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- ESL - Walk-in Stability Rooms
ESL - Walk-in Stability Rooms
Stability chambers and stability rooms are temperature- and humidity-controlled environmental units that provide stable conditions for storage and testing purposes. They are designed for specific loading conditions and provide the precise temperature/humidity control required for testing the long-term, intermediate, or accelerated degradation of a product or its packaging over time.
Our skilled engineers are ready to meet the demands of customers seeking complex, high-quality testing environments, including the stringent stability room guidelines set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Our Stability Rooms combine maximum flexibility with advanced reliability features, providing precise control over temperature and relative humidity (RH).
- Ranging from testing chambers to stability rooms exceeding 5,000 square feet
- Compliance with standard ICH guidelines:
- +5°C temperature only
- +25°C, 40-percent RH
- +25°C, 60-percent RH
- +30°C, 60-percent RH
- +30°C, 65-percent RH
- +40°C, 75-percent 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 built with insulated metal structure
- Material choices 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 to building management and building automation systems
- 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 finishes include stainless steel or embossed white galvanized steel
- Standard panel thickness of four inches
- Floor panel
- Stainless steel, galvanized steel, or diamond plate finishes
- Standard floor load rating of 600 pounds per square foot, with higher rating if necessary
- Factory Mutual (FM) 4880 fire rating available
- Lighting:
- Vapor-proof LED fixtures
- Standard or motion detected lighting controls
- Option for filtered lighting
- Controls:
- Proportional–integral–derivative (PID) or programmable logic controller (PLC)
- Optional redundancy
- Minimum one-year labor and materials with variable extended warranty available
- 24-hour duration
- Monitoring points ranging from 16 to 24 unloaded
- Validation available as an additional service, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)
- 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
We can design our stability rooms to meet a variety of highly specialized requirements, including:
- Customer/project specific customizations