General Technical Bulletin

NU-NR800 Performance Evaluation for Compliance to USP797 and USP800

Within the USP797 and USP800 chapters many aspects of PEC’s are discussed. This includes CACI’s starting with their definition, design characteristics, placement, performance verification and general use. In regard to design characteristics, placement, performance verification and general use, the USP797 states that “It is incumbent on the compounding personnel to obtain from the manufacturer that the CAI/CACI will meet this standard.” To assure that NuAire’s CACI complies, NuAire has performed various testing to the CETA CAG-002 as well as additional performance testing exceeding the specified requirements. To assure compliance we will review the current version of USP797 chapter on each of the above CACI aspects and reference compliance design and/or product performance verification testing as documented in this technical bulletin.

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