Sterile Basics: How to Know if Your Cleanroom Can Consistently Operate Within a State of Control
Author(s): Summers Amy, Stephens Pat
Issue: Jan/Feb 2023 - Volume 27, Number 1
View All Articles in Issue
Page(s): 39-46
Download in electronic PDF format for $65
Abstract: Whether sterile compounds are prepared in a brand new state-of-the-art cleanroom suite or in an aging space, compounders rely heavily on their primary and secondary engineering controls when sterilizing or maintaining sterility of the final preparation. With the release of the latest revision to United States Pharmacopeia Chapter <797>, organizations that prepare sterile compounds must now sample and test each classified area for the presence of microbiological contaminants at a higher frequency. Facilities that are not purpose-built, as well as those that do not operate within a state of control, are predicted to repeatedly exceed action levels as set by the United States Pharmacopeia Convention, Inc. Before the United States Pharmacopeia revision becomes active and enforceable, it is advised that sterile compounding practice sites undergo an environmental-baseline study to gather statistically significant data to demonstrate how the cleanroom(s) perform and to assess whether or not dynamic operations increase the levels of bioburden.
Related Keywords: Amy Summers, PharmD, BCSCP, Pat Stephens, PharmD, CQA, compounded sterile preparations, cleanroom, engineering controls, sterility, microbiological contamination, United States Pharmacopeia Chapter <797>, USP, environmental baseline study, cleanroom air monitoring, cleanroom surface monitoring, microbial contaminants, particulate contamination, environmental monitoring, sampling locations, static testing, dynamic testing
Related Categories: ENVIRONMENTAL , STERILE PREPARATIONS, UNITED STATES PHARMACOPEIA CONVENTIONS, INFORMATION RESOURCES