Patent Grant
7490453
The present invention relates to apparatus and methods for molding container assemblies having containers and stoppers for sealing openings in the containers, such as containers having polymeric stoppers that are needle penetrable for filling the closed container with a substance therethrough and that are laser resealable for laser resealing the needle penetrated region of the stopper, and more particularly, to apparatus and methods for molding, de-molding and assembling such containers and stoppers under aseptic conditions.
A typical aseptically filled container assembly, such as container assemblies for storing and dispensing medicaments, for example, vaccines and pharmaceuticals, or foods and beverages, such as liquid nutrition products, includes a container or container body defining a storage chamber, a fill opening in fluid communication with the container or container body, and a stopper or cap for sealing the fill opening after filling the storage chamber to hermetically seal the medicament, food, beverage or other substance within the container. In order to fill such prior art containers with a sterile fluid or other substance, it is typically necessary to sterilize the unassembled components of the dispenser or container, such as by autoclaving the components and/or exposing the components to gamma radiation. The sterilized components then must be filled and assembled in an aseptic isolator of a sterile filling machine. In some cases, the sterilized components are contained within multiple sealed bags or other sterile enclosures for transportation to the sterile filling machine. In other cases, the sterilization equipment is located at the entry to the sterile filling machine. In a filling machine of this type, every component is transferred sterile into the isolator, the storage chamber of the container is filled with the fluid or other substance, the sterilized stopper is assembled to the container to plug the fill opening and hermetically seal the fluid or other substance in the container, and then a crimping ring or other locking member is assembled to the container to secure the stopper thereto.
One of the drawbacks associated with such prior art container assemblies, and the processes and equipment for filling such container assemblies, is that the filling process is time consuming, and the processes and equipment are expensive. Further, the relatively complex nature of the filling processes and equipment can lead to more defectively filled containers than otherwise desired. For example, typically there are at least as many sources of failure as there are components. In many cases, there are complex assembly machines for assembling the containers that are located within the aseptic area of the filling machine that must be maintained sterile. This type of machinery can be a significant source of unwanted particles. Further, such isolators are required to maintain sterile air within a barrier enclosure. In closed barrier systems, convection flow is inevitable and thus laminar flow, or substantially laminar flow, cannot be achieved. When operation of an isolator is stopped, a media fill test may have to be performed which can last for several, if not many days, and can lead to repeated interruptions and significant reductions in production output for the pharmaceutical, nutritional or other product manufacturer that is using the equipment. In order to address such production issues, government-imposed regulations are becoming increasingly sophisticated and are further increasing the cost of already-expensive isolators and like filling equipment. On the other hand, governmental price controls and marketplace competition for pharmaceuticals and vaccines, including, for example, preventative medicines, and other aseptically filled products, such as liquid nutrition products, discourage such major fmancial investments. Accordingly, there is a concern that fewer companies will be able to afford such increasing levels of investment in sterile filling machines, thus further reducing competition in the pharmaceutical, vaccine, and nutritional product marketplaces.
Some prior art sterile filling machines and processes employ gamma radiation to sterilize the container components prior to filling and/or to terminally sterilize the containers after filling in cases where the product is believed to be gamma-radiation stable. One of the drawbacks of gamma sterilization is that it can damage or otherwise negatively affect the parts to be sterilized, such as by discoloring parts formed of plastic and other gamma-sensitive materials. In addition, if used to terminally sterilize filled containers, gamma radiation can damage the product stored within the container. Accordingly, gamma sterilization has limited applicability, and further, is not always a desirable form of sterilization for many types of products with which it is used.
Other prior art filling machines and processes employ fluid disinfectants or sterilizing agents or sterilants to sterilize the surfaces of the containers that will come into contact with the substance to be stored therein, such as foods or beverages. One such commonly used sterilant is vaporized hydrogen peroxide. In some such prior art filling machines and processes, the containers and stoppers for initially sterilized with a fluid sterilant, such as vaporized hydrogen peroxide, and the open containers are then filled with the product to be contained therein, such as a food or beverage, and then the stoppers or caps are applied to the containers to seal the product within the container. One of the drawbacks of such prior art filling machines and processes is that the fluid sterilant, such as vaporized hydrogen peroxide, necessarily must contact and sterilize the interior surfaces of the containers. As a result, the interiors of the containers, and thus the products filled in the containers can contain vaporized hydrogen peroxide residue. This, in turn, can lead to peroxidation or the formation of free radicals that can alter or otherwise degrade the product formulation during its shelf life, or otherwise can degrade the taste or other qualities of the product in the container.
Accordingly, it is an object of the present invention to overcome one or more of the above described drawbacks and disadvantages of the prior art.
In accordance with a first aspect, the present invention is directed to an apparatus for molding and filling a container having a container body defining an opening in communication with an interior chamber for receiving a substance therein, and a stopper receivable within the opening for sealing the opening and substance received in the container. The apparatus comprises at least one barrier enclosure defining at least one aseptic chamber. The apparatus further comprises at least one mold including within an aseptic chamber at least one first mold cavity shaped to form at least one of the stopper and container body, and at least one first substantially sterile surface extending about the at least one first mold cavity. At least one tool of the apparatus is located within an aseptic chamber and includes an engaging portion engageable with a container body and/or a stopper located within the at least one first mold cavity. At least one of the first mold cavity and tool is movable relative to the other for engaging and de-molding a substantially sterile stopper and/or container body from the at least one first mold cavity. At least one source of sterile air of the apparatus is in fluid communication with the at least one aseptic chamber, and directs a flow of sterile air into the aseptic chamber and over the first sterile surface of the mold for maintaining the sterility of the mold surface and of the stopper and container body during de-molding thereof. A least one first flexible barrier is coupled to the mold between the at least one first sterile surface and a molding machine to substantially prevent the passage of contaminants from the molding machine therethrough. At least one second flexible barrier is coupled to the tool between the at least one engaging portion and a base portion of the tool to substantially prevent the passage of contaminants from the base portion of the tool therethrough. A needle filling and thermal resealing station of the apparatus is configured to receive a sealed, empty sterile container, and includes (i) at least one needle that is movable between a first position for penetrating the stopper and introducing a substance from the needle therethrough and into the interior chamber of the container body, and a second position spaced away from the stopper; and (ii) a thermal source for thermally sealing a needle penetrated region of the stopper upon withdrawal of the needle therefrom.
In one embodiment of the present invention, the mold includes within the aseptic chamber at least one first mold cavity shaped to form the container body, at least one second mold cavity shaped to form the stopper, at least one first substantially sterile surface extending about the first mold cavity, at least one second substantially sterile surface extending about the at least one second mold cavity, and two first flexible barriers. One of the first flexible barriers is coupled to the mold between the at least one first sterile surface and a respective molding machine to substantially prevent the passage of contaminants from the molding machine therethrough. The other first flexible barrier is coupled to the mold between the at least one second sterile surface and a respective molding machine to substantially prevent the passage of contaminants from the molding machine therethrough.
In one embodiment of the present invention, the mold includes a first mold portion and a second mold portion. The first mold portion defines a first sterile surface, the second mold portion defines a second sterile surface, and at least one of the first mold portion is movable relative to the second mold portion between a closed position for molding at least one of the container body and stopper, and an open position with the first and second sterile surfaces spaced relative to each other and defining a portion of the aseptic chamber therebetween. Preferably, the first sterile surface extends about a periphery of the first mold cavity, and the second sterile surface extends about a periphery of the second mold cavity. In one embodiment of the present invention, the apparatus further comprises at least one third substantially sterile surface extending about a periphery of the engaging portion of the tool.
In one embodiment, each of the first, second and third substantially sterile surfaces are defined by respective heated surfaces formed, for example, of a ceramic. In these embodiments, the apparatus preferably further comprises at least one heating source thermally coupled to each heated surface. The apparatus also preferably further comprises at least one temperature sensor operatively coupled to the at least one heating source and adapted to sense the temperature of the heated surface(s). The at least one heating source is responsive to the at least temperature sensor to control the temperature of the heated surface(s).
In one embodiment of the present invention, the apparatus further comprises at least one assembly device including the at least one tool, wherein the at least one assembly device and tool are configured to (i) de-mold a substantially sterile stopper from at least one first mold cavity, (ii) de-mold a substantially sterile container body from at least one first mold cavity, (iii) assemble within at least one aseptic chamber the substantially sterile stopper and container body into a sterile, sealed empty container, and (iv) transfer the sterile, sealed empty container to at least one of a transfer station and the needle filling and thermal resealing station for needle filling with a substance and thermally resealing the filled container. In one embodiment of the invention, the tool includes at least one vacuum port in fluid communication with the engaging portion for drawing a vacuum through the port and, in turn, releasably securing at least one of a substantially sterile stopper and container body thereto.
In accordance with another aspect, the present invention is directed to an apparatus for molding and filling a container having a container body defining an opening in communication with an interior chamber for receiving a substance therein, and a stopper receivable within the opening for sealing the opening and substance received in the container. The apparatus comprises first means for forming at least one enclosed aseptic chamber; second means located within at least one aseptic chamber and defining at least one mold cavity for forming at least one of the stopper and container body; and third means for forming at least one first substantially sterile region extending about the at least one first mold cavity. The apparatus further comprises fourth means located within at least one aseptic chamber and movable relative to the third means for engaging and de-molding at least one of a substantially sterile stopper and container body from the at least one first mold cavity; and fifth means coupled in fluid communication with the at least one aseptic chamber, for directing a flow of sterile air into the aseptic chamber and over the third means and fourth means for maintaining the sterility of the stopper and container body during de-molding thereof. The apparatus further comprises sixth means for preventing the passage of contaminants from a molding machine therethrough and into the at least one aseptic chamber; seventh means for preventing the passage of contaminants from a base portion of the fourth means therethrough and into the aseptic chamber; and eighth means for receiving a sealed, empty sterile container, penetrating the stopper and introducing a substance therethrough and into the interior chamber of the container, and thermally resealing a penetrated region of the stopper.
In one embodiment, the first means is defined by at least one barrier enclosure; the second means is defined by at least one mold; the third means is defined by at least one sterile surface extending about a periphery of the least one mold cavity; the fourth means is defined by an end-of-arm tool including an engaging portion engageable with at least one of a container body and stopper; the fifth means is defined by at least one source of sterile air in fluid communication with the at least one aseptic chamber; the sixth means is defined by at least one flexible barrier; the seventh means is defined by at least one flexible barrier; and the eighth means is defined by a needle filling and thermal resealing station.
In accordance with another aspect, the present invention is directed to a method for molding and filling a container having a container body defining an opening in communication with an interior chamber for receiving a substance therein, and a stopper receivable within the opening for sealing the opening and substance received in the container, comprising the following steps:
In one embodiment, the method further comprises maintaining the at least one first surface of the mold extending about the first mold cavity substantially sterile by heating such surface(s) to a temperature sufficient to destroy substantially any germs thereon.
In another embodiment, the method further comprises the step of assembling with the tool within at least one aseptic chamber the substantially sterile stopper and container body into a sealed, empty sterile container, and transferring with the tool the container to at least one of a transfer station and a needle filling and thermal resealing station.
One advantage of the present invention is that the container bodies and stoppers are sterile at the time of formation due to the heat of the molten plastic used to form the parts, the introduction of the molten plastic into the mold cavity spaces thermally sterilizes the surfaces that contacts the plastic, or at least maintains such surfaces sterile, and thus the surfaces of the container parts are maintained sterile within the mold at the time of formation. Another advantage of the present invention is that when the mold is moved into the open position to allow de-molding of the sterile parts, the mold surfaces extending about the container parts (or mold cavities) are maintained sterile, and the space between the opposing surfaces of the open mold is maintained sterile by the flow of sterile gas therethrough. Yet another advantage is that the flexible barriers further substantially prevent any contaminants from entering the sterile space that otherwise might enter such space from the molding machine or base portion of the tool or related assembly device. A still further advantage is that when the tool engages and de-molds the container parts, the sterile gas flows over the tool and container parts to further maintain their sterility during de-molding. If desired, the tool can be used to assemble the container bodies and stoppers within the aseptic enclosure into sealed, empty sterile containers. Then, the sealed, empty sterile containers can be aseptically needle filled, and laser resealed. Accordingly, the apparatus and method of the invention can obviate the need for an isolator, the need to use gamma radiation to sterilize the container parts, or the need to terminally sterilize the filled containers, thus avoiding the related problems encountered in the prior art.
Other advantages of the present invention will become more readily apparent in view of the following detailed description of the currently preferred embodiment and accompanying drawings.
In
An assembly device 24 is located adjacent to the first and second mold portions 12 and 14, respectively, and is movable relative thereto for assembling the substantially sterile stopper 22 formed within the second mold cavity 20 and the container body 18 formed within the first mold cavity 16 into a sterile or aseptic, sealed container and stopper assembly or “container” 26.
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A container transfer station 34 is mounted within the barrier enclosure 30 for collecting therein the sealed containers 26. The sealed containers 26 then may be packaged, such as in trays or boxes, which in turn may be packaged in one or more bags (such as double or triple bags) in a manner known to those of ordinary skill in the pertinent art. Alternatively, the sealed containers 26 may be fed directly from the transfer station 34 into a needle filling and thermal resealing station 36. The needle filling and thermal resealing station 36 may be located within the same barrier enclosure 30 (or aseptic chamber 32) as the mold portions 12, 14 and assembly device 24, or may be located within a separate barrier enclosure and aseptic chamber (not shown), and if desired, the separate barrier enclosure may be connected to the first aseptic chamber 32 in order to transfer the sealed containers 26 thereto.
The assembly device 24 is located adjacent to the first and second mold portions 12 and 14, respectively, and is movable relative thereto for assembling the molded substantially sterile stoppers 22 and containers 18 into sterile or aseptic, sealed containers 26. The assembly device 24 may take the form of a robot including, for example, a base that extends upwardly from a mounting flange, a first robotic arm that is pivotally driven on the base, and a second robotic arm that is pivotally driven on top of the first robotic arm. Both robotic arms are pivotally driven within the X and Y coordinate plane. The robot preferably further includes a z-drive that is drivingly mounted on the second robotic arm and drivable in the z-axis. In one embodiment, the robot is a “SCARA” robot sold by Epson Corporation under the model designation “E2S SCARA”, such as one of the “E2S clean robots” that is clean room capable (class 10 clean room, for example). One such model is sold by Epson under the model number “E2S451C”. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, these robots are only exemplary, and the assembly device may take the form of any of numerous different robots or other assembly devices that are currently known or that later become known for performing the function of the assembly device 24 as described herein. In addition, the apparatus and/or method of the present invention may employ more than one robot or other assembly device to perform the functions performed by the assembly device 24 and/or to perform additional functions.
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In the illustrated embodiment of the present invention, the apparatus 10 further comprises at least one heating source thermally coupled to the first, second and third sterile surfaces for heating each such surface to a temperature sufficient to destroy substantially any germs or other contaminants located thereon. In one embodiment of the present invention, the at least one heating source is an electric resistance heater. In this embodiment, the apparatus includes first electric resistance heaters 50 imbedded in, fixedly secured to, or otherwise thermally coupled to the first sterile surfaces 40, 42 (
The apparatus 10 further comprises a plurality of temperature sensors 52 operatively coupled to each heating source and adapted to sense the temperature of the respective sterile surface(s). Each heating source is responsive to signals transmitted by the respective temperature sensor 52 to control the temperature of the respective sterile surface(s). In the illustrated embodiment, each of the first, second and third sterile surfaces is heated to a temperature sufficient to sterilize the respective surface and thereby prevent contamination of at least the interior surfaces of the container bodies and stoppers. In one embodiment of the present invention, each of the first, second and third sterile surfaces is heated to a temperature of at least about 80° C., and more preferably, each of the first, second and third sterile surfaces is heated to a temperature within the range of about 80° C. through about 180° C.
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In
The needle filling and thermal resealing station 36 includes on its inlet end an inlet transfer station 66 through which the conveyor 60 passes for transferring the containers 26 mounted on the conveyor 60 into the sterile zone 64. A sterilizing station 68 is located within the housing 62 immediately downstream of the inlet transfer station 66 in the direction of conveyor movement (clockwise in
The over pressure of sterile air or other gas is provided by a sterile gas source 88 including one or more suitable filters, such as HEPA filters, for sterilizing the air or other gas prior to introducing same into the sterile zone 64. A fluid conduit 90 is coupled in fluid communication between the sterile air source 88 and the sterile zone 64 for directing the sterile air into the sterile zone. The apparatus 58 includes one or more vacuum pumps or other vacuum sources (not shown) mounted within a base support 87 of the apparatus and of a type known to those of ordinary skill in the pertinent art. The vacuum source(s) are coupled in fluid communication with an exhaust manifold at the inlet transfer station 66 and an exhaust manifold at the exit transfer station 86 for drawing the air and fluid sterilant out of the sterile zone 64 and exhausting same through a catalytic converter 92 and exhaust conduit 94. The catalytic converter 92 is of a type known to those of ordinary skill in the pertinent art to break down the exhausted hydrogen peroxide into water and oxygen. In the illustrated embodiment, the exhaust manifolds are mounted at the base of the inlet and outlet stations and extend into the base support 87. As can be seen, the exhaust manifolds at the inlet and outlet stations 66 and 86, respectively, draw into the exhaust passageways located within the base support 87 (not shown) both sterile air and fluid sterilant from the sterile zone 64, and non-sterile ambient air located either within the inlet station or outlet station. As a result, any ambient non-sterile air (including any other ambient gases or contaminants) in the inlet and outlet stations are drawn into the exhaust manifolds, and thereby prevented from entering the sterile zone 64 to maintain the sterility of the sterile zone. Similarly, any sterile air or sterilant is substantially prevented from being re-circulated within the sterile zone, and instead, is drawn into the exhaust manifolds after passage over the containers and/or conveyor portion located within the sterile zone. If desired, one or more exhaust manifolds may be located at the base of the sterile zone (i.e., beneath the conveyor 60 or between the overlying and underlying portions of the conveyor 60) for fully exhausting the air and fluid sterilant and otherwise for avoiding the creation of any “dead” zones where air and/or fluid sterilant may undesirably collect. In one embodiment of the present invention, the flow of sterile air within the sterile zone 64 is controlled to cause the air to flow generally in the direction from right to left in
In the illustrated embodiment, the conveyor 60 includes a plurality of flights or like holding mechanisms 96 that clamp each container 26 at or below its neck finish (i.e., at the peripheral region immediately below the mouth or opening of the container body 18) or other desired container region. The flights 96 are pivotally mounted on a belt 98 defining a closed loop and rotatably mounted on rollers 100 located on opposite sides of the apparatus relative to each other. One or more drive motors and controls (not shown) may be mounted within the base support 87 and are coupled to one or both rollers 100 for rotatably driving the conveyor 60 and, in turn, controlling movement of the containers 10 through the apparatus in a manner known to those of ordinary skill in the pertinent art. Each flight 96 of the conveyor 60 includes a plurality of container-engaging recesses 102 laterally spaced relative to each other and configured for engaging the respective necks or other desired portions of the containers 26 to support the containers on the conveyor. Although the container-engaging recesses 102 are illustrated as being semi-circular in order to engage the containers 26, they equally may be formed in any of numerous different shapes that are currently known, or that later become known, in order to accommodate any desired container shape, or otherwise as desired. The flights 96 further define a plurality of vent apertures 104 that are laterally spaced relative to each other, and are formed between and adjacent to the container-engaging recesses 102. The vent apertures 104 are provided to allow the sterile air and fluid sterilant to flow over the portions of the containers 26 located above the flights 96 of the conveyor and, in turn, through the conveyor prior to being exhausted through the exhaust manifolds. In the illustrated embodiment, the vent apertures 104 are provided in the form of elongated slots; however, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the vent apertures may take any of numerous different configurations that are currently known, or that later become known. Preferably, the flights 96 laterally engage the neck portions of the containers 26, and effectively isolate the sterile portions of the containers above the flights from the portions of the containers located below the flights that may not be sterile, or that may include surface portions that are not sterile.
The conveyor 60 defines an inlet end 106 for receiving the containers 26 to be fed into the apparatus, and an outlet end 108 for removing the filled and laser resealed containers from the apparatus. As can be seen, the adjacent flights 96 located at the inlet and outlet ends 106 and 108, respectively, are pivoted relative to each other upon passage over the rollers 100 to thereby define a loading gap 110 at the inlet end of the conveyor and an unloading gap 112 at the outlet end of the conveyor. Accordingly, at the inlet end, the containers 26 may be fed on their sides into the loading gap 110 and received within the container-engaging recesses 102 of the respective flight 96. Then, as the conveyor 60 is rotated in the clockwise direction in
In the illustrated embodiment, each flight 96 of the conveyor is configured to hold four containers 26 spaced laterally relative to each other. Accordingly, in the illustrated embodiment, each sterilizing head 70 located within the sterilizing station 70 includes two sterilant manifolds 114, and four sterilizing nozzles 116 mounted on each sterilant manifold. Each sterilizing nozzle 116 is located over a respective container position on the conveyor to direct fluid sterilant onto the respective container. Similarly, each sterilant flushing head 76 located within the sterilant removing stations 72 and 74 includes two flushing manifolds 118, and each flushing manifold 118 includes four flushing nozzles 120. Each flushing nozzle 120 is located over a respective container position on the conveyor to direct heated sterile air or other gas onto the respective container to re-vaporize if necessary and flush away the fluid sterilant. In the illustrated embodiment, the conveyor 60 is indexed by two rows of containers (or flights) at a time, such that at any one time, two rows of containers are each being sterilized, needle filled, and laser resealed within the respective stations, and four rows of containers are being flushed within the two sterilant removing stations (i.e., the first sterilant removing station 72 applies a first flush, and the second sterilant removing station 74 applies a second flush to the same containers). When each such cycle is completed, the conveyor is indexed forward (or clockwise in
The needle filling station 78 comprises a needle manifold 122 including a plurality of needles 124 spaced relative to each other and movable relative to the flights 96 on the conveyor 60 for penetrating the stoppers 22 of a plurality of containers 26 mounted on the portion of the conveyor within the filling station, filling the containers through the needles, and withdrawing the needles from the filled containers. Each of the laser resealing stations 82 and 84 comprises a plurality of laser optic assemblies 126, and each laser optic assembly is located over a respective container position of the conveyor flights located within the respective laser resealing station. Each laser optic assembly is connectable to a source of laser radiation (not shown), and is focused substantially on a penetration spot on the stopper 22 of the respective container 26 for applying laser radiation thereto and resealing the respective needle aperture. Also in the illustrated embodiment, each laser resealing station 82 and 84 further comprises a plurality of optical sensors (not shown). Each optical sensor is mounted adjacent to a respective laser optic assembly 126 and is focused substantially on the laser resealed region of a stopper 22 of the respective laser optic assembly, and generates signals indicative of the temperature of the laser resealed region to thereby test the integrity of the thermal seal.
In one embodiment, a non-coring filling needle 124 defines dual channels (i.e., a double lumen needle), wherein one channel introduces the substance into the storage chamber 14 and the other channel withdraws the displaced air and/or other gas(es) from the storage chamber. In another embodiment, a first non-coring needle introduces the substance into the chamber and a second non-coring needle (preferably mounted on the same needle manifold for simultaneously piercing the stopper) is laterally spaced relative to the first needle and withdraws the displaced air and/or other gas(es) from the chamber. In another embodiment, grooves are formed in the outer surface of the needle to vent the displaced gas from the storage chamber. In one such embodiment, a cylindrical sleeve surrounds the grooves to prevent the septum material from filling or blocking the grooves (partially or otherwise) and to thereby prevent air and/or other gases within the container from venting therethrough. In each case, the channels or passageways may be coupled to a double head (or channel) peristaltic pump such that one passageway injects the product into the storage chamber, while the other passageway simultaneously withdraws the displaced air and/or other gases from the storage chamber. In some embodiments, there is preferably a substantially zero pressure gradient between the interior of the filled storage chamber of the containers 26 and the ambient atmosphere.
The containers, stoppers, and needle filling and laser resealing station disclosed herein may each be the same as or similar to, or may include features the same as or similar to any of the various features disclosed in, commonly assigned U.S. patent application Ser. No. 11/339,966, filed Jan. 25, 2006, entitled “Container Closure With Overlying Needle Penetrable And Thermally Resealable Portion And Underlying Portion Compatible With Fat Containing Liquid Product, And Related Method”, which is hereby expressly incorporated by reference in its entirety as part of the present disclosure.
In addition, the sterile, empty containers may be constructed in whole or in part, and/or needle filled and thermally resealed, in accordance with the various teachings of any of the following patent applications and patents that are hereby incorporated by reference in their entireties as part of the present disclosure: U.S. patent application Ser. No. 10/766,172 filed Jan. 28, 2004, entitled “Medicament Vial Having A Heat-Sealable Cap, And Apparatus and Method For Filling The Vial”, which is a continuation-in-part of similarly titled U.S. patent application Ser. No. 10/694,364, filed Oct. 27, 2003, which is a continuation of similarly titled co-pending U.S. patent application Ser. No. 10/393,966, filed Mar. 21, 2003, which is a divisional of similarly titled U.S. patent application Ser. No. 09/781,846, filed Feb. 12, 2001, now U.S. Pat. No. 6,604,561, issued Aug. 12, 2003, which, in turn, claims the benefit of similarly titled U.S. Provisional application Ser. No. 60/182,139, filed Feb. 11, 2000; similarly titled U.S. Provisional patent application No. 60/443,526, filed Jan. 28, 2003; similarly titled U.S. Provisional patent application No. 60/484,204, filed Jun. 30, 2003; U.S. patent application No. 10/655,455, filed Sept. 3, 2003, entitled “Sealed Containers And Methods Of Making And Filling Same”; U.S. patent application Ser. No. 10/983,178 filed Nov. 5, 2004, entitled “Adjustable Needle Filling and Laser Sealing Apparatus and Method”; U.S. patent application Ser. No. 11/070,440 filed Mar. 2, 2005, entitled “Apparatus and Method for Needle Filling and Laser Resealing”; U.S. patent application Ser. No. 11/074,513 filed Mar. 7, 2005, entitled “Apparatus for Molding and Assembling Containers with Stoppers and Filling Same”; and U.S. patent application Ser. No. 11/074,454 filed Mar. 7, 2005, entitled “Method for Molding and Assembling Containers with Stoppers and Filling Same”.
In the operation of the apparatus and method of the present invention, the container bodies 18 and stoppers 22 are formed by locating the first and second mold portions 12 and 14 in the closed position (
Preferably throughout the molding and assembly operation the laminar flow source 33 directs the substantially laminar flow of sterile gas into the aseptic enclosure 32. Accordingly, in the open position of the first and second mold portions 12 and 14, respectively, the space between the mold portions is maintained sterile upon opening the mold by the flow of sterile gas therethrough. The flexible barriers 54, 55 and 56 further prevent any germs or other contaminants from entering the aseptic enclosure 32 that otherwise might enter such space from the molding machine or assembly device. Because the opposing surfaces of the molds are sterilized (i.e., the surfaces that are contiguous to, extend outwardly from, and otherwise surround the mold cavities), the surfaces of the container parts and mold cavities are thermally sterilized at the time of formation by the heat of the molten plastic, and the laminar gas source maintains an aseptic space between and adjacent to the mold portions, the sterile container parts are sterile at the time of de-molding and are maintained sterile within the aseptic enclosure 32.
As shown in
If desired, the apparatus 10 may include dual automated assembly devices 25 wherein each automated assembly device is associated with a respective molding machine or mold. Alternatively, the apparatus 10 may include one assembly device for plural molds, or plural molds and assembly devices. In addition, if desired, the stoppers and container bodies may be molded in different cavities in the same molds. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the apparatus and method of the invention may include any of numerous different configurations of molding machines, molds and assembly devices. In an alternative embodiment, the apparatus includes a molding machine and associated mold for molding the container bodies, and another molding machine and associated mold for molding the stoppers. In this embodiment, each molding machine may be paired with a respective automated assembly device, and each assembly device includes a respective assembly arm and associated end-of-arm tooling. In this alternative embodiment, the container bodies 18 and stoppers 22 can be molded side by side, and de-molded and assembled by the dual automated assembly devices within the aseptic enclosure 32 to thereby form sealed, sterile, empty containers 26. In this embodiment, the apparatus may include opposing clamps (not shown) that engage the end-of-arm tools, and move the end-of-arm tools toward each other to, in turn, insert the stoppers 22 into the corresponding openings of the container bodies 18. Once the stoppers 22 are received within the container bodies 18, the clamps are withdrawn, and the sterile, sealed, empty containers 26 are released by the end-of-arm tooling into the transfer station 34 (
One advantage of the currently preferred embodiments of the present invention is that the sterile or aseptic surfaces formed adjacent to the mold cavities, and/or on the assembly device, in combination with the flow of sterile air through the chamber and over the surfaces and container bodies and stoppers during de-molding and assembly thereof, prevents any contaminants from depositing within the sealed, empty sterile containers and thus significantly facilitates the formation of such sealed, empty sterile containers. In addition, the flexible barriers further prevent the transmission of particles or other unwanted contaminants into the aseptic molding and assembly station, and thus further facilitate the formation of sealed, empty sterile containers.
As may be recognized by those skilled in the pertinent art based on the teachings herein, numerous changes and modifications may be made to the above-described and other embodiments of the present invention without departing from its scope as defined in the appended claims. For example, one or more first mold cavities may be located within a first molding machine, one or more second mold cavities may be located within a second molding machine, and if desired, one or both of the first and second molding machines may include a transfer conduit connected between the outlet of the respective mold cavity and an aseptic enclosure for transferring at least one of the molded container body and stopper into the aseptic enclosure and assembling the stopper and container body therein. In addition, the assembly device may be operatively coupled between one or both of the first mold cavity and the second mold cavity and a transfer station or a needle filling and laser resealing station (or like filling station) for transferring assembled stoppers and containers thereto. Still further, the apparatus and method of the present invention may be employed to mold and fill any of numerous different types of containers that may include any of the numerous different configurations of container bodies, stoppers and/or other container closures. Further, any of numerous different sterilants, or methods or apparatus for sterilizing, may be used to render sterile, and maintain sterile, the surfaces formed adjacent to and extending about the peripheries of the mold cavities, and/or the applicable surfaces of the assembly device that engage the container components. In addition, the assembled containers can be filled with any of numerous different products, including pharmaceuticals, such as injectables, ophthalmic, and dermatological products, vaccines, liquid nutrition products and food and beverage products. Accordingly, this detailed description of the preferred embodiments is to be taken in an illustrative, as opposed to a limiting sense.
This patent application claims priority on co-pending U.S. Provisional Patent Application Ser. No. 60/660,935, filed Mar. 11, 2005, entitled “Apparatus And Method For Aseptically Molding And Assembling Containers With Heated Surfaces, And Filling Same”, which is hereby expressly incorporated by reference in its entirety as part of the present disclosure.
| Number | Name | Date | Kind |
|---|---|---|---|
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