Pharmaceutical Walk-In Stability Room

The International Council for Harmonisation (ICH Q1A(R2)) defines specific environmental conditions for different stability study types. Long-term studies require 25°C ± 2°C and 60% RH ± 5% RH, intermediate studies require 30°C ± 2°C and 65% RH ± 5% RH, and accelerated studies require 40°C ± 2°C and 75% RH ± 5% RH. Our TestLabs stability rooms are engineered to maintain these precise conditions with exceptional stability (±1.0°C and ±3% RH), ensuring your stability data meets global regulatory requirements.

FDA 21 CFR Part 11 establishes the criteria under which the FDA considers electronic records and electronic signatures to be trustworthy, reliable, and equivalent to paper records. For pharmaceutical companies, this means your stability testing data must be generated, stored, and managed in systems that include electronic signatures, secure access codes, audit trails, and data integrity controls. Our optional wireless data logging system is fully FDA 21 CFR Part 11 compliant, ensuring your stability study data is audit-ready and defensible during regulatory inspections.

Installation Qualification (IQ) verifies that your stability chamber is installed correctly according to manufacturer specifications. Operational Qualification (OQ) confirms that the chamber performs within defined operational limits under empty conditions. Performance Qualification (PQ) demonstrates consistent performance under real-world loaded conditions with actual product samples. Together, these three qualification stages establish documented proof that your chamber is fit for its intended purpose and capable of generating reliable, defensible stability data. TestLabs offers complete IQ/OQ/PQ protocol execution as an optional service.

Temperature mapping involves placing multiple calibrated temperature and humidity sensors throughout the chamber volume to identify any hot spots, cold spots, or variations in environmental uniformity. This process is performed during both empty and loaded conditions to ensure that every sample in your stability study experiences the same environmental exposure. Poor temperature uniformity can invalidate your stability data, so regulatory agencies require documented temperature mapping as part of the validation process. Our optional validation service includes comprehensive temperature mapping studies to guarantee data integrity.

Walk-in stability chambers are essential for pharmaceutical companies conducting long-term shelf-life studies, biotech firms developing new drug formulations, contract manufacturing organizations (CMOs) handling multiple products, and companies performing packaging validation and stress testing. Beyond pharmaceuticals, stability chambers are used in medical device manufacturing, food and beverage testing, electronics quality assurance, and automotive component validation. Our TestLabs stability rooms are designed to serve all these industries with the precision and reliability required for regulatory compliance.

Yes, absolutely. All TestLabs stability rooms are fully customizable in terms of capacity, dimensions, and internal configuration. We work closely with your engineering team to assess your laboratory layout, electrical infrastructure, and specific testing requirements. Our custom design process ensures that your stability chamber integrates seamlessly into your facility while meeting all your operational and regulatory needs. Contact our sales team at sales@testlabs.my to discuss your specific requirements.

TestLabs provides comprehensive after-sales support across Penang, Selangor, Johor, and Kuala Lumpur. Our services include professional installation and commissioning, operator training, routine preventive maintenance, ISO/IEC 17025 accredited calibration services, spare parts availability, and technical support. We also offer extended warranty packages and can execute periodic requalification protocols to ensure your chamber continues to meet regulatory standards throughout its operational life.