Stability Test chamber apply to Pharmaceutical Industry

Stability Test chamber apply to Pharmaceutical Industry

Stability Tests Are An Important Step In The Development Of New Drugs And Pharmaceutical Substances And An Indispensable Element In The Licensing Process Defined By Federal Regulating Authorities. However, These Tests Are Just As Important For Safeguarding The Quality Of The Product Within The Framework Of Quality Assurance.

Together With Committees From The Pharmaceutical Industry, Experts From The Licensing Authorities (such As The Fda) Have Developed The Ich Guidelines For The Harmonization Of Stability Tests. These Guidelines Define Standardized Storage And Batch Evaluation As Well As The Time Sequence Of The Required Analytic Tests.

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Description

Stability Test chamber apply to Pharmaceutical Industry

Temperature Range : 0c To 80°c

Humidity Range : 30%rh To 98%rh

Feautres:

Non-condensing Steam Injectiontype Humidity System With Stand-by System And Auto Switch Over

Forced Air Circulation Foruniform Temperature Accrossthe Chamber

Low And High Temperaturecut-off Settable Thermostats& High Humidity Cut Offthermostats.

Test Consitions like:

1, long-term test :25℃±2.0℃60%R.H±5%R.H 365 days

2, acceleration test :40℃±2.0℃75%R.H±5%R.H 180 days

3, mid-term test :30℃±2.0℃65%R.H±5%R.H 180 days

Technical Parameters

Model	TH-80	TH-150	TH-225	TH-408	TH-800	TH-1000
Internal Dimension	400x500x400	500x600x500	600x750x500	600x850x800	1000x1000x800	1000x1000x1000
WxHxD (mm)
External Dimension	950x1650x950	1050x1750x1050	1200x1900x1150	1200x1950x1350	1600x2000x1450	1600x2100x1450
WxHxD (mm)
Temperature Range	T min: Low Temperature (A:25℃ B:0℃ C:-20℃ )
	Tmax: High Temperature (80℃ )
Humidity Range	Optional: ( 20%~98%R.H /10%-98% R.H. / 5%-98% R.H )
Analytic Accuracy/	0.1℃; 0.1% R.H/±2.0℃; ±3.0% R.H.
Distribution uniformity
of temperature
and humidity
Control Accuracy	±0.5℃; ±2.5% R.H.
of Temperature and
Humidity
Temperature Rising/	Temperature rising approx. 0.1~3.0℃/min
Falling Speed Rate	temperature falling approx. 0.1~1.5℃/min;
	( The Falling Speed Rate Min.1.5℃per minute is a special optional condition)
Material	Material of the inner box is SUS 304# stainless steel, of the outer box is stainless steel or
	SEE cold-rolled steel with paint coated, Insulation material is resistant to high temperature,
	high density, formate chlorine, ethyl acetum foam insulation materials
Cooling System	Wind cooling or water cooling/single segment compressor(-40℃, double segment
	compressor -70℃)
Protection Devices	Fuse-free switch, overloading protection switch for compressor, high and low voltage
	coolant protection switch, over-humidity and over-temperature protection switch, fuses,
	fault warning system, water short storage warning protection
Optional Accessories	Inner door with operation hole , Recorder, Water Purifier, Dehumidifier
Compressor	French Tecumseh Brand,Germany Bizer Brand
Power	AC220V 1ph 3 lines, 50/60HZ , AC380V 3ph 5 lines , 50/60HZ
Approx. Weight (Kg)	150	180	250	320	400	450