Introduction of Pharmaceutical Stability Test ChamberThe pharmaceutical stability test chamber is suitable for the stability test and verification of
Free QuoteThe pharmaceutical stability test chamber is suitable for the stability test and verification of drugs and new drugs by pharmaceutical companies and drug research institutes. With reference to the Chinese Pharmacopoeia Appendix XIX C Guidelines for Drug Stability Test, GB/T10586-89.GB/T40326-2021 and ICH Q1A, the design and manufacture are designed and manufactured in a scientific way to simulate a long-term stable test required for drug expiration date evaluation. Working temperature, humidity and light environment are necessary equipment for pharmaceutical companies to pass GMP certification.
The pharma stability test chamber is an instrument used to measure the long-term stable temperature, humidity, and light environment required for drug failure evaluation. It is suitable for the accelerated test, long-term tests, high-temperature tests, and high humid tests of drugs and new drugs by pharmaceutical companies. It is the best choice for pharmaceutical companies to conduct drug stability tests.
| Stability Test Conditions | Time | |
| High humidity test | 25℃ ±2.0℃ 90%RH±5%RH OR 25℃ ±1.0℃ 75%RH±5%RH | 10 days |
| Accelerated testing | 40℃ ±2.0℃ 75%RH±5%RH OR 30℃ ±1.0℃ 60%RH±5%RH | 180 days |
| long term test | 5℃ ±2.0℃ 60%RH±5%RH | 365 days |
| High-temperature test | 40℃ 60℃ | 10 days |
| Test name | Test conditions | Time | Note |
| Influencing factor test | 10℃-75℃ | / | / |
| Light Stability Test | 1. Daylight standard: ISO10977 | / | For preparations removed from inner and outer packaging For the removal of the outer packaging of the preparation Formulation testing for marketing packaging |
| 2. The total illumination is not less than 1.2*106Lux/hr | |||
| 3. Near-ultraviolet energy is not less than 200w/hr/㎡ | |||
| 4. Spectral range: 320-400nm (with maximum emission energy at 350-370nm) | |||
| Accelerated test | 40°C ± 2°C / 75% RH ± 5% RH | 6 month | Influence on the quality of raw materials (as might happen during transport) |
| Intermediate condition: 30°C±2°C/65%RH±5%RH | |||
| Refrigerated storage: 5°C ± 3°C (API) accelerated | 12 month | ||
| Test conditions are 25°C ± 2°C/60%RH ± 5%RH | |||
| Long term trial | 25°C ± 2°C/60%RH ± 5%RH or 30°C ± 2°C / 65% RH ± 5% RH | / | / |
| Test name | Test Item | Test conditions | Time | Note |
| Impermeable or semi-permeable preparations for easy packaging | Long term trial | 25°C±2°C/40%RH±5%RH OR 30°C±2°C /35%RH±5%RH | 12 months for new formulations | Water loss ratio |
| Generic preparation 6 months | ||||
| Intermediate test | 30 ° C ± 2 ° C / 65% RH ± 5% RH | 6 month | ||
| Accelerated test | 40°C±2°C/ No more than (NMT)25%RH | 6 month | ||
| Refrigerated preparations | Long term trial | 5°C±3°C | 12 month | If the preparation to be refrigerated is packaged in semi-permeable containers, a low-temperature test under appropriate temperature conditions should also be carried out to evaluate its water loss |
| Accelerated test | 25 ° C ± 2 ° C / 60% RH ± 5% RH | 6 month | ||
| Frozen storage reagents | Long term trial | – 20°C±5°C | 6 month | Understand the impact of short-term deviations from labeling/label storage conditions on the quality of the product |
| Temperature range | 0-60℃ |
| Temperature fluctuation | ±0.5℃ |
| Temperature deviation | ±1.5℃ |
| Humidity range | 30-95%RH |
| Humidity Fluctuation | ±2%RH |
| Humidity deviation | ±3%RH |
| Light intensity | 500-8000Lux (optional） |
| Illumination error | ±500Lux |
| UV irradiance | 80-100uw/cm2 (optional） |
| UV spectral range | 320-400nm |
| Volume | 150L-2000L |
| Sample rack | 2 pc |
| Safety devices | Compressor overload protection, humidification tube dry burning protection, over-temperature protection, electrical short circuit protection, etc. |
| Standard accessories | 1 pump, 1 water tank, 2 sample shelves, 1 50mm cable lead hole |
| Standards and Test Methods | Comply with the accelerated, long-term, intermediate, and high humidity tests in the National Pharmacopoeia, FDA, ICH, and other relevant standards. |
| It also meets the 40°C, 20%R.H, 25°C, 20%R.H low-humidity tests for special drugs such as large infusions. | |
| Meet ICH: Q1B total illumination ≥1.2×106LUX.Hr. | |
| Strong light exposure test 4500LUX±500LUX meets the 2010 guidelines for chemical stability | |
| Equipment use environmental conditions | Ambient temperature: 5-35℃ |
| Ambient humidity: ≤85%R.H | |
| No strong vibration around the device | |
| No flammable, explosive, corrosive substances and dust around the equipment |
| Outer box material | The outer box is processed and formed by high-quality A3 steel plate CNC machine tools, and the surface of the shell is sprayed to make it more smooth and beautiful; |
| Interior material | The inner chamber material uses mirror SUS304B board, which has the characteristics of acid resistance, corrosion resistance, and easy cleaning; |
| Sample holder | The SUS304 sample holder can be adjusted up and down as needed; |
| Test hole | The 50mm test lead hole is on the left side of the studio, and the hole cover can be opened when in use; |
| Door | It adopts a single door design and has a double-layer design inside and outside. The interior is full-size glass, and a double-layer silicone rubber sealing strip is used between the door and the box, which is resistant to high and low temperature, anti-aging, and has good sealing performance. In order to prevent condensation or frost on the door frame and the edge of the door during the low-temperature test, the door frame and the edge of the door are provided with electric heating defrosting device. Single door/double door can be customized |
| Insulation Materials | The use of high-quality door magnetic seals and thermal insulation materials makes the performance of the whole machine superior; thickness 100-200mm optional |
| Air duct circulation system | Since the experimental equipment is professionally designed according to historical experience, it has a reasonable air duct circulation system, so that the temperature and humidity in the box can reach the highest uniformity; |
| Door handle | Adopt a flat non-reaction handle, easy to operate, safe, and reliable; |
| Observation window | The door of the test room is provided with a visual size: of 400×300mm ( width×height) hollow resistive film heating and a frost-proof observation window. The large observation window is equipped with lighting to keep the inside of the box bright, and the tempered glass embedded in the heating body is used to clearly observe the situation in the box at any time. |
| Water tank | The humidification system pipeline is separated from the control circuit board, which can avoid failure due to water leakage in the humidification pipeline and improve safety. |
| Control panel | Full English operating system, touch screen control panel, human-machine friendly, simple, and easy to operate |
| Audible alarm | Equipped with an alarm device to remind when the equipment fails. Once the protection system is installed on the equipment, the equipment will stop running, an audible and visual alarm will be issued, and the fault location and its causes and solutions will be displayed on the instrument. |
| Door lock | With a door lock, it can control the personnel who come into contact with the test equipment |
| Foma Wheel | Can be moved and adjusted in height |
| Temperature and humidity sensor | Adopt electronic sensor, high precision, meet standard requirements, and meet experimental requirements |
| Basic functions | 1. It can be set: product name, power-on time, temperature and humidity, power-off time, |
| 2. With customized temperature and slope setting function | |
| 3. With hold, skip, standby, and two sets of time signal output functions | |
| 4. With temperature display value correction function | |
| 5. With temperature and humidity sensor correction function (with automatic calibration function to ensure the accuracy of the test) | |
| 6. With compressor automatic stop function | |
| 7. With scheduled start/stop operation function | |
| 8. With the function of pause recording | |
| 9. With power failure memory function | |
| Other functions | 1. Password protection: the first level password is the open and close gate |
| The secondary password is the temp humid setting | |
| The third level password is the software system password | |
| 2. Backlight: Set the automatic turn-off time of the backlight, | |
| 3. Display the operating curve of temperature and humidity | |
| 4. Click to enlarge and shrink the graph | |
| 5. Display language: English | |
| 6. Network function, IP address can be set; the chamber can be remotely controlled | |
| USB record | The control instrument has a USB interface (test data can be copied as needed) |
| The meter can automatically store data for 6 months, plus 10G of USB memory, the storage time can reach more than 3 years | |
| 1. You can choose to save the curve to the U disk | |
| 2. You can choose to save the data to the U disk | |
| 3. When the interval for saving data can be set | |
| 4. The form can be printed through computer software |
Safe and reliable grounding protection device;
Various protection devices for time delay, overheating, overcurrent and overvoltage
Over-temperature protection of the working room; water shortage protection of the humidifier;
The compressor has a thermal starting power. When the equipment encounters a power failure, the machine control system maintains historical data temperature and humidity curve data. When the power is restored, the equipment automatically starts and continues to run the current temperature and humidity set value and the remaining time that has not been completed;
Equipped with an external lock system to manage access rights, internal door opening and reverse unlocking function, and internal emergency call sound and light alarm function;
heater short circuit and overload protection;
This equipment is equipped with an emergency stop button
3 user mobile alarms (optional)
AC220V 50HZ Single-phase three-wire system, single-phase 220V
Can adapt 110V, 230V, 240V, 360V, 380V, 415V, etc
