Sterile Basics: How to Know if Your Cleanroom Can Consistently Operate Within a State of Control.

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.