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Aqueous injections for administration into the vascular and central nervous systems pose the greatest risk of harm to patients if there are issues of nonsterility and large errors in ingredients.The intent of this chapter is to prevent harm and fatality to patients that could result from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in CSPs.The publication of the USP in 2004 represents the first official enforceable standard for sterile compounding in the United States.

Porta Fab specializes in the turn-key design and construction of modular clean rooms including applications specifically requiring USP 797 compliance.

Our in-house team of engineers, architects and designers will provide assistance with the design and qualification process, while our nationwide network of local distributors will complete the construction and installation of your new enclosure.

For the purposes of this chapter, CSPs include any of the following: The sections in this chapter are organized to facilitate practitioners’ understanding of the fundamental accuracy and quality practices of CSPs.

They provide a foundation for the development and implementation of essential procedures for the safe preparation of CSP’s in the three risk levels, which are classified according to the potential for microbial, chemical, and physical contamination.

It is important to note that some CSPs are prepared and administered in clinics, at the bedside, in procedural areas, and in operating rooms with little direct pharmacy oversight.

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