JP7286346B2 - Monitoring system for scattering state of pharmaceuticals and method for monitoring scattering state of pharmaceuticals - Google Patents

Description

TECHNICAL FIELD The present invention relates to a system for monitoring the scattering state of pharmaceuticals and a method for monitoring the scattering state of pharmaceuticals.

In recent years, the demand for highly pharmacologically active pharmaceuticals represented by anticancer agents and hormone agents is increasing.
A highly pharmacologically active drug is a drug that has a strong action on the human body, and is considered to have some physiological action on the human body at an atmospheric concentration of only 1 μg/m ³ or less. For this reason, in facilities that handle highly pharmacologically active pharmaceuticals, manufacturing equipment and It is important to take measures to contain (anti-scatter) pharmaceutical powders and drug substance powders in manufacturing facilities. Generally, work is carried out in physically enclosed containment devices (isolators) or airflow-controlled booths, and pharmaceutical powders and raw materials are Process controls are in place to handle drug powders.
In the field of pharmaceutical manufacturing or research and development, it is essential to understand the dispersibility of pharmaceutical powder, measure and analyze the containment state in the local environment. When evaluating the dispersibility and containment of pharmaceutical powders, there is concern that the direct use of pharmaceuticals with high pharmacological activity may adversely affect the health of workers due to adhesion to the skin and inhalation. For this reason, there are many cases in which an alternative powder with high safety is usually used as a simulated powder for evaluation. For example, it is recommended to use lactose (milk sugar) powder as the simulated powder (Non-Patent Document 1). Lactose is widely used because it is harmless to humans, readily soluble in water, and has good stability. However, the quantitative analysis of lactose requires an expensive and large-scale apparatus, and the quantitative analysis procedure is complicated, so it takes several days to obtain data.
In response to this, techniques have been proposed for efficiently evaluating the scattering state of powder with high precision and in real time (Patent Document 1, Non-Patent Document 2). This technique uses a powder (fluorescent simulated powder) that is composited at the particle level by adding a small amount (0.01 to 1% by mass) of a fluorescent substance to simulated powder such as lactose, In this method, the amount of powder scattered at that time is measured using a fluorescence detection device and converted into air concentration. According to this technology, compared to the conventional series of sampling-analysis-analysis work shown in Non-Patent Document 1, at the site of pharmaceutical manufacturing or research and development, the dispersibility and containment state of pharmaceutical powder can be determined in a short time. can be evaluated.

JP 2013-50345 A

SMEPAC Committee, "ISPE (The International Society for Pharmaceutical Engineering Inc.) Good Practice Guide: Particle Containment Performance Evaluation Guideline for Pharmaceutical Devices", 2005, p. 50 Isao Tanaka, 4 others, "Real-time evaluation of containment performance of highly active pharmaceuticals Development of fluorescent drug dust monitoring system", PHARM TECH JAPAN, Jiho Co., Ltd., 2014, Vol. 30, No. 6, p. 93-97

However, in both the method described in Non-Patent Document 1 and the methods described in Patent Document 1 and Non-Patent Document 2, simulated powder when simulating the handling operation of pharmaceutical powder using simulated powder It is not a method for directly measuring the scattering state of pharmaceutical powder or drug substance powder itself. Therefore, from the standpoint of drug manufacturers, there is a strong demand to more directly measure the scattering state of real drug powder rather than simulated powder.

Accordingly, it is an object of the present invention to provide a drug scattering state monitoring system and a drug scattering state monitoring method for directly evaluating the scattering state of pharmaceutical powder in a short period of time.

The above object is achieved by the following configurations.
[1] A collection device for collecting pharmaceutical powder floating in the air;
an analyzer for quantitatively analyzing the pharmaceutical compound contained in the pharmaceutical powder;
a processing device that performs a process of calculating the concentration of the pharmaceutical compound in the air;
and an output device that outputs the result of the processing,
Scattered state of pharmaceuticals, wherein a sample that is a pharmaceutical powder or a pharmaceutical compound contained in the pharmaceutical powder collected by the collecting device is quantitatively analyzed by the analyzer immediately after being carried out from the collecting device. monitoring system.
[2] According to [1], the processing device further performs a process of comparing the density with a preset value and a process of evaluating whether the density is equal to or less than the preset value. monitoring system.
[3] Between the collection device and the analysis device, a sample that is the pharmaceutical powder or a pharmaceutical compound contained in the pharmaceutical powder is directly transported from the collection device to the analysis device The monitoring system according to [1] or [2], which has sample transport means.
[4] The monitoring system according to any one of [1] to [3], wherein the analyzer is a real-time analyzer that quantitatively analyzes the sample in real time.
[5] The monitoring system according to any one of [1] to [4], wherein the output device is a display device that displays the result of the processing.
[6] The monitoring system according to any one of [1] to [5], wherein the drug is a highly pharmacologically active drug.
[7] A sample comprising a collection device, an analysis device, a processing device, and an output device, and a sample that is a pharmaceutical powder or a pharmaceutical compound contained in the pharmaceutical powder collected by the collection device. A method for monitoring the state of scattering of pharmaceuticals using a system for monitoring the state of scattering of pharmaceuticals, wherein quantitative analysis is performed in the analyzer immediately after being carried out from the collection device,
using the collecting device to collect pharmaceutical powder floating in the air;
Quantitatively analyze the pharmaceutical compound contained in the collected pharmaceutical powder using the analyzer,
using the processing device to perform a process of calculating the concentration of the pharmaceutical compound in the air;
using the output device to output the result of the processing;
A method for monitoring the scattering state of pharmaceuticals.
[8] After executing the process of calculating the density,
using the processing device to perform a process of comparing the concentration with a preset value;
using the processing device to perform a process of evaluating whether the concentration is equal to or less than the preset value;
The monitoring method according to [7], wherein the output device is used to output a result of evaluating whether or not the concentration is equal to or lower than the preset value.
[9] In the process of evaluating whether the density is equal to or less than the preset value, the density is equal to or less than the preset value when it is evaluated that the density is not equal to or less than the preset density. The monitoring method according to [8], wherein an alarm is output as a result of evaluating whether or not.
[10] The monitoring method according to any one of [7] to [9], wherein the drug is a highly pharmacologically active drug.

According to the present invention, it is possible to provide a pharmaceutical scattering state monitoring system and a pharmaceutical scattering state monitoring method for directly evaluating the scattering state of pharmaceutical powder in a short period of time.

FIG. 1 is a block diagram showing a monitoring system for the scattering state of pharmaceuticals according to the present invention. FIG. 2 is a schematic diagram showing an example of a gas chromatograph-mass spectrometer. FIG. 3 is a schematic diagram showing an example of a collection device. FIG. 4 is a flow chart showing the method for monitoring the scattering state of pharmaceuticals according to the present invention.

Hereinafter, the system for monitoring the state of scattering of pharmaceuticals of the present invention (hereinafter sometimes simply referred to as the "monitoring system of the present invention") and the method for monitoring the state of scattering of pharmaceuticals of the present invention (hereinafter simply referred to as the "monitoring method of the present invention") ) will be described with reference to the drawings if necessary, but the present invention is not limited by these embodiments.

[Monitoring system for drug scattering]
FIG. 1 is a block diagram showing the monitoring system of the present invention. The monitoring system of the present invention monitors pharmaceutical powders floating in the air in an environment where it is desired that pharmaceutical powders not scatter, among pharmaceutical manufacturing or research and development sites. be.

An example of an embodiment of the monitoring system of the present invention is shown in FIG. 1(A).
A monitoring system 1 shown in FIG. 1A includes a collection device 11, an analysis device 12, a processing device 13 and an output device . Monitoring system 1 may further comprise an input device 15 .

The collecting device 11 is a device for collecting pharmaceutical powder floating in the air.
The collection device 11 introduces the air in the space to be monitored, and collects pharmaceutical powder floating in the introduced air.
Since the monitoring system of the present invention collects and analyzes pharmaceutical powder in the air, that is, the active drug, it is possible to directly evaluate the scattering state of the pharmaceutical powder.

The analyzer 12 is a device that quantitatively analyzes the pharmaceutical compound contained in the pharmaceutical powder collected by the collection device 11 .

The analyzer 12 is not particularly limited as long as it can quantitatively analyze the pharmaceutical compound contained in the pharmaceutical powder collected by the collector 11, but is preferably a real-time analyzer. Here, a real-time analysis device is a device that can quantitatively analyze a sample in a short time. Among real-time analyzers, gas chromatograph (hereinafter sometimes referred to as "GC") or gas chromatograph mass spectrometer (hereinafter referred to as "GC-MS") is used because the time required for quantitative analysis is short and analysis can be performed with high accuracy. ) is particularly preferred. Moreover, the analyzer 12 is preferably capable of not only quantitative analysis but also qualitative analysis. GC and GC-MS are also preferable because they can perform not only quantitative analysis but also qualitative analysis.

The monitoring system 1 carries out a quantitative analysis in an analyzer 12 immediately after a sample, which is a pharmaceutical powder or a pharmaceutical compound contained in the pharmaceutical powder, collected by the collection device 11 is carried out from the collection device 11. is. Here, "immediately" refers to a short time until analysis of the sample carried out from the collection device 11 is started in the analysis device 12 .

The monitoring system 1 is placed between the collection device 11 and the analysis device 12 to directly transport a sample, which is a pharmaceutical powder or a pharmaceutical compound contained in the drug powder, from the collection device 11 to the analysis device 12. sample transport means.
Since the monitoring system of the present invention has the sample conveying means, it is possible to evaluate the scattering state of the pharmaceutical powder in a shorter period of time.

When the pharmaceutical compound contained in the pharmaceutical powder collected by the collection device 11 is analyzed by GC or GC/MS, the pharmaceutical compound is usually heated at a temperature of about 300° C. or less to vaporize, lead to the column. In the present invention, vaporization of the medicinal compound may be performed in the collection device 11 or in the analysis device 12 . That is, the sample conveyed from the collecting device 11 to the analyzing device 12 by the sample conveying means may be the pharmaceutical powder itself collected by the collecting device 11, or gasified pharmaceutical powder. It may be a pharmaceutical compound contained in a pharmaceutical powder.

The processing device 13 is a device that executes processing (drug concentration calculation processing) for calculating the concentration in air of the drug compound contained in the drug powder collected by the collecting device 11 . The content of the drug concentration calculation process may differ depending on the data transmitted from the analyzer 12 to the processor 13 . For example, if the analysis device 12 is a GC device and the gas chromatogram data including the peak retention time and area is transmitted to the processing device 13, the processing device 13 compares with the calibration curve, The type and concentration of the sample analyzed can be calculated.

The processing device 13 further performs a process of comparing the density with a preset value (hereinafter sometimes simply referred to as a "threshold value") and evaluates whether the density is equal to or less than the preset value. It may be a device capable of executing processing.
Here, the preset concentration (threshold value) includes, for example, the Occupational Exposure Limits (OEL). Permissible concentration means that when workers are exposed to a hazardous substance for 8 hours a day, 40 hours a week, at work intensity that is not physically strenuous, if the average exposure concentration of the hazardous substance is below this value, This is the concentration at which almost all workers are judged to have no adverse health effects. Acceptable concentrations are established for many pharmaceutical compounds.

The processing device 13 preferably also has a function of controlling the operation of the collection device 11 and the analysis device 12 . If the operation of the collection device 11 and the analysis device 12 can be controlled by the processing device 13, the operation of the monitoring system of the present invention is simple and easy to handle.

The output device 14 is a device that outputs the result of processing executed by the processing device 13 .
When the concentration of the pharmaceutical compound in air is calculated in the processing device 13, the calculated concentration can be output in the output device 14, for example.
When the processing device 13 evaluates whether the concentration of the pharmaceutical compound in air is equal to or lower than the threshold value, the output device 14 can output the result of the evaluation, for example.
A suitable example of the output device 14 is a display device. When the output device is a display device, the display device can display the concentration of the medicinal compound in the air or whether the concentration of the medicinal compound in the air is below a threshold value. In particular, when the processing device 13 evaluates that the concentration of the medicinal compound in the air is not below the threshold value, in other words, exceeds the threshold value, it is preferable to output an alarm to the output device 14 .
Another suitable example of output device 14 is a communication interface with an external device. When the output device 14 is a communication interface with an external device, the concentration of the pharmaceutical compound in the air is below a set value, or the concentration of the pharmaceutical compound in the air is set to the external device through the communication interface It is conceivable to send out a signal indicating that the value has been exceeded. It is preferable that the external device that receives the signal performs a predetermined operation. For example, an external device receiving a signal indicating that the concentration of a pharmaceutical compound in the air has exceeded a set value can issue an evacuation order to workers to ensure their safety, or force ventilation. It is conceivable to ensure the safety of the working environment by

The input device 15 is for giving instructions to the processing device 13 . For example, a threshold can be entered. Input device 15 may be removed if not needed.

The monitoring system 10 shown in FIG. 1(B) is another embodiment of the monitoring system 1 shown in FIG. 1(A). In monitoring system 10, the number of collectors is increased from one (collector 11) to four (collectors 11a-11d). The number of collection devices is not limited to four, and may be any number. Since the monitoring system 10 has increased the number of collection devices, it can sample at multiple locations at the same time.

A monitoring system 100 shown in FIG. 1(C) is still another embodiment of the monitoring system 1 shown in FIG. 1(A). In the monitoring system 100, the number of collection devices, sample transportation means, and analysis devices varies from 1 each (collection device 11, sample transportation means, analysis device 12) to 4 each (collection devices 11a to 11d, sample transportation means). a to 16d, and analyzers 12a to 12d). The number of collecting devices, sample conveying means, and analyzing devices is not limited to four, and may be any number. Since the monitoring system 100 has increased numbers of collection devices, sample transport means, and analysis devices, sampling can be performed at a plurality of locations at the same time, and waiting time for sample analysis can be eliminated.

FIG. 2 is a schematic diagram showing an example of GC-MS.
The GC-MS shown in FIG. 2 has a gas chromatograph section 21 and a mass spectrum section 22 . A sample injected from the sample injection port 23 of the gas chromatograph section 21 is passed through the column 24 to be fractionated by component and injected into the mass spectrum section 22 . The injected component is ionized by the ion source, passes through the mass filter 27 and is detected by the detector 28 . It preferably has a communication interface with the processor 13 and controls 25, 29 to control the GC-MS.

A gas chromatogram can be obtained by GC, and a gas chromatogram and total ion chromatogram (or fragment ion chromatogram) can be obtained by GC-MS.
Qualitative quantitative analysis using GC or GC-MS requires preparation of a calibration curve using known pharmaceutical compounds. That is, the relationship between the peak area of the chromatogram data and the mass of the medicinal compound is determined, and a calibration curve is prepared in advance from the relationship between the mass of the medicinal compound and the peak area.
Obtain the mass of the medicinal compound from the chromatogram and calibration curve of the medicinal compound contained in the airborne medicinal powder, divide it by the collected air volume, and obtain the concentration of the medicinal compound in the air (e.g. , μg/m ³ ) can be calculated.

As the gas chromatograph or gas chromatograph mass spectrometer used in the monitoring system of the present invention, those capable of real-time and on-site measurement are preferred. A type using a photo ionization detector (PID) as a detector is suitable for the gas chromatograph unit of such a gas chromatograph device or gas chromatograph mass spectrometer. By using a photoionization detector, for example, compared to a hydrogen flame ionization detector (FID: Flame Ionization Detector), hydrogen gas becomes unnecessary, the device can be made smaller and portable, and handling is excellent. .
As a gas chromatograph device that satisfies such conditions, for example, 8610C gas chromatograph (manufactured by SRI Instruments) can be mentioned, and as a gas chromatograph mass spectrometer, for example, process gas monitor MICROPOLE System (manufactured by HORIBA STEC Co., Ltd.) and portable can be mentioned. A mass spectrometer MS-200 (manufactured by HORIBA, Ltd.) can be mentioned.

FIG. 3 is a schematic diagram showing the structure of a collection device 3, which is a preferred embodiment of the collection device 11. As shown in FIG. As shown in FIG. 3, the collection device 3 has an inlet 31 for introducing air in the space to be monitored, and the air in the clean room is introduced through this inlet 31 . The collection device 3 also has a turntable 32 . The turntable 32 is for continuously collecting the air in the space to be monitored, and the collection tubes 33 are mounted at positions that are distributed along the circumference of the turntable 32 . When the turntable 32 stops, the collecting pipe 33 for introducing the air in the space to be monitored faces the inlet 31 , and the air in the space to be monitored can be introduced into the collecting pipe 33 . Then, the air introduced into the collection tube 33 flows through the collection tube 33 .

The collection device 3 introduces air into the space to be monitored at preset collection times, and sequentially collects pharmaceutical powder contained in the introduced air. Collection time can be set arbitrarily. The time required for the collection device 3 to collect the air in the space to be monitored is usually one to several minutes, and the collection can be performed in a short period of time. The collection time is the time from the start of air introduction (collection time) to the next start of air introduction (collection time), and is kept constant after setting.

The collection tube 33 is filled with an adsorbent 34 . The adsorbent 34 adsorbs pharmaceutical powder floating in the air in the space to be monitored. The powder of the drug floating in the air in the space is adsorbed. As the adsorbent 34, for example, a solid adsorbent such as Tenax-G (trade name) (manufactured by GL Sciences) can be used.

The pharmaceutical powder adsorbed by the adsorbent 34 is preferably desorbed from the adsorbent 34 by heat treatment. More specifically, the pharmaceutical powder is heated to about 300° C. under conditions in which an inert gas such as helium or nitrogen is circulated to generate a gas component, which is converted into a pharmaceutical powder by the analysis device 12 in the subsequent stage. A qualitative and quantitative analysis of the contained pharmaceutical compounds is preferred. The adsorbent 34 is preferably one that can be reused after the drug is desorbed.

Estimate the time required for collection.
Assume that the detection sensitivity of the analyzer is 1 ppb.
When a pharmaceutical powder containing a pharmaceutical compound with a molecular weight of 92 is collected on an adsorbent, heated to gasify and analyzed, assuming that the gasification rate of solid to gas is 100%, it is about 3.8 μg / It is possible to analyze pharmaceutical compounds at air concentrations of m ³ or more. Since the collection time is usually about 10 minutes, if it is desired to measure an air concentration of about 3.8 μg/m ³ or less, the collection time is extended to concentrate on the adsorbent. For example, 1 μg/m ³ requires about 40 minutes of air collection.

The monitoring system of the present invention ensures safety by eliminating the leakage of pharmaceutical powders and pharmaceutical compounds from the collection device 11, the sample transport means, and the analysis device 12, and by applying an appropriate treatment device to the exhaust system. can be constructed as a closed system. Therefore, if appropriate measures are taken to prevent leakage of pharmaceutical powders and pharmaceutical compounds in the monitoring system of the present invention, the pharmaceuticals contained in the pharmaceutical powders floating in the air in the space to be monitored Leakage from the monitoring system of the present invention can be prevented even if the concentration of the compound exceeds the permissible concentration.

Pharmaceuticals in the air in the space monitored by the monitoring system of the present invention are not particularly limited, but highly pharmacologically active pharmaceuticals are preferred. This is because even minute amounts of highly pharmacologically active pharmaceuticals have a large effect on the human body, so it is desirable to monitor the concentration of pharmaceuticals in the air and promptly take countermeasures when the allowable concentration is exceeded.

[Method for Monitoring Scattering State of Pharmaceuticals]
FIG. 4 is a flow chart illustrating the monitoring method of the present invention.
The monitoring method of the present invention comprises a collection device, an analysis device, a processing device, and an output device, and is a pharmaceutical powder or a pharmaceutical compound contained in the pharmaceutical powder collected by the collection device. A method for monitoring the state of scattering of pharmaceuticals using a system for monitoring the state of scattering of pharmaceuticals, wherein the sample is quantitatively analyzed by the analyzer immediately after being carried out from the collecting device.

In one embodiment of the monitoring method of the present invention shown in FIG. 4(A), a collection device is used to collect pharmaceutical powder floating in the air (powder collection (S1)). Quantitatively analyze the pharmaceutical compound contained in the collected pharmaceutical powder using the analyzer (quantitative analysis (S2)), and execute the process of calculating the concentration of the pharmaceutical compound in the air using the processor. (concentration calculation (S3)), and the output device is used to output the processing result (concentration calculation result output (S4)).

The collecting device is the same as the collecting device 11 described in relation to the monitoring system of the present invention. As described for the monitoring system of the present invention.

The analyzer is the same as the analyzer 12 described with respect to the monitoring system of the present invention. monitoring system.

The processing device is similar to the processing device 13 described with respect to the monitoring system of the present invention. As described for the system.

The output device is similar to the output device 14 described with respect to the monitoring system of the present invention, and the method of outputting the results of processing using the output device 14 is also as described with respect to the monitoring system of the present invention.

In another embodiment of the monitoring method of the present invention shown in FIG. 4(B), after powder collection (S1), quantitative analysis (S2) and concentration calculation (S3), a processing device was used to calculate Executes a process of comparing the density with a preset value (comparison (S31)), executes a process of evaluating whether or not the calculated density is equal to or less than a preset value (evaluation (S32)), and outputs The device is used to output the result of evaluating whether or not the calculated density is equal to or less than a preset value (output evaluation result (S41)).
S1, S2 and S3 are as described in the embodiment of the monitoring method of the present invention described with reference to FIG. 4(A).

In S31, the calculated density is compared with a preset value (hereinafter sometimes simply referred to as "threshold"), and in S32, it is evaluated whether or not the calculated density is equal to or less than the preset value. However, the preset concentration (threshold value) includes, for example, OEL: Occupational Exposure Limits. Acceptable concentrations are as described for the monitoring system of the present invention.

In S41, for example, the evaluation result can be output as a result of evaluating whether the calculated density is equal to or less than a preset value.
For example, if the output device is a display device, the display device can display the concentration of the medicinal compound in the air or whether the concentration of the medicinal compound in the air is below a threshold. In particular, when the processing device evaluates that the concentration of the medicinal compound in the air is not below the threshold value, in other words, exceeds the threshold value, the output device reports that the calculated concentration is below a preset value. Preferably, an alarm is output as a result of evaluating whether or not there is.
For example, when the output device is a communication interface with an external device, the external device is notified through the communication interface that the concentration of the pharmaceutical compound in the air is less than or equal to a set value, or the concentration of the pharmaceutical compound in the air is set. It is conceivable to send out a signal indicating that the specified value has been exceeded. It is preferable that the external device that receives the signal performs a predetermined operation. For example, an external device receiving a signal indicating that the concentration of a pharmaceutical compound in the air has exceeded a set value can issue an evacuation order to workers to ensure their safety, or force ventilation. It is conceivable to ensure the safety of the working environment by

In the monitoring method of the present invention, the steps from collecting the powder (S1) to outputting the concentration calculation result (S4) or from collecting the powder (S1) to outputting the evaluation result (S41) may be repeated as appropriate. Moreover, after the evaluation (S32), the evaluation result output (S41) may not be performed immediately, and the process from the collection (S1) to the evaluation (S32) may be repeated.

INDUSTRIAL APPLICABILITY According to the monitoring system and monitoring method of the present invention, it is possible to directly and in a short period of time evaluate the scattering state of powder containing a highly pharmacologically active drug, especially in handling work of the drug. This allows the performance of containment equipment and adherence to work procedures to be assessed and appropriate process controls to be implemented.

1 monitoring system for drug scattering state 11 collection device 12 analysis device 13 processing device 14 output device 15 input device

Claims (10)

a collection device for collecting pharmaceutical powder floating in the air;
an analyzer for quantitatively analyzing the pharmaceutical compound contained in the pharmaceutical powder;
a processing device that performs a process of calculating the concentration of the pharmaceutical compound in the air;
and an output device that outputs the result of the processing,
The collection device includes an inlet for introducing air in the space to be monitored, and a turntable for continuously collecting the air in the space to be monitored. Collection tubes are installed at the positions equally divided into
Scattered state of pharmaceuticals, wherein a sample that is a pharmaceutical powder or a pharmaceutical compound contained in the pharmaceutical powder collected by the collecting device is quantitatively analyzed by the analyzer immediately after being carried out from the collecting device. monitoring system. 2. The monitoring system according to claim 1, wherein said processing device further performs a process of comparing said concentration with a preset value and a process of evaluating whether said concentration is equal to or less than said preset value. . A sample conveying means for directly conveying a sample, which is the pharmaceutical powder or a pharmaceutical compound contained in the pharmaceutical powder, from the collecting device to the analyzing device between the collecting device and the analyzing device. 3. The monitoring system of claim 1 or 2, comprising: The monitoring system according to any one of claims 1 to 3, wherein the analyzer is a real-time analyzer that quantitatively analyzes the sample in real time. The monitoring system according to any one of claims 1 to 4, wherein said output device is a display device for displaying a result of said processing. The monitoring system according to any one of claims 1 to 5, wherein said drug is a highly pharmacologically active drug. A sample that is a pharmaceutical powder or a pharmaceutical compound contained in the pharmaceutical powder collected by the collection device is collected by the collection device. A method for monitoring the state of scattering of pharmaceuticals using a monitoring system for the state of scattering of pharmaceuticals, in which quantitative analysis is performed in the analyzer immediately after being carried out from the
The collection device includes an inlet for introducing air in the space to be monitored, and a turntable for continuously collecting the air in the space to be monitored. Collection tubes are installed at the positions equally divided into
using the collecting device to collect pharmaceutical powder floating in the air;
Quantitatively analyze the pharmaceutical compound contained in the collected pharmaceutical powder using the analyzer,
using the processing device to perform a process of calculating the concentration of the pharmaceutical compound in the air;
using the output device to output the result of the processing;
A method for monitoring the scattering state of pharmaceuticals. After executing the process of calculating the concentration,
using the processing device to perform a process of comparing the concentration with a preset value;
using the processing device to perform a process of evaluating whether the concentration is equal to or less than the preset value;
8. The monitoring method according to claim 7, wherein the output device is used to output a result of evaluating whether or not the concentration is equal to or lower than the preset value. In the process of evaluating whether the density is equal to or less than the preset value, whether or not the density is equal to or less than the preset value when it is evaluated that the density is not equal to or less than the preset density The monitoring method according to claim 8, wherein an alarm is output as a result of evaluating the. The monitoring method according to any one of claims 7 to 9, wherein the drug is a highly pharmacologically active drug.

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