In the pharmaceutical and medical technology sectors, precisely controlled environmental conditions determine product quality, efficacy, and regulatory compliance. ThermoTEC offers a wide range of GMP-compliant equipment and systems for stability storage in accordance with ICH guidelines and relevant ASTM standards - from climate, refrigeration, deep-freeze, and ultra-low-temperature cabinets to incubation and photostability cabinets and walk-in chambers.
From small to large, standardized or as a custom solution: We plan and implement your solution tailored to your needs, with dedicated contact persons—from the initial concept through acceptance testing to service.
GMP-compliant cabinet solutions for stability & storage – from climate cabinets to refrigeration, freezing, ultra-low temperature, as well as incubation and photostability cabinets. Typical features: high accuracy, user-friendly operation, sizes from approx. 100 L to 2,000 L, using natural refrigerants.
Walk-in room-in-room solutions for stability studies and storage: climate chambers, refrigeration and freezing cells, and even incubation rooms – adaptable to your on-site conditions and regulatory requirements.
Cabinets and Chambers - GMP-compliant solutions for stability testing and storage.
For testing technology to function reliably in everyday use, more than just a device is needed. ThermoTEC supports you throughout the entire lifecycle - from selection to ongoing operation..
The result for you: less coordination effort, clear points of contact – and a comprehensive range of services.
Product — Consulting, testing solutions, rental models, and equipment available from stock at short notice.
Process — Transparent, on-time procedures – including customer-specific modifications.
Quality — ISO 9001 certified and an accredited testing & calibration laboratory according to ISO 17025.
Service — omprehensive service network, manufacturer-independent, available 24/7.
Support — Ad-hoc support from experienced technicians, customer-specific user training (including commissioning/orientation).
A smooth project workflow is especially important for chamber and room solutions. That’s why we work with clear phases and a binding timeline:
Define requirements, agree on timeline, prepare proposal
Technical design, plans/electrical design/programming, project timeline
Assembly, installation, commissioning, and fine-tuning
Customer-specific tests, verification of requirements, and execution of IQ, OQ, and PQ using validated documentation
Orientation, training, complete documentation
Maintenance, Calibration & Re-qualification for Long-Term Process Reliability
Typical pharmaceutical applications include stability studies, GMP-compliant storage, and controlled incubation—all of which place high demands on homogeneity, documentation, and availability.
For complete documentation, we offer data logger and monitoring systems, including installation, for monitoring and recording the measurement data from your devices and systems – in compliance with FDA 21 CFR Part 11.
GMP-compliant pharmaceutical technology encompasses devices and systems that meet the requirements of Good Manufacturing Practice. These include, for example, climate cabinets and chambers that ensure stable, documentable conditions and enable seamless quality assurance.
For stability studies, climate cabinets, climate chambers, and refrigerators, freezers, and ultra-low temperature freezers are primarily used. These enable the storage and testing of pharmaceutical products under defined conditions in accordance with ICH guidelines.
ICH guidelines define international standards for the stability testing and storage of pharmaceutical products. They ensure that medications are tested under globally comparable conditions and that their quality, safety, and efficacy are maintained.
Cabinet solutions are compact and ideal for smaller test volumes or laboratories. Chamber solutions are walk-in and suitable for larger quantities or long-term stability studies. Both variants offer precise climate control but differ in size and application.
Compliance is ensured through precise control technology, validated systems, as well as qualification (IQ, OQ, PQ), calibration, and comprehensive documentation. In addition, monitoring systems enable the seamless recording of all relevant measurement data.
A 360° partner supports projects from planning through commissioning to service. This reduces interfaces, simplifies coordination, and ensures that all systems function in compliance with standards and can be operated reliably over the long term.
FDA 21 CFR Part 11 regulates the requirements for electronic records and signatures. Systems must ensure that measurement data is stored in a tamper-proof manner and documented in a traceable way.
Typical ranges are +2 °C to +8 °C for refrigeration, -20 °C to -40 °C for deep freezing, and up to -86 °C for ultra-low temperature freezing. Stability tests are conducted at defined temperature and humidity levels in accordance with ICH, depending on the requirements.
In stability studies, pharmaceutical products are tested over a defined period under controlled climatic and storage conditions. The goal is to evaluate shelf life, quality, and efficacy under real-world or accelerated conditions.
Medications must be stored under precisely defined temperature and climatic conditions. Strict regulatory requirements such as GMP, GDP, and ICH apply to ensure the quality and safety of the products.
A GMP-compliant laboratory requires validated climate chambers, cooling and storage solutions, monitoring systems, as well as qualified measurement and documentation systems. Precision, traceability, and standard-compliant processes are crucial.
Are you planning stability studies, looking to expand capacity, or replace existing systems? Talk to us - we provide expert, practical support with a comprehensive service concept.
