Isolator decontamination verification system, isolator decontamination verification method, and decontamination verification program

Abstract

It provides decontamination parameters necessary for isolator decontamination work in a more flexible and accurate manner. [Solution] The isolator decontamination verification system 30, which has a work space isolated from the outside and decontaminates the work space with a sterilizing medium, comprises a condition input unit 32 for inputting conditions during the decontamination work and a parameter calculation means 34 for calculating decontamination parameters. The condition input unit 32 receives input for at least the type and number of loads placed in the work space, and the parameter calculation unit 32 calculates the amount of sterilizing medium to be injected, which is one of the decontamination parameters, from the type and number of loads and the volume of the work space.

Description

Technical Field

[0001] The present invention relates to a decontamination verification system in an isolator, a decontamination verification method for an isolator, and a decontamination verification program.

Background Art

[0002] When actually operating an isolator after delivery, it is necessary to set various decontamination conditions (decontamination parameters) and verify whether the decontamination work can be performed without problems. Since there are many steps in the decontamination verification work, it takes a considerable amount of time, and the time required for the decontamination verification work varies greatly between skilled workers and inexperienced workers. As a method for determining the decontamination conditions, for example, a method has been proposed in which the temperature and humidity, which are decontamination parameters, are determined in consideration of the control accuracy of the air conditioning equipment with respect to the temperature and humidity (see Patent Document 1).

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] However, decontamination of an isolator can be performed under different conditions even for the same isolator, such as when a load such as an instrument is placed inside the isolator or when a pass box is connected. Therefore, in the conventional system, a lot of time has been required for the decontamination verification work to obtain decontamination parameters that conform to the decontamination conditions.

[0005] An object of the present invention is to provide a decontamination verification system, a decontamination verification method, and a decontamination verification program for an isolator that can quickly calculate decontamination parameters of the isolator and shorten the time required for decontamination verification compared to the conventional method regardless of the skill level of the operator.

Means for Solving the Problems

[0006] The first invention of the present invention is an isolator decontamination verification system, which is a support system for the decontamination verification work of an isolator having a work space isolated from the outside and decontaminating the work space with a sterilizing medium, and comprises a condition input means for inputting conditions during the decontamination work and a parameter calculation means for calculating decontamination parameters, wherein the condition input means receives input for at least the type and number of loads placed in the work space, and the parameter calculation means calculates the amount of sterilizing medium injected, which is one of the decontamination parameters, from the type and number of loads and the volume of the work space.

[0007] The second invention of the present invention, an isolator decontamination verification system, is characterized in that, in the first invention, the sterilization medium is hydrogen peroxide, and decontamination is performed by supplying hydrogen peroxide vapor, which is obtained by heating and vaporizing hydrogen peroxide, or hydrogen peroxide mist, which is obtained by atomizing hydrogen peroxide, to the work space.

[0008] A third invention of the present invention is a method for verifying the decontamination of an isolator having a workspace isolated from the outside, characterized by comprising a condition input procedure for inputting the type and number of loads placed in the workspace, and a parameter calculation procedure for calculating the amount of sterilization medium to be injected, which is one of the decontamination parameters, from the type and number of loads and the volume of the workspace.

[0009] The fourth invention of the present invention, an isolator decontamination verification program, is characterized in that a computer for performing decontamination verification of an isolator having a workspace isolated from the outside is configured to function as a condition input means for inputting the type and number of loads placed in the workspace, and a parameter calculation means for calculating the amount of sterilization medium to be injected, which is one of the decontamination parameters, from the type and number of loads and the volume of the workspace. [Effects of the Invention]

[0010] According to the present invention, the decontamination parameters of the isolator can be calculated quickly, and the time required for decontamination verification work can be reduced compared to conventional methods. [Brief explanation of the drawing]

[0011] [Figure 1] This is a schematic front view showing an example of the configuration of an isolator system to which a decontamination verification support system, which is one embodiment of the present invention, is applied. [Figure 2] This is a schematic block diagram showing the configuration of the decontamination verification support system 30 of this embodiment. [Figure 3] This is a schematic side view showing an example of the arrangement of materials (loads) inside the isolator body. [Modes for carrying out the invention]

[0012] Embodiments of the present invention will be described below with reference to the drawings. Figure 1 is a schematic front view showing an example of the configuration of an isolator system to which a decontamination verification support system, which is one embodiment of the present invention, is applied.

[0013] The isolator system 10 includes, for example, an isolator body 12, a pass box 14, a circulation system 16 for circulating air or gas within a work space isolated from the outside, which consists of the isolator body 12 and the pass box 14, and a sterilization medium supply device 18 for supplying a sterilization medium such as hydrogen peroxide gas (vapor) into the work space via the circulation system 16.

[0014] On the front of the isolator body 12, for example, multiple gloves 20 (three in the diagram) are arranged for the user to work in the workspace. The pass box 14 is connected to one side of the isolator body 12, for example. The circulation system 16 includes a pipe 16A that connects the bottom and top surfaces of the isolator body 12 outside the isolator body 12, and a circulation blower 22 and a vaporizer 26 provided in the middle of the pipe 16A.

[0015] The circulating blower 22 draws in / exhausts air or gas from the isolator body 12 and / or pass box 14 from the bottom surface of the isolator body 12 and circulates / supplies it into the isolator body 12 and / or pass box 14 from the top surface of the isolator body 12 through the piping 16A.

[0016] The sterilization medium supply device 18 includes a tank 24 for storing a sterilization medium, such as an aqueous hydrogen peroxide solution. The aqueous hydrogen peroxide solution in the tank 24 is supplied by a pump (not shown) through a supply pipe 18A to a vaporizer 26 located in piping 16A, where it is vaporized. The hydrogen peroxide gas vaporized in the vaporizer 26 is supplied through piping 16A downstream of the vaporizer 26 to the isolator body 12 and / or pass box 14.

[0017] Figure 2 is a schematic block diagram showing the configuration of the decontamination verification support system 30 of this embodiment.

[0018] In this embodiment, the decontamination verification work support system 30 is mounted on a control device built into the isolator system 10, but the decontamination verification work support system 30 may also be mounted on a terminal (computer) such as a PC or tablet that is independent of the isolator system 10. In that case, it is preferable that the decontamination verification work support system 30 is connected to the control device of the isolator system 10 via a wireless or wired communication medium, and that the decontamination parameters set in the decontamination verification work support system 30 are transmitted to the isolator system 10.

[0019] Furthermore, the control device for the isolator system 10 can drive and control the circulation system 16 and the sterilization medium supply device 18, as well as control operations necessary for the decontamination work of the isolator system 10, such as opening and closing valves (not shown) provided in the piping 16A and the sterilization medium supply piping 18A, and can perform decontamination work based on the set decontamination parameters.

[0020] The decontamination verification work support system 30 includes a condition input unit (condition input means) 32 for inputting conditions during decontamination work, a parameter calculation unit (parameter calculation means) 34 for calculating decontamination parameters based on the input of the condition input unit 32, and a display unit (display means) 36 for displaying the decontamination parameters calculated by the parameter calculation unit 34. When connecting an external device such as a PC or a tablet to the isolator system 10, part of the functions of the condition input unit 32, the parameter calculation unit 34, and the display unit 36 may be borne by different devices respectively.

[0021] Examples of items input as conditions during decontamination verification work include information related to the volume of the work space to be decontaminated; information related to the surface area and decontamination difficulty of the decontamination target; and information related to the arrangement of chemical indicators (CI) and bioindicators (BI). Examples of information related to the volume of the work space to be decontaminated include, for example, the volume of the isolator main body 12, the number of gloves, the presence (or number (volume)) of the pass box 14 to be decontaminated, etc. Examples of information related to the surface area and decontamination difficulty of the decontamination target include the type, number, or arrangement (layout) of the materials (loads) used inside the isolator main body 12. Since the volume of the isolator main body 12 and the number of gloves are known for each type number of the isolator, when the decontamination verification work support system 30 is integrated with the isolator system 10, they are given as defaults, and when installed separately on a terminal, it can also be handled by inputting the type number, etc.

[0022] Examples of the types of materials (loads) used inside the isolator main body 12 include a sterility test unit, a cleaning solution bottle, a syringe, an injection needle, gloves, a specimen bag, a specimen vial, a contact plate, an SCD medium, an air sampler, scissors, a pen, a test subject, etc. FIG. 3 is a schematic side view showing an example of the arrangement of materials (loads) inside the isolator main body 12.

[0023] Figure 3 illustrates a configuration in which multiple bag-shaped materials (loads) M1 (e.g., 5 bags x 5 rows) are hung from a suspension rod 12B stretched across the ceiling below the inlet-side HEPA filter 12A, and multiple vial-shaped materials (loads) M2 (e.g., 5 vials x 5 rows) are placed on a rack R on the floor of the workroom.

[0024] The arrangement (layout) of materials (loads), chemical indicators (CI), bioindicators (BI), and other items is specified by, for example, schematically displaying the internal arrangement of the isolator body 12 and pass box 14 on a display unit (monitor) such as the isolator system 10, PC, or tablet, and by the operator moving a cursor or the like on the schematic diagram to place each item. The schematic diagram may be a perspective view, plan view, or side view showing the inside of the work space of the isolator body 12 and pass box 14, or it may be schematicly displaying each level of decontamination shelves such as fixed shelves, hanging rods, and racks installed inside the isolator body 12, either individually or simultaneously.

[0025] Since the types of items used in the isolator system 10 are somewhat limited, for example, icons corresponding to each type of item can be prepared in advance and displayed in the schematic diagram above, allowing the operator to confirm the designated location of each item.

[0026] The parameter calculation unit 34 of this embodiment stores a calculation formula for calculating the amount of sterilization medium (e.g., hydrogen peroxide) to be injected, and calculates the amount of sterilization medium to be injected, which is one of the decontamination parameters, based on at least the type and number of materials (loads) entered in the condition input unit 32 (information relating to the surface area and difficulty of decontamination of the target), and the volume of the work space (information relating to the volume of the work space to be decontaminated).

[0027] For example, the parameter calculation unit 34 determines the total volume of the workspace from the volume of the isolator body 12, the number of gloves, and the presence or absence (or number (volume)) of the pass boxes 14 to be decontaminated, and calculates a value α by multiplying this total volume by a coefficient. It also calculates a sum β by multiplying a coefficient determined for each type of material (load) by the number of each material (load). Finally, it calculates the injection amount by adding α and β together.

[0028] For example, if the total volume of the workspace is 1.5 m³ 3 If the coefficient is 10, then α = 1.5 × 10 = 15. Also, if the coefficient of material (load: paper or nylon product) A is 0.8 and the number of units is 15, the coefficient of material (load: resin product) B is 0.25 and the number of units is 20, and the coefficient of material (load: stainless steel product) C is 0.1 and the number of units is 10, then β = (0.8 × 15) + (0.15 × 20) + (0.1 × 10) = 16, and the amount injected is α + β = 15 + 16 = 31g.

[0029] Examples of decontamination parameters for decontamination verification work calculated by the parameter calculation unit 34 include the temperature of the vaporizer 26 [°C] and the airflow rate of the circulating blower 22 [m³]. 3 Examples include [hours / hour], decontamination holding time [min], first aeration time [min], second aeration time [min], hydrogen peroxide injection volume (sterilization medium injection volume): total amount [g], injection volume per unit time [g / min], and injection time [min].

[0030] The control device of the isolator system 10 drives the circulation system 16 and the sterilization medium supply device 18 based on the decontamination parameters calculated by the parameter calculation unit 34 to perform decontamination verification work. In the decontamination verification work, after the decontamination work is completed, it is determined whether the decontamination work was performed appropriately based on the reactions of chemical indicators (CI), bioindicators (BI), etc. (for example, bioindicators that were placed in the workspace are added to the culture medium after the decontamination work is completed, and it is determined whether the decontamination was performed appropriately based on the degree of their death). If it is determined to be appropriate, the calculated values ​​of each decontamination parameter are retained in the isolator system 10, and thereafter, until there is a change in the usage conditions (until there is a change in materials (loads) or a change in the number of pass boxes, etc.), the values ​​of the decontamination parameters are used for the decontamination work.

[0031] On the other hand, if the decontamination work is deemed inadequate, the decontamination parameters or input conditions are changed by the worker, and the decontamination verification process is repeated. This verification process is repeated until the decontamination work falls within the range deemed appropriate.

[0032] As described above, the decontamination verification support system of this embodiment calculates decontamination parameters, including the amount of sterilization medium to be injected, from the type and number of materials (loads) and the volume of the work space. Therefore, it is possible to provide the decontamination parameters necessary for isolator decontamination work more flexibly and accurately. This makes it possible to more effectively reduce the time required for decontamination verification work and reduce the burden on workers.

[0033] In this embodiment, the explanation mainly described a case in which the decontamination verification support system is incorporated into the isolator system, but the decontamination verification support system may also be provided as a program to make the computer function.

[0034] Furthermore, in this embodiment, the amount of sterilization medium injected is calculated only from the type and number of materials (loads) and the volume of the work space, but other conditions during decontamination work can also be taken into account in the same calculation. Moreover, in this embodiment, only the amount of sterilization medium injected was given as an example of the decontamination parameter calculated by the parameter calculation unit based on the input of the condition input unit, but other decontamination parameters can also be calculated by the parameter calculation unit based on the input of the condition input unit.

[0035] In this specification, decontamination of the isolator includes not only decontamination of spaces connected to the isolator, such as pass boxes, but also decontamination of each space individually.

[0036] In this embodiment, hydrogen peroxide gas (steam) obtained by heating and vaporizing hydrogen peroxide water is used as the sterilizing medium. However, instead of gas, hydrogen peroxide water may be atomized into a mist using an atomizer and supplied to the work area for decontamination. Alternatively, a sterilizing medium other than hydrogen peroxide water may be used. [Explanation of Symbols]

[0037] 10 Isolator Systems 12 Isolator body 14 Passbox 16. Circulation System 18 Sterilization medium supply device 20 gloves 30. Decontamination Verification Work Support System 32 Condition Input Unit (Condition Input Means) 34 Parameter calculation unit (parameter calculation means) 36 Display section (display means) M1, M2 materials (loads)

Claims

1. A support system for decontamination verification work of an isolator having a workspace isolated from the outside and decontaminating the workspace with a sterilizing medium, A condition input method for entering conditions during decontamination work, It includes a parameter calculation means for calculating decontamination parameters, The condition input means inputs at least the type and number of loads to be placed in the workspace, The parameter calculation means calculates the amount of sterilization medium to be injected, which is one of the decontamination parameters, from the type and number of the loads and the volume of the work space. A decontamination verification system for isolators, characterized by the following features.

2. The isolator decontamination verification system according to claim 1, characterized in that the sterilization medium is hydrogen peroxide, and decontamination is performed by supplying hydrogen peroxide vapor, obtained by heating and vaporizing hydrogen peroxide, or hydrogen peroxide mist, obtained by atomizing hydrogen peroxide, to the work space.

3. A method for verifying the decontamination of an isolator having a workspace isolated from the outside, A procedure for inputting conditions, which includes inputting the type and number of loads to be placed in the workspace, A parameter calculation procedure for calculating the amount of sterilization medium to be injected, which is one of the decontamination parameters, based on the type and number of the loads and the volume of the work space. A method characterized by comprising:

4. A computer for verifying the decontamination of an isolator, which has a workspace isolated from the outside, Condition input means for inputting the type and number of loads to be placed in the workspace, A parameter calculation means that calculates the amount of sterilization medium to be injected, which is one of the decontamination parameters, based on the type and number of the loads and the volume of the work space. A decontamination verification program for isolators, characterized by its function as such.

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