Hazardous material treatment equipment
The hazard material treatment device addresses the risk of hazard material release by using a shutter with a closure lock and cover to prevent adhesion, and a support member to maintain the shutter's open position, ensuring safe containment of hazard materials.
Patent Information
- Application Number
- JP2020182974
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2020-10-30
- Publication Date
- 2025-04-03
- Estimated Expiration
- 2040-10-30
AI Technical Summary
In existing hazard material treatment devices with isolators, there is a risk that hazard material can adhere to the shutter surface when it is retracted during chemical filling, potentially leading to the release of hazard material into the non-hazard area when the compartment wall is closed.
The device incorporates a shutter with a closure lock and a guide member, which ensures the shutter remains closed and covered with a cover in the open position, preventing hazard material from adhering to the closed surface. Additionally, a support member maintains the shutter in an open position, keeping the closed surface isolated from the hazard area.
This configuration effectively prevents hazard material from adhering to the shutter's closed surface, thereby preventing its release into the non-hazard area when the compartment wall is closed, ensuring a safer and more controlled environment.
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Abstract
Description
[Technical field]
[0001] The present invention relates to a hazardous material treatment device, and more particularly to a hazardous material treatment device that has an isolator for handling hazardous materials, the internal space of the isolator being divided into a hazard area and a non-hazard area by a partition wall, and the opening of the partition wall can be opened and closed by a shutter. [Background technology]
[0002] Conventionally, the process of filling drugs into containers such as vials has been carried out in a processing device equipped with an isolator whose internal space is maintained in a sterile environment. When handling drugs with high pharmacological activity (highly pharmacologically active drugs) such as anticancer drugs, these drugs act as hazardous substances and may cause health damage to processing workers, so it is necessary to prevent them from leaking out of the isolator into the external worker environment. In order to prevent hazardous substances from leaking from the isolator, the internal space of the isolator is divided into a hazard area where the hazardous substances are handled, and a non-hazardous area elsewhere. Each time a chemical filling operation is completed, the inside of the hazard area is cleaned to wash away any hazardous substances that have scattered and adhered to the equipment and walls. When dividing the isolator into a hazard area and a non-hazard area in this manner, a configuration is known in which a partition wall is provided in the internal space of the isolator and an opening formed in the partition wall can be opened and closed by a shutter (Patent Document 1). [Prior art documents] [Patent documents]
[0003] [Patent Document 1] Patent No. 4524886 Summary of the Invention [Problem to be solved by the invention]
[0004] However, in the configuration of Patent Document 1, if the shutter is provided on the hazard area side, there is a possibility that hazardous substances will adhere to the surface of the shutter if the shutter is simply retracted from the opening during the drug filling operation. As a result, when the opening in the partition wall was closed with the shutter to clean the inside of the hazard area after the chemical filling operation, the closed surface of the shutter, which is the surface facing the non-hazard area, was exposed to the non-hazard area through the opening with hazardous substances adhering to it, creating a risk of the hazardous substances leaking into the non-hazard area. In consideration of such problems, the present invention provides a hazardous material treatment device that prevents hazardous materials from adhering to the closing surface of a shutter when it is open in a hazard area, and that can prevent hazardous materials from flowing into non-hazardous areas when the opening in the partition wall is closed by the shutter. [Means for solving the problem]
[0005] That is, claim 1 The present invention described in A hazardous material treatment apparatus includes an isolator for handling hazardous materials in an internal space maintained in a sterile state, a partition wall for partitioning the internal space of the isolator into a hazard area and a non-hazard area, and a shutter for opening and closing an opening formed in the partition wall, The hazard area is provided with the shutter, a closing lock means for maintaining the shutter in a closed state at a closing position where the shutter closes the opening of the partition wall, and a guide member for guiding the shutter along the partition wall to the closed position and the open position, a cover for covering the closing surface of the shutter in the open position; and an open lock means for maintaining the shutter in a state in which the cover is covered. a support member for supporting the shutter without covering the shutter with the cover; Established When the hazard area and the non-hazard area are communicated, the closing surface of the shutter is covered with the cover in the open position, and the closing surface is maintained in a state where it is not exposed to the hazard area. death, When cleaning the hazard area, the opening is closed by the shutter; When the hazard area and the non-hazard area are communicated to perform decontamination, the shutter is supported by the support member in the open position.It is characterized by the following. Effect of the Invention
[0006] According to the above invention, when the hazard area and non-hazard area are connected, the closing surface of the shutter is covered with the cover and maintained in a state where the closing surface of the shutter is not exposed to the hazard area, so that hazardous substances do not adhere to the closing surface. Therefore, when the shutter closes the opening of the partition wall to separate the hazard area from the non-hazard area, even if the closing surface of the shutter is exposed to the non-hazard area, no hazard substance will flow into the non-hazard area because no hazard substance is attached to the closing surface. [Brief description of the drawings]
[0007] [Figure 1] FIG. 1 is an overall plan view of a hazardous material treatment device according to the present embodiment; [Diagram 2] Front view of the partition wall from the hazard area side [Diagram 3] Front view of the shutter from the hazard area side [Figure 4] A plan sectional view of the partition wall and the shutter. [Diagram 5] FIG. 4 is a side view showing a closed state of the shutter at the closed position. [Figure 6] FIG. 13 is a side view showing the shutter in the open position covered with a cover. [Figure 7] FIG. 11 is a side view showing a state in which the shutter is supported by a support member in the open position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0008] The illustrated embodiment will now be described. FIG. 1 shows a drug filling line 1 as a hazardous substance processing device for filling a container C such as a vial with a drug made of a hazardous substance. The drug filling line 1 of this embodiment includes, from the upstream side of the container C transport path, a container cleaning section 2 that washes empty containers C, a container sterilization section 3 that sterilizes empty containers C, a container transfer section 4 that transfers the sterilized containers C, a filling section 5 that fills empty containers C with drugs, a container sealing section 6 that seals the containers C filled with drugs, and a container exterior washing section 7 that cleans the exterior of the sealed containers C. Of these, the container transfer section 4, the filling section 5 and the container sealing section 6 are located in the internal space of an isolator 8 which is maintained in a sterile state, and the housings 2a, 3a which constitute the container cleaning section 2 and the container sterilization section 3 are connected in an airtight manner to a position adjacent to the upstream side of the isolator 8, and a hazard booth 9 which houses the container exterior washing section 7 is connected in an airtight manner to a position adjacent to the downstream side of the isolator 8.
[0009] The isolator 8 is well known and therefore will not be described in detail, but the internal space of the isolator 8 can be decontaminated by a decontamination means (not shown). Specifically, a decontamination medium such as hydrogen peroxide vapor is filled into the internal space of the isolator 8, which makes it possible to decontaminate the equipment and internal walls housed in the isolator 8. After decontamination, a positive pressure relative to the outside is maintained by supplying sterile air to the internal space using a sterile air supply means (not shown), thereby maintaining a sterile state.
[0010] Below, we will explain each part that makes up the above-mentioned drug filling line 1.First, the container cleaning section 2 is composed of the above-mentioned housing 2a, the interior of which is partitioned from the outside, a supply conveyor 10 connected to the upstream side of the housing 2a for supplying empty containers C, and a cleaning means (not shown) provided inside the housing 2a. The above-mentioned cleaning means is well known and will not be described in detail, but it cleans the inside and outside of the container C and discharges it into the container sterilization section 3.
[0011] Next, the container sterilization section 3 is composed of the housing 3a, the inside of which is partitioned from the outside, and a sterilization means (not shown) provided inside the housing 3a, and sterilizes the washed containers C by heating them. The sterilization means can be a conventionally known one. Here, the housing 2a of the container cleaning section 2 and the housing 3a of the container sterilization section 3 are connected in an airtight manner, and the housing 3a of the container sterilization section 3 and the isolator 8 are connected in an airtight manner. As a result, the container C washed by the container washing section 2 is immediately heat-sterilized in the container sterilization section 3, and then supplied in a sterilized state to the isolator 8 which is maintained in a sterile condition.
[0012] The container transfer section 4 is composed of an output conveyor 11 that discharges the containers C from the container sterilization section 3, and a first star wheel 12 that takes out the containers from the output conveyor 11 one by one and transports them. The above-mentioned discharge conveyor 11 and first star wheel 12 are well known in the art and will not be described in detail here, but using a means such as a screw arranged along the above-mentioned discharge conveyor 11, containers C are supplied one by one to pockets provided on the outer periphery of the first star wheel 12.
[0013] The filling section 5 includes second and third star wheels 13 and 14 for receiving the containers C from the first star wheel 12 of the container transfer section 4, and a filling means for filling each container C with a medicine. The second and third star wheels 13, 14 rotate in synchronization with the first star wheel 12 of the container transfer section 4, and transfer the container C at adjacent positions. The filling means has a configuration capable of filling a plurality of containers C with medicine at the same time, and has a conventionally known configuration, so further explanation will be omitted.
[0014] The container sealing section 6 includes a sealing means for sealing the container C filled with a drug, and a fourth star wheel 15 provided downstream of the sealing means, and an intermediate conveyor 16 for transporting the container C filled with a drug is provided between the filling means of the filling section 5 and the sealing means. The sealing means has a conventionally known configuration, and is configured to seal the mouth of the container using a rubber plug or the like, or to seal the mouth of the container by heating and melting it. The container C sealed by the sealing means is transported to the container exterior washing section 7 via the fourth star wheel 15.
[0015] The container exterior washing section 7 is housed within the hazard booth 9 and is equipped with a fifth star wheel 17 that receives and transports containers C from the fourth star wheel 15 of the container sealing section 6, a container exterior washing means that washes the outside of the sealed container C, and a sixth star wheel 19 for transferring the washed containers to the discharge conveyor 18. The container exterior washing means is configured to inject a washing liquid onto the outside of the sealed container C to wash away any chemicals adhering to the container C, and has a conventionally known configuration. A discharge conveyor 18 is connected to the hazard booth 9, and discharges the container C, which has been washed and transported by the sixth star wheel 19, to a subsequent process.
[0016] Here, the drugs filled in this embodiment are highly pharmacologically active pharmaceutical ingredients such as anticancer drugs, and in order to prevent health damage to workers caused by such highly pharmacologically active pharmaceutical ingredients, it is necessary to prevent the drugs (hazardous substances) from leaking into the external worker environment. Since the above-mentioned medicine is most likely to scatter when the medicine is filled into the container C in the filling section 5, the area containing the filling section 5 and the container sealing section 6 and container exterior washing section 7 located downstream of it constitute a hazard area where there is a risk of the medicine scattering, while the area upstream of the filling section 5 constitutes a non-hazard area where there is little risk of the medicine scattering. Therefore, in this embodiment, a partition wall 21 is provided inside the isolator 8, and the upstream side of this partition wall 21 is set as the non-hazard area A, while the downstream side of the partition wall 21 in the isolator 8 is set as the hazard area B.
[0017] In this embodiment, in order to prevent chemicals consisting of hazardous substances floating in the air from leaking out, the pressure relationship between the non-hazard area A, hazard area B, and hazard booth 9 is set as follows. First, the inside of the isolator 8 is set to a positive pressure relative to the outside, with the non-hazard area A being set to the highest positive pressure and the hazard area B being set to a lower positive pressure. This creates a pressure difference between non-hazard area A and hazard area B, preventing any medicine that splashes in hazard area B from flowing into non-hazard area A. Next, the inside of the hazard booth 9 is set to a negative pressure relative to the external atmospheric pressure, so that the hazard area B has a positive pressure relative to the hazard booth 9. This allows any chemicals that may have scattered in hazard area B to flow into hazard booth 9, and since hazard booth 9 is at a negative pressure relative to atmospheric pressure, it prevents the chemicals from leaking out of hazard booth 9 to the outside.
[0018] On the other hand, the chemicals scattered in the hazard area B may adhere to the equipment constituting the filling section 5 and the container sealing section 6, the inner wall of the isolator 8 constituting the hazard area B, and the partition wall 21. As such, since there is a risk that scattered chemicals may adhere and remain in hazard area B, it is necessary to clean it with water after the chemical filling work is completed. On the other hand, since there is no need to wash with water into the non-hazard area A where there is no risk of drugs flowing in, when washing with water, the opening 21a in the partition wall 21 is closed with a shutter 22 to separate the non-hazard area A from the hazard area B, thereby preventing hazard substances from flowing out from the hazard area B to the non-hazard area A during washing.
[0019] Hereinafter, the partition wall 21 that divides the inside of the isolator 8 into the hazard area B and the non-hazard area A, and the shutter 22 that opens and closes the partition wall 21 will be described. First, as shown in FIG. 1, the partition wall 21 is provided between the container transfer section 4 and the filling section 5 in the isolator 8, specifically at a position that is the boundary between the first star wheel 12 and the second star wheel 13. For this reason, during the drug filling operation, the container C is transported with the opening 21a of the partition wall 21 open, but after drug filling is completed, when the opening 21a of the partition wall 21 is closed with the shutter 22, the second star wheel 13 is removed.
[0020] Fig. 2 shows the partition wall 21 provided in the isolator 8 as viewed from the hazard area B side, and the shutter 22 is indicated by a chain line in Fig. 2. Fig. 3 shows the shutter 22 as viewed from the same direction, Fig. 4 is a plan sectional view of the partition wall 21, and Figs. 5 to 7 show the shutter 22 in each of the closed and open positions. First, in Figure 2, the partition wall 21 has a horizontally long, approximately rectangular opening 21a that connects the hazard area B with the non-hazard area A, and in Figure 2, the opening 21a is located in a position biased to the right side of the partition wall 21 as shown. The shutter 22 is arranged to be able to move back and forth along the partition wall 21 between a closed position located on the right side of the figure, where it closes the opening 21a, and an open position located on the left side of the figure, and the movement of this shutter 22 is performed manually by an operator using a glove 23 provided on the side wall 21A of the hazard area B shown in Figure 4.
[0021] First, the configuration of the shutter 22 shown in Fig. 3 will be described. The shutter 22 is made of a single plate-like member and has a horizontally long rectangular shape similar to the opening 21a, and is large enough to completely close the opening 21a and extend beyond it. In the following description, the surface of the shutter 22 on the non-hazard area A side, i.e., the surface that faces the partition wall 21a and closes the opening 21a when it is in the closed position, will be referred to as the closing surface 22a, and the opposite surface will be referred to as the surface 22b. A lock mechanism 24 is provided on the upper portion of the shutter 22 to fix the shutter 22 in the closed or open position. In addition, a handle 22c for an operator to hold is provided on the surface 22b of the shutter 22 at the end close to the side wall 21A on which the globe 23 of the isolator 8 is provided, and an endless sealing member 25 shaped to surround the opening 21a is fixed to the closing surface 22a. Furthermore, a metal round bar 26 is fixed horizontally to the lower part of the surface 22b of the shutter 22 via an attachment member, and when the shutter 22 is moved between the closed position and the open position, this round bar 26 is guided by a guide member 27 described later.
[0022] As shown in FIG. 4, the locking mechanism 24 is composed of two rotating shafts 28 that are provided at the same height position above the sealing member 25 provided on the closing surface 22a of the shutter 22 and that penetrate vertically through the shutter 22, two arms 29 that are fixed to the parts of each rotating shaft 28 that protrude toward the surface 22b of the shutter 22 and are provided in parallel, a link member 30 that is rotatably connected to the tip of each arm 29, and a plate-shaped locking member 31 that is provided on the end of each rotating shaft 28 that protrudes toward the closing surface 22a of the shutter 22. Further, of the rotating shafts 28, the one of the rotating shafts 28 closer to the handle 22c is provided at its tip end protruding toward the front surface 22a of the shutter 22, with a handle 32 for operation by an operator. With this configuration, when the operator operates the handle 32 to rotate one of the rotating shafts 28, the other rotating shaft 28 also rotates in the same direction via the arms 29 and link member 30, whereby the locking members 31 fixed to the ends of the two rotating shafts 28 on the closing surface 22a side of the shutter 22 simultaneously rotate in the same direction around the rotating shafts 28 between a vertically long upright state and a horizontally long rolled over state.
[0023] As shown in Figures 2 and 5, the partition wall 21 of the isolator 8 on the hazard area B side is provided with multiple guide members 27, aligned at the same height in the horizontal direction, for guiding the movement of the shutter 22 via brackets 21b, with three at each of the closed and open positions of the shutter 22. In FIG. 2, a predetermined gap is provided between adjacent guide members 27, and as shown in FIG. 5, each guide member 27 has a groove 27a having a U-shaped cross section, with the opening of the groove 27a facing upward. The round bar 26 of the shutter 22 is accommodated in the groove 27a of the guide member 27, thereby supporting the shutter 22 and guiding the round bar 26 horizontally along the partition wall 21 when the shutter 22 is moved between the closed position and the open position. Further, the side surface of each groove 27a opposite to the partition wall 21 is extended upward so as to move away from the partition wall 21 to form an inclined guide surface 27b. This allows the operator to move the shutter 22 while being guided by the guide member 27 with the upper portion of the shutter 22 inclined toward the operator relative to the partition wall 21 so as to move away from the partition wall 21. Here, since the round bar 26 of the shutter 22 and the U-shaped cross-sectional groove 27a of the guide member 27 are in line contact rather than surface contact, when the inside of the isolator 8 is decontaminated with decontamination gas or when the hazard area B is washed with water, the area exposed to the space can be made larger, making decontamination and washing more reliable. In addition, by providing a plurality of guide members 27 spaced apart from one another, it becomes difficult for the decontamination components liquefied by condensation or the cleaning liquid used for rinsing to remain in the grooves 27a during the decontamination and rinsing.
[0024] Next, as shown in Figure 4, an opening frame member 33 is provided on the surface of the partition wall 21 facing the hazard area B, protruding from the partition wall 21 so as to surround the opening 21a, and the opening frame member 33 has a U-shaped cross section and a flange portion 33a is formed at the protruding end. An end face 33ab of the flange portion 33a facing the closing face 22a of the shutter 22 is provided as a sealing face that comes into close contact with the seal member 25 provided on the closing face 22a. In this embodiment, the opening 21a is formed including the inner peripheral portion of the opening frame member 33, and the end face 33ab of the flange portion 33a is formed as the peripheral surface of the opening 21a. As shown in Figure 2, a closing side stopper 46 that regulates the end of movement of the shutter 22 when it moves from the open position to the closed position is fixed to the partition wall 21 on the hazard area B side and is positioned above the end portion close to the side wall 21A of the opening frame member 33. The closing side stopper 46 is adapted to abut against an upper corner of the front end in the moving direction from the open position to the closed position, which is on the side wall 21A side of the shutter 22 being moved, thereby restricting the movement end. As a result, the shutter 22 is supported by the guide member 27 and abuts against the closing side stopper 46, so that the closing surface 22a completely covers the opening 21a formed by the opening frame member 33, and further, the sealing member 25 provided on the closing surface 22a is positioned in a closing position that reliably surrounds the opening 21a. To close the opening 21a of the partition wall 21 with the shutter 22, the locking mechanism 24 of the shutter 22 positioned in the closed position is operated so that the closing surface 22a of the shutter 22 is pressed against the flange portion 33a by the closing locking means provided in the closed position to fix the position, and the sealing member 25 is brought into close contact with the end face 33ab of the flange portion 33a, thereby completely sealing the opening 21a and separating the internal space of the isolator 8 into the hazard area B and non-hazard area A.
[0025] In Figure 2, above the opening 21a, two vertically elongated fixed pieces 34 are provided on the partition wall 21 as a closing locking means that engages with the locking mechanism 24 of the shutter 22, and a closing side sensor 35 is provided between these fixed pieces 34. The fixing piece 34 is provided at a predetermined distance from the partition wall 21 and is located adjacent to the side wall 21A of each of the locking members 31 that constitute the locking mechanism 24 of the shutter 22 positioned in the closed position, and protrudes above the flange portion 33a of the opening frame member 33. When the sealing member 25 of the shutter 22 is pressed against the end face 33ab of the flange portion 33a of the opening frame member 33 and an operator operates the handle 32 of the locking mechanism 24 in this state, the two vertically elongated upright locking members 31 rotate clockwise and each assumes a horizontally elongated rolled-over state so as to overlap with the surface of the fixing piece 34 on the partition wall 21 side, the shutter 22 is attracted to the flange portion 33a, and the sealing member 25 provided on the closing surface 22a of the shutter 22 is maintained in a state of being pressed against the end face 33ab of the flange portion 33a. At this time, an inclined surface is formed on the locking member 31 so that the thickness gradually increases from the end on the side adjacent to the fixed piece 34, so that when the locking member 31 is rotated, the locking member 31 easily rides up onto the surface of the fixed piece 34 on the partition wall 21 side.
[0026] The closing side sensor 35 is a proximity sensor provided above the flange portion 33a of the opening frame member 33, and detects that the shutter 22 is in the closed state when the shutter 22 is in close contact with the flange portion 33a with the sealing member 25 sandwiched between them in the closed position. In other words, when the shutter 22 is in the closed position and the upper part is separated from the partition wall 21 and away from the flange portion 33a, or when the shutter 22 is in the open position, the closing side sensor 35 does not detect the shutter 22.
[0027] 2, at the open position adjacent to the closed position where the shutter 22 is located, a cover plate 36 to which the seal member 25 of the shutter 22 is in close contact is provided on the surface of the partition wall 21 on the hazard area B side. A guide member 27 for supporting the round bar 26 of the shutter 22 is provided below the cover plate 36, and a support member 37 is provided above the cover plate 36 as a spaced state maintaining means for supporting the shutter 22 in an inclined state. The cover plate 36 is composed of a flat plate-like member as a cover that covers the closing surface 22a of the shutter 22, and forms a cover surface 36a that is larger than the area surrounded by the sealing member 25 of the shutter 22, and the outer diameter dimension of this cover surface 36a is the same as the outer diameter dimension of the end surface 33ab of the flange portion 33a. As shown in FIG. 6, a support member 38 is provided between the cover plate 36 and the partition wall 21, so that the cover surface 36a of the cover plate 36 is parallel to the partition wall 21 and forms the same plane as the end surface 33ab of the flange portion 33a of the opening frame member 33. With this configuration, when the shutter 22 is raised perpendicular to the guide member 27 and parallel to the partition wall 21 as shown in Figure 6, the shutter 22 is in close contact with the cover plate 36 and the entire circumference of the sealing member 25 is in close contact with the cover surface 36a of the cover plate 36, so that the area inside the sealing member 25 of the closing surface 22a is isolated from the hazard area B.
[0028] As shown in Figures 6 and 7, the support member 37 is fixed to the partition wall 21 by a bracket 21c and is located at a position farther from the partition wall 21 than the cover plate 36. In the open position, the shutter 22 can be tilted so that its upper portion moves away from the partition wall 21, and the upper end of the shutter 22 abuts against a step shape 37a formed at the lower end of the support member 37, thereby supporting the shutter 22 in an inclined state. When the shutter 22 is supported in an inclined position by the support member 37 in this manner, the sealing member 25 of the shutter 22 is completely separated from the cover plate 36, thereby exposing the entire cover surface 26a of the cover plate 36 and the inner area of the sealing member 25 of the closing surface 22a of the shutter 22 to the hazard area B. As shown in FIG. 2, the support member 37 has a length that exceeds the width of the cover plate 36, and an open side stopper 37b is provided at the end opposite the closed position that is far from the side wall 21A. As a result, when the shutter 22 moves from the closed position to the open position, the open side stopper 37b abuts against the upper corner on the forward side in the direction of travel of the shutter 22 to restrict the movement, thereby making it possible to position the shutter 22 in the open position. Furthermore, the step shape 37a at the end of the support member 37 on the closed position side near the side wall 21A is designed to be able to abut against the upper corner of the rear end of the shutter 22 positioned in the closed position in the direction of travel from the open position to the closed position. On the other hand, the closing side stopper 46 is also formed with a step shape 46a similar to the step shape 37a formed on the lower end portion of the support member 37, the step shape 46a being aligned in height with the step shape 37a. As a result, in the closed position, just like in the open position, the step shape 37a at the end of the support member 37 on the closed position side and the step shape 46a of the closed side stopper 46 enable the shutter 22 to be supported with its upper part tilted away from the partition wall 21.
[0029] As shown in Figure 2, an open locking means having a configuration similar to that of the closed locking means provided in the closed position is also provided in the open position of the shutter 22, and two fixed pieces 39 and an open side sensor 40 as open locking means are provided above the cover plate 36 in the same positional relationship as the two fixed pieces 34 and the closed side sensor 35 relative to the opening frame member 33. As a result, the two locking members 31 of the shutter 22 overlap with the two fixed pieces 39 so as to overlap with the two fixed pieces 34, thereby maintaining the shutter 22 in close contact with the cover plate 36. In addition, the opening side sensor 40, like the closing side sensor 35, detects when the shutter 22 is in close contact with the cover plate 36 in the open position, and the opening side sensor 40 does not detect the shutter 22 when the shutter 22 is supported by the support member 37 or when the shutter 22 is in the closed position.
[0030] The closing side sensor 35 and the opening side sensor 40 are connected to a display means (not shown), enabling the operator to check the position and status of the shutter 22 by the information displayed on this display means. Specifically, when the shutter 22 is in the closed position and in close contact with the flange portion 33a of the opening 21a as shown in FIG. 5, the closing side sensor 35 detects this and the display means displays that the opening 21a is in the closed state by the shutter 22. Furthermore, when the shutter 22 is in the open position and in close contact with the cover plate 36 as shown in FIG. 6, the open side sensor 40 detects this and the display means displays that the shutter 22 is in close contact with the cover plate 36. On the other hand, when the shutter 22 is supported by the support member 37 as shown in Figure 7, or when the shutter 22 is not in a completely tight contact with the flange portion 33a or the cover plate 36 as shown in Figures 5 and 6, the closing side sensor 35 and the opening side sensor 40 will not detect the shutter 22, and it will be displayed that the shutter is not in either the state shown in Figure 5 or Figure 6.
[0031] The operation of the medicine filling line 1 having the above configuration will now be described. First, the operation of the drug filling line 1 when filling the container C with drugs will be described. At this time, the shutter 22 of the partition wall 21 is located at the open position and is in close contact with the cover plate 36 shown in Fig. 6. The display means displays this fact by detection of the open side sensor 40. When the shutter 22 is in close contact with the cover plate 36, the area inside the seal member 25 provided on the shutter 22 is isolated from the space of the hazard area B outside the seal member 25 by the shutter 22 and the cover plate 36.
[0032] In this state, when an empty container C is supplied from the supply conveyor 10, the container C is cleaned and sterilized in the cleaning section 2 and container sterilization section 3, and the sterilized container C is transferred from the housing 3a of the container sterilization section 3 to the output conveyor 11 of the container transfer section 4 in the non-hazard area A partitioned by the isolator 8. Since the container transfer section 4 is housed in an isolator 8, the container C is transported in a sterile environment and transferred from the first star wheel 12 to the second star wheel 13 of the filling section 5.
[0033] The container C delivered to the second star wheel 13 passes through the opening 21a of the partition wall 21, and enters the hazard area B of the isolator 8, where the filling of the medicine is carried out in the filling section 5. The container C filled with the medicine is then sealed in the container sealing section 6 provided in the hazard area B, and then supplied by the fourth star wheel 15 to the fifth star wheel 17 of the container exterior washing section 7 provided in the hazard booth 9.
[0034] The container exterior washing section 7 installed in the hazard booth 9 washes the exterior of the container C to remove any chemicals that may have adhered to the container during filling. Then, the container C whose outer surface has been cleaned is handed over from the sixth star wheel 19 of the container outer washing section 7 to a discharge conveyor 18 installed outside the hazard booth 9, and then transported to a downstream process not shown.
[0035] In this way, while the drug is being filled in the drug filling device 1, the drug will be scattered inside the isolator 8 as the filling section 5 provided in the hazard area B fills the drug into the container C. At this time, the opening 21a of the partition wall 21 is open, but since the non-hazard area A on the upstream side of the partition wall 21 is at a higher positive pressure than the hazard area B on the downstream side, the medicine is prevented from flowing out into the non-hazard area A. The medicine scattered in the hazard area B adheres to the parts exposed to the hazard area B, and since the shutter 22 is also located in the hazard area B, there is a risk that the medicine may adhere to the shutter 22 as well. In contrast to this, in the present embodiment, the shutter 22 is in close contact with the cover plate 36 which is positioned in the open position, and when the shutter 22 is in the closed state, the closing surface 22a which is exposed to the non-hazard area A is isolated from the space which constitutes the hazard area B in the area located inside the sealing member 25, so that the drug does not adhere to it.
[0036] Once the drug filling work is completed, hazard area B is washed with water to wash away any drug that may have scattered during filling. In this case, the worker first puts on the gloves 23 provided in the hazard area B of the isolator 8, and operates the locking mechanism 24 of the shutter 22 to release the state in which the shutter 22 is in close contact with the cover plate 36. The worker then grasps the handle 22a of the shutter 22 and tilts the upper part of the shutter 22 away from the partition wall 21 so that the locking members 31 at the top of the shutter 22 do not interfere with the fixed piece 39, the opening side sensor 40, and the fixed piece 34 and the closing side sensor 35.The worker then moves the shutter 22 from the open position to the closed position until it abuts against the closing stopper 46.In this position, each locking member 31 does not interfere with the fixed piece 34 or the closing side sensor 35, and the shutter 22 is in an upright position. As a result, the shutter 22 comes into close contact with the flange portion 33a of the opening frame member 33, and the operator operates the handle 32 of the locking mechanism 24 to bring the seal member 25 of the shutter 22 into close contact with the end face 33ab of the flange portion 33a, as shown in FIG. As a result, the opening 21a of the partition wall 21 is blocked and sealed by the closing surface 22a of the shutter 22, and the inside of the isolator 8 is separated into a hazard area B and a non-hazard area A, and the display means displays this fact by detection of the opening side sensor 35. Here, in order to move the locking member 31 without interference, as shown in FIG. 7, the upper end of the shutter 22 is brought into contact with the step shape 37a of the support member 37, and the shutter 22 is moved along the step shape 37a extending in the horizontal direction. When the opening 21a of the partition wall 21 is closed by the shutter 22 in this manner to divide the inside of the isolator 8, the inside of the hazard area B is washed with water by a water washing means not shown, and the equipment constituting the filling section 5 and the container sealing section 6, as well as the drugs adhering to the inner walls of the hazard area B, are washed away.
[0037] Here, when the opening 21a of the partition wall 21 is closed by the shutter 22, the area of the closing surface 22a of the shutter 22 inside the seal member 25 is exposed to the non-hazard area A through the opening 21a. However, in the case of this embodiment, during filling of the medicine that handles hazardous substances, the shutter 22 is in close contact with the cover plate 36, and therefore the area of the closing surface 22a of the shutter 22 inside the sealing member 25 is isolated from the hazard area B, and therefore no medicine adheres to it. Therefore, even if the opening 21a is closed by the shutter 22 and the area of the closing surface 22a inside the seal member 25 is exposed to the non-hazard area A, there is no risk of the medicine leaking out into the non-hazard area A. In other words, if the entire surface of the shutter 22 remains exposed within the hazard area B while the medicine is being filled, the medicine will also adhere to the area inside the sealing member 25 of the closing surface 22a, and when the opening 21a is closed by the shutter 22, the medicine adhering to that area will flow out into the non-hazard area A.
[0038] Once cleaning of the hazard area has been completed in this manner, the entire internal space of the isolator 8 consisting of the non-hazard area A and hazard area B is decontaminated using a decontamination means (not shown) in preparation for the next drug filling operation. In this case, the operator moves the shutter 22 to the open position, and further tilts the shutter 22 as shown in FIG. In this state, when the decontamination gas is filled from the decontamination means into the entire area of the isolator 8, that is, into the non-hazard area A and the hazard area B, the internal space and walls of the isolator 8 and the installed equipment, etc. are decontaminated. At this time, the shutter 22 is tilted so that its entire surface is exposed to the internal space of the isolator 8, and therefore the entire surface of the shutter 22 is decontaminated by the decontamination gas.
[0039] The cover covering the closing surface 22a of the shutter 22 does not have to be the surface of the cover plate 36, but may be the wall surface of the partition wall 21 on the hazard area B side. In addition, in the above embodiment, a drug filling line 1 that fills containers with drugs has been described as a processing device that handles hazardous substances. However, any hazardous substance processing device that handles hazardous substances can be used as long as it has a configuration that divides the internal space surrounded by a chamber or housing such as an isolator into a hazard area and a non-hazard area. [Explanation of symbols]
[0040] 1. Drug filling line (hazardous substance treatment equipment) 5 Filling section 8 Isolator 9 Hazard Booth 21 Partition Wall 21a Opening 22 Shutter 25 Seal member 33a Flange portion 34 Fixing piece (closing lock means) 36 Cover plate 39 Fixed piece (open lock means) A Non-hazard area B Hazard area C Container
Claims
1. A hazardous material treatment apparatus includes an isolator for handling hazardous materials in an internal space maintained in a sterile state, a partition wall for partitioning the internal space of the isolator into a hazard area and a non-hazard area, and a shutter for opening and closing an opening formed in the partition wall, The hazard area is provided with the shutter, a closing lock means for maintaining the shutter in a closed state at a closing position where the shutter closes the opening of the partition wall, and a guide member for guiding the shutter along the partition wall to the closed position and the open position, a cover for covering a closing surface of the shutter, an open lock means for maintaining the shutter in a state in which the cover is covered, and a support member for supporting the shutter in a state in which the shutter is not covered by the cover are provided at the open position; When the hazard area and the non-hazard area are communicated with each other, the cover covers a closing surface of the shutter in the open position, thereby maintaining the closing surface in a state where it is not exposed to the hazard area; When cleaning the hazard area, the opening is closed by the shutter; A hazardous material treatment apparatus, characterized in that, when the hazardous area and the non-hazardous area are communicated with each other for decontamination, the shutter is supported by the support member in the open position.
2. 2. The hazardous material treatment device according to claim 1, wherein a seal member having a shape surrounding the opening is provided on both the peripheral surface of the opening in the hazard area and the cover, or on the closing surface of the shutter.
Citation Information
Patent Citations
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