Common Stability Study Setpoints
▣
25°C / 60% RH
Long-Term Condition
▥
30°C / 65% RH
Intermediate Condition
♨
30°C / 75% RH
Hot & Humid Condition
♨
40°C / 75% RH
Accelerated Condition
Study conditions must be selected according to the applicable protocol, product and regulatory market.
From Study Setup to Traceable Records
1
Define
User requirements
and study setup
and study setup
→
2
Select Setpoints
Choose study conditions
→
3
Load Samples
Organize study batches
→
4
Monitor
Real-time HMI overview
→
5
Records
Audit trail & reports
Designed for Stability Programmes
≋
Uniform Sample Storage
Controlled conditions support consistent studies.
◉
Continuous Monitoring
Critical and vital parameters remain visible on the HMI.
♧
Secure Alarm Management
Deviations, door opening and events are recorded.
▤
Flexible Shelving
Adjustable perforated SS trays organize multiple study batches.
▣
Observation Window
View samples without opening the primary door.
Data Integrity & User Control
Aligned with 21 CFR Part 11-ready configuration
♙
User Access Levels
Role-based access levels for operators and reviewers.
▢
Password-Protected Settings
Critical parameters are protected from unauthorized changes.
▤
Audit Trail
Automatic audit trail of configuration changes and events.
♙
Operators Log
Track user logins, logouts and activity.
♧
Alarm History
All alarm events are time-stamped and stored for review.
▤
Programmable Recording Interval
Set custom recording intervals for study parameters.
Technical Specifications
A Performance
Temperature Range: 20°C to 60°C
Temperature Accuracy: ±0.5°C
Temperature Uniformity: ±1°C
Humidity Range: 40% to 95% RH
Humidity Accuracy: ±3% RH
Humidity Uniformity: ±5% RH
Temperature Accuracy: ±0.5°C
Temperature Uniformity: ±1°C
Humidity Range: 40% to 95% RH
Humidity Accuracy: ±3% RH
Humidity Uniformity: ±5% RH
B Construction
Interior: Single atmospheric chamber
Exterior: SS 304 stainless steel
Insulation: PUF / CFC-free PUF
Door: Double-door configuration
Shelves: Perforated SS trays
Chamber Capacity: Custom
Outer Dimensions: Custom
Exterior: SS 304 stainless steel
Insulation: PUF / CFC-free PUF
Door: Double-door configuration
Shelves: Perforated SS trays
Chamber Capacity: Custom
Outer Dimensions: Custom
C Controls & Utilities
Controller: PLC-based programmable controller
Display: Capacitive touchscreen HMI
Data Logging: Temperature, humidity and alarms
Programming: Ramp-and-soak profiles
Power Supply: 230 VAC, single phase, 50 Hz
Power Consumption: Product dependent
Compliance: 21 CFR Part 11-ready package
Display: Capacitive touchscreen HMI
Data Logging: Temperature, humidity and alarms
Programming: Ramp-and-soak profiles
Power Supply: 230 VAC, single phase, 50 Hz
Power Consumption: Product dependent
Compliance: 21 CFR Part 11-ready package
Engineered for
Continuous Stability Storage
Continuous Stability Storage
♨
Air Heating
Stable temperature
control
control
❄
Refrigeration
Humidity controlled
cooling system
cooling system
≋
Steam Humidification
Accurate moisture
control
control
◉
Forced-Air Circulation
Uniform conditioned
airflow
airflow
▯
Door Sealing
Secure gasket and
positive locking
positive locking
▤
Adjustable Shelving
Flexible fit for
product positioning
product positioning
Active Monitoring and Protection
✓
Temperature
Deviation
Deviation
♨
Humidity
Deviation
Deviation
◉
Compressor
Protection
Protection
♧
Alarm
Management
Management
▯
Door-Open
Interlock
Interlock
↑
Over-Temperature
Protection
Protection
Stability Testing Applications
⚗
Drug
Substances
Substances
▤
Finished
Formulations
Formulations
◇
Primary
Packaging
Packaging
◫
Light-Protective
Packaging
Packaging
◇
Pharmaceutical
R&
R&
♧
Pharmaceutical
R&D
R&D
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