Stability Test Chamber

photo-stability chamber is equipped with visible and near-ultraviolet light tubes, can independently control the type of light source, and can real-time printing and recording of visible light and near-UV radiation. visible light and near ultraviolet can be set directly and adjusted automatically to precisely control both light sources.

Stability Test Chamber, It can be used in painstaking research of pharmaceutical industry, medical industry, biological technology industry and other industries related to life science. To prove the shelf life of a drug in a certain market, the manufacturer must store it at a relevant temperature and humidity for a specified time. Some medical institutions buy the stability test chambers for important drugs medicine stockpile purpose, Like the storage for patient’s drugs and pills. According to GMP principle, constant and stable test conditions of 25°C/60% RH shall be maintained.

The drug stability test chambers in the stability test chambers field of pharmaceutical industry, the standard of 40°C/75% RH shall remain for 6 months in acceleration test, mainly simulating the temperature, humidity and illumination. The most common conditions are 25°C/60% RH. For a new product accelerated conditions may be 40°C/75% RH.

Other conditions include 30°C/65% RH, 30°C/35% RH and 25°C/40% RH. Another condition is 5°C ±3°C for products intended to be stored in a refrigerator. For products intended for storage in a freezer the test conditions are -20°C ±5° C. I mean the application for stability test chambers

Advantages：

1、Equipped with D65 light source, near ultraviolet wavelength 320-400nm;The light source of each layer is controlled independently;With three levels of user authority, audit trail;

2、Reference Standard: ICHQ1B、Chinese Pharmacopoeia 2020 edition;

3、Light source design: The use of reasonable light source top design, the shelves of different positions of the sample to receive the light source irradiation of good uniformity;

4、Insulation material: Overall high-density polyurethane foam technology, with good insulation and moisture retention performance;

5、Chamber Materials:The exterior is coated with high quality steel plate,The liner is made of mirror stainless steel 304, no pollution

6、Refrigeration system: Imported fully enclosed compressor, high efficiency, low noise, long service life;

7、Control system: Programmable color touch screen controller, with three levels of user rights and audit trail function;more than 7 inches;With three levels of user authority, audit trail;

8、Data management ：Configure needle type micro printer and electronic data storage function，support to use U disk to export the data.

9、Safety device: Compressor overheat and overpressure overload protection, independent overtemperature protection alarm system;

10、Alarm system：On-site beeping alarm;

11、Double Door Structure：Interior door tempered glass door,Open the outer door to observe the samples，The temperature inside the container will not change in a short time，The outer door is solid can keep temperature,It can also prevent the influence of external light;

12、Other configurations：Test hole、Rubber plug、Mobile casters; Door lock;

13、Illumination open：Temperature Fluctuation < ±1.0℃，

Temperature deviation of the same layer: < ±2.0℃ ;

14、Environment Temperature：+5 ～ 35℃ ;

15、Power：AC220V±10% 50HZ;

16、Optional: Temperature-humidity deviation, sudden power failure , control by Remote SMS alarm.

Product Parameters：

Model	STD-80SD	STD-80SDP	STD-150GSD		STD-150GP
	STD-150SD	STD-150SDP	STD-250GSD		STD-250GP
	STD-250SD	STD-250SDP			STD-400GP
Temperature control range	0~65ºC		0~65ºC without illumination 10~50ºC with illumination
Temperature Stability	±0.5ºC
Temperature Uniformity	±2ºC
Humidity Rang	35~95%RH				/
Humidity Stability	±3%RH				/
Illumination	/		0~6000LX adjustable
Illumination difference	/		≤±500LX
Timing Rang	1~99 hours each period
Humidity and temp adjusting	Balance temperature and humidity adjusting			Balance temperature adjusting
Cooling system/cooling mode	Two sets of imported compressor work rotationally ( STD-80SDP only one set)
Controller	Programmable ( LCD screen)	Programmable ( touch screen)	Programmable ( LCD screen)	Programmable ( touch screen)	Programmable ( LCD screen)
Sensor	Temp: Pt100, Humidity: capacitance sensor				Temp: Pt100
Ambient Temperature	RT+5~30ºC
Electrical Requirement	AC220V 50Hz
Power Consumption	2000W/2100W/2300W	2000W/2100W/2300W	2250W/2500W	2250W/2500W	1450W/1700W/3200W
Chamber Volume	80L/150L/250L	80L/150L/250L	150L/250L	150L/250L	150L/250L/400L
Interior Dimension (W×D×H)mm	400×400×500	400×400×500			550×405×670
	550×405×670	550×405×670	550×405×670	550×405×670	600×500×830
	600×500×830	600×500×830	600×500×830	600×500×830	700×550×1140
External Dimension (W×D×H)mm
	550×790×1080	550×790×1080	690×805×1530	690×805×1530	690×805×1530
	690×805×1530	690×805×1530	740×890×1680	740×890×1680	740×890×1680
	740×890×1680	740×890×1680			950×850×1850
Shelves	2/3/3(pcs)	2/3/3(pcs)	3/3(pcs)	3/3(pcs)	3/3/4(pcs)
Safety Device	Compressor overheating and overpressure protection,
	Fan overheating protection Over temperature protection,
	Overload protection, Water protections
Remark	Bulid in mini printer.
	Paperless recorder (Option).
	GP/GSD/GSP series products have installed intensity of illumination detector.
	GP/GSD/GSP series products have installed intensity of illumination detector.

Model	STD-500SD STD-500SDP	STD-800SD STD-800SDP
			STD-1000SD	STD-1500SD	STD-500GSD	STD-800GSD	STD-1000GSD
			STD-1000SDP	STD-1500SDP	STD-500GSP	STD-800GSP	STD-1000GSP
							STD-1500GSP
Temperature control range	0~65ºC				0~65ºC without illumination 10-50ºC with illumination
Temperature Stability	±0.5ºC
Temperture uniformity	±2ºC
Humidity Rang	35~95%RH
Humidity Stability	±3%RH
Illumination	/				0~6000LX adjustable
Illumination difference	/				≤±500LX
Cooling system cooling mode	Two sets of imported compressor work rotationally
Controller	Programmable ( touch screen)
Sensor	Temp: Pt100, Humidity: capacitance sensor
Ambient Temperature	RT+5~30ºC
Electrical Requirement	AC220V 50Hz	AC380V 50Hz			AC220V 50Hz	AC380V 50Hz
Power Consumption	3750W	7150W	7150W	10600W	3910W	7350W	7350W
							10800W
Chamber Volume	500L	800L	1000L	1500L	500L	800L	1000L/1500L
Interior Dimension (W×D×H)mm	670×725×1020	800×590×1650	1050×590×1650	1550×590×1650	670×725×1020	800×590×1650	1050×590×1650
							1550×590×1650
External Dimension (W×D×H)mm	850×1100×1930	1360×890×2000	1610×890×2000	2110×890×2000	850×1100×1930	1360×890×2000	1610×890×2000
							2110×890×2000
Shelves	4(pcs)
Safety Device	Compressor overheating and overpressure protection,
	Fan overheating protection Over temperature protection,
	Overload protection, Water protections
Remark	Bulid in mini printer
	Paperless recorder (Option).
	GP/GSD/GSP series products have installed intensity of illumination detector.
	GSD/GSP series products have 2 layers of light control (Option).
	1000L and 1500L are double doors

Product Features：

Digital measuring and control system WEBSeason touch screen display

Ethernet interface

Lockable doors

Password protected control panel

Door contact switch for door jar alarm

Benchtop model includes 2 shelves and reach-in units includes 6 shelves per door supplied as a standard.

6 feet (Pharma 280) or 4 casters, 2 with brakes (Pharma 600, 1300, 2000)

Water tank, 13 l (Pharma 280) or 19 l (Pharma 600, 1300, 2000) with automatic and manual water supply of demineralized humidification water

Air-cooled refrigeration unit with low noise emission

Patented vapor humidification system (Sterile Steam System)

The control system responds quickly in order to correct setpoint variations caused by door openings or product under test.

Programmable Touch Screen：

Large LCD screen to display more data at same time

English operation menu, display current data curves

100 groups with 1000 periods 999 circulations, max timing for each period is 99 hours 59 minutes.

Auto lock after setting data.

Available to programe on computer via RS-484 or RS-232

Working principle:

Stability chambers are built to artificially replicate conditions for those drugs that might be exposed in different environmental situations. Occasionally, it is used to accelerate the impacts of exposure to atmospheric conditions that may be hostile in any area where this medicine is stored.

Stability chambers work on the principle to retain the relative humidity (RH) and temperature of the chamber with the assistance of thermostats and water reserved in the chamber. According to the law of physics, the air can retain higher humidity with help of high temperatures in the chamber because the high temperatures increase the capacity of air to sustain higher humidity in certain situations.

To test the quality of the medicine under certain temperatures and humidity, a batch of the medicine of interest is located in a stability chamber that has maintained temperature and humidity for a specified amount of duration. Samples are scanned periodically for quality examination. The stability chambers used in the process need to be reliable and consistent because testing takes place over periods ranging from one week to six months, to one year or more.

Photostability is another type of stability testing, or how the drug is impacted when exposed to a certain amount of light and UV over time. Photostability testing examines whether undesirable changes occur to medicine when it is exposed to a combination of white light and UV light. For this test, stability chambers are required to fulfill certain guidelines and can emit the necessary light and UV over time.

In the field of the pharmaceutical industry, stability testing assists to provide information as to how the quality of medicine will adapt with time under a variety of environmental conditions including temperature, humidity, and light exposure. This testing must be accomplished before a drug arrives on the market.

The conditions for using stability chambers are highly specific and expect that the temperature deviates by no more than 2 or 3° depending upon the condition and humidity diverges by no more than five percent. Hence, chambers used for this type of testing must have low temperature and humidity variations that have been verified over a long period of testing. The temperature also needs to be consistent throughout the process. For photostability testing, they must be able to retain light exposure of more than 1.2 million lux hours and emit more than 200 watts of UV energy to samples. Unlike stability testing for temperature and humidity, photostability testing can be accomplished in very little time than can be one week and certain units can be programmed so that the light shuts off when the expected exposure has been attained.