Performance Comparison of Rapid Petrifilm™ Test Methods vs. Conventional Test Methods for Microbiological Testing of Dietary Supplements

Abstract

Abstract Objectives The aim of this study is to show suitability of 3M™ Petrifilm™ across various types of common multi ingredient finished dietary supplement products. Methods In present investigation, parallel analysis and suitability was conducted using gold standard methods prescribed under U.S. Pharmacopeia general chapter dietary supplement ⟨2021⟩/⟨2022⟩, US FDA's Bacteriological Analytical Manual (BAM), and AOAC using 3M™ Petrifilm™. Five commonly used tests in food and dietary supplement quality testing were deployed in this study, namely: Total Aerobic Microbial Count (TAMC), Total Yeast and Mold Count (TYMC), Escherichia coli, Staphylococcus aureus, and Coliforms. Dietary supplements selected for this investigation are from most common types of dietary supplements categories sold in US market i.e., multivitamin and mineral, protein, multi mineral, Prenatal, Vitamin D, and Omega 3 Fish oil. Three individual lots of each of the five products were tested to increase robustness of data. Acceptance criteria was set same as USP ⟨2021⟩/⟨2022⟩ requirements, that is to demonstrate a greater than 70% recovery in comparison to a control. Results AOAC using 3M™ Petrifilm™ results show recovery of >70% compared to control for all five test Total Aerobic Microbial Count (TAMC), Total Yeast and Mold Count (TYMC), Escherichia coli, Staphylococcus aureus, and Coliforms: Multivitamin and mineral product recovery ranges were between 79%–111%, Protein product recovery ranges were between 94%–104%, Multi mineral product recovery ranges were between 94%–107%, Prenatal product recovery ranges were between 74%–117%, Vitamin D product recovery ranges were between 93%–123%, and Omega 3 fish oil product recovery ranges were between 83%–101%. Conclusions We found that AOAC based 3M™ Petrifilm™ methods are suitable for selected major categories of dietary supplement finished products. All results from AOAC using 3M™ Petrifilm™ microbiological testing achieved >70% bioburden recovery in comparison to a control. We also found that AOAC using 3M™ Petrifilm™ provides consistent and comparable results to USP ⟨2021⟩/⟨2022⟩/FDA's BAM results for the same samples as well. Funding Sources Reliance Vitamin.