The comprehensive drug photostability test box developed by Yiheng (with UV)Monitoring and Control), in the original One Constant GSD \ \ GSP \ \ GPOn the basis of the comprehensive stability test box, visible light and ultraviolet light monitoring and control have been added, which enables pharmaceutical and cosmetics companies to comply with GMP regulationsEssential equipment for certification. Compliant with ICHThe light stability testing conditions in the guiding principles.

Creating a long-term stable temperature, humidity, and lighting environment for drug failure evaluation using scientific methods is suitable for pharmaceutical companies to conduct accelerated, long-term, high humidity, and strong light irradiation tests on drugs and new drugs. It is the best choice for pharmaceutical companies to conduct drug stability tests.

Product features:

The lighting system of the comprehensive drug photostability test box

The illumination system of the comprehensive drug photostability test box complies with the photostability test requirements for Q1B new raw materials and new formulations in LCH, as well as the corresponding international manufacturing standards, and meets the 2010 Pharmacopoeia drug stability test guidelines. Simulate a long-term stable temperature, humidity, and photostability testing environment required for drug expiration evaluation using scientific methods. Applicable to the temperature, humidity, and photostability testing requirements of pharmaceutical companies for new raw materials and new formulations.

The lighting system can choose from a shelf style lighting system or an external door lighting system, including visible light tubes and ultraviolet light tubes, which can be separately controlled. Single or double-layer visible light tubes or ultraviolet light tubes can also be selected; Adjustable height of the sample shelf for loading in the workspace. (Optional double-layer lower lighting system)

Light irradiance display monitoring and control

● Break through the defect of the existing drug stability test box that cannot display and monitor irradiance, and reduce the irradiance attenuation caused by the aging of visible light and ultraviolet lamps, which leads to errors in drug stability testing. The light intensity can also be infinitely adjusted 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 tube

The professional ultraviolet lamp tube meets the requirements of ICH for the light stability test of Q1B new raw materials and new formulations. Compared with other ultraviolet lamps, it has the characteristics of stable quality and uniform spectral power, and the spectral power distribution of the light source will not attenuate with the aging of the lamp tube. The advantage is that it can repeat more test results.

Select UV lamp holders that can operate in high humidity conditions.

◆ Humanized design

New fluorine free design: high efficiency, low energy consumption, promoting energy conservation, keeping you at the forefront of a healthy lifestyle.

● Microcomputer controller: stable, accurate, and reliable control, using 304 stainless steel inner liner, four corner semi-circular arc shape, easy to clean, and convenient to operate.

Unique air duct circulation: Ensure even distribution of wind inside the studio.

The left side of the box is equipped with a 25mm diameter test hole as standard.

◆ Continuous operation guarantee

Two sets of imported compressors automatically switch to ensure that drug testing runs continuously for a long time without any malfunctions. Breakthrough the defect of domestic drug testing chambers being unable to operate continuously for a long time.

Continuous operation does not require defrosting, avoiding temperature and humidity fluctuations inside the box caused by defrosting during use.

◆ Quality assurance

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

Choose a humidity sensor that can operate at high temperatures to avoid the hassle of frequent replacement of wet and dry bulb bands.

◆ Programmable touch screen controller（Model with "P”As standard)

Adopting a large touch screen display, the screen operation is simple and the program editing is easy.

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

● It has a capacity of 100 sets of programs, 1000 segments, and 999 loop steps, with a maximum set time of 99 hours and 59 minutes per segment.

After inputting the data and experimental conditions, the controller has a screen lock function to avoid manual touch and shutdown.

Equipped with P.I.D automatic calculation function, it can immediately correct temperature and humidity change conditions, making temperature and humidity control more accurate and stable.

Equipped with RS-232 or RS-485 communication interface, it can be programmed on a computer to monitor the testing process and perform functions such as power on/off.

◆ Recording and fault diagnosis display

When the test box malfunctions, the dynamic display screen will show fault information, and the operational faults of the test box will be clear at a glance.

It can be connected to a printer or 485 communication interface to record temperature and time curves using a computer and printer, providing strong guarantees for data storage and playback during the experimental process.

◆ Wireless alarm system（SMS alarm system

If the equipment user is not on site, when the equipment malfunctions, the system will promptly collect the fault signal and send it to the designated recipient's mobile phone via SMS to ensure timely troubleshooting, recovery testing, and avoid losses.

◆ Safety features

● Independent temperature limiting alarm system, with sound and light alarms to alert the operator, ensuring safe operation of the experiment without accidents.

● Alarm for low or high temperature and over temperature, alarm for high or low humidity.

Standard lockable door: to avoid accidentally opening the door during the testing process, which may cause UV light damage to the experimenters.

● User control panel with password protection to prevent accidental operation by non experimental personnel.

◆ Execution and compliance with standards

2010Guidelines for drug stability testing in the Pharmacopoeia and GB/T10586-2006Regarding clause manufacturing

● Accelerated test: 40 ℃± 2.0 ℃/75% RH ± 5% RH, or 30 ℃± 1.0 ℃/60% RH ± 5% RH for 180 days

Long term test: 25 ℃± 2.0 ℃/60% RH ± 5% RH, or 30 ℃± 2.0 ℃/60% RH ± 5% RH for 365 days

● Strong light exposure test: 4500 ± 500LX for 10 days

● Meet the irradiation requirements of Q1B in ICH: total illuminance ≥ 1.2 × 10 6 LUX. hr, near ultraviolet energy ≥ 200W. hr/m2

The light and ultraviolet irradiation tests can be completed simultaneously.

Provide 3QVerification and Calibration Services

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 drug stability testing chambers, which may result in accumulated errors in temperature and humidity, as well as attenuation of irradiance in the lighting system, Yiheng Company can provide testing calibration and on-site services, and can also provide third-party testing reports.

We can provide third-party testing reports from authoritative metrology departments in Jiangsu and Shanghai (RMB: 2500)

Provide 3Q verification and calibration services

￥ 2500 (additional charge of 800~3000 yuan for on-site fee)