Advanced Technology from Germany — A Reliable Choice for Pharmaceutical Stability Testing
This new generation of pharmaceutical stability test equipment combines the company’s years of design and production experience with adopted German technology.
Overcomes the limitation of existing domestically produced pharmaceutical test chambers that cannot operate continuously for extended periods. It is essential equipment for pharmaceutical-factory GMP certification.
Application Overview
Scientifically establishes long-term stable temperature, humidity and lighting conditions for drug shelf-life evaluation. Suitable for accelerated, long-term, high-humidity and intense-light exposure tests of medicines and new drugs in pharmaceutical companies, it provides a reliable solution for pharmaceutical stability testing.
Product Features
User-Friendly Design
- New CFC-free design offers high efficiency and low energy consumption to promote energy savings and keep you at the forefront of healthy living;
- A microcomputer controller provides stable, accurate, reliable control. The 304 stainless-steel chamber has rounded corners for easy cleaning and convenient operation;
- Air-duct circulation ensures uniform chamber airflow. A 25mm-diameter test port is provided on the left side;
Continuous Operation
- Two imported compressors switch automatically to ensure prolonged continuous pharmaceutical testing without faults, overcoming the limitation of domestically produced pharmaceutical test chambers that cannot operate continuously for extended periods;
- Continuous operation requires no defrosting, avoiding chamber temperature and humidity fluctuations caused by defrosting during use;
Quality Assurance
- Key components, including the temperature/humidity controller, compressors and circulating fan, are imported for stable, safe, reliable operation over extended periods;
Safety Functions
- An independent temperature-limit alarm system provides audible and visual warnings, ensuring safe laboratory operation without accidents;
- Low-temperature, high-temperature and overtemperature alarms, plus high- and low-humidity alarms;
- Password-protected screen locking prevents incorrect operation by non-laboratory personnel;
Imported Humidity Sensor
- A humidity sensor suitable for high-temperature operation avoids frequent replacement of wet-bulb wicks;
UV Sterilization System (Optional)
- The UV sterilization lamp on the rear chamber wall periodically disinfects the interior, effectively killing airborne bacteria in the circulating air and water vapor from the humidification tray, preventing contamination during pharmaceutical testing;
Automatic Illuminance Monitoring and Control (Optional)
- Overcomes the inability of existing domestically produced stability chambers to monitor and control illuminance. An optical sensor provides monitoring and stepless adjustment, reducing illuminance decay and test errors caused by lamp aging;
Data Recording and Fault-diagnosis Display
- If the test chamber develops a fault, the dynamic display shows clear operating fault information;
- A printer or 485 communication interface can be connected to record temperature and time curves using a computer and printer, supporting storage and playback of experimental data;
Programmable Touchscreen Controller
- The large touchscreen is easy to operate and program;
- Chinese and English controller interfaces are selectable, and real-time operating curves can be displayed on the screen;
- Capacity for 100 program groups, 1000 segments and 999 cycle steps, with a maximum time setting of 99 hours 59 minutes per segment;
- After data and test conditions are entered, screen locking prevents shutdown caused by accidental touch;
- P.I.D automatic calculation immediately corrects temperature and humidity change conditions for more precise, stable control;
- An RS-232 or RS-485 communication interface allows programs to be designed on a computer, testing to be monitored, and start-up, shutdown and other functions to be performed;
Applicable Standards
Manufactured according to the 2020 Pharmacopoeia guidelines for pharmaceutical stability testing and relevant clauses of GB/T10586-2006.
- Accelerated testing: 40°C ±2.0°C / 75%RH±5%RH, or 30°C ±1.0°C / 60%RH±5%RH, 180 days
- Long-term testing: 25°C ±2.0°C / 60%RH±5%RH, or / 30°C ±2.0°C / 60%RH±5%RH, 365 days
- For accelerated testing of pharmaceutical preparations packaged in semipermeable containers, such as infusion bags made from low-density polyethylene, plastic ampoules and containers for ophthalmic preparations, tests should be performed at 40°C±2°C / 25% [unclear sign] 5%RH.
- For long-term testing of pharmaceutical preparations packaged in semipermeable containers, tests should be performed at 25°C [unclear sign] 2°C / 40%±5%RH or 30°C [unclear sign] 2°C / 35% [unclear sign] 5%RH.
- Intense-light exposure testing: 4500±500LX, 10 days
Technical Specifications
| Name / Technical Specification | Pharmaceutical Stability Test Chamber | Combined Pharmaceutical Stability Test Chamber | Pharmaceutical Intense-light Stability Test Chamber | |
|---|---|---|---|---|
| Model | LHH-80SD LHH-150SD LHH-250SD |
LHH-80SDP LHH-150SDP LHH-250SDP |
LHH-150GSD LHH-150GSP LHH-250GSD LHH-250GSP |
LHH-150GP LHH-250GP LHH-400GP |
| Temperature Control Range | 0~65°C | 0~65°C (15~50°C with lighting) | ||
| Temperature Fluctuation / Uniformity | ±0.5°C/±2°C | |||
| Humidity Range / Deviation | 25~95%RH/±3%RH | Not provided | ||
| Light Intensity / Error | Not provided | 0~6000LX adjustable, ≤±500LX (stepless dimming) | ||
| Timer Range | 1~99 hours per segment | |||
| Temperature and Humidity Regulation Method | Balanced temperature and humidity regulation | Balanced temperature regulation | ||
| Refrigeration System / Method | Two independent original imported hermetic compressors with automatic changeover (LHH-80SD/80SDP has one independent original hermetic compressor unit) | |||
| Controller | Programmable Touchscreen Controller | |||
| Sensor | Pt100 platinum resistance sensor; capacitive humidity sensor | Pt100 platinum resistance sensor | ||
| Ambient Operating Temperature | +5~30°C | |||
| Power Supply | AC 220V±10% 50HZ | |||
| Operating Power | Approx. 650W / 680W / 750W | Approx. 680W / 680W / 750W / 750W | Approx. 450W / 450W / 600W | |
| Rated Power | 2000W/2800W/3000W | 2950W/2950W/3200W/3200W | 1450W/1700W/3200W | |
| Capacity | 80L / 150L / 250L | 80L / 150L / 250L | 150L / 250L | 150L / 250L / 400L |
| Chamber Dimensions (mm) W×D×H | 400×400×500 550×405×670 600×500×830 |
400×400×500 550×405×670 600×500×830 |
550×405×670 600×500×830 |
550×405×670 600×500×830 700×550×1140 |
| Overall Dimensions (mm) W×D×H | 550×790×1080 690×805×1530 740×890×1680 |
550×790×1080 690×805×1530 740×890×1680 |
690×805×1530 740×890×1680 |
690×805×1530 740×890×1680 950×850×1850 |
| Sample Trays (Standard) | 2 / 3 / 3 shelves | 2 / 3 / 3 shelves | 3 / 3 shelves | 3 / 3 / 4 shelves |
| Built-in printer | Standard | Standard | Standard | Standard |
| Safety Devices | Compressor overheating protection, fan overheating protection, overtemperature protection, compressor overpressure protection, overload protection and water-shortage protection. | |||
| Remarks | 1. 485 interface and built-in printer standard 2. USB interface and wireless alarm system standard on SDP/GSP; optional on SD/GSD/GP series 3. GP/GSD/GSP series: manual stepless dimming, standard illuminance monitor and built-in top lighting 4. Optional double-tier lighting for GP/GSD/GSP series 5. LHH-80SD and LHH-80SDP have one independent original imported hermetic compressor unit. |
|||
Note: Operating power is measured under stable operating conditions of 25°C and 65%RH.