✅ Key Features:
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Compliance & Standards:
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Meets FDA, ICH Q1A & cGMP standards
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Supports long-term, accelerated, and intermediate stability studies
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Validation documentation – DQ, FAT, IQ, OQ, PQ with calibration certificates
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Construction & Controls:
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Advanced refrigeration, humidification, dehumidification, and air handling system
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PID/PLC based multifunctional controller with touch screen interface
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Auto changeover of standby systems for uninterrupted operation
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Ethernet networking, PC & printer interface for real-time monitoring
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Standard & Special Conditions:
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Pre-set stability conditions: 25°C/60%RH, 30°C/65%RH, 40°C/75%RH
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Optional custom configurations: 25°C/40%RH, 30°C/35%RH, 40°C/15%RH, 55°C/20%RH, 55°C/75%RH
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Data Management (21 CFR Part 11 Compliant):
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Secure electronic records & signatures
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Password-protected logins & authority-based access control
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Time-stamped audit trails for batch operations, alarms, configuration changes
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Export-ready reports with Excel conversion
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Performance & Accuracy:
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Temperature Range: 20°C to 60°C, ±0.2°C accuracy
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Temperature Uniformity: ±2°C
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Humidity Range: 40% to 95%RH, ±2%RH accuracy
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Humidity Uniformity: ±3%RH
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Safety & Reliability:
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Standby refrigeration, humidity, and sensor backup
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Audio-visual alarms for deviations and water level monitoring
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Overload protection & safety temperature controller
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SMS alerts for alarms and process values (single/multi-user)
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📦 Technical Specifications:
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Data Logger: 8 or 16 channel calibrated logger (temperature & humidity mapping, validation reports)
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Power Supply: 230V ±10%, 1 Phase AC, 50Hz OR 440V, 3 Phase AC
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Capacity: Custom-built to laboratory or industrial requirements
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Validation: DQ/FAT/IQ/OQ/PQ with calibration certificates
🧪 Applications:
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Pharmaceutical stability testing
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Biotechnology product incubation
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Drug and vaccine research
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Chemical stability and life cycle evaluation
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Accelerated aging and shelf-life studies
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