ICH/FDA Pharmaceutical Stability Chambers

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The PH series from Darwin Chambers was introduced nearly 10 years ago as the first large capacity thermoelectric cooled pharmaceutical stability testing chamber. Hundreds of stability chambers are presently in use by many pharmaceutical, cosmetic, nutraceutical, medical device, and research companies around the world. The advantages of these chambers for stability or shelf-life testing are substantial and include:

Thermoelectric Colloing Unit for Stability Chamber Inherent cooling redundancy
Each PH series chamber we produce includes multiple, independent thermoelectric cooling units. While the cooling devices are quite reliable in and of themselves, the ability of our chambers to maintain temperature even if the chamber suffers multiple failures is unmatched by any refrigeration-based chamber.

Quiet operation
Our customers are continually amazed at the quiet operation of these chambers. There are no compressor noises, no valves clicking, and no large fan motor noises. The PH chambers utilize quiet and highly efficient DC fans. Locating these chambers in laboratory workspaces is an easily viable option.

Simple serviceability
Due to the omission of all refrigeration equipment on this model, refrigeration technicians are not required for chamber servicing. Refrigerated stability chambers are not only costly to service but they also require days (in many cases) to service properly. Due to the nature of refrigeration, leaks and part failures are seldom found before they cause immediate out of temperature conditions. Nearly every component of our thermoelectric-based chambers can be serviced within minutes with a screw-driver. Our ultrasonic humidifier is capable of being removed and reinstalled in less than a minute and operates on non-hazardous 24 volts at low temperatures.

Excellent reliability
We defer to the K.I.S.S. design philosophy and carry this throughout the engineering of this chamber. The PH series chambers have only simple, highly reliable DC fans as the moving components. Fancy touchscreen interfaces are not standard because they add an additional layer of complexity that, in most cases, is not required to maintain excellent control. Warranty duration on the cooling units surpasses all refrigeration-based models on the market.

Superior temperature control and uniformity capability
The PH series chambers are well within the temperature and humidity performance specifications required by FDA, ICH, GMP, USP and other regulating bodies. Our ultrasonic humidification system, while simple in operation, provides excellent humidity control and avoids hot spots often seen during chamber mapping of steam boiler equipped chambers. Thermoelectric cooling and our automatic switching system from cooling to heating control provide consistent results throughout the available temperature range. Standard temperature control at the sensor in these chambers is ±0.2°C (at the sensor) and humidity control is ±0.2%RH (at the sensor).

Greatly reduced direct and indirect energy loads
The PH Series chambers not only utilize far less energy than comparable stability chambers from other manufacturers, but they also introduce far less impact upon building cooling systems. This efficiency “dual benefit” allows our chambers to be located in spaces unsuitable to other chambers. Actual, average wattages required by the PH Series vs. rival chambers can easily amount to hundreds if not thousands of dollars per year. See simulated savings calulation here.

Widely proven, non-proprietary controllers
Standard controllers for the PH Series are manufactured by Fuji Electric and are ideal for stability testing chambers. Unlike many proprietary controllers on the market, this controller is available off the shelf and has been proven in tens of thousands of installations. All necessary functions are included standard and include: Autotuning, Fuzzy Logic, PID control, programmable alarms, calibration capability, offset capability, etc. A touchscreen control interface is optional, but not required. Many additional options are available both regarding control and recording of data.

Wide variety of sizing options
We build chambers from bench-top size to large walk-in size and literally everything in between. Our reach-in chambers fit through standard size door ways.

Full array of service options
White glove installation, commissioning, protocol writing, validation services (including IQ/OQ/PQ), preventive maintenance, on-site repairs, and on-site chamber renovations are only a few of our service capabilities. We also perform these services for chambers produced by other manufacturers, throughout the U.S. and world-wide, where applicable.

International delivery options
We have a wide variety of customers in nearly all parts of the globe. Export crating/shipping, voltage changes, and regulatory body approvals are all routinely performed.

Guaranteed performance to meet FDA/ICH requirements
Needless to say, if a PH Series chamber is purchased for stability testing, if the results do not meet the criteria listed in our quote, customers are not obligated to pay for the chamber. These chambers are intended for FDA/ICH regulated stability testing and they will perform well within required specifications

Affordable pricing and leasing options
We strive to build chambers with the highest reliability and smart design to keep costs as reasonable as possible. Our warranty claims are low and the savings are passed on to the customers up front. Attractive chamber leasing options are available (with zero-dollar buy back at the end of term) that make our chambers very affordable, especially when electrical savings are factored in

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 installation support, 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. We build custom stability testing chambers, from small to walk-in sizes, and a wide variety of other types of chambers as well, from incubators to freezers, so we look forward to assisting your product needs.

PH09 Stability Chamber is a bench-top chamber capable of being stacked.

PH030 Stability Chamber is a chamber with single door.

PH055 Stability Chamber is a chamber with 2 doors. 

PH084 Stability Chamber is a chamber with 3 doors. 

Stability Rooms