With ultraviolet light monitoring and control, additional 15,000 yuan

Comprehensive drug light stability test chamber developed by Yiheng (with UV Monitoring and Control), in Yuanyiheng GSDGSPGP Based on the comprehensive stability test chamber, the monitoring and control of visible and ultraviolet light is added, and it is carried out by pharmaceutical and cosmetics companies. GMP A must-have device for certification. conform to ICH Photostability testing conditions in the guidelines.   

Using scientific methods to create a temperature, humidity and light environment that requires a long-term stable evaluation of drug failure. It is suitable for accelerated tests, long-term tests, high humidity tests and strong light irradiation tests by pharmaceutical companies. It is the best choice for pharmaceutical companies to conduct drug stability tests.

Features:

Light system of integrated pharmaceutical light stability test chamber

● The light system of the integrated drug light stability test chamber is in compliance with lCH Chinese About Q1B The light stability test requirements for new raw materials and new preparations also comply with the corresponding international manufacturing standards and meet the guiding principles of drug stability tests in 2010. Simulate a long-term stable temperature, humidity and light stability test environment required for drug failure period assessment in scientific methods. It is suitable for pharmaceutical companies' requirements for temperature, humidity and light stability tests for new raw materials and new preparations.

● The lighting system can choose shelf light system or external door light system, including visible light tubes and ultraviolet light tubes, can control the visible light tubes and ultraviolet light tubes separately, or can choose a single-layer or double-layer visible light tubes or ultraviolet light tubes.； Adjustable height of the load sample shelf in the workroom. (Optional double-layer lighting system)

Monitoring and control of optical irradiance display

● Break through the defects in the inability to display and monitor the radiation of existing drug stability test chambers, reduce the irradiance attenuation caused by visible light and ultraviolet lamp tubes due to the aging of lamp tubes, resulting in drug stability test errors. The light intensity can also be adjusted steplessly according to user test requirements. We also provide visible and ultraviolet light measurement probes with light sensors, and third-party certified irradiance monitors for users to observe and calibrate.

Professional UV light tube

● Professional UV light tube compliant ICH Chinese About Q1B The light stability test requirements of new raw materials and new preparations are relatively stable compared with other ultraviolet lamps, and the spectral power distribution of the light source will not attenuate as the lamp tube ages. The advantage is that more test results can be repeated.

● Choose an ultraviolet lamp holder that can operate in high humidity.

◆Humanized design

● New fluorine-free design: high efficiency, low energy consumption, and promote energy saving, so that you can always be at the forefront of a healthy life.

● Microcomputer controller: stable, accurate and reliable control, adopts 304 stainless steel inner liner, four corner semicircular arc shape, easy to clean and easy to operate.

● Unique air duct circulation: Ensure uniform wind distribution in the studio.

● The left side of the box has a diameter of 25 mm test hole.

◆Continuous operation guarantee

● The two sets of imported compressors automatically switch to ensure that the drug tests will not fail for a long period of continuous operation. Break through the defect that domestic drug test chambers cannot operate continuously for a long time.

● There is no need to defrost during continuous operation, so as to avoid fluctuations in the temperature and humidity in the box during use.

◆Quality assurance

● Imported products are used in key components such as temperature and humidity controllers, compressors, and circulation fans, and have the characteristics of stable, safe and reliable operation for a long time.

Imported humidity sensor

● Choose a humidity sensor that can operate in a high temperature state to avoid the troubles caused by frequent replacement of dry and wet bulb wet belts.

◆Programmable touch screen controller (Model mid-band“ P” Standard )

● It adopts an ultra-large screen touch screen, making the screen operation simple and program editing easy.

● The controller operation interface is available in Chinese and English, and the real-time operation curve can be displayed on the screen.

● It has a capacity of 100 sets of programs with a 999 cycle step, and the maximum value is set to 99 hours and 59 minutes per period.

● After inputting data and test conditions, the controller has a screen lock function to avoid shutdown due to human touch.

● have P.I.D Automatic calculation function can immediately correct the temperature and humidity changes, making the temperature and humidity control more accurate and stable.

● have RS-232 or RS-485 Communication interface, which can design programs on the computer, monitor the test process and perform functions such as power switches.

◆Recording and troubleshooting display

● When the test chamber fails, the dynamic display screen will have fault information, and the test chamber operation failure will be clear at a glance.

● It can be connected to the printer or 485 communication interface, and the temperature and time curve can be recorded using the computer and printer, providing a strong guarantee for the storage and playback of the test process.

◆Wireless alarm system  (SMS Alarm System )

● If the equipment user is not on site, when the equipment fails, the system will collect the fault signal in a timely manner and send it to the designated receiving personnel's mobile phone as soon as possible to ensure that the fault is promptly eliminated and restored tests are restored to avoid losses.

◆Safety features

● Independent temperature limit alarm system, sound and light alarm reminds the operator to ensure safe operation of the experiment without accidents.

● Low or high temperature and overtemperature alarms, high and low humidity alarms.

● Standard lockable door: avoid accidentally opening the door during the test, resulting in UV Light damage experimenters.

● A password-protected user control panel can be set up to avoid misoperation by non-experts.

◆Implement and meet standards

2010The Guidelines for Drug Stability Test of Pharmacopoeia and GB/T10586-2006 Related terms and conditions

● Accelerated test: 40 ℃ ±2.0℃ / 75%RH±5%RH， Or 30 ℃ ±1.0℃ / 60%RH±5%RH 180 sky

● Long-term trial: 25 ℃ ±2.0℃ / 60%RH±5%RH， Or 30 ℃ ±2.0℃ / 60%RH±5%RH 365 sky

● High light irradiation test: 4500 ±500LX 10 sky

● satisfy ICH middle Q1B Irradiation requirements: Total illumination ≥1.2×10 6 LUX.hr， Nearly UV energy ≥200W.hr/m 2

● Light and UV radiation tests can be completed simultaneously.

Provide 3 Q Verification and calibration services

※ Provide customers with IQ(Installation confirmation )、OQ(Run Confirm )、PQ(Performance confirmation )Wait for one-stop service.

※ In response to the long-term operation of the drug stability test chamber, which will cause test errors caused by temperature and humidity accumulation errors and irradiance attenuation of the light system, Yiheng Company can provide testing calibration and door-to-door services, and can provide third-party testing reports.

※ Can provide third-party testing reports from authoritative metrology departments in Jiangsu and Shanghai

Technical parameters