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Related Experiment Videos

Using medium-fill simulation to establish a benchmark microbiological contamination rate for low-risk-level

Lawrence A Trissel1, Abayomi B Ogundele, Delshalonda S Ingram

  • 1Division of Pharmacy, Box 90, University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030, USA.

American Journal of Health-System Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists
|October 3, 2003
PubMed
Summary

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A benchmark study found that aseptic compounding of prefilled syringes using a medium-fill simulation had a contamination rate below 0.1%. This indicates that sterile injection preparations can achieve low contamination rates when pharmacies validate their processes.

Area of Science:

  • Pharmaceutical Compounding
  • Sterile Preparation Validation
  • Microbial Contamination Control

Background:

  • Establishing benchmark contamination rates is crucial for ensuring the safety of sterile pharmaceutical preparations.
  • Prefilled syringes are commonly used, necessitating reliable aseptic compounding techniques.
  • Current methods for assessing contamination in compounding require validation.

Purpose of the Study:

  • To determine a benchmark contamination rate for aseptic compounding of prefilled syringes.
  • To validate a medium-fill simulation method for detecting microbial contamination.
  • To establish an expected contamination rate for low-risk pharmacy preparations.

Main Methods:

  • Aseptic filling of 1035 sterile 1-mL tuberculin syringes with soybean-casein digest medium.

Related Experiment Videos

  • Incubation of filled syringes at 35°C for seven days to detect bacterial growth.
  • Validation of the methodology using deliberately contaminated syringes to confirm detection accuracy.

    • Main Results:

    • No bacterial growth was detected in any of the 1035 aseptically filled medium-fill syringes.
    • The medium-fill simulation method successfully differentiated between contaminated and uncontaminated syringes.
    • The contamination rate for the aseptic compounding operation was determined to be less than 0.1%.

    Conclusions:

    • A contamination rate below 0.1% is achievable and expected for low-risk prefilled syringe compounding.
    • The medium-fill simulation is a valid method for assessing aseptic compounding processes.
    • Pharmacies should validate their compounding operations to ensure low contamination rates.