1 / 3Stability Chamber ICH Q1A
ICH Q1A pharmaceutical stability chamber 25C 60RH and 40C 75RH for drug stability studies and shelf-life testing
OZ India Stability Chamber ICH Q1A for pharmaceutical drug stability studies at 25C/60RH long-term and 40C/75RH accelerated conditions. CDSCO compliant, CE certified, 21 CFR Part 11 data logging. Ozone India Technology, Greater Noida.
CE & ISO 9001:2015 certified manufacturer · Est. 2014 · 150,000+ installations · Greater Noida, India
Pharmaceutical-grade stability chambers for drug substance and drug product stability studies as per ICH Q1A guidelines. Pre-set conditions: 25 degrees C / 60 percent RH (long-term), 40 degrees C / 75 percent RH (accelerated), 30 degrees C / 65 percent RH (intermediate), 5 degrees C (refrigerated). Microprocessor controller with 21 CFR Part 11 compliant data logging, audit trail, electronic records. Uniform temperature and humidity throughout chamber verified by mapping study. Validation documentation IQ/OQ/PQ available. Used by pharmaceutical manufacturers, API producers, CROs, and CDSCO-approved testing labs. CE certified, ISO 9001:2015.
| Long-Term Condition | 25 degrees C / 60 percent RH |
|---|---|
| Accelerated Condition | 40 degrees C / 75 percent RH |
| Intermediate Condition | 30 degrees C / 65 percent RH |
| Temperature Accuracy | plus minus 0.5 degrees C |
| Humidity Accuracy | plus minus 2 percent RH |
| Volume | 150-5000 litres custom |
| Data Logging | 21 CFR Part 11 compliant audit trail |
| Validation | IQ OQ PQ documentation available |
| Certification | CE, ISO 9001:2015, CDSCO compliant |
- ICH Q1A pre-set conditions — long-term accelerated and intermediate
- 21 CFR Part 11 compliant data logging — FDA CDSCO audit ready
- Uniform temperature humidity — chamber mapping study documentation
- IQ OQ PQ validation package — CDSCO GMP compliance
- Large capacity to 5000 litres — scale from R&D to production stability room
- CE certified CDSCO compliant — approved for drug stability submissions
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Frequently Asked Questions
Yes. Ozone India Technology stability chambers are designed to ICH Q1A(R2) conditions: Zone I/II (25°C ±2°C / 60% RH ±5% RH long-term), Zone III (30°C ±2°C / 35% RH ±5% RH), Zone IVa/IVb (40°C ±2°C / 75% RH ±5% RH accelerated). The chambers are suitable for pharmaceutical ICH stability studies for API and finished drug products.
Yes. The chamber meets the stability testing requirements of CDSCO Schedule Y (Indian pharmaceutical regulations), which reference ICH Q1A conditions. Chamber performance qualification (IQ/OQ/PQ) documentation is available on request to support CDSCO facility audits.
The stability chamber includes high/low temperature and humidity alarms with audible and visual alerts, door-open alarm, power failure alarm with battery backup for data logging, and optional GSM/SMS alert module for remote notification. 21 CFR Part 11 compliant data logging is available as an option.
Stability chambers are available in 100L, 250L, 500L, 800L, 1000L, and 1500L capacities. Walk-in stability rooms are available for large-scale pharmaceutical stability studies requiring bulk storage under controlled ICH conditions.
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OZ Stability Chamber