Pharmaceutical Stability Test Chamber
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Pharmaceutical Stability Test Chamber
Specifically, a pharmaceutical stability test chamber serves as a core piece of testing equipment in the pharmaceutical industry. It simulates various extreme or specific environmental conditions. In doing so, it evaluates the stability and safety of drugs throughout their entire lifecycle – including storage, transportation, and use.
Moreover, the chamber’s core value lies in providing scientific and reliable experimental data for drug development, quality control, and compliance review. It achieves this by accurately replicating changes in key environmental parameters, such as temperature, humidity, and lighting. For example, ICH Q1A(R2) long-term and accelerated testing conditions can be precisely maintained.
| Active Pharmaceutical Ingredient (API) Testing | |||
| Test Name | Test Conditions | Duration | Observaciones |
| 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 | Observaciones |
| 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 | |
The temperature and humidity controller features an original imported color touch screen (5-inch or larger) with program-controlled operation and three‑level authorization password. Additionally, it can store temperature and humidity values for more than five years.
For humidity sensing, the chamber uses an imported VAISALA capacitive humidity sensor that enables direct measurement and requires no maintenance. In terms of refrigeration, the system relies on an original imported fully enclosed compressor, which ensures a long service life.
The chamber also provides flexible data printing: it can print the equipment model, serial number, and real‑time temperature/humidity values and curves. Furthermore, on‑site alarms include audible and visual deviation alarms, plus an independent over‑temperature alarm. For remote monitoring, the system supports SMS alarms (including power outage alerts), and multiple devices can share a single SIM card.
Over‑temperature protection is handled by a double‑insurance dry‑burn protection system and an independent over‑temperature protection that automatically cuts off the power supply. The door lock features a key lock to prevent unauthorized access to pharmaceuticals and protect test integrity. For mobility, the chamber is equipped with four lockable casters.
Visibility is enhanced by an inner glass door, which allows observation of test samples while minimizing disturbances to experimental data. Finally, we provide validation services including IQ/OQ/PQ scheme documents and execution, all in compliance with international standards.
■FOB
■CIF
■Package: Wooden case