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Stability Chamber ICH Q1A

Name: Stability Chamber ICH Q1A
Brand: Ozone India Technology
Availability: InStock

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.

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.

Product Specifications for Stability Chamber ICH Q1A
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