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Effect of two work practice changes on the microbial contamination rates of pharmacy-compounded sterile preparations

Lawrence A Trissel1, Joseph A Gentempo, Lisa M Saenz

  • 1TriPharma Research, Cashiers, NC 28717-0265, USA.

American Journal of Health-System Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists
|April 11, 2007
PubMed
Abstract

Insights

Implementing enhanced glove disinfection protocols, including repeated disinfection with isopropyl alcohol (IPA), significantly reduced contamination rates during aseptic sterile compounding. This practice is crucial for maintaining the integrity of pharmacy-compounded sterile preparations.

Area of Science:

  • Pharmaceutical Sciences
  • Microbiology
  • Healthcare Quality Improvement

Background:

  • Aseptic sterile compounding is critical for patient safety, requiring rigorous techniques to prevent microbial contamination.
  • The United States Pharmacopeia (USP) chapter 797 outlines standards for sterile compounding, emphasizing competency and risk assessment.
  • Evaluating work-practice changes is essential for optimizing contamination control in pharmacy settings.

Purpose of the Study:

  • To assess the effectiveness of two work-practice changes in reducing contamination during medium-risk-level sterile compounding.
  • To compare different glove disinfection strategies in a simulated compounding environment.

Main Methods:

  • A multistep testing procedure simulating complex medium-risk sterile preparations was employed.
  • Three groups were evaluated: Group A (bare/nonsterile gloves with initial 70% isopropyl alcohol (IPA) disinfection), Group B (nonsterile chemotherapy gloves with initial and repeated IPA disinfection), and Group C (sterile gloves with initial and repeated IPA disinfection).
  • Contamination was assessed by culturing growth medium after simulated compounding manipulations.

Main Results:

  • Groups B and C demonstrated significant reductions in contaminated samples compared to Group A.
  • Repeated disinfection of nonsterile chemotherapy gloves with IPA (Group B) and the use of sterile gloves with repeated IPA disinfection (Group C) were effective in lowering contamination rates.
  • The study simulated complex aseptic transfers, including reconstitution and multiple medium transfers.

Conclusions:

  • The use of protective chemotherapy gloves with repeated disinfection using isopropyl alcohol (IPA) effectively decreased the contamination rate of pharmacy-compounded sterile preparations.
  • Annual competency assessment in aseptic sterile compounding is mandatory for pharmacists and technicians.
  • These findings support the implementation of enhanced glove hygiene practices to improve sterile compounding safety.

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