UV Comprehensive Drug Stability Test Chamber

• Customization: Available
• After-sales Service: Life Time
• Warranty: 1 Year
• Model NO.: LHH-150GSD-UV, LHH-150GSP-UV
• 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-150GSD-UV, LHH-150GSP-UV
• Trademark: SRI
• Origin: China Mainland
• HS Code: 8419899090
• Production Capacity: 500 Sets Per Year
• Package Size: 100.00cm * 90.00cm * 190.00cm
• Package Gross Weight: 500.000kg

Product Description

 

UV Comprehensive drug stability test chamber
 

Product Description

The comprehensive drug photostability test box (with UV monitoring and control) developed by Yiheng has added visible and ultraviolet light monitoring and control to the original Yiheng GSD  GSP  GP comprehensive stability test box. It is a GMP certification equipment for pharmaceutical and cosmetic enterprises. Comply with the light stability testing conditions in the ICH guidelines.
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

Lighting system of comprehensive drug photostability test box

1. The lighting system of the comprehensive drug photostability test box complies with the requirements for photostability testing of Q1B new raw materials and new formulations in lCH, as well as corresponding international manufacturing standards, and meets the guiding principles for drug stability testing in the 2015 Pharmacopoeia. Simulate a long-term stable temperature, humidity, and light stability test environment required for the evaluation of drug expiration date using scientific methods. Applicable to the temperature, humidity, and photostability testing requirements of pharmaceutical enterprises for new raw materials and formulations.
2. The lighting system can choose from a shelf type lighting system or an external door lighting system, including visible light tubes and ultraviolet light tubes. The visible light tubes and ultraviolet light tubes can be controlled separately, and single or double layer visible light tubes or ultraviolet light tubes can also be selected; The height of the load sample shelf can be adjusted in the studio. (Optional for double-layer lower lighting system)

Monitoring and control of light irradiance display

1. Breaking through the limitation of the existing drug stability test box's inability to display and monitor irradiance, reducing the attenuation of irradiance caused by visible light and ultraviolet lamp tube aging, resulting in drug stability test errors. The light intensity can also be adjusted steplessly according to user testing requirements. We also provide visible and ultraviolet light measurement probes with light sensors, as well as third-party certified irradiance monitors, for easy observation and calibration by users.

Professional UV lamp tubes

1. Professional UV lamp tubes meet the requirements of the light stability test for Q1B new raw materials and new formulations in ICH. Compared to other UV lamp tubes, they have stable quality and uniform spectral power, and the spectral power distribution of the light source will not decay with the aging of the lamp tube. The advantage is that they can replicate more test results.
2. Select UV lamp holders that can operate in high humidity conditions.

Humanized design

1. New fluorine free design: High efficiency, low energy consumption, promoting energy conservation, keeping you at the forefront of healthy living.
2. Microcomputer controller: Stable, accurate, and reliable control, using 304 stainless steel inner liner, with four corners and a semicircular arc, easy to clean and operate.
3. Air duct circulation: Ensure uniform distribution of wind force inside the studio.
4. The left side of the box is equipped with a 25mm diameter testing hole as standard.

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 caused by defrosting during use.

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 continuous operation.

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.
2. Programmable touch screen controller ("GSP" series is standard)
3. Adopting a large touch screen screen, the screen operation is simple and the program editing is easy.
4. 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.
5. It has a capacity of 100 sets of programs, 1000 segments, and 999 cycle steps.

Data and testing
Execution and compliance with standards
Guidelines for Drug Stability Testing in the 2020 Pharmacopoeia and Relevant Articles of GB/T10586-2006 Manufacturing

1. The ambient temperature corresponding to the following tests is 25 ºC
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
7. Meet the irradiation requirements of Q1B in ICH: total illumination ≥ 1.2 × 106 LUX.hr, near ultraviolet energy ≥ 200W.hr/m2
8. Light and UV irradiation tests can be completed simultaneously.

Provide 3Q verification and calibration services (optional)
Provide customers with one-stop services such as IQ (installation confirmation), OQ (operation confirmation), PQ (performance confirmation), etc.
In response to the long-term operation of the drug stability test chamber, which may result in accumulated temperature and humidity errors and radiation attenuation of the lighting system, Yiheng Company can provide testing calibration and on-site services, as well as third-party testing reports.
Can provide third-party testing reports from Jiangsu and Shanghai metrology departments (RMB 2500)
 

Specifications

 

Technical model	LHH-150GSD-UV LHH-150GSP-UV	LHH-250GSD-UV LHH-250GSP-UV	LHH-500GSD-UV LHH-500GSP-UV	LHH-800GSD-UV LHH-800GSP-UV	LHH-1000GSD-UV LHH-1000GSP-UV LHH-1500GSP-UV	LHH-150GP-UV LHH-250GP-UV LHH-400GP-UV
temperature range	0~65ºC(Illuminated 15~50ºC)
Temperature fluctuation/uniformity	±0.5ºC /±2ºC~±3ºC
Humidity range/deviation	25~95%RH/±3%RH					nothing
Light intensity/error	Cold white fluorescence 0-6000Lux adjustable/± 500Lux, UV light intensity adjustable
UV spectral range	320-400nm
Meets test standards	ICH Q1B command, cold white fluorescence ≥ 1.2 × 106Lux. hr, near-ultraviolet fluorescence ≥ 200 w.hr/m2
Light source configuration	Cold white fluorescent lamp (according to ISO 10977) and UVA near ultraviolet fluorescent lamp
Standard light source	Cold white light lamp (D656500K), UV lamp with a wavelength range of 320-400nm
Refrigeration system/refrigeration method	Two sets of independent original imported fully enclosed compressors with automatic switching
controller	Programmable touch screen controller
source	AC220V 50HZ			AC380V 50HZ		AC220V 50HZ
Operating power	About 680W	About 750W	About 1400W	About 3400W	About 2400W/3000W	About 450W/450W/600W
Rated power	2100W	2500W	3910W	7350W	7350W/10800W	1450W/1700W/3200W
volume	150L	250L	500L	800L	1000L/1500L	150L/250L/400L
Inner Tank Size (mm) W × D × H	550×405×670	600×500×830	670×725×1020	800×590×1650	1050×590×1650 1550×590×1650	550×405×670 600×500×830 700×550×1140
Overall dimension (mm) W × D × H	690×805×1530	740×890×1680	850×1100×1930	1360×890×2000	1610×890×2000 2110×890×2000	690×805×1530 740×890×1680 950×850×1850
Lighting method	Top lighting/box door lighting		Top lighting			Top lighting/box door lighting
Embedded printer	Standard configuration
Safety devices	Compressor overheat protection, fan overheat protection, overtemperature protection Compressor overpressure protection, overload protection, water shortage protection, wired monitoring and alarm system (optional)
Remarks	1. Optional high-precision digital recorder 2. GP, GSD manual stepless dimming, standard light intensity monitor, standard ultraviolet radiation monitor, built-in top UV light or box door light 3. GSP-UV, UV monitoring system for automatic monitoring, with light sensors for visible and UV light measurement probes 4. GSP-UV series can be optionally equipped with multi-layer illuminators

Note: The operating power is measured under the stable operation of the product at 25 ºC and 65% RH test conditions.

 

Detailed Photos

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