Walk In Pharmaceutical Stability Chamber.Pharmaceutical stability test chamber

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.

FAQ

1. How do you ensure the laboratory meets the required temperature uniformity for large-scale batches?

Uniformity is maintained through a combination of a high-pressure centrifugal fan system and a specialized air duct layout. By utilizing a side-delivery and bottom-return airflow pattern, we ensure the air reaches every shelf. During the validation phase (IQ/OQ/PQ), we perform multi-point mapping to prove that even at maximum load, the temperature deviation remains within the $le pm 2°C$ threshold required by ICH guidelines.

2. What measures are in place to prevent data loss during long-term stability studies?

Stability tests often run for months or years, so data continuity is vital. Our systems feature an internal memory buffer in the controller and an optional independent paperless recorder. In the event of a power failure, the system automatically saves the current status and resumes testing as soon as power is restored, while the backup battery maintains the clock and alarm logs.

3. Why is steam humidification preferred over ultrasonic humidification in this lab?

For pharmaceutical stability, steam humidification is the industry standard because it provides a more stable, sterile, and controllable humidity environment. Unlike ultrasonic systems, steam does not introduce mineral dust into the air, which protects both your sensitive samples and the precision sensors from contamination or calcification.

4. Can this facility handle the heat load if I am testing active electronic medical devices?

Yes. While stability labs are primarily for drugs, they can be configured to handle the heat load of powered devices. When you specify your "live load" (total wattage of running devices), we calibrate the refrigeration capacity to ensure the PID system can offset the internal heat without exceeding the temperature deviation limits.

Qinsun Instruments Co., LTD is a professional laboratory testing instrument manufacturer in China,Have been focusing on laboratory instrument R&D more than 30 years and have rich industry experience,Based on international testing standards,We are also the instrument supplier for BV SGS laboratory,We provide one-stop solutions for lab instruments,Free Training and Turn-Key Service,Products exported all over the world,Offer 36 month warranty and are a trustworthy partner.

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