Semiconductor refrigeration/pharmaceutical stability tester

Product Description

Model:
BEHM-100
BEHM-250
BEHM-500

With scientific method to create a long time stable temperature, humidity environment and light environment for drug failure evaluation, it is suitable for accelerated test, long term test, high humidity test and strong light irradiation test of drugs and new drugs by pharmaceutical enterprises, and it is a reliable choice for pharmaceutical enterprises to carry out drug stability test. It is a reliable choice for pharmaceutical companies to carry out stability tests. The product meets the technical requirements of the latest national GMP certification, and also meets the international standards (Q1A and Q1B) for the stability tests of new APIs and preparations.

Humanized design

Microcomputer controller, intelligent touch control, real-time display of parameters, simple and convenient operation, stable, accurate and reliable control;
● Unique air duct circulation to ensure uniform distribution of wind speed inside the studio;
Temperature and humidity controllers, circulating fans and other key components are all well-known brands, with a long period of continuous operation of stable, safe, reliable and so on;

Structural advantages

● The inner liner of the box is made of 304 stainless steel, the corners of the half-arc transition design, smooth and easy to clean, no dead ends;
● The insulation layer adopts the overall foaming process, which has better heat preservation performance and less energy loss;

Color Touch Screen Controller

● Adopting a large touch screen controller with simple interface operation and easy program editing;
● The controller operation interface is available in English and Chinese, and the real-time operation curve can be displayed on the screen;
● Has 8 program segments of 24 steps each, with a set maximum value of 99 hours and 59 minutes per segment;
● After data and test conditions are input, the controller has a locking function to avoid stopping by human touch;
● With P.I.D automatic calculation function, it can correct the temperature and humidity change conditions immediately, so that the temperature and humidity control is more accurate and stable;

Semiconductor refrigeration technology (Peltier)

● Semiconductor refrigeration technology, with high refrigeration efficiency, energy consumption is greatly reduced and other advantages, compared with the compressor refrigeration energy consumption decreased by more than 85%;

Lighting system (optional)
● Low heat dissipation brushless DC motor, large starting torque, wide speed regulation, maintenance-free, breaking through the existing domestic oscillator can not run continuously for a long time defects; ● Light system in line with the requirements of the relevant standards of the ICH Q1A and Q1B, visible light (VIS), ultraviolet (UV) and mixed light system, and can be set at each shelf level of different light intensity, the intensity of the light stepless adjustable between 0 ~ 100%. The light intensity is infinitely adjustable from 0 to 100%;
● The lighting system is a shelf-type lighting, including visible light lamps and UV lamps, visible light lamps and UV lamps can be controlled individually, or you can choose a single layer or double layer of visible light lamps or UV lamps; can be adjusted to the height of the loaded samples shelves in the working chamber. ( Standard with single-tier light source)

Professional UV lamp (optional)

● Professional UV lamps meet ICH requirements for light stability testing of Q1B new APIs and new formulations, and are characterized by consistent quality and uniform spectral power compared to other UV lamps, as well as a spectral power distribution of the light source that does not degrade as the lamp ages, with the benefit of being able to reproduce a greater number of test results;
● Select UV lamp bases that can operate under high humidity;

Light irradiance display monitoring and control (optional)
:: Breaking through the defects of the existing drug stability test chamber irradiance can not be displayed and monitored, to reduce the visible light and ultraviolet lamp due to lamp aging caused by irradiance attenuation, resulting in drug stability test errors. We also provide visible and UV light measurement probes with light sensors and third-party certified irradiance monitors for easy observation and calibration;
Imported Humidity Sensor
● Adoption of capacitive humidity sensor, which can operate at high temperature, avoiding the trouble caused by frequent replacement of wet and dry bulb wet belt;
Data protection function (GMP compliant)
● The device has a screen lock function, and the user can set a password to protect the experimental data from being misused;
● The equipment is compatible with the data interface of the comprehensive equipment management platform of pharmaceutical enterprises, and is able to provide the data access, audit trail and electronic signature data requirements of pharmaceutical enterprises in accordance with GMP and other foreign system review requirements;
● The equipment can trace the data information during the operation of the test chamber, such as operation data, fault data and modification data, providing a strong guarantee for the storage and playback of test process data;
● The equipment is equipped with a micro-printer as standard in accordance with GMP requirements, in order to achieve real-time data printing and non-modifiable food and drug system review requirements;
hierarchical rights management

● Multiple assignable accounts, according to the needs of equipment management, the equipment controller operating privileges can be assigned to the administrator, operator, visitor three levels of authority accounts. The touch screen also supports Chinese and English inputs, and the system can be logged in according to the actual name of the operator. At the same time, the system also has an operation log query function to record the detailed operation logs of each user, which is convenient for equipment operation and maintenance management and audit trail;
Electronic signature function
● The electronic signature function allows real-time printing of electronic signatures based on the login information of the current logger, and the printout file reflects the current device number, time, and other information;
safety function
Protection of equipment:
● The second set of temperature limit alarm system in line with international standards automatically cuts off the heating when the heating is out of control or exceeds the maximum limit temperature, and alarms the operator to remind him/her; ensure the safe operation of the equipment without accidents;
Protection of critical components:
● Key electrical components are equipped with safety protection such as over-current, over-temperature, overload, etc., which can prevent the equipment from accidents;
Protection of samples:
● With the box temperature is higher than the set temperature, the alarm starts to cut off the heater, and sound and light to remind the operator, can protect the sample normal test, do not have accidents;
Protection of operational settings:
● Password-protected user control panel can be set to avoid misuse by non-experimenters;
Provide fault information:
● When a device malfunctions, a fault message appears on the display, ensuring that the fault message is clear at a glance;
Convenient data handling
● USB data transfer interface (USB flash disk) is equipped as standard, which is convenient for data processing;
● Optional RS485 data interface, through the RS485 port to download the data to the computer to save, there are faults can be timely access to information from the computer and diagnosis;

APP Remote viewing and monitoring (optional)
● Keep track of equipment remote status at all times, eliminating the need for weekend duty;
● Remote status of equipment from any location, eliminating the need for on-site duty;
● Any management personnel to grasp the equipment remote status in real time, improve the efficiency of equipment operation, can avoid accidents;
Paperless recorder (optional)
● Paperless recorder can be selected according to the experimental requirements, can independently display and save the data in the box, to meet the relevant requirements of GMP certification;
Wireless alarm system (SMS alarm system) (optional)
● If the equipment user is not on site, when the equipment fails, the system promptly collects the fault signal and sends it to the designated receiver's machine at the first time via SMS to ensure timely troubleshooting and resumption of the test to avoid losses;