sales@bonnin-tech.com
+86 27 59766389
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1.1 Usage
Drug stability test chamber is made in accordance with
the light of new chemicals Pharmaceutical stability testing guidelines and
humid test chamber technical conditions. The equipment may prepare a long and
stable operating temperature and humidity environment by pharmaceutical
scientific method for evaluation of drug failure require. It is used for
companies to test drugs and calibration and stability tests for new drugs.
Pharmaceutical stability chambers to meet the accelerated test, the test of
long-term and high-humidity test, international organizations to identify new
ICH stability testing conditions are also among the above range. Users can also
press the unit Drug stability test chamber to arrange work requirements. At the
same time, it may meet pharmaceutical and veterinary guidelines hygroscopic
stability test specifications in Appendix XIXJ
Pharmaceutical chemical
drug stability test guidelines states: drug production and development shall be
specified temperature, humidity and light irradiation test.
High
humidity test: temperature of 25 ℃ ± 2 ℃, humidity 90% R.H ± 5%, or 75%
± 5%.
Acceleration test: is 40 ℃ ± 2 ℃, 75% ± 5% or 30 ℃ ± 2 ℃, 65% ± 5% .; packaged in
pharmaceutical formulations for semi-permeable containers, such as plastic bags
solution, plastic bottle drops liquid, nasal drops should be 40 ℃ ± 2 ℃, 20% ± 5% or 25 ℃ ± 2 ℃, 20% ± 5%.
Long-term test: is 25 ℃ ± 2 ℃, 60% ± 10%; in pharmaceutical
formulations for packaging semi-permeable containers, such as plastic bags
solution, plastic bottles of eye drops, nasal drops should be 25 ℃ ± 2 ℃, 40% ± 10%.
Additional tests in moderate
conditions: 30℃±2℃, 40%±5%。
High temperature test: is 40 ℃, 60 ℃
2.1 Technical specification
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Product number |
LHH-120SDP |
LHH-225SDP |
LHH-400SDP |
LHH-500SDP |
LHH-700SDP |
|
Studio size |
500x450x600 |
500x500x900 |
660x550x1100 |
750x600x1100 |
900x700x1100 |
|
Dimensions |
980x630x1320 |
980x680x1600 |
1100x730x1700 |
1200x780x1700 |
1000x1400x1700 |
|
Install the power |
1.0Kw |
1.2 Kw |
1.5 Kw |
1.5 Kw |
1.5 Kw |
|
Number of shelves |
2 |
4 |
4 |
4 |
4 |
|
Door size |
750mm |
800mm |
750mm |
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|
Temperature range |
+10--65℃ |
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|
Humidity range |
20-95%R.H |
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|
Temperature fluctuation |
<±0.5℃ |
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|
Temperature uniformity |
<2.0℃ |
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|
Temperature deviation |
<±1.0℃ |
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|
Humidity deviation |
<±3.0%R.H |
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|
Temperature and humidity controller |
Adopt imported color touch screen temperature and humidity controller, PLC control, stable and reliable control, intuitive display, easy operation, setting data can be locked to prevent arbitrary changes in parameters. Controller set control unit start, the cumulative time, Beijing time display, warning function is equal to one, and real-time print test data, but also store data, U disk export and so on. |
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|
Sensor |
Industrial temperature sensor Pt100 platinum resistance, humidity sensor imported French capacitive humidity sensor |
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|
Data record |
Standard micro-printer, real-time print records, recording options curve records or data records, printing interval adjustable |
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|
Heating system |
Nickel-chromium alloy electric heater |
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|
Humidification system |
Special electric steam generator |
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|
Cooling System |
Two fully enclosed refrigeration units, a reasonable system to ensure long-term continuous trouble-free operation (one of the spare) |
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|
Dehumidification system |
Using a dehumidifier, dehumidifier can be adjusted |
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|
The door sealed |
Silicone rubber seal, good sealing performance, and effectively cut off the thermal conductivity of the wall and the box |
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|
Door handle |
The use of buckle-type locking device with a door handle (fishtail type), the switch door convenient, but also can effectively prevent any switch |
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|
Waterway system |
Hidden tank, the controller automatically prompts when the water tank is dry. Long-term flow of water within the system, effectively avoid the drawbacks of bacteria. |
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|
Wireless alarm |
Temperature and humidity deviation alarm function, can be connected to multiple devices, and use the TPP function simultaneously notify multiple cell phone numbers |
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|
safety protection |
Power leakage, short circuit protection, over-temperature equipment, water, water, refrigerator overload and other protection |
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|
Standard configuration |
ø50 test hole, 8W lighting, vacuum glass observation window, micro printer, U disk, 485 communication interface, wireless wifi alarm, casters, etc. |
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Optional |
Recorder, network interface and so on |
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|
Product Standards |
Products to meet the ICH2003 Q1A (R2), CP2010 implementation of the standards GB / T10586-2006: Damp heat chamber technical conditions |
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|
Power supply |
220V ± 10%, 50Hz, |
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Liner material |
SUS304 mirror stainless steel plate |
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|
Shell material |
Adopt imported color touch screen temperature and humidity controller, PLC control, stable and reliable control, intuitive display, easy operation, setting data can be locked to prevent arbitrary changes in parameters. Controller set control unit start, the cumulative time, time display, warning function is equal to one, and real-time print test data, but also store data, U disk export and so on. |
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ADD: Room 3-5, 9/F, Bldg. 6, No. II9 Guannan Industrial Park, 430074, Wuhan of Hubei PR, China
EMAIL:
sales@bonnin-tech.com
TEL:
+86 27 59766389
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