Pre-Use Preparation

​​

1. Review Documentation​​

• Thoroughly read the stability chamber guidelines to understand operational parameters, technical specifications, safety protocols, and maintenance requirements.

2. Equipment Inspection​​

• Verify the chamber’s structural integrity (e.g., no cracks, deformations, or seal failures). Ensure proper functioning of internal components like shelves, racks, and sensors.
• For chambers requiring external connections (e.g., power, data ports), confirm intact wiring and secure connections.

3. Environmental Setup​​

• Place the chamber in a stable, vibration-free area with controlled ambient conditions (+5–35°C). Avoid direct sunlight, moisture, corrosive substances, or heat sources.

Sample Preparation

​​

1. Sample Selection & Handling​​

• Choose samples based on test objectives (e.g., pharmaceuticals must be properly labeled and packaged for stability testing).
• Pre-process samples as needed (e.g., dose-specific aliquoting, sealing).

2. Sample Loading​​

• Arrange samples evenly on shelves/racks to ensure uniform environmental exposure. Prevent overcrowding or obstruction of airflow.

Parameter Configuration

​​

1. Temperature Settings​​

• Input target values via digital controls (resolution: ±0.1°C). Select temperature ranges (e.g., -20°C to 0°C for cryogenic tests; 0°C to 100°C for standard applications).

2. Humidity Control (for humidistatic chambers)​​

• Set RH levels (typical range: 20–95% RH) using onboard controls. Validate accuracy against calibration standards.

3. Advanced Parameters​​

• Configure dynamic cycling (e.g., temperature ramps, humidity cycles) for specialized tests like ICH-compliant stability studies.

Operational Protocol​​

1. Chamber Activation​​

• Seal the chamber door securely. Most systems auto-validate door closure before initiating tests.

2. Run Initiation​​

• Press the start button. Monitor real-time data via built-in displays or remote interfaces (if enabled).

In-Process Monitoring​​

1. Real-Time Tracking​​

• Track temperature/humidity trends using integrated software. Enable alerts for deviations exceeding ±1°C/±3% RH.

2. Incident Management​​

• Halt operations immediately for critical failures (e.g., sensor malfunctions, overheating). Follow stability chamber guidelines for troubleshooting (e.g., recalibrate sensors, contact technical support).

Post-Test Procedures​​

1. System Shutdown​​

• Power down the chamber and disconnect electrical supplies.

2. Sample Retrieval​​

• Handle samples cautiously post-test (e.g., thermal gloves for extreme temperatures). Inspect for physical damage.

3. Maintenance​​

• Clean residual contaminants (e.g., condensation, particulates) with non-abrasive wipes. Schedule periodic recalibration and system checks (e.g., refrigerant levels, fan functionality).