Blueprint for implementing USP chapter 797 for compounding sterile preparations.

Abstract

PURPOSE: Guidelines for adopting and successfully implementing the requirements of the United States Pharmacopeia (USP) chapter 797 for compounding sterile preparations are presented. SUMMARY: The quality of a compounded sterile preparation (CSP) is directly related to the methods used to ensure that the CSP achieves the desired goal of purity, potency, and sterility. A properly designed, constructed, and maintained cleanroom contributes to the quality of CSPs. Design criteria of a sample clean-room are supplied, as are a summary and comparison of the liquid disinfectants that can be used to clean and sanitize the facility and maintain environmental controls. All activities associated with cleaning the cleanroom, including air and surface sampling, must be properly documented in logs, examples of which are provided. A robust employee-training program for properly teaching aseptic technique and a method to verify that personnel have successfully completed the program are integral to compliance with chapter 797 and thoroughly discussed herein. Emerging compounding and testing technology is also discussed. CONCLUSION: Although the task of compliance with the requirements of USP chapter 797 may appear overwhelming, complicated, expensive, and even unattainable, quality can be established via a methodical and organized approach. After the systems have been implemented, maintaining them requires vigilance and follow-up. Compliance with chapter 797 involves up-front and ongoing costs associated with establishing these systems, but the time, energy, and cost required to maintain them are far less than those of retrospective or manual systems of collecting, reviewing, and collating quality assurance data on a monthly basis.