Stability Rooms are controlled environments that maintain precise temperature and humidity conditions for storage and testing applications. Designed to support specific loading requirements, these units provide the consistency needed to evaluate long-term, intermediate, or accelerated degradation of products and their packaging over time.
Environmental Specialties' team of experienced engineers are equipped to deliver high-performance testing environments tailored to complex needs—including full compliance with the stringent stability room guidelines established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Video Credit: Environmental Specialties, LLC
Versatile stability room design
The stability rooms combine maximum versatility with sophisticated dependability features, allowing for precise regulation of temperature and relative humidity (RH).
Sizes and capabilities
Sizes
- Ranging from testing chambers to stability rooms exceeding 5,000 square feet
Capabilities
- Adherence to accepted ICH guidelines:
- +5 °C temperature only
- +25 °C, 40 % RH
- +25 °C, 60 % RH
- +30 °C, 60 % RH
- +30 °C, 65 % RH
- +40 °C, 75 % RH
- Temperature uniformity of +/- 3 °C.
- Single point or variable set-point temperature control accuracy of +/-0.1 °C.
- N+N (2N) 100-percent mechanical redundancy systems with automatic switchover.
- Rooms are built with an insulated metal structure.
- A range of materials are available for corrosive or aggressive cleaning agents.
- Controls compliance with Food and Drug Administration Code of Federal Regulations Title 21 Section 11.
- Standard controls can be integrated into building management and building automation systems.
Construction and features
Architectural features
- Modular metal skinned panels with urethane insulation featuring “cam-locking” tongue-and-groove construction, as well as vinyl gasketed seams fitted on the interior and exterior of each panel to provide moisture- and vapor-tight seal
- Insulated panel finish options: stainless steel or embossed white galvanized steel.
- Standard panel thickness: 4 inches.
- Floor panel
- Stainless steel, galvanized steel, or diamond plate finishes.
- The standard floor load rating is 600 pounds per square foot, with a greater rating if necessary.
- Factory Mutual (FM) 4880 fire rating available.
Electrical features
- Lighting
- Vapor-proof LED fixtures.
- Standard or motion-detected lighting controls.
- Filtered lighting option.
- Controls
- Proportional–integral–derivative (PID) or programmable logic controller (PLC)
- Optional redundancy
Standard offerings
Warranty
- Minimum one-year labor and materials guarantee, with variable extended warranty options.
Site-specific safety plan
Start-up field performance testing
- 24-hour duration
- Monitoring points range from 16 to 24 unloaded
- Validation is offered as a supplemental service, encompassing installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)
Turnover documentation
- Master manual (engineering/design submittal)
- Recommended spare parts
- Major equipment datasheets
- As-built drawings and schematics
- Owner’s instructions
- Controls manual
- Equipment manual
- Warranty statements
- Field testing data
Special options
Stability rooms can be designed to meet a variety of highly specialized requirements, including:
- Customizations tailored to a customer or project.