Scope of use:
A scientific method is used to create an environment of temperature, humidity and illumination needed for drug failure evaluation, which is suitable for the experiment of influencing factors of drugs and new drugs in pharmaceutical enterprises. Electronic record system with three-level authority and audit trail.
Comply with North American FDA 21CFR PART 11 regulations, suitable for CGMP certified users.
Features:
1. Adopt imported high-quality parts to ensure long-term continuous operation and stable and reliable performance.
2.High-resolution dedicated touch screen temperature and humidity controller, excellent man-machine interface.
3. Standard three-level authority, audit trail function, to ensure the authenticity and consistency of data.
4. Imported high-precision humidity sensor, with small drift and no maintenance.
5. Standard micro printer can print temperature and humidity curves and data in real time.
6. Electronic records are standard, and the data of electronic records in the controller can be exported.
7. RS485 interface is standard, and single or multiple instruments can be monitored by computer through networking.
8. Mobile phone short message alarm is standard, and Internet of Things technology is adopted, so SIM card is not required.
9.The visual observation window of the gate is provided with a key lock to prevent irrelevant personnel from opening the door and affecting the test.
10.Two sets of imported fully enclosed heat-resistant compressors with low noise and long service life.
11. Meet the relevant test requirements of FDA, ICH, JJF-2019 and national pharmacopoeia.
12.Circulating water supply system greatly delays the problem of bacteria growing in water system.
13. Meet the low humidity test of 40℃/20%RH and 25℃/40%RH for special drugs such as infusion.
14. Manufacturing execution standard (technical conditions): refer to GB/T 10586-2006.
Technical Parameters:
model | LHH-150GSD-3T | LHH-250GSD-3T | LHH-400GSD-3T | LHH-500GSD-3T | LHH-800GSD-3T | LHH-1000GSD-3T |
Volume (L) | 150 | 250 | 400 | 500 | 800 | 1000 |
temperature range | 0~65℃(without light)10~65℃(with light) |
Temperature fluctuation | ≤±0.5℃ |
Temperature deviation | ≤±1℃ |
Humidity range | 15~95%R.H |
Humidity deviation | ≤±3%R.H |
Illuminance | 10-8000LUX (adjustable) |
Illuminance deviation | ≤±500LUX |
Near UV irradiance | 80~200μw/cm2 (adjustable) |
Humidification method | Electric steam humidifier |
Working temperature | +5~40℃ |
Liner material | Mirror 304 stainless steel |
shell material | Cold rolled steel plate spraying |
safety devices | Power overload protection, independent studio over-temperature protection, compressor overload, overpressure protection, water blockage, water shortage protection |
Working power supply | AC220V±10% 50HZ |
Installation power (W) | 1300 | 1600 | 2100 | 2400 | 2600 | 2800 |
Carrier Plate | 2 | 4 | 4 | 4 | 4 | 4 |
Internal dimensions (mm)* | 500X530X600 | 500X530X950 | 670X600X1000 | 800X650X950 | 1000X800X1000 | 1000X1000X1000 |
Dimensions (mm)* | 990X690X1360 | 990X690X1700 | 1160X760X1730 | 1300X810X1700 | 1500X960X1750 | 1500X1160X1750 |
Note: Dimensions are D x W x H(mm)