FDA/ICH Stability Rooms


Summary

Darwin Chambers Company Stability Rooms offer superior environmental control for a wide variety of products needing a specific temperature and/or humidity conditions, Darwin Chambers is proven to exceed ICH/FDA stability requirements.

For this reason, our FDA/ICH chambers are highly sought. Pharmaceutical shelf-life testing, accelerated stability studies, and testing and storage for cosmetics, animal health products, nutritional supplements, general products, medical devices, packaging materials are just a few applications we service.


Our walk-in designs are based off of four goals:

Quality – All of our products are designed, manufactured, and installed by factory personnel or factory-trained personnel, with an acute understanding of the needs of the pharmaceutical industry. Quality is reflected during all phases of a project, from initial quotation, through installation, and after years of operation. In our opinion, when considering all potential costs for both our customers and our company, quality is clearly not an option, but rather a standard.
Speed – We stock nearly all components necessary to build standard, or reasonably custom, chambers in a very short period of time. All major components to each room are tested prior to shipment. Our temperature control systems are pre-charged, tested, and wired for exceptionally fast on-site installation. We consolidate shipments, where possible, to save on shipping costs, reduce shipping problems, and smooth overall installation logistics. Where competitors often call out 6 month lead-times we may call out 6 weeks or less.
Performance – Utilizing an effective blend of the most trusted and recent technologies available has allowed us to design and produce what we consider to be the highest performing walk-in stability testing chamber. We excel in the actual calculated electrical efficiency of each room using high efficiency EC (Electrically Commutated) fan motors, high performance 4” polyurethane foamed-in-place panels, UV-disinfected ultrasonic humidification, and our unique PFTCU (Precision Fluid Temperature Control Unit). On-site validation services that have included multi-point temperature and humidity mapping have repeatedly proven nearly unbelievable uniformity and control results that far surpass FDA/ICH/GMP guidelines.
Price – All of the most exciting technologies in the world do not mean anything if the price is not within budget. Our chambers exceed performance specifications while lowering cost projections. We, like many other manufacturers, feel price increases on everything from materials, to fuel, to health care and yet have still succeeded in maintaining truly reasonable pricing. We are tirelessly engineering better solutions that improve our product performance, reliability, and price. We believe there are many considerations to include in our price view, including: initial installation costs, electrical efficiency, lost “down” chamber time, service costs, and testing results.

Benefits

  • Outstanding temperature/humidity control and uniformity. FDA/ICH guidelines concerning control performance is easily exceeded. Our typical stability room will produce mapped and validated results of better than ±0.5° C and ±1.0 RH throughout the storage volume of the room. Control at a sensor of ±0.1° C and ±0.3% is normal.
  • Precision Fluid Temperature Control Unit cooling system utilizes a combination of refrigerant technologies and glycol/water heat exchange technologies.
  • A typical 9’W x 10’D x 8’ 4”H walk-In stability room will require fewer than 1000 Watts to operate at 25°C/60% and 30°C/65%. At 40°C/75% the efficiency (typically 500Watts or less) is even better. This savings can be substantial in comparison to competitors (up to $2500 per year) especially when multiplied by the operation of several rooms.
  • Conditioning system can be replaced or relocated quickly due to simple water-type connections.
  • Optional on-site validation services that have included multi-point temperature and humidity mapping have repeatedly proven nearly unbelievable uniformity and control results that far surpass FDA/ICH/GMP guidelines. Equipment utilized: Amphenol/Kaye Validator.
  • Rooms that include an optional redundant refrigeration system allow uninterrupted operation upon a refrigeration failure. The room does not need to be taken out of service during repair, as the failed system can be isolated and serviced with no impact upon the chamber operation.
  • ADA compliance available with no additional cost to the customer.
  • Supplied with vapor proof LED lights which emit significantly more light per unit of input energy than fluorescent bulbs. They also produce less radiant heat, and with less heat used, the cooling requirement for the controlled environment is diminished and the total energy used by an LED-equipped chamber is substantially reduced.
  • Exclusive Antimicrobial Coating on door handle to reduce the spread of bacteria and pathogens.
 

Features

Standard Features

  • 4” Polyurethane Insulated Panels, 100% Foamed-In-Place
  • Embossed White Aluminum Interior Surface Finish
  • Embossed White Galvanized Steel Exterior Surface Finish
  • Exceptional Temperature And Humidity Uniformity
  • Humidity Control At Sensor: ±0.3%
  • Temperature Control At Sensor / Set-Point: ±0.1° C
  • High / Low Alarms
  • Flexible Configurations
  • Complies With LEED Standards
  • Energy Efficient Offering-Lowered Maintenance Costs
  • Pre-tested, Pre-charged Refrigeration Systems
  • Non-proprietary Controls
  • UV sterilized ultrasonic humidification
  • Temperature Range of 20°C to 40°C
  • 25°C/60%, 30°C/60%, 30°C/65%, 40°C/75% capability
  • Controls with Auto-tuning, Fuzzy Logic
  • Dry Alarm Contacts and Modbus Communication for Connections to Building Management Systems

Optional Features

  • Added Dehumidification
  • Extended Temperature And Humidity Ranges
  • Stainless Steel / Special Surfaces
  • Ethernet / Remote Monitoring / Alarming
  • Corrosive Resistant Equipment
  • Added Redundancy in Controls and/or Conditioning
  • Data Logging and/or Chart Recorders
  • Water-Cooled Or Air-Cooled Condensers
  • Custom Lighting Systems
  • High Density Shelving
  • Unlimited Door / View Window Sizing
  • Insulated Glass View ports
  • High Weight Capacity Flooring
  • Calibration / Validation / Maintenance Services
  • Touch Screen Control Interface
  • Electronic Door Lock with Data-Logged Access
  • Direct Refrigeration
  • Sizes Available to the Nearest Inch

The Darwin Advantage

All installed instrumentation is calibrated to NIST traceable standards and provided with a calibration form. In-house, factory calibrations are performed using state-of-the-art equipment with great accuracies. These reports are three-point verifications, traceable calibration documents.