Stability Chambers – PH Series

The Darwin Chambers PH Series Stability Chambers are designed for performance specifications exceeding FDA and ICH requirements. For GMP studies, ultrasonic humidification provides excellent humidity control and avoids hot spots during mapping. Thermoelectric cooling provides more stable temperature control than equivalent refrigeration systems. All PH series chambers incorporate inherent cooling redundancy, quiet operation, simple serviceability and excellent reliability.

The PH Series from Darwin Chambers was introduced nearly 20 years ago as the first large capacity thermoelectric cooled pharmaceutical stability testing chamber. Thousands of our stability chambers are presently in use by many pharmaceutical, cosmetic, nutraceutical, medical device, therapeutic pharmaceuticals, pharmaceutical stress testing, and other research companies around the world. The advantages of these chambers for stability or shelf life testing are substantial.

We build chambers to meet very specific requirements in a wide variety of industries. The PH Series chambers are our most popular offering for good reasons. These chambers produce exacting results and we provide support for them with timely quoting, quick lead times, reliable insulation, trusted validation services, and superior product support in the future. Please do not hesitate to inquire for any further information that may not be provided on our website.

PH03

PH03

The PH03 is an undercounter stability chamber.

PH011

PH011

The PH011 is a bench top stability chamber designed to fit on 24” benchtops or stacked with optional racking.

PH030

PH030

The PH030 is a single-door stability chamber.

PH034

PH034

The PH034 is an extra wide single-door stability chamber.

PH055

PH055

The PH055 is a 2-door stability chamber.

PH068

PH068

The PH068 is a 2-door stability chamber.

PH084

PH084

The PH084 is a 3-door stability chamber.

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PH Series Features

PH Series

The PH series was introduced in 2003 as the first commercially manufactured large capacity Peltier-cooled pharmaceutical stability testing chamber. Over a thousand PH series stability chambers are presently in use by pharmaceutical, cosmetic, nutraceutical, medical device, and research companies around the world. The advantages of these chambers for stability testing include:

Cooling Redundancy

Each PH series chamber includes multiple, independent thermoelectric cooling units. The 7 year warranty on cooling components and the ability of our chambers to maintain temperature even if the chamber suffers multiple failures is unmatched by any other refrigeration-based chamber.

Superior Control

The PH series chambers control well within the specifications required by the FDA and ICH for GMP studies. The ultrasonic humidification system provides excellent humidity control and avoids hot spots seen during chamber mapping of steam boiler equipped chambers. Thermoelectric cooling and automatic switching system from cooling to heating control provide consistent results throughout the available temperature range. Standard control at the sensor in these chambers is ±0.2°C and ±0.3%RH.

Proven Controllers

Standard controllers for the PH series are manufactured by Fuji Electric and are ideal for stability testing chambers. Unlike many proprietary controllers, this controller is commercially available and proven in tens of thousands of installations. Standard functions include: autotuning, fuzzy logic, PID control, programmable alarms, calibration capability, ramp/soak, offset capability, etc. A touchscreen control interface is optional. Other controller manufacturers are also supported (Watlow, Allen Bradley etc.)

Options Available

Chart Recorder
Data Loggers
Dryers
Full swinging interior glass door (034)

Simple Serviceability

Due to the omission of all refrigeration equipment on these models, refrigeration technicians are not required during chamber servicing. Refrigerated stability chambers are not only costly to service, but can require days to service properly. Nearly every component of thermoelectric-based chambers can be serviced within minutes with basic tools. For instance, the ultrasonic humidifier is capable of being removed and reinstalled in less than a minute and operates on non-hazardous 24 volts.

Reduced Energy Loads

The PH Series chambers utilize less energy than comparable stability chambers and introduce less impact upon building cooling systems. This efficiency “dual benefit” allows our chambers to be located in spaces unsuitable for other chambers. Electrical energy savings by the PH series vs. steam boiler equipped chambers can easily amount to hundreds or even thousands of dollars saved per year.

Service and Warranties

We offer 24 hour technical support throughout the lifetime of your chamber. In addition to our standard warranties, we also offer extended warranties for cooling components, parts and labor. We also provide qualifications, validations and preventive maintenance services at an additional cost. Please ask for a quote.

Quiet Operation

The PH chambers utilize quiet and highly efficient DC fans. Locating these chambers in laboratory workspaces is a viable option.

Industries That Use Our Stability Chambers | Use Cases For Stability Chambers

Darwin Chambers provides a wide range of industries with reliable and precise stability chambers to reach their research needs. Including but not limited to:

  • Pharmaceuticals: Stability chambers are critical for testing the shelf-life and efficacy of drugs, ensuring compliance with regulatory standards like FDA and ICH guidelines.
  • Cosmetics: Cosmetic companies use stability chambers to test the durability and quality of skincare and beauty products under different environmental conditions.
  • Food & Beverage: These chambers help assess the longevity and safety of perishable goods, ensuring food products maintain quality throughout their shelf life.
  • Biotechnology: Stability chambers provide precise control over environmental conditions for biological sample storage and research on biomaterials.
  • Medical Devices: They are used to test the reliability and safety of medical devices over time, ensuring they function correctly under various conditions.
  • Nutraceuticals: Companies use stability chambers to validate the consistency and shelf-life of dietary supplements and other health products.
  • Agriculture: Stability chambers are essential for testing seed viability, plant growth, and product stability in agriculture and farming research.
  • Chemical and Material Science: These chambers allow for controlled testing of the stability, durability, and reactivity of chemical compounds and materials.
  • Contract Research Organizations (CROs): CROs utilize stability chambers to conduct testing for pharmaceutical, biotech, and other clients who require environmental control for their products.
  • Construction and Engineering: Stability chambers aid in testing materials like concrete, metals, and composites, ensuring they meet durability standards under different environmental conditions.
  • Education/Universities: Research labs at universities rely on stability chambers for scientific studies, including material science, biology, and chemistry research.
  • Government: Various government agencies use stability chambers for regulatory testing, environmental assessments, and product stability studies.
  • Libraries/Archives and Museums: These institutions use stability chambers to preserve books, artifacts, and cultural items by controlling the environment to prevent deterioration.

Performance Benefits of Darwin Chambers Stability Chambers

Darwin Chambers stability chambers offer unmatched environmental precision, delivering consistent and reliable test results. Our thermoelectric cooling technology and ultrasonic humidification ensure accurate control over temperature and humidity. These features help industries such as pharmaceuticals, biotechnology, and cosmetics meet strict regulatory standards like FDA and ICH. Designed for long-term performance, these stability chambers reduce downtime and operational costs while simplifying complex testing protocols like shelf-life studies and accelerated aging tests.

Custom Stability Chamber Solutions

Darwin Chambers specializes in designing custom stability chambers tailored to meet specific industry needs. From precise temperature and humidity control to additional features like remote monitoring and multi-zone chambers, these solutions ensure clients in industries such as pharmaceuticals, research, and medical devices can achieve their unique testing requirements. Customization allows companies to comply with niche regulatory standards while optimizing testing environments, ensuring flexibility and reliability in their operations.

Compliance with Global Regulatory Standards for Stability Chambers

All Darwin Chambers stability chambers are built to meet and exceed FDA, ICH, and GMP standards. This level of compliance is critical for industries that rely on stability testing to receive product approval. Whether used for pharmaceuticals, biotechnology, or medical devices, these chambers maintain precise environmental conditions, ensuring products are tested under optimal conditions to meet stringent regulatory requirements. Darwin Chambers helps companies achieve faster regulatory approval by minimizing risks associated with non-compliance.

Energy Efficiency and Environmental Impact

Committed to energy efficiency, Darwin Chambers stability chambers use advanced thermoelectric cooling technology that consumes significantly less energy than traditional cooling methods. This design reduces operational costs while maintaining excellent environmental control. Businesses benefit from lower energy consumption, and this eco-friendly approach aligns with corporate sustainability goals. Darwin Chambers offers a solution that balances high performance and sustainability, enabling companies to reduce their carbon footprint without compromising on quality or reliability. Our partnership with the UPS Carbon Neutral Program further reduces our environment impact.

Comprehensive Stability Chamber Maintenance and Support

Darwin Chambers offers complete maintenance and support services, ensuring our stability chambers consistently operate at optimal performance levels. From installation and calibration to ongoing preventive maintenance, our team provides the support necessary to minimize downtime and extend the lifespan of each chamber. Our customer service is responsive and efficient, with warranties available to ensure long-term reliability. Clients can trust Darwin Chambers to provide professional assistance throughout the lifecycle of their chambers, helping you maintain productivity and regulatory compliance.

Frequently Asked Questions (FAQs) About Stability Chambers

What Are the Types of Stability Chambers?

Stability chambers are built to regulate precise temperature ranges from -20°C to 94°C (-4°F to 201°F) and humidity control. At Darwin Chambers, we prioritize these specifications when constructing and installing custom stability chambers tailored to your installation and stability testing requirements.

Our range of stability chambers includes:

Learn more about our stability chambers and stability refrigerators, and how we create a controlled and consistent environments for product testing and research experiments.

What Are Stability Chambers Used For?

Pharmaceutical companies would use these chambers to pass FDA/ICH regulations. Having complete control over temperature, humidity, and light exposure is key for companies researching and developing new drugs. We're able to replicate real-world situations where your drugs operate under direct testing. For pharmaceutical companies, this might include:

  • Packaging Integrity
  • Compliance Testing
  • Quality Testing
  • Product Development Systems
  • Heat and Light Exposure
  • Product Lifespan and Shelf Life Testing

Other industries might use stability chambers for:

  • Quality Assurance Testing
  • Purity / Potency Testing
  • Product Development
  • Aging Studies (Expiration Dates)
  • Compliance Testing
  • Packaging
  • Potency

How Does Stability Testing Work?

Accelerated stability and ICH testing entails subjecting a product to heightened stress conditions, such as elevated temperatures and/or humidity levels. By doing so, degradation patterns under recommended storage conditions can be anticipated by utilizing established correlations between the acceleration factor and degradation rates.

The key word here is accelerated. Products that are stored in stability chambers "age" and are affected by various controlled conditions. This testing is incredibly important in the pharmaceutical industry. Your drugs could degrade or be compromised by environmental hazards like air pressure, humidity, and sunlight. It's important to meet particular guidelines in order to safely produce and sell drugs at retail. Drug manufacturers are often required to show shelf life results that come from stability tests in order to pass FDA/ICH regulations.

The standard order of operations of stability chamber tests includes:

  • Sample Selection
  • Stress Conditions
  • Monitoring and Analysis
  • Data Collection
  • Establishing Shelf Life
  • Meeting Regulatory Compliance

Globally Recognized

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