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Related Experiment Videos

Using a medium-fill simulation to evaluate the microbial contamination rate for USP medium-risk-level compounding.

Lawrence A Trissel1, Joseph A Gentempo, Roger W Anderson

  • 1Division of Pharmacy, The University of Texas M. D. Anderson Cancer Center, Houston 77030, USA.

American Journal of Health-System Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists
|February 22, 2005
PubMed
Summary

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The study found a 5.2% microbial contamination rate in complex sterile compounding. Pharmacists had a lower rate (4.4%) than technicians (6.2%), suggesting touch contamination is a key factor.

Area of Science:

  • Pharmaceutical compounding
  • Microbial contamination
  • Sterile preparations

Background:

  • Complex sterile preparations require meticulous aseptic technique.
  • Assessing contamination rates is crucial for patient safety in healthcare settings.
  • United States Pharmacopeia (USP) guidelines define risk levels for compounding.

Purpose of the Study:

  • To estimate the microbial contamination rate in complex, multiple-step, medium-risk-level sterile compounding.
  • To evaluate the aseptic technique of pharmacists and technicians during compounding.
  • To identify potential sources of microbial contamination in sterile preparations.

Main Methods:

  • Compiled results from 539 aseptic technique evaluations conducted in 2002-2003.
  • Simulated compounding of USP medium-risk-level sterile preparations using sterile growth medium.

Related Experiment Videos

  • Incubated compounded preparations for 14 days to detect microbial growth.

    • Main Results:

    • Overall microbial contamination rate was 5.2% (28 out of 539 evaluations).
    • Pharmacists demonstrated a lower contamination rate (4.4%) compared to technicians (6.2%).
    • Inadvertent touch contamination was identified as a probable primary source of microbial growth.

    Conclusions:

    • Aseptic technique evaluations simulating USP medium-risk compounding revealed a 5.2% contamination rate over two years.
    • Differences in contamination rates between pharmacists and technicians highlight the importance of training and technique.
    • Minimizing touch contamination is critical for reducing microbial contamination in sterile compounding environments.