Calibration Specification for Drug Stability Test Chamber

1 scope

This specification applies to the temperature range（0～65） ℃, relative humidity rangeSurrounding（10～95）% Range of illumination（0~7000）lxRange of ultraviolet radiation illuminance（0～300）μW/cm2 The drug stability test box (hereinafter referred to asTest box) Calibration.

2 Reference document

This specification references the following documents:

JJG 245 Illuminance meter

JJG 879 UV radiometer

JJF 1032 Terminology and definitions of optical radiation measurement

JJF 1101 Calibration Specification for Temperature and Humidity Parameters of Environmental Testing Equipment

GB/T 5170.1Environmental testing for electrical and electronic productsEquipment inspection method 第 1 Part: General Provisions

GB/T 5700Lighting measurement method

GB/T 10586 Technical conditions for wet heat test chamber

Pharmacopoeia of the People's Republic of China（2025 Version 4)9001 Guiding principles for stability testing of raw materials and formulations

For all referenced documents with dates, only the version with dates is applicable to this specification; Any reference document without a date,The latest version (including all modification orders) is applicable to this specification.

3 Terminology and measurement units

3.1 term

3.1.1 Workplaceworking space

The test chamber can maintain the specified test conditions at the specified deviationThe part of space within the difference range.

[Source:GB/T 5170.1—2016 ，3.2.2]

3.1.2 Stable state stable state

The temperature, relative humidity, illuminance, and ultraviolet radiation illuminance at any point in the workspace reach the set values and are maintained atThe state within the given tolerance range.

[Source:GB/T 10586—2006 ，3.4and3.14 There are modifications]

3.1.3 Temperature deviationtemperature deviation

Under the stable state of the test chamber, the temperature of each measuring point in the workspace is measured within the specified timeThe deviation between the temperature and the set temperature.

[Source:GB/T 5170.1—2016 ，3.2.4]

3.1.4 Temperature uniformitytemperature uniformity

In a stable state of the test chamber, the workspace is at a certain momentThe maximum difference in temperature between any two points. [Source:GB/T 5170.1—2016 ，3.2.8]

3.1.5 Temperature fluctuationtemperature fluctuation

In a stable state of the test chamber, the temperature at any point in the workspace varies with time within a specified time intervalThe amount of change.

[Source:GB/T 5170.1—2016 ，3.2.6]

3.1.6 Relative humidity deviationrelative humidity deviation

Under the stable state of the test chamber, each measuring point in the workspace is measured within the specified timeThe deviation between the relative humidity and the set relative humidity.

[Source:GB/T 5170.1—2016 ，3.2.5]

3.1.7 Relative humidity fluctuationrelative humidity fluctuation

In a stable state of the test chamber, the relative humidity at any point in the workspace varies with the specified time intervalThe amount of change in time.

[Source:GB/T 5170.1—2016 ，3.2.7]

3.1.8 Illuminationilluminance

The luminous flux incident on a surface element containing a point on the surfaced∅Divide by the area of the surface elementdAThe merchant. [Source:GB/T 5700—2023 ，3. 1]

3.1.9 Illuminance deviationilluminance deviation

In a stable state of the test chamber, the set values and measured average illuminance of each measuring point in the workspace are within the specified time The difference in value.

3.1.10 Uniformity of Illuminationuniformity ratio of illuminance

Specify the ratio of minimum illuminance to average illuminance on the surface.

[Source:GB/T 5700—2023 ，3.9]

3.1.11 Ultraviolet radiation illuminanceultraviolet irradiance

The ultraviolet radiation illuminance at a point on the surface is the ultraviolet radiation flux incident on the panel containing that pointd∅e Divide by the area of the paneldAThe merchant.

[Source:JJF 1032—2005 ，2.13 There are modifications]

3.1.12 Exposure to radiationradiant exposure

Exposure to radiation refers to the amount of radiation emitted over a specified time periodΔtInternally, the ultraviolet radiation illuminance at the designated pointEe Integrating time yields Exposure to radiation levels.

[Source:JJF 1032—2005 ，2.15 There are modifications]

3.2 Measurement Unit

Temperature: Unit name is Celsius, symbol is℃;

Relative humidity: unit symbol is%；

Illumination: Unit name is lux, symbol islx；

UV radiation illuminance: unit name is watts per square meter or microwatts per square meterSquare centimeters, symbolized byW/m2orμW/cm2；

Radiation exposure: Unit name is watt second per square meter or watt hour per square meter, symbol isW·s /m2 or W·h/m2；

Time: Unit name is seconds, symbol iss.