Freeze-drying apparatus

Abstract

A freeze-drying apparatus (8) includes means (9) for moving the container, such as a vial or the like, along the surface of a support container (10) to load the container into and / or unload it from a freeze-drying chamber (200), characterized in that the means comprises two articulated arms, each articulated arm comprising a rigid first upper arm and a rigid first lower arm interconnected by a first rotary joint, the ends of the two articulated arms being connected to a rigid transfer rod via articulated joints (40, 20), the articulated joints being spaced apart from each other when viewed along the extension axis of the transfer rod, the two articulated arms being synchronously driven by at least one drive unit such that the transfer rod is movable along the loading and / or unloading axis to load the container into or unload it from the freeze-drying chamber.

Description

Technical Field

[0001] This invention relates to a freeze-drying apparatus, including means for moving containers such as vials along the surface of a support container to load the containers into and / or unload them from the freeze-drying chamber. Background Technology

[0002] Loading and unloading devices often require a large area in the cleanroom in front of the freeze-drying processing chamber, and are difficult to install within the available internal volume of sterile isolation units. Existing loading and unloading solutions are also not easily accessible with gloves if manual operation is required. Sometimes, certain areas of these devices are simply inaccessible with gloves due to the distance between the glove opening and these areas.

[0003] Loading and unloading equipment is a complex mechanical system that is difficult to clean, inspect, and disinfect according to the requirements for handling pharmaceuticals. They often have inaccessible areas. Some systems use flexible corrugated pipes with recessed areas that are unreachable, making cleaning or disinfection practically impossible when these systems are in certain positions. Summary of the Invention

[0004] The present invention addresses these problems by providing a freeze-drying apparatus conforming to claim 1.

[0005] The freeze-drying equipment features a compact design that provides linear push-pull motion of a transfer rod for loading or unloading containers (e.g., single vials, vials in frames or trays, vials in nests, pre-filled syringes or cartridges for freeze-drying) while minimizing space occupation in a cleanroom. The articulated arms and transfer rods are compact and can be fully housed within an optional isolator, allowing for complete gloved access to all components exposed to processing, facilitating cleaning, sterilization, and inspection.

[0006] In one embodiment, the extension axis of the transfer rod extends in a straight line to facilitate loading and / or unloading of multiple containers.

[0007] Preferably, the loading and / or unloading axis extends in a straight line to facilitate loading and / or unloading of multiple containers.

[0008] According to a preferred embodiment, the loading and / or unloading axis is perpendicular to the extension axis of the transfer rod, thereby providing a robust and reliable mechanism.

[0009] In particular, the transfer rod may include a pusher plane extending in a direction parallel to the extension axis of the transfer rod and acting in a pushing manner on a plurality of containers. Alternatively or additionally, the transfer rod may also include additional elements (e.g., grippers, extension profiles, hooks, or similar devices) acting in a traction manner on the plurality of containers.

[0010] Preferably, the two articulated arms move in opposite directions of rotation, thereby providing a stable and symmetrical mechanism.

[0011] Optionally, the freeze-drying equipment includes a drive unit for the vertical movement of the two articulated arms and the transfer rod.

[0012] The two articulated arms preferably have the same effective length to facilitate the linear movement of the transfer rod and avoid the transfer rod being subjected to lateral or bending forces.

[0013] Each of the two articulated arms includes a rigid first upper arm and a rigid first lower arm interconnected by a first rotary joint. This articulated arm provides a simple yet robust two-element linkage. The corresponding ends of this articulated arm are referred to as "wrists." These "wrists" are associated with the ends of each lower arm, the ends of which are located away from the first rotary joint forming the "elbow."

[0014] The upper arms of the two hinged arms preferably have the same length, and the lower arms of the two hinged arms preferably have the same length.

[0015] In particular, the rotation axes of all joints are parallel to each other so that the two articulated arms and transfer rods produce planar motion in a plane parallel to a flat, particularly horizontal or slightly inclined support surface on which the container will be pushed and pulled along the loading and / or unloading axis.

[0016] In the storage position of the articulated arms, the upper and lower arms of each articulated arm are preferably parallel or substantially parallel to the extension axis of the transfer rod. This achieves a very compact footprint, allowing both articulated arms and the transfer rod to be fully installed within the available volume of an optional sealing isolation device.

[0017] According to a preferred embodiment, at least one of the articulated arms includes a second upper arm and a second lower arm, which are interconnected by a second rotary joint, thereby providing a particularly stable quadrilateral four-element linkage device.

[0018] The second upper arm is preferably driven by at least one drive unit (or another drive unit) so that the second upper arm and the first upper arm of the same articulated arm move in opposite directions of rotation.

[0019] To minimize installation space, the first upper arm is driven around a first axis, and the second upper arm is driven around a second axis, wherein the first axis and the second axis are concentric with each other.

[0020] According to a preferred embodiment, an articulated arm is arranged on a first side of the support platform, while at least one drive unit is arranged on a second side of the support platform, opposite to the first side. Therefore, rotational movement only on the first side of the support platform facilitates the integration of the freeze-drying equipment into pharmaceutical application facilities for the safe handling of sterile and / or toxic products. In particular, the first side lacks a bellows and a telescopic device protected by a bellows.

[0021] In particular, mounting at least one drive unit below the support platform of the loader and outside the processing area allows for maintenance without compromising the sealing and sterility of the freeze-drying equipment's processing area above the support platform, while protecting the products within the processing area. Similarly, when handling toxic products, the freeze-drying equipment's configuration protects operators and maintenance technicians from exposure to the toxic substances. Having at least one drive unit located below the support platform also prevents the processing area from being contaminated by lubricating oil from at least one drive unit.

[0022] This arrangement allows the two articulated arms to rotate only, resulting in a very simple design that facilitates aseptic processing, cleaning, and disinfection. It can also be installed within designated pharmaceutical processing areas. The drive unit can be physically isolated on the other side of the isolation area provided by the support platform, thus eliminating the limitation of the processing area.

[0023] The support platform not only physically isolates the two articulated arms from their drive units, but also provides structural support for the two articulated arms.

[0024] In particular, the first side mentioned above is part of a sorting and processing area (e.g., a cleanroom), while the second side mentioned above is outside the sorting and processing area. Attached Figure Description

[0025] The invention can be better understood and implemented by observing the accompanying drawings, which illustrate an exemplary but non-limiting embodiment, wherein:

[0026] Figure 1 A perspective view of an embodiment of a freeze-drying apparatus is shown, which includes loading and unloading devices integrated within a sealed isolator, and its storage location is shown.

[0027] Figure 2 It shows Figure 1 A perspective view of the equipment, with arrows indicating the direction of movement of different components of the freeze-drying equipment, where the processing chamber opening is in the open position, and the bridging platform extends to a single and continuous horizontal surface to connect the buffer platform belonging to the loading and unloading device and the standing platform located inside the processing chamber;

[0028] Figure 3 yes Figure 1 and Figure 2The diagram shows a perspective view of the device, but the bridging platform is retracted to close the opening (shown in the closed position).

[0029] Figure 4 yes Figure 1 A perspective view of the loading and unloading device in the equipment, wherein the loading and unloading device is in the extended position;

[0030] Figure 5 It shows the relationship with Figure 4 A consistent perspective view, with arrows indicating the direction of movement of the main components required to move from the retracted position to the extended position, wherein retraction of the device is achieved by reversing these directions of movement;

[0031] Figure 6 A cross-sectional view of the four-bar articulated arm and drive unit of the loading and unloading device of the freeze-drying equipment is shown;

[0032] Figure 7 A cross-sectional view of the double-link articulated arm and the loading and unloading device drive unit of the freeze-drying equipment is shown;

[0033] Figure 8 It shows Figure 6 An enlarged cross-sectional view of the four-bar articulated arm details the rotary bearing between the concentric rotating shaft and the washer, which provides a seal between the machining area and the technical area, which are located above and below the support platform, which acts as an isolation barrier, respectively.

[0034] Figure 9 , Figure 10 , Figure 11 , Figure 13 and Figure 14 The diagram illustrates a series of actions involved in loading containers onto the platform or rack of a freeze-drying apparatus.

[0035] Figure 9 A perspective view of the first step of the freeze-drying equipment is shown, in which the loading and unloading device loads a line of containers onto the feed conveyor, wherein a line of vials is ready to be pushed into the processing chamber;

[0036] Figure 10 It shows Figure 9 A perspective view of the second step of the freeze-drying equipment, in which the loading and unloading device has pushed a line of containers into the processing chamber, wherein the loading and unloading device is in the retracted storage position after being pushed and is ready to receive the next line of containers.

[0037] Figure 11 It shows Figure 9 and Figure 10 A perspective view of the freeze-drying equipment in the image, partially loaded with multiple rows of containers;

[0038] Figure 12 yes Figure 11 Top view of the freeze-drying equipment;

[0039] Figure 13 It shows Figures 9 to 12 A perspective view of the freeze-drying equipment in the final step of the loading operation, where the loading and unloading devices are fully extended, transferring an entire set of containers to a standing platform inside the processing chamber. The entire set of vials now fills the standing platform to its full capacity; and

[0040] Figure 14 It shows Figures 9 to 13 A perspective view of a freeze-drying unit in the transition phase between completing the loading of one standing platform and beginning the loading of the next. A full standing platform is moved vertically away, and the next empty standing platform is positioned for loading. The loading and unloading unit retracts completely into its storage position to receive containers again. Detailed Implementation

[0041] In the accompanying drawings, freeze-drying equipment is generally designated by reference numeral 8. The freeze-drying equipment includes loading and unloading devices 9, referred to as "device 9" in the following description.

[0042] The freeze-drying chamber of freeze-drying equipment 8 is indicated by reference numeral 200 in the attached drawing. For example... Figure 1 As shown, the processing chamber 200 includes at least one standing platform 202a or multiple standing platforms arranged in a stacked manner 202, such as five platforms 202a, 202b, 202c, 202d, and 202e. Lateral guides 203a are provided on opposite sides of each standing platform 202a to 202e to prevent the container 10 from falling from the side when pushed onto the standing platforms 202a to 202e by means of means 9, which are located in an area 100 outside the processing chamber 200.

[0043] The processing chamber 200 includes at least one opening 201, which can be closed and sealed by a movable door 204. During loading and unloading, the opening 201 remains open, while during processing, the door 204 is closed and sealed.

[0044] The device 9 preferably includes a fixed buffer platform 104, a movable bridging platform 105, and a conveying device 106. Guide devices 203b, aligned with guide devices 203a, are also provided on two opposite sides of platforms 104 and 105. In one specific embodiment, the various parts of the device 9 are mounted on a support platform 110 and integrated within a sealing isolator 300.

[0045] Figure 2 The movement of some components in this embodiment is shown:

[0046] - The transfer rod 60 belonging to the device 9 moves linearly along the horizontal loading and / or unloading axis 62, which is parallel to the planar platforms 104, 105 and 202a, parallel to the lateral guide device 203, and perpendicular to the opening 201 of the processing chamber 200;

[0047] - Buffer platform 104 remains stationary. It does not move;

[0048] - The diagram shows the bridging platform 105 hinged relative to the buffer platform 104 via rotational motion. This is just one example of how the platform moves;

[0049] - The door 204 of the machining chamber opens the opening 201 of the machining chamber 200 by moving vertically. Again, this mode of movement is merely an example;

[0050] - The standing platforms 202a, 202b, 202c, 202d and 202e can move vertically so that they can be accurately positioned one after another relative to the conveyor 106, the buffer platform 104 and the bridging platform 105;

[0051] Both the processing chamber 200 and the isolation chamber 300 are stationary.

[0052] Figure 2 The door 204 is shown in the open position, and the bridging platform 105 is in the extended position. It cooperates with the buffer platform 104 and the standing platform 202a to form a continuous horizontal surface 63 on which the container 10 can be supported and moved. Therefore, surface 63 represents a supporting surface.

[0053] Figure 3 It shows the relationship with Figure 2 The same components are used, but now that door 204 is closed, bridging platform 105 retracts to create a gap for door 204 to close.

[0054] Figure 4 and Figure 5 A perspective view of the device 9 is shown, which includes a drive unit 70 for moving and synchronizing the movement of the two articulated arms 102, 103. Figure 6 Detailed cross-sectional views of the hinge arm 102 and its auxiliary arms 102a and 102b are shown. Figure 7 A detailed cross-sectional view of the hinge arm 103 is shown.

[0055] like Figure 4 and Figure 5As shown, a preferred embodiment of the invention includes a drive unit 70, such as a motor for moving arms 102, 103, and a power device that transmits the rotation of the drive unit 70 to shafts 48, 49, 24 and causes them to rotate synchronously. The drive unit 70 moves shaft 72, on which a synchronous pulley 77 or equivalent power transmission element and gear 75 are attached. When shaft 72 rotates, its rotation is transmitted to gear 75 and pulley 77. The pulley 77 then transmits the rotation to shaft 49 belonging to articulated arm 102 via synchronous belt 79, particularly to its secondary arm 102a.

[0056] Gear 75 and gear 74 cooperate to transmit the rotation of shaft 72 to shaft 71, while simultaneously reversing the rotation direction of shaft 71. The rotation direction of shaft 71 is opposite to that of shaft 72.

[0057] A timing pulley 73 is attached to shaft 71. The pulley 73 transmits the rotation of shaft 71 to timing pulley 52 via timing belt 78. Pulley 52 is attached to shaft 48 of the secondary arm 102b belonging to the articulated arm 102.

[0058] In an embodiment where the synchronous pulleys 51, 52, 73, and 77 are identical, and the gears 74 and 75 are also identical, the rotational speed of the drive unit 70 is directly transmitted to the shaft 49, which rotates at the same speed and in the same direction as the drive unit 70. On one side, the rotation of the drive unit 70 is also directly transmitted to the shaft 48, which rotates at the same speed as the drive unit 70 and the shaft 49, but in the opposite direction. Now, shafts 49 and 48 rotate at the same speed but in opposite directions, as do the corresponding extensions of the first upper arm 46 and the second upper arm 47. The first upper arm 46 of the hinged arm 102 and the first upper arm 43 of the hinged arm 103 are of the same length. The distance between the first rotary joint 45 and the hinge portion 42 is the same as the length of the second upper arm 47. In this structure, as... Figure 4 and Figure 5 As shown, when the upper arms 47 and 46 rotate in opposite directions and at the same speed, the second rotary joint 44 of the auxiliary arm 102b and the first rotary joint 45 of the auxiliary arm 102a transmit the motion to the corresponding lower arms 43 and 41, thereby generating linear movement of the articulated joint 40 at the end of the articulated arm 102.

[0059] In one embodiment, another synchronous pulley 53 is attached to the synchronous pulley 52 of shaft 48. Pulley 53 rotates together with shaft 49 and pulley 52. ​​Pulley 53 is connected to pulley 26 via synchronous belt 80 and transmits the rotation of shaft 49 to shaft 24, which belongs to hinge arm 103. In one embodiment, synchronous pulleys 53 and 26 are identical, so the rotational speed and direction of shaft 49 are directly transmitted to shaft 24, which is attached to pulley 26 and belongs to hinge arm 103.

[0060] The length of the articulated arm 103 is the same as that of the secondary arm 102a of the articulated arm 102. The articulated arm 103 includes a first upper arm 23, a first rotary joint 22, and a first lower arm 21. At the end of the first lower arm 21, the rotary joint 20 connects the articulated arm 103 to the transfer rod 60.

[0061] Since the rotational speed of shaft 24 is exactly the same as that of shaft 49, but in the opposite direction, the articulated arms 102a and 103 (both connected to the transfer rod 60 via an articulated joint 40, 20) rotate in the same direction.

[0062] like Figure 5 As shown, when the drive unit 70 rotates at an angular velocity w in a specific direction, the first arm 47 and the second arm 23 rotate synchronously at the same speed w, while the first arm 46 also rotates synchronously at the same speed, but in the opposite direction (-w). This produces linear movement of the joints 20 and 40, thereby causing the transfer rod 60 to move linearly along the loading and / or unloading axis 62. The linear movement of the transfer rod 60 is generated solely by the rotational motion of the linkage system of the two articulated arms 102 and 103.

[0063] like Figure 6 , Figure 7 and Figure 8 As shown in the detailed cross-sectional view, in another specific aspect of the exemplary embodiment, the support elements 50, 25 of the hinged arms 102, 103 are mounted such that shafts 48, 49, 24 extend through the horizontal support platform 110. Shaft 49 is mounted on the support element 50 via a rotary bearing 91, while shaft 48 is mounted inside shaft 49 via a bearing 92. Dynamic seals 93, 94 are used to seal the gaps between shafts 49 and 48 and between shafts 49 and support element 50, while a static seal 95 is used to seal the gap between support element 50 and support platform 110.

[0064] With this structure for shaft 26 and support element 25, the hinge arms 102 and 103 can be separated from the drive unit 70 and designed with only the hinge joint and rotating parts. Since the drive unit 70 is more difficult to meet the requirements of pharmaceutical and aseptic processing, it can be separated on the other side of the support platform 110, away from the pharmaceutical processing area. The resulting structure can be integrated into the isolator 300, wherein the volume of the hinge arms 102 and 103 and the transfer rod 60 above the support platform 110 is contained within the housing of the isolator 300, while the volume below the support platform 110, including the drive unit 70, is contained outside the housing of the isolator 300.

[0065] Figures 9 to 14A general schematic diagram of the device 9 in different locations is shown to illustrate the loading sequence of transferring the product container 10 from the area 100 located outside the processing chamber 200 to the standing platform 202b located inside the processing chamber 200.

[0066] Figure 9 The first step of the loading sequence is shown, including the main components and arrows indicating the direction of movement of these components. The conveyor 106 receives product containers 10 from the filling device outside the freeze-drying equipment 8 and conveys the containers in a horizontal direction parallel to the processing chamber opening 201. Various possible arrangements (not within the scope of this description) are used between the filling machine and the conveyor 106 to arrange the containers 10 in a line on the conveyor 106 and parallel to its direction of movement.

[0067] Figure 10 The second step of the loading process is illustrated. A single row of containers 10, fed by conveyor 106, is pushed toward the processing chamber 200. Specifically, as the device 9 moves forward with a short stroke, the transfer rod 60 moves along the straight loading and / or unloading axis 62 toward the interior of the processing chamber 200, pushing the containers 10 from the conveyor 106 onto the buffer platform 104. During this operation, the containers 10 remain in a straight line. Once the containers 10 have been transferred to the buffer platform 104, the device 9 retracts with another short stroke, bringing the transfer rod 60 back to its original retracted storage position. The freeze-drying equipment 8 is now ready to receive the loading of the next row of containers 10.

[0068] repeat Figure 10 The process described herein involves accumulating a series of containers 10 onto a buffer platform 104. As the process proceeds, the accumulated containers 10 (e.g., vials) will fill the buffer platform 104, the bridging platform 105, and part of the standing platform 202b.

[0069] Figure 11 and Figure 12 The freeze-drying apparatus 8 is shown after loading 10 rows of containers 10. Figure 12 It is a top view showing a typical arrangement in which the continuously loaded containers 10 are staggered to achieve a compact hexagonal distribution of the containers 10, thereby maximizing capacity.

[0070] Figure 13 The final loading step of a single standing platform 202b is shown. Once enough containers 10 have accumulated, the device 9 will perform a long-distance movement to transfer all containers 10 from the buffer platform 104 and bridging platform 105 through the processing chamber opening 201 to the standing platform 202b located within the processing chamber 200. Once this movement is complete, the standing platform 202b is loaded.

[0071] Figure 14The process of loading a standing platform 202b and preparing the next empty standing platform 202a is illustrated. Device 9 retracts and moves transfer lever 60 back to its starting or storage position outside the processing chamber 200. The loaded standing platform 202b is moved vertically away, and the next empty standing platform 202a is moved in for loading. Figures 9 to 14 The process is repeated until all standing platforms are filled with container 10.

Claims

1. A freeze-drying apparatus (8) comprising means (9) for moving the container (10) along a surface (63) of a support container (10) to load the container (10) into and / or unload it from a freeze-drying chamber (200), characterized in that, The device (9) includes two hinged arms (102, 103), each of which includes a rigid first upper arm (46, 23) and a rigid first lower arm (41, 21) connected to each other via first rotary joints (45, 22). The ends of the two hinged arms (102, 103) are connected to a rigid transfer rod (60) via hinge joints (40, 20). When viewed along the extension axis (61) of the transfer rod (60), the hinge joints (40, 20) are spaced apart from each other. The two hinged arms (102, 103) are driven synchronously by at least one drive unit (70) such that the transfer rod (60) can move along the loading and / or unloading axis (62) to load the container (10) into or unload it from the freeze dryer processing chamber (200). In the storage position of the articulated arms (102, 103), the first upper arm (46, 23) and the first lower arm (41, 21) of each articulated arm (102, 103) are arranged parallel or substantially parallel to the extension axis (61) of the transfer rod (60).

2. The freeze-drying apparatus (8) according to claim 1, characterized in that, The loading and / or unloading axis (62) is perpendicular to the extension axis (61) of the transfer rod (60).

3. The freeze-drying apparatus (8) according to claim 1 or 2, characterized in that, The two hinged arms (102, 103) move in opposite directions of rotation.

4. The freeze-drying apparatus (8) according to claim 1 or 2, characterized in that, At least one of the articulated arms (102, 103) includes a second upper arm (47) and a second lower arm (43) interconnected by a second rotary joint (44).

5. The freeze-drying apparatus (8) according to claim 4, characterized in that, The second upper arm (47) is driven by the at least one drive unit (70) such that the second upper arm (47) and the first upper arm (46) of the same articulated arm (102, 103) move in opposite directions of rotation.

6. The freeze-drying apparatus (8) according to claim 5, characterized in that, The first upper arm (46) is driven about a first axis (49), and the second upper arm is driven about a second axis (48), with the first axis (49) and the second axis (48) being concentric with each other.

7. The freeze-drying apparatus (8) according to any one of claims 1, 2, 5, and 6, characterized in that, The articulated arms (102, 103) are arranged on the first side of the support platform (110), and the at least one drive unit (70) is arranged on the second side of the support platform (110) opposite to the first side.

8. The freeze-drying apparatus (8) according to claim 7, characterized in that, The first side is part of the classification processing area, and the second side is outside the classification processing area.

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