eecton Dickinson Manufacturing Process Specification Title: Vi er Neutralization Buffer
Effective: Upon ECO Release
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PURPOSE
Procedure No Pagel of 8
Batch No
Date:
following conditions: This document describes the Gravimetric manufacture of Viper Neutralization Buffer
Rea
ent
Bicine GI cerol DMSO Proclin Tween 20
Concentration 251.0mM 17.1% 19.62% 0.03% 0.01%
The Formulation Contained within this document shall be for a Batch Size of ! ?.1:1 SCOPE Molecular Diagnostics- Viper SP 2.1 SAP: Autorelease; RC: To File Only .0 WARNINGS, PRECAUTIONS, AND CRITICAL TIME FRAMES 3.1 All equipment and reagents used for the manufacture of this reagent sho this purpose and must never come in contact with Target DNA. 3.2 Prepare this mixture only in areas designated Target-Free and Amplico 3.3 This preparation contains DMSO. Exercise caution. Refer to the MSC 3.4 Explanation of the calculations found within this document. Bicine: 0.251M*163.2g/mL*Batch Size (L) = weight of Bicine Regur cl7p im1_1111
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