NU-PR797 Performance Evaluation for Compliance to USP797

General Technical Bulletin

NU-PR797 Performance Evaluation for Compliance to USP797

Dive into the NuAire Model NU-PR797 Positive Pressure Recirculating Compounding Aseptic Isolator's technical intricacies and compliance with USP 797 standards. This detailed document serves as an essential resource for pharmacists and laboratory personnel. It meticulously outlines how the NU-PR797 meets the stringent requirements of USP Chapter 797 for Pharmaceutical Compounding - Sterile Preparations. The document explains the vital role of Restricted-access barrier systems (RABS), particularly Compounding Aseptic Isolators (CAIs), in maintaining the highest quality of Compounded Sterile Preparations (CSPs).

Key highlights include the model's adherence to design characteristics, performance verification, and general use as stipulated by USP 797. It delves into the specifics of ensuring an ISO Class 5 environment, the critical aspect of air filtration and purification, and the importance of maintaining first air quality in the Direct Compounding Area (DCA). The document also addresses the necessity of regular surface and deep cleaning, disinfecting protocols, and personnel hygiene practices in line with USP 797 guidelines.

Furthermore, it presents the results of extensive performance verification and cross-contamination testing, demonstrating the NU-PR797's capability to sustain ISO Class 5 conditions during dynamic compounding processes. This comprehensive review affirms the isolator's compliance with USP 797 and provides a foundation for developing standard compounding work instructions, emphasizing the importance of maintaining aseptic conditions.

Please download this document for an insightful overview of the NuAire Model NU-PR797's functions, features, and compliance with critical pharmaceutical standards, ensuring your facility follows the highest safety and quality measures.