CN101342963A - Container with valve assembly for filling and dispensing substances, and apparatus and method for filling - Google Patents

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 The valve assembly opens upon connecting the syringe to the vial to allow the substance within the vial to be withdrawn from the vial and into the syringe by actuating a plunger of the syringe, and the valve assembly closes upon disconnecting the vial and syringe to hermetically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

Be used to fill the container with valve module and filling device and method with dispensable materials

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 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 for referencial use in conjunction with its disclosure, as a part of the present invention.

Technical field

The present invention relates to be used to store and divide the container of power dispensers and other material and the method for filling this container, particularly, in container, has the valve that is used for sealing substance, and can make flask for medicinal preparations, distributing box and the container of material, and the apparatus and method that are used to fill this container from this distribution.

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 by it is radiated, autoclaving, in the filling of sterilization, fill then and assembling.

U.S. Patent 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 ", the U.S. Patent No. 10/766 of common pending trial, 172 are called " having the medical pharmacy bottle of heat seal lid and the apparatus and method of filling this flask for medicinal preparations ", and the U.S. Patent No. 10/655 of common pending trial, 455 are called the improvement that discloses in " method of the container that leakproof tank and making and filling are same " above-mentioned prior art, 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, flask for medicinal preparations with lid of resealable, portion within it, for example pass through to implement 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, by 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 saves 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

An aspect of of the present present invention provides a container or a distributing box that is used for splendid attire medicine and other material, and as 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 enters 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 valve seat separately the release position and the detent position of engage valve seat 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 move between sealing and release position 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, a fill system is provided, 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 by 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 by 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) by 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) by the valve module of opening material is drawn by filling member, and be incorporated into the cavity of flask for medicinal preparations; And

(e) at least one moves relative to another with 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 embodiments, 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, and 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 by syringe is connected on the flask for medicinal preparations, the pusher of mobile 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, so that syringe is connected on the flask for medicinal preparations, the 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 by check valve then, as 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, as 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 embodied.

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, its releasable syringe that is used to open valve that is connected, by syringe is connected 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 by the pusher on the injector-actuated, otherwise, by 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 thereon, is used for extracting material by the flask for medicinal preparations cavity and being injected in the syringe by 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 to extract material from flask for medicinal preparations;

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 enters 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, extracting material via valve module from flask for medicinal preparations, 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 thereon;

Figure 29 is the partial cutaway schematic of the flask for medicinal preparations assembly of Figure 27, provides syringe further connection and frangible bonded assembly fragmentation thereon;

Figure 30 is the partial cutaway schematic of the flask for medicinal preparations assembly of Figure 27, provides material and extracts from the flask for medicinal preparations cavity 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 byReference numeral 10 representatives.Flask formedicinal preparations 10 comprises that amain 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 avalve seat 18 and a flexible valve member 20.Main body 12 hascavity 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 andvalve seat 18 tight joint, between the two, form fluid-tight, and seal up the material of thecavity 20 the insides institute splendid attire in the flask for medicinal preparations, in the release position, movement ofvalve parts 20 make it to be separated withvalve seat 18, between them, form opening, then, form material, material is introducedcavity 22 and dispensable materials therefrom through valve module.

Cap assemblies 14 comprises a jack (hub) 24, and portion limits an axially extendedpassage 26 within it, to receiveflexible valve member 20 and thevalve seat 18 of surface formation within it.Flask for medicinalpreparations installation surface 28 is formed on the circumference ofjack 24, and as described below, is suitable for the mounting portion of threads engage syringe, and flask for medicinal preparations and syringe are coupled together (Figure 10).Flexible valve member 20 29 has firstannular seal surface 30 at an upper portion thereof, and it forms fluid-tight between the two in detent position engage valve seat 18.Flexible valve member 20 further has theannular projection 32 of a projection, and it is placed in theannular groove 34 that is formed at accordingly in thevalve seat 18, remains on the detent position valve member is releasable.Flexible valve member 20 also comprises secondannular seal surface 36, and it is firstannular seal surface 30 axially spaced-aparts relatively, and is sealably coupled to and is formed on accordingly on thejack 24 in-to-in annular seal surface 38.Can see that the diameter of second annular seal surface 38 (or width) is bigger than firstannular seal surface 30, when being positioned at the release position, between valve member and valve seat, form the passage of an opening.

Valvemember 20 further limits abase portion 40, and it comprises theperipheral flange 42 of the outward flange tight joint of andmain body 12, and the inwall tight joint of andmain body 12, between the two, to form theannular seal surface 44 of fluid-tight.If desired,annular seal surface 44 can comprise some circumferential ribs, so that form fluid-tight.Thebase portion 40 ofvalve member 20 further has aMonolithic spring 48, and it can makeflexible valve member 20 move axially between sealing and release position, makes the valve member bias voltage enter detent position usually.In exemplary embodiment,spring 48 comprises the approximate arch or thehemispheric part 50 that are formed at the bottom, and an axially extended hollow betweenarcuate part 50 andannular seal surface 30 and 36 be roughly columniform part 52.Joint atarcuate part 50 andcylindrical part 52 has ahole 54 to passflexible 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 thehole 54 of required any amount, the flow hole can be taked any different structure, for example, is to reach the required flow of material that enters and/or flow out the cavity of flask for medicinal preparations.

Flexible valve member 20 can have a large amount of ribs orother protrusion 56 in its outer end, its relative to each other spaced radial to engage filling member (Fig. 9), as described below, with movement of valve parts between release position and detent position, material is flowed between filling member and valve member, and be convenient to flow of liquid and enter syringe through valve member.As shown in the figure, in current preferred embodiment, be not always to need rib 50.And, in certain embodiments, to remove rib in the N/R place, enter into flask for medicinal preparations with the liquid of realizing having certain flow and other material or by the filling member valve of flowing through, or enter into syringe from the flask for medicinal preparations valve of flowing through.

Flexible valve member 20 be preferably by can making with the flexible polymer material of the material compatibility of institute's splendid attire in the flask for medicinal preparations, and appropriate physical properties occurs, can preserve material, realizes the function of said valve member here.In one embodiment of the invention, the thermoplastic material can be the compound of first kind of material and second kind of material, first kind of material is preferably styrene block copolymer, as the material of being sold with KRATON or DYNAFLEX trade mark, second kind of material is preferably paraffin, for example is the material of being sold with ENGAGE or EXACT trade mark.In one embodiment of the invention, first kind of material and second kind of material mix in 50: 50 scope, amount to into weight and are about 90: 10 (as, first kind of material: second kind of material).Above-mentioned mixing is compared with first kind of material self, and benefit is to have improved the barrier propterty of water or aqueous vapor, thereby has improved the pot-life of product; Reduced friction coefficient; Plasticity or mold flow velocity have been promoted; Reduce hysteretic loss.Interchangeable,flexible valve member 20 can be made of KRATON itself or a kind of polysulphide rubbers.Those of ordinary skill in the related art just can know according to the instruction of being carried out here, the compound of these materials and material is exemplary, any at present known to or the different material that in the future can know, can realize the flexible valve member identical function or the compound of material can use.

Cap assemblies 14 comprises acircumferential flange 58 that lid can be fastened on the main body, and it is laid on the inside face of theannular surface 60 that is embedded in the projection in the main body corresponding annular groove 64.Can see that the surperficial inclined-plane that a curve is arranged ofannular surface 60 can make theflange 58 of lid axially slide into the open end of flask for medicinal preparations main body, and tip in 62, so that lid is fastened on the main body within it.Same as given, thecircumferential flange 42 offlexible valve member 20 is pressed betweenlid 14 and themain body 12, forms fluid-tight between the two.

Flask formedicinal preparations assembly 10 also comprises aprotective case 64, protective case for example be by binder, ultra-sonic welded, buckle or any at present known to or in the future known to realize being anchored on the fastening mechanism of this function on the flange ofcap assemblies 14 and/or main body 12.Cover 64 has ahole 68 on thewall 66 thereon, enters into valve member so therefrom pass with groove.Mainly illustrate as Fig. 6, preferred, fill in it behind institute's splendid attire material being about to flask for medicinal preparations, releasablely onupper wall 66 fix one and can prevent the disorderly sealingmember 70 of pendulum, disorderly put in transportation and the storage process preventing.Can prevent disorderly the sealingmember 70 of pendulum can take any at present and the device of this function of realization in the future, for example be the sheet metal that there is glue at the back side on the releasableupper wall 66 that is fixed on cover.

As shown in Figure 9, in the operation of flask formedicinal preparations 10, by moving axially fillingmember 72, to engaging withrib 56 on the outside face offlexible valve member 20, 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 moveinward valve member 20, the top 29 of valve member axially is pressed in thebase portion 40, andarch spring section 50 side direction outwards move like this, and the hollow circuit cylinder section axial inwardly and 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, forms valve opening 74 (Fig. 9) between the two.On the release position, to release as arrow among Fig. 9, material can flow out from fillingmember 72, thevalve opening 74 of flowing through, thehole 54 on thevalve member 20 of flowing through, and enter in thecavity 22 ofmain body 12.

Fillingmember 72 can take at present and in the future known to any dissimilar filling member of function that being used to realize filling member disclosed herein.For example, filling member can have in one or more cavitys that simultaneously material are incorporated into flask for medicinal preparations by filling member and the stream of extracting gases therefrom.In this example, filling member is connected and is used for producing attractive force and via the vacuum source of stream from the cavity extracting gases in stream.As shown in Figure 9, fillingmember 72 drivings are connected on thedriver element 75, make it to engage withvalve member 20 or separate with mobile fillingmember.Filling member 72 also with the substance source 76 that is incorporated into the material 78 in the flask for medicinal preparations by 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 pump in the flask for medicinal preparations withmaterial 78 by fillingmember.Filling member 78 has a conduit that is used for material is therefrom passed introducing, and one is used for covering 82 with theinstallation surface 28 contacted peripheries of flask for medicinal preparations.

Cavity 22 is filled to required liquid when high, moves axially fillingmember 72, make it away fromvalve member 20 withdriver element 75, then,spring 48 is outside driving valve parts axially, and hydrodynamicreciprocating sealing surface 30 and 36 makes it respectively and the corresponding surface ofvalve seat 18 and 38 sealed engagement.Theannular surface 32 of valve member projection is placed invalve seat 18 corresponding grooves, and thenvalve member 20 just is anchored on the detent position by releasable.

An advantage of exemplary embodiment of the present is, thespring 48 that is roughly arch or spill produces a large amount of elastic force, makevalve member 20 move to detent position, make the sealing surfaces of valve member and valve base sealing connect to be incorporated in and form fluid-tight between the two by the release position.Those skilled in the art are according to lecturing as can be known here, theelastic part 48 ofvalve member 20 can be taked any shape not of the same race and/or structure, can by known at present or can know in the future, be used to realize make as 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 elastic force on the valve member with control.Yet the advantage that is roughly arch configuration is that arch, is convenient to keep its fluid-tight atcontainer 10 in whole pot-life and use 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 finished 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), and the lamella air flow source provides the windstream of the filtration/sterilization that is roughly lamella shape to flask for medicinal preparations in flask for medicinal preparations filling and/or transportation.In currently preferred embodiment of the present invention, aseptic fill assembly is applicable to filling medicament bottle, syringe or other splendid attire medicine, for example distributing box of vaccine or pharmaceutical products.Yet those skilled in the art are according to lecturing as can be known here, and 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 according to lecturing as can be known here, feed unit can take any kind at present known to or the device of the function that in the future can know, be used to realize feed unit 86, the for example vibration feed unit of any different types, or " pick up and put " (pick and place) robot system.

Before settling flask for medicinal preparations or other container on thefeed unit 86, preferably airtight container (as tool lid flask for medicinal preparations and sealing valve member thereon) is carried out disinfection, as by container is exposed to gamma radiation in 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 " method of transfer port and transmission sterile product ", flask for medicinal preparations assembly or other leak free empty receptacle can be sealed, be 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 by 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 take any kind at present known to or the dissimilar ray that in the future can know, realize this function, as gamma radiation, electron ray and/or laser beam.

Engage a forwarder 90 on thefeed 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 take any not of the same race at present known to or the connecting gear that in the future can know, realize the function of forwarder described here.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 are at ad-hoc locations reception of forwarder or the container of support flask for medicinal preparations, as clamping plate.Forwarder drives and is connected in motor or other suitable drive source (not shown), and it can be started, be 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 take any dissimilar at present known to or the electron source that in the future can know, realize electron source function described here.The electron ray ray is a kind of ion energy, 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 the valve member 20 of flask for medicinal preparations or cap assemblies and jack 24.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 in conjunction with 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 in 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 of U section has an inlet part and electron ray radiation cavity part thereon.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, so that valve member 20 is being exposed 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 only are 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 ") as applicable sterilization.

The fillingmember 84 of sterilization also preferably has the device thatplatform 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 carried out these special devices only are exemplary here, any dissimilar at present known to or can know in the future, realize that the device that the permission visible light passes 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 described 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 installing each other in straight line, 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 (as described in Figure 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 with any different at present known to or can know in the future, realize that the mode of the function of filling platform described here installs or drive.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 mentioned above, so make up electron ray and fill platform, like this, fillingmember 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 is in conjunction with the operation of electron ray with the air sterillization of whole electron ray cavity, and acting on is that filling member is sterilized, 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, the air ionization in the electron ray cavity to promote the propagation of free electron, fillingplatform 84 aseptics further can have been strengthened.And, found in the aseptic filling machine as a lot of prior aries that feature of the present invention does not need insulator.

Electron source 88 in the electron ray cavity and other application components, transmission system and fill assembly can and the patent application of following pending trial in disclosed content same or similar, U. S. application No.10/600,525, name is called " having the aseptic filling machine that pin is filled platform in the electron ray cavity "; The U.S. Provisional Application No.60/518 of application on November 7th, 2003,267, name is called " pin is filled and the package sealing with laser platform "; The U.S. Provisional Application No.60/518 of application on November 10th, 2003,685, name is called " pin is filled and the package sealing with laser platform ", and each application transfers the application's cessionary, and its content quotation is at this for your guidance.

In one embodiment of the invention, as shown in Figure 9, aseptic fill assembly comprises a lamellaair flow source 92 known to the those of ordinary skill in the related art, in order in filling process, provides the filtration/sterile air stream of lamella shape above flask for medicinal preparations or other containers.In the application of filling medicament bottle assembly, lamellaair flow source 92 is especially favourable in shown in figure 32 not in the electron ray cavity.

Shown in Fig. 9 A, aseptic fill assembly can comprise one or moreadditional stations 79 of fillingplatform 77 downstreams that are positioned at.Additional stations 79 can comprise a freeze-drying platform, as described below, the visible system that is used to check each valve seal of the type known to a kind of those of ordinary skill in the related art, 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 by the level detection inspection, or, flask for medicinal preparations or other containers that detects pulled out from forwarder because label has labeled wrong or do not posted.Then, with the discharginggear 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 as can be known any other the device of function that is used to realize said these devices here in the future.

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, fills medicine or other materials exactly after container being exposed to γ light or the radiation of direct electron bundle, thereby prevents that radiation will be to being contained in the medicine in the container or the degraded of other mass transfer.

In order to extract material in flask for medicinal preparations, as 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 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 in the negative thread of syringe, with being connected on the syringe that flask for medicinal preparations easily unclamps.Like this, conversely, make the open end 98 axial combinations of syringe, and push the projection 56 that is formed on the valve member 20, as 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 by 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 disconnected.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's instruction by here as can be known, the connector part of flask for medicinal preparations and/or syringe can take any different known today or day in the future as can be known be 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 different types 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 using 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 formedicinal preparations assembly 110 and foregoing flask formedicinal 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 formedicinal preparations assembly 110 and flask formedicinal preparations assembly 10 major different are, the shape ofvalve member 120 and valve member are installed on the jack (hub) 124 ofcap 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 thevalve member 120 or in the recessedjack 124 of exposed surface, the sealing surfaces 118 of valve seat with 138 and corresponding sealing surfaces 130 different with foregoing individual features shape respectively with 136.With with the front in conjunction with the identical mode of the described flask for medicinal preparations of Fig. 9 and9A 10 to flask formedicinal preparations 110 medicines or other materials.

Figure 14 illustrates, and theopen end 198 of syringe 194 is connected byfemale connection device 196 spirals on theinstallation surface 128 ofcap assemblies 114, is connected in syringe with what flask for medicinal preparations easily unclamped.Like this, conversely, make theopen end 198 axial combinations of syringe, and push and be formed atvalve 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 thepusher 200 of syringe 194, causes vacuum, the material in the flask formedicinal preparations cavity 122 is drawn in the cavity of syringe 194 by valve opening 174.By removing volume required material in the flask formedicinal preparations cavity 122, then flask for medicinal preparations and syringe are rotated relative to each other, syringe 194 and flask for medicinal preparations are disconnected.After flask formedicinal preparations 110 removed from syringe 194,valve member 120 returned detent position, but and the surplus materials in the tight seal flask formedicinal 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 a flange 324 that extends downwards, 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 in 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.As shown in figure 15, spring section 350 enters into detent position with valve member 320 bias voltages usually, as shown in figure 16, 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 mentioned above, taking advantage of a situation axially extends internally, and then valve 374 is opened.

Valve member 320 also comprises acircumferential sealing surface 330 of combining closely withvalve seat 310, and sealingmember 316, sealing member is positioned at the inboard ofvalve seat 318, and limit a circumferential surface, circumferential surface is combined closely with thesurface 338 that is formed on thejack 314 accordingly, further to realize fluid-tight in its closedposition.Valve member 320 further limits an axiallyextended passage 337 that is formed at its base portion, it is at the opening 374 (Figure 16) of valve and extend through that fluid engages communicatively between theliquid flow hole 354 ofspring section 350, and liquid flow hole can make the fluid stream valve of flowing through shown in arrow among Figure 16.Can be in the identical mode of foregoing and flask formedicinal preparations assembly 10, fillingmedicament bottle assembly 310 in aseptic fill assembly can be extracted fluid out and is injected in the syringe from flask for medicinal preparations.

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.As 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 made by elastic material.Same in current preferred embodiment, valve portion 439 and valve seat 441 form an interference fit, further realize fluid-tight.As shown in figure 18, the filling of flask for medicinal preparations assembly 410 is by 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 to extract materials out in flask formedicinal preparations cavity 422, valve member mutually will be to firm, and have one to make the therefromfluid passage 437 of process of material.Shown in Figure 19 and 20,flange 428 screw joint of thescrew thread coupling 496 ofsyringe 494 andjack 424 are with theend 498push valve parts 420 with syringe.Conversely, sealingmember 436 is axially moved inward and, then valve is opened, flow of material is therefrom passed through away from valve seat.As shown in figure 21, material can flow out from theinner chamber 422 of flask for medicinal preparations, passes through axially extendedopenings 454 in thebellows 450, and passes thestream 437 of valve, enters the inner chamber of syringe.Behind flask for medicinal preparations disconnection syringe, bellows 450return 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 use 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 made by elastic material.Same in current preferred embodiment, valve portion 539 and valve seat 541 form an interference fit, further realize fluid-tight.As shown in figure 25, bring in filling medicament bottle assembly 510 by 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 known today, or day as can be known arbitrary difformity and/or structure 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, 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.As 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 by 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.As 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 disconnect, 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 of entering into that is used for to flask for medicinal preparations assembly 610 weighting substances 678.As 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 portions that cover 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 made by elastic material.Same in current preferred embodiment, valve portion 639 and valve seat 641 form an interference fit, further realize fluid-tight.As shown in figure 27, the filling of flask for medicinal preparations assembly 610 is by 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.

By a connection of easily unloading 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 of easily unloading is designed to, and when applying enough axial forces in the outer end to rigid valve parts 620, rigid valve parts 620 is broken, to pipette material in flask for medicinal preparations.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 by spiral.When being connected to syringe 694 spirals on the jack 624, 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 fully with flask for medicinal preparations, be applied to the connection 647 that the power on the valve member 620 just enough fractures and easily unloads, conversely, valve member 620 is handled from covering to discharge 614, and sent in the cavity 622 of flask for medicinal preparations.As 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 disconnect, and the pin (not shown) are connected on the adaptor union 696 of syringe, think patient infusion.Empty flask for medicinal preparations 610 can be abandoned then.

In Figure 31,Reference numeral 710 representative usually embodies another flask for medicinal preparations assembly of the present invention.Flask formedicinal preparations assembly 710 and foregoing flask formedicinal preparations assembly 610 are similar, therefore identical Reference numeral front add numeral " 7, replace " 6 ", be used for representing identical parts.Flask formedicinal preparations assembly 710 and flask formedicinal preparations assembly 610 major different are the structure of valve module and being connected of easily unloading.As given,valve seat 741 is made of the axiallyextended flange 725 of lid 714.Flange 725 has the axiallyextended hole 743 that therefrom passes.Rigid valve parts 720 are placed in thehole 743, and therigid valve parts 720 in thefixedly hole 743 that sealing/attachingparts 747 can discharge form fluid-tight between the two again.Rigid valve parts 720 can be taked any different known today or days as can be known packing ring or other sealing members of being used to realize said sealing/attaching parts function here in thefuture.Flange 725 has thelid 749 of an annular, and the link stopper of sealing/attachingparts 747 is installed when it is used as the rigid valve parts of assigning roughly the same inhole 743.

For fillingmedicament bottle assembly 710, open valve with enough pressure,material 578 is introduced passedvalve inlet 735, make flow of material through valve, and enter into the inner chamber 722 of flask for medicinal preparations.Then, in order to extract material from the flask for medicinal preparations assembly, theflange 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 pushesrigid valve parts 720 and pass hole 743.When syringe was connected fully with flask for medicinal preparations,rigid valve parts 720 were subjected to the power of inwardly enough distances, make sealing/attachingparts 747 pass the inner ofhole 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 disconnect, and the pin (not shown) are connected on the adaptor union of syringe, think patient infusion.Empty flask formedicinal preparations 710 can 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 by 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 vacuum cavity known to the person of ordinary skill in the relevant.In one embodiment of the invention, the freeze-drying platform is one and is arranged in Fig. 9 and fills 79 of platform 77 downstreams.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 known at present or the arbitrary different freeze-drying process that in the future can know 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, syringe can 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's instruction by here can be carried out various improvement to described above or other embodiments of the invention, and not depart from claim institute restricted portion as can be known.For example, the parts of flask for medicinal preparations can by any different known today or days in the future as can be known be used to realize that the material of various functions of components makes.Valve module can be taked any different known today or days as can be known structure of function that is used to realize different valve modules described here in the future.Equally, flask for medicinal preparations can adopt any different known today or days as can be known shape and structure 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 be filled in the fill assembly, this fill assembly comprise with substance source with fluid mode of communicating bonded assembly filling member, be used for material is introduced described device, described 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 in the mode that fluid is communicated with, material is incorporated in the cavity by valve module, wherein valve module comprises axially extended valve seat, and be stacked in flexible valve member on the valve seat, flexible valve member and valve seat have formed the normally closed interface that limits their fluid-tight between the two, and in response at the interface that under the enough pressure material is incorporated into from filling member between valve member and valve seat, flexible valve member is outwardly-bent with respect to valve seat, to open valve module and to allow material to enter cavity by 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 valve member and valve seat form normally closed circumferential seam at the interface, therefrom pass through under enough pressure to allow 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 removable entering and the engaging of valve module, so that material is incorporated into the cavity by valve module from tubular pipeline.

10. device as claimed in claim 1, wherein axially extended valve seat and flexible valve bonnet form access valve, so that material is incorporated in the cavity by access valve, and valve module also comprise normally closed 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, 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;

By 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 with material from filling member is incorporated into interface between valve member and the valve seat so that valve member is outwardly-bent with respect to valve seat, subsequently, make flow of material cross the interface between valve member and the valve seat and flow in the cavity;

Stop material from the interface between filling member inflow 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; 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 with the device sterilization of leak free sky.

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, wherein the step that the device of leak free sky is radiated comprises with in gamma radiation, electron ray and the laser beam at least one device is implemented radiation.

16. method as claimed in claim 12, also comprise the steps: to provide device with valve module, wherein axially extended valve seat and flexible valve bonnet form access valve, so that material is incorporated in the cavity by access valve, and valve module also comprise normally closed outlet valve and form cavity and ambient atmosphere between fluid-tight; And come dispensable materials by 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 by 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.

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