AOAC ERP MICRO AUGUST 2018

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

Pre-collaborative and Collaborative Report Peel Plate EB

Table 10- Quality Control of 3 lots of Peel Plate EB Lot Number Date of Manufacture Sterility Check # positive/#tested

Accelerated Test

Check P a from VRBAG

One year 25C Stress Test

VBR 0.33 0.29 0.35

PL

PP-EB-009 Dec 20 2016 PP-EB-010 Jan 16 2016 PP-EB-011 Mar 8 2018

0/36 0/30 0/24

Pass Pass Pass

0.24

July 2018

0.35 August 2018

0.32 Oct. 2018 a T-test probability (P) of being statistically the same. Specification is greater than 0.01 Value is average of 3 EB strains compared. VBR-Reference method VBRA comparison; PL-previous Peel Plate EB comparison.

ERP Use Only

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