner and ©verpaek and Methods of Making Same " filed October 0_; 20 1. which was previousl incorporated _: herein, may be used to mmr&cture a dispenser having greater than two layers. Two or more separate materials may be filled into the spaces betwee the layers. The dispenser may be configured to mi the separate materials upon dispense,

|061J i ather embodiments, th dispensers of the present disclosure may include baffles, bafSirig. features, or other discontinuities in tile interior snrfaeefs) thereof w retard settling of the suspended solids containe therein durin storage and/or transportaiion.

[06 3 The dispensers described herein may be configured m a y suitable shape, including bitt not limited, to square, rectangular, triangular or pyfamida cylindrical, or ^■ y other nitable polygon or other shape. Differently shaperl dispensers ca;n_: improve packing density during storage and/or transportation,; and ma redoce overall transportation costs, Additionally, differently shaped, dispensers can be tjs to

such as^; to provide an indicator of the contents provided within the dispensers or to i3eif$¾r

the contents are to be ;used₃ etc, in stii fhrther embodtaents, ire- dispensers described herein may be: configered as any sui table shape in order to "rehafir the: dispensers ith existing dispense assemblies or dispensrs stems._.

[063] In some embodiments, the dispensers described, herein ma ineta le symbols and/or writing that is molded into the dispensers or one or more components thereof. Such symbols an or writing may include, but is not limited to Barnes, logos, instracti»ns, warnings, etc, Such maiding may be done during or after She mann&eiinhig process: of the dispensers or one or more components thereof hi one emhodiment s»eh molding: may he: readily accomplished during the fehflcatloa process by, for example, embossing the mold for the dispensers or one or mows components thereof The molded symbols and or wri ting may be used, for example, to differentiate products ,

[08 1 In some embodiments, one or more colors m& absorhant materials may be added to the materials of the dispensers or one or mare components thereof during or after trie mariufecturiBg process to help protect the coiiteatiis of thiC dispensers irona the external environment, to decorate the dis ensers., or to use as as indicator or identifier of contents within the dispeasers or otherwise to differentiate multiple dispensers, etc.. Colors ma be added using, for e ample, dyes, pigments, nanopartioles,_. or an other suitable mschanisTO, Absorbast materials may ineinde materials that absorb ultraviolet light, infrared ight, and or radio frequency signals, etc,

f08S] .Similarly, in some embodiments, the dispensers or one or more components thereof may be provided with difiereni textures or finishes. As with color and molded symbol and/o writing. the different textures or finishes ata be used to differenijate prodaets, to provide an indicator of the mntents: provided within the dispensers, or to identify for which application or applications the contents are to be used, etc. In one embodiment, th texture or finish may be designed to be a substantially non- sli texture or finish or the like, and including or adding such a texture or finish to the dispensers or one or more components thereof may: help improve graspability or handling of the packaging system, and thereby reduce or minimize the risk of dropping of th dispensers,: The texture or finish may be readily accomplishe during the fabrication process by_s for example, providing a moid for the dispensers or one or mom components thereof with the appropriate snrfaee features. In other embodiments, the molded dispensers may be coated with the texture or finish. In som emhodhaents:, the texititre or finish may be provided on substantiall the entire dispenser or sufestanbaiiy the entirety of one or more components thereof; However, in other -embodiments* the texture or finish may be provided on only a portion, of the dispenser or a. portion of one or more components thereof.

[066¾ Similarly, in some embodiments, the exterior and/or inte ior walls of the dispensers of one or more components thereof may have any suitable coating; provided ihereo The coating may increase material compatibility, decrease permeability., increase strength, increase pinhole resistance, increase stability, provide anti-staiie capabilities or otherwise redace static,, etc. Such: coatings can include coatings o polymers or plastic, metal, glass, adhesives, eie, and. niay he appSed during the mantf acturin p ocess by, for example coating a ref rm: vised in blmv-inoMIng, or may be applied past manuiketaring,: such as by spraying, dipping, filling, etc. [067J In some embodiments, the: dispensers may include one or more handles.

The one or more handl es can be of any shape: or ske, and ma he located: at. an suitable position of die: dispensers. Types of handles can itidttde, hot are not limited o, handles that are located at the Cop and/or sides; are ergpRomie; are removable or detachable; are molded into me dispensers or are provided after fabrication of ike dispensers (suei. as by, for example sna †¾, adhesive, riyetifig, screwed on, bayonei-1% etc.); etc. Different handles aad/or handl ing options can be provided and may depend on, for example. hni not limited: to_* the anticipated contents of the dispensers, the applicatio for the dispensers, the size and shape of the dispensers, the. anticipated dispensing system for the dispensers, etc,

fQ68] In spine embodiments, the dispensers may include two or more Iayers₅ such as an overpaek and a liner, multiple verpacks_s or multiple liners. In further embodiments, a dispenser may include at least tee layers_* which may Help ensure enhanced. containment of the contents therein, increase structural strength, and'or decrease per eabiHi , etc. Any of the layers may be made irons the same or different materials, soeh as bpthot Inpited to, the ffiateiiafe previoiiiiiy discussed herein.

|06S] In some embodiments, and if suitable for the industry application, the dispensers or one or more eorBp neniS: thereof may be mahnfectttre from materials that can be recycled, or x cPYer , and in some embodiments, used in another process by the same or a different end user, thereby allowing such end wser(s) to lessen their impact on the envirpnffient or lower iaeir ove all ejuissfons, l or example, n one embodimeat the dispensers or one or mam components thereof may be marmfactured from .. materials that may he incinerated, such that th heat generated therefrom may he captured and incorporated or used in another process b the sanie or different end user. In general the dispensers or one or more components,

can he recycled, or that may he converted into raw materials that ma be used again, [07OJ In :some erohodiffienrs, structural features may be designed into the dispensers that add strength, and integrity to he dispensers or one or more eorri oaents thereof. For example, the base (or chime in. some: embodiments), top, and sides of the dispensers may -all be areas that experiences increased shake and external forces dwring f lJing, transportation, Installation, and use (e.g., dispensing). Accordingly, & one embodiment, added thickness or structural edifices (e.g., bridge iressel design) rnay be added to support stressed ^': regions of the dispensers, hich can add .sit^ tti. andintegrity^' to the dispensers, Furthermore, any connection region in the dispensers may also experience increased stress during use. Accordingly, any of these such regions may include structural features that add strength through, tor ex-ample, increased thicknes and/or specifically tailored designs. In further embodiments, the use of triangular shapes could be used to add increased strength to any of the above described structures; however, other designs or mechanical support features ma be used,

[071] In some embodiments, the dispensers or one or more components thereof, including any overpacfc or liner(s), may include reinforcement features, such as but not- limited to, a mesh, ffber(s), epoxy, or resin, etc, that may be integrated or added to the dispensers or one or more components thereof, or portions thereof, in order tp add reinforcement o strength, S^:uch reinforcement may assist in high: pressure: dispense applications, o in applications for dispensing high viscosity contents or corrosive contents.

1072} In some embodifflents. the dispensers may include level sensing features or sensors. Such level sensin features or sensors a uso visual, electronic, ultrasonic, or other suitable mechanisms for identifying, indicating, or detei¾nining : the level of the contents stored in the^: dispensers. For example, in one embodiment, the dispensers or a portion thereof may be made from a- substantially translucent of transparent: material that may be used to view the level of the_: contents stored therein,

[073] In furthe embodiments, . -flow · ^'metering^' technology may be integrated into or operably coupled with the connectors for a direct measurement of material being delivered from: the packaging system, to a down stream, process, A direct measurement of the material being delivered could provide the end user with data which ma help ensure process repeatability or reproducibility. In one embodiment, the flow meter may provide an analog or digital readout of the material .flow. The flow meter, or other component of tire system, can take the characteristics of the material f including but not limited to viscosity and concentration) and other flow parameters into consideration: to provide an accurate flow measurement. Additionally, or alternatively, the flow meter can be configured to work with, and accurately measure, a specific-material stored and dispensed from the dispenser, is: one embodiment, the inlet ..pressure can he cycled, or adjusted, to maintain a ¾ibstantiaily constant outlet pressure or flow rate.

[074] The various shipping and dispensing system embodiments of the present disclosure have severs! advantages over traditional packaging systems. Many of die advantages have been noted throughout the application and include, but. are not limited to: sterility of the contents from die time of fill to complete dispense; substantially reduced or eliminated germ Ingress during idling; longer shelf l ife of the contents of the liner; portable dispense; enables sterile dispense automation; easier portable dispense, which can eliminate hand-pump dispense. Othe advantages wil , be recognized by those skilled in the art and may vary from industry application to industry application, f075] In the foregoing description various embodiments of the invention have been presented for the purpose of ii lustration and description. They are not intended: to be exhaustive or to limit the. invention to the precise form disclosed. Obvious modifications or variations are possible in. light of the above teachings,. The einbodrmehts were chosen and described to provide the best illustration of the principals of the invention and its practical application, and to enable one of ordinary skill in the art to utilize: the invention i -vari us:-erobodtments: nd^'--wi&-^:v¾ii m modifications as are, suited to. the particular use contemplated. All such .modifications and^::varkiions are within the scope of the invention as detennin d by the appended claims when interpreted in accordance with., the breadth they are fairly, legally, and equitably^■' entitled.

Claims

Claims

What, is claimed is:

1 , A liner-based -assembly for use with pressure dispense comprising:

an overpaek;

a liner disposed within the overpaek; and

a filling connector that is securable to at least one of the overpaek and the liner, the -connector including a membrane for substantially aseptic filling,

2, The liner-based assembly of claim. 1 , wherein the membrane comprises a re- seala le eiastomeric stopper.

3, The liner-based assembly of claim 2, wherein tile re-seal able elastomeric stopper is configured ibr re-sealing. with the assistance of beat

4, The liner-based assembly of claim 2, wherein the liner and overpaek are irradiated.

5, The liner-based assembly of claim I , further comprising a dispense coniiector operahly connected with ai least one of the overpaek and the Hner_y over the filling connector, the dispense connector at least one of comprising or operably connected to a one-way val ve,

6, The liner-based assembly of claim 5, wherein the line is collapsible away torn the overpaek.

7, The liner-based assembly of claim; 6, further comprising a portable pressure source ibr pressurizing an annular space between the overpaek and liner for collapsing the line and dispensing the contents thereof 8, The liner-based assembly o aini 5, wherein the one-way valve comprises an elastomeric portion, defining an opening and generally operabl coupled with a plug member positioned within the opening, the plug member being relativel stiff as compared to the elastomeric portion, wherein in a closed position, the elastorrseric portion, is sealed against the plug member, and wherein, when a pressure is applied against the elastomeric portion, the elastomeric portion is flexes in a maimer configured to permit only one-way flow through the opening.

9, A method: fo providing a sterile transporting and pressure dispense system, fee method comprising:

providing an overpaek mid a liner disposed within the overpaek;

irradiating the overpaek and liner for sterility; and

securing: a connector to at. least one of the overpaek and the liner, the connector including a mem raim-for-subj>t «jtiaily-as^tiG filling,

10, The method of claim 9, wherein the membrane comprise a re-sealable

eiastomeric stopper.

1.1. The method of claim 1 Ό, further comprising filling the liner by piercing the elastomeric stopper with a . needle and passing a material through the needle into the liner.

12. The method of claim 1 1 , further comprising removing, the needle upon completion of filling and applying heat to assist in re-sealing the elastomeric stopper.

.13, The method of claim II, further comprisin emoving heads aee gas from the interior of the liner upon, completion of filling the liner.

14. The method of claim 1 ¾ _: w herein the connecto comprises a one- way valve for permitting headspace gas to pass i one directiofi out of the liner.

15. The method of claim % for er com.pri sing pro vi ding a .dispense; connector that is operably connected with at least one of the overpack. and the liner, the dispense connector at least one of comprising or operably connected to a one-way valve,

16. The method of claim 15, wherein providing a dispense connector comprises providing a portable pressure source for pressurizing an annular space between the overpack and liner_*

17. Th e method of claim. 16 , wh erein the portable -pressure sour ce compri seg a disposable compressed gas cartridge,

18. A liner -based assembl for use with pressure dispense comprising:

an overpack;

a liner disposed within the overpack, the liner configured for collapsing away from the overpack upon the introduction of a gas or fluid into an annular space: etween the overpack and liner; and

a dispense connector that is securable to at least one of the overpack and the liner, the dispense connector comprising -a passage in fluid communication with the annular space and at least one of comprising or operably connected to a- one- way dispense- valve in fluid communication with a interior of the liner,

19. The liner-based assembly of claim 18, wherein the one-wa valve comprises an elastomeric portio defining an opening and generally operably coupled with a plug member positioned within, the opening, th e plug member being relatively stiff as compared to the elastomerie portion, wherein in a closed position, the elasiomeric portion is sealed against the plug member, and wherein. -when a pressure is applied against the eiastonierie portion, the elastom eric porti on is flex es in a nianner configured to permit only one-way flow through the opening.

20. Tbe liner-based assembly of claim 18,_: wherein the liner and oyef aek are irradiated.