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Advanced Environmental Monitoring to Align with Updated USP <797> and <800> Standards
Advanced Environmental Monitoring to Align with Updated USP <797> and <800> Standards

With the updated USP <797> and <800> regulations having come into effect on November 1st, 2023, pharmaceutical compounding faces new challenges in environmental control. These standards, vital to ensuring the safety and efficacy of compounded sterile preparations (CSPs), emphasize a risk-based approach to beyond-use dates and the criticality of precise environmental controls. For facilities looking to meet these new benchmarks, understanding and preparing for compliance is paramount.

USP Standards and Setra FLEX Compatibility:

USP <797> has introduced new categorizations for (CSPs), focusing on environmental quality and control measures. Setra FLEX's ability to display Differential Pressure (DP), Temperature (T), and Relative Humidity (RH) aligns with these newly implemented requirements. Its sophisticated monitoring system ensures compliance with the stringent environmental controls mandated by USP <797> for Category 2 and 3 CSPs, which require meticulous environmental monitoring and control.

Setra Systems Setraflex

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