JP2013244340A - Aseptic processor and tube connection method of the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To connect a filling means 4 inside an isolator 6 and a storage means 8 on the outside by a simple operation with a simple configuration.SOLUTION: A pipe 28 for communicating the inside and outside is attached to a wall surface 6b of an isolator 6 inside which a filling means 4 is disposed, and an inner side opening 28c and an outer side opening 28d are made sealable. One end of an inner side liquid supply tube 18A for supplying a liquid chemical is connected to a nozzle 16 of the filling means 4, and the other end of the liquid supply tube 18A passes through an inner side sealing member 30 of the pipe 28 keeping airtightness. On the outside of the isolator 6, a storage means 8 for storing the liquid chemical to be sent to the filling means 4 is disposed, and one end of an outer side liquid supply tube 18B is connected. An end out of the isolator 6 of the inner side liquid supply tube 18A and the other end of the outer side liquid supply tube 18B are connected by aseptic connectors 38A and 38B.

Description

  The present invention relates to an aseptic processing apparatus and a tube connecting method of an aseptic processing apparatus, and more particularly, to an aseptic processing apparatus and an aseptic method characterized by connecting an externally disposed tube to processing means provided in an isolator. The present invention relates to a tube connecting method of a processing apparatus.

  An invention that connects a chemical solution filling device installed in an aseptic region such as an isolator and a chemical solution adjustment tank arranged outside is already known (see, for example, Patent Document 1). In this "pipe aseptic connection method" described in Patent Document 1, a chemical solution filling device is housed in an isolator that is an aseptic region, and a chemical solution channel tube and a first connection tube are connected to the chemical solution filling device. ing. In addition, a chemical liquid adjustment tank is installed outside the isolator, and a second connection pipe is connected to the chemical liquid adjustment tank via a chemical liquid supply pipe.

  The wall portion of the isolator is provided with a small chamber that can be sealed and communicated with the inner side and the outer side of the isolator, and further, sterilization means for sterilizing the small chamber is provided.

  In the invention described in Patent Document 1, the second connecting pipe connected to the chemical solution adjusting tank is put into a small chamber from the outside of the isolator, and the small chamber is hermetically sealed. After sterilization, the closed state of the chamber is released from the inside of the isolator, and the first connecting pipe on the inner side is connected to the second connecting pipe.

Japanese Patent No. 4334937

  In the configuration of Patent Document 1, a small chamber for connection is provided on the wall surface of the isolator, and it is necessary to sterilize in the small chamber every time the connection is made, for example, when the chemical solution in the chemical solution adjustment tank disappears and this tank is replaced. With this configuration, there are problems such as an increase in size, cost, and complicated operation. Further, since the second connecting pipe is sterilized with a decontamination gas such as hydrogen peroxide gas, there is a concern that the decontamination gas component remains.

  The present invention includes an isolator having processing means therein, a cylindrical member that is attached through the wall surface of the isolator and communicates with the inside and outside of the isolator, and an outer sealing member that seals an outer opening of the cylindrical member. And an inner sealing member that seals the inner opening of the cylindrical member, a fluid tube for circulating a fluid between the inside and the outside of the isolator, and a decontamination means for decontaminating the inside of the isolator, The fluid tube includes an inner fluid tube that penetrates the inner sealing member, and an outer fluid tube that is disposed outside the isolator, and the inner fluid tube and the outer fluid tube are disposed inside the tube. And an aseptic connection connector for connection without exposure to the external atmosphere, and when the decontamination inside the isolator, the outside opening of the cylindrical member is the outside Sealed with a closing member, and when the processing means is operated, the inner opening of the cylindrical member is sealed with the inner sealing member, and the inner fluid tube is connected to the outer fluid tube via the aseptic connection connector. It is characterized by.

  According to a second invention, in the first invention, the tubular member has a flange surrounding the outer periphery of the outer opening and the inner opening, and the outer sealing member and the inner sealing member are each provided with the flange. And a clamp means for fixing the outer sealing member and the inner sealing member to the tubular member in a state where the outer edge portions are overlapped with the flange.

  Further, a third invention is the filling means according to the first invention or the second invention, wherein the processing means provided inside the isolator is a filling means for filling a container with a filling liquid, and the external fluid tube is It is connected to a filling liquid storage means arranged outside the isolator.

  According to a fourth aspect of the present invention, there is provided a tubular member that penetrates the wall surface of the isolator provided with a processing means inside and communicates the inside and the outside, and the outside opening of the tubular member is sealed with an outside sealing member to After decontamination, aseptically packed inner sealing member and inner fluid tube are taken out inside the isolator, and one end is housed inside the isolator with the inner fluid tube penetrating the inner sealing member. The end is accommodated inside the cylindrical member, the inner opening of the cylindrical member is sealed by the inner sealing member, and then the outer opening of the cylindrical member is opened and the other end of the inner fluid tube is pulled out. Then, the tube connection method of the sterilization apparatus is characterized in that the connection is made with an external fluid tube arranged outside the isolator through a sterilization connection connector.

  According to the aseptic processing apparatus and the tube connecting method of the aseptic processing apparatus of the present invention, a cylindrical member penetrating the inside and outside is provided on the wall surface of the isolator, the inner opening of the cylindrical member is sealed with the inner sealing member, and the inner fluid tube is Since it is connected to the outer fluid tube via the aseptic connection connector, the operation is simple with a simple structure, and it can be manufactured at low cost.

FIG. 1 is a configuration diagram showing the overall configuration of an aseptic processing apparatus. Example 1 2 (a) to 2 (c) are diagrams sequentially showing the steps of connecting the filling means and the storage means.

  Filling means is disposed inside the isolator as processing means, and storage means for storing a filling liquid to be sent to the filling means is installed outside. The cylindrical member is fixed to the wall surface of the isolator through the inside and outside, and the inner opening and the outer opening can be sealed by the inner sealing member and the outer sealing member, respectively. The inner sealing member is inserted with an inner side liquid supply tube having a nozzle of a filling means attached at one end and an aseptic connection connector at the other end in an airtight state. The inner side liquid supply tube and the inner sealing member are stored in a bag in a decontaminated state in advance, and are stored inside from the open / close door of the isolator. The cylindrical member is sealed on the outer side by an outer sealing member, and further, the inner side is sealed by the inner sealing member. At this time, the nozzle at one end of the inner liquid supply tube is set in the filling means, and the sterile connector at the other end is accommodated in the cylindrical member. After that, the outer sealing member of the cylindrical member is removed, the sterile connection connector housed inside is pulled out, and the sterile connection connector attached to the external liquid feeding tube connected to the storage means installed outside Connect with. In this way, by connecting the inner side liquid feeding tube and the outer side liquid feeding tube outside the isolator via the aseptic connection connector, the processing means in the isolator can be connected to the processing means in the isolator with a simple operation and outside the isolator. Achieving the purpose of connecting tubes.

  Hereinafter, the present invention will be described with reference to embodiments shown in the drawings. The aseptic processing apparatus according to this embodiment is configured as an aseptic filling apparatus, and a filling means 4 for filling a filling liquid such as a chemical solution in a container 2 is accommodated in an isolator 6 as a processing means. Further, a chemical solution storage means 8 (a bag in this embodiment) for supplying the chemical solution to the filling means 4 is disposed outside the isolator 6. A decontamination means 9 is connected to the isolator 6 so that the inside can be decontaminated. Further, it has a function of supplying aseptic air, and can maintain a sterile condition by keeping the inside at a positive pressure after decontamination by the decontamination means 9.

  In the filling means 4, a nozzle holder 14 is attached to a stand 12 installed on the base 10 of the isolator 6, and a nozzle 16 oriented in the vertical direction is attached to the nozzle holder 14. The nozzle 16 is supplied with a chemical solution from a liquid supply tube (indicated by reference numeral 18 as a whole) that is a fluid tube. A pinch valve 20 is attached on the stand 12 and opens and closes the liquid passage in the liquid feeding tube 18. Further, a container supply means 22 for supplying the container 2 below the nozzle 16 is provided, and the container 2 is sequentially supplied below the nozzle 16 for filling. As the fluid tube, a resin tube such as a silicon tube is used.

  A glove 24 is attached to the wall surface 6 a of the isolator 6, and an operator can operate the filling means 4 installed inside from the outside of the isolator 6 using the glove 24. In addition, a sealable opening / closing door 26 is attached to the other wall surface 6 b of the isolator 6. By opening the opening / closing door 26, articles can be stored and taken out in the isolator 6.

  Further, a flanged pipe 28 is attached to the wall surface 6 b of the isolator 6. Flange 28a, 28b protrudes from both ends of the pipe 28, and the flanges 28a, 28b are overlapped with outer edge portions overlapping the flanges 28a, 28b provided on the sealing members (caps) 30, 32, and clamped. 34 and 36 can be fixed and hermetically sealed. Further, the caps 30 and 32 can be removed, and one or both of the inner opening 28c and the outer opening 28d of the pipe 28 can be opened. In the state at the time of filling shown in FIG. 1, the inner opening 30c of the pipe 28 is sealed by the inner cap 30, and the liquid feeding tube (inner liquid feeding tube 18A) penetrating the inner cap 30 while maintaining airtightness. The end opposite to the nozzle 16 is taken out of the isolator 6. An aseptic connection connector 38A for connecting to the external liquid supply tube 18B from the storage means 8 is attached to the external end of the internal liquid supply tube 18A. When the aseptic connection connector 38A is connected to the aseptic connection connector 38B of the external liquid feeding tube 18B described later, the openings of the respective sealed connectors 38A and 38B are aligned to release the seal, and the tubes 18A, The connection is made while maintaining the sterility without exposing the interior of 18B to the external atmosphere. The aseptic connection connectors 38A and 38B are already known from JP 2005-532889 A and the like.

  The chemical liquid storage means (bag 8) installed outside the isolator 6 is configured to send the stored chemical liquid to the filling means 4 by the liquid supply tube 18, and at the bottom of the external liquid supply tube 18B. One end is connected. A sterile connection connector 38B is attached to the other end of the external liquid feed tube 18B, and is connected to the sterile connection connector 38A of the internal liquid feed tube 18A taken out from the isolator 6. An open / close valve 40 is provided near the bag 8 of the external liquid supply tube 18B to cut off the communication of the liquid passage. In addition, a peristaltic pump 42 is provided in the external side liquid supply tube 18B, and the chemical liquid in the bag 8 is sent out by the operation of the peristaltic pump 42 and supplied to the filling means 4 side through the filter 44. The

  Next, a process of connecting the filling means 4 arranged in the isolator 6 and the storage means (bag 8) arranged outside the isolator 6 of the aseptic filling apparatus will be described. At the time of connection, the cap 32 is attached to the opening 28d located on the outside of the isolator 6 of the flanged pipe 28, and the outer opening 28d is hermetically sealed by the clamp 36. The clamp 34 used for sealing the inner opening 28 c of the flanged pipe 28 is stored in the isolator 6 in advance. In this state, first, the opening / closing door 26 provided on the wall surface 6b of the isolator 6 is opened, and the bag 46 containing the inner cap 30, the inner liquid feeding tube 18A, and the like is inserted (FIG. 2A). reference). Inside the bag 46 are housed the inner side liquid supply tube 18A, the nozzle 16 and the aseptic connector 38A provided at both ends thereof, and the cap 30. The inner-side liquid feeding tube 18A penetrates the cap 30, and the gap is sealed. The bag 46 is decontaminated by irradiation with radiation such as an electron beam or gamma ray from the outside in a state in which the contents are contained, and the contents are aseptically packaged.

  After putting the bag 46 in the isolator 6, the open / close door 26 is closed and sealed. Since the aseptic condition in the isolator 6 is destroyed when the bag 46 is accommodated, after the inside of the isolator 6 is sealed, decontamination of hydrogen peroxide vapor, ethylene oxide gas, etc. from the decontamination means 9 into the isolator 6 Gas is introduced to decontaminate the inside of the isolator 6 and the outer surface of the bag 46.

  Next, the operator operates the glove 24 to break the bag 46 to take out the internal article, attach the cap 30 to the inner opening 28c of the flanged pipe 28, and the clamp that has already been stored in the isolator 6. Fix with 30 and seal. The flanged pipe 28 is in a state in which both the outer opening 28d and the inner opening 28c are sealed, and the aseptic connection connector 38A side of the inner liquid feeding tube 18A is housed in the flanged pipe 28. Further, the nozzle 16 attached to the inner side end of the inner side liquid supply tube 18A is set in the nozzle holder 14 on the stand 12 (state shown in FIG. 2B).

  After the inner side of the isolator 6 is set, the cap 32 is removed from the opening 28d on the outer side of the isolator of the flanged pipe 28 and opened. The inner side liquid supply tube 18A and the aseptic connection connector 38A are pulled out from the flanged pipe 28, and the aseptic connection connector 38B of the outer side liquid supply tube 18B connected to the bag 8 as a liquid storage means is coupled (FIG. 4 ( c)). In this invention, the structure of the part which has penetrated the wall surface 6b of the isolator 6 can be simplified, and cost reduction can be aimed at. Since the flanged pipe 28 and the caps 30, 32 are fixed by the clamps 34, 36, the openings 28c, 28d of the flanged pipe 28 are sealed, so the structure is simple and the handling is easy. . Further, the bag 46 may be decontaminated with a pass box (not shown) provided in the isolator 6 and carried into the decontaminated isolator. Moreover, it can comprise as a single use processing means by making it a disposable which comprised the tube and the cap with the cheap resin molded product. In particular, when configured as a filling device, aseptic filling can be realized without performing pipe cleaning when changing the liquid type by aseptically connecting a bag or tube. Further, as the processing means provided in the isolator 6, various processing means such as an air cleaner that blows aseptic air into the container and a transport means that vacuum-sucks and transports articles and workpieces are envisaged. The fluid may be a gas depending on the processing means provided, and can be applied to any use of supplying and discharging fluid regardless of liquid or gas.

4 Filling means 6 Isolator 6b Wall surface of isolator 8 Reserving means (bag)
18 Liquid feed tube 18A Internal liquid feed tube 18B External liquid feed tube 28 Cylindrical member (pipe with flange)
28c Inner opening of the cylindrical member 28d Outer opening of the cylindrical member 30 Inner sealing member (cap)
32 Outer sealing member (cap)
38A Aseptic connector 38B Aseptic connector

Claims (4)

An isolator provided with a processing means inside, a cylindrical member that is attached through the wall surface of the isolator and communicates with the inside and outside of the isolator, an outer sealing member that seals an outer opening of the cylindrical member, and the cylinder An inner sealing member that seals the inner opening of the member, a fluid tube for circulating a fluid between the inside and the outside of the isolator, and a decontamination means for decontaminating the inside of the isolator,
The fluid tube includes an inner fluid tube that penetrates the inner sealing member, and an outer fluid tube that is disposed outside the isolator, and the inner fluid tube and the outer fluid tube are disposed inside the tube. With a sterile connection connector that connects without exposing to the external atmosphere,
When decontamination inside the isolator, the outer opening of the cylindrical member is sealed with the outer sealing member, and when the processing means is operated, the inner opening of the cylindrical member is sealed with the inner sealing member, and the inner fluid tube Is connected to an external fluid tube through the aseptic connection connector.   The cylindrical member has a flange that surrounds the outer peripheries of the outer opening and the inner opening, and the outer sealing member and the inner sealing member each have outer edge portions that overlap the flange, and these outer edge portions are connected to the flange. The aseptic processing apparatus according to claim 1, further comprising clamp means for fixing the outer sealing member and the inner sealing member to the cylindrical member in a state of being overlapped. The processing means provided inside the isolator is a filling means for filling a container with a filling liquid,
The sterilization apparatus according to claim 1 or 2, wherein the external fluid tube is connected to a filling liquid storage means disposed outside the isolator. A cylindrical member that penetrates the wall surface of the isolator provided with processing means inside and communicates inside and outside is provided, and the outside opening of this cylindrical member is sealed with an outer sealing member, and the inside of the isolator is decontaminated, and then is aseptically packaged. Take out the inner sealing member and the inner fluid tube inside the isolator,
With the inner fluid tube penetrating the inner sealing member, one end is accommodated in the isolator and the other end is accommodated in the cylindrical member. The inner sealing member opens the inner opening of the cylindrical member. After that, the outer opening of the cylindrical member is opened and the other end of the inner fluid tube is pulled out to be connected to the outer fluid tube arranged outside the isolator through a sterile connection connector. A tube connection method of an aseptic processing apparatus characterized by the above.

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