Drug stability test chamber
发布时间:2020-08-18
The drug stability test box is suitable for the stability test and verification of drugs and new drugs by pharmaceutical companies and drug scientific research units. It is designed and manufactured in accordance with the guidelines for drug stability test in Appendix XIX C of the Chinese Pharmacopoeia and the relevant provisions of GB/T10586-89, and scientifically simulates a long-term stable working temperature, humidity and light environment required for evaluation of drug expiration dates. A necessary equipment for pharmaceutical companies to pass GMP certification.
Features
1. Humanized design, integrated microcomputer controller, stable, accurate and reliable control, 304 stainless steel liner, semi-circular arc shape at four corners, easy to clean and easy to operate.
2. Integrate unique air duct circulation to ensure uniform wind distribution inside the studio. There is a 25mm diameter test hole on the left side of the box.
3. Two sets of imported compressors are automatically switched to ensure that the drug test runs continuously for a long time without failure. Break through the defect that the domestic drug test chamber cannot be operated continuously for a long time.
4. There is no need to defrost for continuous operation, and avoid the fluctuation of temperature and humidity in the box due to defrosting during use.
5. The independent temperature limit alarm system can alert the operator with sound and light to ensure the safe operation of the laboratory without accidents. Low temperature or deviation and over temperature alarm.
6. Choose a humidity sensor that can operate at high temperature to avoid the trouble caused by frequent replacement of wet and dry bulbs.
7. When the test box fails, the dynamic display screen will show the fault information, and the operation failure of the test box is clear at a glance. It can be connected to a printer or 485 communication interface, and the temperature and time curve can be recorded by a computer and a printer, which provides a strong guarantee for the data storage and playback of the test process.
8. Adopt super large touch screen screen, simple screen operation and easy program editing.
9. The operation interface of the controller is available in Chinese and English, and the real-time operation curve can be displayed on the screen.
10. It has a capacity of 100 groups of programs, 1000 segments, 999 cycle steps, and the maximum value of each segment of time is 99 hours and 59 minutes.
11. With P.I.D automatic calculation function, the temperature and humidity changing conditions can be corrected immediately, making the temperature and humidity control more accurate and stable.
12. With RS-232 or RS-485 communication interface, programs can be designed on the computer to monitor the test process and perform functions such as switching on and off.
13. Implementation and meeting standards
The 2015 edition of the "Chinese Pharmacopoeia", the fourth general clause 9001 "Guiding Principles for Stability Testing of Raw Materials and Preparations" stipulates the requirements of relevant drug stability testing conditions.
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 agreed to designate a public stability test. The goal of these tests is to gather information as a recommendation on the stability of raw materials or medicines. The most comprehensive goal is to prove that the medicines are exposed to temperature and humidity during the prescribed period. , Illumination or effectiveness in a comprehensive environment.
14. Storage conditions for stability test of long-term retained samples:
Temperature: +25℃±2℃
Humidity: 60±5%RH
Duration: 12 months
Storage conditions for accelerated stability test
Temperature: +40℃±2℃
Humidity: 75±5%RH
Duration: 6 months
Illumination under strong light conditions: 4500±500LUX
2. Technical parameter requirements
| Product name | Drug stability test chamber (no light) | ||
| model | HS-80（SD、SDP) | HS-150(SD、SDP) | HS-250(SD、SDP) |
| Controller | SD is a programmable LCD controller, SDP is a programmable touch screen controller | ||
| Liner size（mm） | 400*400*500 | 550*400*670 | 600*500*830 |
| Dimensions（mm) | 550*790*1080 | 690*800*1530 | 740*890*1680 |
| Temperature control range | 0—60℃ | ||
| Temperature fluctuation/uniformity | ±0.5℃/±2℃ | ||
| Humidity range | 40—95%RH | ||
| Humidity deviation | ±3%RH | ||
| Light intensity/error | NO | ||
| refrigerating system |
Two sets of independent original fully enclosed imported compressors automatically switch
HS-80 (SD, SDP) is a set of independent original imported fully enclosed compressors
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| Temperature and humidity control method | Balanced temperature and humidity control method | ||
| sensor | Pt100 platinum resistance capacitive humidity sensor | ||
| power supply | AC 220V±10% 50HZ | ||
| power | 1900W | 2200W | 2400W |
| Pallet (block) | 2 | 3 | 3 |
| Embedded printer | Have | Have | Have |
| safety equipment |
Compressor overheating protection, fan overheating protection, over temperature protection, compressor over pressure protection,
Overload protection, water shortage protection.
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