AOAC ERP MICRO AUGUST 2018

OMAMAN-44 A: Collaborative Study Manuscript Expert Review Panel Use Only August 2018

504

of means values indicated that the candidate method produced similar results (< 0.10 Log 10

) between

the 24 h and 48 h incubation time points indicating that either time point is acceptable for use. Based on 505

the data presented, the reproducibility values obtained for all contamination levels were generally 506

similar between the candidate and reference methods, indicating that both the between-laboratory 507

variations and within-laboratory variations were consistent between the candidate and reference 508

method. These values indicate that for reproducibility, no meaningful statistical differences (absolute 509

510

) were observed in the data between the candidate and reference methods when

value of <0.50 Log 10

test portions were analyzed by different analysts at each laboratory or within each sample set at a given 511

512

laboratory .

513

514

Product Consistency (lot-to-lot) and Stability Studies

515

516

Peel Plate EB are quality tested after manufacture following the Charm Sciences, Inc. quality control

documents which are part of the quality management system, QMS just recently certified under the ISO 517

9001 (2015) system. Encompassed in the quality control evaluation are random collection of QC samples 518

throughout the aseptic production, 2 tests per every 50 manufactured. These are put through a series 519

520

of evaluations.

521

Sterility checks call for 60 tests per lot, where a lot encompasses a week’s production. Tests are

rehydrated with 1 mL sterile water and incubated 72 h. There are to be no detected Enterobacteriaceae 522 ERP Use Only in any of the tests, and if one or more are detected an additional 200 tests performed with less than 1% 523 containing 1 Enterobacteriaceae or less. 524 Performance checks are performed in comparison to VRBAG reference method using comparing 525

n=10 test pairs of various Enterobacteriaceae strains. Additionally naturally EB contaminated chicken 526

samples have been added to verify both exclusion and selection of EB with verification of detected 527

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