JP6143080B2 - Spray agent containing simulated powder for scattering state evaluation, and method for evaluating powder scattering state - Google Patents

Description

  The present invention relates to a spray agent containing a simulation powder for scattering state evaluation, a method for evaluating the scattering state of powder, and a powder handling facility. In more detail, the present invention is used to evaluate the state of powder scattering in powder handling facilities such as powder production facilities and research and development facilities that affect the human body such as highly pharmacologically active pharmaceuticals. The present invention relates to a spray containing a state evaluation simulated powder, a method for evaluating the scattering state of the powder using the spray, and a powder handling facility for evaluating the scattering state of the powder by the evaluation method.

A highly pharmacologically active drug is a drug that has a strong medicinal effect on the human body in a small amount, typified by anticancer drugs and hormone drugs. For example, there are highly pharmacologically active pharmaceuticals that bring some physiological activity to the human body at an air concentration of 1 μg / m ³ or less. In such drug handling facilities, the prevention of scattering of pharmaceutical powders in manufacturing equipment and equipment (pharmaceutical powders) from the viewpoints of product quality control (preventing contamination), preventing health hazards to workers, and preventing environmental pollution. (Containment of body) measures are important. In general, work is performed in a physically enclosed containment device such as an isolator. However, there are demands for cost reduction and flexible production systems for pharmaceutical manufacturing, and there is a high need for handling pharmaceutical powders in semi-open facilities (semi-enclosed facilities) such as clean booths.

  At the manufacturing and R & D sites, it is indispensable to know the scattering characteristics of pharmaceutical powders and measure and analyze the containment in the site environment. And when pharmaceutical powder is scattered in the field environment, and when evaluating the containment (evaluation of the scattering state of the pharmaceutical powder), using a drug with high pharmacological activity itself, adhesion to the skin, aspiration, etc. There is a concern that it will adversely affect workers. For this reason, the scattered state is often evaluated using a highly safe simulated powder instead of using the pharmaceutical powder.

  In Non-Patent Document 1, it is recommended to use lactose (lactose) powder as a simulated powder. Lactose powder is widely used because it is harmless to the human body, easily dissolved in water, and has good stability. However, in order to quantitatively analyze the lactose powder scattered in the facility to be measured, an expensive and large-scale apparatus and complicated work are required. Specifically, sampling of powder scattered in the measurement target facility by filtering or wiping, transporting this to the analysis facility, and analyzing / evaluating with equipment such as high performance liquid chromatograph or ion chromatograph Has been done. For this reason, it often takes about several days to a week to obtain the result, and it is difficult to perform the evaluation in a short time in the facility to be measured.

  Patent Document 1 discloses an invention in which adenosine 5'-triphosphate (ATP) powder having a specific particle size is used as a simulated powder in evaluating the scattering state of a powder. In this invention, a sampling sheet is installed in the facility to be measured, the ATP powder is scattered, and the ATP powder adhering to the sheet is quantitatively analyzed. Since quantitative analysis of ATP powder can be performed using a detection device that can be brought into the field, an evaluation result can be obtained on the spot. By using ATP powder that can be quantified with high sensitivity with a simple device as a simulated powder, the labor and time required for quantitative measurement are being improved, but the time required from sampling to analysis results can be further reduced. It was desired.

  The inventors of the present application have previously disclosed a method for efficiently evaluating a powder scattering state with high accuracy and in real time (Patent Document 2). This invention uses a simulated powder obtained by adhering a small amount of fluorescent light-emitting substance to a powder such as lactose and scatters it in the facility to be measured, and measures it with a fluorescence detection device. This is a method of converting to air concentration. According to this invention, compared with the methods disclosed in Non-Patent Document 1 and Patent Document 1, an evaluation result can be obtained in a shorter time at the measurement site.

ISPE (The International Society for Pharmaceutical Engineering Inc.) Good Practice Guide Guidelines for evaluating the containment performance of pharmaceutical equipment, edited by SMEPAC Committee, ISBN 1-931879-51-6

JP 2010-276468 A JP2013-50345A

  In Patent Document 2 described above, it has become possible to obtain the evaluation result of the scattering state in a short time, and further, a simulated powder in place of the powder of a highly pharmacologically active pharmaceutical agent is scattered in the facility to be evaluated. Therefore, in order to evaluate the scattering state, there is a demand for a method for easily and reproducibly scattering within the facility in a stable state without causing decomposition or aggregation of the simulated powder.

  In view of the above circumstances, the present invention is a spray agent containing a simulated powder for scattering state evaluation that can easily and easily reproduce simulated powder in a facility, and a powder scattering state using the spray agent It is an object of the present invention to provide a powder handling facility in which the scattering state of powder is evaluated by the evaluation method.

In order to achieve the above object, the present invention provides the following means.
In the spray agent of the present invention, a spray powder comprises a composition containing a simulated powder used in place of the powder for evaluating the scattering state of the powder, a dispersion solvent for dispersing the simulated powder, and a propellant. The simulated powder is composed of saccharide particles, and the dispersion solvent is ethanol, hydrogenated polyisobutene, cyclopentasiloxane, caprylyl methicone, isopropyl myristate, ethylhexyl palmitate, cetyl ethylhexanoate. , Isopropyl palmitate, dialkyl carbonate, or isopropyl alcohol, wherein the simulated powder is not dissolved in the dispersion medium in the composition .
The particle size of the particles constituting the simulated powder is preferably 0.5 μm to 30 μm.
The particles may be composite particles in which a labeling substance is combined.

The powder scattering state evaluation method of the present invention is a powder scattering state evaluation method for evaluating the scattering state of the powder using a simulated powder instead of the powder, the spray agent being injected, and the evaluation object A step of scattering the simulated powder in the space.
In the powder scattering state evaluation method, the simulated powder dispersed in the space to be evaluated is fluorescently emitted, and the fluorescence emission amount is measured by a detection device, and a calibration curve prepared in advance is measured. It is preferable to have a step of obtaining the air concentration of the simulated powder by comparing with the fluorescence emission amount.

The powder handling facility related to the present invention is a powder handling facility provided with a space for handling powder, and the powder scattering state in the space was evaluated by the powder scattering state evaluation method. It is characterized by.

According to the spray of the present invention, it is possible to easily scatter a simulated powder in place of a powder such as a highly pharmacologically active drug in the space to be evaluated. Furthermore, since it is possible to inject in a stable state without causing decomposition or aggregation of the simulated powder, a predetermined amount of the simulated powder can be injected into the evaluation target space with good reproducibility.
In addition, when the particle size of the simulated powder is 0.5 μm to 30 μm, the simulated powder can easily give a particle size distribution and density close to those of actual powders such as highly pharmacologically active pharmaceuticals. Accurate evaluation is possible.

According to the method for evaluating the powder scattering state of the present invention, by using a spray agent, the step (operation) of scattering the simulated powder in the space to be evaluated can be easily performed with good reproducibility. As a result, it becomes possible to quickly obtain the evaluation result of the powder scattering state.
In addition, the simulated powder dispersed in the space to be evaluated is made to emit fluorescence, the amount of fluorescence emitted is measured by a detection device, and the calibration powder prepared in advance is compared with the measured fluorescence emission amount to simulate powder. By performing the step of obtaining the air concentration of the powder, the powder scattering property is evaluated in real time at the measurement site, and the powder scattering property and containment performance in facilities, equipment, and equipment equipped with the space to be evaluated are evaluated. It becomes possible to do.
In addition, in the space provided in the powder handling facility, by confirming in advance using the simulated powder the scattering state and containment state when the powder is scattered, it is confirmed that the predetermined standard is satisfied, and the powder is handled. It can be determined whether the facility is suitable for handling powder.

It is a SEM image (x500 times) of the lactose particle sprayed from the spray agent of the Example. It is a SEM image (x1000 times) of the lactose particle injected from the spray agent of an example.

  Hereinafter, the present invention will be described based on preferred embodiments.

《Spray agent》
The spray agent of the present embodiment contains a simulated powder used in place of the target powder in order to evaluate the scattering state of the powder (hereinafter referred to as “target powder”) and a dispersion solvent for dispersing the simulated powder. And a propellant filled in a spray container.

  For sprays, for example, in the handling facilities of target powders with high pharmacological activity, such as pharmaceutical manufacturing facilities and research and development facilities, the scattering state such as scattering properties and containment properties when the target powders are scattered is evaluated. Used for purposes. In addition, this spray agent is applicable not only for the target powder of a highly pharmacologically active pharmaceutical product but also for evaluating the scattering state of any powder.

<Simulated powder>
The simulated powder constituting the spray agent is preferably a powder similar to the target powder. Specifically, the physical properties such as the particle size, shape and density of the simulated powder are preferably close to the target powder.

  The particle size of the particles constituting the simulated powder (particle size of the simulated powder) is not particularly limited, but is preferably 0.01 μm to 500 μm, more preferably 0.1 to 100 μm, and even more preferably 0.5 μm to 30 μm. . When the particle size of the simulated powder is within the above range, the scattering state of the target powder can be more accurately evaluated by imitating the particle size of the target powder used in a general pharmaceutical manufacturing facility or the like. . The particle size may be a primary particle size or a secondary particle size. The particle size of the simulated powder filled in the spray container is preferably the same as the particle size when the simulated powder is scattered in the air. That is, when preparing the composition filled in the spray container, the particle size of the simulated powder used as a raw material is preferably 0.01 μm to 500 μm, more preferably 0.1 to 100 μm, and 0.5 μm to 30 μm. Further preferred. Further, the particle size of the simulated powder contained in the aerosol sprayed from the spray agent is preferably 0.01 μm to 500 μm, more preferably 0.1 to 100 μm, and further preferably 0.5 μm to 30 μm.

  The particle diameter of the particles here is a volume average diameter measured by a laser scattering particle size distribution measuring apparatus.

  The particle size distribution of the particles constituting the simulated powder is not particularly limited, and may be appropriately adjusted according to the particle size distribution of the actual target powder. For example, the particle size distribution of the simulated powder can be adjusted by classification. By classifying the simulated powder having a wide particle size distribution width, the particle size distribution width may be narrowed. Conversely, a plurality of simulated powders having a narrow particle size distribution width may be mixed to prepare a simulated powder having a wide particle size distribution width.

The shape of the particles constituting the simulated powder is not particularly limited, and examples thereof include shapes that can approximate various polyhedrons, spheres, or ellipsoidal rotators.
The density of the particles constituting the simulated powder is not particularly limited, and may be, for example, about the same as the density of the lactose particles constituting the known lactose powder.

  The simulated powder may be composed only of particles having the same physical properties, or may be composed of a plurality of types of particles having different physical properties.

  The raw material of the particles constituting the simulated powder is not particularly limited as long as it is difficult to dissolve in the dispersion solvent constituting the spray agent and the propellant. This raw material is preferably a raw material that does not cause substantial harm even if the particles are sucked or adhered to the worker.

  The particles constituting the simulated powder may be organic particles or inorganic particles. Examples of the organic particles include particles made of a saccharide such as lactose, particles made of a synthetic resin, and particles made of a polymer compound such as cellulose. Examples of the inorganic particles include ceramic particles, metal particles, semiconductor particles, and oxide semiconductor particles.

  Furthermore, the particles constituting the simulated powder may be particles formed by combining a plurality of materials. For example, composite particles in which core particles (particles forming a basic skeleton) made of organic particles or inorganic particles are combined with a labeling substance that enables highly sensitive detection can be given.

  Examples of the labeling substance include fluorescent substances such as riboflavin (vitamin B2) and other biological substances. The biological material is preferably selected from known biological materials from the viewpoint of causing no substantial harm even if absorbed by the human body.

  The scattering property of the simulated powder is greatly influenced by the density of the particles. For this reason, it is necessary to make the density of the simulated powder close to the actual target powder. From this viewpoint, it is conceivable to use, for example, particles having a low particle density such as hollow or porous, or particles having a high particle density such as metal oxide particles as the particles constituting the simulated powder. These particles may be used as core particles, and a fluorescent material may be attached to the surface thereof to form a composite simulated powder. As a result, a simulated powder having a density close to that of the actual target powder and capable of being detected by fluorescence emission is obtained.

<Dispersion solvent>
The dispersion solvent constituting the spray agent is not particularly limited as long as it can disperse the simulated powder and is difficult to dissolve the simulated powder, and a dispersion solvent used for a known spray agent can be applied. Specifically, it may be appropriately selected according to the type of simulated powder, for example, ethanol, isopropyl alcohol, water, hydrogenated polyisobutene, cyclopentasiloxane, caprylyl methicone, isopropyl myristate, ethylhexyl palmitate, ethylhexane. Examples of the solvent include cetyl acid, isopropyl palmitate, and dialkyl carbonate (C14,15).

<Composition>
In the composition containing the simulated powder and the dispersion solvent, the concentration (mixing ratio) of each component may be appropriately adjusted according to the type of each component. If the concentration of the simulated powder is too high, the particles may agglomerate or clog the spray port of the spray container. On the other hand, if the concentration of the simulated powder is too low, the concentration of the simulated powder contained in the aerosol sprayed from the spray container becomes low, making it difficult to efficiently disperse the simulated powder. From such a viewpoint, the weight ratio of the simulated powder to the dispersion solvent in the composition (simulated powder: dispersion solvent) is preferably 1: 1 to 1:15, more preferably 1: 1.5 to 1:10. 1: 1.8 to 1: 5 are more preferable. The content of the simulated powder with respect to the total mass of the composition is preferably 5 to 35% by weight, more preferably 10 to 35% by weight, and still more preferably 15 to 35% by weight. Furthermore, the content of the dispersion solvent with respect to the total mass of the composition is preferably 65 to 95% by weight, more preferably 65 to 90% by weight, and still more preferably 65 to 85% by weight. However, it is not limited to these.

<Propellant>
The propellant filled in the spray container is not particularly limited as long as the composition can be sprayed from the spray container as an aerosol, and propellants used for known sprays can be applied. The propellant is preferably a propellant that is difficult to decompose the simulated powder and the dispersion solvent contained in the composition.
Specifically, it may be appropriately selected according to the types of the simulated powder and the dispersion solvent. For example, liquefied gas such as HFO-1234ze, liquefied petroleum gas (LPG), dimethyl ether (DME), carbon dioxide gas, nitrogen gas, Compressed gas such as nitrous oxide can be mentioned.

  The weight ratio of mixing the composition and the propellant (composition: propellant) is suitably filled in the spray container, and if necessary, the composition may be sprayed from the spray container as an aerosol (aerosol). If it can, it will not be restrict | limited. The weight ratio is, for example, preferably 1: 2 to 1:25, more preferably 1: 5 to 1:20, and still more preferably 1: 8 to 1:20. However, it is not limited to these.

<Spray container>
The spray container filled with the composition containing the simulated powder and the dispersion solvent and the propellant is a spray container having pressure resistance that can withstand the filling pressure (internal pressure) of the propellant and hermeticity that prevents the composition from leaking. Is preferred. As such a spray container, a spray container used for a known aerosol product, for example, a known spray container having a structure in which the composition is released from the valve by the power of a propellant gas can be applied.

The internal structure of the spray container may be a structure in which the composition and the propellant are filled in the same space, or the composition and the propellant are filled in different spaces that are separated from each other, and the composition and the jet are injected. The double structure which mixes an agent may be sufficient.
The method for filling the spray container with the composition and the propellant is not particularly limited, and is performed by a known method.

<Method for evaluating powder scattering state>
The powder scattering state evaluation method of the present embodiment is a powder scattering state evaluation method that evaluates the scattering state of the target powder using a simulated powder instead of the target powder. A step (powder scattering step) of scattering the simulated powder in the target space. This evaluation method may have steps other than the powder scattering step. As other steps, a step of detecting the scattered simulated powder (detection step), a step of quantifying the detected simulated powder (quantification step), and evaluating the scattering state of the simulated powder in the space to be evaluated Step (evaluation step) is mentioned. Known methods can be applied to the detection step, the quantitative step, and the evaluation step.

  Below, two methods are concretely demonstrated about a powder scattering step.

<First method of powder scattering step>
In the powder scattering step, first, aerosol containing simulated powder is generated in the evaluation target space by spraying a spray agent, and particles constituting the simulated powder floating in the evaluation target space are detected. Then, the scattering state of the simulated powder is evaluated. The method for detecting particles floating in the space is not particularly limited, and examples thereof include a fluorescence detection method described later.

<Second method of powder scattering step>
In the powder scattering step, first, aerosol containing the simulated powder is generated in the evaluation target space by spraying the spray agent, and the particles constituting the simulated powder falling in the evaluation target space fall. Wait for a certain time. Thereafter, the scattered state of the simulated powder is evaluated by detecting particles adhering to the ground or wall constituting the space to be evaluated or a desk or the like installed in the space. The method for detecting the fallen simulated powder is not particularly limited. For example, a sampling sheet is previously set on the ground, wall, or desk in the space to be evaluated, and the fallen simulated powder is dropped on the sheet. It may be quantified by a known detection method.

  In order to adjust the concentration of the simulated powder in the aerosol that is scattered from the spray agent in the space to be evaluated, the concentration of the simulated powder contained in the composition constituting the spray agent, and the mixture of the composition and the propellant The ratio, the diameter of the spray port of the spray container (the diameter of the spray port), the spray pressure (internal pressure of the spray container), the spray time, etc. may be adjusted as appropriate. In addition, when a plurality of injections are performed, a predetermined amount of simulated powder can be repeatedly injected with good reproducibility if the injection times are the same.

The weight concentration of the simulated powder dispersed in the space to be evaluated can be calculated based on the volume of the space. For example, when a spray agent that is known to be able to inject 9 mg of simulated powder in 2 seconds is sprayed and sprayed into an indoor space of 50 m ³ for 2 seconds, the weight concentration of the simulated powder in a uniformly diffused state Is calculated to be 180 μg / m ³ . Further, if the content of the simulated powder contained in the composition constituting the spray agent is reduced to 1/50, the spraying time of the new spray agent is reduced to 1/2, and the spray is injected into the indoor space, 1 Simulated powder can be scattered at a weight concentration of 8 μg / m ³ .

  By analyzing the detected simulated powder quantitatively or qualitatively, the scattered state of the simulated powder in the space to be evaluated can be evaluated. Assuming that the scattering characteristics of the actual target powder handled in the evaluation target space are similar to the scattering characteristics of the simulated powder, know the scattering status of the actual target powder from the scattering condition of the simulated powder and actually The scattering state of the target powder can be evaluated.

<Quantification by fluorescence>
In the powder scattering state evaluation method of the present embodiment, as a step other than the powder diffusion step, the simulated powder dispersed in the evaluation target space is caused to emit fluorescent light, and the amount of the fluorescent light emission is detected by a detection device. You may have the step which calculates | requires and calculates | requires the density | concentration in air | atmosphere of a simulation powder by comparing the calibration curve created beforehand and the measured fluorescence emission amount.

  Examples of the material of the simulated powder capable of emitting fluorescence include riboflavin (vitamin B2), nicotinamide adenine dinucleotide (NADH), and fluorescent polystyrene microspheres which are fluorescent substances. By spraying a spray agent, particles containing a fluorescent substance are scattered in the space to be evaluated, and an apparatus capable of detecting the amount of fluorescent emission on site is used. By this method, the scattering state of the simulated powder can be measured in real time. Examples of the detection apparatus that can detect the amount of fluorescence emission of riboflavin on-site include a real-time bacterial detector manufactured by Bio Vigilant System, an ultrabitlet aerodynamic particle sizer manufactured by TSI, and the like.

  Such a detection apparatus can measure the density | concentration in the evaluation object space (in air) of the particle | grains (powder) whose particle size is about 0.5-30 micrometers, for example. At the same time, self-emission is performed by irradiating particles containing a fluorescent light-emitting substance with a short wavelength laser, and the amount of fluorescent light emission is measured. The amount of particles and the amount of fluorescent light-emitting substance in the space to be evaluated can be measured by comparing a calibration curve prepared in advance with the measured amount of fluorescent light emission.

  Moreover, you may evaluate whether the simulation particle is diffusing in the space (second space) adjacent to the space (first space) to be evaluated. Detectors are installed in the first space and the second space, the air concentration of the simulated powder in the first space and the second space is monitored, and the amount of the simulated powder detected in the second space is within the expected range. It can be evaluated whether or not. If the simulated powder is not detected in the second space or if the detected amount is lower than a predetermined value, it can be determined that the containment property of the simulated powder in the first space is good.

<Powder handling facility>
The powder handling facility of the present embodiment is a powder handling facility having a space for handling powder, and the powder handling state in which the powder scattering state in the space is evaluated by the above-described powder scattering state evaluation method. It is a facility. The size of the space provided in this facility (the size of the facility) is not particularly limited. Examples of the powder handling facility include a powder handling room, a powder handling booth, a clean booth, a glove box, and a powder storage room in a pharmaceutical manufacturing factory.

Since the allowable exposure control amount (OEL: Occupational Exposure Limits) of a pharmaceutical having a particularly high pharmacological activity is generally 1 μg / m ³ or less, the method for evaluating the scattering state of the simulated powder of this embodiment uses a highly pharmacologically active pharmaceutical. It can be applied to the evaluation of target facilities (apparatus, equipment).

<Preparation of spray>
An aerosol container having a volume of 100 ml is filled with a simulated powder having a particle diameter of 0.5 to 30 μm and a dispersion solvent in the prescribed amounts shown in the following table, and after the aerosol valve is attached to the container, The specified amount of propellant shown was filled. Next, a button was attached to the aerosol container, and the aerosol container was shaken up and down 20 times to create a spray. As the aerosol valve, two types of stems having a hole diameter of φ0.51 mm and a housing having a lower hole diameter of φ1.58 mm and a horizontal hole of φ0.76 mm were used. As the button, a type having a nozzle diameter of 0.51 mm was used.

  In the preparation of Table 1, lactose particles were used as a simulated powder, and 99% ethanol was used as a dispersion solvent. Moreover, HFO-1234ze (E), LPG, or DME was used as a propellant.

  The prepared spray was stored at room temperature for 2 weeks, and the dispersibility of the simulated powder in an aerosol container (pressure glass bottle) was evaluated. The results are also shown in Table 1. In the evaluation of Table 1, “◯” indicates that the powder is uniformly dispersed, and “x” indicates that the simulated powder is hardened and not dispersed on the bottom of the container.

  Further, using a laser diffraction particle size distribution measuring apparatus (spraytech RTS, lens 100 mm), the prepared spray agent was sprayed at a position 15 cm from the laser beam, and the particle diameter of the sprayed simulated powder was measured. The results are also shown in Table 1.

  In the preparation examples of Table 1, 99% ethanol was used as a dispersion solvent, but as other dispersion solvents, hydrogenated polyisobutene, cyclopentasiloxane, caprylyl methicone, isopropyl myristate, ethylhexyl palmitate, cetyl ethylhexanoate, It was confirmed that isopropyl palmitate, dialkyl carbonate, and isopropyl alcohol can be used.

<Use of spray agent>
A spray agent prepared in the same manner as described above was sprayed on a resin sheet 10 cm away from the spray can for 2 seconds, and the dry weight of lactose particles adhering to the resin sheet after the solvent was volatilized was measured. When the same measurement was performed 12 times in total, as shown in Table 2, an average of about 9 mg of lactose particles was injected. More specifically, the average value of lactose particles in aerosol sprayed 12 times was 9.0 mg, the standard deviation was 0.78, and the coefficient of variation was 8.67%. The coefficient of variation was 10% or less, and stable injection was possible.

  After spraying the prepared spray agent onto a small piece of paper for electron microscope observation from a spray can and drying it, SEM images were taken and no large aggregation of lactose particles was observed (see FIGS. 1 and 2). That is, it was possible to inject while maintaining the state of the lactose particles used as the raw material.

  The configurations and combinations thereof in the embodiments described above are examples, and the addition, omission, replacement, and other modifications of the configurations can be made without departing from the spirit of the present invention.

Claims (5)

Simulated powder used in place of the powder in order to evaluate the scattering state of the powder, and a composition containing a dispersion solvent for dispersing the simulated powder, and a propellant are filled in a spray container ,
The simulated powder is composed of saccharide particles,
The dispersion solvent is ethanol, hydrogenated polyisobutene, cyclopentasiloxane, caprylyl methicone, isopropyl myristate, ethylhexyl palmitate, cetyl ethylhexanoate, isopropyl palmitate, dialkyl carbonate, or isopropyl alcohol.
The spray powder, wherein the simulated powder is not dissolved in the dispersion solvent in the composition .   The spray agent according to claim 1, wherein the particle size of the simulated powder is 0.5 μm to 30 μm. The spray agent according to claim 1 or 2, wherein the particles are composite particles in which a labeling substance is combined. A powder scattering state evaluation method for evaluating the scattering state of the powder using simulated powder instead of powder,
A method for evaluating a powder scattering state, comprising the step of spraying the spray agent according to any one of claims 1 to 3 and scattering the simulated powder in a space to be evaluated. Causing the simulated powder dispersed in the space to be evaluated to emit fluorescence and measuring the amount of fluorescence emitted by a detection device;
The powder scattering state evaluation method according to claim 4 , further comprising a step of obtaining an air concentration of the simulated powder by comparing a calibration curve prepared in advance with the measured fluorescence emission amount.