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PH Series Pharmaceutical Stablility Testing Chambers; 9, 30, 55 & 85 cubic feet

SKU:
Darwin Chambers FDA/ICH Stability PH Series Reach-In Chambers


Product Description

The Darwin PH Series incubators of Pharmaceutical/FDA Stablility Test Chambers use utilize ultra-reliable Thermo Electric/Peltier cooling and heating and instustry leading ultrasonic humidification. The PH Series offers superior uniformity, quiet operation, and inherent redundancy to product and store your most important samples and product.  For performance specifications specifications required by FDA, ICH, GMP, USP and other regulating bodies, our PH Chambers maintain uniform humidity and temperatures as low as 10°C (PH09) or 20°C (all others) up to 60°C (Standard--higher temp modifications available).

 

Our 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:

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.

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. 

PH085 Stability Chamber is a chamber with 3 doors. 

Stability Rooms

Warranty Information

Why should you use Thermoelectrics and Ultrasounic technology?:

Save on operating costs (cost savings decrease as chamber size increases)
Remove the need for a refrigeration technician repair
Less heat output = lower air conditioning loads, less retrofit, less amperage needed
Are more reliable - no moving parts
Remove localized hot and cold areas
Run at a greatly reduced noise level
Have an element average life of 23 years

Details:

Ultrasonic Humidification
Completed thermoelectric unit for addition to stability chamber

Humidified chambers typically have a pan of water that is heated with electricity or an element sprayed with water creating steam. This leads to heat being introduced into the chamber as well as imprecise addition of humidity. Mineral scale build-up is also quick. In conditions with dewpoints close to the actual temperature, this creates supersaturated localized conditions and lead to condensation in the chamber at conditions where there should be none ( for example 40 degrees Celsius and 75% RH).

Our systems add humidity through an ultrasonic vapor generator. We can turn it off and on in mere seconds. It doesn't generate any heat. It doesn't overshoot or continue to add humidity past the set point. It doesn't collect mineral scale. However, they do require replacement of inexpensive titanium ceramic discs every 10,000 hours of use - which most users do themselves. We also suggest the hook-up of deionized/distilled water or use of reverse osmosis units (we sell these). Otherwise, mineral scale build-up will occur in the chamber.
The take home bullets on ultrasonic humidification:

Saves 93% on operating costs at 25 degrees Celsius
Has less heat output- room air conditioning loads are reduced
Is more reliable and operation can be checked visually
Diminishes localized hot and cold areas within the chamber leading to less condensation issues
Is maintained or repaired easily by operators even with limited skills
Runs at almost no noise level
Reduces maintenance and costs

Thermoelectrics
Thermoelectric unit for environmental chamber

Current chamber technology is complex. Almost all manufacturers run a refrigeration system full time. In temperature control applications, heat is then added to this system to obtain the desired temperature.

In humidity control situations, the refrigeration is used to lower humidity by allowing condensation on the cooling components in the chambers. There is often a "hot gas bypass" system or and "latent coil system". Occasionally, there are defrost cycles so that ice doesn't form on the cooling components. All this adds up to high operating costs, a lot of moving parts, and an automatic call to THEIR service department (not an ordinary refrigeration technician) when problems do arise. When you add the room you've especially made to deal with all the heat that these refrigeration units put out, it adds up to a lot of money and time. To complicate things, efficiency gains using this technology are gained by, among other things, using thinner gauges of tubing - resulting in refrigeration leaks appearing quicker than in previous decades.

Humidity unit chamberThermoelectric technology, the technology we like to employ in certain situations that do not require large amounts of heat removal, has progressed in recent years. Essentially, a small wafer can take heat from one side of the component and move it to another side. When the polarity is reversed, it does the reverse. When cooling fins and fans are added to the system, it becomes one of the best ways to maintain temperatures. The units can be pulsed in seconds, thereby allowing some of the most precise control. One of the benefits is that we can run cooling units at a minimal temperature difference. In situations where condensation on the unit is desired, freeze ups are eliminated.

We typically run two of the thermoelectric units on the single door models and more on the larger units. If heat removal requirements aren't great, they act as a redundant cooling feature. We suggest yearly maintenance to verify both units are operating.

These units are backed by our longest warranty and require no license to remove/repair due to the lack of refrigeration.

Another benefit is the reduction in noise volume. The units employ fans similar to what one can find in their personal computers. That isn't a lot of noise.

Most of the justification for these units is long term costs. Using our PH030 as an example:
Model Darwin Chambers PH030 Competitor 34 cubic foot chamber
Condition 25 degrees C/ 60% humidity 25 degrees C/ 60% humidity
Running Load Amperes (RLA) 4.5 8.5
Voltage 120 230
Averge price kwh national $0.12/kwh $0.12/kwh
Average Cost/Day $1.56 $5.63/day
Additional Cost/Year

$1,487
Yearly BTU Created 16140794

58435654
Air Conditioning Costs /Year $210

$760
Total Additional Costs/Year $2037

These numbers go up or down depending on your region, rates, rate tier, and conditions required.


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