ALP Walk-In Stability Chamber
The Gold Standard for Pharmaceutical Stability Testing
In the pharmaceutical, biotechnology, and quality control industries, ensuring drug product safety, efficacy, and shelf life is non-negotiable. Stability testing is a critical process that determines how the quality of a drug substance or drug product changes over time under various environmental conditions. From this data, pharmaceutical companies establish packaging specifications, storage conditions, and expiration dates that protect both patients and regulatory compliance. For laboratories conducting large-scale stability studies, the ALP Walk-In Stability Chamber offers the ideal solution-combining precision engineering, GMP compliance, and customizable capacity to meet the most demanding testing requirements.
Widely Used in Pharmaceuticals, Biotech, and Quality Control
ALP's Walk-In Stability Chamber is specifically designed for stability studies of formulations, active pharmaceutical ingredients (APIs), and packaging materials. It serves as an essential tool for pharmaceutical manufacturers, biotech research institutions, and contract testing laboratories that require GMP certification.
The equipment is purpose-built to support:
Long-term stability testing at 25°C ± 2.0°C, 60% RH ± 5% RH for up to 365 days
Accelerated stability testing at 40°C ± 2.0°C, 75% RH ± 5% RH or 30°C ± 1.0°C, 60% RH ± 5% RH for 180 days
High humidity testing at 25°C ± 2.0°C, 90% RH ± 5% RH
Temperature stress testing at 40°C and 60°C
Photostability testing for new drug substances and products as per ICH Q1B requirements
Full Compliance with International Regulatory Standards
The ALP Walk-In Stability Chamber is independently developed and manufactured to meet the most rigorous regulatory standards worldwide.
The equipment fully complies with:
ICH Q1A (R2) guidelines for stability testing of new drug substances and products
GMP requirements for data acquisition systems and environmental control
FDA 21 CFR Part 11 standards for electronic records and audit trails
Pharmacopoeia of the People's Republic of China (2020 edition) for chemical drug stability studies
Through comprehensive DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) validation protocols, ALP provides documented evidence that the equipment meets production process requirements, design specifications, and national GMP standards. The equipment's performance is validated to ensure consistent maintenance of critical conditions such as 25°C ± 2°C / 60% RH ± 5% RH over extended periods of 2–3 years.
Superior Technical Performance and Precision
The ALP Walk-In Stability Chamber delivers exceptional accuracy and uniformity essential for reliable stability studies:
Internal Dimensions: as customer's requirement.
Temperature Range: +20°C to +45°C
Humidity Range: 50% to 80% RH
Temperature Fluctuation: ±0.5°C
Temperature Uniformity: ≤2°C
Temperature Deviation: ±2°C
Humidity Fluctuation: ±3% RH
Humidity Deviation: ±3% RH
Display Resolution: Time 0.1 min, Temperature 0.01°C, Humidity 0.1% RH
The chamber features a high-strength polyurethane insulation system with 100 ~ 150 mm thickness on all six sides, ensuring excellent thermal stability. The internal workspace is constructed from SUS304 stainless steel (t=1.0~1.5 mm), while the exterior uses electrostatic-sprayed color steel plate for durability and easy maintenance.
Advanced Engineering for Unmatched Reliability
The air supply circulation system employs an opposing air supply method that prevents dust accumulation and ensures uniform temperature and humidity distribution throughout the workspace. The forced ventilation internal circulation system, powered by a turbine rotor motor with centrifugal multi-blade impeller, eliminates blind corners and guarantees consistent environmental conditions.
The refrigeration system features two fully enclosed Copeland (USA) compressors-one active and one standby. This redundant configuration ensures uninterrupted operation: if one compressor fails, the other activates immediately, guaranteeing continuous long-term stability testing. The system includes an oil separator, Castel solenoid valve for defrost regulation, and Danfoss drier filter for optimal refrigerant performance.
Intelligent Control and Data Management
- Real-time monitoring of temperature, humidity, and system status
- Programmable and constant-value operation modes
- Password protection with three security levels
- USB data export and storage (10G USB drive supports over 3 years of data)
- Optional dot matrix printer for temperature/humidity curve printing
- RS232, RS485, and network communication interfaces for remote monitoring
- Free communication protocol for seamless integration with existing systems
- WeChat and mobile APP alarm push notifications to at least 5 designated personnel
Comprehensive Safety Protection
- Grounding protection and system leakage protection
- Compressor overpressure, overload, overcurrent, and over-temperature protection
- Workspace over-temperature protection
- Heater short circuit and overload protection
- Main power supply phase sequence protection
- Temperature upper/lower limit deviation alarm
- Humidifier dry-burn protection
- Three-color alarm light indicating operational status
Customized Solutions and Global Support
With over 20 years of experience in environmental testing instrumentation, ALP TECHNOLOGY (T&M) LTD greatest strength lies in its ability to customize test chamber products and provide a complete range of services including design, production, installation, and maintenance. ALP's testing systems have been successfully deployed in more than 50 countries and regions across five continents, serving government institutions, Fortune 500 corporations, and leading research organizations worldwide.
Why Choose ALP TECHNOLOGY?
- Regulatory Excellence: Full compliance with ICH, GMP, FDA, and WHO standards
- Uncompromising Reliability: Redundant compressor systems ensure uninterrupted testing
- Precision Performance: Superior temperature and humidity uniformity for accurate stability data
- Intelligent Data Management: 21 CFR Part 11-ready with comprehensive audit trails
- Global Service Network: Expert support across five continents
- Customization Capability: Tailored solutions for specific laboratory requirements
Whether you are standardizing a new product line or solving a difficult failure issue, ALP TECHNOLOGY is ready to help.
✉️ E-mail: info@alp-environment.com
🔗 Website: www.alp-environment.com
"Technological Excellence Rooted in Integrity" - engineered into every test, delivered with every partnership.