Medicine/Drug Stability Test Chamber - Ultraviolet Light

Overview of use:
Comprehensive drug light stability test box (with UV monitoring and control), based on the original MSC-THLPTHLTL comprehensive stability test box to increase the monitoring and control of visible light and ultraviolet light, is a must for pharmaceutical and cosmetics companies to carry out GMP certification equipment. Meets the light stability test conditions in the ICH guidelines.

Scientifically create a temperature, humidity environment and light environment that requires long-term stability for drug failure evaluation. It is suitable for pharmaceutical companies to accelerate tests, long-term tests, high-humidity tests and strong light exposure tests on drugs and new drugs. It is a pharmaceutical company. The best choice for drug stability testing.

Features:
◆Integrated drug light stability test box illumination system
● The illumination system of the comprehensive drug light stability test chamber complies with the light stability test requirements of the new raw materials and new preparations of Q1B in lCH, and also meets the corresponding international manufacturing standards, meeting the 2015 pharmacopoeia drugs.
Stability test guidelines. A scientific method was used to simulate a long-term stable temperature, humidity, and light stability test environment required for drug failure period assessment. It is suitable for pharmaceutical companies to test the temperature, humidity and light stability of new APIs and new formulations.
● The lighting system can choose the shelf lighting system or the external door lighting system, including visible light tube and ultraviolet light tube. It can control the visible light tube and the ultraviolet light tube separately. It can also choose single or double layer visible light tube or ultraviolet light. Lamp; adjustable height of the load sample shelf in the work chamber. (Optional for double-layer lighting system)
◆Light irradiance display monitoring and control
● Breaking through the defects of the existing drug stability test chamber, the irradiance cannot be displayed and monitored, and the irradiance attenuation caused by the aging of the lamp tube of the visible light and the ultraviolet lamp tube is reduced, resulting in the error of the drug stability test. The light intensity can also be adjusted steplessly according to the user's test requirements. We also provide visible light and ultraviolet light measuring probes with light sensors, and third-party certified irradiance monitors for user observation and calibration.
◆Professional UV lamp
● Professional UV lamp complies with the light stability test requirements of Q1B new API and new formulation in ICH. Compared with other UV lamps, it has the characteristics of stable quality and uniform spectral power, and the spectral power distribution of the light source does not follow the lamp. Aging causes attenuation, and the benefit is that more test results can be repeated.
● Use a UV lamp holder that can operate in high humidity.
◆Humanized design
● New fluorine-free design: high efficiency, low energy consumption, and energy saving, so that you are always at the forefront of healthy living.
● Microcomputer controller: The control is stable, accurate and reliable. It adopts 304 stainless steel inner tank, four-corner semi-circular arc shape, easy to clean and easy to operate.
● Unique duct circulation: Ensure uniform wind distribution inside the studio.
● There is a test hole with a diameter of 25mm on the left side of the cabinet.
◆Continuous operation guarantee
● Two sets of imported compressors are automatically switched to ensure that the drug test runs continuously for a long time without failure. Breaking through the shortcomings of domestic drug test chambers that cannot be operated continuously for a long time.
● Continuous operation does not require defrosting to avoid fluctuations in temperature and humidity in the tank during use.
◆Quality assurance
● The key components such as temperature and humidity controller, compressor and circulating fan are all imported products, which are characterized by long-term continuous operation, stable, safe and reliable.
◆Imported humidity sensor
● Use a humidity sensor that can operate at high temperatures to avoid the troubles caused by frequent replacement of wet and dry wet belts.
◆ Programmable touch screen controller ("THLP" series is standard)
● With large screen touch screen, the screen is easy to operate and the program editing is easy.
● The controller operation interface is available in both English and Chinese. The real-time running graph can be displayed on the screen.
● It has a capacity of 100 sets of 1000 segments and 999 cycles. The maximum value is set to 99 hours and 59 minutes per time.
● After inputting data and test conditions, the controller has a screen lock function to avoid human touch and stop.
● With P.I.D automatic calculation function, the temperature and humidity change conditions can be corrected immediately, so that the temperature and humidity control is more precise and stable.
● With RS-232 or RS-485 communication interface, you can design programs on the computer, monitor the test process and perform functions such as switching on and off.
◆ Recording and troubleshooting display
● When the test box fails, the dynamic display will show fault information, and the test box operation failure will be clear at a glance.
● It can be connected to printer or 485 communication interface. It can record temperature and time curve with computer and printer, which provides powerful guarantee for data storage and playback of test process.
◆Wireless alarm system (SMS alarm system) - optional
● If the equipment user is not at the site, when the equipment fails, the system collects the fault signal in time and sends it to the designated receiver's mobile phone through the SMS at the first time to ensure timely troubleshooting and recovery test to avoid loss.
◆Safety function
● Independent temperature limit alarm system, sound and light alarm prompts the operator to ensure safe operation of the experiment without accidents.
● Low or high temperature and over temperature alarm, high humidity and low alarm.
● Standard lockable door: avoid accidental opening of the door during the test, which causes UV light to damage the experimenter.
● User-control panel with password protection can be set to avoid misoperation by non-experimental personnel.

      

Provide 3Q verification and calibration services (optional)
※ Provide customers with one-stop services such as IQ (installation confirmation), OQ (operation confirmation), and PQ (performance confirmation).
※ For the long-term operation of the drug stability test chamber, the test error caused by the accumulated temperature and humidity error and the irradiance attenuation of the illumination system may be provided. Yiheng Company can provide inspection and calibration and on-site service, and can provide third-party test reports.
※ Third-party test report for Jiangsu and Shanghai authoritative measurement departments (optional)

Execution and satisfaction criteria
2015 edition of the pharmacopoeia drug stability test guidelines and GB/T10586-2006 related provisions
● Accelerated test: 40 ° C ± 2.0 ° C / 75% RH ± 5% RH, or 30 ° C ± 1.0 ° C / 60% RH ± 5% RH 180 days
● Long-term test: 25°C ±2.0°C/60%RH±5%RH, or /30°C±2.0°C/60%RH±5%RH 365 days
● Strong light irradiation test: 4500±500LX 10 days
● Meet the irradiation requirements of Q1B in ICH: total illumination ≥1.2×106 LUX.hr, near-ultraviolet energy ≥200W.hr/m 2
● Light and UV irradiation tests can be done simultaneously.

Specifications:

Optional