Microbiology Methods for ERP Review 3-2020

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Ben Bastin (Study contact)

Q Laboratories

1930 Radcliff Drive

Cincinnati, Ohio 45204

Email: bbastin@qlaboratories.com

2.0 8 9 A total of 14–16 collaborators will be solicited to participate in this study. A minimum of 10 valid 10 laboratory data sets are required to successfully complete the study. Each collaborator will receive 11 instructions for performing the study (Appendix 10.1) and required materials prior to the start of the 12 study. Training on the DS2 Instrument and the Solus One Salmonella method will be provided as 13 necessary. 16 17 A collaborative study will be conducted in accordance with the AOAC INTERNATIONAL Methods 18 Committee Guidelines for Validation of Microbiological Methods for Food and Environmental Surfaces 19 (2). The Solus One Salmonella method will be compared to the FDA BAM Chapter 5 reference method 20 for the detection of Salmonella in 375 g instant NFDM. A proprietary enrichment will be used for the 21 Solus method, so this study will be conducted as an unpaired study. 22 23 The instant NFDM will be screened for the presence of naturally contaminating Salmonella and total 24 aerobic plate count ( note : for the FDA BAM method, if the level of background microflora is > 10 4 cfu/g, 25 then the tetrathionate (TT) broth must be incubated at 43 ± 0.2°C in a circulating, thermostatically ‐ 26 controlled, water bath, and if the level is ≤ 10 4 cfu/g, then TT should be incubated at 35 ± 2.0°C). 27 Naturally contaminated matrix is preferred if available. If naturally contaminated matrix is not available, 28 artificially contaminated matrix will be prepared. It is anticipated that artificial contamination will be 29 required for the instant NFDM. The matrix will be divided into 3 test materials. One test material 30 remains non ‐ inoculated and serves as the uncontaminated level, one test material is contaminated at a 31 level that will produce a reference method POD (POD R ) or candidate method POD (POD C ) in the range of 32 0.25–0.75 (approximately 0.2–2 CFU/test portion), and finally one test material is contaminated at a 33 level to assure a POD C of nearly 1.0 (approximately 5–10 CFU/test portion). Twelve replicate test 34 portions per material will be tested by the candidate method (36 test portions) and the reference 35 method (36 test portions). 36 37 On the day that the analysis of the test samples is initiated, a 5 ‐ tube 3 ‐ level Most Probably Number 38 (MPN) estimation of contamination levels will be conducted using the FDA BAM reference method. The 39 MPN analysis scheme may also make use of the reference method replicates (see Appendix J, Annex A of 40 the AOAC Guidelines for details). The Least Cost Formulations, Ltd. (LCF) MPN Calculator ‐ Version 1.6 (3) 41 Collaborators 14 15 3.0 Study Design

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