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Scalable test box
Using scientific and rigorous methods to simulate the long-term stable temperature, humidity, light, and UV environment required for drug failure asse
Product details
Product Name: Expandable Test Chamber
model: BXS-1600SI
Using scientific and rigorous methods to simulate the long-term stable temperature, humidity, light, and UV environment required for drug failure assessment, suitable for pharmaceutical companies to conduct factor tests, accelerated tests, and long-term tests on raw materials and finished drugs
Design features:
The basic model is a fully temperature controlled model, and humidity control system, lighting control system, and ultraviolet control system can be added according to different customer needs. Corresponding to different configurations: biochemical incubator, constant temperature and humidity incubator, mold incubator, drug stability test chamber, drug strong light stability test chamber, comprehensive drug stability test chamber.
Basic features:
7-inch high-definition touch screen, touch based operation, making the display more intuitive and the operation simpler;
BRIGHT II intelligent operating system can automatically compensate for control parameter values according to environmental changes;
Programmable multi segment parameter setting: 30 segments with 99 cycles design;
Comes with data management function: The controller can store data records for more than 10 years (non SD card storage), and can view instrument temperature record data or curves in real time. It also supports exporting data in an immutable file format using a USB flash drive for viewing and backup, and can trace data;
Comes with event management function: The control system can record device events with exact time, such as startup, shutdown, door opening, door closing, menu parameter setting and modification, fault alarm, etc., making it easy for customers to clearly grasp the device's operating status. It also supports exporting in an immutable file format using a USB flash drive for viewing and backup, and tracing data;
Permission grading management function: Administrators can customize and assign all device operation permissions (the device has 14 different operation functions) to 5 operators, and each operator's operation will generate a unique traceable imprint in the event record;
The equipment comes with a circulating air volume adjustment system, which can manually adjust the circulating air volume according to the sample loading situation to ensure that the equipment reaches a good operating state;
Equipped with multi-level password management function to prevent arbitrary operations;
Variable frequency refrigeration system, with fast temperature recovery after opening the door, and can ensure long-term frost free and stable operation of the equipment under non extreme conditions;
Equipped with an inner door anti fog system, it avoids affecting sample observation when opening the outer door for observation, and greatly reduces the risk of condensation and dew on the inner door;
Improve protection functions: upper and lower limit over temperature alarm, over temperature shutdown protection, door opening alarm, sensor fault alarm, overload protection, leakage protection, compressor over temperature protection.
Meet the requirements for stability testing of new active pharmaceutical ingredients, active pharmaceutical ingredients, and formulations in the 2020 edition of the Chinese Pharmacopoeia and ICH guidelines (including impact factor testing, long-term testing, accelerated testing, etc.)
Reference standard GB/T 10586-2006
Core components:
Adopting imported energy-saving and environmentally friendly compressors, imported high-performance fans, and imported high-precision temperature sensors.
Structural features:
Double layered door design with panoramic tempered glass observation inner door to avoid parameter fluctuations during sample observation;
One USB interface, one RS232 interface, and one RS485 interface are configured for the device;
Standard mechanical lock to prevent unauthorized opening of doors;
Standard embedded printer;
Equipped with a detachable compressor condenser maintenance window, convenient for customers to regularly clean the condenser;
Equipped with an internal door condensate water recovery system and a cavity condensate water recovery system;
The inner cavity adopts a rounded design for easy cleaning;
The shelf adopts a drawer style structural design, which allows for arbitrary positioning and facilitates sample loading and sampling;
There is a verification hole with an inner diameter of 3cm on each side of the device, which is convenient for customers to wire during the measurement or verification process;
The door seal adopts advanced magnetic sealing structure, which has good sealing effect and is easier to operate than mechanical buckle sealing structure when opening and closing the door.
Basic technical specifications:
model: BXS-1600SI
Temperature control range: 0 ℃ -85 ℃ (without humidity), 10-60 ℃ (with humidity)
Resolution: 0.1 ℃
Volatility (at 25 ℃): ± 0.3 ℃
Uniformity (at 25 ℃): ± 1 ℃
Input power: 2700W
Timing range: 30 segments with 99 cycles/1-9999 hours per segment
Inner container size (length x width x height) (mm): 1400 x 850 x 1350
Dimensions (length x width x height) (mm): 1562 x 1220 x 2040
Load carriers (standard/maximum): 4/12 pieces
Freight information:
Gross weight (kg): 620
Net weight (kg): 440
Outer packaging dimensions (mm) length x width x height: 1640 x 1360 x 2300
Scalable system:
| name | configuration | characteristic |
| Humidity control system | Imported high-precision humidity sensor, water level sensor, humidification water tank, humidification electric heating tube and other complete humidity control systems | The humidification system is an independent surface evaporation humidification system outside the chamber, which has the characteristics of low failure rate, good stability, and easy maintenance; Wide humidity control range, small volume: 15% -98%, large volume: 20-98%; Real time viewing of instrument temperature and humidity record data; Equipped with automatic water replenishment function, water shortage alarm function, and power-off function; Humidity upper and lower limit alarm function. |
| Lighting control system | Shelf type lighting module: including a complete set of lighting control modules such as lighting sensors, driver modules, and a set of shelf type lighting systems. Multiple sets can be individually controlled (up to four sets) | Adopting a shelf type light source (one light probe per layer, with separate display and control of light intensity for each layer, without interference), to avoid the problem of uneven light exposure of the test samples, and the height of the layer lighting board can be adjusted arbitrarily; Using high-end imported light sensors, real-time monitoring and accumulation of actual light reception values of the test samples are carried out to ensure the repeatability of experiments affected by single factors of light; The light intensity adopts stepless regulation setting, which can directly set the light intensity according to the required light value; Real time display of light intensity value instrument, supporting printing; The total illumination of the light test in accordance with the technical guidance principles for stability research of chemical drugs (active pharmaceutical ingredients and formulations) shall not be less than 1.2 × 106Testing requirements for Lux · hr. |
| Shelf type lighting source | The light intensity is automatically adjusted by the lighting module and cannot be displayed or printed | |
| UV control system | Shelf type UV module: including a complete set of UV control modules such as UV amplitude sensor, driver module, and a set of shelf type UV system. Multiple sets can be individually controlled (up to four sets) | Adopting a shelf type light source (with one UV radiation value probe on each layer, each layer's UV radiation value is displayed and controlled separately without interfering with each other), to avoid the problem of uneven light exposure of the test sample, and the height of the layer illumination plate can be adjusted arbitrarily; Using high-end imported ultraviolet radiation sensors, real-time monitoring and accumulation of actual near ultraviolet reception values of test samples are carried out to ensure the reproducibility of experiments affected by single factors of near ultraviolet radiation; The UV radiation value is set with stepless regulation, and the controller is equipped with a UV radiation value total calculator. When the total value is reached, the UV lamp will automatically turn off; Real time display of ultraviolet radiation value instrument, supporting printing; According to the technical guidance principles for stability research of chemical drugs (active pharmaceutical ingredients and formulations), the total amount of near ultraviolet energy should not be less than 200w · hr/m2The experimental requirements. |
| Shelf type UV light source | The UV radiation value is automatically adjusted by the UV module and cannot be displayed or printed |
Technical parameters for humidity expansion:
Moisture control range: 20% -98%
Humidity fluctuation: ± 3%
Input power: 3300W
Note: The temperature control range, resolution, fluctuation, uniformity, timing range, inner container size, external dimensions, and load carrier are the same as the basic model.
Light (UV) extension technical parameters:
Temperature control range: 0-85 ℃ in the absence of light, 10-85 ℃ in the presence of light
Illumination range: 0-10000 Lux (infinitely adjustable)
Illuminance deviation: ± 500Lux
UV amplitude value: 0-2W/m2
UV spectral range: 320-400nm
Input power: 3050W
Shelf type lighting (UV) (maximum) (including at least 1 set of modules): 4 sets
Note: The resolution, fluctuation, uniformity, timing range, inner container size, external dimensions, and loading bracket are all the same as the base model.
The UV amplitude value and UV spectral range parameters are applicable to the UV extended version.
Humidity+Light (UV) Extended Technical Parameters:
Temperature control range: 0-85 ℃ when there is no humidity or light, 10-85 ℃ when there is no humidity or light;
10-60 ℃ when there is humidity and no light, 15-60 ℃ when there is humidity and light;
Moisture control range: 20% -98%
Humidity fluctuation: ± 3%
Illumination range: 0-10000 Lux (infinitely adjustable)
Illuminance deviation: ± 500Lux
UV amplitude value: 0-2W/m2
UV spectral range: 320-400nm
Input power: 3650W
Shelf type lighting (UV) (maximum) (including at least 1 set of modules): 4 sets
Note: The resolution, fluctuation, uniformity, timing range, inner container size, external dimensions, and loading bracket are all the same as the base model.
The UV amplitude value and UV spectral range parameters are suitable for humidity+UV extension.
Note: Working environment temperature: 10-30 ℃ Working power supply: 220V±10V 50/60Hz
Optional accessories:
| name | describe | |
| Humidity control module | Including humidity control system and complete set of humidification accessories | |
| Shelf type module | Single light illumination | Including a complete lighting control system and a set of shelf style lighting modules |
| Single Purple Outside | Including a complete UV control system and a set of shelf mounted UV modules | |
| Illumination UV | Including a complete set of UV lighting control system and a set of shelf type UV lighting modules | |
| Shelf type light source | Single light illumination | The illuminance is automatically adjusted by the lighting module and cannot be displayed or printed |
| Single Purple Outside | The UV value is automatically adjusted by the UV module and cannot be displayed or printed | |
| Illumination UV | The illuminance and UV value are automatically adjusted by the UV module, and cannot be displayed or printed | |
| monitoring software | FDA version | Can meet FDA requirements |
| GMP version | Can meet GMP requirements | |
| Additional shelves | In addition to the standard shelves, optional shelves are also required | |
| GPRS SMS alarm | After the alarm is generated, send the alarm status SMS to the designated mobile phone | |
| 3Q verification file | Provide 3Q validation documents that comply with GMP requirements | |
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