NU-NTE800 Performance Evaluation for USP797 and USP800

General Technical Bulletin

NU-NTE800 Performance Evaluation for USP797 and USP800

The "NU-NTE800 Performance Evaluation for USP797 and USP800" document presents an extensive review of NuAire's Compounding Aseptic Containment Isolator (CACI), focusing on its compliance with USP Chapters 797 and 800. It elaborates on the CACI's design characteristics, placement, performance verification, and usage, ensuring adherence to the latest pharmaceutical compounding standards. Key aspects include testing for ISO Class 5 environment compliance, ensuring product sterility, and protecting personnel during hazardous drug handling. This bulletin is an essential guide for pharmacy professionals upholding high safety and quality standards.

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USP 797 and USP 800 PEC Requirements

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Understanding Compounding Isolators

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Setting the Blower Password on the Aeromax Control System

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