P3-74 Validation of MilliporeSigma MAS-100® VF Active Air Sampler to Support Preparation of an Environmental Monitoring Program for FSMA Compliance

Wednesday, August 3, 2016
America's Center - St. Louis
Lisa John, Merck KGaA, Darmstadt, Germany
Thierry Muller, Merck KGaA, Molsheim, France
Tony Ancrum, Merck KGaA, Darmstadt, Germany
Charlotte Lindhardt, Merck KGaA, Darmstadt, Germany
Regina Petrasch, Merck KGaA, Darmstadt, Germany
Introduction: The Food Safety Modernization Act (FSMA) requires an Environmental Monitoring Program to be incorporated into the Food Safety Plan (FSP) if environmental air comes into contact with food during processing. The testing method must produce repeatable and reproducible results. Active air samplers can meet this criteria by producing good biological and physical efficiencies. Product testing according to ISO 14698-1:2003 Annex B guideline also ensures reliable fulfillment of this requirement.

Purpose: To evaluate the active air sampler performance according to ISO 14698-1:2003 Annex B guideline.

Methods: Study was conducted by an independent expert public laboratory, using Trypticase Soy agar ICR+ media plates on tested and reference systems. Physical efficiency: Bacillus atrophaeus spores in Potassium Iodide (KI) solutions were aerosolized and sampled. KI concentration (0 to 7% (w/v)) determined average particles size in a range of 1 µm to 6 µm mass mean diameter. Result expressed as recovery percentage of colonies counted on tested system versus reference membrane impaction air sampler. Biological efficiency: mixed suspensions of B. atrophaeus (BA) spores and Staphylococcus epidermidis (SE) cells were aerosolized and sampled. Result expressed as recovery percentage of counted colonies ratio SE/BA sampled by the active air sampler versus the ratio obtained on the reference Casella slit sampler.

Results: Physical efficiency (ten repeats per size): 84.2±14.8% at 1 µm mass mean diameter, 85.8±11.2% at 1.3 µm, 94.2±10.9% at 2.2 µm and 99.7±9.7% at 5.4 µm. Biological efficiency (twenty repeats): 76.48±26.42%.

Significance: Physical efficiency indicates high recoveries at all sizes. Biological efficiency indicates effectiveness at sampling cells without significant loss of viability. Results demonstrate that the MAS-100 VF is an efficient solution for capturing bacteria-laden air particles repeatably and reproducibly, and could be incorporated into the Environmental Monitoring Program of the FSMA Food Safety Plan for reliable environmental air sampling.