Logo - International Journal of Pharmaceutical Compounding

Quality-Control Analytical Methods: Sterility Failure Investigations

Author(s):  Venti Eden M

Issue:  Sep/Oct 2006 - Dermatology
View All Articles in Issue

Abstract:  Sterility testing is an important step in verifying that the aseptic process has rendered a preparation sterile. Ensuring sterility involves the oversight and control of many factors, including compounding personnel, pharmacy environment, equipment and materials used in the compounding of sterile preparations, and compounding and aseptic methods. A pharmacy should have a standard operating procedure in place for investigating sterility failures, and an important focus in the procedure should be good documentation. Routine evaluations of a pharmacy’s compounding practices should be considered even though such evaluations may present a challenge to the pharmacy’s quality control system. Proper training and encouragement of staff to present possible sterility problems could make the difference in avoiding compounding failures.

Related Keywords: sterile preparations, sterility testing, quality control, USP

Related Categories: STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

Purchase this article for download in electronic PDF format from IJPC at for $75 at:
https://ijpc.com/Abstracts/Abstract.cfm?ABS=2449

Search the entire IJPC archive by keyword, topic, or issue at:
https://ijpc.com/Products