JP2004323110A - Device for filling container - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a device for filling a pharmaceutical container in a substantially sterilized environment. <P>SOLUTION: The device includes a sterilized zone 64 which is not substantially contaminated, an upright wall which divides the non-sterilized zone and an enclosing body which defines the sterilized zone by co-operating with the upright wall. The device further comprises a transfer section which receives an empty container outside the sterilized zone, a transport section which is at least partially disposed in the sterilized zone, and a filling device which fills the pharmaceutical in the container in the sterilized zone when the container is moved through the sterilized zone. The filling device comprises at least one dispenser 49 disposed in the sterilized zone and a drive disposed in the non-sterilized zone. The device may further comprise one device which can be moved together with at least one dispenser. The device is formed so as to control the flow of the pharmaceutical from the dispenser and can be moved so as to be disegaged from the container, a filling engagement and such the conditions. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  This application claims priority from US Provisional Patent Application Ser. No. 60 / 311,823, filed Aug. 14, 2001, which is incorporated by reference in US Patent Application Serial No. 10/179, filed June 25, 2002. No. 575 is a continuation-in-part application. By reference to these patent applications, the content disclosed in these patent applications is incorporated herein.

  The present invention relates generally to a filling device, and more particularly, to an improved filling device configured to fill containers, such as vials, with a liquid product, such as a pharmaceutical.

  In the pharmaceutical industry, many formulations, for example, injections and swallows, are placed in containers such as bottles. These containers are often small. In-line filling machines, ie, in-line fillers, are used to package these pharmaceutical formulations in a highly sterile manner.

  In-line fillers are "isolated" to maintain a high degree of sterility. An isolated in-line filler is connected to the enclosure by a horizontal or substantially horizontal table, or by connecting the enclosure to a vertical wall, to provide a clean and sterile package for packaging the formulation. Define a unique area. In the case of a table, the components of the filling system are mounted on the table such that only the components necessary for packaging the formulation are located in the sterile area. Drive mechanisms and other components that are difficult to maintain a high degree of sterility are below the table.

In the case of the vertical wall filler disclosed in U.S. Pat. No. 5,673,535, the components of the filling system are mounted on the wall such that only the components required for packaging the formulation are located in the sterile area. It is attached. Drive mechanisms and other components that are difficult to maintain a high degree of sterility are on the opposite side of the wall from the sterile area.
U.S. Pat. No. 5,673,535

  In another aspect, an in-line filler can be used without an enclosure defining a sterilization zone. These types of fillers are kept in a "clean room" where the entire room is maintained at the required high degree of sterility. Optionally, for clean room applications, the filling system may include an enclosure to enclose the mechanical drive and other components. This confine these components to the non-sterile zone.

  Conventional fillers may include a filling system such as, for example, a pump-operated filling system or a time and pressure filling system. In a time-pressure system, a liquid product can be supplied from a stationary pressurized manifold via a plurality of flexible supply lines to a corresponding plurality of dispensers, such as filling needles, nozzles, and the like. In any type of filling system, a valve may be associated with each flexible supply line.

  The amount of liquid dispensed can be controlled by a valve. In order to dispense the desired amount, the valve can be opened for a certain period of time, depending, inter alia, on the pressure and temperature of the liquid product. The valve may be formed as a pinch valve that pinches the flexible supply line to stop the flow of liquid and reduces the pinching force to start the flow. When the valve is open, the liquid product can be dispensed from the dispenser into a corresponding plurality of bottles.

  The dispenser may be associated with a structure that follows the movement of the bottle as it advances through the filling system along the conveyor system. In the case of a needle-type filling dispenser, this configuration is called a needle bridge. Due to the flexibility of the liquid supply line, the dispenser can move if the product supply manifold remains stationary. Because the valves of conventional fillers are also stationary, the dispensers can move relative to their corresponding valves. This relative movement changes the shape of the flexible supply line, thereby changing its internal volume. As a result, the accuracy of the filling system is compromised.

  Further, the measurement of the temperature and pressure of a liquid product has conventionally been performed in a product supply manifold. Since the temperature away from the dispenser is measured, errors are likely to occur in the filling if the fluid flow properties change significantly with temperature.

  An object of the present invention is to solve the above-mentioned problems of the prior art.

  According to one aspect of the present invention, there is provided an improved apparatus for filling pharmaceutical containers in a substantially clean and sterile environment. The apparatus defines an upright wall that divides the apparatus into a substantially clean sterile zone and a non-sterile zone, and cooperates with the upright wall to define a sterile or non-sterile zone. Including the surrounding enclosure. The apparatus further includes a transport for receiving empty containers from outside the sterilization zone, and a transport for moving the containers through the sterilization zone, at least partially disposed within the sterilization zone. The apparatus includes a filling device that fills the container with a medicament in the sterilization zone as the container moves through the sterilization zone. The filling device includes at least one dispenser located in a sterilization zone and a drive mechanism located in a non-sterilization zone. The filling device extends between the filling mechanism dispenser in the sterilization zone and the drive mechanism in the non-sterilization zone through a sealed opening in the upright wall. The device further includes a device configured and positioned to control the flow of the medicament from the at least one dispenser, the device being movable with the at least one dispenser. At least one dispenser is moveable into and out of engagement with the container.

  According to another aspect of the present invention, an apparatus for filling a container in a substantially sterile environment includes a frame and a substantially contaminated device arranged at least in part in a side-by-side relationship. An upright wall supported by the frame that divides into a sterile zone and a non-sterile zone, and an enclosure that cooperates with the upright wall to define a sterile zone. The apparatus further includes a transfer unit that receives an empty container from outside the sterilization zone, a transport unit that is at least partially disposed in the sterilization zone, and that moves the container through the sterilization zone, and a container that includes the transport unit. A filling station that fills the container with medicament as it is moved through the sterilization zone. This filling station is located in the sterilization zone. The apparatus further includes a drive mechanism located in the non-sterilization zone in operable communication with the filling station, and a coupling device between the drive mechanism and the filling station. The coupling device may extend through a sealed opening in the upright wall. The apparatus includes at least one dispenser associated with a filling station, and a device configured and positioned to control a flow of medicament from the at least one dispenser. The device is moveable with at least one dispenser, wherein the at least one dispenser is moveable into and out of engagement with the container.

  According to yet another aspect of the present invention, an apparatus for filling a container in a substantially sterile environment comprises a frame means and a substantially contaminated device disposed at least in part in a side-by-side relationship. Upright wall means supported by the frame, dividing into unsterilized and non-sterilized zones; and enclosure means supported by the frame means and cooperating with the upright wall means to define a sterile zone. Including. The apparatus is at least partially disposed in the sterilization zone, a transport means for moving the container through the sterilization zone, and for transferring an empty container from outside the sterilization zone to a transport means in the sterilization zone. Container transfer means and means for filling the container with the medicament when the container is moved through the sterilization zone by the transport. The means for filling the container may be located in the sterilization zone. The apparatus further includes a drive means disposed within the non-sterilization zone for actuating the means for filling the container, and a connection for operably connecting the drive to the means for filling the container. Including means. The coupling means may extend through the sealed opening of the upright wall means. The device includes at least one dispenser associated with the filling means, and a device configured and positioned to control a flow of medicament from the at least one dispenser. The device is moveable with at least one dispenser, wherein the at least one dispenser is moveable into and out of engagement with the container.

  According to yet another aspect of the present invention, an apparatus for filling a pharmaceutical container in a substantially sterile environment comprises an upright dividing the apparatus into a substantially non-contaminated sterilization zone and a non-sterilization zone. Including walls. These zones are arranged at least partially in a side-by-side relationship. The apparatus further includes an enclosure cooperating with the upright wall to define a sterilization zone, a transfer receiving empty pharmaceutical containers from outside the sterilization zone, and a plurality of actuators arranged in a continuous relationship. Including. Each of these actuators is at least partially located in the sterilization zone, the drive is located in the non-sterilization zone, and at each of the actuators a given operation is performed on the pharmaceutical container. You. Each of the actuators extends through a sealed opening in an upright wall between a portion within the sterilization zone and a drive within the non-sterilization zone. The device is further configured to direct a flow of the medicament into the medicament container, wherein the transport portion is configured to move the medicament container via the plurality of actuators, the medicament container being disposed at least partially within the sterilization zone, and At least one dispenser configured and a device configured and positioned to control a flow of medicament from the at least one dispenser. The apparatus is moveable with at least one dispenser, wherein the at least one dispenser is moveable into and out of engagement with the container.

It should be understood that the above description and the following description are merely examples, and do not limit the present invention.
BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary embodiments of the invention and, together with the description, serve to explain the principles of the invention.

  Next, embodiments of the present invention will be described in detail below. Some examples of these embodiments are shown in the accompanying drawings. According to the present invention, a filling device is provided. The filling device is used, for example, to fill containers such as vials with liquid.

  Referring to FIGS. 1, 2 and 3, a bottle filling apparatus embodying the present invention is generally designated by the reference numeral 41, which incorporates the modifications and improvements discussed in detail herein. Except for this, it is the same as that disclosed in US Pat. No. 5,673,535. Although the device 41 is adapted to be used to sequentially fill continuously supplied bottles with injections, the present invention provides for filling any type of container in a clean and sanitary environment. Are thinking.

  With particular reference to FIG. 2, the apparatus 41 includes a sterilized inner supply envelope 42 through which the bottle 14 rests on a conveyor 48. The inner supply enclosure 42 is the entrance to the sterilization zone discussed below, and it is important that the bottle 14 now enters in a sterile state. For this purpose, the enclosure 42 is connected to a conventional bottle washer / sterilization tunnel 50. The tunnel performs a procedure including a number of steps, including depyrogenization, that accepts unsterilized bottles and sterilizes the bottles, and removes the sterilized bottles from the sterilized inner supply enclosure 42 conveyor. 48. At this point, the sterilized bottle is transferred to the vibrating belt inner supply station 43. This inward supply station moves the bottles to a transfer starwheel 44, which sequentially charges the bottles 14 into the main container conveyor 45 or 45 '. Although FIGS. 1, 2, and 3 show a vertical conveyor 45, an improved horizontal conveyor 45 'shown and described with respect to FIGS. 7 and 8 may be used.

  The conveyors 45, 45 'take out the bottles 14 at random and sequentially move the bottles to a pre-fill inspection weighing station 46 which determines a pre-fill reference weight. The bottles are then conveyed by conveyors 45, 45 'through a filling station 47 provided with filling means 414 including a plurality of nozzles 49, as described in further detail below.

  After filling, the bottle 14 is moved by the conveyors 45, 45 'via the post-filling inspection and weighing station 52. This station removes each of the randomly selected empty bottles pre-weighed at the pre-fill inspection weigh station 46. By comparing the weights to each other in this way, it is ensured that a specific amount of the pharmaceutical formulation has been dispensed into each bottle. The weigh station may include a contact weighing device or a non-contact weighing device.

  The conveyors 45, 45 'then move the bottles via the stop station 53, where each filled bottle is closed with a stopper and sealed. The bottle 14 is then moved into a discharge-outer supply station 54 where the bottle is removed from the conveyor 45, 45 'and transported to the packaging station by means not shown.

  Referring to FIG. 3, device 41 includes an elongated frame. Certain components of the frame are shown in this cross-sectional view. These include a vertical leg member 55, a lateral rail member 56, a mounting plate 57, and a vertical frame support member 58 extending between the lateral rail member 56 and the plate 57. The frame support member 58 is disposed at an intermediate position between the vertical leg members 55. It will be appreciated that these various components 55-58 are repeated over the length of the frame of the device.

  A vertically arranged mounting plate 59 is fixed to several frame supports 58 and extends lengthwise over the length of the device 41 (see also FIG. 2). A portion of the vertical mounting plate 59 extends above the mounting plate 57. A thin stainless steel plate 61 sized to coincide with the vertical mounting plate 59 is mounted to the plate 59 in a spaced relationship. The stainless steel plate 61 defines an elongated barrier, a rear plate of a stainless steel cabinet, generally designated by the reference numeral 63. This cabinet defines an internal sterilization zone 64. The area outside the cabinet 63 (ie, the left part of the barrier plate 61 in FIG. 3) constitutes a non-sterilization zone, generally designated by the reference numeral 70.

  Referring to FIGS. 1, 2 and 3, the sterilization cabinet 63 includes a front plate 65, shown in the schematic view of FIG. However, as shown in FIG. 2, the front plate 65 is provided with several outward steps to accommodate the various components described above. Referring again to FIG. 1, a cabinet top 66 and a cabinet bottom 67 interconnect the rear plate 61 and the front plate 65, and the cabinet ends are closed by plates 68,69.

  As shown in FIG. 2, the main entrance to the sterilization zone 64 is the sterilization tunnel 42, as discussed above. The stop station 53 further includes a stopper inlet or docking port 53a, through which a sterilized stopper can be sanitized as is known in the art. The only outlet from the sterilization zone 64 is a discharge-outer supply station 54, which includes, for example, a plurality of prior art star wheels. The first starwheel is located within the sterilization zone 64 and the second starwheel is located outside the sterilization zone 64. Bottle 14 is transported between these first and second star wheels through a small opening in cabinet 63. The sterilization zone 64 may be maintained at a higher pressure than the surroundings to prevent air from escaping through the bottle outlet between the starwheels, thus preventing contaminants from entering. Means for maintaining such pressure (not shown) are conventional and typically include a supply of air that has been filtered to remove contaminants.

  In one embodiment, the cabinet 63 is provided with a plurality of prior art glove ports 80 or other conventional means for sealingly accessing the sterilization zone 64. Preferably, the glove ports 80 are located at spaced locations so that the operator of the device 41 has access at all locations along the bottle movement line.

  Referring to FIG. 1, the drain portion 71 of the cabinet 63 projects below the filling station 47. Each bottom portion 67 adjacent to the drain portion 71 is inclined downward toward the drain portion 71. The bottom of the drain section 71 defines a plurality of collection drain pans 71A, 71B, and 71C. These drain pans are connected to drains 72A, 72B, and 72C, respectively. Each of these drains 72A, 72B, and 72C is connected to a common drain pipe 74 by a sealed joint 73. The purpose of these drain components is discussed in further detail below.

  4 and 5, the filling device comprises a filling station 47, a product supply manifold 411, at least one supply line 412, and a filling device, such as a bottle filling means 414, configured to fill the containers. Including. The product supply manifold may be located in the sterilization zone 64 or may be located in the non-sterilization zone 70. Each supply line 412 may be located between the product supply manifold 411 and the bottle filling means 414. Each supply line 412 may be formed as a conduit. The conduit may have at least a portion 413 of the conduit elastically deformable. Bottle filling means 414 may include at least one dispenser 49. It should be understood that one supply line 412 is provided for each dispenser 49 and may be associated therewith. The dispenser 49 may be formed as, for example, a filling needle, a nozzle, or the like. Optionally, the dispenser 49 may be provided with a mechanical, electrical, or electro-mechanical displacement sensor 417.

  The filling device may further include at least one valve 418. This valve 418 may include, for example, a pinch valve provided on and associated with each supply line 412 and dispenser 49. Accordingly, there may be a one-to-one correspondence between the supply line 412, the dispenser 49, and the valve 418. The portion 420 of the supply line 412 between the valve 418 and the dispenser 49 may be rigid or semi-rigid.

  Bottle filling means 414 may further include a structure 426, such as a walking beam, coupled to dispenser 49 and valve 418. This structure 426 may be configured to follow the movement of the bottle 14 advancing along the conveyor 45, 45 'via the bottle filling means 414 during the filling process.

  Dispenser 49 and valve 418 may be associated with structure 426 such that there is substantially no relative movement between dispenser 49 and valve 418 as structure 426 moves. In the case of a needle-type filling dispenser, the structure 426 may be a needle bridge walking beam for a needle.

  The filling device is a drive operably connected to the bottle filling means 414 via a mechanism 434 passing from a non-aseptic zone 70 through a sealed opening 436 to a aseptic zone 64. 151 (see FIG. 2), for example, including a drive pulley. Mechanism 434 supports structure 426 that includes housing 438. Referring to FIG. 5, the housing 438 may include a valve actuator 440. Housing 438 provides a seal between surrounding sterile zone 64 and an interior non-sterile or non-sterile zone 433. The mechanism 434 may also be hollow to operate the filling device and / or to provide a non-sterile or non-sterile zone 435 that includes a sealed path 442 in communication with the non-sterile zone 70 for the drive facility 150. Is also good. The driving equipment 150 is, for example, a driving device 151, a power supply, a movement-operation control device, or the like, and supports the operation and operation of the valve 418. The valve actuator 440 may be separated from the valve 418 by a flexible membrane 444 that forms a seal between the sterile zone 64 and the non-sterile zone 433.

  Further, a temperature sensor 446 may be positioned at or near the dispenser 49. Thus, the temperature of the liquid product can be measured near the dispenser 49, rather than in the more remote product supply manifold 411. As such, filling errors associated with product temperature sensitive fluid flow characteristics can be reduced.

  Referring to FIGS. 2, 3, and 6, the vertical container conveyor 45 includes a conveyor belt 87 having a row of sprocket holes 88 disposed along each edge. The conveyor belt 87 is driven endlessly by a pair of both sprocket wheels 89, 90 (only the sprocket wheel 89 is shown in FIG. 6). The sprocket wheels 89, 90 can rotate about a horizontal axis as indicated by reference numeral 91 in FIG. 3, the horizontal shaft on which the drive sprocket wheel 89 rotates is not shown for simplicity. These shafts extend through the stainless steel plate 61 and appropriate seals of the mounting plate 59 and are driven as discussed below. In such a configuration, the width of the conveyor 45 is slightly reduced. Further, as discussed below, the width of the cabinet 63 and the sterilization zone 64 is significantly reduced from the initial size because the drive for the conveyor 45 is located outside the sterilization cabinet 63.

  Referring now to FIG. 7, in a preferred embodiment, an improved horizontal container conveyor 45 'for transporting bottles is formed with a drive sprocket wheel or the like 89' that rotates about a vertical axis. Is also good. For example, as shown in FIGS. 7 and 8, horizontal conveyor 45 'may include one or more conveyor belts 87 configured to move upper container holder 800 and lower container holder 802 via a conveyor path. 'May be included. The lower container holder 802 supports the containers 14 and the upper container holder 800 holds the containers 14 away from each other and holds these containers substantially immobile relative to each other. The distance between adjacent upper container holders 800 may be adjustable to accommodate containers 14 of various sizes. In such a conveyor 45 ', the containers are conveyed on the sides of the belt 87, rather than above the belt 87, as discussed above. Thus, although in this variant of the conveyor 45 ', the width of the cabinet 63 and the sterilization zone 64 is greater, the conveyor belt 87' of the variant has a greater configuration than that of transporting the containers on the belt 87. Low potential for contamination.

  With reference to FIG. 2, the working station located in the sterilization zone 64 is driven by an actuation means, for example a drive, located outside the sterilization zone 64 (ie inside the non-sterilization zone 70). These various actuation means, although separate, may be driven in an interrelated manner to synchronize the various operations performed within the sterilization zone 64. The electric motor 131 functions as a main drive unit for various operation units. For other actuation means, separate servomotors are used which are actuated in synchronization with the main drive motor 131, as described below.

  A drive pulley 133 is provided at at least one end of the motor 131. The drive pulley 133 is connected to a driven pulley 137 via a drive belt 136. The driven pulley 137 is mounted on a common drive shaft, generally designated by reference numeral 138. Drive shaft 138 includes a plurality of interconnected drive shaft segments 138 AE.

  Drive shaft segment 138A is connected to a pulley / timing belt configuration via right angle gear drive 139. A drive connection 142 extends through a sealed opening 139 in the wall of cabinet 63 and connects pulley / timing belt 141 to oscillating belt inner supply station 43.

  Drive shaft segment 138A is connected to shaft segment 138B via right angle drive 144. A right angle drive 145 is connected between drive shaft segments 138B and 138C. Right angle drive 145 is provided for driving starwheel 44 via pulley / belt feature 146 and drive connection 147. The drive connection 147 extends through the mounting plate 59 of the cabinet 63 via the same type of seal member as the seal member 143.

  Drive shaft segment 138C is connected via pulley / belt feature 148 to right-angle gear drive 149 with drive pulley 151 (see FIG. 3). Drive pulley 151 is coupled to drive walking beam 426 via at least one actuator 86. Each of these actuators extends through a mounting plate 59 via a seal member similar to seal member 143.

  The pre-fill weighing station 46 and the post-fill weighing station 52 may be separately driven by a servomotor (not shown for clarity) that is operated synchronously with respect to the main drive motor 131. Pre-fill check weigh station 46 includes a drive connection 152, and post-fill check weigh station 52 includes a drive connection 153.

  The shaft drive segment 138D is connected via a pulley / belt feature 154 to a right-angle gear drive 155, which drives a pulley / belt feature 156. It is in turn connected to a drive connection 157, which operates part of the stop station 53. Other components of the stop station are driven by another variable speed motor.

  The shaft drive segment 138D is further connected to a gear drive 158. This gear drive drives a pulley / belt feature 159. A drive connection 161 connects feature 159 to discharge / outside supply station 54 via a seal member similar to seal member 143.

  A shaft drive segment 138E is connected to a right angle gear drive 162, which drives a pulley / belt configuration 163. A drive connection 164 extends through the seal member and mounting plate 59 and connects feature 163 to drive sprocket wheel 89. Sprocket wheel 90 is a driven wheel and does not include a direct drive.

  With particular reference to FIGS. 1 and 3, the sterilization zone 64 in the sterilization cabinet 63 is periodically cleaned by a technique using steam and / or disinfectant cleaning, while leaving all internal components in place. Can be sterilized. As a result, effective disinfection and decontamination of the cleaning zone 64 can be performed on a regular basis much easier than decontaminating the entire room, ie a very large zone. Furthermore, this greatly reduces the cost of operation and maintenance of the device 41.

  In operation, a liquid product is supplied from a product supply manifold 411 located in the sterile zone 64 to the corresponding dispenser 49 via one or more supply lines 412. Valve 418 can control the amount of liquid dispensed from dispenser 49.

  To dispense the desired amount, valve 418 may be opened for a predetermined period of time, for example, depending on the pressure and temperature of the liquid product near dispenser 49. As shown in FIG. 5, the valve 418 is designed as a pinch valve that pinches the elastically deformable portion 413 of the supply line 412 to stop the flow of liquid and reduce the pinching force to start the flow. Is also good. When valve 418 is open, liquid product may be dispensed from dispenser 49 into a corresponding plurality of vials.

  The conveyor 45 or 45 'moves the bottle 14 via the bottle filling means 414. The structure 426 may follow the movement of the bottle 14 as it advances through the bottle filling means 414 along the conveyor system 422. Because the portion 413 of the supply line 412 is flexible, the dispenser 49 can move to engage with the bottle 14 by interlocking movement, reciprocation, etc., while the product supply manifold 411 remains stationary. Because valve 418 and dispenser 49 can move with structure 426, the internal configuration or flow shape of portion 420 of supply line 412 between dispenser 49 and valve 418 changes substantially during movement of structure 426 during the filling process. There is no. As a result, the accuracy of the filling device is not impaired.

  It will be apparent to those skilled in the art that various modifications and variations can be made to the filling device without departing from the scope or spirit of the invention. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. The specification and examples are considered to be merely illustrative.

1 is a schematic view of a conventional container filling device modified in accordance with certain aspects of the present invention. It is a top view of the container filling apparatus of the modification of FIG. It is a cross-sectional view of the container filling apparatus of the modification along the III-III line of FIG. 1 is a sectional view of a filling device according to an embodiment of the present invention. FIG. 5 is a sectional view of a part of the filling device shown in FIG. 4. 1 is a partial perspective view of a known exemplary vertical container conveyor that can be used in a container filling apparatus according to the present invention. 1 is a partial perspective view of a known exemplary horizontal container conveyor that can be used in a container filling apparatus according to the present invention. FIG. 8 is a cross-sectional view of the exemplary horizontal container conveyor along line VIII-VIII of FIG. 7.

Explanation of reference numerals

14 Bottle 41 Bottle Filler 42 Sterilized Inner Supply Enclosure 43 Vibrating Belt Inner Supply Station 44 Transfer Star Wheel 45 Main Container Conveyor 46 Prefill Inspection and Weighing Station 47 Filling Station 48 Conveyor 49 Nozzle 50 Bottle Washer / Disinfection Tunnel 52 Post Fill Inspection Weigh Station 53 Stop Station 54 Discharge Outer Supply Station 55 Vertical Leg Member 56 Lateral Rail Member 57 Mounting Plate 58 Vertical Frame Support Member 59 Mounting Plate 61 Stainless Steel Sheet 63 Stainless Steel Cabinet 64 Internal Sterilization Zone 65 Front Plate 70 Non-sterilization zone

Claims (29)

An apparatus for filling a container in a substantially sterile environment,
An upright wall dividing the device for filling the container into a substantially non-contaminated sterilization zone and a non-sterilization zone arranged at least in part in a side-by-side relationship;
An enclosure cooperating with the upright wall to define one of the sterilization zone and the non-sterilization zone;
A transfer unit that receives an empty container from a position outside the sterilization zone;
At least a part is disposed in the sterilization zone, a transport unit that moves the container via the sterilization zone,
A filling mechanism for filling the container with a pharmaceutical product in the sterilization zone when the container moves through the sterilization zone, comprising at least one dispenser disposed in the sterilization zone; and A drive disposed in the non-sterilization zone, and through a sealed opening in the upright wall between the filling mechanism dispenser in the sterilization zone and the drive in the non-sterilization zone. The filling mechanism extending,
A device configured and positioned to control the flow of a medicament from the at least one dispenser, the device being movable with the at least one dispenser, the at least one dispenser being in charge engagement with the container. And said device being reciprocally movable in at least one of a vertical direction and a horizontal direction so as to be disengaged from the engaged state.   2. The apparatus for filling containers according to claim 1, further comprising a transport for moving the containers through the sterilization zone.   The apparatus for filling containers according to claim 1, further comprising a frame supporting the upright wall and the enclosure.   2. The apparatus for filling containers according to claim 1, further comprising a coupling device between said drive and said filling mechanism dispenser, said coupling device passing through said sealed opening of said upright wall. Device for filling containers.   The apparatus for filling a container according to claim 1, further comprising a plurality of actuators, wherein the actuators include the filling mechanism, wherein the actuators are arranged in a continuous relationship; At least a portion of each of the actuators is located within the sterilization zone, and each of the actuators includes a drive located within the non-sterilization zone, with respect to the container at each of the actuators. A given operation is performed and each of the actuators passes through the sealed opening in the upright wall between the portion in the sterilization zone and the drive in the non-sterilization zone. Device for filling containers.   The apparatus for filling a container according to claim 5, wherein the plurality of actuators comprises a closing device.   The apparatus for filling containers according to claim 1, wherein the enclosure includes a bottom wall and a drain disposed within the bottom wall.   Apparatus for filling containers according to claim 1, wherein the upright wall comprises a substantially vertical wall member. An apparatus for filling a container in a substantially sterile environment,
Frame and
Upstanding walls supported by the frame, which divide the device for filling the containers into a substantially non-contaminated sterilization zone and a non-sterilization zone arranged at least in part in a side-by-side relationship;
An enclosure cooperating with the upright wall to define the sterilization zone;
A transfer unit that receives an empty container from a position outside the sterilization zone;
At least a part is disposed in the sterilization zone, a transport unit that moves the container via the sterilization zone,
A filling station located in the sterilization zone, which fills the container with a medicament when the container is moved through the sterilization zone by the transporter;
A drive operatively connected to the filling station and disposed within the non-sterilization zone;
A coupling device between the drive and the filling station extending through a sealed opening in the upright wall;
At least one dispenser coupled to the filling station;
A device configured and positioned to control the flow of a medicament from the at least one dispenser, the device being movable with the at least one dispenser, the at least one dispenser being in charge engagement with the container. And said device being movable out of said engaged state.   The apparatus for filling containers according to claim 9, wherein the enclosure comprises a bottom wall and a drain disposed in the bottom wall.   Apparatus for filling containers according to claim 9, wherein the upright wall comprises a substantially vertical wall member.   The apparatus for filling containers according to claim 11, wherein the substantially vertical wall member and the enclosure comprise stainless steel. The apparatus for filling containers according to claim 9, wherein the transporter comprises:
First and second drive wheels each arranged to rotate about a substantially horizontal axis and arranged in facing relation;
An endless conveyor belt surrounding the first and second drive wheels and defining upper and lower flights;
An apparatus for filling containers, comprising: a plurality of container transport members secured in spaced relation to the endless conveyor belt.   14. The apparatus for filling containers according to claim 13, wherein each of the container transport members is arranged in a resting relationship on an outer surface of the endless conveyor belt.   15. The apparatus for filling containers according to claim 14, wherein a width of each of the container transport members substantially corresponds to a width of the endless conveyor belt.   16. The apparatus for filling containers according to claim 15, wherein each of the container transport members defines a platform sized and configured to receive and supportably transport one of the containers. Equipment for filling.   17. The apparatus for filling containers according to claim 16, wherein each of said container transport members is laterally disposed above said platform to provide lateral support for containers of different sizes. An apparatus for filling a container, further comprising an open V-shaped recess.   The apparatus for filling containers according to claim 9, wherein the filling station comprises a plurality of dispensers arranged in a substantially linear relationship. An apparatus for filling a container in a substantially sterile environment,
Frame means;
Upstanding wall means supported by the frame means, which divides the device for filling the container into a substantially non-contaminated sterile zone and a non-sterile zone arranged at least in part in a side-by-side relationship;
Enclosure means supported by the frame means and cooperating with the upright wall means to define the sterilization zone;
At least a part is disposed in the sterilization zone, and transport means for moving the container via the sterilization zone,
Container transfer means for transferring an empty container from a position outside the sterilization zone to the transport means in the sterilization zone,
Means for filling the container with a medicament, disposed in the sterilization zone, when the container is moved through the sterilization zone by the transport means;
Driving means disposed in the non-sterilization zone for activating the means for filling the container;
Connecting means extending through the sealed opening of the upright wall means and operably connecting the drive to means for filling the container;
At least one dispenser coupled to the means for filling;
A device configured and positioned to control the flow of a medicament from the at least one dispenser, the device being movable with the at least one dispenser, the at least one dispenser being in charge engagement with the container. And said device being movable out of said engaged state. An apparatus for filling a pharmaceutical container in a substantially sterile environment,
An upright wall dividing the device for filling the medicament container into a substantially non-contaminated sterile zone and a non-sterile zone arranged at least in part in a side-by-side relationship;
An enclosure cooperating with the upright wall to define the sterilization zone;
A transfer unit that receives an empty pharmaceutical container from a position outside the sterilization zone;
A plurality of actuators arranged in a continuous relationship, each of the actuators being at least partially disposed within the sterilization zone, and each of the actuators being disposed within the non-sterilization zone; A drive is located at each of the actuators, wherein a given operation is performed on the medicament container at each of the actuators, each of the actuators includes the portion within the sterilization zone and the portion within the non-sterilization zone. The plurality of actuators extending through the sealed opening of the upright wall between a drive and
At least a portion is disposed in the sterilization zone, a transport unit that moves the medicine container via the plurality of actuators,
At least one dispenser configured and configured to direct a flow of medicament into the medicament container;
A device configured and positioned to control the flow of a medicament from the at least one dispenser, the device being movable with the at least one dispenser, the at least one dispenser being in charge engagement with the container. Device for filling a pharmaceutical container, said device being able to move out of said engaged state.   21. The apparatus for filling pharmaceutical containers according to claim 20, further comprising a transport for moving the containers through the sterilization zone.   21. The apparatus for filling a pharmaceutical container according to claim 20, further comprising a frame supporting the upright wall and the enclosure.   21. The apparatus for filling a pharmaceutical container according to claim 20, further comprising a plurality of drives, wherein the drives are in operable communication with corresponding first portions of the plurality of actuators. An apparatus for filling a pharmaceutical container, wherein the drive is located in the non-sterilization zone.   24. The apparatus for filling a pharmaceutical container according to claim 23, comprising a plurality of coupling devices between each of the plurality of drives and a corresponding first portion of the plurality of actuators, the coupling device comprising: Apparatus for filling a medicament container extending through the sealed opening in the upright wall.   21. The apparatus for filling a pharmaceutical container according to claim 20, wherein the plurality of actuators comprise a filling mechanism and a closing device.   21. The apparatus for filling a pharmaceutical container according to claim 20, wherein the enclosure comprises a bottom wall and a drain disposed within the bottom wall.   21. The apparatus for filling a pharmaceutical container according to claim 20, wherein said upstanding wall comprises a substantially vertical wall member.   21. The apparatus for filling a pharmaceutical container according to claim 20, further comprising a sealed access to enter the sterilization zone from outside the sterilization zone during operation of the apparatus. Equipment for.   29. The apparatus for filling a pharmaceutical container according to claim 28, wherein said sealed access includes a glove port.

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