Adjustable filling and sealing method and apparatus therefor

Abstract

An assembly includes a support and drive assembly, a first structure and a second structure. The first structure is in operable communication with and supported by the support and drive assembly. The first structure includes at least one filling or needle assembly and is adjustable to receive a plurality of filling or needle assemblies. The second structure is supported by the support and drive assembly. The second structure includes at least one seal assembly and is adjustable to receive a plurality of seal assemblies. A method includes determining a number of containers or vials that are to be filled concurrently and adjusting an assembly to include at least one filling or needle assembly and at least one seal assembly. A number of the filling or needle assemblies and the seal assemblies equals the number of containers or vials.

Claims

1. A method comprising: determining a number of containers that are to be filled concurrently; and adjusting an adjustable assembly, which is adjustable to receive one or more filling assemblies and one or more seal assemblies, to include at least one of said filling assemblies and at least one of said seal assemblies such that a number of said filling assemblies and said seal assemblies equals said number of containers.

2. The method of claim 1, further comprising feeding said number of containers into said adjustable assembly in a side by side relationship.

3. A method as defined in claim 1, wherein said filling assemblies include a number of filling members equal to said number of containers.

4. A method as defined in claim 1, wherein said containers comprise vials.

5. A method as defined in claim 3, wherein said filling member comprises a needle.

6. A method as defined in claim 1, further comprising the steps of filling the containers with said filling assembles and sealing the containers after filling the containers with said seal assemblies.

7. A method as defined in claim 1, wherein said seal assemblies are adapted to transmit radiation to seal apertures created by said filling assemblies.

8. A method as defined in claim 7, wherein said seal assemblies each comprise a laser optic device adapted to transmit said radiation.

9. A method as defined in claim 8, wherein said laser optic device includes a laser source.

10. A method as defined in claim 8, wherein said laser optic device is connected to an external laser source.

11. A method as defined in claim 1, wherein the adjustable assembly is adjustable to receive one or more sense assemblies and includes at least one of said sense assemblies.

12. A method as defined in claim 11, further comprising: piercing each of said containers with a filling member of the filling assemblies; withdrawing said filling member from a respective container; and sealing said containers.

13. A method as defined in claim 12, wherein said at least one sense assembly is configured to determine a temperature of an aperture to be sealed on a respective container formed during the piercing step, and further comprising the steps of determining said temperature and determining whether the aperture is sufficiently heated to seal the aperture after the sealing step.

14. A method as defined in claim 11, wherein said at least one sense assembly comprises an infrared sensor.

15. A method as defined in claim 1, wherein said adjustable assembly is configured to releasably retain said filling assemblies and said seal assemblies.

16. A method as defined in claim 1, wherein said filling assemblies are configured to deliver substance into said containers, and further comprising the step of delivering substance respectively into each of said containers.

17. A method as defined in claim 1, wherein each of said filling assemblies comprises a filling member, and further comprising the steps of: moving said containers to said adjustable assembly; stopping said containers at said adjustable assembly; piercing each of said containers with a respective said filling member; withdrawing said respective filling member from each of said containers; and sealing said containers.

18. A method as defined in claim 1, wherein the one or more filling assemblies and the one or more seal assemblies are located in different stations.

19. A method as defined in claim 1, wherein the one or more seal assemblies are located downstream of the one or more filling assemblies.

20. A method as defined in claim 1, wherein said adjusting step comprises one or more of: individually adding at least one of said filling assemblies to the adjustable assembly; or individually adding at least one of said seal assemblies to the adjustable assembly.

21. A method as defined in claim 1, wherein said adjustable assembly is adjustable to receive a plurality of filling assemblies and a plurality of seal assemblies; wherein each of said one or more filling assemblies comprises a filling member; and wherein said adjustable assembly comprises: at least one first support and at least one second support laterally spaced relative to said at least one first support, wherein said one or more filling assemblies are supported between said at least one first support and said at least one second support; and a drive unit configured to move said filling member of each of said one or more filling assemblies between penetrating and non-penetrating positions.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 is a perspective view of one embodiment of a needle filling and laser sealing assembly, a vial or other container to be filled and sealed, and schematic representations of a laser beam provided by the assembly and radiation sensed by the assembly;

(2) FIG. 2 is a side elevational view of the assembly and vial of FIG. 1, with the needle manifold in a position whereby the needle is inserted into the vial and illustrating the substantially laminar flow of aseptic air laterally over the vials and/or other containers being filled and/or re-sealed;

(3) FIG. 3 is a top elevational view of the assembly of FIG. 1;

(4) FIG. 4 is another side elevational view of the assembly of FIG. 1, without the vial or container;

(5) FIG. 5 is a perspective view of the assembly of FIG. 1, without the vial or container;

(6) FIG. 6 is another perspective view of the assembly of FIG. 1;

(7) FIG. 7 is a back elevational view of the assembly of FIG. 1;

(8) FIG. 8 is a side elevational view of the assembly of FIG. 1, with the needle manifold removed therefrom;

(9) FIG. 9 is a top elevational view of the assembly of FIG. 1 with the needle manifold removed therefrom;

(10) FIG. 10 is a perspective view of the assembly of FIG. 1 with the needle manifold removed therefrom;

(11) FIG. 11 is a perspective view of the assembly of FIG. 1 with the needle manifold removed therefrom;

(12) FIG. 12 is a front elevational view of the assembly of FIG. 1 and a cover installed on the needle manifold;

(13) FIG. 13 is a side elevational view of the assembly of FIG. 1 and a cover installed on the needle manifold;

(14) FIG. 14 is a perspective view of the assembly of FIG. 1 and the cover of FIG. 13;

(15) FIG. 15 is a side elevational view of the needle manifold with a cover removably connected thereto;

(16) FIG. 16 is a side elevational view of the needle manifold with the cover;

(17) FIG. 17 is a perspective view of the needle manifold with the cover;

(18) FIG. 18 is a top elevational view of the needle manifold;

(19) FIG. 19 is a side elevational view of the needle manifold without the cover;

(20) FIG. 20 is a side elevational view of the needle manifold;

(21) FIG. 21 is a perspective view of the needle manifold;

(22) FIG. 22 is an elevational view of a needle assembly of FIG. 1;

(23) FIG. 23 is a cross-sectional view of the needle assembly of FIG. 22 along line 30-30;

(24) FIG. 24 is a side elevational view of a seal and sense assembly of the assembly of FIG. 1;

(25) FIG. 25 is a front elevational view of the seal and sense assembly of FIG. 24;

(26) FIG. 26 is a side elevational view of the assembly of FIG. 1 with the needle manifold removed and after adjustment of the sealing and sensing manifold and addition of three additional sealing and sensing assemblies;

(27) FIG. 27 is a perspective view of the assembly of FIG. 26;

(28) FIG. 28 is a side elevational view of the needle manifold after adjustment and addition of three additional needle assemblies;

(29) FIG. 29 is a perspective view of the assembly of FIG. 26 and the needle manifold as shown in FIG. 26; and

(30) FIG. 30 is a perspective view of the assembly of FIG. 29.

DETAILED DESCRIPTION

(31) Referring to FIGS. 1-7, an assembly 100 is illustrated. The assembly 100 is used in filling a vial 102 or other container with medicaments or other substances by temporary introduction of a needle 104 or syringe through a resealable cap or stopper 106 and sealing such vials or containers after such filling. The assembly 100 may be used, for example, in association with a conveyor system(s) that transports the vials or containers to/from the assembly and/or an enclosure to help prevent contaminants from reaching the assembly and/or vials or containers.

(32) In addition, the assembly and/or methods described herein may be used, for example, in apparatus and/or methods disclosed in U.S. Pat. No. 6,604,561, which issued Aug. 12, 2003 entitled, “MEDICAMENT VIAL HAVING A HEAT-SEALABLE CAP, AND APPARATUS AND METHOD FOR FILLING THE VIAL”, U.S. patent application Ser. No. 10/655,455, filed Sep. 3, 2003 entitled, “SEALED CONTAINERS AND METHODS OF MAKING AND FILLING SAME”, U.S. patent application Ser. No. 10/766,172, filed on Jan. 28, 2004 entitled, “MEDICAMENT VIAL HAVING A HEAT-SEALABLE CAP, AND APPARATUS AND METHOD FOR FILLING THE VIAL”, U.S. patent application Ser. No. 10/600,525, filed Jun. 19, 2003 entitled, “STERILE FILLING MACHINE HAVING NEEDLE FILLING STATION WITHIN E-BEAM CHAMBER”, and U.S. patent application Ser. No. 60/550,805, filed Mar. 5, 2004 entitled, “APPARATUS FOR NEEDLE FILLING AND LASER RESEALING, each of which is hereby expressly incorporated by reference as part of the present disclosure. The assembly and/or methods described herein may also use one or more portions of the apparatus and/or methods disclosed in one or more of such applications. Furthermore, it should be recognized that one or more portions of the assembly and/or methods described herein may be used in association with one or more portions of the apparatus and/or methods disclosed in such applications.

(33) The assembly 100 includes a first structure, which is referred to hereinafter as the needle manifold 110, and a support and drive assembly 114. The assembly 100 may also include a second structure, which is referred to hereinafter as the seal and sense unit manifold 112. The seal and sense unit manifold 112 is utilized if the user desires to seal the needle penetration area and sense that the seal is proper in the same assembly. Note that schematic representations of a laser beam 116 provided by the seal and sense unit manifold 112 and radiation 118 sensed by the seal and sense unit are also shown as dashed lines throughout the drawings.

(34) The needle manifold 110 includes one or more needle assemblies 120 (only one being shown in FIG. 1) and one or more support assemblies 122. As shown in FIG. 28, if more than one needle assembly 120 is employed, the needle assemblies (shown as 120A, 120B, 120C, and 120D) are, for example, arranged linearly and adjacent to one another (side by side) at respective positions in the manifold 110. Each needle assembly 120 includes the needle 104 and a needle support 124. The needles 104 are used to deliver medicament or other substance(s) into vials or other containers. In order to accommodate multiple needle assemblies 120, the needle manifold 110 is adjustable in that needle assemblies 120 can be added to and/or removed from the manifold 110 in order to provide a specific number of needles 104 desired in a particular application.

(35) Referring again to FIGS. 1-7, each of the needles 104 has a port in flow communication with one or more sources of medicament or other substances (not shown). This flow communication may be provided, for example, by flexible tubes (not shown). Providing multiple needles makes it possible to fill multiple containers concurrently, if desired. As can be seen, each needle 104 is preferably a non-coring needle.

(36) The support assemblies 122 are shown disposed at opposite ends of the needle manifold 110 on opposite sides of the needle assembly(s) 120. Each support assembly 122 includes a stopper portion 130. The needle manifold 110 is removable from the assembly, so as to enable the needle manifold 110 to undergo maintenance, cleaning, sterilization, and/or repair or replacement. FIGS. 8-11 illustrate the assembly 100 with the needle manifold removed. As will be further described below, the needle manifold 110 and the support and drive assembly 114 are provided with complementary catches that engage one another to releasably retain the needle manifold 110 to the support and drive assembly 114.

(37) The seal and sense unit manifold 112 includes one or more seal and sense assemblies 140 (only one being shown in FIG. 1). As shown in FIGS. 26 and 27, if the manifold 112 has more than one assembly 140, the seal and sense assemblies (shown as 140A, 140B, 140C, and 140D) are, for example, arranged linearly and adjacent to one another at respective positions in the seal and sense unit manifold 112. Each seal and sense assembly 140 may include, for example, a laser optic source assembly 142, an infrared (“IR”) sensor 144, and a support portion 146. Each laser optic assembly 142 is adapted to provide the laser beam 116 to reseal a resealable cap or stopper 106 on the vial 102 after the vial 102 has been filled by needle 104. It is understood that the needle 104 penetrates the stopper 106 in order to fill the vial 102. The laser beam reseals the penetration area on the stopper 106. Each of the laser optic assemblies 142 may include a laser source or may be connected, for example, to a respective fiber optic cable (not shown) that connects the respective laser optic assembly to a respective laser source. Providing multiple laser optic assemblies 142 makes it possible to reseal multiple vials or containers concurrently.

(38) While the seal and sense manifold 112 (or second structure) and the seal and sense assembly 140 are discussed throughout this application as being one unit, it is understood the seal assembly and the sense assembly may be two separate units and that the manifold 112 may include only one of those assemblies. In addition, assembly 100 may have only a seal assembly, which would seal the penetration area created by the needle. In an exemplary embodiment, the seal assembly is the laser optic source assembly 142 and the sense assembly is the IR sensors 144, which are illustrated in the figures.

(39) The IR sensors 144 may be used, for example, to detect the temperature of the needle penetration region during resealing, and therefore can be used to determine whether the cap or stopper 106 (FIG. 1) was sufficiently reheated to achieve resealing. Each of the IR sensors 144 includes, or is connected to, a respective IR sensor module (not shown). Providing multiple IR sensors 144 enables sensing the temperature of multiple vials or containers concurrently, for example, as they are being resealed or immediately thereafter.

(40) As with the needle manifold 110 (FIG. 28), the sealing and sensing unit manifold 112 is adjustable in that sealing and sensing assemblies 140 can be added to, and/or removed from, the manifold in order to provide a specific number of sealing and sensing assemblies desired in a particular application. In some embodiments, the manifold 112 also may be provided with a removable cover to protect the assemblies, e.g., during transport.

(41) Referring to FIGS. 1-11, the support and drive assembly 114 is adapted to drivingly support the needle manifold 110 and also to support the seal and sense manifold 112. This assembly 114 may include, for example, a pair of generally L-shaped stands 150, each having a base 152 and support column 154 extending therefrom. Each base has a drive shaft 156 extending therefrom, that is drivingly connected to a drive unit, e.g., a stepper motor (not shown) that has a lead screw drivingly coupled to a base plate (not shown) and is mounted, for example, within the base or beneath a base plate (not shown) supporting the assembly 100.

(42) The support and drive assembly 114 further includes a brace 160 fixedly secured at opposite ends to a pair of laterally-extending support arms 168. Each support arm 168 is fixedly secured to the upper end of a respective drive shaft 156 and is vertically movable therewith. The assembly 114 further includes a pair of thumb screws 162, and each thumb screw includes a head portion 164 and a rod portion 166. Each rod portion 166 extends through one end of the brace 160 and respective support arm 168. The free end of each rod portion 166, which is the opposite end from thumb screw 162, threadedly engages a respective threaded hole 169 formed in a respective support 130 of the needle manifold 110 to releasably retain the needle manifold 110 to the support and drive assembly 114. It should be understood that other types of releasable connectors may be employed, including but not limited to, fasteners (e.g., bolts), clamps, etc.

(43) Referring to FIGS. 1-11 and 18-21, each support arm 168 defines on its free end an approximately u-shaped recess 172 for receiving therein a complementary shaped, laterally-extending flange 174 formed on the respective support portion 130 of the needle manifold 110. Thus, in order to assemble the needle manifold 110 to the support arms 168, the user grips the laterally-extending flanges 174 of the manifold 110 and lowers the flanges into the respective u-shaped recesses 172 of the support arms. Then, the user pushes the thumb screws 162 forwardly such that the threaded ends of the rod portions 166 are received within the respective threaded holes 169 of the support portions 130. The user then simply turns the head portions 164 of the thumb screws to fixedly secure the manifold to the support arms.

(44) One advantage of the illustrated embodiment of the present invention is that the user may be located on the opposite side of the station 100 relative to the vials or containers 102 (or the location for filling and/or re-sealing the containers). In addition, since the user need only grip the laterally-extending flanges 174 of the needle manifold 120 to install the manifold, the user's hands will not extend over the location at which the vials or other containers are filled and/or resealed (i.e., the user need not break the needle plane), but rather will be located to the sides of this area. Accordingly, this design further prevents the possibility that the needle filling and/or laser re-sealing location might become contaminated during removal or installation of the needle manifold.

(45) Another advantage of the illustrated embodiment is that the needle filling and laser sealing station 100 can be mounted within a sterile enclosure that includes glove ports for allowing an operator's hands to access the interior of the enclosure therethrough. Further, a user can easily remove and install the needle manifold by employing such glove ports or other means for accessing the interior of a sterile enclosure. As indicated above, the user need only manipulate the thumb screws to remove and install the needle manifold.

(46) In addition, the filling, sealing and sensing assembly 100 may be provided with laminar flow 170 (FIG. 2) as part of the overall system for helping reduce the possibility of contamination. In this embodiment, the laminar airflow is substantially horizontal or substantially parallel to the base plate of the assembly.

(47) Referring FIGS. 12-14, needle 104 is illustrated with a cover 134. Because the needles 104 preferably define non-coring, sharp tips 132 that are capable of causing injury and/or becoming damaged during removal, transport, or installation of the manifold onto, or off of the assembly, the manifold 110 may be adapted to receive the cover 134 that limits or prevents access to the needles during certain times. As will be further described below, the manifold 110 and cover 134 each may be provided with complementary catches that engage one another to releasably retain the cover to the manifold. In this embodiment, for example, the needle manifold 110 defines one or more grooves 136, and the cover 134 defines one or more flanges 138 that are removably received by the groove(s) to retain the cover to the manifold at desired times.

(48) Referring to FIGS. 12-17, the cover 134 includes a laterally-extending handle 196 that extends approximately perpendicular to the axis or axes of the needle(s) 104. The cover 134 further defines an elongated slot 198 extending from one end of the cover to the other for receiving within the housing the needles 104. As indicated by the arrow 200, the cover 134 is removed by gripping the handle 196 and pulling the cover laterally in the direction of the arrow 200. In doing so, the flanges 138 of the cover 134 slidably move through the grooves 136 of the manifold until the cover is released therefrom. The open end of the cover defined by the slot 198 located opposite the handle 196 allows the cover to be slipped away from the needles.

(49) One of the advantages of the cover 134 is that it allows a user to safely handle the needle manifold during sterilization, installation and/or removal. Preferably, the cover and components of the needle manifold are made of suitable materials to allow gamma or other sterilization thereof prior to installation in the station 100. If desired, and as indicated in broken lines in FIG. 18, the base of the slot 198 may define a recess or receptacle 202 for receiving fluid, such as the medicament or other substance to be pumped through the needles 104 and into the containers. After the needle manifold 110 is installed, and the fill tubes (not shown) are connected to the inlets 184 of the needles 104, it is typically necessary to purge any air from the fill tubes and needles prior to filling the vials or other containers. During the purging process, it may be necessary to release the medicament or other substance through the needles to ensure that the needles and lines connected thereto are substantially airless. The cover 134 and receptacle 202 thereof may be used during the purging process to collect any such fluid or other substance released from the needles. Then, the cover may be removed and the collected fluid or other substance discarded.

(50) Referring to FIG. 12, the support and drive assembly 114 may be mounted on a base plate or other support 186 defining laterally-spaced apertures 188 for receiving therethrough the drives shafts 156. As indicated in broken lines, the support 188 may define any desired number of additional apertures 188′ to accommodate different configurations of the needle manifold, and thereby allow the stands 150 to be located where necessary to accommodate the different configurations of the needle manifold. Alternatively, the support 186 may define one or more elongated slots rather than discrete apertures 188 to thereby allow the shafts to be moved laterally therethrough to accommodate the different needle manifold configurations.

(51) Referring to FIGS. 22 and 23, the support 124 of each needle assembly 120 defines a pair of substantially parallel apertures 176 extending through the support and oriented approximately perpendicular to the axis of the respective needle 104. A pair of needle shafts 178 is received through the respective apertures 176 and extends outwardly on opposite sides of the support 124. As shown typically in FIG. 20, the ends of the shafts 178 are press fit or otherwise fixedly received within corresponding apertures 180 formed in the end supports 122 of the manifold to assemble the needle assembly 120 to the end supports 122. In the multi-needle assembly embodiment of FIG. 28, the shafts 178 (FIG. 23) are sufficiently long to mount the desired number of needle assemblies between the end supports 122 of the needle manifold.

(52) Referring again to FIGS. 22 and 23, each needle support 124 defines opposing grooves 136, and each end support 122 likewise defines opposing grooves 136 that are aligned with the grooves of the needle assemblies to create continuous grooves 136 in the assembled needle manifold. The needle support 124 defines an aperture 182, and the input end 184 of the respective needle 104 extends into the aperture 182. The input end 184 of the needle 104 is spaced inwardly relative to the wall of the aperture 182 to allow an inlet tube (not shown) to be secured to the needle inlet and fit therebetween. If desired, the needle support 124 may be made of two parts 124A, 124B that are secured together by one or more fasteners (not shown) to clamp, or otherwise fixedly secure the respective needle 104 therebetween.

(53) Another advantage of the illustrated embodiments of the present invention is that the number of needles 104 and/or needle assemblies 120 mounted on the needle manifold easily may be adjusted by simply adjusting the lengths of the needle shafts 178. Thus, a user may maintain any desired number of needle assemblies 120, and associated needle shafts 178 and braces 160, to accommodate the different desired manifold configurations.

(54) Referring to FIGS. 24 and 25, the support 124 of each seal and sense assembly 140 defines a pair of substantially parallel apertures 190 extending through the support and oriented approximately perpendicular to the axes of the drive shafts 156 (FIG. 1). A pair of mounting shafts 192 is received through the respective apertures 190 and extends outwardly on opposite sides of the support 146. The ends of the shafts 192 are press fit or otherwise fixedly received within corresponding apertures 194 formed in the end support columns 154 to assemble the seal and sense assembly to the columns. In the multi-sensor and multi-needle assembly embodiment of Referring to FIG. 27, the shafts 192 are sufficiently long to mount the desired number of seal and sense assemblies between the end columns 154.

(55) Referring to FIGS. 29 and 30, another advantage of the illustrated embodiments of the present invention is that the user may include any desired number of seal and sense assemblies to accommodate any desired number of needle manifolds. Thus, a user may maintain, in addition to any desired number of needle manifolds, braces and needle shafts as described above, and an associated number of seal and sense assemblies and associated mounting shafts. Thus, the stations of the currently preferred embodiments of the present invention easily lend themselves to being adjusted by users in the manner indicated, or alternatively, to being manufactured in different single or multi-needle, and/or single or multi-sense and seal assembly, configurations.

(56) Although each needle assembly 120 shown above has only one needle, the needle assemblies are not limited to one needle. For example, in some other embodiments, one or more of the needle assemblies 120 may have two or more needles. Although the needle assemblies 120 are shown arranged linearly and adjacent one another, this is not required. The support assemblies 122 need not be disposed at the ends of the needle manifold. For example, in some embodiments, one or more support assemblies may be disposed between one or more needle assemblies.

(57) It should be understood that the needle manifold 110 may be used without the sealing and sensing manifold 112. Thus, one aspect of the present disclosure is an apparatus for use in association with a filling station, where the apparatus comprises a manifold having two stoppers, spaced apart from one another, for capturing at least one needle assembly therebetween, at least one of the stoppers being movable relative to the other to change the size of the spacing therebetween to allow a change in the number of needle assemblies captured therebetween.

(58) Similarly, the sealing and sensing manifold may be used without the needle manifold. Moreover, it should be understood that the sealing or sensing portion of the sealing and sensing manifold may be employed without the other, to provide a sealing manifold and/or a sensing manifold. Alternatively, the sealing and sensing manifold may be located downstream of the needle manifold.

(59) In addition, it should be understood that an adjustable needle manifold may be employed without a cover. Further, it should also be understood that the cover may be employed on a non-adjustable manifold.

(60) Thus, while there have been shown and described various embodiments, it will be understood by those skilled in the art that the present invention is not limited to such embodiments, which have been presented by way of example only, and that various changes and modifications may be made without departing from the spirit and scope of the invention.