Ich GMP Pharm Industrial Drug Stability Climate Temp Humidity Environmental Test Walk-in Room Chamber

Product Details
Customization: Available
Specification: Customized
Trademark: ECW
Gold Member Since 2018

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Plant Area
>2000 square meters
Management System Certification
ISO 9001
  • Ich GMP Pharm Industrial Drug Stability Climate Temp Humidity Environmental Test Walk-in Room Chamber
  • Ich GMP Pharm Industrial Drug Stability Climate Temp Humidity Environmental Test Walk-in Room Chamber
  • Ich GMP Pharm Industrial Drug Stability Climate Temp Humidity Environmental Test Walk-in Room Chamber
  • Ich GMP Pharm Industrial Drug Stability Climate Temp Humidity Environmental Test Walk-in Room Chamber
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Basic Info.

Model NO.
E-T-1000
Production Capacity
100

Product Description

in the pharmaceutical industry to 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 25degree/60%RH humidity long-term stability test conditions. In the accelerated test, the humidity of 40degree/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
4) Meet the ICH2003Q1A (2) guidelines and the GMP 2010 version of the Chinese Pharmacopoeia stability test conditions:
1. Accelerated test: 40ºC±2ºC/75%RH±5%RH
2. Intermediate conditions: 30ºC±2ºC/65%RH±5%RH
3. Long-term test: 25ºC±2ºC/60%RH±5%RH or 30ºC±2ºC/65%RH±5%RH
 
Internal size 1000w*1000D*1000Hmm or customized
External size 1550w*1600D*1900Hmm
Temp range 0--100ºC
Temperature resolution 0.1ºC
Temperature uniformity ≤±2ºC
Temperature deviation ≤±2ºC
Cooling 0.7-1.2ºC/min non-linear no-load
Heating temperature 3-5ºC/min non-linear no-load
Humidity range 20%R.H~98%R.H
Humidity deviation ≤±2%R.H (humidity>75%RH) ≤±5%R.H (humidity75%RH
Humidity fluctuation ±1%R.H
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
Safety protection overload protection, compressor overheating, overcurrent, overpressure, heating and dry burning, overtemperature alarm system in the box
 
Item name: Material Qty
Compressor Tecumseh (France) 2sets
Condenser Fin type with inlet cooling fan (Kuweili) 1set
Evaporator Customized (Zhongli) 1set
Expansion valve Danfoss/Honeywell 2pcs
Solenoid valve FDF (Sanhua group) 2pcs
Solenoid valve FDF(Sanhua group ) 2pcs
Pressure controller Danfoss 1pc
Oil separator S-4004 1pc
Filter EMERSON 1pc
Refrigerant:R404A Honeywell lot
Copper pipes Taishun 1set
Temperature       and        humidity controller TEMI880 touch screen 1set
Over      temperature     protection
instrument;
EGO(CHNT) 1pc
Temperature Sensor; Pt100 2pcs
Humidity Sensor Pt100 1pc
Contactor CJX2(CHNT) 2pcs
Solid state relay SSR(Yangming) 3pcs
Time delay relay ANV(Yangming) 2pc
Intermediate relay Omron lot
Heating Pipe Customized 2sets
Switching power supply (leakage protection) DZ47LE(CHNT) 1set
Transformer Customized 1pcs
Control switch panel Customized 1set
Warning light Customized 1set
Heating protection Customized 1set

Ich GMP Pharm Industrial Drug Stability Climate Temp Humidity Environmental Test Walk-in Room Chamber

 

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