ICH Stability Chamber

ICH Stability Chamber

Bring your stability testing in-house, saving time and improving efficieny with a ICH Stability Chamber from CRS. Our chambers our available for purchase or hire making them a fantastic alternative to off-site stability studies and storage.

The CRS ICH Stability Chamber used a combined temperature and humidification conditioner with supply air ducting running the entire length of the chamber ceiling and return air ducts at floor level on both sides of chamber.

Main features:

  • Temperature: +/- 0.2 °C
  • Relative Humidity: +/- 0.5% Rh
  • Smart Controller: allowing multiple setpoints & controlled cycling between temperatures
  • Lighting
  • No boilers, small steam injectors
  • DI or distilled water not required

Features

Stability chambers, or rooms, from CRS are designed with an integrated, easy-to-use control system providing a stable, humidity and temperature-controlled environment which guarantees constancy of operation.

Companies that adopt these free-standing, conditioned walk-in rooms can stand to reap huge benefits in terms of increase shelf space and maximising their available space.

By opting for a conditioned walk-in cold room, you can take advantage of massive cost savings when compared to using multiple reach-in chambers.

Lower your energy costs, reduce servicing demands, reduce your installation costs and cut the floor space required, all while increasing usable space.

Technical Specification

We offer insulated, portable walk-in rooms designed to specific sizes and applications. The room generator will maintain relative humidity control to 0.5%RH and temperature control to 0.2°C.

Our stability chambers also feature a unique smartpad controller with serial interface for external operation and offers an alarm facility.

The ICH Stability Chambers has been mapped and validated for shelf life studies under the following conditions, including intermediate testing and accelerated testing per ICH Q1A (R2).


Long-Term & Intermediate conditions of
25°C/40%RH, 25°C/60%RH, 30°C/65%RH, and 30°C/75%RH


Accelerated storage conditions of
40°C/not more than 25%RH, 40°C/75%RH


Refrigerated storage conditions of
2°C – 8°C (5°)


Further Information

Advantages of our portable Stability Rooms include:

  • Precise control tolerances
  • No boilers, steam injectors or high purity water required
  • Requires approximately half the energy usage as standard steam injection systems
  • Very low water usage. Most rooms can operate on less than 1 gallon of water per day
  • System does not require deionized (DI) or reverse osmosis (RO) Water
  • System maintains a reservoir of water which is capable of operating for several days during process water interruption

This graph shows validation data performed on our ICH Stability Chamber. The standard deviation rates for the entire data set indicate that the room is being controlled very tightly throughout the validation cycle.


Biological Storage

CRS are proud to offer a wide range of conditions required for Biological Storage and are able to offer bespoke solutions as required.

  • 5°C ± 3°C
  • –20°C ± 5°C
  • –80°C ± 10°C

Sample Types Stored

  • Blood & Plasma
  • Explant Device Storage (e.g. hip replacements)
  • Pathology & Legal samples
  • Bone
  • DNA/RNA
  • Fluids & Urine
  • Agro & Plant samples
  • Serum
  • Other Biological Materials

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Company Registration Number: 212485. For purposes of quality control and staff training, CRS reserve the right to record all sales and enquiry calls, both incoming and outgoing. If you have any queries about the uses of recorded phone calls please contact us via enquiry@crs.ie.