Scope of application:

The Comprehensive Pharmaceutical Stability Test Chamber is a specialized piece of equipment designed to simulate real-world storage and transportation conditions for pharmaceuticals by precisely controlling temperature, humidity, and light exposure. It’s tailored specifically for pharmaceutical companies, biotechnology institutions, and research organizations. Its primary applications include assessing drug stability (through accelerated, long-term, and photostability studies), determining shelf life (by predicting product degradation under simulated temperature, humidity, and light conditions), and supporting quality control efforts—such as optimizing packaging and storage strategies. The chamber meets international standards like GMP, FDA, and ICH, while also providing critical scientific insights for new drug development and material durability testing (e.g., in cosmetics and food packaging).

Structural features:

Outer Enclosure: The enclosure is crafted from high-quality cold-rolled steel sheet, finished with an electrostatic powder-coating process that creates a dense protective layer on the surface, ensuring durability, strength, and exceptional rust resistance. A standard 25mm test hole is included on the left side, while the outer door is equipped with a secure safety lock.

Workshop: The inner liner is made of SUS304 stainless steel with a mirror-polished finish. The shelf brackets feature a quick-release design for easy assembly and disassembly.

Built-in UV sterilization (sterilization time adjustable).

Observe the glass: The double-door design features tempered glass as the inner observation panel, allowing you to directly open the outer door and check the status of the workspace. Its excellent sealing performance ensures that the internal temperature remains unaffected.

Ventilation System: A robust, cross-flow ventilation structure that creates an efficient air circulation system, enhancing temperature response speed while improving temperature uniformity and minimizing thermal fluctuations.

Control Panel: Featuring a microcomputer-based smart touch-screen temperature controller with high precision, zero overshoot, and multi-set data displayed on a single screen. It includes temperature correction and timing functions, allowing users to set up to 30 program segments with cycle durations ranging from 0 to 9,999 cycles. Additionally, the panel offers remote alarm and remote control capabilities.

Equipped with a USB interface for real-time data storage. Comes standard with a miniature dot-matrix printer.

Refrigeration System: Features dual-compressor cooling—each unit serves as a backup for the other, or they can be used in rotation—effectively extending service life and ensuring stable operation of the equipment (Note: Models with 280 liters or larger capacity are equipped accordingly).

Light Source: Employs a cold light source that generates minimal heat, ensuring greater temperature stability within the chamber. The chamber features vertically mounted, top-mounted lighting with two layers of illumination panels, delivering even light distribution to every point inside the unit. Additionally, the system offers free dimming options, allowing users to precisely set the desired light intensity—either increasing or decreasing the brightness as needed.

UV System: The UV meter provides real-time readings, ensuring compliance with the technical guidelines for stability studies of chemical drugs (active pharmaceutical ingredients and formulations), which require a total near-UV energy exposure of at least 200 W·hr/m². UV irradiance is measured in μW/cm² (ranging from 80 to 100), while the UV spectral range spans from 320 to 400 nm.

Humidification System: Equipped with a top-tier brand humidity sensor and featuring built-in humidification technology, this system utilizes a 316 stainless steel humidification tube to generate steam via heating, ensuring precise humidity control with minimal internal fluctuations and excellent uniformity. Additionally, it comes with an external 25L water tank that provides up to 15–20 days of operation on a single fill.

Standard Pharmacopoeia: This product meets the relevant requirements outlined in GMP, FDA, ICH, and national pharmacopoeias.

Safety Systems: Inner chamber temperature protection, compressor overcurrent protection, compressor overpressure protection, low-water protection, heater overheating protection, audible and visual alarm upon fault detection, and auxiliary thermostat.

Product Specifications

Note: The test data was sourced from Laboratory 137.