CN101342963B - Container with valve assembly for filling and dispensing substances, and apparatus and method for filling - Google Patents
Container with valve assembly for filling and dispensing substances, and apparatus and method for filling Download PDFInfo
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- CN101342963B CN101342963B CN2008101294948A CN200810129494A CN101342963B CN 101342963 B CN101342963 B CN 101342963B CN 2008101294948 A CN2008101294948 A CN 2008101294948A CN 200810129494 A CN200810129494 A CN 200810129494A CN 101342963 B CN101342963 B CN 101342963B
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Abstract
A vial has a body defining a chamber for receiving a substance therein; and a valve assembly coupled in fluid communication with the chamber and defining (i) an open position permitting at least one of (a) passage of the substance through the valve assembly and into the chamber for storing the substance in the chamber, and (b) passage of the substance out of the chamber for dispensing the substance therefrom; and (ii) a closed position forming a fluid-tight seal between the chamber and exterior of the container. A filling member engages a flexible valve member of the valve assembly to move the valve member between the closed and open positions to fill and seal the vial, respectively. A syringe is connectable to the vial. The valve assembly opens upon connecting the syringe to the vial to allow the substance within the vial to be withdrawn from the vial and into the syringe by actuating a plunger of the syringe, and the valve assembly closes upon disconnecting the vial and syringe to hermetically seal and store the substance remaining in the syringe for later use.
Description
The application is to be on April 28th, 2004 applying date, and application number is 200480014416.3, and denomination of invention is divided an application for the one Chinese patent application of " being used to fill the container with valve module and filling device and method with dispensable materials ".
Related application
The application requires the U. S. application No.60/465 with application on April 28th, 2003; 992, name is called " being used to fill and the container with valve module of dispensable materials and the apparatus and method that are used to fill this container "; The U. S. application No.60/469 of application on May 12nd, 2003; 677, name is called " distributing box and the apparatus and method that are used to fill distributing box ", the U. S. application No.60/471 of application on May 19th, 2003,592, name is called " distributing box and the apparatus and method that are used to fill distributing box " and is preceence; Here combine its disclosure for referencial use, as a part of the present invention.
Technical field
The present invention relates to be used to store and divide power dispensers and the container of other material and the method for filling this container; Particularly; In container, has the valve that is used for sealing substance; And flask for medicinal preparations, distributing box and container that material is joined from this punishment, and the apparatus and method that are used to fill this container.
Background technology
Containers for medical use and distributing box, for example the aseptic filling of flask for medicinal preparations is a relative complex and expensive process.Before filling, flask for medicinal preparations and stopper at first will clean, sterilize, for example through it is radiated, autoclaving, in the filling of sterilization, fill then and assembling.
United States Patent(USP) No. 6; 684; 846 are called " having the medical pharmacy bottle of heat seal lid and the apparatus and method of filling this flask for medicinal preparations ", and 10/766,172 of the United States Patent(USP) No. of common pending trial is called " having the medical pharmacy bottle of heat seal lid and the apparatus and method of filling this flask for medicinal preparations "; And the United States Patent(USP) No. 10/655 of common pending trial; 455 are called in " method of the container that leakproof tank and making and filling are same " and disclose the improvement to above-mentioned prior art, and each application transfers the application's cessionary, and its content quotation at this for your guidance.Disclosed apparatus and method comprise in the application of these common pending trials, have the flask for medicinal preparations of the lid of resealable, within it portion; For example through the enforcement radiation, with the empty flask for medicinal preparations sterilization of leak free, with pin or similar injection part puncture stopper; Fill flask for medicinal preparations empty, that went out bacterium with the medicine that comprises in it or other material; Through applying heat energy, for example be laser beam then, the pin hole on the stopper is resealed.
Have lot of advantages although have the flask for medicinal preparations of the stopper of resealable, with respect to the flask for medicinal preparations and the plug assembly of prior art, its practices thrift cost, simple and can guarantee aseptic.In addition, a lot of existing flask for medicinal preparations and plug assembly can not with the syringe mechanical connection, mechanical connection, same flask for medicinal preparations just can be used for providing the medicine of multiple dosage or the material of being contained in it.
Accordingly, one object of the present invention overcomes existing flask for medicinal preparations and stopper or flask for medicinal preparations and existing one or more deficiencies of plug assembly and shortcoming exactly.
Summary of the invention
One side of the present invention provides a container or a distributing box that is used for splendid attire medicine and other material, and like flask for medicinal preparations, it comprises a main body, limits the cavity of taking in material within it; A valve module is connected with the fluid mode of communicating with cavity, limits (i) release position, makes at least one (a) material through valve module, and enters into cavity, so that material is stored in the cavity, (b) comes out in the cavity of material by dispensable materials; (ii) detent position forms fluid-tight between the cavity of flask for medicinal preparations and outside.
In a current preferred embodiment of the present invention, valve module is in its release position, allows material to pass valve module and gets into cavity, so that material is stored in the cavity, and allows material to flow out cavity with dispensable materials therefrom.Same in a current preferred embodiment of the present invention, valve module has a flexible valve member and a valve seat, flexible valve member can and the detent position of valve seat release position and engage valve seat separately between move.In one embodiment of the invention, flask for medicinal preparations comprises a lid and a sealing element, and lid engages with main body, and limits valve seat, and sealing element forms fluid-tight between the two between lid and main body.
Preferably, flask for medicinal preparations of the present invention or other distributing box or container also comprise an installation surface, and it can be connected with syringe, so that syringe is connected with the fluid mode of communicating with valve module.In currently preferred embodiment of the present invention, valve module comprises a flexible valve member, and when being connected to syringe on the installation surface, it can move between sealing and release position.In one embodiment of the invention, valve module is placed in the installation surface, can between sealing and release position, move relative to installation surface.Equally, in currently preferred embodiment of the present invention, flexible valve member has a sealing surfaces that engages with valve seat; Between them, form fluid-tight; And a Monolithic spring, when valve member was moved to the release position by detent position, portion put aside energy within it; And discharge the energy of storing, valve member is moved to detent position by the release position.In a current preferred embodiment of the present invention, spring is an annular surface around the circumferential extension of sealing surfaces.In another current preferred embodiment of the present invention, spring is curved.In another current preferred embodiment of the present invention, spring is to be similar to arch.In each embodiment of these embodiment, flexible valve member inside has at least one hole, and material is therefrom flow through.
Another aspect of the present invention provides a fill system, and it comprises the container or the distributing box of a splendid attire medicine or other material; Flask for medicinal preparations for example; And the fill assembly of a sterilization, comprising a filling member, it can engage with valve module; Be connected with the fluid mode of communicating with substance source, material is incorporated in the cavity through valve module.At least one can move relative to another in valve module and the filling member, and movement of valve assembly between sealing and release position is incorporated into material in the cavity through valve module from filling member.
Another aspect of the present invention provides a kind of method of filling the container or the distributing box of splendid attire medicine or other material, for example the method for filling medicament bottle.Flask for medicinal preparations or other container or distributing box comprise a main body, limit the cavity of taking in material within it; A valve module is connected with the fluid mode of communicating with cavity, limits (i) release position, makes at least one (a) material through valve module, and enters into the cavity that is used for the storage chamber substance in vivo, (b) comes out in the cavity of material by dispensable materials; (ii) detent position forms fluid-tight between the cavity of flask for medicinal preparations and outside.This method may further comprise the steps:
(a) with the empty flask for medicinal preparations sterilization of leak free;
(b) through at least one fills up material to engaging with another with the empty flask for medicinal preparations of sterilizing in movement of valve assembly and the filling member;
(c) when engaging filling member, valve module is moved to the release position;
(d) through the valve module of opening material is drawn by filling member, and be incorporated into the cavity of flask for medicinal preparations; And
(e) with at least one moves relative to another in valve module and the filling member, so that valve module is separated with filling member, next, valve module is moved to detent position, with the material in the seal chamber.
In currently preferred embodiment of the present invention, the step of empty flask for medicinal preparations sterilization comprised the empty flask for medicinal preparations of leak free is radiated.Equally in these embodiment, the step of the empty flask for medicinal preparations of radiation leak free is included in before the filling step and/or in the process, flask for medicinal preparations is implemented at least one radiation in gamma radiation, electron ray and the laser beam.
Equally in currently preferred embodiment of the present invention; This method also comprises through syringe is connected on the flask for medicinal preparations; Move the pusher of syringe, with step by extraction material in the flask for medicinal preparations, and next; By extracting material in the cavity of flask for medicinal preparations and being injected in the syringe, syringe and flask for medicinal preparations are separated.Equally in currently preferred embodiment of the present invention; This method also comprises by detent position to release position movement of valve assembly, syringe is connected on the flask for medicinal preparations pusher of mobile syringe; Extract material via open valve module;, to detent position movement of valve assembly syringe and flask for medicinal preparations are separated by the release position, with remaining material in the sealing flask for medicinal preparations.
An advantage of the invention is that container and stopper are assembled and sterilized under the situation of sky, can fill the material of sterilizing to the assembly of the sterilization of sky through check valve then, like medicine.Like this, container of the present invention and plug assembly can many become original aseptic filling, the rank of the aseptic assurance of enhancement that can be very big with what lack than the container of prior art and plug assembly.And another advantage is that flask for medicinal preparations of the present invention, other container or distributing box be the material of splendid attire various dose within it; Like medicine; Comprise for example vaccine or injecting fluid, and can with one or more syringe mechanical connections, therefrom to distribute a plurality of dosage.
Other purpose of the present invention and advantage will be in conjunction with the drawings, and following DETAILED DESCRIPTION OF THE PREFERRED is able to embody.
Description of drawings
Fig. 1 is the transparent view of imbody flask for medicinal preparations assembly of the present invention, comprises that is used for a filling medicament bottle assembly, and the valve module of dispense liquid or other material therefrom;
Fig. 2 is the transparent view of the flask for medicinal preparations assembly of Fig. 1, and cover is removed, so that lid and valve module to be shown in more detail;
Fig. 3 is the exploded drawings of the flask for medicinal preparations assembly of Fig. 1;
Fig. 4 is the profile perspective of the flask for medicinal preparations assembly of Fig. 1;
Fig. 5 is another profile perspective of the flask for medicinal preparations assembly of Fig. 1;
Fig. 6 is some scheme drawings of local section of the flask for medicinal preparations assembly of Fig. 1;
Fig. 7 is some scheme drawings of local section of the flask for medicinal preparations assembly of Fig. 1, removes the valve of some parts with the diagram detent position;
Fig. 8 is and the similar view of Fig. 7 just to provide the valve of release position;
Fig. 9 is some scheme drawings of local section of the flask for medicinal preparations assembly of Fig. 1; It is installed in the device that is used for the filling medicament bottle, provides the filling member push valve parts of device, makes it to move to the release position by detent position; Otherwise, be introduced into liquid or other material in the cavity of flask for medicinal preparations by valve;
Fig. 9 A is the part schematical top view that is used for the aseptic filling device of filling medicament bottle assembly;
Figure 10 is some scheme drawings of local section of the flask for medicinal preparations assembly of Fig. 1, and its releasable syringe that is used to open valve that is connected is through being connected to syringe on the flask for medicinal preparations; Via relief valve, extract liquid or other material in the flask for medicinal preparations cavity, and make it to enter in the syringe through the pusher on the injector-actuated; Otherwise; Through syringe and flask for medicinal preparations are separated, make valve turn back to common detent position, seal remaining liquid in the flask for medicinal preparations;
Figure 11 is the section-drawing that embodies another flask for medicinal preparations assembly of the present invention, has the spring different with the flask for medicinal preparations element shapes of Fig. 1;
Figure 12 is the profile perspective of the flask for medicinal preparations assembly of Figure 11;
Figure 13 is the decomposition diagram of the flask for medicinal preparations assembly of Figure 11;
Figure 14 is the part sectional view of the flask for medicinal preparations assembly of Figure 11, provides connection syringe on it, is used for extracting material by the flask for medicinal preparations cavity and being injected in the syringe through valve module;
Figure 15 is the partial cutaway schematic that embodies another flask for medicinal preparations assembly of the present invention, and wherein, valve module has the spring of a bellows shape;
Figure 16 is the partial cutaway schematic of the flask for medicinal preparations assembly of Figure 15, provides the valve module of release position, to be incorporated into material in the flask for medicinal preparations and/or from flask for medicinal preparations, to extract material;
Figure 17 is the partial cutaway schematic that embodies another flask for medicinal preparations assembly of the present invention, and wherein, valve module has the spring of a bellows shape of rigid valve parts;
Figure 18 is the partial cutaway schematic of the flask for medicinal preparations assembly of Figure 17, provides flow of material and gets into flask for medicinal preparations with the filling medicament bottle;
Figure 19 is the partial cutaway schematic of the flask for medicinal preparations assembly of Figure 17, provides on the syringe bonded assembly valve module;
Figure 20 is the partial cutaway schematic of the flask for medicinal preparations assembly of Figure 17, provides syringe and is connected to fully on the flask for medicinal preparations, from flask for medicinal preparations, extracting material via valve module, and enters in the syringe;
Figure 21 is the partial cutaway schematic of the flask for medicinal preparations assembly of Figure 17, provides material and flow in the syringe from flask for medicinal preparations;
Figure 22 is the section-drawing that embodies another flask for medicinal preparations assembly of the present invention, comprises a valve module that is used for the filling medicament bottle;
Figure 23 is the profile perspective of the flask for medicinal preparations assembly of Figure 22;
Figure 24 is the decomposition diagram of the flask for medicinal preparations assembly of Figure 22;
Figure 25 is the part sectional view of the flask for medicinal preparations assembly of Figure 22, provides its filling;
Figure 26 is the part sectional view of the flask for medicinal preparations assembly of Figure 22, provides material and therefrom extracts and enter in the syringe;
Figure 27 is the partial cutaway schematic that embodies another flask for medicinal preparations assembly of the present invention, comprises a frangible valve member;
Figure 28 is the partial cutaway schematic of the flask for medicinal preparations assembly of Figure 27, provides syringe connection above that;
Figure 29 is the partial cutaway schematic of the flask for medicinal preparations assembly of Figure 27, and it is broken to provide syringe further connection and frangible bonded assembly above that;
Figure 30 is the partial cutaway schematic of the flask for medicinal preparations assembly of Figure 27, provides material and from the flask for medicinal preparations cavity, extracts and enter in the syringe;
Figure 31 is the partial cutaway schematic that embodies another flask for medicinal preparations assembly of the present invention, comprises another valve module.
The specific embodiment
In Fig. 1, embody flask for medicinal preparations assembly of the present invention usually by Reference numeral 10 representatives.Flask for medicinal preparations 10 comprises that a main body 12, cap assemblies 14 and one are installed in cap assemblies in-to-in valve module 16.Shown in Fig. 4-8, valve module 16 comprises a valve seat 18 and a flexible valve member 20.Main body 12 has cavity 22, and it is connected with the fluid mode of communicating with valve module 16.Be described in detail as following, flexible valve member 20 can move between detent position shown in Fig. 4-7 and the release position shown in Fig. 8-10, at detent position; Flexible valve member 20 and valve seat 18 tight joint form fluid-tight between the two, and seal up the material of the cavity 20 the insides institute splendid attire in the flask for medicinal preparations; In the release position; Movement of valve parts 20 make it to be separated with valve seat 18, between them, form opening, then; Form material through valve module, material is introduced cavity 22 and dispensable materials therefrom.
Valve member 20 further limits a base portion 40, and it comprises a peripheral flange 42 with the outward flange tight joint of main body 12, and the inwall tight joint of and main body 12, between the two, to form the annular seal surface 44 of fluid-tight.If desired, annular seal surface 44 can comprise some circumferential ribs, so that form fluid-tight.The base portion 40 of valve member 20 further has a Monolithic spring 48, and it can make flexible valve member 20 between sealing and release position, move axially, and makes the valve member bias voltage get into detent position usually.In exemplary embodiment, spring 48 comprises the approximate arch or the hemispheric part 50 that are formed at the bottom, and an axially extended hollow between arcuate part 50 and annular seal surface 30 and 36 be roughly columniform part 52.Joint at arcuate part 50 and cylindrical part 52 has a hole 54 to pass flexible valve member 20, when valve is positioned at the release position, material is therefrom passed.Those of ordinary skill in the related art just can know according to the instruction of being carried out here; Valve member 20 can comprise the hole 54 of required any amount; The flow hole can be taked any different structure, for example, is the flow of material that will reach required entering and/or flow out the cavity of flask for medicinal preparations.
Flask for medicinal preparations assembly 10 also comprises a protective case 64, and protective case for example is through binder, ultra-sonic welded, buckle or any present fastening mechanism that realizes this function of knowing or know in the future, is anchored on the flange of cap assemblies 14 and/or main body 12.Cover 64 has a hole 68 on the wall 66 above that, enters into valve member so therefrom pass with groove.Like what Fig. 6 mainly illustrated, preferred, fill in it behind institute's splendid attire material being about to flask for medicinal preparations, releasable fixing one can prevent the disorderly sealing member 70 of pendulum on upper wall 66, disorderly puts in transportation and the storage process preventing.Can prevent the random sealing member 70 of pendulum can take any at present with the device of this function of in the future being known of realization, for example be the sheet metal that there is glue at the back side on the releasable upper wall 66 that is fixed on cover.
As shown in Figure 9; In the operation of flask for medicinal preparations 10, through moving axially filling member 72, to the outside face of flexible valve member 20 on rib 56 engage; Next to push filling member, make valve member shaft come the filling medicament bottle to inwardly entering into the release position by detent position.Can see, axially move inward valve member 20, the top 29 of valve member axially is pressed in the base portion 40, and arch spring section 50 side direction outwards move like this, and the hollow circuit cylinder section axial inwardly with outwards moves.Like this, make the top 29 of valve to move inward, its sealing surfaces 30 and 36 is removed from corresponding sealing surfaces 18 and 38 respectively, between the two, forms valve opening 74 (Fig. 9).On the release position, to release like arrow among Fig. 9, material can flow out from filling member 72, the valve opening 74 of flowing through, the hole 54 on the valve member 20 of flowing through, and enter in the cavity 22 of main body 12.
Filling member 72 can take at present to realize with being used to of being known in the future any dissimilar filling member of the function of filling member disclosed herein.For example, filling member can have and one or morely is incorporated into material in the cavity of flask for medicinal preparations by filling member simultaneously and the stream of extracting gases therefrom.In this example, filling member is connected and is used in stream, producing attractive force and via the vacuum source of stream from the cavity extracting gases.As shown in Figure 9, filling member 72 drivings are connected on the driver element 75, make it to engage with valve member 20 or separate to move filling member.Filling member 72 also with the substance source 76 that is incorporated into the material 78 in the flask for medicinal preparations through filling member be housed engage with fluid mode of communicating bonded assembly.Preferably, substance source 76 comprises that one or more being used for is pumped into the pump in the flask for medicinal preparations with material 78 through filling member.Filling member 78 has a conduit that is used for material is therefrom passed introducing, and one is used for covering 82 with the installation surface 28 contacted peripheries of flask for medicinal preparations.
An advantage of exemplary embodiment of the present is; The spring 48 that is roughly arch or spill produces a large amount of elastic force; Make valve member 20 move to detent position, make sealing surfaces and the valve base sealing of valve member connect to be incorporated in and form fluid-tight between the two by the release position.Those skilled in the art are known according to what lecture here; The elastic part 48 of valve member 20 can be taked any shape not of the same race and/or structure, can by present that know or can know in the future, be used to realize process like any material not of the same race of the function of spring described here.And, can spring the shape and/or the material of structure, put on the elastic force on the valve member with control.Yet the advantage that is roughly arch configuration is that arch, is convenient in whole pot-life and use, keep its fluid-tight at container 10 to (or radially) and axial power to the valve member apply side.
Shown in Fig. 9 and 9A; The filling of flask for medicinal preparations is preferably accomplished in an aseptic fill assembly; Aseptic fill assembly comprises a sterile board 84 and a lamella air flow source 92 (not shown among Fig. 9 A), the lamella air flow source flask for medicinal preparations fill and/or transportation in to flask for medicinal preparations the windstream of the filtration/sterilization that is roughly lamella shape is provided.In currently preferred embodiment of the present invention, aseptic fill assembly is applicable to filling medicament bottle, syringe or other splendid attire medicine, the for example distributing box of vaccine or pharmaceutical products.Yet those skilled in the art are according to knowing of being lectured here, aseptic fill assembly can be used for any one other material, for example cosmetics and food product equally.Aseptic fill assembly comprises a feed unit 86 of other container that supports flask for medicinal preparations, syringe or be delivered to the case 84 of aseptic fill assembly.In exemplary embodiment, feed unit 86 is the form of rotating table, and rotating table supports a plurality of flask for medicinal preparations, syringe or other container, and container is delivered in the aseptic fill assembly with set rate.Those skilled in the art are known according to what lecture here; Feed unit can be taked the device of any kind of that at present know or can know in the future, the function that be used to realize feed unit 86; The vibration feed unit of for example any variety classes type, or " pick up and put " (pick and place) robot system.
Before settling flask for medicinal preparations or other container on the feed unit 86, preferably airtight container (like tool lid flask for medicinal preparations and sealing valve member on it) is carried out disinfection, as through container is exposed to gamma radiation with a kind of mode well known to those skilled in the art.In addition, according to U.S. Pat 5,186; 772, name is called " method, transmission cover and the shell that transmit article " and U. S. application No.10/421,249; Name is called the instruction in " transfer port and the method for transmitting sterile product "; Flask for medicinal preparations assembly or other leak free empty receptacle can be sealed, sterilized and be sent to aseptic fill assembly, and each application transfers the application's cessionary, and its content quotation at this for your guidance.
After putting into aseptic fill assembly, flask for medicinal preparations or other container can be once more through being carried ray to be sterilized (perhaps, selectable, sterilize the first time) by the empty flask for medicinal preparations of active source case leak free, and before filling with further assurance sterilize fully in essential surface.Ray can be taked any kind of dissimilar ray of knowing or can knowing, realize this function in the future at present, like gamma radiation, electron ray and/or laser beam.
Engage a forwarder 90 on the feed unit 86, be used to receive flask for medicinal preparations that feed unit sends and aseptic fill assembly passed in the flask for medicinal preparations transmission with predetermined speed.In exemplary embodiment of the present invention, the preferably single-row relative to each other transmission container of forwarder 90.Forwarder 90 can be taked any present that know or can know in the future, connecting gear of realizing the function of forwarder described here not of the same race.For example, forwarder can be taked to vibrate and supply with the form that drives, or takes continuous conveyor or some star gears, and it comprises, for example is that some ad-hoc locations at forwarder receive the container that perhaps supports flask for medicinal preparations, like clamping plate.Forwarder drives and is connected in motor or other suitable drive source (not shown), and it can be started, stopped by computing machine or the control of other control setup (not shown), the adjustment operation of other parts of control rate and forwarder and aseptic fill assembly.
In one embodiment of the invention, active source 88 comprises an electron source that is installed in the electron beam chamber (not shown among Fig. 9) at least, has a filling platform 77 that contains filling member 72 in the electron beam chamber.Electron source can be taked any dissimilar present that know or can know in the future, electron source of realizing electron source function described here.The electron ray ray is a kind of ion ability, is characterized in low penetration rate and high dose rate usually.Electronics contacts with the exposure article, will change different chemistry and molecular bond, comprises the regenerable cell of germ, so the electron ray ray is particularly suited for the container sterilization into flask for medicinal preparations, syringe and other splendid attire medicine or other sterile substance.Shown in Fig. 9 A, electron ray 88 produces electron ray 89, and electron ray is quickened by electric current and the electronics of the intensive high electric current that conversion is produced constitutes.Preferably, electron ray 89 filling member 72 that focuses on each container engage, to open valve and to the surface of vessel filling medicine or other material.Giving an example, under the situation that is flask for medicinal preparations, for example is the flask for medicinal preparations with aforesaid valve module, before engaging filling member 72, electron ray 89 is focused on the upper surface of valve member 20 and jack 24 of flask for medicinal preparations or cap assemblies.In addition, reflecting surface can be installed in forwarder opposite face relative to each other, and in order to electron ray, and/or reflection and scattered electron reflex to the side of flask for medicinal preparations assembly, is similarly these surface sterilizings.Selectable, perhaps combine this reflecting surface, can use a plurality of electron sources, wherein each electron source focuses on flask for medicinal preparations or other container surface and surface portion separately, to guarantee the sterilization of each target surface area.
Electron beam chamber makes up with mode well known to those skilled in the art, its have an electron ray cavity and conform to the application safety standard prevent the device that electronics leaks from cavity.In one embodiment of the invention, forwarder 90 has the path of approximate U-shaped in the electron ray cavity, and wherein first section of U has an inlet part and electron ray radiation cavity part on it.Preferably; Can select the energy of electric current, reference scanning position and electron ray 89, the speed of forwarder 90 and/or the direction and the position of arbitrary reflecting surface; With to valve member 20 exposures and upper surface, as on valve member and the surface that filling member 72 engages, and in filling member 72 and the contacted lip-deep biological load test of flask for medicinal preparations; Reach minimum and be the decay of 3log, be preferably the decay of 6log.In addition, as a kind of additional alarming device, can preferably one or more aforesaid variablees, with the decay of 3log at least on the noncontact surface of the side that reaches flask for medicinal preparations and filling member.These clear and definite disinfection standards are merely exemplary; Yet, that can disinfection standard be set to want or needed, meet with the checking specific products; For example be U.S. FDA or applicable European standard, guarantee standard (" SAL ") like applicable sterilization.
The filling member 84 of sterilization also preferably has the device that platform 77 is filled in visual detection.This device can take β to intercept window (i.e. a window, it intercepts any electron ray, but allows visible light therefrom to pass), and/or is installed in the framework, is used for the CCD to external detector transmission filling platform image, video or other photographic camera.Those skilled in the relevant art just can know that according to the instruction of being carried out these special devices only are exemplary here, and any dissimilar device present that know or can know in the future, that realization allows visible light to pass function can use.
Filling platform 77 is positioned at relative section of electron ray cavity U-shaped forwarder path or exports on the side.In one embodiment of the invention, fill platform 77 and comprise that some are installed in the filling member above the forwarder 90, wherein, each filling member with top said identical mode drive installation on forwarder.Accordingly; Each filling member movably is placed on the valve member of filling the container in the platform with flask for medicinal preparations or other and engages and separate; With to flask for medicinal preparations or other vessel filling medicine or other its in the material of institute's splendid attire, when filling medicament bottle or other container, extract filling member then.In one embodiment, fill platform and comprise one group of six filling member 72 of installation in alignment each other, filling member be placed on forwarder 90 above, six flask for medicinal preparations of coaxial filling or other container simultaneously.Filling member 72 can be installed on the common driver element 75 (of Fig. 9), and perhaps the drivable respectively valve member with flask for medicinal preparations or other container of each filling member engages and separates.Those skilled in the relevant art just can know according to the instruction of being carried out here; Fill platform and can comprise the filling member of any requirement, perhaps install or drive with the mode of the function of any different present that known or can know, realization filling platforms described here in the future.Simultaneously, for the assembly or the whole production amount of regulating aseptic fill assembly, aseptic fill assembly can comprise a plurality of filling platforms that are installed in the same electron ray cavity, perhaps comprises a plurality of electron rays and fill assembly.Preferably, electron ray housing 87 has a port or passage (not shown) movably, fills platform 77 arriving and/or keep in repair and replace.
As stated, so make up electron ray and fill platform, like this, filling member 72 is installed in the electron ray cavity.As a result, the free electron in the electron ray cavity can clash into filling member.It combines the operation of electron ray with the air sterillization of whole electron ray cavity, acts on to be the filling member sterilization, and/or keeps the aseptic of filling member in whole filling process.Accordingly because in electron ray cavity 87 filling containers or other flask for medicinal preparations, just do not have flask for medicinal preparations contaminated risk and between filling at electron beam sterilization.If desired, can the air ionization in the electron ray cavity to promote the propagation of free electron, filling platform 84 aseptics have further been strengthened.And, found in the aseptic filling machine as a lot of prior aries that characteristic of the present invention does not need insulator.
In one embodiment of the invention; As shown in Figure 9; Aseptic fill assembly comprises a lamella air flow source 92 that those of ordinary skill in the related art knew, in order in filling process, the filtration/sterile air stream of lamella shape is provided above flask for medicinal preparations or other containers.Shown in figure 32 not in the electron ray cavity in the application of filling medicament bottle assembly, lamella air flow source 92 is especially favourable.
Shown in Fig. 9 A, aseptic fill assembly can comprise one or more additional stations 79 of filling platform 77 downstream that are positioned at.Additional stations 79 can comprise a freeze-drying platform; Be described below; The visible system that is used to check each valve seal of the type that a kind of those of ordinary skill in the related art knew; Be used to detect each flask for medicinal preparations or other container inner fluids or other materials liquid level, be installed into the fluid level detection system of liquid level accurately to guarantee it, and label platform.In addition, shown in Fig. 9 A, aseptic fill assembly can comprise a retraction means 81; Be used for when detecting; For example be through the level detection inspection, or, the flask for medicinal preparations or other containers that detect pulled out from forwarder because label has labeled wrong or do not posted.Then, with the discharging gear 83 of unloading flask for medicinal preparations or other containers receivable flask for medicinal preparations or other containers are transplanted on and are used to the gathering-device 85 packing and transport.Retraction means and discharging gear can be taked star gear, pick and place machine device people or known today or day can be known in the future is used to realize any other the device of the function of said these devices here.
A very big benefit of currently preferred embodiment of the present invention is that it can guarantee it is real aseptic filling, and is not only aseptic filling.Current preferred embodiment also has a benefit, after container being exposed to γ light or the radiation of direct electron bundle, fills medicine or other materials exactly, thereby prevents that radiation will be to being contained in medicine or the degraded of other mass transfer in the container.
In order in flask for medicinal preparations, to extract material, shown in figure 10, open end 98 spirals of syringe 94 are connected on the installation surface 28 of cap assemblies 14.Representative type syringe 94 comprises that one is connected to the female connection device 96 on the pin (not shown) with it.A kind of adaptor union 96 is on sale under Leur lock trade mark.Correspondingly, but installation surface 28 screw joint of flask for medicinal preparations are connected on the syringe what flask for medicinal preparations was prone to unclamp in the negative thread of syringe.Like this, conversely, the open end 98 of syringe is axially combined, and push the convexity 56 that is formed on the valve member 20, shown in figure 10, then valve member is moved to the release position by detent position.Then, valve member 20 is positioned at the release position, outwards spurs the pusher of syringe 94, causes vacuum, the material 78 in the flask for medicinal preparations cavity 22 is drawn in the cavity of syringe 94 through valve opening 74.By removing volume required material 78 in the flask for medicinal preparations cavity 22, then flask for medicinal preparations and syringe are rotated relative to each other, syringe 94 and flask for medicinal preparations are broken off.After flask for medicinal preparations 10 removed from syringe 94, spring 58 moved axially valve member 20, makes it to enter into detent position, but and the surplus materials 78 in the tight seal flask for medicinal preparations cavity 22.
Those of ordinary skill in the related art can know through the instruction here, and the connector part of flask for medicinal preparations and/or syringe can take any different known today or day can be known in the future is used to realize the structure of the function of said these parts here.For example, flask for medicinal preparations or container or distributing box can form the external screw thread adaptor union, and syringe can form the female connection device.Interchangeable, can use the screw thread coupling of variety classes type or non-threaded adaptor union equally.
A very big benefit of exemplary embodiments of the present invention is, flask for medicinal preparations or container or distributing box can be adorned the material of various dose, and in the storage flask for medicinal preparations under tight seal, aseptic condition between each dosage remaining material.Correspondingly, in the currently preferred embodiment of the present invention, the material that provides is unshielded vaccine or other injection products.Because flask for medicinal preparations can make material be in state aseptic, tight seal, so can avoid the use of anti fouling composition from first dosage to a last dosage.
In Figure 11-13, Reference numeral 110 representative usually embodies another flask for medicinal preparations assembly of the present invention.Flask for medicinal preparations assembly 110 and foregoing flask for medicinal preparations assembly 10 are similar, and therefore identical Reference numeral front adds numeral " 1 ", perhaps uses numeral " 2 " replacement " 1 ", is used for representing identical parts.Flask for medicinal preparations assembly 110 is with flask for medicinal preparations assembly 10 major different, and the shape of valve member 120 and valve member are installed on the jack (hub) 124 of cap assemblies 114 and the mode of tight engagement with it.As what we saw, Monolithic spring 148 limits an annular, curved part 150, and it defines an arcuate part different with foregoing corresponding arcuate part 50.In addition, above the valve member 120 or in the recessed jack 124 of exposed surface, the sealing surfaces 118 of valve seat and 138 and sealing surfaces 130 is different with foregoing individual features shape respectively with 136 accordingly.To combine the identical mode of the described flask for medicinal preparations of Fig. 9 and 9A 10 to flask for medicinal preparations 110 medicines or other materials with the front.
Figure 14 illustrates, and the open end 198 of syringe 194 is connected through female connection device 196 spirals on the installation surface 128 of cap assemblies 114, is connected in syringe with what flask for medicinal preparations was prone to unclamp.Like this, conversely, the open end 198 of syringe is axially combined, and push and be formed at valve member 120, then valve member is moved to the release position by detent position.Then, valve member 120 is positioned at the release position, outwards spurs the pusher 200 of syringe 194, causes vacuum, the material in the flask for medicinal preparations cavity 122 is drawn in the cavity of syringe 194 through valve opening 174.By removing volume required material in the flask for medicinal preparations cavity 122, then flask for medicinal preparations and syringe are rotated relative to each other, syringe 194 and flask for medicinal preparations are broken off.After flask for medicinal preparations 110 removed from syringe 194, valve member 120 returned detent position, but and the surplus materials in the tight seal flask for medicinal preparations cavity 122.
In Figure 15 and 16, Reference numeral 310 representative usually embodies another flask for medicinal preparations assembly of the present invention.Flask for medicinal preparations assembly 310 and foregoing flask for medicinal preparations assembly 10 are similar, and therefore identical Reference numeral front adds numeral " 3 ", rather than " 1 ", is used for representing identical parts.Flask for medicinal preparations assembly 310 and flask for medicinal preparations assembly 10 major different are the structure of valve module.As what we saw, valve module 316 comprises a flexible valve member 320 that is separated with pedestal 340.Cap assemblies 314 comprises one to the flange that extends below 324, and it is positioned on the relative side of lid with respect to jack 324, forms a circular cylindrical cavity that is used for the pedestal of receiving valve parts 320 in it.Pedestal 340 has a flange 342, and it directly forms sealing closely with foregoing mode at cap assemblies and main body (not shown); Yet pedestal 340 further limits the spring section 350 of a bellows-shaped, and it contacts with the inner of valve member.Shown in figure 15; Spring section 350 enters into detent position with valve member 320 bias voltages usually, and is shown in figure 16, and spring section 350 is responded to inwardly pushing or the movement of valve parts are applied to the power shown in Figure 16 arrow on valve member 320 exposed ends; For example; Filling member or syringe applied force as stated, taking advantage of a situation axially extends internally, and then valve 374 is opened.
In Figure 17-21, Reference numeral 410 representative usually embodies another flask for medicinal preparations assembly of the present invention.Flask for medicinal preparations assembly 410 and foregoing flask for medicinal preparations assembly 310 are similar, and therefore identical Reference numeral front adds numeral " 4 ", replaces " 3 ", is used for representing identical parts.Flask for medicinal preparations assembly 410 and flask for medicinal preparations assembly 310 major different are the structure of valve module.Valve module 410 has first stream 435 that is used for to the flask for medicinal preparations weighting substance, and the inner chamber that this can the flask for medicinal preparations assembly is extracted material out and is injected into second stream 437 in the syringe.Shown in figure 17, pedestal 420 has the axially extended valve portion 439 of an annular, and the flange 425 of lid 414 limits a corresponding axially extended valve seat 441.Figure 17 further provides, and the wall thickness of valve portion 439 is successively decreasing to the direction that moves to bellows or spring section 450 from the base shaft that is formed near the valve portion the flange 422.Valve portion 439 on common detent position and valve seat 441 combine closely, form fluid-tight.As foregoing valve member 20, pedestal 420 is preferably processed by elastic material.Same in current preferred embodiment, valve portion 439 forms an interference fit with valve seat 441, further realizes fluid-tight.Shown in figure 18, the filling of flask for medicinal preparations assembly 410 is through drawing the opening 435 of material to valve with enough pressure from the filling member (not shown); Make valve member 439 outwardly-bent and away from valve seat; And then open valve, and material is passed through, go forward side by side into flask for medicinal preparations cavity 422.
In order in flask for medicinal preparations cavity 422, to extract materials out, valve member mutually will be to firm, and have one to make the therefrom fluid passage 437 of process of material.Shown in Figure 19 and 20, the screw thread coupling 496 of syringe 494 and flange 428 screw joint of jack 424 are with the end 498 push valve parts 420 with syringe.Conversely, sealing member 436 is axially moved inward and, then valve is opened, flow of material is therefrom passed through away from valve seat.Shown in figure 21, material can flow out from the inner chamber 422 of flask for medicinal preparations, passes through axially extended opening 454 in the bellows 450, and passes the stream 437 of valve, gets into the inner chamber of syringe.Behind flask for medicinal preparations disconnection syringe, bellows 450 return valve member 420 bias voltages to its common detent position, form fluid-tight, and then have preserved remaining material in the flask for medicinal preparations, in order to using later on.
In Figure 22-26, Reference numeral 510 representative usually embodies another flask for medicinal preparations assembly of the present invention.Flask for medicinal preparations assembly 510 and foregoing flask for medicinal preparations assembly 410 are similar, and therefore identical Reference numeral front adds numeral " 5 ", replaces " 4 ", is used for representing identical parts.Flask for medicinal preparations assembly 510 and flask for medicinal preparations assembly 410 major different are the structure of valve module.The valve member 520 of rigidity has a fluid line 535; It passes valve member and extends; And be connected with the fluid mode of communicating with the access valve parts, the access valve parts have the rigidity valve seat 541 and the flexible valve member 539 along the circumferential extension of rigidity valve seat that are formed at valve member 520 outside faces.Further provide among Figure 22, the wall thickness of valve portion 539 successively decreases to the direction that the inner chamber 522 to flask for medicinal preparations moves at the base shaft from valve portion.Valve portion 539 on common detent position and valve seat 541 combine closely, form fluid-tight.As foregoing valve member 20, pedestal 520 is preferably processed by elastic material.Same in current preferred embodiment, valve portion 539 forms an interference fit with valve seat 541, further realizes fluid-tight.Shown in figure 25, bring in filling medicament bottle assembly 510 through the opening that filling member 572 is inserted into jack 524.With enough pressure material is guided to valve member 520 and opening 535 thereof, make valve member 539 outwardly-bent and, and then open valve, material is passed through, go forward side by side into flask for medicinal preparations cavity 522 away from valve seat.Valve portion 539 and valve seat 541 can adopt arbitrary difformity and/or structure known today or that day can be known in the future; The disclosed shape of patent application and/or the structure of these pending trials for example; These applications transfer cessionary of the present invention and its content quotation at this for your guidance; The U. S. application No10/640500 that on August 13rd, 2003 proposed; Name is called " being used to store container and valve module with dispensable materials ", the U.S. Provisional Application No60/528429 that on December 10th, 2003 proposed, and name is called " being used to store valve module and pipeline external member with dispensable materials "; The U.S. Provisional Application No.60/539602 that proposed on January 27th, 2003, name is called " being used to store tubular container and check valve assembly with dispensable materials ".
Shown in Figure 22-26; Pedestal 540 has an axially extended hole 543 that passes pedestal, and it is used to receive rigid valve parts 520, and valve member has circumferential flange 545; It is placed in the corresponding grooves 547 that is formed in the pedestal 540, is used for the valve member in the releasable permanent seat.Shown in figure 26; In order in flask for medicinal preparations cavity 522, to extract material out and to inject in the syringe 594; Adaptor union on the syringe 596 being fixed on the jack 524 of flask for medicinal preparations assembly 510, for example is that the negative connector 596 with syringe through spiral joins on the flange 528 of flask for medicinal preparations jack 524.The point 598 of syringe and the end surface of valve member 520 are engaged, and the push valve parts, make it axially inwardly to pass hole 543.Shown in figure 26, when syringe 594 was connected on the flask for medicinal preparations fully, rigid valve parts 520 axially passed hole and move enough distances, hole and flexible valve member 539 are separated, and are connected with the fluid mode of communicating with the inner chamber 522 of flask for medicinal preparations.In this case, the propelling unit of syringe will be pulled, and the material of pulling in the cavity makes it to pass hole 535, pass valve member 520 and enter into the inside of syringe.Then, syringe and flask for medicinal preparations break off, and the pin (not shown) are connected on the adaptor union 596 of syringe, think patient infusion.
In Figure 27-30, Reference numeral 610 representative usually embodies another flask for medicinal preparations assembly of the present invention.Flask for medicinal preparations assembly 610 and foregoing flask for medicinal preparations assembly 510 are similar, and therefore identical Reference numeral front adds numeral " 6 ", replaces " 5 ", is used for representing identical parts.Flask for medicinal preparations assembly 610 and flask for medicinal preparations assembly 510 major different are the structure of valve module.Flask for medicinal preparations assembly 610 has first stream 635 in the valve module 616 that enters into that is used for to flask for medicinal preparations assembly 610 weighting substances 678.Shown in figure 27, pedestal 640 has the axially extended valve portion 639 of an annular, and rigid valve parts 620 have corresponding axially extended valve seat 641.Figure 27 further provides, and the wall thickness of valve portion 639 is successively decreasing to the direction that the inner chamber 622 to the flask for medicinal preparations assembly moves from the outer shaft with the valve portion that covers 614 joints.Valve portion 639 on common detent position and valve seat 641 combine closely, form fluid-tight.As foregoing valve member 20, pedestal 620 is preferably processed by elastic material.Same in current preferred embodiment, valve portion 639 forms an interference fit with valve seat 641, further realizes fluid-tight.Shown in figure 27, the filling of flask for medicinal preparations assembly 610 is through material 578 is guided to the opening 635 of valve with enough pressure from the filling member (not shown); Make valve member 639 outwardly-bent and away from valve seat; And then open valve, and material is passed through, go forward side by side into flask for medicinal preparations cavity 622.
Through a connection that is prone to unload 647 with the rigid valve parts 620 releasable base portions that are connected to jack 624.Thereby in the process of filling medicament bottle, as previously mentioned, 620 fastening being installed in of rigid valve parts are covered on 614, play the effect of valve seat, are used for the filling medicament bottle, and in storage process, fluid-tight between maintenance and the valve portion 639.Yet the connection 647 that is prone to unload is designed to, and when applying enough axial forces in the outer end to rigid valve parts 620, rigid valve parts 620 is broken, in flask for medicinal preparations, to pipette material.Shown in Figure 28-30, in order in flask for medicinal preparations cavity 622, to extract materials 678 out and to inject in the syringe 694, the adaptor union on the syringe 696 is fixed on the flange 628 of jack 624 of flask for medicinal preparations, for example be adaptor union is joined on the jack through spiral.When syringe 694 spirals being connected to 624 last times of jack, the end surface 698 of syringe engages with the end surface of rigid valve parts 620, and it is applied an axial inside power.When syringe 694 is connected with flask for medicinal preparations fully, be applied to the connection 647 that the power on the valve member 620 just enough fractures and is prone to unload, conversely, valve member 620 from covering releasing and processing 614, and is sent in the cavity 622 of flask for medicinal preparations.Shown in figure 30, then, the propelling unit (not shown) of injector-actuated 694 extracts material 678, passes the open end of flask for medicinal preparations and enters into syringe.Then, syringe and flask for medicinal preparations break off, and the pin (not shown) are connected on the adaptor union 696 of syringe, think patient infusion.Can empty flask for medicinal preparations 610 be abandoned then.
In Figure 31, Reference numeral 710 representative usually embodies another flask for medicinal preparations assembly of the present invention.Flask for medicinal preparations assembly 710 is similar with foregoing flask for medicinal preparations assembly 610, therefore identical Reference numeral front add numeral " 7, replace " 6 ", be used for representing identical parts.Flask for medicinal preparations assembly 710 and flask for medicinal preparations assembly 610 major different are the structure of valve module and being connected of being prone to unload.As given, valve seat 741 is made up of the axially extended flange 725 of lid 714.Flange 725 has the axially extended hole 743 that therefrom passes.Rigid valve parts 720 are placed in the hole 743, and the rigid valve parts 720 in the fixedly hole 743 that sealing/attaching parts 747 can discharge form fluid-tight between the two again.Rigid valve parts 720 can be taked any different known today or packing ring or other sealing members of being used to realize said sealing/attaching parts function here that day can be known in the future.Flange 725 has the lid 749 of an annular, and it is used as the link stopper that sealing/attaching parts 747 is installed when in hole 743, assigning rigid valve parts roughly the same.
For filling medicament bottle assembly 710, open valve with enough pressure, material 578 is introduced passed valve inlet 735, make flow of material through valve, and enter into the inner chamber 722 of flask for medicinal preparations.Then, in order from the flask for medicinal preparations assembly, to extract material, the flange 728 that the syringe (not shown) is connected to flask for medicinal preparations jack 724 makes.This makes the end surface of syringe engage conversely, and axially pushes rigid valve parts 720 and pass hole 743.When syringe was connected with flask for medicinal preparations fully, rigid valve parts 720 received the power of inwardly enough distances, make sealing/attaching parts 747 pass the inner of hole 743 then, and enter in the cavity 722.As a result, rigid valve parts 720 fall in the inner chamber body 722 of flask for medicinal preparations, but the propelling unit of injector-actuated then, and the material of bleeding in the flask for medicinal preparations enters into syringe.Then, syringe and flask for medicinal preparations break off, and the pin (not shown) are connected on the adaptor union of syringe, think patient infusion.Can empty flask for medicinal preparations 710 be abandoned then.
An advantage of capacitance divider of the present invention and valve module is that it can be used for filling, storing and/or distribute medicine and other materials of freeze-drying.Draw material from filling member to the vessel filling freeze dried substance, after passing valve member and entering into the cavity of container, along with valve member is positioned at its release position, cavity is drained.Cavity can through in the freeze-drying platform, place be installed in match the, the container on device, preferably a plurality of containers, with fixed container position relative to each other, the freeze-drying platform has one type the vacuum cavity that the association area those of ordinary skill is known.In one embodiment of the invention, the freeze-drying platform is one and is arranged in Fig. 9 and fills 79 of platform 77 downstream.In freeze-drying platform 79, move second device matching and the valve member of flask for medicinal preparations and engage, valve member is moved to its release position, then with the arbitrary different freeze-drying process of knowing or can knowing at present in the future with medicine or other material freeze-drying.After the material in the flask for medicinal preparations is by freeze-drying, move second device, make it to be separated with valve member, make the interior freeze dried substance of vacuum cavity of valve member sealing and airtight container then.
In use, can syringe be connected to the installation surface of container, to open valve with identical mode noted earlier.In syringe, dilution is injected in the cavity then, mixed diluting liquid and freeze dried substance, compound just can have been injected then.
Those of ordinary skill in the related art can know through the instruction here, can carry out various improvement to top described or other embodiments of the invention, and not depart from claim institute restricted portion.For example, the parts of flask for medicinal preparations can be different known today or day can be known in the future is used to realize that the material of various functions of components processes by any.Valve module can take any different known today or day can be known in the future is used to realize the structure of the function of different valve modules described here.Equally, flask for medicinal preparations can adopt any different known today or shape and structures that day can be known in the future.And, can change the form and the structure of the element of aseptic fill assembly disclosed herein, can add a platform arbitrarily to aseptic fill assembly.In addition, container can be arbitrary different flask for medicinal preparations, syringe or other containers or distributing box.Further, principle of the present invention can be applied to the container beyond the flask for medicinal preparations equally, for example, can be used for the container that arbitrary different being used to stored and distributed different material.Correspondingly, DETAILED DESCRIPTION OF THE PREFERRED only is exemplary, but not determinate.
Claims (17)
1. device that can in fill assembly, be filled, this fill assembly comprise with substance source with fluid mode of communicating bonded assembly filling member, be used for material is introduced said device, said device comprises:
Main body is limited with the cavity that is used for taking in material within it; And
Valve module; This valve module is connected between filling member and the cavity with the mode that fluid is communicated with; Material is incorporated in the cavity through valve module, and wherein valve module comprises axially extended valve seat, and is stacked in the flexible valve member on the valve seat; Flexible valve member and valve seat have formed the NORM CLSD interface that limits their fluid-tight between the two; And in response under the enough pressure material being incorporated into the interface between valve member and valve seat from filling member, flexible valve member is outwardly-bent with respect to valve seat, to open valve module and to allow material to get into cavity through this valve module.
2. device as claimed in claim 1, wherein valve module defines the interface that extends axially of annular between valve member and valve seat.
3. device as claimed in claim 1, wherein valve seat is with respect to valve member rigidity comparatively, and valve member is comparatively flexible with respect to valve seat.
4. device as claimed in claim 3, wherein comparatively flexible valve member centers on the comparatively circumferential extension of the valve seat of rigidity.
5. device as claimed in claim 1, wherein at valve member and valve seat at the interface, valve member and valve seat form interference fit, thereby form the fluid-tight between them.
6. device as claimed in claim 1, wherein valve member limits the wall thickness that reduces gradually towards cavity in the axial direction.
7. device as claimed in claim 1, wherein flexible valve member is extended around valve seat annular, and at the NORM CLSD of the formation at the interface circumferential seam of valve member and valve seat, therefrom passes through under enough pressure with the permission material.
8. device as claimed in claim 1, wherein valve module comprises the main body that defines the ingress port that the mode that is communicated with fluid links to each other with filling member, and a plurality of entry pores that fluid is communicated with between the interface of ingress port and valve member and valve seat.
9. device as claimed in claim 1 combines with filling member, and wherein filling member defines and is used for the tubular pipeline of material from wherein passing through, and the engaging of removable entering and valve module, so that material is incorporated into the cavity through valve module from tubular pipeline.
10. device as claimed in claim 1, wherein axially extended valve seat forms access valve with flexible valve bonnet, so that material is incorporated in the cavity through access valve, and valve module also comprise the NORM CLSD outlet valve and form cavity and ambient atmosphere between fluid-tight.
11. device as claimed in claim 10; Wherein outlet valve comprises valve member and valve seat; Valve member defines the fluid-tight between them in the normally closed position engage valve seat, and valve member can move allowing with respect to valve seat and passes through between valve member and valve seat from the fluid of cavity.
12. method to the device weighting substance; Wherein this device comprises main body and valve module; This main part limitation is used for taking in the cavity of material within it; This valve module comprises axially extended valve seat and flexible valve member, and this flexible valve member is stacked on the valve seat and forms the normally closed interface that defines the fluid-tight between valve member and the valve seat, and wherein said method comprises the steps:
Provide have leak free, the device of the cavity of empty sterilization;
Through in movement of valve assembly and the filling member at least one it is communicated with another fluid, weighting substance in the cavity of the sky of sterilization;
Under enough pressure, material is incorporated into the interface between valve member and the valve seat from filling member,, subsequently, makes flow of material cross the interface between valve member and the valve seat and flow in the cavity so that valve member is outwardly-bent with respect to valve seat;
Stop material and flow into the interface between valve member and the valve seat, flexible valve member is formed define the normally closed interface of the fluid-tight between valve member and the valve seat, and utilize the cavity sealing substance subsequently from filling member; With
In valve module and the filling member at least one moved with respect to another, be communicated with breakaway valve assembly and filling member fluid each other.
13. method as claimed in claim 12 also comprises the step that the device that leak free is empty is sterilized.
14. method as claimed in claim 13, wherein sterilization steps comprises that the device to the leak free sky radiates.
15. method as claimed in claim 14, the step of wherein the empty device of leak free being radiated comprise with in gamma radiation, electron ray and the laser beam at least one device is implemented to radiate.
16. method as claimed in claim 12; Also comprise the steps: to provide device with valve module; Wherein axially extended valve seat forms access valve with flexible valve bonnet; So that material is incorporated in the cavity through access valve, and valve module also comprise the NORM CLSD outlet valve and form cavity and ambient atmosphere between fluid-tight; And come dispensable materials through outlet valve from cavity.
17. method as claimed in claim 16, wherein allocation step comprises from cavity and distributes the material of a plurality of dosage through outlet valve, and at each dosage all with respect to after the ambient atmosphere sterilization and being sealed in the cavity, keep material to be kept in the cavity.
Applications Claiming Priority (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US46599203P | 2003-04-28 | 2003-04-28 | |
| US60/465,992 | 2003-04-28 | ||
| US46967703P | 2003-05-12 | 2003-05-12 | |
| US60/469,677 | 2003-05-12 | ||
| US47159203P | 2003-05-19 | 2003-05-19 | |
| US60/471,592 | 2003-05-19 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2004800144163A Division CN100420609C (en) | 2003-04-28 | 2004-04-28 | Container with valve assembly for filling and dispensing substances, and apparatus and method for filling |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101342963A CN101342963A (en) | 2009-01-14 |
| CN101342963B true CN101342963B (en) | 2012-07-04 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2004800144163A Expired - Fee Related CN100420609C (en) | 2003-04-28 | 2004-04-28 | Container with valve assembly for filling and dispensing substances, and apparatus and method for filling |
| CN2008101294948A Expired - Fee Related CN101342963B (en) | 2003-04-28 | 2004-04-28 | Container with valve assembly for filling and dispensing substances, and apparatus and method for filling |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2004800144163A Expired - Fee Related CN100420609C (en) | 2003-04-28 | 2004-04-28 | Container with valve assembly for filling and dispensing substances, and apparatus and method for filling |
Country Status (1)
| Country | Link |
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| CN (2) | CN100420609C (en) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8042581B2 (en) * | 2007-09-07 | 2011-10-25 | Scott David Green | Valve assembly for powder dispenser |
| BRPI0818513A2 (en) * | 2007-10-04 | 2014-10-07 | Medical Instill Tech Inc | Apparatus and method for forming and aseptically filling liquid products |
| GB2483087A (en) * | 2010-08-26 | 2012-02-29 | Breeze Product Design Ltd | Refillable Dispenser with Deformable Membrane |
| FR2976265B1 (en) | 2011-06-08 | 2014-08-29 | Biocorp Rech Et Dev | CLOSURE DEVICE AND CONTAINER EQUIPPED WITH SUCH A DEVICE |
| CN104334213B (en) * | 2012-01-17 | 2018-10-26 | 皮博士研究所有限责任公司 | Multiple dose vials and method |
| CH706952B1 (en) * | 2012-09-11 | 2016-12-15 | Gea Aseptomag Ag | Valve device, container with valve device and method for filling or emptying a container. |
| AU2013339904A1 (en) * | 2012-11-01 | 2015-06-18 | Otsuka Pharmaceutical Factory, Inc. | Drug container storage device, drug container storage system, and method for sucking drug |
| US9903478B2 (en) | 2013-08-27 | 2018-02-27 | Gea Aseptomag Ag | Valve apparatus; arrangement with valve apparatus and method for operating an arrangement |
| US10278897B2 (en) * | 2015-11-25 | 2019-05-07 | West Pharma. Services IL, Ltd. | Dual vial adapter assemblage including drug vial adapter with self-sealing access valve |
| WO2018014167A1 (en) * | 2016-07-18 | 2018-01-25 | 刘金凤 | Device capable of temporarily storing cerebrospinal fluid |
| IL249408A0 (en) | 2016-12-06 | 2017-03-30 | Medimop Medical Projects Ltd | Liquid transfer device for use with infusion liquid container and pincers-like hand tool for use therewith for releasing intact drug vial therefrom |
| IL254802A0 (en) | 2017-09-29 | 2017-12-31 | Medimop Medical Projects Ltd | Dual vial adapter assemblages with twin vented female vial adapters |
| CN108482841A (en) * | 2018-03-30 | 2018-09-04 | 中山市华宝勒生活用品实业有限公司 | A kind of interior cap assemblies easy to use |
| US11230400B2 (en) * | 2018-05-07 | 2022-01-25 | V Anrx Pharmasystems Inc. | Method, device and system for filling pharmaceutical containers |
| CN109764149A (en) * | 2019-03-18 | 2019-05-17 | 亚美斯特（天津）医疗器械有限公司 | Check configuration, pressure indicator and pressure indicating mechanism |
| CN115092527B (en) * | 2022-07-01 | 2023-07-04 | 厦门斯坦瑞科技有限公司 | Liquid feeding structure |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5046645A (en) * | 1988-02-19 | 1991-09-10 | Mckesson Corporation | Syphon package with mechanically attached valve |
| US5509433A (en) * | 1993-10-13 | 1996-04-23 | Paradis; Joseph R. | Control of fluid flow |
| US5676346A (en) * | 1995-05-16 | 1997-10-14 | Ivac Holdings, Inc. | Needleless connector valve |
-
2004
- 2004-04-28 CN CNB2004800144163A patent/CN100420609C/en not_active Expired - Fee Related
- 2004-04-28 CN CN2008101294948A patent/CN101342963B/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5046645A (en) * | 1988-02-19 | 1991-09-10 | Mckesson Corporation | Syphon package with mechanically attached valve |
| US5509433A (en) * | 1993-10-13 | 1996-04-23 | Paradis; Joseph R. | Control of fluid flow |
| US5676346A (en) * | 1995-05-16 | 1997-10-14 | Ivac Holdings, Inc. | Needleless connector valve |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101342963A (en) | 2009-01-14 |
| CN1826265A (en) | 2006-08-30 |
| CN100420609C (en) | 2008-09-24 |
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