Common test conditions and precautions for using drug stability test chambers
Common test conditions and precautions for using drug stability test chambers

30

2026

-

05

Common test conditions and precautions for using drug stability test chambers

I. Commonly Used Test Conditions (ICH Q1A + Chinese Pharmacopoeia)

1. Long-Term Testing (To Determine Shelf Life)

- 25℃ ±2℃ / 60%RH ±5%RH, 12-24 months

- Tropical/Hot and Humid Regions: 30℃ ±2℃ / 65%RH ±5%RH

2. Accelerated Testing (To Rapidly Assess Stability)

- 40℃ ±2℃ / 75%RH ±5%RH, 6 months

- If related substances show a significant increase/decrease of >5% within 6 months, intermediate conditions of 30℃/65%RH are required.

3. Influencing Factor Testing (Forced Degradation, for R&D/Registration)

- High Temperature: 60℃, 10 days

- High Humidity: 25℃ / 90%RH ±5%RH, 10 days

- Light Exposure: 4500±500 lux, total illuminance ≥1.2×10⁶ lux·hr; Near UV ≥200 W·hr/m²

- Low Temperature/Freeze-Thaw Cycle: -20℃ ±5℃, 3 cycles (simulated cold chain)

4. Special Pharmaceuticals

- Refrigerated Goods: 5℃ ±3℃ / 60%RH ±5%RH, long-term

- Frozen Goods: -20℃ ±5℃, long-term
II. Usage Precautions (Compliance + Avoiding Scams)

✅ 1. Installation and Environment

- Environment: 5-30℃, ≤85%RH, away from heat sources, direct sunlight, and strong electromagnetic interference

- Ground: Level, with sufficient load-bearing capacity; leave ≥30cm of space around the perimeter for heat dissipation

- Power Supply: 220V±10%, independent grounding, to avoid tripping/drifting

- Water Source: Distilled water/deionized water/water for injection must be used; tap water is strictly prohibited (scale, algae, corrosion)

✅ 2. Validation and Calibration (Required for GMP)

- For first use: IQ/OQ/PQ (9-15 point temperature and humidity mapping, 24-48h)

- Regular use: Once a year; retest after major overhaul/relocation

- Sensors: Calibrate once a year (metrological traceability)

✅ 3. Sample Placement

- Loading capacity: ≤20% of chamber volume, heat-generating samples ≤10%

- Spacing: ≥5cm between samples, do not obstruct air outlets/sensors

- Layering: Place samples evenly in each layer, upper layers should not press down on lower layers

- Sealing: Seal liquid/volatile samples; light-sensitive samples should be packaged in a light-proof manner

✅ 4. Operation and Door Opening/Closing

- Door opening: Minimize and speed up opening; pause humidification before opening to prevent condensation and icing

- Fluctuations: Single door opening <1 minute, ≤3 times per day

- Stability: No load for 30 minutes before placing samples, ensure temperature and humidity are stable before adding samples

✅ 5. Daily Maintenance

- Water Tank: Weekly cleaning, monthly water change, prevents algae and blockages

- Defrosting: For long-term low-temperature operation, defrost every two weeks at 40℃ for 2 hours.

- Cleaning: Clean the inner tank with a soft cloth and neutral detergent; strong acids and alkalis are prohibited.

- Data: Full audit and traceability; parameter modifications are double-checked and documented.

✅ 6. Safety Red Lines

- Prohibited from entering the tank: Flammable, explosive, volatile, toxic, and highly corrosive substances.

- Prevent burns/electric shocks: Do not touch heating/cooling components during operation; do not touch electrical components with wet hands.

- Power outage: Power restored within 30 minutes; otherwise, transfer samples to a spare tank.

Common test conditions and precautions for using drug stability test chambers

Common test conditions and precautions for using drug stability test chambers

2026-05-30

What is a linear rapid temperature chamber, and what is a nonlinear rapid temperature chamber?

What is a linear rapid temperature chamber, and what is a nonlinear rapid temperature chamber?

2026-04-30