WO2016135988A1 - Water holding container for steam supply use - Google Patents

Water holding container for steam supply use Download PDF

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Publication number
WO2016135988A1
WO2016135988A1 PCT/JP2015/056008 JP2015056008W WO2016135988A1 WO 2016135988 A1 WO2016135988 A1 WO 2016135988A1 JP 2015056008 W JP2015056008 W JP 2015056008W WO 2016135988 A1 WO2016135988 A1 WO 2016135988A1
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WO
WIPO (PCT)
Prior art keywords
opening
water
container
chuck
steam supply
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Application number
PCT/JP2015/056008
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French (fr)
Japanese (ja)
Inventor
西川　茂道
功章 宮川
Original Assignee
ワケンビーテック株式会社
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Application filed by ワケンビーテック株式会社 filed Critical ワケンビーテック株式会社
Priority to PCT/JP2015/056008 priority Critical patent/WO2016135988A1/en
Priority to JP2017501825A priority patent/JPWO2016135988A1/en
Publication of WO2016135988A1 publication Critical patent/WO2016135988A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26—Accessories or devices or components used for biocidal treatment

Definitions

  • the present invention relates to a water supply container for steam supply.
  • the water supply container for supplying steam is moved to an incubator, a biohazard countermeasure cabinet, a CPC sterilization chamber, a pass box, a CPC sterilization chamber, an autoclave, a pass box, and a CPC with a natural flow of work in one direction.
  • the present invention relates to a water supply container for steam supply that can move waste while minimizing the risk of cross contamination.
  • the work flow line and the arrangement of facilities and equipment are set so that it is possible to clearly distinguish people, cells and tissues, culture equipment, and the entry and exit of waste.
  • the flow lines of workers are fundamental to prevent cross-contamination and mixing of cells and tissues. Consideration is given to the flow of people and goods, such as a one-way flow line that does not revert to, and a pass box that is a dedicated carry-in entrance to deliver goods.
  • the incubator for cell / tissue culture used in the CPC is usually 37 ° C. 5% CO 2 , and the inside of the incubator chamber is humidified by adding sterilized water to the tray and saturated with water vapor. It is necessary to create an atmospheric environment.
  • the inventors replaced the tray filled with sterilized water, put water in a bag-like humidity supply container in advance, sealed it, installed it in the storage room of the incubator installed in the CPC, A bag-like humidity supply container for supplying humidity to an indoor atmosphere has been proposed (see Patent Document 1).
  • the proposed humidifying container is composed of a soft bag body having a wide opening, and when water is put and sealed, water may spill out from the bag body around the container, so it is necessary to avoid work in the CPC. there were.
  • Patent Document 2 a bag-like humidity supply container in which the opening in the bag-like humidity supply container is sealed and a water supply / discharge port having a cap is newly provided therein.
  • Patent Document 2 a water supply / discharge port having a cap.
  • the problem in the bag-like humidity supply container was solved by providing a dedicated water supply / discharge port having a cap.
  • the water supply to the container uses a water supply tool connected to the supply / discharge port, water does not leak out during the water supply, but a dedicated water supply tool is required and lacks versatility. Improvement was desired.
  • the use of a new humidifying device complicates the operator's work flow, and the total volume of medical waste transported from the sterile area of the CPC increases, so it is necessary to take measures. It was.
  • a general-purpose sterilization bag is brought into the CPC in advance and attached to the space next to the equipment in each place, and used cells and tissues, used culture fluid, culture equipment, and water are put into them. We are taking measures to carry it out of the room.
  • the ceiling, walls and floor surfaces of the work area shall be smooth and free of cracks and gaps, and will not collect dust and dust, and will not generate dust.
  • the boundary between the wall and the wall is a curved surface, and special considerations such as easy cleaning of dust and dirt are made.
  • hygiene management becomes complicated and air circulation in the CPC is hindered. Therefore, it is not preferable to attach such a device in the CPC, and improvement is required.
  • the problem to be solved by the present invention is to provide a water supply container for steam supply capable of obtaining a steam supply capacity substantially equivalent to that of a conventional humidifying tray, and a cell / tissue used in CPC, a culture solution, Cross-contamination with minimal work man-hours such as putting wastes such as culture dishes and multiwell plates into the empty space of the water supply container for steam supply after supplying steam and closing the resealable open / close chuck It can be sealed in a preventive environment, reducing the total volume of medical waste transported from within the sterile area of the CPC and moving waste while minimizing the risk of cross-contamination with one-way natural work flow It is to provide a water supply container for steam supply that is made possible. And it is providing the water retention container for vapor
  • the first means of the present invention for solving the above problems is to stack two substantially rectangular plastic resin films, seal three sides out of these, and open the other one as an opening.
  • a bag-like water supply container for steam supply wherein a non-woven fabric having moisture permeability, water resistance and bacterial barrier properties is disposed at the center of at least one of the plastic resin films, and a plurality of the openings are provided in the opening.
  • Water supply for steam supply characterized in that a re-sealing opening / closing chuck is provided at an opening portion closer to the center than the insertion hole so that water can be retained therein. It is a container.
  • the second means of the present invention for solving the above-mentioned problem is that two substantially rectangular plastic resin films are overlapped, three of these are sealed, and the other one can be opened as an opening.
  • the water supply container for supplying steam according to the first means of the present invention is characterized in that a used culture instrument or culture solution can be put inside and the chuck can be resealed.
  • the third means of the present invention for solving the above-mentioned problems is that one rectangular plastic resin film is brought close to the short sides facing each other so that the center in the longitudinal direction is the bottom of the container. Are folded in the short direction to form two opposite sides of the A side and the B side having different upper side heights, and the left and right sides of the A side and B side that are overlapped are sealed.
  • a bag-like space can be formed inside by wearing, and before sealing, the folded portion in the short direction is further folded back to the inner surface side with the same width on both the A surface and the B surface on the inner surface side.
  • a bag-shaped water supply container for steam supply having an opening that can be freely opened on the upper end side of the A-side and B-side having different heights by sealing the overlapped sides after forming Small amount of plastic resin film
  • At least one central part is provided with a non-woven fabric having moisture permeability, water resistance and bacterial barrier properties, and the opening is provided with a plurality of suspension insertion holes, closer to the center than the insertion holes. Opening and closing chuck that can be resealed at the opening enables water to be retained inside, opens the sealed chuck after supplying steam, and then re-seals the chuck by placing a used culture instrument or culture solution inside
  • This is a water supply container for steam supply, characterized in that it can be performed.
  • a fourth means of the present invention for solving the above-mentioned problem is a bag body carrying water prepared by a base material having airtightness, and a part of the bag body has air permeability and moisture permeability.
  • a water supply container for steam supply characterized by having a resealable opening and closing chuck for opening and closing the opening of the bag body comprising a chuck male part and a chuck female part at the lower end. .
  • the re-sealable opening / closing chuck includes a chuck male part that protrudes from a substantially arrowhead-shaped head part, and an inner claw that forms an arcuate concave part.
  • the water retention container for steam supply according to any one of the means of the present invention, characterized by comprising a chuck female portion formed by protruding an outer claw.
  • Another means of the present invention for solving the above-mentioned problems is any one of the means of the present invention characterized in that one of the chuck male part and the chuck female part is colored. It is a water retention container for steam supply as described.
  • Another means of the present invention for solving the above problem is that a part of the airtight base material constituting the opening protrudes further upward than the other upper end of the opening. It is a water supply container for steam supply according to any one of the means of the present invention.
  • Another means of the present invention for solving the above-mentioned problems is the water supply container for steam supply according to any one of the means of the present invention, characterized in that it is sterilized by gamma irradiation. .
  • the water supply container for supplying steam is in a double bag state loaded in an outer bag prepared by a base material having airtightness.
  • the water supply container for steam supply according to any one of the above.
  • the water supply container for supplying steam according to the present invention makes it possible to obtain a steam supply capacity substantially equivalent to that of a conventional humidifying tray.
  • waste such as cells / tissues, culture solution, and consumables such as culture dishes and multiwell plates used in the CPC can be left in the water supply container for steam supply after supply of steam. It can be sealed in a cross-contamination-preventing environment with the minimum number of man-hours required to enter the space and close the resealable open / close chuck.
  • the water supply container for steam supply according to the present invention can greatly reduce the total capacity of waste.
  • the water supply container for steam supply of the present invention it is possible to prevent the occurrence of cross-contamination accidents due to leakage of wastes such as cells / tissues, culture solution, and used culture equipment sealed in the water supply container for steam supply after steam supply. It becomes possible to prevent.
  • the water remaining in the water supply container for steam supply after supplying steam is used for sterilization of wastes such as cells / tissues, culture solutions and consumables used in the CPC.
  • wastes such as cells / tissues, culture solutions and consumables used in the CPC.
  • a CPC that can be used effectively together with a water holding container and the total amount of water that can be brought in is limited, it is not necessary to replenish water for autoclaving.
  • the water supply container for steam supply according to the present invention contributes to standardization of work procedures related to manufacturing process management.
  • (A) is the front view seen from the surface provided with the nonwoven fabric provided with moisture permeability, water resistance, and bacteria barrier property
  • (b) is the back view which looked at it from the back side surface.
  • It is a water supply container for steam supply in which the insertion hole for suspension of the present invention is an elongated hole on the side, and is a front view seen from a surface provided with a nonwoven fabric having moisture permeability, water resistance and bacterial barrier properties.
  • (A) is a figure explaining the water retention container for steam supply before use.
  • (B) shows a state in which the water supply container for steam supply is hung on the hanger rack for water supply container for steam supply by using the insertion hole for suspension, the resealable opening / closing chuck is opened, and water is prepared It is a figure explaining.
  • (C) is a figure explaining the state which put water in the water supply container for steam supply, closed the resealable opening / closing chuck, and removed from the hanger rack for water supply containers for steam supply. It is a figure explaining the procedure which arrange
  • (C) is a state in which the resealing openable / closable chuck of the water supply container for steam supply after the supply of steam containing the used culture container is closed again so that it can be moved in the CPC room in a cross contamination prevention environment.
  • the material used to form the water supply container for steam supply of the present invention is not particularly limited, A plastic resin film can be used as a gas-tight base material in a container that holds water for supplying steam. And, in order to supply the steam derived from the water retained in the steam supply water retaining container outside the steam supply water retaining container, and further using a nonwoven fabric having moisture permeability, water resistance and bacterial barrier properties To do.
  • the above-mentioned plastic resin film is a resin film having water retention (water resistance) and heat resistance against heating in an autoclave.
  • These may have a laminated film structure composed of a multilayer structure.
  • preferable materials include a laminate composed of nylon and linear low density polyethylene (L-LDPE), and metal deposition.
  • L-LDPE linear low density polyethylene
  • a film laminate having a multilayer structure of a film layer and a thermoplastic resin may be used. When it is necessary to consider long-term storage, bacterial barrier properties, oxygen resistance, etc., these materials can be appropriately employed.
  • the non-woven fabric having moisture permeability, water resistance, and bacteria barrier property is a film-like substrate having air permeability, moisture permeability, and bacteria barrier property, and is used for water retained in a water container for supplying steam. It is possible to permeate the derived steam.
  • Commercially available high-density ethylene-based non-woven fabric such as Tyvek (registered trademark) can be used, and preferably it maintains excellent moisture permeability and water resistance and bacterial barrier properties even after electron beam irradiation.
  • Medical DuPont Tyvek 1073B or 1059B sold by Asahi DuPont Flashspan Products Co., Ltd. which does not occur and contracts slightly after high-pressure steam sterilization, can be used.
  • the water supply container for steam supply of the present invention can be integrated by using heat fusion, an adhesive, or the like, and preferably integrated by using heat fusion (FIG. 1). , FIG. 2).
  • a part of a laminate made of substantially rectangular nylon and linear low density polyethylene (L-LDPE) is folded in a mountain shape so as to form a steam supply water holding container having a thickness as shown in FIGS. Then, a valley fold, a mountain fold, and a mountain fold, and a non-woven fabric having moisture permeability, water resistance, and bacterial barrier properties such as a substantially rectangular tyvek 1073B are stacked on the end of the laminated body.
  • L-LDPE substantially rectangular nylon and linear low density polyethylene
  • a laminated body made of approximately rectangular nylon and linear low-density polyethylene (L-LDPE) is layered, heat-sealed, three sides of the periphery are sealed, and the other one can be opened as an opening.
  • This is a bag-like water supply container for steam supply.
  • the bottom becomes three-dimensional and has a thickness (FIG. 3 (b), FIG. 3C). By increasing the thickness, it is possible to increase the amount of water retained inside and increase the total amount of steam that can be supplied.
  • a laminate made of substantially rectangular nylon and linear low-density polyethylene (L-LDPE) is further stacked on the end of a non-woven fabric having moisture permeability, water resistance and bacterial barrier properties such as 1073B such as Tyvek.
  • L-LDPE substantially rectangular nylon and linear low-density polyethylene
  • the length of the body can be slightly shortened, and in this way, the other end of the bag-like water supply container for steam supply that can be freely opened has a shape in which one end of the end of the opening protrudes (FIG. 1). 2), it is possible to pinch one end of the opening with an operator's finger or tweezers, etc., preventing inadvertent contamination of the interior, and opening the water supply container for steam supply This is preferable because the operation of opening the part becomes easy.
  • the water supply container for steam supply is provided with a plurality of suspension insertion holes in the opening.
  • the shape of the insertion hole for suspension may be any shape, but preferably the shape is such that the corner is rounded so that the hole is not easily broken even if a heavy object is suspended. It is possible to make the shape of a long narrow hole so as to open the opening more naturally when it is applied.
  • the water supply container for steam supply is provided with an openable / closable chuck at an opening closer to the center than the insertion hole.
  • the re-sealable opening / closing chuck is composed of a chuck male part and a chuck female part, and is integrated with the plastic resin film of the water supply container for steam supply by heat fusion or the like.
  • the shape of the chuck may include, for example, a chuck male part that protrudes from a substantially arrowhead-shaped head part, and an inner claw that forms an arcuate recess and a chuck female part that protrudes from an outer claw. As long as it can be resealed and can maintain a sealed state even after autoclave sterilization, it may have other shapes.
  • the re-sealable opening / closing chuck may be colored, and more preferably, one of the male chuck and the female chuck is colored. In this way, if the work for closing the re-sealable opening / closing chuck is insufficient, the color of the sealing part becomes light and it can be grasped that the water supply container for steam supply is not sealed. Cross-contamination accidents caused by errors such as leakage of water in the steam supply container due to errors, or leakage of cells / tissues, culture fluid, used culture equipment, etc. enclosed in the steam supply container after steam supply Occurrence can be prevented in advance.
  • the water supply container for steam supply of the present invention can be provided as being sterilized in advance.
  • the method of sterilizing the water supply container for supplying steam is not particularly limited, but a method generally used as a method for sterilizing an infusion set or medical device is adopted.
  • ethylene oxide gas sterilization, ⁇ -ray irradiation sterilization, electron beam sterilization, radiation Methods of sterilization, ultraviolet irradiation sterilization, hydrogen peroxide sterilization, and ethanol sterilization can be used.
  • ⁇ -ray irradiation sterilization or electron beam sterilization is preferably used as the sterilization method.
  • the ⁇ -ray irradiation energy in ⁇ -ray irradiation sterilization is preferably in the range of about 5 kGy to 30 kGy so that sterilization can be performed without deteriorating the water supply container for steam supply.
  • the water supply container for steam supply according to the present invention can be subjected to ⁇ -ray irradiation sterilization after double packaging so that the package can be opened and taken out and used immediately.
  • the water supply container for steam supply of the present invention is used after filling water for supplying steam.
  • the water supply container for steam supply according to the present invention is hung on a hook provided in a biohazard countermeasure cabinet or a hanger rack for a water supply container for steam supply, opens a resealable opening / closing chuck, and supplies water from the opening. Fill.
  • a highly processed LPS (lipopolysaccharide) free one such as reverse osmosis treatment
  • the resealable open / close chuck is closed, autoclaved, and sterilized package It is possible to move it into the CPC sterilization chamber after enclosing it in a double package.
  • the water supply container for steam supply which is filled with water and has a resealable opening / closing chuck closed, is placed in the incubator, the door is closed, the temperature is kept at 37.0 ° C., and steam is supplied into the incubator chamber.
  • the water supply container for supplying steam is taken out from the incubator, hung on the hook provided in the biohazard prevention cabinet or the hanger rack for the water supply container for supplying steam, and the resealable open / close chuck is opened. From the opening, waste such as cells / tissues, culture solution, and used culture equipment is charged, the resealable open / close chuck is closed again, and from the CPC sterilization chamber to the CPC sterilization chamber through the pass box After moving to a cross-contamination prevention environment, autoclaving is performed.
  • the water supply container for supplying steam can be naturally operated in one direction, from the incubator to the biohazard prevention cabinet to the CPC sterilization chamber to the pass box to the CPC sterilization chamber to the autoclave to the pass box to the CPC. It is possible to move waste while minimizing the risk of cross-contamination with the flow line.
  • Nylon and linear low-density polyethylene which are plastic resin films having water retention (water resistance) and heat resistance against heating in an autoclave, are used as members for constituting the water supply container for steam supply of the present invention.
  • L-LDPE linear low-density polyethylene
  • a Tyvek (1073B) that does not allow water to pass through and transmits only water vapor and gas, and integrates the above members by thermal fusion to produce a water supply container for supplying steam.
  • Example 1 a water supply container for steam supply was manufactured as shown in FIG.
  • the dimensions were 220 mm (W) x 380 mm (H) x 48 mm (D), and the surface area of the moisture permeable part by Tyvek was 480 cm 2 (200 mm x 240 mm).
  • the insertion hole for suspension was a round hole.
  • the plastic resin film constituting the opening on the side where either the male side or the female side chuck in the re-sealable opening / closing chuck is provided is provided with the other chuck. It is made longer than the plastic resin film which comprises the opening part of the side which is.
  • Example 2 a water supply container for steam supply was manufactured as shown in FIG. The dimensions and the like were the same as in Example 1, and the suspension insertion hole was a long and narrow slot.
  • Example 3 a water supply container for steam supply was manufactured in the same manner as in Example 1, and a resealable opening / closing chuck with a colored chuck on the male side was used.
  • Example 4 a water supply container for steam supply was manufactured in the same manner as in Example 1, and a resealing open / close chuck with a colored female chuck was used.
  • Example 1 The water supply container for steam supply of Example 1 was hung on the hanger rack for water supply container for steam supply using the insertion hole for suspension, and the resealable opening / closing chuck was opened. Water required for the following test was put in the water supply container for steam supply.
  • the plastic resin film constituting the opening on the side where either the male chuck or the female chuck is arranged constitutes the opening on the side where the other chuck is arranged Since it is made longer than the plastic resin film to be opened, the opening of the suspended water supply container for steam supply can be opened naturally with the long resin film part, and the work is easy. It was.
  • the water supply container for steam supply according to the present invention (dimensions) (Mm): 220 (W) x 380 (H) x 48 (D), moisture supply surface area of 480 cm 2 (200 mm x 240 mm)), and a 492 cm 2 humidified tray as a comparison
  • the steam supply capacity when used was confirmed.
  • the water supply container for steam supply of Example 1 or the humidifying tray was placed in the incubator, the door was closed, and the humidified water was kept at 37.0 ° C. Thereafter, the door was opened for 120 seconds, the door was closed again, and the humidity in the incubator was measured.
  • Example 2 The water supply container for steam supply of Example 1 was hung on the hanger rack for water supply container for steam supply using the insertion hole for suspension, and the resealable opening / closing chuck was opened. Water was put in the water supply container for steam supply so that the total amount was 1 L, the resealable opening / closing chuck was closed, and the opening was sealed. The water supply container for steam supply was removed from the rack, and sterilization was performed at 121 ° C. for 20 minutes using an autoclave (manufactured by Tommy Seiko, model: KS-243).
  • the autoclave could be performed as usual.
  • the resealable open / close chuck of the water supply container for steam supply was tightly closed, and no damage was found in the water supply container for steam supply itself.
  • the resealable opening / closing chuck was opened and the amount of water therein was confirmed, the amount of water contained in the water container for steam supply was reduced by only 21 mL.
  • the sterilized water supply container for steam supply in Experimental Example 2 was returned to room temperature, then placed in an incubator, the door was closed, and the temperature was kept at 37.0 ° C. Thereafter, the door was opened for 120 seconds, the door was closed again, and the humidity in the incubator was measured.
  • the water supply container for steam supply of the present invention can be prepared as a sterilized water supply container for steam supply containing sterilized water in advance by supplying water and performing autoclave sterilization, and can be provided in the CPC It has become clear that steam can be sufficiently supplied into the incubator.
  • a water supply container for supplying steam after the steam supply test was prepared.
  • the water supply container for steam supply was suspended from the hanger rack for the water supply container for steam supply using the insertion hole for suspension, and a resealable opening / closing chuck was opened. Put water in a total amount of 1L, close the resealable open / close chuck, reseal the opening of the steam supply water retaining container, remove the steam supply water retaining container from the rack, and use an autoclave. Sterilization was performed at 121 ° C. for 20 minutes.
  • the autoclave could be performed as usual.
  • the resealable open / close chuck of the water supply container for steam supply was tightly closed, and no damage was found in the water supply container for steam supply itself. It has been clarified that the water supply container for steam supply according to the present invention can be sterilized without being damaged even if the water after supplying steam remains inside.
  • the autoclave could be performed as usual.
  • the resealable open / close chuck for the water supply container for steam supply is tightly closed, and the water supply container for steam supply itself is not damaged. It was possible to perform reliably in the container.
  • the autoclave could be performed as usual.
  • the resealable open / close chuck for the water supply container for steam supply is tightly closed, and the water supply container for steam supply itself is not damaged. It was possible to perform reliably in the container. Even if the position of the hook was slightly deviated, the suspension insertion hole was a long narrow hole, so it could be easily suspended from the hook.
  • the resealable opening / closing chuck is opened, the opening naturally starts to open due to the weight of water in the water container for steam supply, and further to the vicinity of the narrow elongated hole fixed to the hook. Since it opened, it was easy to put waste into the water supply container for steam supply.
  • Example 7 An experiment for sterilization was performed in the same manner as in Experimental Example 5 except that the water supply container for steam supply of Example 3 or Example 4 was used.
  • the autoclave could be performed as usual.
  • the resealable open / close chuck for the water supply container for steam supply is tightly closed, and the water supply container for steam supply itself is not damaged. It was possible to perform reliably in the container.
  • the chuck is colored in the re-sealable opening / closing chuck, if the re-sealable opening / closing chuck is not sufficiently closed, the color of the sealing part becomes light and it becomes easy to grasp the sealing state. It was.
  • waste such as cells / tissues, culture solution, and consumables such as culture dishes and multiwell plates used in the CPC can be used as a stand for the water supply container for steam supply or bio
  • waste such as cells / tissues, culture solution, and consumables such as culture dishes and multiwell plates used in the CPC
  • the water supply container for steam supply is moved in an incubator, a biohazard countermeasure cabinet, a CPC sterilization chamber, a pass box, a CPC sterilization chamber, an autoclave, a pass box, and a CPC with a natural work flow in one direction. It became clear that it was possible to move waste while minimizing the risk of cross-contamination.

Abstract

The present invention provides a novel bag-type water holding container for steam supply use, in which almost rectangular two plastic resin films are overlaid on each other, three sides in the peripheries of the laminate of the films are sealed, and the remaining one side is rendered openable and therefore serves as an opening, said water holding container being characterized in that a non-woven fabric having vapor permeability, water resistance and bacteria barrier properties is arranged at the center of at least one of the plastic resin films, multiple hanging through-holes are provided at the opening, and a re-sealable opening/closing zipper is provided at a part of the opening which is located in the rather central position than the through-holes to thereby enable water to be held in the inside of the films. The zipper which is sealed after the supply of steam is opened, and a used culture tool or a culture solution is placed in the inside of the container, and then the zipper is re-sealed. In this manner, it becomes possible to prevent the occurrence of cross contamination in a cell processing center (CPC) and it also becomes possible to sterilize the used culture tool or the culture solution with an autoclave.

Description

蒸気供給用保水容器Water supply container for steam supply
　本発明は、蒸気供給用保水容器に関するものである。とりわけ、該蒸気供給用保水容器を、インキュベーター～バイオハザード対策用キャビネット～ＣＰＣ無菌室内～パスボックス～ＣＰＣ滅菌処理室～オートクレーブ～パスボックス～ＣＰＣ外へと、１方向の自然な作業動線で、交叉汚染のリスクを極小にしながら廃棄物を移動させることが可能な、蒸気供給用保水容器に関するものである。 The present invention relates to a water supply container for steam supply. In particular, the water supply container for supplying steam is moved to an incubator, a biohazard countermeasure cabinet, a CPC sterilization chamber, a pass box, a CPC sterilization chamber, an autoclave, a pass box, and a CPC with a natural flow of work in one direction. The present invention relates to a water supply container for steam supply that can move waste while minimizing the risk of cross contamination.
　近年、ヒトから採取した細胞や組織から、各種の組み換え細胞、ｉＰＳ細胞、ＥＳ細胞、およびそれらを分化・誘導した細胞や組織が調製され、患者に投与する細胞医療及び再生医療が行われている。また、研究施設においても、細胞治療及び再生医療を新規開発するため、様々な試験研究が積極的に推進されている。それらにおいては、細胞や組織の取得、作製、培養および保存の工程が必須となっている。そこで、細胞治療及び再生医療における高い安全性、品質ならびに医薬としての性能を、安定的に確保することが可能となるよう、上記各工程における標準化された技術を確立するとともに、使用する機器や細胞調製施設（ＣＰＣ）の標準化と、それら機器や施設の使用手順の標準化を進めることが、強く望まれている。 In recent years, various types of recombinant cells, iPS cells, ES cells, and cells and tissues obtained by differentiating them have been prepared from cells and tissues collected from humans, and cell medicine and regenerative medicine administered to patients have been performed. . In addition, various research studies are actively promoted in research facilities in order to newly develop cell therapy and regenerative medicine. In those, the process of acquisition, preparation, culture and storage of cells and tissues is essential. Therefore, in addition to establishing standardized technologies in each of the above steps so that it is possible to stably ensure high safety, quality, and pharmaceutical performance in cell therapy and regenerative medicine, devices and cells used There is a strong demand for standardization of preparation facilities (CPC) and standardization of procedures for using the equipment and facilities.
　そこで、通常のＣＰＣでは、作業動線と施設や機器の配置が、人、細胞や組織、培養器具および廃棄物の出入りを明確に区分することが可能となるように設定されているところ、上記のような、個々の患者に対応した再生医療や細胞治療に用いる細胞や組織を調製するＣＰＣにおいては、さらに、交差汚染や細胞・組織の混合を防止するため、作業者の動線が基本的に逆戻りしない一方向の動線となるようにし、専用搬入口であるパスボックスを設置して物品を受け渡すなど、人や物の動線への配慮が行われている。 Therefore, in the normal CPC, the work flow line and the arrangement of facilities and equipment are set so that it is possible to clearly distinguish people, cells and tissues, culture equipment, and the entry and exit of waste. In CPC that prepares cells and tissues used for regenerative medicine and cell therapy corresponding to individual patients, the flow lines of workers are fundamental to prevent cross-contamination and mixing of cells and tissues. Consideration is given to the flow of people and goods, such as a one-way flow line that does not revert to, and a pass box that is a dedicated carry-in entrance to deliver goods.
　しかしながら、作業目的に応じた適切な広さと設備を十分に整えることが出来ない場合があり、パスボックスも搬入可能な物品の大きさに制限があり、後から大きな専用の機器を搬入することは困難を伴う場合がある。また、細胞や組織の分化・誘導を行うために培養工程が複雑な手順をとるものも多くなり、ＣＰＣ設計当初の想定とは異なり、作業者の動線の一部が、逆戻りしたり交叉する事象が発生している。また、一連の作業に要する時間も長くなり、作業者に疲労やストレスがたまり、人的ミスが生じる危険性が増大している。 However, there may be cases where it is not possible to adequately prepare the appropriate space and equipment according to the purpose of the work, and there is a limit to the size of articles that can be carried in the pass box. May be difficult. In addition, in many cases, the culturing process takes a complicated procedure to differentiate and induce cells and tissues, and unlike the initial assumption of CPC design, part of the flow line of the operator is reversed or crossed. An event has occurred. In addition, the time required for a series of work is increased, and fatigue and stress are accumulated on the worker, and there is an increased risk of human error.
　そのため、既に設置されたＣＰＣにおいて、作業者の動線の一部が、逆戻りしたり交叉したとしても、交差汚染や細胞・組織の混合を確実に防止することができるようにするとともに、作業手順の簡素化と安全化および作業時間の短縮を図るための新たな器具の開発が、強く望まれていた。 Therefore, in the already installed CPC, even if a part of the operator's flow line is reversed or crossed, it is possible to reliably prevent cross contamination and mixing of cells / tissues and work procedures. Development of a new instrument for simplifying and improving safety and shortening the working time has been strongly desired.
　その一つとして、ＣＰＣ内に設置するインキュベーターにおける水分による汚染対策器具がある。ＣＰＣ内で用いられる細胞・組織培養用のインキュベーターは、通常、３７度５％ＣＯ2などとし、さらに、トレーに滅菌水を張るなどしてインキュベーターの庫室内を加湿して、水蒸気で飽和させた雰囲気環境にする必要がある。 As one of them, there is an instrument for preventing contamination by moisture in an incubator installed in a CPC. The incubator for cell / tissue culture used in the CPC is usually 37 ° C. 5% CO 2 , and the inside of the incubator chamber is humidified by adding sterilized water to the tray and saturated with water vapor. It is necessary to create an atmospheric environment.
　しかし、個々の患者に対応した細胞治療や再生医療に用いる細胞や組織を調製するような厳密な安全性の確保が要求されるＣＰＣでは、カビの発生を抑え排水口からの外気の逆流を防ぐ必要がある。そのため、ＣＰＣにおける無菌区域には、流しや排水口を設置せず、ＣＰＣ内に持ち込み使用する水を滅菌処理したものだけに制限するとともに持ち込み量も一定範囲内に制限し、さらに使用後は残さず外へ持ち出す制限を加える。そのため、滅菌水を直接トレーに入れ、開放状態で加湿する工程は避けるべきであり、改善が望まれていた。 However, in CPC that requires strict safety such as preparation of cells and tissues used for cell therapy and regenerative medicine corresponding to individual patients, generation of mold is suppressed and backflow of outside air from the drain outlet is prevented. There is a need. For this reason, no sinks or drains are installed in the aseptic area of the CPC, the water that is brought into the CPC is limited to sterilized water, and the amount brought in is limited to a certain range. Add restrictions to bring it out. Therefore, the process of putting sterilized water directly into the tray and humidifying it in an open state should be avoided, and improvement has been desired.
　上記改善の要求に対し、発明者らは、滅菌水を張るトレーに換えて、予め水を袋状湿度供給容器内に入れ密封し、ＣＰＣ内に設置されたインキュベーターの庫室内に設置し、庫室内の雰囲気に湿度を供給する袋状湿度供給容器を提案している（特許文献１を参照）。しかし、上記提案の加湿容器は、広い開口部を有する軟質な袋体からなり、水を入れ密封する際に袋体から水が容器周辺にこぼれる場合があるためＣＰＣ内での作業は避ける必要があった。 In response to the above request for improvement, the inventors replaced the tray filled with sterilized water, put water in a bag-like humidity supply container in advance, sealed it, installed it in the storage room of the incubator installed in the CPC, A bag-like humidity supply container for supplying humidity to an indoor atmosphere has been proposed (see Patent Document 1). However, the proposed humidifying container is composed of a soft bag body having a wide opening, and when water is put and sealed, water may spill out from the bag body around the container, so it is necessary to avoid work in the CPC. there were.
　そこで、さらに発明者らは、上記袋状湿度供給容器における開口部を封じ、そこに、新たにキャップを有する水の供給排出口を設けた袋状湿度供給容器を提案している（特許文献２を参照）。このようにして、キャップを有する、専用の水の供給排出口を設けたことにより、上記袋状湿度供給容器における問題点は解消した。しかし、上記容器への水の供給は、供給排出口に接続した水供給用具を用いるため、水供給時に水が漏れ出さないが、専用の水供給用具を要するため汎用性に欠けるものであり、改善が望まれていた。さらに、新たな加湿専用器具を使用することで作業者の作業動線も複雑になり、また、ＣＰＣにおける無菌区域内から搬出する医療廃棄物の総体積が増えることから、対策を講じる必要が生じていた。 Therefore, the inventors have proposed a bag-like humidity supply container in which the opening in the bag-like humidity supply container is sealed and a water supply / discharge port having a cap is newly provided therein (Patent Document 2). See). Thus, the problem in the bag-like humidity supply container was solved by providing a dedicated water supply / discharge port having a cap. However, since the water supply to the container uses a water supply tool connected to the supply / discharge port, water does not leak out during the water supply, but a dedicated water supply tool is required and lacks versatility. Improvement was desired. In addition, the use of a new humidifying device complicates the operator's work flow, and the total volume of medical waste transported from the sterile area of the CPC increases, so it is necessary to take measures. It was.
　ところで、再生医療や細胞治療では、特に、個々の患者に対応した再生医療や細胞治療に用いる細胞や組織を調製することが必須となっているため、細胞や組織の調製にあたっては、異なる患者に使用する細胞や組織が交叉汚染をすることを、厳に避けなければならない。そのため、個々の患者の治療が完了するごとに、ＣＰＣ内の汚染要因となる、細胞や組織、使用済みの培養液、培養器具、及び、水や加湿容器を全てＣＰＣ外に搬出し、ＣＰＣ内及び設置されている機器を全て洗浄・滅菌し、ＣＰＣ内に交叉汚染の要因となるものが残っていないことを、検査にて確認するという、厳密な工程を行うことが求められる。 By the way, in regenerative medicine and cell therapy, it is essential to prepare cells and tissues for use in regenerative medicine and cell therapy especially for individual patients. It must be strictly avoided that the cells and tissues used are cross-contaminated. Therefore, every time the treatment of each individual patient is completed, the cells and tissues, used culture fluid, culture equipment, water and humidification containers, which become contamination factors in the CPC, are all taken out of the CPC. In addition, it is required to carry out a strict process of cleaning and sterilizing all installed devices and confirming by inspection that there are no cross contamination factors remaining in the CPC.
　さらに、網膜組織のような組織を移植する再生医療などにおいては、多数の細胞を増殖させる必要があるために、作製途中で多くの細胞や組織が使用済みの培養液や培養器具とともに排出される。最終工程で使用しなかった予備の組織は、廃棄しなければならない。そして、特に、液体を取り扱う廃棄工程では、エアロゾル状の目に見えない飛沫が発生しやすく、培養作業中や使用済みの細胞や組織、培養液および培養器具の排出作業時に、エアロゾル状の目に見えない飛沫による交叉汚染の発生を防ぐよう、慎重な対応と汚染予防措置が必要となっている。 Furthermore, in regenerative medicine for transplanting a tissue such as a retinal tissue, it is necessary to proliferate a large number of cells. Therefore, many cells and tissues are discharged together with used culture solutions and culture tools during the production. . Any spare tissue that is not used in the final process must be discarded. In particular, in the disposal process of handling liquid, aerosol-like invisible droplets are likely to be generated, and during the culturing operation and when discharging used cells and tissues, culture solution and culture equipment, Careful measures and pollution prevention measures are necessary to prevent the occurrence of cross-contamination due to invisible droplets.
　そこで、通常は、汎用の滅菌用袋をＣＰＣ内に予め持ち込み、各所の機器横のスペースに付設し、それらに使用済みの細胞や組織、使用済みの培養液、培養器具及び水を入れ、ＣＰＣ室外へ搬出する対応をとっている。 Therefore, usually, a general-purpose sterilization bag is brought into the CPC in advance and attached to the space next to the equipment in each place, and used cells and tissues, used culture fluid, culture equipment, and water are put into them. We are taking measures to carry it out of the room.
　しかし、ＣＰＣ内は、汚染防止のため、作業区域の天井、壁および床の表面を、なめらかでひび割れや隙間がなく、塵や埃が貯まりにくい構造とし、かつ、塵埃を発生しないものとし、床と壁の境界は曲面として塵や埃を清拭しやすくするなどの特別な配慮がされているものであるところ、上記対応では、衛生管理が煩雑になるとともに、ＣＰＣ内の空気循環を妨げられることにより塵や埃がたまりやすくなるため、そのような器具をＣＰＣ内に付設することは好ましくなく、改善が求められている。 However, in order to prevent contamination inside the CPC, the ceiling, walls and floor surfaces of the work area shall be smooth and free of cracks and gaps, and will not collect dust and dust, and will not generate dust. The boundary between the wall and the wall is a curved surface, and special considerations such as easy cleaning of dust and dirt are made. However, in the above measures, hygiene management becomes complicated and air circulation in the CPC is hindered. Therefore, it is not preferable to attach such a device in the CPC, and improvement is required.
特開２００５－２９５８２５号公報JP 2005-295825 A 実用新案登録第３１２９６１０号公報Utility Model Registration No. 3129610
　本発明が解決しようとする課題は、従来の加湿トレイとほぼ同等の蒸気供給能力を得ることが可能となる蒸気供給用保水容器を提供し、ＣＰＣ内で使用した細胞・組織、培養液や、培養皿やマルチウェルプレートなどの消耗品などの廃棄物を、蒸気供給後の蒸気供給用保水容器の空きスペースに投入し、再封止可能な開閉チャックを閉じるという最小の作業工数で、交叉汚染防止環境下に密封でき、ＣＰＣにおける無菌区域内から搬出する医療廃棄物の総体積を減らすとともに、１方向の自然な作業動線で、交叉汚染のリスクを極小にしながら廃棄物を移動させることが可能とする蒸気供給用保水容器を提供することである。そして、使用する機器やＣＰＣの標準化と、それら機器や施設の使用手順の標準化に寄与することができる、蒸気供給用保水容器を提供することである。 The problem to be solved by the present invention is to provide a water supply container for steam supply capable of obtaining a steam supply capacity substantially equivalent to that of a conventional humidifying tray, and a cell / tissue used in CPC, a culture solution, Cross-contamination with minimal work man-hours such as putting wastes such as culture dishes and multiwell plates into the empty space of the water supply container for steam supply after supplying steam and closing the resealable open / close chuck It can be sealed in a preventive environment, reducing the total volume of medical waste transported from within the sterile area of the CPC and moving waste while minimizing the risk of cross-contamination with one-way natural work flow It is to provide a water supply container for steam supply that is made possible. And it is providing the water retention container for vapor | steam supply which can contribute to standardization of the apparatus and CPC to be used, and the standardization of the use procedure of those apparatuses and facilities.
　上記の課題を解決するための本発明の第１の手段は、略矩形状のプラスチック樹脂フィルムを２枚重ね合わせて、これらの周囲のうち三方を封着し、残り一方を開口部として開口自在とした袋状の蒸気供給用保水容器であって、前記プラスチック樹脂フィルムの少なくとも１枚の中央部には透湿性及び耐水性とバクテリアバリア性を備えた不織布を配し、前記開口部には複数の吊下用挿通孔を備え、該挿通孔よりも中央部寄りの開口部に再封止可能な開閉チャックを設けて、内部に水を保水可能としたこと、を特徴とする蒸気供給用保水容器である。 The first means of the present invention for solving the above problems is to stack two substantially rectangular plastic resin films, seal three sides out of these, and open the other one as an opening. A bag-like water supply container for steam supply, wherein a non-woven fabric having moisture permeability, water resistance and bacterial barrier properties is disposed at the center of at least one of the plastic resin films, and a plurality of the openings are provided in the opening. Water supply for steam supply, characterized in that a re-sealing opening / closing chuck is provided at an opening portion closer to the center than the insertion hole so that water can be retained therein. It is a container.
　上記の課題を解決するための本発明の第２の手段は、略矩形状のプラスチック樹脂フィルムを２枚重ね合わせて、これらの周囲のうち三方を封着し、残り一方を開口部として開口自在とした袋状の蒸気供給用保水容器であって、前記プラスチック樹脂フィルムの少なくとも１枚の中央部には透湿性及び耐水性とバクテリアバリア性を備えた不織布を配し、前記開口部には複数の吊下用挿通孔を備え、該挿通孔よりも中央部寄りの開口部に再封止可能な開閉チャックを設けて、内部に水を保水可能とし、蒸気供給後に封止したチャックを開け、さらに内部に使用済の培養器具や培養液を入れチャックを再封止することを可能としたこと、を特徴とする、本発明の第１の手段の蒸気供給用保水容器である。 The second means of the present invention for solving the above-mentioned problem is that two substantially rectangular plastic resin films are overlapped, three of these are sealed, and the other one can be opened as an opening. A bag-like water supply container for steam supply, wherein a non-woven fabric having moisture permeability, water resistance and bacterial barrier properties is disposed at the center of at least one of the plastic resin films, and a plurality of the openings are provided in the opening. An opening / closing chuck that can be resealed at the opening closer to the center than the insertion hole, allowing water to be retained inside, opening the sealed chuck after supplying steam, Furthermore, the water supply container for supplying steam according to the first means of the present invention is characterized in that a used culture instrument or culture solution can be put inside and the chuck can be resealed.
　上記の課題を解決するための本発明の第３の手段は、１枚の矩形のプラスチック樹脂フィルムをその長手方向中央部が容器底部となるように該プラスチック樹脂フィルムの対向する短辺同士を近接させるように短手方向に折り曲げることで上辺の高さの異なるＡ面とＢ面の向かい合う２面を形成するものであって、さらにＡ面とＢ面の左右の重ね合わさった辺同士をそれぞれ封着することで内部に袋状の空間を形成しうるものであって、封着前に短手方向の折り返し部をさらに内面側にＡ面Ｂ面ともに等幅に内面側に折り返すことで底面を形成してから前記重ね合わさった辺同士を封着することで、高さの異なるＡ面とＢ面の上端側に開口自在とした開口部を備えた袋状の蒸気供給用保水容器であって、前記プラスチック樹脂フィルムの少なくとも１枚の中央部には透湿性及び耐水性とバクテリアバリア性を備えた不織布を配し、前記開口部には複数の吊下用挿通孔を備え、該挿通孔よりも中央部寄りの開口部に再封止可能な開閉チャックを設けて、内部に水を保水可能とし、蒸気供給後に封止したチャックを開け、さらに内部に使用済の培養器具や培養液を入れチャックを再封止することを可能としたこと、を特徴とする蒸気供給用保水容器である。 The third means of the present invention for solving the above-mentioned problems is that one rectangular plastic resin film is brought close to the short sides facing each other so that the center in the longitudinal direction is the bottom of the container. Are folded in the short direction to form two opposite sides of the A side and the B side having different upper side heights, and the left and right sides of the A side and B side that are overlapped are sealed. A bag-like space can be formed inside by wearing, and before sealing, the folded portion in the short direction is further folded back to the inner surface side with the same width on both the A surface and the B surface on the inner surface side. A bag-shaped water supply container for steam supply having an opening that can be freely opened on the upper end side of the A-side and B-side having different heights by sealing the overlapped sides after forming Small amount of plastic resin film At least one central part is provided with a non-woven fabric having moisture permeability, water resistance and bacterial barrier properties, and the opening is provided with a plurality of suspension insertion holes, closer to the center than the insertion holes. Opening and closing chuck that can be resealed at the opening enables water to be retained inside, opens the sealed chuck after supplying steam, and then re-seals the chuck by placing a used culture instrument or culture solution inside This is a water supply container for steam supply, characterized in that it can be performed.
　上記の課題を解決するための本発明の第４の手段は、気密性を有する基材によって調製された水を担持する袋体であって、その袋体の一部に通気性、透湿性を有しかつバクテリアバリア性の膜状基材によって調製された蒸気供給部を有し、該袋体の開口部の上端部の内側に袋体を刺通する複数の吊り下げ穴と、該穴より下端に、チャック雄部とチャック雌部とからなる該袋体の開口部を開閉するための再封止可能な開閉チャックとを有するものとしたことを特徴とする、蒸気供給用保水容器である。 A fourth means of the present invention for solving the above-mentioned problem is a bag body carrying water prepared by a base material having airtightness, and a part of the bag body has air permeability and moisture permeability. A plurality of hanging holes for penetrating the bag body inside the upper end of the opening of the bag body, A water supply container for steam supply characterized by having a resealable opening and closing chuck for opening and closing the opening of the bag body comprising a chuck male part and a chuck female part at the lower end. .
　上記の課題を解決するための本発明の他の手段は、上記再封止可能な開閉チャックが、略矢尻状の頭部を突出してなるチャック雄部と、円弧状凹部を形成する内側鉤爪と外側鉤爪を突出してなるチャック雌部とからなることを特徴とする、本発明の手段のいずれか１に記載の蒸気供給用保水容器である。 Another means of the present invention for solving the above-mentioned problems is that the re-sealable opening / closing chuck includes a chuck male part that protrudes from a substantially arrowhead-shaped head part, and an inner claw that forms an arcuate concave part. The water retention container for steam supply according to any one of the means of the present invention, characterized by comprising a chuck female portion formed by protruding an outer claw.
　上記の課題を解決するための本発明の他の手段は、前記チャック雄部とチャック雌部のいずれか一方が着色されたものであることを特徴とする、本発明の手段のいずれか１に記載の蒸気供給用保水容器である。 Another means of the present invention for solving the above-mentioned problems is any one of the means of the present invention characterized in that one of the chuck male part and the chuck female part is colored. It is a water retention container for steam supply as described.
　上記の課題を解決するための本発明の他の手段は、該開口部を構成する気密性を有する基材の一部が、開口部の他の上端部よりもさらに上方に突出しているものであることを特徴とする、本発明の手段のいずれか１に記載の蒸気供給用保水容器である。 Another means of the present invention for solving the above problem is that a part of the airtight base material constituting the opening protrudes further upward than the other upper end of the opening. It is a water supply container for steam supply according to any one of the means of the present invention.
　上記の課題を解決するための本発明の他の手段は、ガンマ線照射により滅菌処理されるものであることを特徴とする、本発明の手段のいずれか１に記載の蒸気供給用保水容器である。 Another means of the present invention for solving the above-mentioned problems is the water supply container for steam supply according to any one of the means of the present invention, characterized in that it is sterilized by gamma irradiation. .
　上記の課題を解決するための本発明の他の手段は、蒸気供給用保水容器が、気密性を有する基材によって調製された外袋内に装填される２重袋状態にある本発明の手段のいずれか１に記載の蒸気供給用保水容器である。 Another means of the present invention for solving the above problem is that the water supply container for supplying steam is in a double bag state loaded in an outer bag prepared by a base material having airtightness. The water supply container for steam supply according to any one of the above.
　本発明の蒸気供給用保水容器により、従来の加湿トレイとほぼ同等の蒸気供給能力を得ることが可能となる。 The water supply container for supplying steam according to the present invention makes it possible to obtain a steam supply capacity substantially equivalent to that of a conventional humidifying tray.
　本発明の蒸気供給用保水容器により、ＣＰＣ内で使用した細胞・組織、培養液や、培養皿やマルチウェルプレートなどの消耗品などの廃棄物を、蒸気供給後の蒸気供給用保水容器の空きスペースに投入し、再封止可能な開閉チャックを閉じるという最小の作業工数で、交叉汚染防止環境下に密封できる。 By using the water supply container for steam supply according to the present invention, waste such as cells / tissues, culture solution, and consumables such as culture dishes and multiwell plates used in the CPC can be left in the water supply container for steam supply after supply of steam. It can be sealed in a cross-contamination-preventing environment with the minimum number of man-hours required to enter the space and close the resealable open / close chuck.
　本発明の蒸気供給用保水容器により、廃棄物の総容量を大幅に削減することが可能となる。 The water supply container for steam supply according to the present invention can greatly reduce the total capacity of waste.
　本発明の蒸気供給用保水容器により、インキュベーター～バイオハザード対策用キャビネット～ＣＰＣ無菌室内～パスボックス～ＣＰＣ滅菌処理室～オートクレーブ～パスボックス～ＣＰＣ外へと、１方向の自然な作業動線で、交叉汚染のリスクを極小にしながら廃棄物を移動させることが可能となる。 With the water supply container for steam supply of the present invention, a natural work flow in one direction from the incubator to the biohazard countermeasure cabinet to the CPC sterilization chamber to the pass box to the CPC sterilization chamber to the autoclave to the pass box to the CPC Waste can be moved while minimizing the risk of cross-contamination.
　本発明の蒸気供給用保水容器により、蒸気供給後の蒸気供給用保水容器に封入した細胞・組織や培養液、使用済培養器具などの廃棄物が漏れだすことによる交叉汚染事故の発生を未然に防止することが可能となる。 With the water supply container for steam supply of the present invention, it is possible to prevent the occurrence of cross-contamination accidents due to leakage of wastes such as cells / tissues, culture solution, and used culture equipment sealed in the water supply container for steam supply after steam supply. It becomes possible to prevent.
　本発明の蒸気供給用保水容器により、蒸気供給後の蒸気供給用保水容器内に残った水を、ＣＰＣ内で使用した細胞・組織、培養液や消耗品などの廃棄物の滅菌において、蒸気供給用保水容器とともに有効に利用でき、持ち込み可能な水の総量が制限されているＣＰＣにおいて、オートクレーブのための水を新たに補充する必要がなくなる。 With the water supply container for steam supply according to the present invention, the water remaining in the water supply container for steam supply after supplying steam is used for sterilization of wastes such as cells / tissues, culture solutions and consumables used in the CPC. In a CPC that can be used effectively together with a water holding container and the total amount of water that can be brought in is limited, it is not necessary to replenish water for autoclaving.
　本発明の蒸気供給用保水容器により、製造工程管理に関する作業手順の標準化に寄与するものとなる。 The water supply container for steam supply according to the present invention contributes to standardization of work procedures related to manufacturing process management.
本願発明の蒸気供給用保水容器を示した説明図である。（ａ）は、透湿性及び耐水性とバクテリアバリア性を備えた不織布が備えられた面から見た正面図、（ｂ）はそれを裏側の面から見た背面図である。It is explanatory drawing which showed the water retention container for steam supply of this invention. (A) is the front view seen from the surface provided with the nonwoven fabric provided with moisture permeability, water resistance, and bacteria barrier property, (b) is the back view which looked at it from the back side surface. 本願発明の吊下用挿通孔が横に細い長穴となっている蒸気供給用保水容器で、透湿性及び耐水性とバクテリアバリア性を備えた不織布が備えられた面から見た正面図である。It is a water supply container for steam supply in which the insertion hole for suspension of the present invention is an elongated hole on the side, and is a front view seen from a surface provided with a nonwoven fabric having moisture permeability, water resistance and bacterial barrier properties. . 本発明の蒸気供給用保水容器における、蒸気供給用の水を封入する手順の説明図である。（ａ）は、使用前の蒸気供給用保水容器を説明する図である。（ｂ）は、蒸気供給用保水容器を、蒸気供給用保水容器用ハンガーラックに吊下用挿通孔を用いて吊り下げ、再封止可能な開閉チャックを開け、水を入れる準備をした状態を説明する図である。（ｃ）は、蒸気供給用保水容器に水を入れ、再封止可能な開閉チャックを閉め、蒸気供給用保水容器用ハンガーラックから外した状態を説明する図である。It is explanatory drawing of the procedure which encloses the water for steam supply in the water retention container for steam supply of this invention. (A) is a figure explaining the water retention container for steam supply before use. (B) shows a state in which the water supply container for steam supply is hung on the hanger rack for water supply container for steam supply by using the insertion hole for suspension, the resealable opening / closing chuck is opened, and water is prepared It is a figure explaining. (C) is a figure explaining the state which put water in the water supply container for steam supply, closed the resealable opening / closing chuck, and removed from the hanger rack for water supply containers for steam supply. 蒸気供給用の水が封入された本発明の蒸気供給用保水容器をインキュベーターの庫内に配設する手順を説明する図である。It is a figure explaining the procedure which arrange | positions the water supply container for steam supply of this invention with which the water for steam supply was enclosed in the store | warehouse | chamber of an incubator. 本発明の蒸気供給後の蒸気供給用保水容器に、使用済の培養用容器を入れ、封入する手順を説明する図である。（ａ）は、蒸気供給後の蒸気供給用保水容器を示す図である。（ｂ）は、蒸気供給後の蒸気供給用保水容器を蒸気供給用保水容器用ハンガーラックに吊下用挿通孔を用いて吊り下げ、再封止可能な開閉チャックを再度開け、開口部から使用済の培養用容器を蒸気供給用保水容器内に入れる手順を説明する図である。（ｃ）は、使用済の培養用容器を入れた蒸気供給後の蒸気供給用保水容器の、再封止可能な開閉チャックを再度閉じ、交叉汚染防止環境にしてＣＰＣ室内を移動可能にした状態を説明する図である。It is a figure explaining the procedure which puts the used culture | cultivation container in the water supply container for steam supply after the steam supply of this invention, and is enclosed. (A) is a figure which shows the water retention container for steam supply after steam supply. (B) Hang the water supply container for supplying steam after supply of steam to the hanger rack for water supply container for supplying steam using the insertion holes for suspension, reopen the resealable opening / closing chuck, and use it from the opening It is a figure explaining the procedure which puts the completed culture container in the water retention container for steam supply. (C) is a state in which the resealing openable / closable chuck of the water supply container for steam supply after the supply of steam containing the used culture container is closed again so that it can be moved in the CPC room in a cross contamination prevention environment. FIG.
　本発明を実施するための形態について、適宜図面を参照しつつ以下に説明する。 DETAILED DESCRIPTION Embodiments for carrying out the present invention will be described below with reference to the drawings as appropriate.
　（素材、製造法について）
　本発明の蒸気供給用保水容器の部材を形成するために用いる材料は特に限定されないが、
蒸気供給用の水を保水する容器には、気密性を有する基材として、プラスチック樹脂フィルムを用いることができる。そして、蒸気供給用保水容器の外に、蒸気供給用保水容器内に保水した水に由来する蒸気を供給するため、さらに、透湿性及び耐水性とバクテリアバリア性を備えた不織布を用いたものとする。 (About materials and manufacturing methods)
The material used to form the water supply container for steam supply of the present invention is not particularly limited,
A plastic resin film can be used as a gas-tight base material in a container that holds water for supplying steam. And, in order to supply the steam derived from the water retained in the steam supply water retaining container outside the steam supply water retaining container, and further using a nonwoven fabric having moisture permeability, water resistance and bacterial barrier properties To do.
　上記のプラスチック樹脂フィルムは、保水性（耐水性）及びオートクレーブでの加熱に対する耐熱性を備えた樹脂フィルムである。これらは多層構造の積層体からなる積層フィルム構造であってもよく、たとえば好ましい素材としては、ナイロンと直鎖状低密度ポリエチレン（Ｌ－ＬＤＰＥ）からなる積層体などが挙げられるほか、金属の蒸着膜層と熱可塑性樹脂の多層構造のフィルム積層体などであってもよい。長期保存やバクテリアバリア性、耐酸素性などを考慮する必要がある際には、これらの素材は適宜採用することができる。 The above-mentioned plastic resin film is a resin film having water retention (water resistance) and heat resistance against heating in an autoclave. These may have a laminated film structure composed of a multilayer structure. For example, preferable materials include a laminate composed of nylon and linear low density polyethylene (L-LDPE), and metal deposition. A film laminate having a multilayer structure of a film layer and a thermoplastic resin may be used. When it is necessary to consider long-term storage, bacterial barrier properties, oxygen resistance, etc., these materials can be appropriately employed.
上記の透湿性及び耐水性とバクテリアバリア性を備えた不織布としては、通気性、透湿性を有しかつバクテリアバリア性の膜状基材であって、蒸気供給用保水容器内に保水した水に由来する蒸気を透湿させることが可能なものである。タイベック（登録商標）などの市販の高密度エチレン系の不織布を用いることができ、好適には、電子線照射後も優れた透湿性及び耐水性とバクテリアバリア性を保ち、紙粉（リント）が発生せず、高圧蒸気滅菌後の収縮も僅かな、旭・デュポン　フラッシュスパン　プロダクツ株式会社から販売される医療用デュポンタイベック1073Bまたは1059Bを用いることができる。 The non-woven fabric having moisture permeability, water resistance, and bacteria barrier property is a film-like substrate having air permeability, moisture permeability, and bacteria barrier property, and is used for water retained in a water container for supplying steam. It is possible to permeate the derived steam. Commercially available high-density ethylene-based non-woven fabric such as Tyvek (registered trademark) can be used, and preferably it maintains excellent moisture permeability and water resistance and bacterial barrier properties even after electron beam irradiation. Medical DuPont Tyvek 1073B or 1059B sold by Asahi DuPont Flashspan Products Co., Ltd., which does not occur and contracts slightly after high-pressure steam sterilization, can be used.
　本発明の蒸気供給用保水容器は、熱融着、接着剤等を用い、一体化させたものとすることができ、好ましくは、熱融着を用いて一体化させたものとする（図１、図２）。
　図１～５に示すような厚みを有する蒸気供給用保水容器の構成となるように、略矩形状のナイロンと直鎖状低密度ポリエチレン（Ｌ－ＬＤＰＥ）からなる積層体の一部を山折りし、次いで谷折りし、さらに山折りし、さらに山折りした積層体の端部に、略矩形状のタイベック1073Bなどの透湿性及び耐水性とバクテリアバリア性を備えた不織布を重ね、更に、その端部に、略矩形状のナイロンと直鎖状低密度ポリエチレン（Ｌ－ＬＤＰＥ）からなる積層体を重ね、熱融着し、周囲のうち三方を封着し、残り一方を開口部として開口自在とした袋状の蒸気供給用保水容器とする。山折り～谷折り～山折りした部分を設けることで、袋状の蒸気供給用保水容器の中に水を入れると、底部が立体的になり厚みを有するものとなる（図３（ｂ）、図３（ｃ）など）。厚みを持たせることで、内部に保水する水の量を増やし、供給可能な蒸気の総量を増やすことが可能となり、また、蒸気供給後の蒸気供給用保水容器の中に、より多くの培養容器や培養液などの廃棄物を封入して密封し、交叉汚染が防止されるようにしてＣＰＣの滅菌室まで移動させ、オートクレーブによる滅菌処理に処すことが可能となる。
　またさらに、上記タイベックなど1073Bなどの透湿性及び耐水性とバクテリアバリア性を備えた不織布の端部に更に重ねた、略矩形状のナイロンと直鎖状低密度ポリエチレン（Ｌ－ＬＤＰＥ）からなる積層体の長さを若干短くすることができ、このようにすると、開口自在とした袋状の蒸気供給用保水容器の残り一方を開口部の端部の一端が飛び出た形状となるため（図１、図２）、作業者の指やピンセット等の器具で開口部の端部の一端をつまむことが可能となり、不用意に内部を汚染することが防止されるとともに、蒸気供給用保水容器の開口部を開く操作が容易になるので好ましい。 The water supply container for steam supply of the present invention can be integrated by using heat fusion, an adhesive, or the like, and preferably integrated by using heat fusion (FIG. 1). , FIG. 2).
A part of a laminate made of substantially rectangular nylon and linear low density polyethylene (L-LDPE) is folded in a mountain shape so as to form a steam supply water holding container having a thickness as shown in FIGS. Then, a valley fold, a mountain fold, and a mountain fold, and a non-woven fabric having moisture permeability, water resistance, and bacterial barrier properties such as a substantially rectangular tyvek 1073B are stacked on the end of the laminated body. At the end, a laminated body made of approximately rectangular nylon and linear low-density polyethylene (L-LDPE) is layered, heat-sealed, three sides of the periphery are sealed, and the other one can be opened as an opening. This is a bag-like water supply container for steam supply. By providing a mountain fold, valley fold, or mountain fold portion, when water is put into a bag-like water supply container for steam supply, the bottom becomes three-dimensional and has a thickness (FIG. 3 (b), FIG. 3C). By increasing the thickness, it is possible to increase the amount of water retained inside and increase the total amount of steam that can be supplied. It is possible to enclose and seal the waste such as the culture medium and move to the sterilization chamber of the CPC so as to prevent cross-contamination and to perform sterilization by autoclave.
Furthermore, a laminate made of substantially rectangular nylon and linear low-density polyethylene (L-LDPE) is further stacked on the end of a non-woven fabric having moisture permeability, water resistance and bacterial barrier properties such as 1073B such as Tyvek. The length of the body can be slightly shortened, and in this way, the other end of the bag-like water supply container for steam supply that can be freely opened has a shape in which one end of the end of the opening protrudes (FIG. 1). 2), it is possible to pinch one end of the opening with an operator's finger or tweezers, etc., preventing inadvertent contamination of the interior, and opening the water supply container for steam supply This is preferable because the operation of opening the part becomes easy.
　また、上記の蒸気供給用保水容器には、開口部には複数の吊下用挿通孔を備えるようにする。吊下用挿通孔の形状は、どのような物であっても良いが、好ましくは、重量のあるものを吊り下げても穴が破れにくくするよう、角が丸くなった形状とするか、重量が掛かる際により自然に開口部を開くよう横に細い長穴の形状とすることができる。 Also, the water supply container for steam supply is provided with a plurality of suspension insertion holes in the opening. The shape of the insertion hole for suspension may be any shape, but preferably the shape is such that the corner is rounded so that the hole is not easily broken even if a heavy object is suspended. It is possible to make the shape of a long narrow hole so as to open the opening more naturally when it is applied.
　さらに、上記の蒸気供給用保水容器には、該挿通孔よりも中央部寄りの開口部に再封止可能な開閉チャックを設けたものとする。該再封止可能な開閉チャックは、チャック雄部とチャック雌部とからなるものとし、熱融着などにより、蒸気供給用保水容器のプラスチック樹脂フィルムと一体化させる。該チャックの形状は、例えば、略矢尻状の頭部を突出してなるチャック雄部と、円弧状凹部を形成する内側鉤爪と外側鉤爪を突出してなるチャック雌部とからなるものとすることができ、再封止可能であり、オートクレーブ滅菌を行っても封止状態を保つことが可能であれば、他の形状を有していても良い。 Furthermore, it is assumed that the water supply container for steam supply is provided with an openable / closable chuck at an opening closer to the center than the insertion hole. The re-sealable opening / closing chuck is composed of a chuck male part and a chuck female part, and is integrated with the plastic resin film of the water supply container for steam supply by heat fusion or the like. The shape of the chuck may include, for example, a chuck male part that protrudes from a substantially arrowhead-shaped head part, and an inner claw that forms an arcuate recess and a chuck female part that protrudes from an outer claw. As long as it can be resealed and can maintain a sealed state even after autoclave sterilization, it may have other shapes.
　さらに、上記の再封止可能な開閉チャックは、着色したものとすることができ、より好ましくは、雄側のチャックまたは雌側のチャックの一方を着色したものとすることが好ましい。このようにすることで、再封止可能な開閉チャックを閉じる作業が不十分であると封止部の色が薄くなり、蒸気供給用保水容器が密閉されていないことが把握できるため、人的エラーによる蒸気供給用保水容器内の水の漏出や、蒸気供給後の蒸気供給用保水容器に封入した細胞・組織や培養液、使用済培養器具などの廃棄物が漏れだすことによる交叉汚染事故の発生を未然に防止することが可能となる。 Furthermore, the re-sealable opening / closing chuck may be colored, and more preferably, one of the male chuck and the female chuck is colored. In this way, if the work for closing the re-sealable opening / closing chuck is insufficient, the color of the sealing part becomes light and it can be grasped that the water supply container for steam supply is not sealed. Cross-contamination accidents caused by errors such as leakage of water in the steam supply container due to errors, or leakage of cells / tissues, culture fluid, used culture equipment, etc. enclosed in the steam supply container after steam supply Occurrence can be prevented in advance.
　本発明の蒸気供給用保水容器は予め滅菌されたものとして提供され得る。蒸気供給用保水容器を滅菌する方法は特に限定されないが、輸液セットや医療機器を滅菌する方法として一般に用いられる方法が採用され、例えば、エチレンオキサイドガス滅菌、γ線照射滅菌、電子線滅菌、放射線滅菌、紫外線照射滅菌、過酸化水素滅菌、エタノール滅菌の方法を用いることができる。そして、製造の容易性やコスト低減を考慮し、該滅菌方法として、好ましくは、γ線照射滅菌又は電子線滅菌を用いる。γ線照射滅菌におけるγ線の照射エネルギーは、蒸気供給用保水容器を劣化させない程度にて滅菌することができるよう、５ｋＧｙ～３０ｋＧｙ程度の範囲までとすることが好ましい。 The water supply container for steam supply of the present invention can be provided as being sterilized in advance. The method of sterilizing the water supply container for supplying steam is not particularly limited, but a method generally used as a method for sterilizing an infusion set or medical device is adopted. For example, ethylene oxide gas sterilization, γ-ray irradiation sterilization, electron beam sterilization, radiation Methods of sterilization, ultraviolet irradiation sterilization, hydrogen peroxide sterilization, and ethanol sterilization can be used. In view of ease of production and cost reduction, γ-ray irradiation sterilization or electron beam sterilization is preferably used as the sterilization method. The γ-ray irradiation energy in γ-ray irradiation sterilization is preferably in the range of about 5 kGy to 30 kGy so that sterilization can be performed without deteriorating the water supply container for steam supply.
　さらに、本発明の蒸気供給用保水容器は、パッケージを開封し取り出し、即使用を開始することが出来るよう、二重包装した上で、γ線照射滅菌を施したものとすることができる。 Further, the water supply container for steam supply according to the present invention can be subjected to γ-ray irradiation sterilization after double packaging so that the package can be opened and taken out and used immediately.
　（本発明の蒸気供給用保水容器の使用手順について）
　本発明の蒸気供給用保水容器は、内部に蒸気供給用の水を充填してから使用する。本発明の蒸気供給用保水容器は、バイオハザード対策用キャビネット内に設けられたフックや、蒸気供給用保水容器用ハンガーラックに吊り下げ、再封止可能な開閉チャックを開け、開口部から水を充填する。充填する水は、逆浸透処理などの高度処理されたＬＰＳ（リポポリサッカライド）フリーのものを用いることが好ましく、さらに、オートクレーブにより加熱滅菌処理されたものを用いることが好ましい。ＣＰＣ滅菌室内のバイオハザード対策用キャビネット内などで充填することが好ましいが、予めバイオハザード対策用キャビネットで充填し、再封止可能な開閉チャックを閉鎖して、オートクレーブ処理をし、滅菌済のパッケージに封入し二重包装した上で、ＣＰＣ滅菌室内に移動させてもよい。 (About the use procedure of the water supply container for steam supply of this invention)
The water supply container for steam supply of the present invention is used after filling water for supplying steam. The water supply container for steam supply according to the present invention is hung on a hook provided in a biohazard countermeasure cabinet or a hanger rack for a water supply container for steam supply, opens a resealable opening / closing chuck, and supplies water from the opening. Fill. As the water to be filled, it is preferable to use a highly processed LPS (lipopolysaccharide) free one such as reverse osmosis treatment, and it is preferable to use one that has been heat sterilized by an autoclave. It is preferable to fill in the biohazard countermeasure cabinet in the CPC sterilization chamber, but it is filled in advance in the biohazard countermeasure cabinet, the resealable open / close chuck is closed, autoclaved, and sterilized package It is possible to move it into the CPC sterilization chamber after enclosing it in a double package.
　水を充填し、再封止可能な開閉チャックを閉鎖した蒸気供給用保水容器は、インキュベーター内に置き、ドアを閉め３７．０℃にて保温し、インキュベーターの庫内に蒸気を供給させる。 * The water supply container for steam supply, which is filled with water and has a resealable opening / closing chuck closed, is placed in the incubator, the door is closed, the temperature is kept at 37.0 ° C., and steam is supplied into the incubator chamber.
　蒸気供給後の蒸気供給用保水容器は、インキュベーターから取り出し、バイオハザード対策用キャビネット内に設けられたフックや、蒸気供給用保水容器用ハンガーラックに吊り下げ、再封止可能な開閉チャックを開け、開口部から、細胞・組織や培養液、使用済培養器具などの廃棄物を投入し、再封止可能な開閉チャックを再び閉じ、ＣＰＣ滅菌室内から、パスボックスなどを通して、ＣＰＣ滅菌処理室へと交叉汚染防止環境下に移動させたのち、オートクレーブ処理を行う。このようにすることで、蒸気供給用保水容器を、インキュベーター～バイオハザード対策用キャビネット～ＣＰＣ無菌室内～パスボックス～ＣＰＣ滅菌処理室～オートクレーブ～パスボックス～ＣＰＣ外へと、１方向の自然な作業動線で、交叉汚染のリスクを極小にしながら廃棄物を移動させることが可能となる。
　 After the steam supply, the water supply container for supplying steam is taken out from the incubator, hung on the hook provided in the biohazard prevention cabinet or the hanger rack for the water supply container for supplying steam, and the resealable open / close chuck is opened. From the opening, waste such as cells / tissues, culture solution, and used culture equipment is charged, the resealable open / close chuck is closed again, and from the CPC sterilization chamber to the CPC sterilization chamber through the pass box After moving to a cross-contamination prevention environment, autoclaving is performed. In this way, the water supply container for supplying steam can be naturally operated in one direction, from the incubator to the biohazard prevention cabinet to the CPC sterilization chamber to the pass box to the CPC sterilization chamber to the autoclave to the pass box to the CPC. It is possible to move waste while minimizing the risk of cross-contamination with the flow line.
　以下に、本発明の蒸気供給用保水容器を製造し使用した実施例を示す。本発明はこれらの記載に何ら制限を受けるものではない。 Hereinafter, examples in which the water supply container for steam supply according to the present invention was manufactured and used will be shown. The present invention is not limited to these descriptions.
　本発明の蒸気供給用保水容器を構成するための部材として、保水性（耐水性）及びオートクレーブでの加熱に対する耐熱性を備えたプラスチック樹脂フィルムであるナイロンと直鎖状低密度ポリエチレン（Ｌ－ＬＤＰＥ）からなる積層体と、水を通さず水蒸気・気体のみを透過するタイベック（1073B）を用い、上記各部材を熱融着により一体化させ、蒸気供給用保水容器を製造する。 Nylon and linear low-density polyethylene (L-LDPE), which are plastic resin films having water retention (water resistance) and heat resistance against heating in an autoclave, are used as members for constituting the water supply container for steam supply of the present invention. ) And a Tyvek (1073B) that does not allow water to pass through and transmits only water vapor and gas, and integrates the above members by thermal fusion to produce a water supply container for supplying steam.
　実施例１として、図１のようにして蒸気供給用保水容器を製造した。寸法は220mm(W)×380mm(H)×48mm(D)とし、さらにタイベックによる透湿部の表面積が480cm2（200mm×240mm）となるようにした。吊下用挿通孔は丸穴とした。また、図１のように、再封止可能な開閉チャックにおける雄側又は雌側のチャックのいずれか一方が配されている側の開口部を構成するプラスチック樹脂フィルムが、他方のチャックが配されている側の開口部を構成するプラスチック樹脂フィルムよりも長くなるようにしている。 As Example 1, a water supply container for steam supply was manufactured as shown in FIG. The dimensions were 220 mm (W) x 380 mm (H) x 48 mm (D), and the surface area of the moisture permeable part by Tyvek was 480 cm 2 (200 mm x 240 mm). The insertion hole for suspension was a round hole. In addition, as shown in FIG. 1, the plastic resin film constituting the opening on the side where either the male side or the female side chuck in the re-sealable opening / closing chuck is provided is provided with the other chuck. It is made longer than the plastic resin film which comprises the opening part of the side which is.
　実施例２として、図２のようにして蒸気供給用保水容器を製造した。寸法等は実施例１と同様とし、吊下用挿通孔は横に細い長穴とした。 As Example 2, a water supply container for steam supply was manufactured as shown in FIG. The dimensions and the like were the same as in Example 1, and the suspension insertion hole was a long and narrow slot.
　実施例３として、実施例１と同様に蒸気供給用保水容器を製造し、再封止可能な開閉チャックにおいて雄側のチャックを着色したものを用いた。 As Example 3, a water supply container for steam supply was manufactured in the same manner as in Example 1, and a resealable opening / closing chuck with a colored chuck on the male side was used.
　実施例４として、実施例１と同様に蒸気供給用保水容器を製造し、再封止可能な開閉チャックにおいて雌側のチャックを着色したものを用いた。 As Example 4, a water supply container for steam supply was manufactured in the same manner as in Example 1, and a resealing open / close chuck with a colored female chuck was used.
　＜実験例１＞
　実施例１の蒸気供給用保水容器を、吊下用挿通孔を用いて蒸気供給用保水容器用ハンガーラックに吊り下げ、再封止可能な開閉チャックを開けた。蒸気供給用保水容器内に、水を下記試験に必要となる量入れた。再封止可能な開閉チャックにおける雄側又は雌側のチャックのいずれか一方が配されている側の開口部を構成するプラスチック樹脂フィルムが、他方のチャックが配されている側の開口部を構成するプラスチック樹脂フィルムよりも長くなるようにされているため、吊り下げた蒸気供給用保水容器の開口部を、長くなっている樹脂フィルム部分を持って自然に開けることができ、作業が容易であった。 <Experimental example 1>
The water supply container for steam supply of Example 1 was hung on the hanger rack for water supply container for steam supply using the insertion hole for suspension, and the resealable opening / closing chuck was opened. Water required for the following test was put in the water supply container for steam supply. In the resealable opening / closing chuck, the plastic resin film constituting the opening on the side where either the male chuck or the female chuck is arranged constitutes the opening on the side where the other chuck is arranged Since it is made longer than the plastic resin film to be opened, the opening of the suspended water supply container for steam supply can be opened naturally with the long resin film part, and the work is easy. It was.
　次に、加湿バットによる自然蒸発式の方式が採用されたインキュベーターである、フォーマ ステリサイクルCO2インキュベーター 370（サーモフィッシャーサイエンティフィック株式会社製）を使用し、本発明の蒸気供給用保水容器（寸法（mm）：220(W)×380(H)×48(D)、透湿部表面積 480cm2（200mm×240mm））を用いる場合の蒸気供給能力と、比較対照として492cm2サイズの加湿トレイを用いる場合の蒸気供給能力とを、それぞれ確認した。実施例１の蒸気供給用保水容器、または、加湿トレイをインキュベーター内に置き、ドアを閉め３７．０℃にて加湿水を保温した。その後、ドアを１２０秒間開き、再びドアを閉め、インキュベーター内の湿度を測定した。 Next, using the Forster Recycle CO 2 Incubator 370 (manufactured by Thermo Fisher Scientific Co., Ltd.), which is an incubator that employs a natural evaporation method using a humidified bat, the water supply container for steam supply according to the present invention (dimensions) (Mm): 220 (W) x 380 (H) x 48 (D), moisture supply surface area of 480 cm 2 (200 mm x 240 mm)), and a 492 cm 2 humidified tray as a comparison The steam supply capacity when used was confirmed. The water supply container for steam supply of Example 1 or the humidifying tray was placed in the incubator, the door was closed, and the humidified water was kept at 37.0 ° C. Thereafter, the door was opened for 120 seconds, the door was closed again, and the humidity in the incubator was measured.
　その結果、本発明の蒸気供給用保水容器と加湿トレイは、ほぼ同等の蒸気供給能力が発揮されたことが確認された。 As a result, it was confirmed that the water supply container for steam supply and the humidifying tray of the present invention exhibited substantially the same steam supply capability.
　＜実験例２＞
　実施例１の蒸気供給用保水容器を、吊下用挿通孔を用いて蒸気供給用保水容器用ハンガーラックに吊り下げ、再封止可能な開閉チャックを開けた。蒸気供給用保水容器内に、水を総量１Ｌになるように入れ、再封止可能な開閉チャックを閉じ、開口部を封止した。該蒸気供給用保水容器をラックから外し、オートクレーブ（トミー精工製、型式：KS-243）を用いて１２１℃、２０分の条件にて滅菌処理を行った。 <Experimental example 2>
The water supply container for steam supply of Example 1 was hung on the hanger rack for water supply container for steam supply using the insertion hole for suspension, and the resealable opening / closing chuck was opened. Water was put in the water supply container for steam supply so that the total amount was 1 L, the resealable opening / closing chuck was closed, and the opening was sealed. The water supply container for steam supply was removed from the rack, and sterilization was performed at 121 ° C. for 20 minutes using an autoclave (manufactured by Tommy Seiko, model: KS-243).
　その結果、オートクレーブを通常通り行うことができた。蒸気供給用保水容器の再封止可能な開閉チャックはしっかりと閉じており、蒸気供給用保水容器自体に破損は確認されなかった。再封止可能な開閉チャックを開け、中の水の量を確認したところ、蒸気供給用保水容器に入れた水は２１ｍＬしか減っていなかった。 As a result, the autoclave could be performed as usual. The resealable open / close chuck of the water supply container for steam supply was tightly closed, and no damage was found in the water supply container for steam supply itself. When the resealable opening / closing chuck was opened and the amount of water therein was confirmed, the amount of water contained in the water container for steam supply was reduced by only 21 mL.
　本発明の蒸気供給用保水容器は、水を内部入れて滅菌を行っても、容器の破損は起きず、再封止可能な開閉チャックも開くことなく、入れた水の量をほぼ保持したままで滅菌処理を実施できることが明らかとなった。
　＜実験例３＞ Even if the water supply container for steam supply of the present invention is sterilized with water inside, the container will not be damaged, and the resealable opening / closing chuck is not opened, and the amount of water added is almost maintained. It became clear that sterilization could be carried out.
<Experimental example 3>
　実験例２の滅菌済の蒸気供給用保水容器を室温に戻し、その後、インキュベーター内に置き、ドアを閉め３７．０℃にて保温した。その後、ドアを１２０秒間開き、再びドアを閉め、インキュベーター内の湿度を測定した。 The sterilized water supply container for steam supply in Experimental Example 2 was returned to room temperature, then placed in an incubator, the door was closed, and the temperature was kept at 37.0 ° C. Thereafter, the door was opened for 120 seconds, the door was closed again, and the humidity in the incubator was measured.
　その結果、上記滅菌済の蒸気供給用保水容器は、加湿トレイを用いる場合とほぼ同等の蒸気供給能力を発揮していることが確認された。本発明の蒸気供給用保水容器は、水を入れてオートクレーブ滅菌を行うことで、予め滅菌済の水が入った滅菌済の蒸気供給用保水容器として準備し、ＣＰＣ内に提供することができるものであること、インキュベータ内を十分に蒸気を供給できることが明らかとなった。
　＜実験例４＞ As a result, it was confirmed that the sterilized water supply container for steam supply exhibited substantially the same steam supply capacity as that when the humidifying tray was used. The water supply container for steam supply of the present invention can be prepared as a sterilized water supply container for steam supply containing sterilized water in advance by supplying water and performing autoclave sterilization, and can be provided in the CPC It has become clear that steam can be sufficiently supplied into the incubator.
<Experimental example 4>
　実験例１と同様にして、蒸気供給試験後の蒸気供給用保水容器を用意した。吊下用挿通孔を用いて、該蒸気供給用保水容器を、蒸気供給用保水容器用ハンガーラックに吊り下げ、再封止可能な開閉チャックを開けた。水を総量１Ｌになるように入れ、再封止可能な開閉チャックを閉じ、蒸気供給用保水容器の開口部を再封止した後、該蒸気供給用保水容器をラックから外し、オートクレーブを用いて１２１℃、２０分の条件にて滅菌処理を行った。 In the same manner as in Experimental Example 1, a water supply container for supplying steam after the steam supply test was prepared. The water supply container for steam supply was suspended from the hanger rack for the water supply container for steam supply using the insertion hole for suspension, and a resealable opening / closing chuck was opened. Put water in a total amount of 1L, close the resealable open / close chuck, reseal the opening of the steam supply water retaining container, remove the steam supply water retaining container from the rack, and use an autoclave. Sterilization was performed at 121 ° C. for 20 minutes.
　その結果、オートクレーブを通常通り行うことができた。蒸気供給用保水容器の再封止可能な開閉チャックはしっかりと閉じており、蒸気供給用保水容器自体に破損は確認されなかった。本発明の蒸気供給用保水容器は、蒸気供給後の水が内部に入ったままでも、破損されることなく滅菌処理ができることが明らかとなった。 As a result, the autoclave could be performed as usual. The resealable open / close chuck of the water supply container for steam supply was tightly closed, and no damage was found in the water supply container for steam supply itself. It has been clarified that the water supply container for steam supply according to the present invention can be sterilized without being damaged even if the water after supplying steam remains inside.
　＜実験例５＞
　そこで、さらに、実験例１と同様にして、蒸気供給試験後の蒸気供給用保水容器を用意し、吊下用挿通孔を用いて、蒸気供給試験後の蒸気供給用保水容器を、バイオハザード対策用キャビネットに吊り下げたフックに吊り下げ、再封止可能な開閉チャックを開けた。蒸気供給用保水容器の中に、培養皿やマルチウェルプレートを複数個入れ、再封止可能な開閉チャックを閉じ、蒸気供給用保水容器の開口部を再封止した。その後、オートクレーブを用いて１２１℃、２０分の条件にて滅菌処理を行った。 <Experimental example 5>
Therefore, in the same manner as in Experimental Example 1, a water supply container for steam supply after the steam supply test is prepared, and the water supply container for steam supply after the steam supply test is used as a biohazard countermeasure using the penetrating insertion hole. It was hung on a hook hung on a cabinet and opened a resealable opening / closing chuck. A plurality of culture dishes and multiwell plates were placed in the water supply container for steam supply, the resealable open / close chuck was closed, and the opening of the water supply container for steam supply was resealed. Thereafter, sterilization was performed using an autoclave at 121 ° C. for 20 minutes.
　その結果、オートクレーブを通常通り行うことができた。また、蒸気供給用保水容器の再封止可能な開閉チャックはしっかりと閉じており、蒸気供給用保水容器自体に破損は確認されず、培養皿やマルチウェルプレートの滅菌処理を、蒸気供給用保水容器内で確実に行うことができた。 As a result, the autoclave could be performed as usual. In addition, the resealable open / close chuck for the water supply container for steam supply is tightly closed, and the water supply container for steam supply itself is not damaged. It was possible to perform reliably in the container.
　＜実験例６＞
　実施例２の蒸気供給用保水容器を用い、その他は、実験例５と同様にして、滅菌処理を行う実験を行った。 <Experimental example 6>
An experiment for sterilization was performed in the same manner as in Experimental Example 5 except that the steam supply water retaining container of Example 2 was used.
　その結果、オートクレーブを通常通り行うことができた。また、蒸気供給用保水容器の再封止可能な開閉チャックはしっかりと閉じており、蒸気供給用保水容器自体に破損は確認されず、培養皿やマルチウェルプレートの滅菌処理を、蒸気供給用保水容器内で確実に行うことができた。フックの位置が少々ずれていても、吊下用挿通孔が横に細い長穴となっているため、容易にフックに吊り下げることができた。さらに、再封止可能な開閉チャックを開けると、蒸気供給用保水容器内の水の重みで自然に開口部が開き始め、さらにフックに固定された横に細い長穴の近傍まで自然に開口部が開くため、蒸気供給用保水容器への廃棄物の投入が行い易かった。 As a result, the autoclave could be performed as usual. In addition, the resealable open / close chuck for the water supply container for steam supply is tightly closed, and the water supply container for steam supply itself is not damaged. It was possible to perform reliably in the container. Even if the position of the hook was slightly deviated, the suspension insertion hole was a long narrow hole, so it could be easily suspended from the hook. Furthermore, when the resealable opening / closing chuck is opened, the opening naturally starts to open due to the weight of water in the water container for steam supply, and further to the vicinity of the narrow elongated hole fixed to the hook. Since it opened, it was easy to put waste into the water supply container for steam supply.
　＜実験例７＞
　実施例３又は実施例４の蒸気供給用保水容器を用い、その他は、実験例５と同様にして、滅菌処理を行う実験を行った。 <Experimental example 7>
An experiment for sterilization was performed in the same manner as in Experimental Example 5 except that the water supply container for steam supply of Example 3 or Example 4 was used.
　その結果、オートクレーブを通常通り行うことができた。また、蒸気供給用保水容器の再封止可能な開閉チャックはしっかりと閉じており、蒸気供給用保水容器自体に破損は確認されず、培養皿やマルチウェルプレートの滅菌処理を、蒸気供給用保水容器内で確実に行うことができた。また、再封止可能な開閉チャックにおいてチャックを着色しているため、再封止可能な開閉チャックの閉鎖が不十分であると封止部分の色が薄くなり、封止状態を把握しやすくなっていた。 As a result, the autoclave could be performed as usual. In addition, the resealable open / close chuck for the water supply container for steam supply is tightly closed, and the water supply container for steam supply itself is not damaged. It was possible to perform reliably in the container. In addition, since the chuck is colored in the re-sealable opening / closing chuck, if the re-sealable opening / closing chuck is not sufficiently closed, the color of the sealing part becomes light and it becomes easy to grasp the sealing state. It was.
　本発明の蒸気供給用保水容器を用いれば、ＣＰＣ内で使用した細胞・組織、培養液や、培養皿やマルチウェルプレートなどの消耗品などの廃棄物を、蒸気供給用保水容器用スタンドやバイオハザード対策用キャビネットに吊り下げたフックに吊り下げた蒸気供給後の蒸気供給用保水容器の空きスペースに投入し、再封止可能な開閉チャックを閉じるという最小の作業工数で、交叉汚染防止環境下に密封できるとともに、廃棄物の総容量を大幅に削減することが可能となることが明らかとなった。そして、該蒸気供給用保水容器を、インキュベーター～バイオハザード対策用キャビネット～ＣＰＣ無菌室内～パスボックス～ＣＰＣ滅菌処理室～オートクレーブ～パスボックス～ＣＰＣ外へと、１方向の自然な作業動線で、交叉汚染のリスクを極小にしながら廃棄物を移動させることが可能となることが明らかとなった。 If the water supply container for steam supply of the present invention is used, waste such as cells / tissues, culture solution, and consumables such as culture dishes and multiwell plates used in the CPC can be used as a stand for the water supply container for steam supply or bio In an environment that prevents cross-contamination with the minimum number of man-hours required to fill the empty space of the water supply container for steam supply after steam supply suspended from the hook suspended in the hazard countermeasure cabinet and close the resealable open / close chuck. It has become clear that the total capacity of waste can be greatly reduced. Then, the water supply container for steam supply is moved in an incubator, a biohazard countermeasure cabinet, a CPC sterilization chamber, a pass box, a CPC sterilization chamber, an autoclave, a pass box, and a CPC with a natural work flow in one direction. It became clear that it was possible to move waste while minimizing the risk of cross-contamination.
　また、ＣＰＣ外へ搬出する際に必要とされる１２１℃、２０～６０分などの条件にてオートクレーブを行うには、オートクレーブに水を供給することが必須であるところ、持ち込み可能な水の総量が制限されているＣＰＣにおいて、オートクレーブのための水を新たに補充することなく、蒸気供給後の蒸気供給用保水容器内に残った水を、ＣＰＣ内で使用した細胞・組織、培養液や消耗品などの廃棄物の滅菌において、蒸気供給用保水容器とともに有効に利用できることが明らかとなった。 In addition, in order to perform autoclaving under conditions such as 121 ° C and 20 to 60 minutes, which are required when carrying out of the CPC, it is essential to supply water to the autoclave. In CPC, where water is used for autoclaving, the water remaining in the water supply container for steam supply after steam supply is replaced with the cells / tissues used in the CPC, the culture solution, and the exhaustion. It became clear that it can be effectively used with a water supply container for steam supply in the sterilization of waste such as goods.
　本発明の手段により従来の加湿トレイとほぼ同等の蒸気供給能力を得ることが可能となるとともに、ＣＰＣ内で使用した細胞・組織、培養液や、培養皿やマルチウェルプレートなどの消耗品などの廃棄物を、蒸気供給後の蒸気供給用保水容器の空きスペースに投入し、再封止可能な開閉チャックを閉じるという最小の作業工数で、交叉汚染防止環境下に密封でき、ＣＰＣにおける無菌区域内から搬出する医療廃棄物の総体積を減らすとともに、１方向の自然な作業動線で、交叉汚染のリスクを極小にしながら廃棄物を移動させることが可能なる。そして、使用する機器やＣＰＣの標準化と、それら機器や施設の使用手順の標準化に寄与することができる、新たな蒸気供給用保水容器を提供することができる。 By means of the present invention, it becomes possible to obtain a steam supply capability substantially equivalent to that of a conventional humidifying tray, and also the cells / tissues used in the CPC, the culture solution, consumables such as culture dishes and multiwell plates Waste can be sealed in a cross-contamination prevention environment with the minimum number of man-hours of putting waste into the empty space of the water supply container for supplying steam after the supply of steam and closing the resealable open / close chuck. It is possible to reduce the total volume of medical waste transported from the vehicle and to move the waste while minimizing the risk of cross-contamination with a natural work flow in one direction. And the new water supply container for steam supply which can contribute to standardization of the apparatus and CPC to be used, and the standardization of the use procedure of those apparatuses and facilities can be provided.
　１　　開口部
　２　　透湿性及び耐水性とバクテリアバリア性を備えた不織布
　３　　吊下用挿通孔
　４　　再封止可能な開閉チャック
　５　　蒸気供給用保水容器用ハンガーラック
　６　　水
　７　　インキュベーター
　８　　培養細胞・培養液が入った培養皿
　１０　蒸気供給用保水容器 DESCRIPTION OF SYMBOLS 1 Opening part 2 Nonwoven fabric provided with moisture permeability, water resistance, and bacterial barrier property 3 Suspension insertion hole 4 Resealable opening / closing chuck 5 Hanger rack for water supply container for steam supply 6 Water 7 Incubator 8 Cultured cell / culture solution 10 culture dish with water supply container for steam supply

Claims (4)

  1. 　略矩形状のプラスチック樹脂フィルムを２枚重ね合わせて、これらの周囲のうち三方を封着し、残り一方を開口部として開口自在とした袋状の蒸気供給用保水容器であって、前記プラスチック樹脂フィルムの少なくとも１枚の中央部には透湿性及び耐水性とバクテリアバリア性を備えた不織布を配し、前記開口部には複数の吊下用挿通孔を備え、該挿通孔よりも中央部寄りの開口部に再封止可能な開閉チャックを設けて、内部に水を保水可能としたこと、を特徴とする蒸気供給用保水容器。 A bag-shaped water supply container for steam supply, wherein two plastic resin films each having a substantially rectangular shape are overlapped, three sides thereof are sealed, and the other one is opened as an opening, and the plastic resin A non-woven fabric having moisture permeability, water resistance and bacterial barrier properties is disposed at the center of at least one film, and the opening has a plurality of suspension insertion holes, closer to the center than the insertion holes. A water supply container for steam supply, characterized in that an opening / closing chuck that can be resealed is provided in an opening of the water supply so that water can be retained therein.
  2. 　略矩形状のプラスチック樹脂フィルムを２枚重ね合わせて、これらの周囲のうち三方を封着し、残り一方を開口部として開口自在とした袋状の蒸気供給用保水容器であって、前記プラスチック樹脂フィルムの少なくとも１枚の中央部には透湿性及び耐水性とバクテリアバリア性を備えた不織布を配し、前記開口部には複数の吊下用挿通孔を備え、該挿通孔よりも中央部寄りの開口部に再封止可能な開閉チャックを設けて、内部に水を保水可能とし、蒸気供給後に封止したチャックを開け、さらに内部に使用済の培養器具や培養液を入れチャックを再封止することを可能としたこと、を特徴とする、請求項１に記載の蒸気供給用保水容器。 A bag-shaped water supply container for steam supply, wherein two plastic resin films each having a substantially rectangular shape are overlapped, three sides thereof are sealed, and the other one is opened as an opening, and the plastic resin A non-woven fabric having moisture permeability, water resistance and bacterial barrier properties is disposed at the center of at least one film, and the opening has a plurality of suspension insertion holes, closer to the center than the insertion holes. An open / close chuck that can be resealed is provided in the opening of the interior so that water can be retained in the interior, the sealed chuck is opened after supplying steam, and the chuck is resealed by placing a used culture instrument or culture solution inside. The water retention container for steam supply according to claim 1, characterized in that it can be stopped.
  3. 　１枚の矩形のプラスチック樹脂フィルムをその長手方向中央部が容器底部となるように該プラスチック樹脂フィルムの対向する短辺同士を近接させるように短手方向に折り曲げることで上辺の高さの異なるＡ面とＢ面の向かい合う２面を形成するものであって、さらにＡ面とＢ面の左右の重ね合わさった辺同士をそれぞれ封着することで内部に袋状の空間を形成しうるものであって、封着前に短手方向の折り返し部をさらに内面側にＡ面Ｂ面ともに等幅に内面側に折り返すことで底面を形成してから前記重ね合わさった辺同士を封着することで、高さの異なるＡ面とＢ面の上端側に開口自在とした開口部を備えた袋状の蒸気供給用保水容器であって、前記プラスチック樹脂フィルムの少なくとも１枚の中央部には透湿性及び耐水性とバクテリアバリア性を備えた不織布を配し、前記開口部には複数の吊下用挿通孔を備え、該挿通孔よりも中央部寄りの開口部に再封止可能な開閉チャックを設けて、内部に水を保水可能とし、蒸気供給後に封止したチャックを開け、さらに内部に使用済の培養器具や培養液を入れチャックを再封止することを可能としたこと、を特徴とする蒸気供給用保水容器。 A rectangular plastic resin film is bent in the short direction so that the short sides facing each other are close to each other so that the center in the longitudinal direction is the bottom of the container. It forms two opposite surfaces of the surface and the B surface, and can further form a bag-like space inside by sealing the overlapping sides of the left and right surfaces of the A surface and the B surface, respectively. By sealing the folded sides in the short direction before sealing, and forming the bottom surface by folding back to the inner surface side with the same width on both the A surface and the B surface on the inner surface side, A bag-like water supply container for steam supply having an opening that can be freely opened on the upper side of the A and B surfaces having different heights, wherein at least one central portion of the plastic resin film has moisture permeability and Water resistance and bacte A non-woven fabric having an barrier property is arranged, the opening is provided with a plurality of suspension insertion holes, and an opening / closing chuck that can be resealed is provided in the opening closer to the center than the insertion hole. Water supply for steam supply, characterized in that it is possible to retain water, open the sealed chuck after supplying steam, and re-seal the chuck by inserting a used culture instrument or culture solution inside container.
  4. 　気密性を有する基材によって調製された水を担持する袋体であって、その袋体の一部に通気性、透湿性を有しかつバクテリアバリア性の膜状基材によって調製された蒸気供給部を有し、該袋体の開口部の上端部の内側に袋体を刺通する複数の吊り下げ穴と、該穴より下端に、チャック雄部とチャック雌部とからなる該袋体の開口部を開閉するための再封止可能な開閉チャックとを有するものとしたことを特徴とする、蒸気供給用保水容器。 A bag body carrying water prepared by a base material having airtightness, and a vapor supply prepared by a membrane-type base material having air permeability, moisture permeability and bacteria barrier property in a part of the bag body A plurality of suspension holes that pierce the bag body inside the upper end portion of the opening of the bag body, and a lower end of the hole, the chuck male portion and the chuck female portion. A water supply container for supplying steam, comprising a resealable opening / closing chuck for opening and closing the opening.
PCT/JP2015/056008 2015-02-28 2015-02-28 Water holding container for steam supply use WO2016135988A1 (en)

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS62137034U (en) * 1986-02-20 1987-08-28
JPH0557008A (en) * 1991-09-03 1993-03-09 Aoki Corp Medical waste liquid vessel for sterilizing autoclave
JP2002172715A (en) * 2000-12-06 2002-06-18 Seisan Nipponsha:Kk Method and apparatus for manufacturing bag with zipper made of synthetic resin
JP2005295825A (en) * 2004-04-07 2005-10-27 Wakenyaku Kk Bag-shaped humidity supply vessel
JP2009125162A (en) * 2007-11-20 2009-06-11 Jms Co Ltd Medical container and medical container set
JP2013212853A (en) * 2012-04-02 2013-10-17 Dainippon Printing Co Ltd Packaging bag with zipper
JP3194302U (en) * 2014-09-03 2014-11-13 株式会社リングストン Free-standing square bottom bag with chuck

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS62137034U (en) * 1986-02-20 1987-08-28
JPH0557008A (en) * 1991-09-03 1993-03-09 Aoki Corp Medical waste liquid vessel for sterilizing autoclave
JP2002172715A (en) * 2000-12-06 2002-06-18 Seisan Nipponsha:Kk Method and apparatus for manufacturing bag with zipper made of synthetic resin
JP2005295825A (en) * 2004-04-07 2005-10-27 Wakenyaku Kk Bag-shaped humidity supply vessel
JP2009125162A (en) * 2007-11-20 2009-06-11 Jms Co Ltd Medical container and medical container set
JP2013212853A (en) * 2012-04-02 2013-10-17 Dainippon Printing Co Ltd Packaging bag with zipper
JP3194302U (en) * 2014-09-03 2014-11-13 株式会社リングストン Free-standing square bottom bag with chuck

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