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

Area of Science:

• Pharmacy Education
• Sterile Compounding
• Quality Assurance

Background:

• Aseptic technique validation testing is crucial for pharmacy students before health-system practice experiences.
• Current pharmacy curricula lack detailed descriptions of integrating United States Pharmacopeia (USP) Chapter 797 standards for validation testing.

Purpose of the Study:

• To describe the successful incorporation of aseptic technique validation testing into a pharmacy curriculum.
• To establish a model for implementing USP Chapter 797-compliant validation testing prior to advanced pharmacy practice experiences.

Main Methods:

• Implemented environmental and engineering controls for a segregated compounding area.
• Incorporated medium-risk media fill and gloved fingertip tests (GFT) for second and third-year pharmacy students.
• Conducted validation testing and knowledge assessments for graduating classes from 2018-2020.

Main Results:

• 234 students completed validation testing with uncommon media fill test failures.
• Initial gloved fingertip test failure rates were 16.1%-22.1% for second-year students and 3.2%-5.8% for third-year students.
• Consistent results were observed across three consecutive student cohorts.

Conclusions:

• The integration of aseptic technique validation testing into the pharmacy curriculum was successful and yielded consistent outcomes.
• The study provides practical guidance on class size, facility needs, protocol implementation, and resource allocation for validation testing.
• Students received documentation of annual training and validation, aligning with health-system pharmacy practice standards.