US20190203963A1 - Temperature characteristic evaluation method - Google Patents

Temperature characteristic evaluation method Download PDF

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Publication number
US20190203963A1
US20190203963A1 US16/209,358 US201816209358A US2019203963A1 US 20190203963 A1 US20190203963 A1 US 20190203963A1 US 201816209358 A US201816209358 A US 201816209358A US 2019203963 A1 US2019203963 A1 US 2019203963A1
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Prior art keywords
temperature
temperature data
difference
computer
limit value
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English (en)
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Hidetoshi Yoshida
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Nagano Science Co Ltd
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Nagano Science Co Ltd
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Assigned to NAGANO SCIENCE CO., LTD reassignment NAGANO SCIENCE CO., LTD ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: YOSHIDA, HIDETOSHI
Publication of US20190203963A1 publication Critical patent/US20190203963A1/en
Priority to US17/315,426 priority Critical patent/US11614248B2/en
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    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24HEATING; RANGES; VENTILATING
    • F24FAIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F11/00Control or safety arrangements
    • F24F11/30Control or safety arrangements for purposes related to the operation of the system, e.g. for safety or monitoring
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24HEATING; RANGES; VENTILATING
    • F24FAIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F11/00Control or safety arrangements
    • F24F11/62Control or safety arrangements characterised by the type of control or by internal processing, e.g. using fuzzy logic, adaptive control or estimation of values
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24HEATING; RANGES; VENTILATING
    • F24FAIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F11/00Control or safety arrangements
    • F24F11/62Control or safety arrangements characterised by the type of control or by internal processing, e.g. using fuzzy logic, adaptive control or estimation of values
    • F24F11/63Electronic processing
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N17/00Investigating resistance of materials to the weather, to corrosion, or to light
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N17/00Investigating resistance of materials to the weather, to corrosion, or to light
    • G01N17/002Test chambers
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N17/00Investigating resistance of materials to the weather, to corrosion, or to light
    • G01N17/02Electrochemical measuring systems for weathering, corrosion or corrosion-protection measurement
    • GPHYSICS
    • G06COMPUTING OR CALCULATING; COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F17/00Digital computing or data processing equipment or methods, specially adapted for specific functions
    • G06F17/10Complex mathematical operations
    • G06F17/11Complex mathematical operations for solving equations, e.g. nonlinear equations, general mathematical optimization problems
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24HEATING; RANGES; VENTILATING
    • F24FAIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F2110/00Control inputs relating to air properties
    • F24F2110/10Temperature

Definitions

  • the present invention relates to a temperature characteristic evaluation method for evaluating temperature characteristics of an internal space of a climate chamber.
  • a climate test in which the medicines are preserved for long-term in constant temperature and humidity is performed.
  • a constant climate chamber is used as one of the climate chambers (see e.g., Japanese Patent Application Publication No. 2008-275345 and Japanese Patent Application Publication No. 2010-107062).
  • the constant climate chamber is provided with a test chamber, a humidifying part, a cooling part, a heating part, and a blowing part.
  • the medicines are preserved for a regulated time period inside the test chamber in which the temperature and the humidity are maintained constantly by operating the humidifying part, the cooling part, the heating part, and the blowing part.
  • the temperature and the humidity inside the test chamber of the constant climate chamber are maintained within a predetermined range during a preservation period.
  • the temperature and the humidity in a predetermined position inside the test chamber of the constant climate chamber are always measured by a monitoring sensor or a control sensor.
  • the uniformities of the temperature and the humidity inside the test chamber of the constant climate chamber are measured every fixed period (e.g., 1 year). Therefore, it is guaranteed that the temperature and the humidity inside the test chamber are maintained within a predetermined range during a preservation period.
  • a document showing the climate test which is performed in a regulated condition is submitted to a related agency.
  • the disclosed embodiments of the present invention have been developed in view of the above-mentioned and/or other problems in the related art.
  • the disclosed embodiments of the present invention can significantly improve upon existing methods and/or apparatuses.
  • An object of the present invention is to provide a temperature characteristic evaluation method for evaluating temperature characteristics of an internal space of a climate chamber with a low cost and high reliability.
  • the temperature characteristic evaluation method includes the steps of: (1) obtaining a set temperature of the climate chamber, which is set from a controller built in the climate chamber, as set temperature data by a computer, acquiring ambient temperature data by the computer based on an ambient temperature, which is a temperature inside a space where the climate chamber is placed, measured by a first temperature sensor installed inside the space, and acquiring internal temperature data by the computer based on an internal temperature of the internal space measured by a second temperature sensor installed inside the space; (2) acquiring a plurality of combinations of the set temperature data, the ambient temperature data, and the internal temperature data as a plurality of temperature data groups in the computer by acquiring set temperature data, ambient temperature data, and internal temperature data in a similar manner as the step of (1) by changing at least one of the set temperature and the ambient temperature; (3) obtaining a differential group in each of the plurality
  • the temperature characteristic evaluation method further includes the steps of: (6) calculating an inclination coefficient of the temperature function by the computer.
  • the step of (5) performing the evaluation includes a step of setting an allowable coefficient range for the inclination coefficient of the temperature function, and a step of judging whether or not the inclination coefficient of the temperature function is within the allowable coefficient range.
  • the step of (5) performing the evaluation includes a step of setting an allowable range for a second difference as a second differential allowable range; a step of obtaining a second difference by the computer; and a step of calculating a margin level of the second difference at an upper limit value or a lower limit value of the second differential allowable range.
  • the step of obtaining the second difference includes a step of acquiring ambient temperature data based on an ambient temperature measured by the first temperature sensor at a first point of time after the temperature function is obtained and acquiring set temperature data, a step of calculating a first difference at the first point of time based on the acquired ambient temperature data and the acquired set temperature data at the first point of time, and a step of calculating a second difference at the first point of time based on the first difference at the first point of time and the temperature function.
  • the temperature characteristic evaluation method includes the steps of: (7) calculating an upper limit value and a lower limit value of a first differential allowable range, which is an allowable range of the first difference, by substituting an upper limit value and a lower limit value of the second differential allowable range to the second difference of the temperature function by the computer; and (8) calculating an upper limit value and a lower limit value of an allowable range of the ambient temperature data by the computer based on the upper limit value and the lower limit value of the first differential allowable range and the set temperature data.
  • the climate chamber includes an air-conditioning part, a blowout port blowing air conditioned by the air-conditioning part into the internal space, and a suction port suctioning air of the internal space into the air-conditioning part.
  • the set temperature is a temperature of the air of the blowout port or the suction port.
  • the temperature characteristic evaluation method includes the steps of: (1) obtaining a set temperature of the climate chamber, which is set from a controller built in the climate chamber, as set temperature data by a computer, acquiring ambient temperature data by the computer based on an ambient temperature, which is a temperature inside a space where the climate chamber is placed, measured by a temperature sensor installed inside the space, and acquiring internal temperature data by the computer based on internal temperatures of the internal space in a plurality of positions respectively measured by a plurality of temperature sensors; (2) acquiring a plurality of combinations of the set temperature data, the ambient temperature data, and the plurality of internal temperature data in the computer as a plurality of temperature data groups in the plurality of positions respectively by acquiring set temperature data, ambient temperature data, and a plurality of internal temperature data in a similar manner as the step of (1) by changing at least one of the
  • the temperature characteristic evaluation method further includes the steps: (6) calculating inclination coefficients of the plurality of temperature functions by the computer.
  • the step of (5) performing the evaluation includes a step of setting an allowable coefficient range for the inclination coefficients of the plurality of temperature functions, and a step of judging whether or not the inclination coefficients of the plurality of temperature functions are within the allowable coefficient range.
  • the step of (5) performing the evaluation includes a step of setting an allowable range for a second difference as a second differential allowable range; a step of obtaining a second difference in each of the plurality of positions by the computer; and a step of calculating a margin level of the second difference at an upper limit value or a lower limit value of the second differential allowable range.
  • the step of obtaining the second difference includes a step of acquiring ambient temperature data based on an ambient temperature measured by the first temperature sensor at a first point of time after the plurality of temperature functions is obtained and acquiring set temperature data, a step of calculating a first difference at the first point of time based on the acquired ambient temperature data and the acquired set temperature data at the first point of time, and a step of calculating a plurality of second differences at the first point of time based on the first difference at the first point of time and the plurality of temperature functions.
  • the temperature characteristic evaluation method further includes the steps of: (7) calculating an upper limit value and a lower limit value of a plurality of the first differential allowable ranges, which are an allowable range of the first difference, by substituting an upper limit value and a lower limit value of the second differential allowable range to the second difference of the plurality of temperature functions by the computer; and (8) calculating an upper limit value and a lower limit value of an allowable range of the ambient temperature data by the computer based on the upper limit value and the lower limit value of the plurality of the first differential allowable ranges and the set temperature data.
  • the climate chamber in the temperature characteristic evaluation method, includes an air-conditioning part, a blowout port blowing air conditioned by the air-conditioning part into the internal space, and a suction port suctioning air of the internal space into the air-conditioning part.
  • the set temperature is a temperature of the air of the blowout port or the suction port.
  • the temperature characteristic evaluation method includes the steps of: (1) obtaining a set temperature of the climate chamber, which is set from a controller built in the climate chamber, as set temperature data by a computer, acquiring ambient temperature data by the computer based on an ambient temperature, which is a temperature inside a space where the climate chamber is placed, measured by a temperature sensor installed inside the space, and acquiring internal temperature data by the computer based on internal temperatures of the internal space in a plurality of positions respectively measured by a plurality of temperature sensors; (2) acquiring a plurality of combinations of the set temperature data, the ambient temperature data, and the plurality of internal temperature data in the computer as a plurality of temperature data groups in the plurality of positions respectively by acquiring set temperature data, ambient temperature data, and internal temperature data in a similar manner as the step of (1) by changing at least one of the set temperature and the ambient
  • the step of (6) obtaining the second differences at the second point of time includes a step of acquiring ambient temperature data by measuring an ambient temperature at the second point of time by the temperature sensor installed inside the space where the climate chamber is placed and acquiring set temperature data, and a step of calculating a first difference at the second point of time based on the ambient temperature data acquired at the second point of time and the acquired set temperature data, and a step of calculating a plurality of second differences at the second point of time based on the first difference at the second point of time and the plurality of temperature functions.
  • the climate chamber in the temperature characteristic evaluation method, includes an air-conditioning part, a blowout port blowing air conditioned by the air-conditioning part into the internal space, and a suction port suctioning air of the internal space into the air-conditioning part.
  • the set temperature is a temperature of the air of the blowout port or the suction port.
  • FIG. 1 a is a perspective view showing a constant climate chamber used for a temperature characteristic evaluation method according to the present embodiment.
  • FIG. 1 b is a perspective view showing a state in which a door of the constant climate chamber of FIG. 1 a is opened.
  • FIG. 2 is a vertical cross-sectional view of the constant climate chamber of FIGS. 1 a and 1 b.
  • FIG. 3 a is a schematic horizontal cross-sectional view showing an arrangement of temperature and humidity sensors positioned at four corners of an upper end of an internal space.
  • FIG. 3 b is a schematic horizontal cross-sectional view showing an arrangement of temperature and humidity sensors positioned at four corners of a lower end of the internal space.
  • FIG. 4 is a block diagram showing a connection between the constant climate chamber and a computer.
  • FIG. 5 is a flowchart showing a method for calculating a temperature function.
  • FIG. 6 is a flowchart showing a method for calculating a temperature function.
  • FIG. 7 is a schematic diagram showing an example of the temperature function.
  • FIG. 8 is a diagram showing an example of the temperature functions in the eight positions inside the internal space of the constant climate chamber.
  • FIG. 9 is a diagram showing an example of a method for setting an allowable coefficient range.
  • FIG. 10 is a diagram showing an example of a method for calculating a margin level of the second difference.
  • FIG. 11 is a diagram showing an example of method for determining an allowable range of ambient temperature variations.
  • FIG. 12 is a diagram showing an example of a climate test for medicines.
  • FIG. 1 a is a perspective view showing a constant climate chamber used for a temperature characteristic evaluation method according to the present embodiment.
  • FIG. 1 b is a perspective view showing a state in which a door of the constant climate chamber of FIG. 1 a is opened.
  • FIG. 2 is a vertical cross-sectional view of the constant climate chamber of FIG. 1 a .
  • a constant climate chamber 1 shown in FIGS. 1 a , 1 b and 2 is a climate chamber used for a climate test, for example, stability test of medicines.
  • the constant climate chamber 1 is provided with a rectangular parallelepiped upper housing 2 and a rectangular parallelepiped lower housing 3 .
  • the upper housing 2 includes a front opening. In the front opening of the upper housing 2 , a door 20 capable of opening and closing is provided. At the door 20 , an operation panel 21 and a display device 22 are installed.
  • a partition wall 4 is provided inside the upper housing 2 .
  • the partition wall 4 divides a closed space inside the upper housing 2 into an internal space IS, which is a test chamber, and an air conditioning space (hereinafter referred to as an air-conditioning space) 5 .
  • an air-conditioning space hereinafter referred to as an air-conditioning space 5 .
  • the internal space IS one or a plurality of shelf boards 23 are installed. On the shelf boards 23 , test objects 24 such as medicines, etc. are placed.
  • a blowout port 41 is provided, and in the lower part of the partition wall 4 , a suction port 42 is provided.
  • a temperature and humidity sensor SE 0 is installed at the vicinity of the blowout port 41 .
  • the temperature and humidity sensor SE 0 may be installed at the vicinity of the suction port 42 .
  • a humidifying part 51 includes a water storing pan 51 a and a sheathed heater 51 b .
  • the cooling/dehumidifying part 52 includes, for example, a cooling device.
  • the heating part 53 includes, for example, a wire strip heater.
  • the blowing part 54 includes, for example, a sirocco fan.
  • an exhaust passage 6 is provided in the back side of the upper housing 2 and the lower housing 3 .
  • an air introducing port 31 is provided on the front surface of the lower housing 3 .
  • a compressor 32 Inside the lower housing 3 , a compressor 32 , a cooling fan 33 , and a condenser 34 are arranged.
  • the condenser 34 is connected with the cooling/dehumidifying part 52 via a coolant pipe 35 .
  • an electromagnetic opening/closing valve 38 and an expansion valve 39 are provided in the coolant pipe 35 .
  • the cooling/dehumidifying part 52 is connected with the compressor 32 via a coolant pipe 36
  • the compressor 32 is connected with a condenser 34 via a coolant pipe 37 .
  • the coolant introduced from the cooling/dehumidifying part 52 is introduced to the compressor 32 through the coolant pipe 36 , and it is compressed by the compressor 32 .
  • the compressed coolant is introduced to the condenser 34 through the coolant pipe 37 , and it is condensed by the condenser 34 .
  • the condensed coolant is introduced to the expansion valve 39 through the coolant pipe 35 and the electromagnetic opening/closing valve 38 , and it is expanded by the expansion valve 39 .
  • the expanded coolant is introduced to the cooling/dehumidifying part 52 .
  • the humidifying part 51 humidifies air inside the air-conditioning space 5 .
  • the cooling/dehumidifying part 52 cools and dehumidifies the humidified air by the evaporation heat of the coolant.
  • the heating part 53 heats the cooled and dehumidified air. As shown in a void arrow, the air in which the temperature and the humidity are adjusted in the air-conditioning space 5 is blown into the inside of an internal space IS through the blowout port 41 by the blowing part 54 . The air inside the internal space IS is suctioned into the inside of the air-conditioning space 5 through the suction port 42 .
  • a controller 7 is provided inside the lower housing 3 .
  • the controller 7 controls the humidifying part 51 , the cooling/dehumidifying part 52 , the heating part 53 , and the blowing part 54 based on a measurement value of the temperature and humidity sensor SE 0 . Therefore, the temperature and the humidity inside the internal space IS are respectively maintained at a set temperature and a set humidity.
  • an operation panel 21 and a display device 22 are connected.
  • the calculation of the temperature function may be performed at a factory prior to factory shipment, or it may be performed at a manufacturer of medicines or a research institution after the factory shipment of the constant climate chamber 1 .
  • the temperature function is calculated in a state in which a test object 24 is not placed inside the internal space IS or a state in which a test object 24 is placed.
  • the constant climate chamber 1 of FIGS. 1 a and 1 b is built inside a room of a building.
  • one or a plurality of temperature and humidity sensors is installed in the internal space IS of the constant climate chamber 1 .
  • the temperature and humidity sensors are respectively installed in the eight positions P 1 to P 8 inside the internal space IS.
  • FIG. 3 a is a schematic horizontal cross-sectional view showing an arrangement of the temperature and humidity sensors positioned at the four corners of the upper end of the internal space IS.
  • FIG. 3 b is a schematic horizontal cross-sectional view showing an arrangement of the temperature and humidity sensors positioned at the four corners of the lower end of the internal space IS.
  • the upper housing 2 is provided with an external wall 201 , a thermal insulation material 202 , and an interior wall 203 .
  • the external wall 201 is formed by a metal plate, for example, a stainless steel plate, etc.
  • the interior wall 203 is formed by a metal plate, for example, a galvanized steel plate, etc.
  • As the thermal insulation material 202 for example, a hard urethane foam and a glass wool are used.
  • the temperature and humidity sensors SE 1 to SE 4 are respectively installed in the four corner positions P 1 to P 4 of the upper end inside the internal space IS. With respect to the four corner positions P 1 to P 4 of the upper end inside the internal space IS, the temperature sensors ST 1 to ST 4 are respectively installed in the four positions Pe 1 to Pe 4 on the surface of the external wall 201 . Further, as shown in FIG. 3 b , the temperature and humidity sensors SE 5 to SE 8 are respectively installed in the four corner positions P 5 to P 8 of the lower end inside the internal space IS. Further, with respect to the four corner positions P 5 to P 8 of the lower end inside the internal space IS, the temperature sensors ST 5 to ST 8 are respectively installed in the four positions Pe 5 to Pe 8 on the surface of the external wall 201 .
  • the internal temperature and humidity of the internal space IS are measured by the temperature and humidity sensors SE 1 to SE 8 . Further, the ambient temperature of the constant climate chamber 1 is measured by the respective temperature sensors ST 1 to ST 8 .
  • the ambient temperature means the air temperature of a place where the constant climate chamber 1 is installed. In the present embodiment, the ambient temperature is the temperature on the surface of the external wall 201 of the constant climate chamber 1 . The ambient temperature may be the temperature in a certain place in the vicinity of the constant climate chamber 1 .
  • a set temperature of the internal space IS is set in a predetermined value by using the operation panel 21 . Further, a set humidity of the internal space IS is set in a predetermined value. Therefore, in order to maintain the temperature and the humidity of the blowout port 41 in the internal space IS at the set temperature and the set humidity respectively, the humidifying part 51 , the cooling/dehumidifying part 52 , the heating part 53 , and the blowing part 54 are controlled by the controller 7 .
  • the present invention relates to the improvement of the temperature characteristic evaluation method of the internal space IS, so that it does not mention the humidity characteristic evaluation method of the internal space IS. Therefore, in the present embodiment, the temperature function related to the temperature is calculated.
  • the temperature inside the internal temperature IS is not influenced from the variation of the humidity, so that in the present invention, the humidity is not considered in the calculation of the temperature function.
  • the temperature function is calculated by using a computer which is connected to the constant climate chamber 1 .
  • FIG. 4 is a block diagram showing a connection between the constant climate chamber and the computer.
  • the computer 10 such as a personal computer, etc. is connected to the controller 7 , the temperature and humidity sensors SE 1 to SE 8 , and the temperature sensors ST 1 to ST 8 of the constant climate chamber 1 .
  • the computer 10 acquires a set temperature value as set temperature data DS from the controller 7 .
  • the computer 10 acquires measurement values of the internal temperature as internal temperature data DI 1 to DI 8 respectively from the temperature and humidity sensors SE 1 to SE 8 , and acquires measurement values of an ambient temperature as ambient temperature data DA 1 to DA 8 respectively from the temperature sensors ST 1 to ST 8 .
  • FIGS. 5 and 6 are a flowchart showing a method for calculating a temperature function.
  • the calculation of the temperature function is performed in each of the plurality of positions P 1 to P 8 , but hereinafter, the calculation method of the temperature function at an arbitrary one position Pi inside the internal space IS will be described.
  • the number “i” is an arbitrary integer of 1 to 8.
  • the operator inputs a set temperature in the controller 7 of the constant climate chamber 1 by using the operation panel 21 .
  • the computer 10 acquires a set temperature value as the set temperature data DS from the controller 7 (Step S 1 ).
  • the computer 10 acquires an ambient temperature measurement value as the ambient temperature data from the temperature sensor STi, and acquires an internal temperature measurement value as the internal temperature data from the temperature and humidity sensor SEi (Step S 2 ).
  • the computer 10 judges whether or not the number of times of acquiring the ambient temperature data and the internal temperature data reaches “m” times (Step S 3 ).
  • the number “m” is integer of equal to or more than 1.
  • the computer 10 returns to Step S 2 and acquires the ambient temperature data and the internal temperature data.
  • the computer 10 When the number of times of acquiring the ambient temperature data and the internal temperature data reaches “m” times, the computer 10 respectively calculates an average value of the acquired “m” ambient temperature data as ambient temperature data DAi and an average value of the acquired “m” internal temperature data as internal temperature data DIi (Step S 4 ), and the combination of the set temperature data DS, the ambient temperature data DAi, and the internal temperature data DIi is stored as a temperature data group (Step S 5 ). By calculating the average value of the ambient “m” temperature data and the average value of the “m” internal temperature data, the effect of the variations of the measurement values of the ambient temperature and the internal temperature due to noise, etc. can be eliminated.
  • the computer 10 judges whether or not “n” temperature data groups are stored (Step S 6 ).
  • the number “n” is integer of equal to or more than 2.
  • the operator changes at least one of the set temperature and the ambient temperature.
  • the computer 10 judges whether or not at least one of the set temperature and the ambient temperature is changed (Step S 7 ).
  • the computer 10 waits until at least one of the set temperature and the ambient temperature is changed.
  • the computer 10 performs the processes of Steps S 1 to S 7 , and stores another one temperature data group.
  • Step S 6 the computer 10 calculates a difference between the ambient temperature data DAi and the set temperature data DS in each temperature data group (hereinafter referred to as the first difference ⁇ x)(Step S 8 ). Further, the computer 10 calculates a difference between the internal temperature data DIi and the set temperature data DS in each temperature data group (hereinafter referred to as the second difference ⁇ y)(Step S 9 ). Further, the computer 10 stores the combination of the first difference ⁇ x and the second difference ⁇ y in each temperature data group as a differential group (Step S 10 ). In this way, “n” differential groups are obtained.
  • the computer 10 calculates a temperature function based on the “n” differential groups (Step S 11 ). Specifically, the computer 10 approximates the “n” differential groups in a linear function by a regression analysis and obtains the linear function as a temperature function.
  • the computer 10 stores the obtained temperature function (Step S 12 ). Specifically, an inclination coefficient and an intercept coefficient of the temperature function are stored.
  • FIG. 7 is a schematic diagram showing an example of the temperature function.
  • the horizontal axis of FIG. 7 indicates the difference between the ambient temperature and the set temperature (the first difference ⁇ x), and the vertical axis indicates the difference between the internal temperature and the set temperature (the second difference ⁇ y).
  • FIG. 8 toll are the same.
  • a plurality of differential groups is plotted as measuring points mp on a ⁇ x- ⁇ y plane.
  • the linear function is calculated as a temperature function Fi by the regression analysis of the plurality of measuring points mp.
  • the temperature function Fi is indicated as the following formula.
  • A indicates an inclination coefficient
  • B indicates an intercept coefficient.
  • the intercept coefficient occurs based on the characteristics of the temperature and humidity sensors. As described later, the temperature characteristics of the internal space of the constant climate chamber 1 can be evaluated by using the temperature function Fi.
  • FIG. 8 is a diagram showing an example of the temperature functions in the eight positions inside the internal space IS of the constant climate chamber 1 .
  • the set temperature sets 20° C., 40° C., and 60° C., and in each of the set temperatures, the ambient temperature data and the internal temperature data are acquired in the eight positions P 1 to P 8 .
  • three temperature data groups are acquired, and three differential groups are calculated.
  • the relationship between the first difference ⁇ x and the second difference ⁇ y is plotted on the ⁇ x- ⁇ y plane.
  • the temperature functions F 1 to F 8 are respectively calculated by the method shown in FIGS. 5 and 6 .
  • the difference between the ambient temperature and the set temperature (the first difference ⁇ x) is in a range of ⁇ 40° C. to 10° C., and the difference between the internal temperature and the set temperature (the second difference ⁇ y) becomes sufficiently smaller than ⁇ 2° C.
  • FIG. 9 is a diagram showing an example of a method for calculating a margin level of the second difference.
  • a variation range of the first difference ⁇ x (hereinafter referred to as the first difference variation range) is set.
  • the first difference variation range is set based on the variation range of the temperature of the air in a place where the constant climate chamber 1 is installed and based on the set temperature.
  • the upper limit value of the first difference variation range is indicated as Xa
  • the lower limit value of the first difference variation range is indicated as ⁇ Xb.
  • the allowable range of the second difference ⁇ y (hereinafter referred to as the second differential allowable range) is set.
  • the second differential allowable range is set in a temperature condition regulated in the climate test.
  • the upper limit value of the second differential allowable range is indicated as Ea
  • the lower limit value of the second differential allowable range is indicated as ⁇ Eb.
  • the set temperature is 25° C. and when the ambient temperature is varied in a range of 10° C. to 30° C., the upper limit value Xa of the first difference variation range is 5° C., and the lower limit value ⁇ Xb of the first difference variation range is ⁇ 15° C. Further, when the allowable error of the internal temperature is ⁇ 2° C., the upper limit value Ea of the second differential allowable range is +2° C., and the lower limit value ⁇ Eb of the second differential allowable range is ⁇ 2° C.
  • the maximum value and the minimum value of the second difference ⁇ y in the temperature function Fi within the first difference variation range ⁇ Xb to Xa are obtained.
  • the second difference ⁇ y max in the upper limit value Xa of the first difference variation range becomes the maximum value
  • the second difference ⁇ y min in the lower limit value ⁇ Xb of the first difference variation range becomes the minimum value.
  • the margin level Ma of the second difference ⁇ y max with respect to the upper limit value Ea of the second differential allowable range is calculated by, for example, the following formula.
  • the margin level having the smaller value among the margin levels Ma, Mb becomes the minimum margin level.
  • the margin level Ma is the minimum margin level in the temperature function Fi.
  • the calculation method of the margin level is not limited to the aforementioned example, but the margin level may be calculated by other methods.
  • the margin level Ma of the second difference ⁇ y max with respect to the upper limit value Ea of the second differential allowable range and the margin level Mb of the second difference ⁇ y min with respect to the lower limit value ⁇ Eb of the second differential allowable range may be calculated by the following formulas.
  • the margin level of the second difference ⁇ yk corresponding to an arbitrary first difference ⁇ xk is calculated by the following method.
  • the margin level Mk of the second difference ⁇ yk with respect to the upper limit value Ea of the second differential allowable range is calculated by, for example, the following formula (6).
  • the margin level Mk of the second difference ⁇ yk with respect to the lower limit value ⁇ Eb of the second differential allowable range is calculated by, for example, the following formula (7).
  • the second difference ⁇ yk may be calculated by the following formulas.
  • the margin level Mk of the second difference ⁇ yk can be calculated in each of the difference values between the ambient temperature and the set temperature.
  • the margin level of the second difference ⁇ yk at the arbitrary point of time after the temperature function Fi is obtained is calculated.
  • the second difference ⁇ yk at the arbitrary point of time can be obtained in the following method.
  • the ambient temperature data DAi is obtained, and the set temperature data DS is obtained.
  • the first difference ⁇ xk is calculated from the ambient temperature data DAi and the set temperature data DS.
  • the second difference ⁇ yk is calculated.
  • the second difference ⁇ yk can be obtained by measuring the ambient temperature.
  • the actual operation means to operate the constant climate chamber 1 for the climate test of the test objects 24 .
  • the second difference ⁇ yk may be calculated.
  • the margin level of the second difference ⁇ yk with respect to the upper limit value Ea or the lower limit value ⁇ Eb of the second differential allowable range it is possible to estimate whether or not the second difference ⁇ y at an arbitrary point of time during the plurality of points of time or at an arbitrary point of time in the future is within the second differential allowable range.
  • FIG. 10 is a diagram showing an example of a method for setting the allowable coefficient range.
  • an intercept coefficient B of the temperature function Fi is taken to be 0.
  • the first difference variation range ⁇ Xb to Xa and the second differential allowable range ⁇ Eb to Ea are set.
  • the second difference ⁇ y is within the second differential allowable range ⁇ Eb to Ea, so that the maximum inclination coefficient is A max and the minimum inclination coefficient is A min. That is, the allowable coefficient range of the temperature function is equal to or more than A min and equal to or less than A max.
  • the variation of the difference (the second difference ⁇ y) between the internal temperature and the set temperature by the variation of the ambient temperature is within the second differential allowable range Eb to Ea. Therefore, based on whether or not the inclination coefficient A of each temperature function Fi is within the allowable coefficient range A min to A max, it is possible to judge whether or not the variation of the internal temperature by the variation of the ambient temperature is within the regulated allowable range. With this, the evaluation related to the temperature characteristics of the internal space of the constant climate chamber 1 can be performed.
  • the setting method of the allowable coefficient range is not limited to the aforementioned example. For example, by adding a predetermined value to the inclination coefficient Ai of each temperature function Fi which is calculated at first, the upper limit value of the allowable coefficient range may be determined. By subtracting a predetermined value from the inclination coefficient Ai of each temperature function Fi, the lower limit value of the allowable coefficient range may be determined. In this case, the inclination coefficient Ai of each temperature function Fi ⁇ the range of the predetermined value is set as the allowable coefficient range.
  • each temperature function Fi In each of the plurality of positions P 1 to P 8 , based on the plurality of differential groups ( ⁇ x, ⁇ y) and each temperature function Fi, the coefficient of determination of each temperature function Fi is calculated.
  • the coefficient of determination indicates a degree of which the temperature function Fi is fit with respect to the plurality of differential groups ( ⁇ x, ⁇ y) obtained by actual measurements.
  • Based on the coefficient of determination calculated in each temperature function Fi it is possible to judge whether or not the temperature characteristics are evaluated by using the temperature function in each of the positions P 1 to P 8 inside the internal space IS. For example, when the decision variable of the temperature function Fi is equal to or more than a threshold value which is preliminary set, it can be judged that the temperature characteristics can be evaluated by using the temperature function in the position corresponding to the temperature function Fi. On the other hand, when the decision variable of the temperature function Fi is less than the threshold value which is preliminary set, it can be judged that the temperature characteristics cannot be evaluated by using the temperature function in the position corresponding to the temperature function Fi.
  • FIG. 11 is a diagram showing an example of a determination method of the allowable range of the variation of the ambient temperature.
  • the upper limit value Va of the first differential allowable range is calculated by the above formula (11).
  • the lower limit value ⁇ Vb of the first differential allowable range is calculated by the above formula (13).
  • the internal temperature of the constant climate chamber 1 can determine the allowable range of the variation of the ambient temperature in order to satisfy the temperature condition.
  • the set temperature is 40° C.
  • the upper limit value Va of the first differential allowable range is 10° C.
  • the lower limit value ⁇ Vb is ⁇ 35° C.
  • the allowable range of the variation of the ambient temperature becomes 5° C. to 50° C.
  • the internal temperature of the constant climate chamber 1 can satisfy the temperature condition.
  • the temperature functions F 1 to F 8 in the plurality of positions P 1 to P 8 of the internal space IS of the constant climate chamber 1 are obtained.
  • a worst point and a best point related to the temperature characteristics of the internal space IS of the constant climate chamber 1 are judged by any of the following judgement methods based on the plurality of temperature functions F 1 to F 8 .
  • the minimum margin levels calculated in the plurality of temperature functions F 1 to F 8 are used. Among the minimum margin levels for the plurality of temperature functions F 1 to F 8 , the position corresponding to the temperature function having the least minimum margin level is judged as the worst point. Further, among the minimum margin levels for the plurality of temperature functions F 1 to F 8 , the position corresponding to the temperature function having the most minimum margin level is judged as the best point.
  • the margin levels of the second difference ⁇ y corresponding to the arbitrary first difference ⁇ xk in the plurality of points P 1 to P 8 are calculated, and the position having the least margin level may be judged as the worst point, and the position having the most margin level may be judged as the best point.
  • the worst point and the best point can be judged.
  • the inclination coefficients A of the plurality of temperature functions F 1 to F 8 are used.
  • the absolute values of the inclination coefficients A of the plurality of temperature functions F 1 to F 8 are calculated.
  • the position corresponding to the temperature function having the absolute value of the most inclination coefficient A is judged as the worst point, and the position corresponding to the temperature function having the absolute value of the least inclination coefficient A is judged as the best point.
  • the worst point and the best point may be judged.
  • the climate test in the stable temperature atmosphere can be performed.
  • the temperatures test for medicines are preserved in a fixed period of time under the environment satisfying a fixed temperature condition and a fixed humidity condition, and whether or not the effect of the medicines maintains is tested.
  • the temperature condition of a long-term preservation test is 25° C. ⁇ 2° C. or 30° C. ⁇ 2° C.
  • the minimum test period is 12 months.
  • the temperature condition of an acceleration test is 40° C. ⁇ 2° C., and the minimum test period is 6 months.
  • FIG. 12 is a diagram showing an example of the climate test for medicines.
  • the temperature characteristics of the internal space IS of the constant climate chamber 1 are evaluated.
  • the plurality of temperature and humidity sensors SE 1 to SE 8 and the plurality of temperature sensors ST 1 to ST 8 are installed in the constant climate chamber 1 , and the temperature functions F 1 to F 8 in the plurality of positions P 1 to P 8 of the internal space IS are calculated by the method shown in FIGS. 5 and 6 .
  • the evaluations of the temperature characteristics are performed by the aforementioned methods. For example, for all of the temperature functions F 1 to F 8 , it confirms that the minimum margin levels are equal to or more than a predetermined standard value, the absolute values of the inclination coefficients A are equal to or more than a predetermined standard value, and the coefficients of determination of the plurality of temperature functions F 1 to F 8 are equal to or more than a predetermined standard value.
  • the temperature characteristics of the internal space IS of the constant climate chamber 1 are evaluated.
  • the temperature functions F 1 to F 8 in the plurality of positions P 1 to P 8 of the internal space IS are calculated, and by using the calculated temperature functions F 1 to F 8 , in the positions P 1 to P 8 , the evaluations of the temperature characteristics are performed by the aforementioned methods.
  • the evaluations at the point of time t 2 are performed in a state in which the test objects 24 are not placed inside the internal space IS of the constant climate chamber 1 and in a state in which the test objects 24 are placed inside the internal space IS of the constant climate chamber 1 .
  • the temperature characteristics of the internal space IS of the constant climate chamber 1 are evaluated at the point of time t 3 of which the climate test starts.
  • the evaluations at the point of time t 3 are performed in a state in which the test objects 24 are placed inside the internal space IS of the constant climate chamber 1 .
  • the evaluations may be performed before placing the test objects 24 inside the internal space IS of the constant climate chamber 1 .
  • the second difference ⁇ y is obtained in each of the plurality of positions P 1 to P 8 of the internal space IS, and the margin level of each of the obtained second differences ⁇ y is evaluated. Further, the plurality of temperature functions F 1 to F 8 in the plurality of positions P 1 to P 8 of the internal space IS are calculated, and for the plurality of temperature functions F 1 to F 8 , the margin levels, the inclination coefficients or the coefficients of determination may be evaluated. Alternatively, only for the worst point of the internal space IS, the second difference ⁇ y is obtained, and the margin level of the obtained second difference ⁇ y may be evaluated. Further, only for the worst point of the internal space IS, the temperature function is calculated, and for the calculated temperature function, the margin level, the inclination coefficient, or the coefficient of determination may be evaluated.
  • the temperature characteristics of the internal space IS of the constant climate chamber 1 are evaluated.
  • the door 20 is temporary opened, and after installing the plurality of temperature and humidity sensors SE 1 to SE 8 and the plurality of temperature sensors ST 1 to ST 8 , the door 20 is closed.
  • the measurement value of the temperature and humidity sensor S 0 of the constant climate chamber 1 is stabilized in the set temperature, by measuring the internal temperature and the ambient temperature in each of the positions P 1 to P 8 , the second difference ⁇ y is obtained, and the margin level of each the obtained second difference ⁇ y is evaluated.
  • the plurality of temperature functions F 1 to F 8 in the plurality of positions P 1 to P 8 of the internal space IS are calculated, and for the plurality of temperature functions F 1 to F 8 , the margin levels, the inclination coefficients or the coefficients of determination may be evaluated.
  • the second difference ⁇ y is obtained, and the margin level of the obtained second difference ⁇ y may be evaluated.
  • the temperature function is calculated, and for the calculated temperature function, the margin level, the inclination coefficient, or the coefficient of determination may be evaluated.
  • the ambient temperatures at the positions Pe 1 to Pe 8 may be measured.
  • the values of the first difference ⁇ x are calculated, and by substituting the values of the first difference ⁇ x to the the first difference ⁇ x of the aforementioned formula (1), the second differences ⁇ y are calculated. Whether or not each of the obtained second differences ⁇ y is within the second differential allowable range (e.g., ⁇ 2° C.) is confirmed, and the margin level of each of the obtained second differences ⁇ y is evaluated.
  • the second differential allowable range e.g., ⁇ 2° C.
  • the second difference ⁇ y is obtained, and whether or not the obtained second difference ⁇ y is within the second differential allowable range is confirmed, and the margin level of the obtained second difference ⁇ y may be evaluated.
  • the value of the second difference ⁇ y is within the second differential allowable range in the worst point, it is estimated that the values of the second differences ⁇ y in other positions are within the second differential allowable range.
  • the temperature functions F 1 to F 8 calculated in the evaluations at the point of time t 3 and the temperature functions F 1 to F 8 calculated in the evaluations at the point of time t 4 it can estimate the presence or the absence of the variations of the temperature characteristics of the internal space during the period of time from the point of time t 3 to the point of time t 4 .
  • the second differences ⁇ y may be obtained.
  • the temperature function is calculated, for the calculated temperature function, the margin level, the inclination coefficient, or the coefficient of determination may be evaluated.
  • the temperature characteristics of the internal space IS of the constant climate chamber 1 are evaluated.
  • the temperature functions F 1 to F 8 calculated in the evaluations at the point of time t 4 and the temperature functions F 1 to F 8 calculated in the evaluations at the point of time t 5 it can estimate the presence or the absence of the variations of the temperature characteristics of the internal space in a period of time from the point of time t 4 to the point of time t 5 .
  • the second difference ⁇ y can be obtained. Therefore, it can be guaranteed that the internal temperature in each of the positions P 1 to P 8 at the arbitrary point of time during the period of time from the point of time t 3 to the point of time t 4 and the period of time from the point of time t 4 to the point of time t 5 satisfies the temperature condition.
  • the temperature function Fi obtained by the temperature characteristic evaluation method according to the present embodiment indicates the effect which influences the difference between the internal temperature and the set temperature.
  • the first difference ⁇ x in the temperature function Fi can be obtained by changing at least one of the set temperature and the ambient temperature, so that without changing the ambient temperature largely, the first difference ⁇ x can be obtained in a wide temperature range. Therefore, the temperature function Fi can be calculated with high accuracy.
  • the period of time for stabilizing the temperature is shorter than the case in which the ambient temperature of the constant climate chamber 1 is changed, and the power consumption becomes low.
  • the temperature characteristic evaluation method according to the present embodiment it is possible to calculate the temperature function Fi by changing the set temperature without changing the ambient temperature. Therefore, it is possible to reduce the waiting time and the power consumption.
  • the temperature and humidity sensor SE 0 for controlling the temperature of the internal space IS of the constant climate chamber 1 in the set temperature is arranged in the vicinity of the blowout port 41 .
  • the temperature and humidity sensor SE 0 may be arranged in the vicinity of the suction port 42 , or the temperature and humidity sensor SE 0 may be arranged in the vicinity of the blowout port 41 and the vicinity of the suction port 42 , or the temperature and humidity sensor SE 0 may be arranged in other positions inside the internal space IS.
  • the plurality of temperature sensors ST 1 to ST 8 for measuring the ambient temperature is arranged to contact with the surface of the external wall 201 of the constant climate chamber 1 .
  • the plurality of temperature sensors ST 1 to ST 8 may be arranged in a space vicinity of the external wall 201 of the constant climate chamber 1 .
  • one or the plurality of temperature sensors may be commonly arranged.
  • the computer 10 in order to calculate the plurality of temperature functions F 1 to F 8 , the computer 10 is connected to the controller 7 .
  • the controller 7 may include the functions of the computer 10 .
  • the temperature characteristics mean, for example, an influence degree in which the internal temperature is influenced by variations of the ambient temperature, or an influence degree in which a margin level of the second difference is influenced by variations of the ambient temperature.
  • the first difference indicating the difference between the climate chamber and the ambient temperature and the second difference indicating the difference between the internal temperature of the climate chamber and the set temperature are obtained, and the temperature function indicating the relationship between the first difference and the second difference is obtained.
  • the function indicates the difference between the internal temperature and the set temperature
  • the temperature function indicates an influence of the ambient temperature to the difference between the internal temperature and the set temperature.
  • the first difference in the temperature function is obtained by changing at least one of the set temperature and the ambient temperature, so that without changing the ambient temperature largely, the plurality of values of the first difference can be obtained in a wide range. Therefore, the temperature function can be obtained with high accuracy. By using such temperature function, it is possible to evaluate the internal temperature at an arbitrary point of time with high accuracy. Further, accordingly, it is possible to evaluate temperature characteristics in the internal space of the climate chamber with a low cost and with high accuracy.
  • the second difference at the first point of time can be calculated by measuring the ambient temperature at the first point of time. Therefore, without measuring the internal temperature, the temperature characteristics of the internal space at the first point of time can be evaluated.
  • the required upper limit value and the required lower limit value of the allowable range of the ambient temperature can be judged. Accordingly, by adjusting the ambient temperature within the allowable range, it is possible to maintain the difference between the internal temperature and the set temperature within the second differential allowable range.
  • a position corresponding to a temperature function having the least minimum margin level is judged as a worst point.
  • a position corresponding to a temperature function having an absolute value of the most inclination coefficient is judged as a worst point.
  • a position corresponding to a temperature function having the most minimum margin level is judged as a best point.
  • a position corresponding to a temperature function having an absolute value of the least inclination coefficient is judged as a best point.
  • the difference between the internal temperature and the set temperature can be calculated by measuring the ambient temperature at the second point of time. Therefore, it is not required to arrange thermometers in the internal space for measuring the internal temperature, so that the operation cost and the component cost are reduced.
  • the temperature in a position where it is easily influenced to the internal temperature is obtained as an ambient temperature. Accordingly, the accuracy of the evaluation of the temperature characteristics is improved. Further, the measurement of the ambient temperature can be easily performed.
  • the term “preferably” is non-exclusive and means “preferably, but not limited to.”
  • the terminology “present invention” or “invention” is meant as a non-specific, general reference and may be used as a reference to one or more aspects within the present disclosure.
  • the language present invention or invention should not be improperly interpreted as an identification of criticality, should not be improperly interpreted as applying across all aspects or embodiments (i.e., it should be understood that the present invention has a number of aspects and embodiments), and should not be improperly interpreted as limiting the scope of the application or claims.
  • the terminology “embodiment” can be used to describe any aspect, feature, process or step, any combination thereof, and/or any portion thereof, etc. In some examples, various embodiments may include overlapping features.

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