Compounding Pharmacies

Compounding Pharmacies

USP <797>Compounding Pharmacies

USP <797> provides practice and quality standards for all persons who make Compounded Sterile Preparations (CSP) drugs and nutrients and for all environments in which they are prepared.

It describes conditions and practices to prevent harm, including death, to patients that could result from microbial, chemical and physical contamination, endotoxins and variability in the intended strength of ingredients

USP <797> requires that the preparation of CSPs occur in ISO Class 5 (Class 100) environments, buffer areas of ISO Class 7 (Class 10,000), and ante-areas of ISO Class 8 (Class 100,000).

Achieving and maintaining USP <797> compliance in sterile compounding cleanroom environments requires the practice of special cleaning procedures and protocols.

Cleaning Guides

Click here to open our Quick Reference Guide on USP <797> cleaning compliance and click here to open our USP <797> Products Guide.


Texwipe offers a comprehensive array of cleanroom consumables including Sterile IPA, Sterile Dry and Pre-Wet Wipers, Autoclavable Mops, Disinfectants and Cleaning Validation swabs that are designed to make USP <797> compliance easier for you.