Pharmaceutical Stability Test Chamber
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Pharmaceutical Stability Test Chamber
The drug stability environmental testing chamber is one of the core testing equipment in the pharmaceutical industry, designed to simulate various extreme or specific environmental conditions, evaluate the stability and safety of drugs throughout their entire life cycle of storage, transportation, and use. Its core value lies in providing scientific and reliable experimental data for drug development, quality control, and compliance review by accurately replicating changes in key environmental parameters such as temperature, humidity, and lighting.
| Active Pharmaceutical Ingredient (API) Testing | |||
| Test Name | Test Conditions | Duration | Замечания |
| Influencing Factors Test | Above 10°C (e.g., 50°C, 60°C, etc.) 75% RH or higher (e.g., 90% RH, etc.) | ||
| Photostability Test | Daylight Standard: (ISO10977)(1993) Total illuminance not less than 1.2×106 Lux- hr near-ultraviolet energy not less than 200w•hr/m2. Wavelength Range: 320 ~ 400nm (with Maximum Emission in 350 ~ 370nm)
| Test on Active Pharmaceutical Ingredient or on Formulation without Inner Packaging (if needed); Test on Formulation without Outer Packaging (if needed); Test on Marketed Packaged Formulation;
| |
| Accelerated Test | 40°C+2°C/75%RH+5%RH | 6months | Refrigerated Storage: 5°C±3°C (API); Accelerated Impact on API Quality (e.g., Possible |
| Intermediate Conditions: 30°C±2°C/65% RH±5% RH | 12months | ||
| Long-term Test | 25°C+2°C/60%RH+5%RH 30°C+2°C/65%RH+5%RH | ||
| Formulation Testing | |||
| Test Name | Test Conditions | Duration | Замечания |
| I. Formulations Packaged in Non-Permeable or Semi-Permeable Containers: Water Loss Ratio | |||
| Long-term Test | 25℃±2C/40%RH±5%RH or 30C±2C/35%RH±5%RH | New formulation: 12 months; Generic formulation: 6 months | |
| Intermediate test | 30°C+2°C/65%RH+5%RH | 6months | |
| Accelerated Test | 40°C+2°C/25%RH+5%RH | 6months | |
| II. Refrigerated Preparations: If refrigerated preparations are packaged in semi-permeable containers, they should also undergo low humidity testing under appropriate temperature conditions to assess water loss. | |||
| Long-term Test | 5℃±3℃ | 12months | |
| Accelerated Test | 25°C+2°C/60%RH+5%RH | 6months | |
| III. Frozen Storage Formulations: Understand the impact of short-term deviations from the storage conditions specified in instruction/label on the quality of the preparation. | |||
| Long-term Test | -20°C+5°C | 12months | |
- Temperature and Humidity Controller:
Original imported color touch screen controller, program-controlled with 5-inch or larger screen and three-level authorization password. Able to store temperature and humidity values for over 5 years.
- Humidity Sensor:
Imported VAISALA capacitive humidity sensor with direct measurement and maintenance-free operation;
- Refrigeration Compressor:
Original imported fully enclosed compressor for long service life
- Data Printing:
Capable of printing equipment model and serial number, as well as real-time temperature and humidity values and curves.
- On-site Alarm:
On-site temperature and humidity deviation with audible and visual alarm; Independent
Over-temperature alarm.
- Remote Alarm:
Remote SMS alarm (including power outage alarm), multiple devices can share a single SIM card;
- Over-temperatureProtection:
Equipped with double insurance dry-burn protection system. Equipped with an independent over-temperature protection system that automatically cuts off the power supply;
- Door Lock:
Equipped with a key lock to prevent unauthorized personnel from accessing the pharmaceuticals and affecting the test.
- Mobility:
Four casters, lockable.
- Visibility:
Observe the test samples through the inner glass door, minimizing changes to the experimental data.
- Validation:
Provide IQ/OQ/PQ validation scheme documents and execution services in compliance with international standards.
■FOB
■CIF
■Package: Wooden case
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