Stability chambers are critical for conducting long-term stability studies for pharmaceutical products, vaccines, and other temperature-sensitive goods. These chambers must operate under controlled conditions that follow guidelines such as the ICH standards:
25°C / 60% RH (Long-term)
30°C / 65% RH (Intermediate)
40°C / 75% RH (Accelerated)
5°C (Cold Storage Studies)
Westcal’s Stability Chamber Temperature Mapping service ensures that your stability chambers meet these requirements, providing reliable and consistent environmental conditions for accurate study results.
Stability chambers play a vital role in pharmaceutical and clinical research by simulating long-term storage conditions. Any fluctuation in temperature or humidity can compromise study outcomes and regulatory compliance. Our Stability Chamber Temperature Mapping service ensures that your chamber operates within prescribed conditions, supporting accurate results for stability studies and ensuring adherence to international guidelines.
Our comprehensive Stability Chamber Temperature Mapping service includes the following steps:
Temperature and Humidity Behavior Recording: We monitor both temperature and humidity levels throughout the chamber to assess uniformity and stability.
Long-Term Condition Validation: We validate the chamber’s performance under continuous and uninterrupted operation, ensuring stability across extended periods.
Compliance with Guidelines: We ensure that your stability chamber meets ICH, WHO, MOH, and study-specific protocols, supporting regulatory and compliance requirements.
Fluctuation Identification: We identify fluctuations in temperature or humidity caused by load, sensors, or airflow distribution, ensuring stable conditions for your products.
Accurate Stability Chamber Temperature Mapping is essential to avoid:
Inaccurate Stability Study Results: Mapping ensures that the chamber provides consistent conditions, supporting reliable study data.
Regulatory Non-Compliance: Proper mapping ensures your chamber meets ICH, WHO, and other pharmaceutical regulatory expectations.
Long-Term Equipment Reliability: Consistent mapping helps reduce the risk of equipment failure and extends the life of your stability chamber.
After the completion of Stability Chamber Temperature Mapping, we provide:
Temperature & RH Uniformity Report: Detailed analysis of temperature and relative humidity (RH) uniformity within the chamber.
Stability Assessment and Deviation Summary: In-depth summary of the stability performance, identifying any deviations or areas of concern.
Compliance-Ready Documentation: A comprehensive report with the required documentation for audits and regulatory inspections.
Ensure the reliability and accuracy of your stability studies with Westcal’s Stability Chamber Temperature Mapping service. Contact us to schedule a consultation and ensure your stability chambers are operating within the required conditions for regulatory compliance and scientific accuracy. Let us help you maintain the highest standards in your research and testing processes.