阅读说明：本技术 低温物品的除污方法及在低温物品的除污方法中使用的传送盒 (Method for decontaminating low-temperature articles and transport box used in method for decontaminating low-temperature articles ) 是由 川崎康司 角田大辅 益留纯 二村春华 矢崎至洋 北野司 郭志強 小川亚由美 于 2020-03-17 设计创作，主要内容包括：本发明提供能够实现低温物品的表面的除污效果的完善并且缩短作业时间而实现除污作业的高效化的低温物品的除污方法及在低温物品的除污方法中使用的传送盒。包括对低温物品的外表面赋予除污剂的赋予工序和对赋予了除污剂的低温物品照射超声波而对所述低温物品的表面进行干燥的干燥工序。在赋予工序中,朝向低温物品的表面供给除污剂的雾、浓雾或气体而在该低温物品的表面形成除污剂的冷凝膜。另外,在干燥工序中,朝向低温物品的表面供给干燥空气。(The invention provides a decontamination method for a low-temperature article, which can improve the decontamination effect of the surface of the low-temperature article, shorten the operation time and realize high efficiency of decontamination operation, and a conveying box used in the decontamination method for the low-temperature article. The method comprises a step of applying a stain remover to the outer surface of the low-temperature article and a step of drying the surface of the low-temperature article by irradiating the low-temperature article applied with the stain remover with ultrasonic waves. In the imparting step, mist, dense mist, or gas of the stain remover is supplied toward the surface of the low-temperature article, and a condensed film of the stain remover is formed on the surface of the low-temperature article. In the drying step, dry air is supplied to the surface of the low-temperature article.)

1. A method of decontaminating a cryogenic article, comprising:

a step of applying a stain remover to the outer surface of the low-temperature article; and

and a drying step of irradiating the low-temperature article to which the stain remover has been applied with ultrasonic waves to dry the surface of the low-temperature article.

2. The method for decontaminating a cryogenic article according to claim 1,

in the drying step, dry air is supplied toward the surface of the low-temperature article.

3. The decontamination method for a cryogenic article according to claim 1 or 2,

in the applying step, the mist of the stain removing agent is supplied toward the surface of the low-temperature article, and a condensed film of the stain removing agent is formed on the surface of the low-temperature article.

4. The decontamination method for a cryogenic article according to claim 3,

in the drying step, an ultrasonic flow is generated in a direction perpendicular to the surface of the plate by ultrasonically vibrating a vibrating plate disposed around the low-temperature article,

and applying ultrasonic vibration and acoustic radiation pressure to the condensation film of the stain remover on the surface of the low-temperature article.

5. A transport box used in the method for decontaminating a low-temperature article according to any one of claims 1 to 4,

the conveying box is provided with a working chamber for decontaminating low-temperature articles, a decontamination agent supply unit, a dry air supply unit and an ultrasonic vibration unit,

the stain remover supply unit supplies a stain remover to the inside of the working chamber containing the low-temperature articles in a state of stain remover mist,

the dry air supply unit supplies dry air to the surface of the low-temperature goods,

the ultrasonic vibration unit includes a vibration plate disposed near an inner wall surface of the working chamber, and generates an acoustic flow by ultrasonic waves in a vertical direction from a plate surface by performing ultrasonic vibration on the vibration plate,

the drying air and the acoustic flow are applied to the low-temperature article in the working chamber, thereby drying a condensation film of the stain remover formed on the surface of the low-temperature article.

Technical Field

The present invention relates to a method for removing contaminants from low-temperature articles, and more particularly to a method for removing contaminants from low-temperature articles using ultrasonic vibration. Further, the present invention relates to a conveyance case used in a method of decontaminating a low-temperature article.

Background

In a manufacturing site for manufacturing pharmaceuticals, foods, and the like, or a medical site such as an operating room, it is important to maintain the sterile state in the room. In particular, in decontamination of a sterile room, which is a working room for pharmaceutical Manufacturing, it is necessary to complete high-level decontamination verification in conformity with GMP (Good Manufacturing Practice, pharmaceutical Manufacturing quality control code).

In such a small-scale work in an aseptic environment, a small chamber is used as a work chamber, and a separator is used, which enables a worker to perform work from the outside of the chamber through gloves and a half-length garment. The chamber of the isolator is provided with an air supply and exhaust device for maintaining a sterile state so as not to mix in contaminants from the outside environment. In addition, when necessary instruments and articles are carried into the isolator in a sterile state from the external environment, the sterile state is also maintained.

For example, when an article is loaded into the isolator, a small-sized loading preparation chamber called a conveyance box is provided. An operator who carries an article into the isolator first carries the article into the conveyance box. At this time, the carry-in door between the isolator and the conveyance box is closed. Next, the carry-in door between the transport box and the outside environment is closed, and the articles are decontaminated together with the inside of the transport box. After the decontamination in the transport box is completed and the decontamination gas or the like is removed, the carry-in door between the isolator and the transport box is opened to carry the article into the isolator.

In recent years, hydrogen peroxide (gas or mist) has been widely used for decontamination of work rooms (hereinafter referred to as decontamination target rooms) such as isolators and transport boxes and articles to be carried in. The hydrogen peroxide has a strong sterilization effect, is inexpensive and easily available, and is effective as an environmentally friendly decontamination gas that is finally decomposed into oxygen and water. Patent document 1 below describes that the decontamination effect by hydrogen peroxide is caused by a condensation film of hydrogen peroxide water condensed on the surface of the site to be decontaminated.

Documents of the prior art

Patent document

Patent document 1: japanese examined patent publication No. 61-4543

Disclosure of Invention

Problems to be solved by the invention

However, there are small containers (vials and the like) in which a thermally unstable drug and a freeze-dried drug are stored and cells and the like used for regenerative medicine are contained among the articles to be carried into the isolator for decontamination in the transport box, and these articles are carried into the transport box in a refrigerated or frozen state (generally, at about-140 ℃ to 10 ℃) and decontaminated.

In the decontamination of these low-temperature articles, when the gas, the dense mist or the mist of the decontamination agent is supplied, dew condensation of the decontamination agent occurs immediately on the surface of the low-temperature article. However, since the surface temperature of the low-temperature article is low, there is a problem that progress of desmear is slow and a long time is required for desmear operation. On the other hand, recovery to room temperature before articles are carried into an aseptic space such as a separator by decontamination in the transport box, or the necessity of a long time for decontamination operation are also problematic in terms of workability and stability of pharmaceutical products and the like.

Accordingly, an object of the present invention is to solve the above-described problems and to provide a method for decontaminating a low-temperature article and a transport cassette used in the method, which can improve the decontamination effect of the surface of the low-temperature article, shorten the operation time, and improve the efficiency of the decontamination operation.

Means for solving the problems

As a result of intensive studies to solve the above problems, the present inventors have found that the above object can be achieved by efficiently drying a condensate film of a stain remover which forms dew on the surface of a low-temperature article by ultrasonic irradiation, and have completed the present invention.

That is, according to the description of claim 1, the method for decontaminating a low-temperature product according to the present invention includes: a imparting step of imparting a stain removing agent to the outer surface of the low-temperature article (40); and a drying step of irradiating the low-temperature article to which the stain remover has been applied with ultrasonic waves to dry the surface of the low-temperature article.

In addition, according to the invention described in claim 2, in the method for decontaminating a low-temperature product described in claim 1, the drying step is performed by supplying dry air to the surface of the low-temperature product.

Further, according to the invention described in claim 3, in the method for removing contaminants from a low-temperature product described in claim 1 or 2, the method is characterized in that in the applying step, a mist (31) of the contaminant removing agent is supplied toward the surface of the low-temperature product, and a condensed film of the contaminant removing agent is formed on the surface of the low-temperature product.

Further, according to the invention as set forth in claim 4, in the method for removing contaminants from a low-temperature product set forth in claim 3, the method is characterized in that in the drying step, the vibration disks (21, 22) disposed around the low-temperature product are ultrasonically vibrated to generate an acoustic flow by ultrasonic waves in a vertical direction from the disk surfaces (21a, 22a), and the ultrasonic vibration and the acoustic radiation pressure are applied to the condensate film of the contaminant removal agent on the surface of the low-temperature product.

Further, according to the description of claim 5, the conveyance box according to the present invention is a conveyance box used in the method of decontaminating a low-temperature article according to any one of claims 1 to 4, the conveyance box including a working chamber (10) for decontaminating a low-temperature article (40), a decontamination agent supply unit (30) for supplying a decontamination agent in a state of a decontamination agent mist (31) to the inside of the working chamber in which the low-temperature article is stored, a dry air supply unit (60) for supplying dry air to the surface of the low-temperature article, and an ultrasonic vibration unit (21, 22) including vibration plates (21, 22) disposed near the inner wall surface of the working chamber, the vibration plates being ultrasonically vibrated to generate an ultrasonic acoustic flow in a vertical direction from plate surfaces (21a, 22a), the drying air and the acoustic flow are applied to the low-temperature article in the working chamber, thereby drying a condensation film of the stain remover formed on the surface of the low-temperature article.

Effects of the invention

According to the above configuration, the method for removing contaminants from a low-temperature article according to the present invention includes an applying step and a drying step. The imparting step imparts a stain remover to the outer surface of the low-temperature article. In addition, the drying step irradiates the low-temperature article to which the stain remover has been applied with ultrasonic waves to dry the surface of the low-temperature article. Thus, the decontamination method for low-temperature articles can improve the decontamination effect of the surface of the low-temperature articles, shorten the operation time, and improve the efficiency of decontamination operation.

Further, according to the above configuration, in the drying step, the dry air is supplied toward the surface of the low-temperature article. This enables the above-described effects to be more specifically exhibited.

Further, according to the above configuration, in the applying step, the mist, the dense mist, or the gas of the stain remover is supplied toward the surface of the low-temperature article. As a result, a condensed film of the stain remover is formed on the surface of the low-temperature article. This enables the above-described effects to be more specifically exhibited.

Further, according to the above configuration, in the drying step, the vibration plate disposed around the low-temperature article is ultrasonically vibrated. Ultrasonic vibration is performed by the vibration plate, and an ultrasonic-based acoustic flow is generated in a vertical direction from the plate surface thereof. Further, ultrasonic vibration and acoustic radiation pressure are applied to the condensation film of the stain remover on the surface of the low-temperature article. This enables the above-described effects to be more specifically exhibited.

Further, according to the above configuration, the transport box according to the present invention includes a working chamber, a detergent supply unit, a dry air supply unit, and an ultrasonic vibration unit. The stain remover supply unit supplies the stain remover to the inside of the working chamber containing the low-temperature articles in a state of stain remover mist. The dry air supply unit supplies dry air to the surface of the low-temperature article. The ultrasonic vibration unit includes a vibration plate disposed near an inner wall surface of the working chamber, and generates an acoustic flow by ultrasonic waves in a vertical direction from a plate surface by performing ultrasonic vibration on the vibration plate. By causing the dry air and the acoustic flow to act on the low-temperature article in the working chamber in this way, the condensed film of the stain remover formed on the surface of the low-temperature article can be dried. Thus, the conveying box can improve the decontamination effect of the surface of the low-temperature article, shorten the operation time and realize high efficiency of decontamination operation.

Drawings

Fig. 1 shows an outline of the inside of a conveyance case used in the method for decontaminating a low-temperature article according to the present embodiment, where (a) is a state of an application step and (B) is a state of a drying step.

Fig. 2 is a schematic perspective view showing a state in which a plurality of ultrasonic speakers are arranged in a speaker base in the vibration plate provided in the transmission box of fig. 1.

Detailed Description

Hereinafter, a method for decontaminating a low-temperature product and a transport box used in the method for decontaminating a low-temperature product according to the present invention will be described in detail with reference to embodiments. The present invention is not limited to the following embodiments.

In the present embodiment, the method of decontaminating a low-temperature article is performed by a step of applying a decontamination agent to the outer surface of the low-temperature article to be decontaminated and a step of drying the surface of the low-temperature article to which the decontamination agent has been applied by irradiating the surface with ultrasonic waves. Fig. 1 shows an outline of the inside of a conveyance case used in the method for decontaminating a low-temperature article according to the present embodiment, where (a) is a state of an application step and (B) is a state of a drying step.

(addition procedure)

First, the providing step will be explained. In fig. 1a, the transmission box 10 is a housing made of stainless steel, and is connected to a wall surface of a separator (not shown) via an opening/closing door (inner door), and has an opening/closing door (outer door) facing the outside environment on the other wall surface. The connection state between the transmission box 10 and the isolator and the structure of the opening/closing door are not particularly limited, and are similar to those of the conventional transmission box. The position of the transport box with respect to the spacer is not limited to the side wall surface, and may be connected to the upper wall surface or the bottom wall surface. In fig. 1, the interior door, the exterior door, the air supply and exhaust device, and the like are not shown.

In fig. 1, a low-temperature article 40 carried into the isolator from the outside environment is carried into the center of the inside of the conveyance box 10. In fig. 1 (a), a cover 50 made of glass is provided from the upper part to the lower side part of the low-temperature product 40. The cover 50 is provided so that a mist of the detergent supplied from a detergent supply unit (described later) is concentrated in the vicinity of the outer surface of the low-temperature article 40. The cover 50 may be provided as necessary in the providing step.

In the present embodiment, the low-temperature product 40 is a decontamination target and is a freeze-dried vial. The low-temperature product 40 is carried into the isolator after being decontaminated inside the conveyance box 10. In fig. 1 (a), 2 vibration plates 21 and 22 as ultrasonic vibration means are disposed inside the transport box 10. These vibration disks 21 and 22 do not operate in the applying step, and are explained in the drying step described later.

Next, the stain remover supply unit will be described. In the present embodiment, the two-fluid nozzle 30 is used as the stain remover supply means, andis placed on the bottom wall surface 13 of the conveyance case 10 (see fig. 1 a). In the present embodiment, hydrogen peroxide water (H) is used as the stain remover₂O₂An aqueous solution). The detergent is not limited to hydrogen peroxide water, and any detergent may be used as long as it is a liquid detergent.

The two-fluid nozzle 30 atomizes hydrogen peroxide water by compressed air from a compressor (not shown) to form hydrogen peroxide mist 31, and supplies the hydrogen peroxide mist to the inside of the conveyance case 10. In the present invention, the mist supply device is not limited to the two-fluid nozzle, and the mist generating mechanism, the output, and the like are not particularly limited. In fig. 1 (a), the hydrogen peroxide mist 31 generated from the two-fluid nozzle 30 is supplied to the inside of the hood 50 and concentrated around the low-temperature article 40. Here, the hydrogen peroxide mist 31 is cooled at a low surface temperature of the low-temperature articles 40, and forms condensation films by condensation on the surfaces of the low-temperature articles 40.

In the present embodiment, the stain remover mist is used in the applying step. However, the method of applying the stain remover to the outer surface of the low-temperature article according to the present invention is not limited to the supply of the stain remover mist by the two-fluid nozzle or the like. For example, after a detergent is applied in advance by a hand sprayer or the like, the low-temperature article having a condensation film formed on the surface thereof may be carried into the conveyance box. Alternatively, the low-temperature article may be immersed in an aqueous solution of a stain remover adjusted to a predetermined concentration, and the low-temperature article with the condensation film formed on the surface may be carried into the conveyance case.

The mist of the detergent used in the present embodiment is broadly explained, and includes a state of droplets of the detergent which are finely divided and float in the air, a state in which a gas of the detergent and the droplets are mixed, a state in which the detergent undergoes a phase change in which condensation and evaporation are repeated between the gas and the droplets, and the like. The particle size is also broadly interpreted to include a fine mist, a dense mist, droplets, and the like.

Therefore, the mist according to the present invention includes mist called mist (also sometimes defined as 10 μm or less) or dense mist (also sometimes defined as 5 μm or less) and mist having a particle size of not less than that, as the case may be. In the present invention, condensation takes time, but the present invention also includes a detergent gas.

Drying Process

Next, the drying step will be explained. In fig. 1 (B), a low-temperature article 40 having a condensed film of hydrogen peroxide water formed on the surface thereof in the applying step is accommodated in the conveyance case 10. The cover 50 covering the cryogenic article 40 is removed. Further, 2 vibration plates 21 and 22 are disposed so as to sandwich the low-temperature article 40 from the left and right. The 2 oscillating plates 21 and 22 are arranged such that the oscillating surfaces 21a and 22a face horizontally in the transport cassette 10 with the opposing side wall surfaces 11 and 12 of the 4 side walls of the transport cassette 10 as the rear surfaces. The 2 vibration plates 21 and 22 are arranged so that the plate surfaces (vibration surfaces 21a and 22a) face each other, and a low-temperature article 40 is arranged at the center thereof.

Here, the vibration plate 21 (22) will be explained as well. Fig. 2 is a schematic perspective view showing a state in which a plurality of ultrasonic speakers are arranged on a speaker base from the vibration plate provided in the transmission box of fig. 1. In fig. 2, the vibration plate 21 includes a base and a plurality of transmitters. In the present embodiment, the speaker base 25 is used as the base, and the ultrasonic speaker 26 is used as the emitter. In the present embodiment, 25 ultrasonic speakers 26 are arranged on the plane 25a of the speaker base 25 so that the radiation directions (front left direction in the figure) of the vibration surfaces 26a are uniform. The number of ultrasonic speakers is not particularly limited.

In the present embodiment, a super-directional ultrasonic speaker is used as the ultrasonic speaker 26. Specifically, ultrasonic speakers (DC12V, 50mA) of a frequency modulation system for emitting ultrasonic waves having a frequency of about 40KHz are used. The type, size, structure, output, and the like of the ultrasonic speaker are not particularly limited. In the present invention, the vibration plate provided in the mist control device is not limited to the ultrasonic speaker, and the generation mechanism, frequency range, output, and the like of the ultrasonic wave are not particularly limited.

In the present embodiment, by unifying the emission directions of the vibration surfaces 46a of the plurality of (25) ultrasonic speakers 26 and operating the emitters in the same phase, the ultrasonic waves in the front directions of the respective ultrasonic speakers 46 are intensified to each other and the ultrasonic waves in the lateral directions of the respective ultrasonic speakers 46 are cancelled to each other. As a result, when the ultrasonic speaker 26 disposed on the speaker base 25 ultrasonically vibrates, a highly directional sound flow that travels in the air in the vertical direction from each vibration surface 26a is generated. Further, by controlling the frequency and output of the ultrasonic speaker 26 by an ultrasonic control device (not shown), an efficient decontamination operation can be performed.

In fig. 1 (B), an air supply pipe 60 and an air discharge pipe 70 are provided. The air supply pipe 60 is provided on the bottom wall surface 13 of the transport box 10 and supplies dry air to the inside of the transport box 10. Instead of the dry air, other dry gas, for example, nitrogen gas may be supplied. The exhaust duct 70 is provided on the side wall surface 12 of the transport box 10, and exhausts the wet air generated by drying inside the transport box 10 and the evaporated detergent gas to the outside. Note that, in fig. 1 (B), the two-fluid nozzle 30 is not operated, and therefore, the description thereof is omitted.

In this state, when dry air is supplied from the air supply pipe 60 and the ultrasonic speaker 26 of each vibration plate performs ultrasonic vibration, strong directional sound flows that travel in the vertical direction from the 2 vibration surfaces 21a and 22a are generated. These acoustic flows cause ultrasonic vibration and pressing based on acoustic radiation pressure to act on the surface of the low-temperature article 40, respectively. As a result, the condensation film of the hydrogen peroxide water condensed on the low-temperature articles 40 vibrates, and the condensation of the hydrogen peroxide water is promoted together with the drying of the condensation film by the action of the dry air, thereby promoting the decontamination effect of the oxidation.

Next, a method for removing contaminants from low-temperature articles according to the present invention using the transport box 10 according to the present embodiment will be specifically described by way of examples. In addition, the present invention is not limited to the following examples.

[ examples ] A method for producing a compound

In this example, the outer surface of a freeze-dried vial (surface temperature: 0 ℃ C., content: 5ml of distilled water) was decontaminated in a transfer box, and the vial was carried into an isolator. Further, the vial used was a polyethylene material vial having a height of 7cm, a diameter of 2cm and a capacity of 15 ml.

Decontamination effect of the outer surface of the freeze-dried vials using enzyme indicators: EI (enzyme indicator). EI is a means for measuring the residual enzyme activity by fluorescence after the test and confirming the decontamination effect, and compared with conventional BI (Biological Indicator), it is possible to confirm the effect in a short time without requiring a culture operation. In recent years, the comparative equivalence to BI has been confirmed and spread. An LRD value (Log score Reduction) based on logarithmic Reduction of the number of bacteria was calculated from the fluorescence intensity of the EI after decontamination, and 4 to 6LRD or more confirmed as a sufficient decontamination effect in the interior of the transport cassette was judged as being acceptable.

In the present embodiment, the transport box 10 of fig. 1 is used. The transport box 10 uses a volume of 0.0022m³(15 cm in vertical direction, 12cm in horizontal direction, and 12cm in depth, and the inner wall surface is a stainless steel plate), 2 vibration plates 21, 22 were arranged. The hydrogen peroxide application step is performed by 4 methods, that is, (1) an immersion method, (2) a manual spraying method, (3) a spraying method (using a two-fluid nozzle), and (4) an atomization method (using an ultrasonic humidifier: using an atomizer). In the (3) spraying method and the (4) atomizing method, spraying was performed using hydrogen peroxide water (35W/V%). In addition, in (1) the dipping method and (2) the manual spraying method, hydrogen peroxide water diluted to 6W/V% was used.

The amount of hydrogen peroxide generated, the application time, the total amount of hydrogen peroxide applied, the air flow rate in the drying step, and the drying time are shown in table 1. In the applying step, the total applying amount of the dipping method (1) cannot be measured. In the drying step, the air flow rate is increased in comparison with the drying by the manual spray method (2). The LRD values and temperature rises of the vials decontaminated under these conditions are shown in table 1.

[ TABLE 1 ]

As is clear from table 1, the methods other than the atomization method (4) all showed good LRD values, and sufficient decontamination effects were confirmed in a short time. In addition, in the atomization method (4), it is considered that it takes time for the condensation film on the surface of the vial to form. The cause of the temperature rise on the vial surface is not clear, but is thought to be due to vibrational energy imparted by the acoustic flow. In addition, it is considered to be caused by rapid oxidative decomposition of hydrogen peroxide water. However, it is considered that the temperature rise of this level in a short time is not a level that affects the quality of the low-temperature product to be decontaminated.

When hydrogen peroxide mist or the like is supplied to a low-temperature article in this way, the surface thereof is immediately wetted (formation of a condensation film). It was found that when dry air was supplied to the wet area and an acoustic current of ultrasonic vibration was applied, the evaporation effect was accelerated in a short time of about 3 minutes, and the surface concentration of hydrogen peroxide water was increased at once, whereby a significant decontamination effect was obtained.

Therefore, according to the present embodiment, it is possible to provide a method for decontaminating a low-temperature article and a transport cassette used in the method for decontaminating a low-temperature article, which can improve the decontamination effect of the surface of the low-temperature article, shorten the operation time, and improve the efficiency of the decontamination operation.

In carrying out the present invention, the present invention is not limited to the above embodiment, and various modifications are possible as follows.

(1) In the above embodiment, the two-fluid nozzle is used for applying the stain remover in the applying step. However, the present invention is not limited to this, and an ultrasonic humidifier (atomizer) or a manual sprayer used in the examples may be used, or immersion into a decontamination solution may be used.

(2) In the above-described embodiment, as the vibration plate, a vibration plate in which a plurality of ultrasonic speakers are arranged on a speaker base is used. However, the present invention is not limited to this, and any vibration plate may be used as long as it is a vibration plate in which langevin vibrators are fixed to a stainless steel plate having a fixed area and a vibration plate having another plate surface that performs ultrasonic vibration.

(3) In the above embodimentIn the embodiment, hydrogen peroxide water (H) is used as the stain remover₂O₂An aqueous solution). However, the present invention is not limited thereto, and any stain remover may be used as long as it is a liquid stain remover used as a stain remover.

(4) In the above embodiment, 2 vibration disks are arranged on the 2-sided side wall. However, the present invention is not limited to this, and 4 vibration disks may be arranged on 4 side walls, or 2 to 6 vibration disks may be arranged on 6 surfaces of 4 side walls to which upper wall surfaces and bottom wall surfaces are added.

Description of the reference numerals

10 … transport boxes 11, 12, 13 … wall

21. 22 … vibration surface of vibration disk 21a, 22a …

25 … speaker base 25a … speaker base plane

26 … ultrasonic speaker 26a … ultrasonic speaker vibration surface

30 … two-fluid nozzle 31 … hydrogen peroxide mist

40 … cryogenic article 50 … hood 60 … gas supply duct 70 … exhaust duct.