Drug /Medicine /Pharmaceutical Stability Test Chamber

• Customization: Available
• After-sales Service: Life Time
• Warranty: 1 Year
• Model NO.: LHH-80SD, LHH-150SD, LHH-250SD
• Lead Time: 7-15working Days
• Application: Drug Stability Tester
• Supply Area: Global
• Shipping: Sea, Land, Air
• Standards: GB/T10586-2006
• Transport Package: Wooden, Carton
• Specification: LHH-80SD, LHH-150SD, LHH-250SD
• Trademark: SRI
• Origin: China Mainland
• HS Code: 8419899090
• Production Capacity: 500 Sets Per Year
• Package Size: 100.00cm * 90.00cm * 185.00cm
• Package Gross Weight: 500.000kg

Product Description

 

Drug /Medicine /Pharmaceutical Stability Test ChamberProducteatur

Product Description

The new generation of drug stability testing equipment integrates years of design and production experience of the company, and introduces and digests German technology. Breaking through the defect of existing domestically produced drug test boxes being unable to operate continuously for a long time is a GMP certified equipment for pharmaceutical factories.
Usage Overview:
Creating a scientifically stable temperature, humidity, and lighting environment for drug failure evaluation is suitable for pharmaceutical companies to conduct accelerated, long-term, high humidity, and strong light exposure tests on drugs and new drugs. It is a suitable choice for pharmaceutical companies to conduct drug stability tests.
 

Features

Humanized design

1. A brand new fluorine-free design, with high efficiency, low energy consumption, and energy conservation, keeps you at the forefront of healthy living.
2. A microcomputer controller with stable, accurate, and reliable control, using a 304 stainless steel inner liner and a semicircular arc at the four corners, easy to clean and easy to operate.
3. Air duct circulation ensures uniform distribution of wind power within the studio. There is a 25mm diameter test hole on the left side of the box.

Continuous operation guarantee

1. Two sets of imported compressors automatically switch to ensure long-term continuous operation of drug testing without any malfunctions. Breaking through the defect of domestic drug test boxes being unable to operate continuously for a long time.
2. Continuous operation does not require defrosting to avoid fluctuations in temperature and humidity inside the box during use due to defrosting.

Quality assurance

1. Key components such as temperature and humidity controllers, compressors, and circulating fans are all imported products, which have the characteristics of stable, safe, and reliable long-term operation.

Safety functions

1. An independent temperature limit alarm system can provide audible and visual alarms to remind operators, ensuring safe operation of the laboratory without accidents.
2. Alarm for low or high temperature and over temperature, and alarm for high or low humidity.
3. Equipped with password lock screen function to prevent non experimental personnel from misoperating.

Imported humidity sensor

1. Select a humidity sensor that can operate at high temperatures to avoid the troubles caused by frequent replacement of wet and dry bulbs.

UV sterilization system (optional)

1. The ultraviolet sterilization lamp is placed on the back wall of the box, which can regularly disinfect the inside of the box, effectively killing floating bacteria in the circulating air and humidified water vapor inside the box, thereby effectively preventing pollution during drug testing.

Automatic monitoring and control of light intensity (optional)

1. Breaking through the shortcomings of existing domestically produced stability test boxes that cannot monitor and control the light intensity, a light sensor is used for monitoring and stepless adjustment, reducing the attenuation of light intensity and test errors caused by lamp tube aging.

Data recording and fault diagnosis display

1. When the test box malfunctions, the dynamic display screen will display fault information, and the operating faults of the test box are clear at a glance.
2. It can be connected to a printer or 485 communication interface, and temperature and time curves can be recorded using a computer and printer, providing strong guarantee for data storage and playback during the test process.
3. Programmable touch screen controller
4. Adopting a large touch screen screen, the screen operation is simple and the program editing is easy.
5. The controller operation interface is available in both Chinese and English for selection, and the real-time operation curve can be displayed on the screen.
6. It has a capacity of 100 sets of programs, 1000 segments, and 999 cycle steps.
7. After inputting data and test conditions, the controller has a screen locking function to avoid manual touch and shutdown.
8. Equipped with P.I.D automatic calculation function, it can immediately correct temperature and humidity changes, making temperature and humidity control more accurate and stable.
9. Equipped with RS-232 or RS-485 communication interface, it can design programs on a computer, monitor the testing process, and perform functions such as switching on and off.

Execution and compliance with standards:

1. Guidelines for Drug Stability Testing in the 2020 Pharmacopoeia and Relevant Articles of GB/T10586-2006 Manufacturing
2. Accelerated test: 40 ºC± 2.0 ºC/75% RH ± 5% RH, or 30 ºC± 1.0 ºC/60% RH ± 5% RH for 180 days
3. Long term test: 25 ºC± 2.0 ºC/60% RH ± 5% RH, or/30 ºC± 2.0 ºC/60% RH ± 5% RH for 365 days
4. For accelerated testing of drug formulations packaged in semi permeable containers, such as infusion bags prepared from low density polyethylene glycol, plastic ampoules, and eye preparation containers, the test should be conducted at a temperature of 40 ºC± 2 ºC/25% ± 5% RH
5. For long-term testing of drug formulations packaged in semi permeable containers, the test should be conducted at a temperature of 25 ºC soil 2 ºC/40% ± 5% RH or 30 ºC ± 2 ºC/35% ± 5% RH
6. Strong light exposure test: 4500 ± 500LX for 10 days

★ Stability test conditions: In the ICH guidelines, GMP defines requirements in terms of functionality, performance, and documentation. Europe, Japan, and the United States have agreed to develop a common stability test, which aims to gather information as a recommendation for the stability of raw materials or drugs. The goal is to demonstrate the effectiveness of drugs exposed to temperature, humidity, light, or a comprehensive environment within a specified period of time.
★ Storage conditions for long-term stability test of retention samples:
Temperature:+25 ºC± 2 ºC Humidity: 60 ± 5% RH
Time: 12 months
★ Storage conditions for accelerated stability testing
Temperature:+40 ºC± 2 ºC Humidity: 75 ± 5% RH
Time: 6 months Strong light exposure conditions Illuminance: 4500 ± 500LX
The above relevant data is for reference only, and the corresponding test environment temperature is 25 ºC

 Technical Parameter
 

Specifications

 

name	Drug Stability Test Chamber			Comprehensive drug stability test box	Drug Strong Light Stability Test Box
model	LHH-80SD LHH-150SD LHH-250SD	LHH-80SDP LHH-150SDP LHH-250SDP		LHH-150GSD LHH-150GSP LHH-250GSD LHH-250GSP	LHH-150GP LHH-250GP LHH-400GP
temperature range	0~65ºC			0~65ºC(Illuminated 15~50ºC)
Temperature fluctuation/uniformity	±0.5ºC/±2ºC
Humidity range/deviation	25~95%RH/±3%RH				nothing
Light intensity/error	nothing			0~6000LX adjustable ≤ ± 500LX (infinite dimming)
Timing range	1-99 hours per segment
Temperature and humidity control method	BTHC				Balanced temperature regulation method
Refrigeration system/refrigeration method	Two sets of independent original imported fully enclosed compressors automatically switch (LHH-80SD/80SDP is a set of independent original fully enclosed compressors)
controller	Programmable touch screen controller
sensor	Pt100 platinum resistor Capacitive humidity sensor				Pt100 platinum resistor
Working environment temperature	+5~30ºC
source	AC220V±10%   50HZ
Operating power	About 650W/680W/750W			About 680W/680W/750W/750W	About 450W/450W/600W
power	2000W/2800W/3000W			2950W/2950W/3200W/3200W	1450W/1700W/3200W
volume	80L 150L 250L		80L 150L 250L	150L 250L	150L 250L 400L
Inner Tank Size (mm) W×D×H	400×400×500 550×405×670 600×500×830		400×400×500 550×405×670 600×500×830	550×405×670 600×500×830	550×405×670 600×500×830 700×550×1140
Overall dimensions (mm) W×D×H	550×790×1080 690×805×1530 740×890×1680		550×790×1080 690×805×1530 740×890×1680	690×805×1530 740×890×1680	690×805×1530 740×890×1680 950×850×1850
Load tray (standard)	2/3/3 blocks		2/3/3 blocks	2/3/3 blocks	2/3/3 blocks
Embedded printer	standard configuration		standard configuration	standard configuration	standard configuration
Safety devices	Compressor overheat protection, fan overheat protection, overtemperature protection, compressor overpressure protection, overload protection, and water shortage protection.
Remarks	1. Standard 485 interface and embedded printer 2. SDP, GSP standard USB interface and wireless alarm system SD, GSD, GP series optional 3. GP, GSD, GSP series, manual stepless dimming, standard light intensity monitor, built-in top illuminator 4. GP, GSD, GSP series, optional with two-layer illuminator 5. LHH-80SD and LHH-80SDP are a set of independent original fully enclosed imported compressors

 

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