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Nanchang Jiedao Scientific Instrument Co., Ltd

E-mail
3244592133@qq.com
Phone
15270926955
Address
1803-4, Building A, Mingzhu Plaza, No. 49 Jiefang West Road, Nanchang City, Jiangxi Province

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Boxun Drug Stability Test Chamber

NegotiableUpdate on 01/01

Model

Nature of the Manufacturer: Producers

Product Category

Place of Origin

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Overview

The Boxun Drug Stability Test Chamber simulates the long-term stable temperature, humidity, light, and UV environment required for drug failure evaluation using scientific and rigorous methods. It is suitable for pharmaceutical companies to conduct factor tests, accelerated tests, and long-term tests on raw materials and finished drugs.

Product Details

The Shanghai Boxun Drug Stability Test Box BXY-250I simulates the long-term stable temperature, humidity, light, and UV environment required for drug failure evaluation using scientific and rigorous methods. It is suitable for pharmaceutical companies to conduct factor tests, accelerated tests, and long-term tests on raw materials and finished drugs

The Shanghai Boxun Drug Stability Test Chamber is a precision experimental equipment used to simulate and precisely control environmental conditions such as temperature, humidity, and lighting. Its core purpose is to provide a long-term and stable storage environment for drugs during drug development, production, and quality control processes, in order to accelerate or real-time research on the stability and shelf life of drugs under various climatic conditions.

The main uses include:

Long term stability test:

Simulate the long-term storage of drugs under the storage conditions specified on the label (such as 25 ° C ± 2 ° C/60% ± 5% RH). This is the core basis for determining the expiration date of drugs.

Accelerated stability test:

Place drugs under more stringent conditions (such as 40 ° C ± 2 ° C/75% ± 5% RH) and predict their long-term stability and shelf life under normal conditions through short-term chemical and physical changes. This greatly shortens the research and development cycle.

Influencing factor test (strong destructive test):

To investigate the effects of single factors such as light, high temperature, and high humidity on drugs, with the aim of understanding the inherent stability and possible degradation pathways of drugs, and providing a basis for prescription, process, packaging, and storage conditions.

High temperature test: such as 60 ° C

High humidity test: such as 25 ° C/90% RH

Light test: Equipped with dedicated light sources (such as ultraviolet and visible light) to investigate light stability.

Intermediate condition test:

When there is a significant change in the results of the acceleration test, a supplementary test is conducted under conditions between long-term and acceleration (such as 30 ° C ± 2 ° C/65% ± 5% RH).

Applicable objects: not only chemical drugs, but also traditional Chinese medicine, biological products, active pharmaceutical ingredients, excipients, and final drug packaging materials.

Shanghai Boxun's drug stability test chamber technology is mature, and its design and performance are centered around meeting GMP/GLP regulatory requirements. The following is an analysis of the key technical points:

Core Systems and Technologies:

Temperature and humidity control system (core of the core):

Refrigeration system: Compressor units such as Tecumseh from France or Bock from Germany are usually used to ensure strong refrigeration and long-term reliability. The system is mostly a cascade refrigeration system to meet the needs of a wide temperature range (such as 0 ° C to 65 ° C).

Heating system: using finned or armored electric heating tubes, combined with PID intelligent control, for rapid and precise heating.

Humidification system: using boiler steam humidification, with fast humidification speed and uniform humidity control.

Dehumidification system: Using a compressor for cooling and dehumidification, the effect is stable and reliable.

Accurate control and display system:

Controller: High precision microcomputer PID controllers are often imported (such as OYO from Japan and Sanyuan from South Korea) or independently developed. Touch screen is the mainstream configuration, with intuitive operation.

Sensors: Platinum resistance PT100 is used as the temperature sensor, and capacitive polymer film humidity sensor is used as the humidity sensor to ensure the accuracy of data acquisition.

Uniformity and accuracy assurance technology:

Air duct circulation system: adopting forced circulation air design, ensuring the uniformity of temperature and humidity in the studio through high-performance centrifugal fans and carefully designed air ducts.

Air mixing technology: By using an internal fan to stir the air, temperature stratification and humidity blind spots can be avoided.

Security guarantee system:

Independent overtemperature protection: In addition to the built-in overtemperature alarm of the main controller, there is also an independent overtemperature protector that provides dual protection.

Leakage, short circuit, overcurrent protection: standard electrical safety configuration.

Water shortage protection: When the humidification water tank is short of water, it automatically cuts off heating and alarms to prevent dry burning and damage.

Data recording and audit tracking (model): It can be connected to a computer, record temperature and humidity data throughout the process through software, and has user permission management and audit tracking functions, complying with regulatory requirements such as FDA 21 CFR Part 11.

Features:

1. 4.3-inch LCD touch screen, touch operation, intuitive display, convenient operation;

2. BRIGHT I intelligent operating system can automatically compensate for control parameter values according to environmental changes;

3. Programmable multi segment parameter setting: 30 segments with 99 cycles design;

4. Data management function: The controller can store data records for more than 5 years (non SD card storage), and can view instrument temperature and humidity record data 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;

5. Event management function: The control system can automatically record device events with exact time, such as startup, shutdown, menu parameter settings and modifications, fault alarms, etc., making it convenient for customers to have a clear understanding of the device's operating status. It also supports exporting to a USB flash drive in an immutable file format for viewing and backup, and tracing data;

6. Multi level password management function to prevent arbitrary operations;

7. Variable frequency refrigeration system, with fast temperature and humidity recovery after opening the door, and can ensure long-term frost free and stable operation of the equipment under non extreme conditions;

8. 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;

9. The drug stability test box BXY-250I adopts imported energy-saving and environmentally friendly compressors, imported high-performance fans, and imported high-precision temperature and humidity sensors;

10. Using high-quality heating elements for surface evaporation humidification, it has the characteristics of low failure rate and good stability;

11. Improve protection functions: upper and lower limit over temperature and over humidity alarm, over temperature shutdown protection, door opening alarm, water shortage alarm, sensor fault alarm, overload protection, leakage protection, compressor over temperature protection, automatic water replenishment function, and power-off function.

Structural characteristics:

1. Double layered door design with panoramic tempered glass observation inner door to avoid parameter fluctuations during sample observation;

2. The device comes with a side mounted large capacity water storage tank, saving space and making it easy to add water;

3. One USB interface and one RS485 interface are configured for the device;

4. Standard mechanical lock to prevent unauthorized opening of doors;

5. Standard embedded printer;

6. Equipped with a detachable compressor condenser maintenance window, convenient for customers to regularly clean the condenser;

7. Equipped with an internal door condensate water recovery system and a cavity condensate water recovery system;

8. The inner cavity adopts a rounded design for easy cleaning;

9. 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;

10. 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.

Technical Specifications:

Model: BXY-250I

Temperature control range: 0-70 ℃ (without humidification), 10-60 ℃ (with humidification)

Resolution: 0.1 ℃

Volatility (at 25 ℃): ± 0.5 ℃

Uniformity (at 25 ℃): ± 1 ℃

Moisture control range: 25% -95%

Humidity fluctuation: ± 3%

Input power: 1950W

Timing range: 30 segments with 99 cycles/1-9999 hours per segment

Inner container size (length x width x height) (mm): 510 x 450 x 1090

Dimensions (length x width x height) (mm): 650 x 880 x 1724