Wuhan Bonnin Technology Ltd, Laboratory Instruments Expert in China

Product Description

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 ℃

 

Features

1)Studio mirror stainless steel liner, shell electrostatic spray coating process, the whole nice shape.

2)The surface of the working chamber concealed screws, no rust inside to ensure no leakage phenomenon.

3)Is provided with a large rectangular observation windows and lights, easy to observe the test.

4)Fishtail belt buckle pull handle, easy and convenient door open, but also effectively prevent the collision switch box door drawbacks.

5)The use of imported high-precision color touch screen controller, powerful, high control accuracy. Set the alarm in one load starts, indicating Intuitive, easy to operate.

6)Humidity sensor, high accuracy, small amount of drift, can fully guarantee the high reliability requirements of humidity.

7)Import humidity sensor, high accuracy, small amount of drift, can fully guarantee the high reliability requirements of humidity.

8)Independent over-temperature protection system, safe and reliable.

9)Recording with real-time printing, exporting U disk data, temperature and humidity deviation alarm messages, the cumulative running time and other functions

10) Equipment can be a long low power operation, energy saving and environmental protection, the main technical indicators are better than the technical requirements of GMP requirements.

 

Technical specification 

Product number LHH-120SDP LHH-225SDP LHH-400SDP LHH-500SDP LHH-800SDP
Studio size 500x450x600 500x500x900 660x550x1100 750x600x1100 900x620x1350
Dimensions 980x630x1320 980x680x1600 1100x730x1700 1200x780x1700 1450x780x1960
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
Temperature range +10–65℃
Humidity range 20-95%R.H
Temperature fluctuation <±0.5℃
Temperature uniformity <2.0℃
Temperature deviation <±1.0℃
Humidity deviation <±3.0%R.H
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.
Sensor Industrial temperature sensor Pt100 platinum resistance, humidity sensor imported French capacitive humidity sensor
Data record Standard micro-printer, real-time print records, recording options curve records or data records, printing interval adjustable
Heating system Nickel-chromium alloy electric heater
Humidification system Special electric steam generator
Cooling System Two fully enclosed refrigeration units, a reasonable system to ensure long-term continuous trouble-free operation (one of the spare)
Dehumidification system Using a dehumidifier, dehumidifier can be adjusted
The door sealed Silicone rubber seal, good sealing performance, and effectively cut off the thermal conductivity of the wall and the box
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
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.
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
safety protection Power leakage, short circuit protection, over-temperature equipment, water, water, refrigerator overload and other protection
Standard configuration ø50 test hole, 8W lighting, vacuum glass observation window, micro printer, U disk, 485 communication interface, wireless wifi alarm, casters, etc.
Optional Recorder, network interface and so on
Product Standards Products to meet the ICH2003 Q1A (R2), CP2010 implementation of the standards GB / T10586-2006: Damp heat chamber technical conditions
Power supply 220V ± 10%, 50Hz,
Liner material SUS304 mirror stainless steel plate
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.

Enquiry For Pharma Drug Stability Test Chamber