STABILITY CHAMBER GUIDELINES: OPERATIONAL PROCEDURES AND BEST PRACTICES​​

2025-05-16 56

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 chambers 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 (+535°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: 2095% 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).

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