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China Ich GMP Pharm Industrial Drug Stability Climate Temp Humidity Environmental Test chamber

Main functions

The drug stability test chamber is specially used in the pharmaceutical industryto conduct drug stability investigation tests to determine the
validity period of drugs. It meets the long-term, accelerated and intermediate
tests in the National Pharmacopoeia, FDA, ICH
and other relevant standards, and also meets the 40°C, 20%RH low-humidity test
for special drugs such as large infusions. Drug stability test chambers are
used for intensive research in the pharmaceutical industry, medicine, biotechnology industry and all related
industries including life sciences. Requirements of GMP principle 25
/60%RH humidity long-term stability test conditions. In the
accelerated test, the humidity of 40
/75%RH is
tested for 6 months. It is the field of stability test system in the
pharmaceutical industry. It mainly
simulates the temperature, humidity and light test in the environmental
climate.

  1. Manufacturing
    execution standard (technical conditions): refer to GB/T 10586-2006 Technical Conditions of Damp Heat Test Chamber

  2. Guiding principle: IEC 60068-3-5 Environmental test
    of electrical and electronic products - performance confirmation of temperature
    test chamber

  3. GB
    5226.1-2002/IEC 60204-1:2000 Safety of Machinery - Electrical and Mechanical
    Equipment - Part 1: General Specifications


Meet the ICH2003Q1A (2) guidelines and the GMP 2010 version of the
Chinese Pharmacopoeia stability test conditions

    1. Accelerated test: 40℃±2/75%RH±5%RH

    2. Intermediate
      conditions: 30
      ℃±2/65%RH±5%RH


3. Long-term
test: 25
℃±2/60%RH±5%RH or 30℃±2/65%RH±5%RH



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Product Description

Main functions

The drug stability test chamber is specially used in the pharmaceutical industryto conduct drug stability investigation tests to determine the
validity period of drugs. It meets the long-term, accelerated and intermediate
tests in the National Pharmacopoeia, FDA, ICH
and other relevant standards, and also meets the 40°C, 20%RH low-humidity test
for special drugs such as large infusions. Drug stability test chambers are
used for intensive research in the pharmaceutical industry, medicine, biotechnology industry and all related
industries including life sciences. Requirements of GMP principle 25
/60%RH humidity long-term stability test conditions. In the
accelerated test, the humidity of 40
/75%RH is
tested for 6 months. It is the field of stability test system in the
pharmaceutical industry. It mainly
simulates the temperature, humidity and light test in the environmental
climate.

  1. Manufacturing
    execution standard (technical conditions): refer to GB/T 10586-2006 Technical Conditions of Damp Heat Test Chamber

  2. Guiding principle: IEC 60068-3-5 Environmental test
    of electrical and electronic products - performance confirmation of temperature
    test chamber

  3. GB
    5226.1-2002/IEC 60204-1:2000 Safety of Machinery - Electrical and Mechanical
    Equipment - Part 1: General Specifications


Meet the ICH2003Q1A (2) guidelines and the GMP 2010 version of the
Chinese Pharmacopoeia stability test conditions

    1. Accelerated test: 40℃±2/75%RH±5%RH

    2. Intermediate
      conditions: 30
      ℃±2/65%RH±5%RH


3. Long-term
test: 25
℃±2/60%RH±5%RH or 30℃±2/65%RH±5%RH




Internal size

1000w*1000D*1000Hmm

External size

1550w*1600D*1900Hmm

Temp range

0--100

Temperature   resolution

0.1ºC

Temperature deviation

≤±2

Temperature uniformity

≤±2

Cooling

0.7-1.2/min non-linear no-load

Heating temperature

3-5/min non-linear no-load

Humidity range

20%R.H98%R.H

Humidity   deviation

≤±2%R.H   (humidity>75%RH) ≤±5%R.H (humidity75%RH

Humidity fluctuation

±1%R.H

Humidity uniformity

≤±2

Humidity   resolution

0.1%R.H

UV irradiance

80-100μw/cm²

UV spectral range

320~400   nm

Illumination   range (Lux)

0~10000

Illumination deviation   (Lux)

±500

Power

9KW

Power supply

380V±10%V;   50Hz

External   material

brushed stainless steel

Internal material

SUS#304   stainless steel

Other configurations

Internal   material viewing window (500*600mm), test hole (50*1), 2 layer trays, 1 232 interface

Safety protection

overload   protection, compressor overheating, overcurrent, overpressure, heating and   dry burning, overtemperature alarm system in the box

Installation and use conditions:

  1. Ambient condition around the device

    1. Ambient temperature: 535

    2. Ambient humidity: 85%R.H

    3. Environmental conditions for guaranteed performance: (Ensure cooling rate and limit temperature)

    4. Atmospheric pressure: 86 ~ 106KPa;

    5. Air quality: no high-concentration dust and corrosive gas, no flammable and explosive gas;

    6. Ground requirements: flat, no strong vibration;

    7. Use distilled water or deionized water for humidification of equipment;

  2. Space conditions: For the convenience of installation, debugging, operation and maintenance, please place the equipment according to the space required by the following.

    1. There should be at least a space of not less than 200mm between the test box and the surrounding of the room;

    2. There should be a space for the normal opening and closing of the box door at the opening door of the equipment;

  3. Equipment power supply conditions

    1. Frequency and error: 50±0.5Hz;

    2. Voltage and error: AC 380V±10%V;

    3. Main switch: requires an independent space