Comparative analysis of moisture vapor transmission rate data: MOCON vs. USP

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Title: Comparative analysis of moisture vapor transmission rate data: MOCON vs. USP
Author: Maiola, Anthony
Abstract: The primary objective of this study was to directly compare two distinctly diverse package moisture permeation test methods. The two methods that were compared were the USP <671> Containers Permeation: Single Unit Container and Unit Dose Containers for Capsules and Tablets and the MOCON Modulated Infrared Sensor Method (ASTM F 1249). The tests generate a value known as an MVTR (Moisture Vapor Transmission Rate) value. The focus of this study was to determine whether there is a significant statistical difference between results of the two methods, specifically for unit dose blister packaging. Since MVTR is a package integrity characteristic, it is particularly important to the pharmaceutical industry because of the FDA regulations that govern packaging materials and components. After four different pharmaceutical grade packaging materials were evaluated and analyzed, the statistical results show that there is a significant difference between the two test methods. However it was discovered that due to lack of sensitivity of testing equipment, the statistical data analysis might be suspect.
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Date: 2000

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