What experiments are mainly done in the constant temperature and humidity laboratory in gmp

Long-term product retention samples, accelerated expedition test, bacterial culture, fungal culture, etc..

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Pharmaceutical companies with constant temperature and humidity laboratory

(long-term product sampling room, accelerated investigation test room, bacterial culture room, fungal culture room)

Technical specifications

Main uses:

Mainly used as a pharmaceutical factory and pharmaceutical company product sampling room, accelerated test room, fungal and bacterial culture room It is mainly used as the testing room with constant temperature and humidity demand for pharmaceutical factories and pharmaceutical companies. Pharmaceutical companies through the GMP certification or GMP management of the necessary equipment configuration.

Main technical parameters:

Temperature range: 20 ℃ ~ 45 ℃ (interval can be set arbitrarily), volatility ± 0.5 ℃, uniformity 2 ℃.

Relative humidity: 25%~90% (can be set arbitrarily in the interval), fluctuation ±2%, uniformity 5%.

Indoor average wind speed: ≤ 0.5m/s.

Temperature and humidity deviation, temperature and humidity fluctuations, temperature and humidity uniformity in accordance with:

Chinese People's Republic of China **** and the country's national measurement technical specifications, "JJF1101-2003 environmental test equipment, temperature, humidity, calibration specifications," or otherwise agreed upon technical parameters.

Structural parameters:

1, indoor height: usually 2 ~ 2.5m.

2, indoor length and width: determined by the specific site.

3, Room material: polystyrene or polyurethane color steel plate / stainless steel.

4, Usually the floor can not be insulated.

5, energy consumption: 80m2, for example, according to the indoor area, about 1 ~ 1.3Kwh/m2-24h, the actual energy consumption and working temperature and humidity, environmental climate and so on. Due to the use of more advanced energy-saving air treatment, than the traditional constant temperature and humidity chamber energy saving 60-70%.

Control system:

1, Siemens programmable controller, Chinese interface touch screen. Temperature and humidity curve record, fault record self-diagnosis. Security password setting.

2, temperature and humidity data can be easily downloaded to the U disk and converted into Excel files. Can be equipped with a micro-printer to print real-time temperature and humidity data. Convenient for GMP management.

3, dual temperature and humidity sensors, can be rotated measurement identification, annual inspection and measurement does not affect the normal use of the laboratory.

4, ultrasonic humidification, humidification without the introduction of heat, more energy efficient.

Test Methods:

1, in accordance with the People's Republic of China **** and the country's national measurement specifications

"JJF1101-2003 environmental test equipment temperature, humidity calibration specifications"

2, constant temperature and humidity chamber, temperature and humidity control point (center point) acceptance: the following parameters to do the corresponding test

Set the control parameters ( Center point): temperature 25±1℃, humidity 40±2%RH.

Wherein, the humidity can be specified by the user in the above parameter range at any 3 points for testing.

3, constant temperature and humidity chamber, temperature and humidity uniformity acceptance: available another temperature / humidity sensor (reserved wire length

degree of access to any point in the room), placed in the user-specified location, the difference in temperature is not greater than 2 ℃, the difference in humidity

value of not more than 5% RH.

Temperature and humidity sensors used to measure the legal metrology department should have the Valid qualified identification certificate.