Overview of Application:
Create a scientifically designed environment with long-term stability in temperature, humidity, and light exposure, suitable for pharmaceutical companies' accelerated, long-term, high-humidity, and intense light exposure tests for drugs and new drugs. It serves as a preferred option for pharmaceutical stability testing.
Product Features:
Human-Centric Design
1.New non-fluorine design, low energy consumption, and energy-saving promotion put you at the forefront of a healthy lifestyle.
2. Microcomputer controller with stable, accurate, and reliable performance, featuring a 304 stainless steel inner liner with rounded corners for easy cleaning and convenient operation.
3. Unique airflow circulation ensures even air distribution within the studio. There is a 25mm diameter test hole on the left side of the housing.
Continuous Operation Assurance
Two imported compressors automatically switch, ensuring uninterrupted and continuous operation of the drug testing for extended periods without failure. Overcoming the domestic drug testing chamber's inability to run continuously for long durations.
Continuous operation without defrosting, avoiding fluctuations in internal temperature and humidity during use due to defrosting.
◆Quality Assurance
Temperature and humidity controllers, compressors, circulating fans, and other key components are all imported, featuring long-term stable and reliable performance.
◆ Features
① UniqueLimiting temperature alarm system, capable of sound and light alarms to alert the operator, ensuring laboratory operations do not encounter accidents.
② Low or high temperature and over-temperature alarms, high or low humidity alarms.
③ Password-locked screen function to prevent unauthorized personnel from operating.
◆ Import Humidity Sensor
Choose a humidity sensor capable of operating at high temperatures to avoid the hassle of frequently replacing the wet bulb wick.
Ultraviolet Sterilization System (Optional)
The ultraviolet sterilization lamp is placed on the back wall inside the box, allowing for regular disinfection of the interior. It effectively kills floating bacteria in the circulating air inside the box and the steam from the humidifying disk, thereby effectively preventing contamination during the drug testing period.
Automatic Light Intensity Monitoring and Control (Optional)
Overcoming the current shortcoming of domestic stable test chambers that cannot monitor and control illumination, this model utilizes light sensors for monitoring and offers infinite adjustable settings, reducing illumination decay and test errors caused by the aging of bulbs.
◆ Documentation Record & Fault Diagnosis Display
When the test box malfunctions, error messages will display on the dynamic screen, making it clear at a glance that the test box is running into issues.
Connectable to printers or 485 communication interfaces, it allows for recording temperature and time curves on a computer with a printer, ensuring robust data storage and playback for the testing process.
Programmable Touch Screen Controller (Optional)
1. Features a large touchscreen display, with simple screen operation and easy program editing.
2. The controller features an operation interface with both Chinese and English options, with the real-time operation curve graph displayed on the screen.
3. Capacity for 100 programs with 1,000 segments and 999 loop steps, with each time setting allowing up to 99 hours and 59 minutes.
4. After entering data and test conditions, the controller features a screen lock function to prevent shutdown due to accidental human touch.
5. Features P.I.D automatic calculation function, allowing for immediate adjustment of temperature and humidity change conditions, ensuring more stable temperature and humidity control.
6. Equipped with RS-232 or RS-485 communication interfaces, programmable on a computer for monitoring test processes and executing on/off operations.
Compliance and Standard Achievement:
Guidelines for Stability Testing of Medicinal Products in the 2015 Edition of the Pharmacopoeia and relevant clauses of GB/T10586-2006
★ Stability Test Conditions:
In the ICH guidelines, GMP and FDA define requirements in terms of functionality, performance, and documentation. Europe, Japan, and the United States agree to establish a common stability testing protocol, with the aim of consolidatingInformation, as a recommendation for the stability of raw materials or pharmaceuticals, aims to demonstrate the efficacy of drugs exposed to temperature, humidity, light, or a combined environment over a specified period.
