ASTM F1608 Standard Test Method for Microbial Ranking of Porous Packaging Materials ( Exposure Chamber Method). Agenda • Basic overview of the test method • Proposed changes for the future. Microbial Ranking Test - ASTM F1608 Determines the Log Reduction Value (LRV) of porous material Packages placed into Sample size must be Filters are blended a chamber and a minimum of 47mm and plated to exposed to a specific in width determine titer values organism (Bacillus) Copyright Nelson Laboratories 2014 3 How it works.. Microbial Ranking Test Copyright Nelson Laboratories 2012 9 Supplies • • • • • 55 Soybean Casein Digest Agar Plates 500 mL Soybean Casein Digest Broth 1000 mL Sterile Water 7 (0.45 um) Nitrocellulose filters Plating equipment 3 key proposed changes 1) Equipment availability 2) Chamber evacuation process. 3) Titration methods 1) Standard equipment issue… • DeVilbiss #40 Nebulizer no longer available. 2) Exposure chamber evacuation “After exposure, turn off the vacuum, and the fan. Evacuate the chamber for 15 min by connecting the vacuum source to the chamber through a microbial filter assembly” 3) Titration methods 0.6 Weight Meltblown Reference Material Tyvek 0.45µm Pre-sterilized Filters Extraction Method Blended Vortex (10-1 Only) Vortex including Direct Plating Blended Vortex Blended Vortex Standard Deviation 0.8 0.6 0.6 0.2 0.2 0.2 0.1 Reproducibility 2.2 1.8 1.6 0.7 0.6 0.5 0.4 Thank you
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