JP6258021B2 - Isolator - Google Patents

Description

  The present invention relates to an isolator including an interface for connecting the inside and outside of a device in a state where a sterile environment is maintained.

  In recent years, in the field of drug development and manufacturing, the introduction of single-use products (single-use disposable products) that eliminate the need for a sterilization process before use or a washing process after use has been actively promoted. Single-use products (consisting of sterilized bags, tubes, nozzles, filters, etc.) are used especially for the production of highly active preparations (drugs that affect the human body in small quantities, such as anticancer agents and immunosuppressants) In addition, filling is performed inside an isolator maintained in a sterile environment to reduce the risk of cross contamination.

  Single-use products are manufactured by multiple manufacturers, and the specifications differ for each manufacturer. For this reason, the specifications of the interface constituting the connection part inside and outside the isolator are also different for each manufacturer. The pharmaceutical manufacturer selects a single-use product (manufacturer) to be used according to the suitability of the drug, and the contract manufacturer that has received the consignment production of the product from the pharmaceutical manufacturer is the single manufacturer of the manufacturer selected under the direction of the pharmaceutical manufacturer. The filling work of the product using the isolator is performed using the use product. Therefore, if the isolator has only one interface, the types of preparations that can be manufactured are limited, and the range of contracts from pharmaceutical manufacturers is narrowed. In addition, when the interface is changed to the isolator each time according to the single-use product (manufacturer) to be handled, it is necessary to test airtightness in addition to the replacement work, which is disadvantageous in terms of time, labor, and cost. Furthermore, it is conceivable to provide a plurality of interfaces with different specifications in the isolator. However, if a space for installing a plurality of interfaces is secured, the size of the apparatus is increased.

  A first object of the present invention is to provide an isolator that can easily cope with a plurality of interfaces while maintaining space saving.

The isolator according to the present invention is an isolator having a side surface provided with an opening for communicating the inside and the outside of the isolator, and a plurality of closing means for closing the opening, each of the closing means connecting the inside and the outside of the isolator. It has a joint part with different specifications to which the pipe is joined, the plurality of closing means are arranged around the opening part, and the closing means for closing the opening part can be selected as necessary.

  The second invention is characterized in that, in the first invention, when the closing means closes the opening, a fixing means for fixing the closing means is provided.

  According to a third aspect of the present invention, in the first or second aspect of the invention, one side of the closing means that is close to the opening is pivotally supported, and the closing means is configured in a door shape. It is.

  According to the present invention, it is possible to provide an isolator that can easily cope with a plurality of interfaces while maintaining space saving.

It is a schematic diagram which shows the structure of the isolator which is one Embodiment of this invention used with a single use product. It is a top view which shows arrangement | positioning of the door and opening part in the state in which all the doors were opened. FIG. 3 is a plan view showing the arrangement of doors in a state where an opening is closed by one door in the arrangement of FIG. 2. It is a schematic diagram which shows the connection procedure to the glove box of the single use apparatus shown by FIG. It is a top view which shows arrangement | positioning of the door of the 1st modification of this embodiment. It is a top view which shows arrangement | positioning of the opening part and door of the 2nd modification of this embodiment. It is a top view which shows arrangement | positioning of the opening part and door of the 3rd modification of this embodiment. It is a schematic diagram which illustrates the connection procedure to the glove box of the single use apparatus of a specification different from FIG.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. FIG. 1 is a schematic diagram showing a configuration of an isolator (sterility maintenance apparatus) according to an embodiment of the present invention used with a single use product, and FIG. 1 shows a state where the single use product is mounted on the isolator. .

  The isolator 10 includes a glove box 11 that is maintained in a sterile state. The glove box 11 is held on a pedestal 12. A work glove 13 is attached to the front surface of the glove box 11, and various kinds of work such as attachment work of members in the glove box 11 are performed by an operator wearing the glove 13.

  On the wall surface of the glove box 11, an opening portion 14 provided with an opening 14 </ b> A that communicates the inside and the outside of the glove box 11 is provided. A plurality of doors (closing means) for closing the opening 14 are provided around the opening 14. In the present embodiment, the opening 14 has a substantially square shape, and four substantially square doors 15 </ b> A to 15 </ b> D are disposed outside the wall surface so as to surround the opening 14 (see FIG. 2). The opening 14A can be airtightly closed by one door selected from the doors 15A to 15D and the seal member 16 surrounding the opening 14A (blocking means). The doors 15A to 15D are provided with interfaces (joints) 18A to 18D (see FIG. 2) corresponding to the single use products 17 having different specifications (manufacturers). FIG. 1 shows a state in which the door 15A including the interface 18A disposed above the opening 14 is closed and the opening 14A is closed. Note that a door in a state where the opening 14A is closed or a door not in use can be fixed at each position by a fixing means (not shown) (see FIG. 4 for the fixing means in the closed position).

  In the glove box 11, for example, a filling device 19, a stopper device (not shown), a transport device 21, and the like are provided as necessary. The wall surface of the glove box 11 is further provided with a carry-in port 23 for carrying the filling container 22 and the lid into the glove box 11, and the sterilized filling container 22 etc. is carried into the glove box 11 through the carry-in port 23. Is done. The filled container 22 carried into the glove box 11 is held by, for example, the transport device 21. The filling container 22 held by the transporting device 21 has a medicine from the single use product 17 guided into the glove box 11 through an interface (18A in the illustrated example) of a door (15A in the illustrated example) with the opening 14A closed. Is filled. The glove box 11 is provided with a decontamination device such as a hydrogen peroxide gas generator. Before the single-use product 17 is connected to the glove box 11 via the interface, the decontamination gas is contained in the glove box 11. And the inside of the glove box 11 can be decontaminated.

  Single-use devices include, for example, bags filled with drugs, tubes (piping) for transporting drugs, open / close valves that control the supply of drugs, filling nozzles for pouring drugs from tubes to filling containers, drugs Filters for filtration, pumps for transporting drugs (chemicals), attachments attached to interfaces, and some or all of sensors and joints, etc. as necessary are included. The sterilization process is performed by etc.

  A single use product 17 illustrated in FIG. 1 includes a bag 25, an opening / closing valve 26, a tube 27, a pump 28, a filter 29, an attachment 30, and a filling nozzle 31. That is, the medicinal solution (medicine) M enclosed in the bag 25 is supplied to the tube 27 through the opening / closing valve 26, transported through the tube 27 by the pump 28, and passes through the attachment 30 attached to the interface 18 </ b> A via the filter 29. The tube 27 is attached to the tip of the tube 27 and discharged from the filling nozzle 31 held by the filling device 19 in the glove box 11 to the filling container 22. The procedure for connecting the single use product 17 to the glove box 11 will be described later.

  Next, the arrangement of the opening 14 and the four doors 15A to 15D in the present embodiment will be described with reference to FIGS.

  FIG. 2 shows a state where all the doors 15A to 15D are opened and the opening 14A is opened, and FIG. 3 shows a state where the opening 14A is closed by the door 15A. In FIG. 2, the opening 14 has a substantially square shape, and a substantially square opening 14 </ b> A whose four corners are R-processed is provided at the center thereof. A seal member 16 is provided around the opening 14A so as to surround the opening 14A.

  Each of the doors 15 </ b> A to 15 </ b> D has a square shape that is approximately the same size as the opening 14. In the illustrated example, the lower side of the door 15A is attached along the upper side of the opening 14 by a pair of hinges 32A, and the left side of the door 15B is attached along the right side of the opening 14 by a pair of hinges 32B. The upper side of the door 15C is attached along the lower side of the opening 14 by a pair of hinges 32C, and the right side of the door 15D is attached along the left side of the opening 14 by a pair of hinges 32D.

  That is, each of the doors 15 </ b> A to 15 </ b> D is rotatable about one side (side) close to the opening 14, and overlaps the opening 14 when closing the opening 14 </ b> A. Further, each of the doors 15 </ b> A to 15 </ b> D is provided with seal receiving portions 33 </ b> A to 33 </ b> D at positions where the doors 15 </ b> A to 15 </ b> D come into contact with the seal member 16 provided in the opening 14 when the door is closed.

  Next, with reference to FIG. 4, the connection procedure to the glove box 11 of the single use product 17 illustrated in FIG. 1 is demonstrated.

  4A to 4E schematically show the connection procedure of the single use product 17 in time series. First, in FIG. 4A, the door 15A is selected from the four doors 15A to 15D, rotated around the hinge 32A, and overlapped with the opening 14. The interface 18A provided in the door 15A includes, for example, an opening 34 provided substantially at the center of the door 15A and an outer surface of the door 15A so as to surround the opening 34 (a surface facing outward when the door 15A is closed). The rim portion 35 is provided and a lid 36 that closes the opening 34.

  For example, holes 37 are formed in the vicinity of the corner of the side of the door 15A opposite to the hinge 32A. On the other hand, a bolt 38 is provided upright on the outer surface of the opening 14 at a position corresponding to the hole 37. That is, as shown in FIG. 4B, when the door 15A is closed and the door 15A is overlaid on the opening 14, the bolt 38 protrudes from the door 15A through the hole 37, and the entire circumference of the seal member 16 is the door. Adheres closely to the inner surface of 15A. When a nut 39 is screwed into a bolt 38 projecting from the door 15A and the nut 39 is tightened, the door 15A is pressed against the opening 14 with the seal member 16 interposed therebetween, and the opening 14A is hermetically closed by the seal member 16. . That is, the door 15A is fixed at the closed position using the bolt 38 and the nut 39 as fixing means.

  Next, the temporary lid 40 is fitted inside the rim portion 35 of the door 15 </ b> A, and the opening 34 of the interface 18 </ b> A is sealed from the outside by the temporary lid 40. After the temporary lid 40 is attached to the interface 18A, the lid 36 that closes the opening 34 of the interface 18A is removed inside the glove box 11 by the operator using the glove 13. At this time, the inner lid 40 </ b> A of the temporary lid 40 that is in close contact with and fixed to the outer surface of the lid 36 is integrally removed. Thereafter, the decontamination gas is supplied from the decontamination device 24 into the glove box 11, and the decontamination inside the glove box 11 is performed. Thereby, the periphery of the interface 18A of the door 15A exposed to the inside of the glove box 11, and the surfaces of the removed lid 36 and the inner lid 40A are decontaminated with the decontamination gas (D layer in FIG. 4B).

  When the decontamination is completed, as shown in FIG. 4C, the operator fits the lid 36 into the opening 34 of the interface 18 </ b> A again using the globe 13, and the opening 34 is closed by the lid 36. Then, the temporary lid 40 is removed from the rim portion 35 of the interface 18A together with the inner lid 40A. As shown in FIG. 4D, the attachment 30 is fitted into the rim portion 35 from which the temporary lid 40 has been removed, and the attachment 30 is attached to the interface 18A of the door 15A.

  The attachment 30 forms a cup-shaped main body 30A, an open end of the cup-shaped main body 30A, is fitted to the rim portion 35 and is attached to the interface 18A, and is formed inside the mounting portion 30B. It is comprised from the cover 30C which seals opening of 30 A of main bodies. In the main body 30A, a tube 27 and a filling nozzle 31 attached to the tip of the tube 27 are housed and sealed by a lid 30C. The tube 27 and the filling nozzle 31 in the main body 30A are sterilized in advance with an electron beam, a gamma ray or the like.

  When the attachment portion 30B is fitted into the rim portion 35 and the attachment 30 is attached to the interface 18A, the outer surface of the lid 36 is brought into close contact with the outer surface of the lid 30C as shown in FIG. And the lid 30C are integrated. Thereafter, as shown in FIG. 4 (e), from the inside of the glove box 11, the operator removes the lid 36 integrated with the lid 30 </ b> C of the attachment 30 using the glove 13 from the interface 18 </ b> A, and the inside of the attachment 30. To the glove box 11. Thereafter, the operator takes out the filling nozzle 31 and the tube 27 from the main body 30 </ b> A of the attachment 30 and attaches them to the filling device 19 provided in the glove box 11.

  As described above, according to the present embodiment, a door having an interface with a different specification (joint part of a single use device) is prepared around the opening, and the door to be used is selected according to the single use device to be used. However, it is possible to deal with single-use devices having a plurality of different specifications simply by closing the opening. As a result, it is possible to easily cope with a plurality of interfaces while maintaining space saving.

  5 to 7 show modified examples of the opening and the door. In this embodiment, the opening has a substantially square shape, and the four doors are arranged on the four sides of the opening. However, in the modified examples of FIGS. 5 and 6, the three doors are provided only on three sides of the substantially square opening. A door is placed. The modification of FIG. 5 corresponds to a configuration in which the door 15D is removed from the present embodiment. On the other hand, FIG. 6 is an example in which the opening 41 provided in the opening 42 is circular instead of square, and the seal member 43 is also arranged in a circle along the opening.

  FIG. 7 is an example in which the opening 44 has a substantially equilateral triangular shape, and three doors 45A, 45B, and 45C having substantially congruent triangular shapes are arranged along the three sides of the opening 44. The In FIG. 7, the opening, the interface, and the like are omitted, but various shapes such as a circle, a triangle, and a quadrangle are conceivable as the shape of the opening provided in the opening portion 44. In addition, a regular pentagon and a regular hexagon are also conceivable as the shape of the opening. In this case, it is possible to prepare 5 types of interfaces and 6 types of interfaces, respectively.

  Next, with reference to FIG. 8A to FIG. 8E, a connection procedure of an interface having a specification different from that in FIG. 4 is illustrated. In addition, about the structure substantially the same as the structure shown by FIG. 4, the description is abbreviate | omitted using the same referential mark.

  The door 50 in FIG. 8 corresponds to, for example, any of the doors 15B to 15D in FIG. 2 and is attached to one side of the opening 14 via a hinge 51, and the opening 14 is closed by a bolt 38 and a nut 39, for example. Fixed in state. The interface 52 provided in the door 50 is provided upright on the door 50, and is provided with a main pipe 53 that communicates the back and front of the door 50, and a corner that is provided orthogonal to the main pipe 53 and in which the operation unit 54P is inserted. It is mainly comprised from the cylinder part 54. FIG.

  When the state shown in FIG. 8A is changed to the state shown in FIG. 8B, and the door 50 is fixed to the opening 14 with the seal member 16 sandwiched between the bolt 38 and the nut 39, the state shown in FIG. Then, the outer attachment 55 is inserted from the outer opening end of the main pipe 53 and pushed to a predetermined position. A pair of holes substantially equal to the inner diameter of the main pipe 53 is provided in the operation portion 54P, and one hole is disposed at a position coaxial with the main pipe 53 in the initial state. The distal end of the outer attachment 55 is sealed with a lid 55 </ b> A, and the pushed lid 55 </ b> A is positioned inside the one hole of the operation portion 54 </ b> P in the rectangular tube portion 54 that crosses the main pipe 53.

  In the state of FIG. 8C, decontamination gas is supplied from the decontamination device 24 into the glove box 11 and decontamination of the interface 52 is performed. Thereafter, the decontaminated inner attachment 56 is inserted from the open end in the glove box 11 of the main pipe 53 and pushed into a predetermined position as shown in FIG. Similarly to the outer attachment 55, the tip of the inner attachment 56 is also sealed with a lid 56A, and the pushed-in lid 56A is inside the one hole of the operation portion 54P in the rectangular tube portion 54 that crosses the main pipe 53. And contacts the lid 55A of the outer attachment 55.

  When the operation portion 54P inserted in the rectangular tube portion 54 is pushed in the state of FIG. 8D, the lid positioned in the one hole of the operation portion 54P as shown in FIG. 8E. 55A and 56A move to the outside of the main pipe 53, and the other hole of the operation portion 54P moves to a position coaxial with the main pipe 53, and between the outer attachment 55 and the inner attachment 56 in the main pipe 53. A fluid passage is formed. Thereafter, when the operator further pushes in the outer attachment 55 and the inner attachment 56 to bring both end surfaces into close contact with each other, the outer attachment 55 and the inner attachment 56 are joined via the interface 52. In FIG. 8, for the sake of convenience, the outer attachment 55 and the inner attachment 56 are drawn as a single unit, but actually, piping parts such as tubes are connected.

  In this embodiment, the door is hinged around the opening with a hinge. However, the closing means such as the door can be arranged around the opening, and the closing means for closing the opening can be selected as necessary. If so, there is no need to use a hinge. For example, the structure which slides the obstruction board provided with the interface arrange | positioned in the standby position around an opening part to the obstruction | occlusion position which obstruct | occludes an opening part, or the structure once removed from a standby position and attached to an opening part may be sufficient.

DESCRIPTION OF SYMBOLS 10 Isolator 11 Glove box 14 Opening part 14A Opening 15A-15D Door 16 Seal member 17 Single use product 18A-18D Interface 32A-32D Hinge

Claims (3)

An opening that communicates the inside and outside of the isolator is provided on the side surface,
An isolator having a plurality of closing means for closing the opening,
Each of the closing means has a joint part with different specifications to which pipes connecting the inside and the outside of the isolator are joined,
The plurality of closing means are disposed around the opening,
An isolator characterized in that a closing means for closing the opening can be selected as necessary.   The isolator according to claim 1, further comprising a fixing unit that fixes the closing unit when the closing unit closes the opening.   The isolator according to claim 1 or 2, wherein one side of the closing means that is close to the opening is pivotally supported, and the closing means is configured in a door shape.

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