Implementation and sequencing of a compounded sterile preparation validation testing protocol for second- and...

Incorporation of aseptic technique validation testing in a pharmacy curriculum consistent with United States Pharmacopeia Chapter 797 Standards is not well described. Validation testing is optimally placed prior to assignment to health-system introductory and advanced pharmacy practice experiences.

Environmental and engineering controls consistent with a segregated compounding area were implemented. Medium risk media fill and gloved fingertip test (GFT) testing were incorporated to achieve initial and subsequent training in the second and third curricular years, respectively.

For the graduating classes of 2018 through 2020, 234 students completed validation testing and knowledge assessment. Failure of the media fill test was uncommon. Failure of the initial GFT testing occurred in 16.1% to 22.1% of second-year students and 3.2% to 5.8% of third-year students. No significant differences were seen between three consecutive student classes.

Incorporation of validation testing was successful, with consistent results. Procedures and results provide guidance with respect to student class size, available facility/equipment needs, implementation of validation protocols, and associated resources. Each student is provided with documentation of annual training and validation testing consistent with existing standards for health-system pharmacy practice.