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Related Experiment Videos

Method for testing the sterility of total nutrient admixtures.

J W Levchuk1, R J Nolly, N Lander

  • 1Department of Pharmaceutics, University of Tennessee, Memphis 38163.

American Journal of Hospital Pharmacy
|June 1, 1988
PubMed
Summary

A new sterility test for total nutrient admixtures (TNA) using USP membrane filtration was developed. This method is effective for hospital pharmacists, though specific evaluations are needed for different fat emulsions.

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Area of Science:

  • Pharmaceutical Science
  • Microbiology
  • Quality Control

Background:

  • Total nutrient admixtures (TNA) require reliable sterility testing.
  • Existing methods may not be suitable for complex TNA formulations containing fat emulsions.

Purpose of the Study:

  • To develop and evaluate a sterility test for TNAs using the United States Pharmacopeia (USP) membrane filtration procedure.
  • To assess the suitability of different membrane filters and optimize the testing process.

Main Methods:

  • Evaluated polyvinylidene fluoride (PVDF) membranes for flow rate, compatibility, and stability.
  • Performed microbial challenges with five organisms using standard culture media.
  • Developed a peptone rinse technique to mitigate TNA-induced media haziness.

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Main Results:

  • PVDF membranes demonstrated superior performance for TNA filtration.
  • The developed method effectively detected low-level microbial contamination.
  • A 0.1% peptone rinse and careful observation minimized false-positive results.
  • Average test time for hospital pharmacists was 14.2 minutes.

Conclusions:

  • The USP membrane filtration procedure is adaptable for hospital pharmacists to test TNA sterility.
  • Specific sterility test evaluations are necessary for TNAs compounded with different fat emulsion products.