Walk In Pharmaceutical Stability Chamber
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Whats/App: +86 181 0160 0864
The Pharmaceutical Stability Testing Laboratory is a high-precision environmental simulation facility designed to provide stable, long-term temperature and humidity conditions for evaluating the shelf-life and degradation of medicinal products. Whether you are conducting accelerated stress tests or long-term stability studies, this laboratory ensures that your active pharmaceutical ingredients (APIs), finished dosage forms, and medical devices are evaluated under conditions that strictly mirror global regulatory requirements. It serves as a cornerstone for pharmaceutical R&D and manufacturing, providing the empirical data necessary for product registration and safety assessment.
Applications
Pharmaceutical Stability Testing Laboratory is designed for conducting accelerated humidity and heat testing, long-term stability testing, and constant humidity and heat testing on pharmaceutical intermediates, active pharmaceutical ingredients, finished pharmaceutical products, and medical devices. It also supports cultivation of plant and animal samples and bacterial cultures, as well as low-temperature storage, enabling analysis and evaluation of product behavior. This facility serves dedicated research in pharmaceuticals, medicine, biotechnology, food processing, electronics, and all life science-related industries.
Standards
WHO Principles Require:
Long-term stability testing conditions at 25°C/60% RH humidity.
The 40°C/75% RH humidity standard for 6-month accelerated testing is primarily applied in the pharmaceutical industry's stability testing systems, simulating environmental climate conditions including temperature, humidity, and light exposure.
Features
1.Modular Structural Integrity: The lab utilizes a unitized assembly design, allowing you to expand the internal volume or relocate the facility with minimal effort as your production scales.
2.Advanced Airflow Design: By employing a side-top air supply and side-bottom return principle, the system eliminates dead zones, ensuring that even a fully loaded room maintains exceptional temperature and humidity uniformity.
3.Precise Control Algorithms: You benefit from a micro-integral PID control system that coordinates cooling, heating, and humidification to prevent parameter overshoot and ensure rapid recovery after door openings.
4.Regulatory-Grade Monitoring: The high-sensitivity PT100 sensors and dual-mode (program/constant) operation allow you to meet the most stringent ICH stability protocols without manual intervention.
5. Safety Suite: The system includes multi-level protection against over-temperature, low water levels, compressor over-pressure, and phase-sequence anomalies, ensuring 24/7 unmanned operation safety.
Parameters
| Item | Specification |
|---|---|
| Test Area Dimension | Specific dimensions to be designated by the customer based on usage conditions! |
| External Dimension | Subject to the quotation plan |
| Operating Temperature Range | SBY: 0°C ~ +60°C |
| Relative Humidity Range | 30% ~ 95% RH |
| Temperature Deviation | ≤±2°C (≤1°C for incubation chambers) |
| Humidity Deviation | ±5% RH |
| Temperature Fluctuation | ≤±0.5°C |
| Heating Time | ≤30 min |
| Cooling Time | 30 min ~ 180 min (varies by model) |
| Material | Exterior: A3 color steel plate + spray coating; Interior: SUS#304 stainless steel; Insulation layer: PU foam |
| Temperature & Humidity Control System | Imported fully-hermetic or semi-hermetic compressor from Europe, America, Japan, or Korea; Refrigerant: R134a; Axial flow fan with side/top air outlet; High-performance heater; Steam humidification; ADP critical point condensation dehumidification; Air-cooled or water-cooled options |
| Controller | Adopt Yonghe's own brand or Korean TH500/TH300 touch screen controller; Display precision: Temperature 0.1°C, Humidity 0.1% RH; Operation modes: Program mode, fixed value mode; Control method: Microcomputer PID with integral operation; Input signal: PT100 platinum resistance |
| Observation Window | Multi-layer hollow anti-fog explosion-proof glass |
| Safety Devices | Over-temperature protection, leakage protection, water shortage protection, humidification system protection, compressor over-pressure/overload/over-current protection, fan overload protection, phase sequence protection |
| Power Supply | AC380V (1±10%) V, 50±0.5 Hz, 3-phase 4-wire + protective earth |
| Optional Accessories | Temperature & humidity recorder (capable of simultaneous recording of temperature/humidity signals and multiple test points), large observation window, test hole, SMS alarm, high/low temperature deviation alarm, dual-compressor system, etc. |
| Extendable Products | Constant temperature incubation chamber, constant temperature & humidity test chamber, high-low temperature test chamber, constant temperature room, aging test chamber, burnout test chamber, etc. |
| Special Notes | Customizable dimensions available to meet customer requirements |
Accessories
1.Data Recording: Multi-channel temperature and humidity recorders (paper or paperless) for regulatory auditing.
2.Access Ports: Standard 50mm diameter test holes with silicone plugs for external cable routing.
3.Visual Monitoring: Multi-layered hollow explosion-proof glass observation windows with anti-frost coatings.
4.Systems: SMS remote alarm modules and local sound/light indicators for deviation alerts.
5.Redundancy: Dual-compressor backup systems to ensure zero downtime during critical long-term studies.
Test Procedures
1.Startup and Monitoring:
Start the test chamber and monitor parameters such as temperature and humidity in real time to ensure they remain stable within the set range.
Record data regularly, such as sampling and testing at the end of the 1st, 2nd, 3rd, and 6th months for long-term tests.
2.Abnormal Condition Handling:
If parameters deviate from set values, immediately stop the test, inspect the equipment, and take corrective actions.
3.Recording Requirements:
Document test conditions, timestamps, and results in detail to ensure data integrity and accuracy.
4.Data Analysis:
Evaluate drug stability under varying conditions and assess degradation trends.
Prepare reports including test conditions, data, conclusions, and recommendations.
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